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FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997
(Senate - September 11, 1997)

Text of this article available as: TXT PDF [Pages S9133-S9157] FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997 The PRESIDING OFFICER. The clerk will report the bill. The legislative clerk read as follows: A bill (S. 830) to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes, which had been reported from to the Committee on Labor and Human Resources, with an amendment to strike all after the enacting clause and inserting in lieu thereof the following: SECTION 1. SHORT TITLE. This Act may be cited as the ``Food and Drug Administration Modernization and Accountability Act of 1997''. SEC. 2. TABLE OF CONTENTS. The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. References. TITLE I--IMPROVING PATIENT ACCESS Sec. 101. Mission of the Food and Drug Administration. Sec. 102. Expedited access to investigational therapies. Sec. 103. Expanded humanitarian use of devices. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES Sec. 201. Interagency collaboration. Sec. 202. Sense of the committee regarding mutual recognition agreements and global harmonization efforts. Sec. 203. Contracts for expert review. Sec. 204. Accredited-party reviews. Sec. 205. Device performance standards. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION Sec. 301. Collaborative determinations of device data requirements. Sec. 302. Collaborative review process. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES Sec. 401. Policy statements. Sec. 402. Product classification. Sec. 403. Use of data relating to premarket approval. Sec. 404. Consideration of labeling claims for product review. [[Page S9134]] Sec. 405. Definition of a day for purposes of product review. Sec. 406. Certainty of review timeframes. Sec. 407. Limitations on initial classification determinations. Sec. 408. Clarification with respect to a general use and specific use of a device. Sec. 409. Clarification of the number of required clinical investigations for approval. Sec. 410. Prohibited acts. TITLE V--IMPROVING ACCOUNTABILITY Sec. 501. Agency plan for statutory compliance and annual report. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES Sec. 601. Minor modifications. Sec. 602. Environmental impact review. Sec. 603. Exemption of certain classes of devices from premarket notification requirement. Sec. 604. Evaluation of automatic class III designation. Sec. 605. Secretary's discretion to track devices. Sec. 606. Secretary's discretion to conduct postmarket surveillance. Sec. 607. Reporting. Sec. 608. Pilot and small-scale manufacture. Sec. 609. Requirements for radiopharmaceuticals. Sec. 610. Modernization of regulation of biological products. Sec. 611. Approval of supplemental applications for approved products. Sec. 612. Health care economic information. Sec. 613. Expediting study and approval of fast track drugs. Sec. 614. Manufacturing changes for drugs and biologics. Sec. 615. Data requirements for drugs and biologics. Sec. 616. Food contact substances. Sec. 617. Health claims for food products. Sec. 618. Pediatric studies marketing exclusivity. Sec. 619. Positron emission tomography. TITLE VII--FEES RELATING TO DRUGS Sec. 701. Short title. Sec. 702. Findings. Sec. 703. Definitions. Sec. 704. Authority to assess and use drug fees. Sec. 705. Annual reports. Sec. 706. Effective date. Sec. 707. Termination of effectiveness. TITLE VIII--MISCELLANEOUS Sec. 801. Registration of foreign establishments. Sec. 802. Elimination of certain labeling requirements. Sec. 803. Clarification of seizure authority. Sec. 804. Intramural research training award program. Sec. 805. Device samples. Sec. 806. Interstate commerce. Sec. 807. National uniformity for nonprescription drugs and cosmetics. Sec. 808. Information program on clinical trials for serious or life- threatening diseases. Sec. 809. Application of Federal law to the practice of pharmacy compounding. SEC. 3. REFERENCES. Except as otherwise expressly provided, wherever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). TITLE I--IMPROVING PATIENT ACCESS SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION. Section 903 (21 U.S.C. 393) is amended-- (1) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (2) by inserting after subsection (a) the following: ``(b) Mission.-- ``(1) In general.--The Administration shall protect the public health by ensuring that-- ``(A) foods are safe, wholesome, sanitary, and properly labeled; ``(B) human and veterinary drugs are safe and effective; ``(C) there is reasonable assurance of safety and effectiveness of devices intended for human use; ``(D) cosmetics are safe; and ``(E) public health and safety are protected from electronic product radiation. ``(2) Special rules.--The Administration shall promptly and efficiently review clinical research and take appropriate action on the marketing of regulated products in a manner that does not unduly impede innovation or product availability. The Administration shall participate with other countries to reduce the burden of regulation, to harmonize regulatory requirements, and to achieve appropriate reciprocal arrangements with other countries.''. SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES. Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``Subchapter D--Unapproved Therapies and Diagnostics ``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS. ``(a) In General.--Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may provide to a person after compliance with the provisions of this section, an investigational drug (including a biological product) or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition, or any other disease or condition designated by the Secretary as appropriate for expanded access under this section if-- ``(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved; ``(2) the licensed physician determines that the risk to the person from the investigational drug or investigational device is not greater than the risk from the disease or condition; ``(3) the Secretary determines that an exemption for the investigational drug or investigational device is in effect under a regulation promulgated pursuant to section 505(i) or 520(g) and the sponsor of the drug or device and investigators comply with such regulation; ``(4) the Secretary determines that the manufacturer of the investigational drug or investigational device is actively pursuing marketing approval with due diligence; ``(5) the Secretary determines that expanded access to the investigational drug or investigational device will not interfere with adequate enrollment of patients by the investigator in the ongoing clinical investigation of the investigational drug or investigational device authorized under section 505(i) or 520(g); and ``(6) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the expanded use of the investigational drug or investigational device in accordance with this section. ``(b) Protocols.--A manufacturer or distributor may submit to the Secretary 1 or more expanded access protocols covering expanded access use of a drug or device described in subsection (a). The protocols shall be subject to the provisions of section 505(i) or 520(g) and may include any form of use of the drug or device outside a clinical investigation, prior to approval of the drug or device for marketing, including protocols for treatment use, emergency use, or uncontrolled trials, and single patient protocols. If the request for expanded access to an investigational drug or investigational device is intended for a single patient only, the Secretary may waive the requirements of paragraphs (3) and (4) of subsection (a) and accept a submission under section 505(i) or 520(g) for an exemption for the investigational drug or investigational device for the single patient use. In the case of an emergency that does not allow sufficient time for a submission under section 505(i) or 520(g), the Secretary may, prior to the submission, authorize the shipment of the investigational drug or investigational device for a single patient use. ``(c) Notification of Availability.--The Secretary shall inform national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this section, except that this subsection shall not apply to expanded access protocols for single patient use. ``(d) Termination.--The Secretary may at anytime terminate expanded access provided under subsection (a) for an investigational drug or investigational device if the requirements under this section are no longer met.''. SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES. Section 520(m) (21 U.S.C. 360j(m)) is amended-- (1) in paragraph (2), by adding at the end the following flush sentences: ``The request shall be in the form of an application submitted to the Secretary. Not later than 60 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.''; (2) in paragraph (4)-- (A) in subparagraph (B), by inserting after ``(2)(A)'' the following: ``, unless a physician determines that waiting for such an approval from an institutional review committee will cause harm or death to a patient, and makes a good faith effort to obtain the approval, and does not receive a timely response from an institutional review committee on the request of the physician for approval to use the device for such treatment or diagnosis''; and (B) by adding at the end the following flush sentences: ``In a case in which a physician described in subparagraph (B) uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.''; and (3) by striking paragraph (5) and inserting the following: ``(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met.''. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES SEC. 201. INTERAGENCY COLLABORATION. Section 903(b) (21 U.S.C. 393(b)), as added by section 101(2), is amended by adding at the end the following: ``(3) Interagency collaboration.--The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.''. [[Page S9135]] SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS. It is the sense of the Committee on Labor and Human Resources of the Senate that-- (1) the Secretary of Health and Human Services should support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States; (2) the Secretary of Health and Human Services should regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements; and (3) the Office of International Relations of the Department of Health and Human Services (as established under section 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383)) should have the responsibility of ensuring that the process of harmonizing international regulatory requirements is continuous. SEC. 203. CONTRACTS FOR EXPERT REVIEW. Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end the following: ``SEC. 906. CONTRACTS FOR EXPERT REVIEW. ``(a) In General.-- ``(1) Authority.--The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with expertise in a relevant discipline, to review, evaluate, and make recommendations to the Secretary on part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 708 relating to the confidentiality of information. ``(2) Increased efficiency and expertise through contracts.--The Secretary shall use the authority granted in paragraph (1) whenever the Secretary determines that a contract described in paragraph (1) will improve the timeliness or quality of the review of an application or submission described in paragraph (1). Such improvement may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies. ``(b) Review of Expert Review.-- ``(1) In general.--Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter within 60 days after receiving the recommendations. ``(2) Limitation.--A final decision under paragraph (1) shall be made within the applicable prescribed time period for review of the matter as set forth in this Act or in the Public Health Service Act (42 U.S.C. 201 et seq.). ``(3) Authority of secretary.--Notwithstanding subsection (a), the Secretary shall retain full authority to make determinations with respect to the approval or disapproval of an article under this Act, the approval or disapproval of a biologics license with respect to a biological product under section 351(a) of the Public Health Service Act, or the classification of an article as a device under section 513(f)(1).''. SEC. 204. ACCREDITED-PARTY REVIEWS. Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``SEC. 523. ACCREDITED-PARTY PARTICIPATION. ``(a) Accreditation.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall accredit entities or individuals who are not employees of the Federal Government, to review reports made to the Secretary under section 510(k) for devices and make recommendations to the Secretary regarding the initial classification of such devices under section 513(f)(1), except that this paragraph shall not apply to reports made to the Secretary under section 510(k) for devices that are-- ``(A) life-supporting; ``(B) life sustaining; or ``(C) intended for implantation in the human body for a period of over 1 year. ``(2) Special rule.--The Secretary shall have the discretion to accredit entities or individuals who are not employees of the Federal Government-- ``(A) to review reports made to the Secretary under section 510(k) for devices described in subparagraphs (A) through (C) of paragraph (1), and make recommendations of initial classification of such devices; or ``(B) to review applications for premarket approval for class III devices under section 515 and make recommendations with respect to the approval or disapproval of such applications. ``(b) Accreditation.--Within 180 days after the date of enactment of this section, the Secretary shall adopt methods of accreditation that ensure that entities or individuals who conduct reviews and make recommendations under this section are qualified, properly trained, knowledgeable about handling confidential documents and information, and free of conflicts of interest. The Secretary shall publish the methods of accreditation in the Federal Register on the adoption of the methods. ``(c) Withdrawal of Accreditation.--The Secretary may suspend or withdraw the accreditation of any entity or individual accredited under this section, after providing notice and an opportunity for an informal hearing, if such entity or individual acts in a manner that is substantially not in compliance with the requirements established by the Secretary under subsection (b), including the failure to avoid conflicts of interest, the failure to protect confidentiality of information, or the failure to competently review premarket submissions for devices. ``(d) Selection and Compensation.--Subject to subsection (a)(2), a person who intends to make a report described in subsection (a), or to submit an application described in subsection (a), to the Secretary shall have the option to select an accredited entity or individual to review such report or application. Upon the request by a person to have a report or application reviewed by an accredited entity or individual, the Secretary shall identify for the person no less than 2 accredited entities or individuals from whom the selection may be made. Compensation for an accredited entity or individual shall be determined by agreement between the accredited entity or individual and the person who engages the services of the accredited entity or individual and shall be paid by the person who engages such services. ``(e) Review by Secretary.-- ``(1) In general.--The Secretary shall require an accredited entity or individual, upon making a recommendation under this section with respect to an initial classification of a device or approval or disapproval of an application for premarket approval, to notify the Secretary in writing of the reasons for such recommendation. ``(2) Time period for review.-- ``(A) Initial classification.--Not later than 30 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. ``(B) Premarket approval.--Not later than 60 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an approval or disapproval of an application for a device, the Secretary shall make a determination with respect to the approval or disapproval. ``(3) Special rule.--The Secretary may change the initial classification under section 513(f)(1), or the approval or disapproval of the application under section 515(d), that is recommended by the accredited entity or individual under this section, and in such case shall notify in writing the person making the report or application described in subsection (a) of the detailed reasons for the change. ``(f) Duration.--The authority provided by this section terminates-- ``(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) are available to review devices for each of at least 70 percent of the generic types of devices subject to review under subsection (a); or ``(2) 4 years after the date on which the Secretary notifies Congress that at least 35 percent of the devices that are subject to review under subsection (a), and that were the subject of final action by the Secretary in the fiscal year preceding the date of such notification, were reviewed by the Secretary under subsection (e), whichever occurs first. ``(g) Report.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall contract with an independent research organization to prepare and submit to the Secretary a written report examining the use of accredited entities and individuals to conduct reviews under this section. The Secretary shall submit the report to Congress not later than 6 months prior to the conclusion of the applicable period described in subsection (f). ``(2) Contents.--The report by the independent research organization described in paragraph (1) shall identify the benefits or detriments to public and patient health of using accredited entities and individuals to conduct such reviews, and shall summarize all relevant data, including data on the review of accredited entities and individuals (including data on the review times, recommendations, and compensation of the entities and individuals), and data on the review of the Secretary (including data on the review times, changes, and reasons for changes of the Secretary).''. SEC. 205. DEVICE PERFORMANCE STANDARDS. (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended by adding at the end the following: ``Recognition of a Standard ``(c)(1)(A) In addition to establishing performance standards under this section, the Secretary may, by publication in the Federal Register, recognize all or part of a performance standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet premarket submission requirements or other requirements under this Act to which such standards are applicable. ``(B) If a person elects to use a performance standard recognized by the Secretary under subparagraph (A) to meet the requirements described in subparagraph (A), the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to fulfill or satisfy any requirement under this Act. ``(2) The Secretary may withdraw such recognition of a performance standard through publication of a notice in the Federal Register that the Secretary will no longer recognize the [[Page S9136]] standard, if the Secretary determines that the standard is no longer appropriate for meeting the requirements under this Act. ``(3)(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds-- ``(i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or ``(ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review. ``(B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1). ``(C) A person relying on a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of 2 years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.''. (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding at the end the following: ``(x) The falsification of a declaration of conformity submitted under subsection (c) of section 514 or the failure or refusal to provide data or information requested by the Secretary under section 514(c)(3).''. (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended-- (1) by striking ``(e)'' and inserting ``(e)(1)''; and (2) by inserting at the end the following: ``(2) If it is, declared to be, purports to be, or is represented as, a device that is in conformity with any performance standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.''. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA REQUIREMENTS. Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding at the end the following: ``(C)(i)(I) The Secretary, upon the written request of any person intending to submit an application under section 515, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate the effectiveness of a device for the conditions of use proposed by such person, to support an approval of an application. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, and, if available, information regarding the expected performance from the device. Within 30 days after such meeting, the Secretary shall specify in writing the type of valid scientific evidence that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person. ``(II) Any clinical data, including 1 or more well- controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary-- ``(aa) that such data are necessary to establish device effectiveness; and ``(bb) that no other less burdensome means of evaluating device effectiveness is available that would have a reasonable likelihood of resulting in an approval. ``(ii) The determination of the Secretary with respect to the specification of valid scientific evidence under clause (i) shall be binding upon the Secretary, unless-- ``(I) such determination by the Secretary would be contrary to the public health; or ``(II) based on new information (other than the information reviewed by the Secretary in making such determination) obtained by the Secretary prior to the approval of an application for an investigational device exemption under section 520(g), the Secretary finds that such determination is scientifically inappropriate.''. SEC. 302. COLLABORATIVE REVIEW PROCESS. Section 515(d) (21 U.S.C. 360e(d)) is amended-- (1) in paragraph (1)(A), by striking ``paragraph (2) of this subsection'' each place it appears and inserting ``paragraph (4)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A)(i) The Secretary shall, upon the written request of the applicant involved, meet with the applicant not later than 100 days after the receipt of an application, from the applicant, that has been filed as complete under subsection (c), to discuss the review status of the application. ``(ii) If the application does not appear in a form that would require an approval under this subsection, the Secretary shall in writing, and prior to the meeting, provide to the applicant a description of any deficiencies in the application identified by the Secretary and identify the information (other than information the Secretary needs to make a finding under paragraph (4)(C)) that is required to bring the application into an approvable form. ``(iii) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph. ``(B) The Secretary shall notify the applicant immediately of any deficiency identified in the application that was not described as a deficiency in the written description provided by the Secretary under subparagraph (A).''. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES SEC. 401. POLICY STATEMENTS. Section 701(a) (21 U.S.C. 371(a)) is amended-- (1) by striking ``(a) The'' and inserting ``(a)(1) The''; and (2) by adding at the end the following: ``(2) Not later than February 27, 1999, the Secretary, after evaluating the effectiveness of the Good Guidance Practices document published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.''. SEC. 402. PRODUCT CLASSIFICATION. Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end the following: ``Subchapter D--Classification of Products and Environmental Impact Reviews ``SEC. 741. CLASSIFICATION OF PRODUCTS. ``(a) Request.--A person who submits an application or submission (including a petition, notification, and any other similar form of request) under this Act, may submit a request to the Secretary respecting the classification of an article (including an article that is a combination product subject to section 503(g)) as a drug, biological product, or device, or respecting the component of the Food and Drug Administration that will regulate the article. In submitting the request, the person shall recommend a classification for the article, or a component to regulate the article, as appropriate. ``(b) Statement.--Not later than 60 days after the receipt of the request described in subsection (a), the Secretary shall determine the classification of the article or the component of the Food and Drug Administration that will regulate the article and shall provide to the person a written statement that identifies the classification of the article or the component of the Food and Drug Administration that will regulate the article and the reasons for such determination. The Secretary may not modify such statement except with the written consent of the person or for public health reasons. ``(c) Inaction of Secretary.--If the Secretary does not provide the statement within the 60-day period described in subsection (b), the recommendation made by the person under subsection (a) shall be considered to be a final determination by the Secretary of the classification of the article or the component of the Food and Drug Administration that will regulate the article and may not be modified by the Secretary except with the written consent of the person or for public health reasons.''. SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL. (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows: ``(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in-- ``(i) approving another device; ``(ii) determining whether a product development protocol has been completed, under section 515 for another device; ``(iii) establishing a performance standard or special control under this Act; or ``(iv) classifying or reclassifying another device under section 513 and subsection (l)(2). ``(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency action described in subparagraph (A).''. (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 360g(a)) is amended-- (1) in paragraph (8), by adding ``or'' at the end; (2) in paragraph (9), by striking ``, or'' and inserting a comma; and (3) by striking paragraph (10). SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT REVIEW. (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 360e(d)(1)(A)) is amended by adding at the end the following flush sentences: ``In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.''. (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is amended by adding at the end the following: ``(C) Whenever the Secretary requests information to demonstrate that the devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to make a substantial equivalence determination. In making such a request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and shall request information accordingly. ``(D) The determinations of the Secretary under this section and section 513(f)(1) with respect to the intended use of a device shall be based on the intended use included in proposed labeling of the device submitted in a report under section 510(k).''. [[Page S9137]] SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: ``(ii) In any provision relating to a review of any application or submission (including a petition, notification, and any other similar form of request), made under this Act with respect to an article that is a new drug, device, biological product, new animal drug, an animal feed bearing or containing a new animal drug, color additive, or food additive, that is submitted to the Secretary to obtain marketing approval, to obtain classification of a device under section 513(f)(1), or to establish or clarify the regulatory status of the article-- ``(1) the term `day' means a calendar day in which the Secretary has responsibility to review such an application or submission; and ``(2) a reference to a date relating to the receipt of such an application or submission by the Secretary shall be deemed to be a reference to the date on which the Secretary receives a complete application or submission within the meaning of this Act and the regulations promulgated under this Act.''. SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES. (a) Clarification on the 90-Day Timeframe for Premarket Notification Reviews.--Section 510(k) (21 U.S.C. 360) is amended by adding at the end the following flush sentence: ``The Secretary shall review the notification required by this subsection and make a determination under section 513(f)(1) not later than 90 days after receiving the notification.''. (b) Certainty of 180-Day Review Timeframe.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is amended by inserting after paragraph (2) the following: ``(3) Except as provided in paragraph (1), the period for the review of an application by the Secretary under this subsection shall be not more than 180 days. Such period may not be restarted or extended even if the application is amended.''. SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION DETERMINATIONS. Section 510 (21 U.S.C. 360) is amended by adding at the end the following: ``(m) The Secretary may not withhold a determination of the initial classification of a device under section 513(f)(1) because of a failure to comply with any provision of this Act that is unrelated to a substantial equivalence decision, including a failure to comply with the requirements relating to good manufacturing practices under section 520(f).''. SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND SPECIFIC USE OF A DEVICE. Not later than 270 days after the date of enactment of this section, the Secretary of Health and Human Services shall promulgate a final regulation specifying the general principles that the Secretary of Health and Human Services will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)). SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL. (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking ``clinical investigations'' and inserting ``1 or more clinical investigations''. (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: ``Substantial evidence may, as appropriate, consist of data from 1 adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation), if the Secretary determines, based on relevant science, that such data and evidence are sufficient to establish effectiveness.''. SEC. 410. PROHIBITED ACTS. Section 301(l) (21 U.S.C. 331(l)) is repealed. TITLE V--IMPROVING ACCOUNTABILITY SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL REPORT. Section 903(b) (21 U.S.C. 393(b)), as amended by section 201, is further amended by adding at the end the following: ``(4) Agency plan for statutory compliance.-- ``(A) In general.--Not later than 180 days after the date of enactment of this paragraph, the Secretary, after consultation with relevant experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act and other relevant statutes. The Secretary shall biannually review the plan and shall revise the plan as necessary, in consultation with such persons. ``(B) Objectives of agency plan.--The plan required by subparagraph (A) shall establish objectives, and mechanisms to be used by the Secretary, acting through the Commissioner, including objectives and mechanisms that-- ``(i) minimize deaths of, and harm to, persons who use or may use an article regulated under this Act; ``(ii) maximize the clarity of, and the availability of information about, the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act, including information for potential consumers and patients concerning new products; ``(iii) implement all inspection and postmarket monitoring provisions of this Act by July 1, 1999; ``(iv) ensure access to the scientific and technical expertise necessary to ensure compliance by the Secretary with the statutory obligations described in subparagraph (A); ``(v) establish a schedule to bring the Administration into full compliance by July 1, 1999, with the time periods specified in this Act for the review of all applications and submissions described in clause (ii) and submitted after the date of enactment of this paragraph; and ``(vi) reduce backlogs in the review of all applications and submissions described in clause (ii) for any article with the objective of eliminating all backlogs in the review of the applications and submissions by January 1, 2000. ``(5) Annual report.-- ``(A) Contents.--The Secretary shall prepare and publish in the Federal Register and solicit public comment on an annual report that-- ``(i) provides detailed statistical information on the performance of the Secretary under the plan described in paragraph (4); ``(ii) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; ``(iii) analyzes any failure of the Secretary to achieve any objective of the plan or to meet any statutory obligation; ``(iv) identifies any regulatory policy that has a significant impact on compliance with any objective of the plan or any statutory obligation; and ``(v) sets forth any proposed revision to any such regulatory policy, or objective of the plan that has not been met. ``(B) Statistical information.--The statistical information described in subparagraph (A)(i) shall include a full statistical presentation relating to all applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act and approved or subject to final action by the Secretary during the year covered by the report. In preparing the statistical presentation, the Secretary shall take into account the date of-- ``(i) the submission of any investigational application; ``(ii) the application of any clinical hold; ``(iii) the submission of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for approval or clearance; ``(iv) the acceptance for filing of any application or submission described in clause (iii) for approval or clearance; ``(v) the occurrence of any unapprovable action; ``(vi) the occurrence of any approvable action; and ``(vii) the approval or clearance of any application or submission described in clause (iii).''. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES SEC. 601. MINOR MODIFICATIONS. (a) Action on Investigational Device Exemptions.--Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: ``(6)(A) The Secretary shall, not later than 120 days after the date of enactment of this paragraph, by regulation modify parts 812 and 813 of title 21, Code of Federal Regulations to update the procedures and conditions under which a device intended for human use may, upon application by the sponsor of the device, be granted an exemption from the requirements of this Act. ``(B) The regulation shall permit developmental changes in a device (including manufacturing changes) in response to information collected during an investigation without requiring an additional approval of an application for an investigational device exemption or the approval of a supplement to such application, if the sponsor of the investigation determines, based on credible information, prior to making any such changes, that the changes-- ``(i) do not affect the scientific soundness of an investigational plan submitted under paragraph (3)(A) or the rights, safety, or welfare of the human subjects involved in the investigation; and ``(ii) do not constitute a significant change in design, or a significant change in basic principles of operation, of the device.''. (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 360e(d)(1)(B)) is amended by adding at the end the following: ``(iii) The Secretary shall accept and review data and any other information from investigations conducted under the authority of regulations required by section 520(g), to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if-- ``(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or ``(II) the data or information relates to a device approved under this section, is available for use under this Act, and is relevant to the design and intended use of the device for which the application is pending.''. (c) Action on Supplements.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is further amended by adding at the end the following: ``(6)(A)(i) A supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 520(f). [[Page S9138]] ``(ii) The holder of an approved application who submits a notice under clause (i) with respect to a manufacturing change of a device shall not distribute the device for a period of 14 days after the date on which the Secretary receives the notice. ``(B)(i) Subject to clause (ii), in reviewing a supplement to an approved application, for an incremental change to the design of a device that affects safety or effectiveness, the Secretary shall approve such supplement if-- ``(I) nonclinical data demonstrate that the design modification creates the intended additional capacity, function, or performance of the device; and ``(II) clinical data from the approved application and any supplement to the approved application provide a reasonable assurance of safety and effectiveness for the changed device. ``(ii) The Secretary may require, when necessary, additional clinical data to evaluate the design modification to provide a reasonable assurance of safety and effectiveness.''. SEC. 602. ENVIRONMENTAL IMPACT REVIEW. Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is further amended by adding at the end the following: ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW. ``Notwithstanding any other provision of law, no action by the Secretary pursuant to this Act shall be subject to an environmental assessment, an environmental impact statement, or other environmental consideration unless the Secretary demonstrates, in writing-- ``(1) that there is a reasonable probability that the environmental impact of the action is sufficiently substantial and within the factors that the Secretary is authorized to consider under this Act; and ``(2) that consideration of the environmental impact will directly affect the decision on the action.''. SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM PREMARKET NOTIFICATION REQUIREMENT. (a) Class I and Class II Devices.--Section 510(k) (21 U.S.C. 360(k)) is amended by striking ``intended for human use'' and inserting ``intended for human use (except a device that is classified into class I under section 513 or 520 unless the Secretary determines such device is intended for a use that is of substantial importance in preventing impairment of human health or such device presents a potential unreasonable risk of illness or injury, or a device that is classified into class II under section 513 or 520 and is exempt from the requirements of this subsection under subsection (l))''. (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) is amended by inserting after subsection (k) the following: ``(l)(1) Not later than 30 days after the date of enactment of this subsection, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a notification under subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary not to require the notification shall be exempt from the requirement to provide notification under subsection (k) as of the date of the publication of the list in the Federal Register. ``(2) Beginning on the date that is 1 day after the date of the publication of a list under this subsection, the Secretary may exempt a class II device from the notification requirement of subsection (k), upon the Secretary's own initiative or a petition of an interested person, if the Secretary determines that such notification is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 30-day comment period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice.''. SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION. Section 513(f) (21 U.S.C. 360c(f)) is amended-- (1) in paragraph (1)-- (A) in subparagraph (B), by striking ``paragraph (2)'' and inserting ``paragraph (3)''; and (B) in the last sentence, by striking ``paragraph (2)'' and inserting ``paragraph (2) or (3)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A) Any person who submits a report under section 510(k) for a type of device that has not been previously classified under this Act, and that is classified into class III under paragraph (1), may request, within 30 days after receiving written notice of such a classification, the Secretary to classify the device into class I or II under the criteria set forth in subparagraphs (A) through (C) subsection (a)(1). The person may, in the request, recommend to the Secretary a classification for the device. The request shall describe the device and provide detailed information and reasons for the recommended classification. ``(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A) for classification of a device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1), the Secretary shall by written order classify the device. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph into class I or II shall be a predicate device for determining substantial equivalence under paragraph (1). ``(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 501(f)(1)(B) until approved under section 515 or exempted from such approval under section 520(g). ``(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.''. SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES. (a) Release of Information.--Section 519(e) (21 U.S.C. 360i(e)) is amended by adding at the end the following flush sentence: ``Any patient receiving a device subject to tracking under this section may refuse to release, or refuse permission to release, the patient's name, address, social security number, or other identifying information for the purpose of tracking.''. (b) Publication of Certain Devices.--Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall develop and publish in the Federal Register a list that identifies each type of device subject to tracking under section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each device not identified by the Secretary of Health and Human Services under this subsection or designated by the Secretary under section 519(e)(2) shall be deemed to be exempt from the mandatory tracking requirement under section 519 of such Act. The Secretary of Health and Human Services shall have authority to modify the list of devices exempted from the mandatory tracking requirements. SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET SURVEILLANCE. (a) In General.--Section 522 (21 U.S.C. 360l) is amended by striking ``Sec. 522.'' and all that follows through ``(2) Discretionary surveillance.--The'' and inserting the following: ``Sec. 522. (a) Discretionary Surveillance.--The''. (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 360l(b)) is amended to read as follows: ``(b) Surveillance Approval.-- ``(1) In general.--Each manufacturer that receives notice from the Secretary that the manufacturer is required to conduct surveillance of a device under subsection (a) shall, not later than 30 days after receiving the notice, submit for the approval of the Secretary, a plan for the required surveillance. ``(2) Determination.--Not later than 60 days after the receipt of the plan, the Secretary shall determine if a person proposed in the plan to conduct the surveillance has sufficient qualifications and experience to conduct the surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health and to provide safety and effectiveness information for the device. ``(3) Limitation on plan approval.--The Secretary may not approve the plan until the plan has been reviewed by a qualified scientific and technical review committee established by the Secretary.''. (c) Duration of Surveillance.--Section 522 (21 U.S.C. 360l), as amended by subsection (b), is further amended by adding at the end the following: ``(c) Duration of Surveillance.-- ``(1) In general.--Each manufacturer required to conduct surveillance of a device under subsection (a) shall be required to conduct such surveillance for not longer than 24 months. ``(2) Extension of the period of surveillance.--If the Secretary determines that additional surveillance is needed to identify the incidence of adverse events documented during the initial period of surveillance that were not foreseen at the time of approval or classification of the device, the Secretary may extend the period of surveillance for such time as may be necessary after providing the person required to conduct such surveillance an opportunity for an informal hearing to determine whether or not additional surveillance is appropriate and to determine the appropriate period, if any, for such surveillance.''. SEC. 607. REPORTING. (a) Reports.--Section 519 (21 U.S.C. 360i) is amended-- (1) in subsection (a)-- (A) in the first sentence by striking ``make such reports, and provide such information,'' and inserting ``and submit such samples and components of devices (as required by paragraph (10)),''; and (B) by inserting after the first sentence the following: ``Every person who is a manufacturer or importer of a device intended for human use shall make reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to assure the safety and effectiveness of such device.''; (C) in the last sentence by striking ``sentence'' and inserting ``sentences''; (D) in paragraph (8), by striking ``; and'' and inserting a semicolon; and (E) by striking paragraph (9) and inserting the following: ``(9) shall require distributors to keep records and make such records available to the Secretary upon request; and''; (2) by striking subsection (d); and (3) in subsection (f), by striking ``, importer, or distributor'' each place it appears and inserting ``or importer''. (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended-- (1) by redesignating paragraph (4) as paragraph (5); (2) by inserting after paragraph (3), the following: ``(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or''; and (3) by adding at the end the following flush sentence: [[Page S9139]] ``In this subsection, the term `wholesale distributor' means any person who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.''. SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE. Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end the following: ``(4) A new drug manufactured in a pilot or o

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FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997
(Senate - September 11, 1997)

Text of this article available as: TXT PDF [Pages S9133-S9157] FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997 The PRESIDING OFFICER. The clerk will report the bill. The legislative clerk read as follows: A bill (S. 830) to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes, which had been reported from to the Committee on Labor and Human Resources, with an amendment to strike all after the enacting clause and inserting in lieu thereof the following: SECTION 1. SHORT TITLE. This Act may be cited as the ``Food and Drug Administration Modernization and Accountability Act of 1997''. SEC. 2. TABLE OF CONTENTS. The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. References. TITLE I--IMPROVING PATIENT ACCESS Sec. 101. Mission of the Food and Drug Administration. Sec. 102. Expedited access to investigational therapies. Sec. 103. Expanded humanitarian use of devices. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES Sec. 201. Interagency collaboration. Sec. 202. Sense of the committee regarding mutual recognition agreements and global harmonization efforts. Sec. 203. Contracts for expert review. Sec. 204. Accredited-party reviews. Sec. 205. Device performance standards. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION Sec. 301. Collaborative determinations of device data requirements. Sec. 302. Collaborative review process. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES Sec. 401. Policy statements. Sec. 402. Product classification. Sec. 403. Use of data relating to premarket approval. Sec. 404. Consideration of labeling claims for product review. [[Page S9134]] Sec. 405. Definition of a day for purposes of product review. Sec. 406. Certainty of review timeframes. Sec. 407. Limitations on initial classification determinations. Sec. 408. Clarification with respect to a general use and specific use of a device. Sec. 409. Clarification of the number of required clinical investigations for approval. Sec. 410. Prohibited acts. TITLE V--IMPROVING ACCOUNTABILITY Sec. 501. Agency plan for statutory compliance and annual report. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES Sec. 601. Minor modifications. Sec. 602. Environmental impact review. Sec. 603. Exemption of certain classes of devices from premarket notification requirement. Sec. 604. Evaluation of automatic class III designation. Sec. 605. Secretary's discretion to track devices. Sec. 606. Secretary's discretion to conduct postmarket surveillance. Sec. 607. Reporting. Sec. 608. Pilot and small-scale manufacture. Sec. 609. Requirements for radiopharmaceuticals. Sec. 610. Modernization of regulation of biological products. Sec. 611. Approval of supplemental applications for approved products. Sec. 612. Health care economic information. Sec. 613. Expediting study and approval of fast track drugs. Sec. 614. Manufacturing changes for drugs and biologics. Sec. 615. Data requirements for drugs and biologics. Sec. 616. Food contact substances. Sec. 617. Health claims for food products. Sec. 618. Pediatric studies marketing exclusivity. Sec. 619. Positron emission tomography. TITLE VII--FEES RELATING TO DRUGS Sec. 701. Short title. Sec. 702. Findings. Sec. 703. Definitions. Sec. 704. Authority to assess and use drug fees. Sec. 705. Annual reports. Sec. 706. Effective date. Sec. 707. Termination of effectiveness. TITLE VIII--MISCELLANEOUS Sec. 801. Registration of foreign establishments. Sec. 802. Elimination of certain labeling requirements. Sec. 803. Clarification of seizure authority. Sec. 804. Intramural research training award program. Sec. 805. Device samples. Sec. 806. Interstate commerce. Sec. 807. National uniformity for nonprescription drugs and cosmetics. Sec. 808. Information program on clinical trials for serious or life- threatening diseases. Sec. 809. Application of Federal law to the practice of pharmacy compounding. SEC. 3. REFERENCES. Except as otherwise expressly provided, wherever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). TITLE I--IMPROVING PATIENT ACCESS SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION. Section 903 (21 U.S.C. 393) is amended-- (1) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (2) by inserting after subsection (a) the following: ``(b) Mission.-- ``(1) In general.--The Administration shall protect the public health by ensuring that-- ``(A) foods are safe, wholesome, sanitary, and properly labeled; ``(B) human and veterinary drugs are safe and effective; ``(C) there is reasonable assurance of safety and effectiveness of devices intended for human use; ``(D) cosmetics are safe; and ``(E) public health and safety are protected from electronic product radiation. ``(2) Special rules.--The Administration shall promptly and efficiently review clinical research and take appropriate action on the marketing of regulated products in a manner that does not unduly impede innovation or product availability. The Administration shall participate with other countries to reduce the burden of regulation, to harmonize regulatory requirements, and to achieve appropriate reciprocal arrangements with other countries.''. SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES. Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``Subchapter D--Unapproved Therapies and Diagnostics ``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS. ``(a) In General.--Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may provide to a person after compliance with the provisions of this section, an investigational drug (including a biological product) or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition, or any other disease or condition designated by the Secretary as appropriate for expanded access under this section if-- ``(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved; ``(2) the licensed physician determines that the risk to the person from the investigational drug or investigational device is not greater than the risk from the disease or condition; ``(3) the Secretary determines that an exemption for the investigational drug or investigational device is in effect under a regulation promulgated pursuant to section 505(i) or 520(g) and the sponsor of the drug or device and investigators comply with such regulation; ``(4) the Secretary determines that the manufacturer of the investigational drug or investigational device is actively pursuing marketing approval with due diligence; ``(5) the Secretary determines that expanded access to the investigational drug or investigational device will not interfere with adequate enrollment of patients by the investigator in the ongoing clinical investigation of the investigational drug or investigational device authorized under section 505(i) or 520(g); and ``(6) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the expanded use of the investigational drug or investigational device in accordance with this section. ``(b) Protocols.--A manufacturer or distributor may submit to the Secretary 1 or more expanded access protocols covering expanded access use of a drug or device described in subsection (a). The protocols shall be subject to the provisions of section 505(i) or 520(g) and may include any form of use of the drug or device outside a clinical investigation, prior to approval of the drug or device for marketing, including protocols for treatment use, emergency use, or uncontrolled trials, and single patient protocols. If the request for expanded access to an investigational drug or investigational device is intended for a single patient only, the Secretary may waive the requirements of paragraphs (3) and (4) of subsection (a) and accept a submission under section 505(i) or 520(g) for an exemption for the investigational drug or investigational device for the single patient use. In the case of an emergency that does not allow sufficient time for a submission under section 505(i) or 520(g), the Secretary may, prior to the submission, authorize the shipment of the investigational drug or investigational device for a single patient use. ``(c) Notification of Availability.--The Secretary shall inform national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this section, except that this subsection shall not apply to expanded access protocols for single patient use. ``(d) Termination.--The Secretary may at anytime terminate expanded access provided under subsection (a) for an investigational drug or investigational device if the requirements under this section are no longer met.''. SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES. Section 520(m) (21 U.S.C. 360j(m)) is amended-- (1) in paragraph (2), by adding at the end the following flush sentences: ``The request shall be in the form of an application submitted to the Secretary. Not later than 60 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.''; (2) in paragraph (4)-- (A) in subparagraph (B), by inserting after ``(2)(A)'' the following: ``, unless a physician determines that waiting for such an approval from an institutional review committee will cause harm or death to a patient, and makes a good faith effort to obtain the approval, and does not receive a timely response from an institutional review committee on the request of the physician for approval to use the device for such treatment or diagnosis''; and (B) by adding at the end the following flush sentences: ``In a case in which a physician described in subparagraph (B) uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.''; and (3) by striking paragraph (5) and inserting the following: ``(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met.''. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES SEC. 201. INTERAGENCY COLLABORATION. Section 903(b) (21 U.S.C. 393(b)), as added by section 101(2), is amended by adding at the end the following: ``(3) Interagency collaboration.--The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.''. [[Page S9135]] SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS. It is the sense of the Committee on Labor and Human Resources of the Senate that-- (1) the Secretary of Health and Human Services should support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States; (2) the Secretary of Health and Human Services should regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements; and (3) the Office of International Relations of the Department of Health and Human Services (as established under section 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383)) should have the responsibility of ensuring that the process of harmonizing international regulatory requirements is continuous. SEC. 203. CONTRACTS FOR EXPERT REVIEW. Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end the following: ``SEC. 906. CONTRACTS FOR EXPERT REVIEW. ``(a) In General.-- ``(1) Authority.--The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with expertise in a relevant discipline, to review, evaluate, and make recommendations to the Secretary on part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 708 relating to the confidentiality of information. ``(2) Increased efficiency and expertise through contracts.--The Secretary shall use the authority granted in paragraph (1) whenever the Secretary determines that a contract described in paragraph (1) will improve the timeliness or quality of the review of an application or submission described in paragraph (1). Such improvement may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies. ``(b) Review of Expert Review.-- ``(1) In general.--Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter within 60 days after receiving the recommendations. ``(2) Limitation.--A final decision under paragraph (1) shall be made within the applicable prescribed time period for review of the matter as set forth in this Act or in the Public Health Service Act (42 U.S.C. 201 et seq.). ``(3) Authority of secretary.--Notwithstanding subsection (a), the Secretary shall retain full authority to make determinations with respect to the approval or disapproval of an article under this Act, the approval or disapproval of a biologics license with respect to a biological product under section 351(a) of the Public Health Service Act, or the classification of an article as a device under section 513(f)(1).''. SEC. 204. ACCREDITED-PARTY REVIEWS. Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``SEC. 523. ACCREDITED-PARTY PARTICIPATION. ``(a) Accreditation.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall accredit entities or individuals who are not employees of the Federal Government, to review reports made to the Secretary under section 510(k) for devices and make recommendations to the Secretary regarding the initial classification of such devices under section 513(f)(1), except that this paragraph shall not apply to reports made to the Secretary under section 510(k) for devices that are-- ``(A) life-supporting; ``(B) life sustaining; or ``(C) intended for implantation in the human body for a period of over 1 year. ``(2) Special rule.--The Secretary shall have the discretion to accredit entities or individuals who are not employees of the Federal Government-- ``(A) to review reports made to the Secretary under section 510(k) for devices described in subparagraphs (A) through (C) of paragraph (1), and make recommendations of initial classification of such devices; or ``(B) to review applications for premarket approval for class III devices under section 515 and make recommendations with respect to the approval or disapproval of such applications. ``(b) Accreditation.--Within 180 days after the date of enactment of this section, the Secretary shall adopt methods of accreditation that ensure that entities or individuals who conduct reviews and make recommendations under this section are qualified, properly trained, knowledgeable about handling confidential documents and information, and free of conflicts of interest. The Secretary shall publish the methods of accreditation in the Federal Register on the adoption of the methods. ``(c) Withdrawal of Accreditation.--The Secretary may suspend or withdraw the accreditation of any entity or individual accredited under this section, after providing notice and an opportunity for an informal hearing, if such entity or individual acts in a manner that is substantially not in compliance with the requirements established by the Secretary under subsection (b), including the failure to avoid conflicts of interest, the failure to protect confidentiality of information, or the failure to competently review premarket submissions for devices. ``(d) Selection and Compensation.--Subject to subsection (a)(2), a person who intends to make a report described in subsection (a), or to submit an application described in subsection (a), to the Secretary shall have the option to select an accredited entity or individual to review such report or application. Upon the request by a person to have a report or application reviewed by an accredited entity or individual, the Secretary shall identify for the person no less than 2 accredited entities or individuals from whom the selection may be made. Compensation for an accredited entity or individual shall be determined by agreement between the accredited entity or individual and the person who engages the services of the accredited entity or individual and shall be paid by the person who engages such services. ``(e) Review by Secretary.-- ``(1) In general.--The Secretary shall require an accredited entity or individual, upon making a recommendation under this section with respect to an initial classification of a device or approval or disapproval of an application for premarket approval, to notify the Secretary in writing of the reasons for such recommendation. ``(2) Time period for review.-- ``(A) Initial classification.--Not later than 30 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. ``(B) Premarket approval.--Not later than 60 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an approval or disapproval of an application for a device, the Secretary shall make a determination with respect to the approval or disapproval. ``(3) Special rule.--The Secretary may change the initial classification under section 513(f)(1), or the approval or disapproval of the application under section 515(d), that is recommended by the accredited entity or individual under this section, and in such case shall notify in writing the person making the report or application described in subsection (a) of the detailed reasons for the change. ``(f) Duration.--The authority provided by this section terminates-- ``(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) are available to review devices for each of at least 70 percent of the generic types of devices subject to review under subsection (a); or ``(2) 4 years after the date on which the Secretary notifies Congress that at least 35 percent of the devices that are subject to review under subsection (a), and that were the subject of final action by the Secretary in the fiscal year preceding the date of such notification, were reviewed by the Secretary under subsection (e), whichever occurs first. ``(g) Report.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall contract with an independent research organization to prepare and submit to the Secretary a written report examining the use of accredited entities and individuals to conduct reviews under this section. The Secretary shall submit the report to Congress not later than 6 months prior to the conclusion of the applicable period described in subsection (f). ``(2) Contents.--The report by the independent research organization described in paragraph (1) shall identify the benefits or detriments to public and patient health of using accredited entities and individuals to conduct such reviews, and shall summarize all relevant data, including data on the review of accredited entities and individuals (including data on the review times, recommendations, and compensation of the entities and individuals), and data on the review of the Secretary (including data on the review times, changes, and reasons for changes of the Secretary).''. SEC. 205. DEVICE PERFORMANCE STANDARDS. (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended by adding at the end the following: ``Recognition of a Standard ``(c)(1)(A) In addition to establishing performance standards under this section, the Secretary may, by publication in the Federal Register, recognize all or part of a performance standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet premarket submission requirements or other requirements under this Act to which such standards are applicable. ``(B) If a person elects to use a performance standard recognized by the Secretary under subparagraph (A) to meet the requirements described in subparagraph (A), the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to fulfill or satisfy any requirement under this Act. ``(2) The Secretary may withdraw such recognition of a performance standard through publication of a notice in the Federal Register that the Secretary will no longer recognize the [[Page S9136]] standard, if the Secretary determines that the standard is no longer appropriate for meeting the requirements under this Act. ``(3)(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds-- ``(i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or ``(ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review. ``(B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1). ``(C) A person relying on a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of 2 years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.''. (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding at the end the following: ``(x) The falsification of a declaration of conformity submitted under subsection (c) of section 514 or the failure or refusal to provide data or information requested by the Secretary under section 514(c)(3).''. (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended-- (1) by striking ``(e)'' and inserting ``(e)(1)''; and (2) by inserting at the end the following: ``(2) If it is, declared to be, purports to be, or is represented as, a device that is in conformity with any performance standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.''. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA REQUIREMENTS. Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding at the end the following: ``(C)(i)(I) The Secretary, upon the written request of any person intending to submit an application under section 515, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate the effectiveness of a device for the conditions of use proposed by such person, to support an approval of an application. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, and, if available, information regarding the expected performance from the device. Within 30 days after such meeting, the Secretary shall specify in writing the type of valid scientific evidence that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person. ``(II) Any clinical data, including 1 or more well- controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary-- ``(aa) that such data are necessary to establish device effectiveness; and ``(bb) that no other less burdensome means of evaluating device effectiveness is available that would have a reasonable likelihood of resulting in an approval. ``(ii) The determination of the Secretary with respect to the specification of valid scientific evidence under clause (i) shall be binding upon the Secretary, unless-- ``(I) such determination by the Secretary would be contrary to the public health; or ``(II) based on new information (other than the information reviewed by the Secretary in making such determination) obtained by the Secretary prior to the approval of an application for an investigational device exemption under section 520(g), the Secretary finds that such determination is scientifically inappropriate.''. SEC. 302. COLLABORATIVE REVIEW PROCESS. Section 515(d) (21 U.S.C. 360e(d)) is amended-- (1) in paragraph (1)(A), by striking ``paragraph (2) of this subsection'' each place it appears and inserting ``paragraph (4)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A)(i) The Secretary shall, upon the written request of the applicant involved, meet with the applicant not later than 100 days after the receipt of an application, from the applicant, that has been filed as complete under subsection (c), to discuss the review status of the application. ``(ii) If the application does not appear in a form that would require an approval under this subsection, the Secretary shall in writing, and prior to the meeting, provide to the applicant a description of any deficiencies in the application identified by the Secretary and identify the information (other than information the Secretary needs to make a finding under paragraph (4)(C)) that is required to bring the application into an approvable form. ``(iii) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph. ``(B) The Secretary shall notify the applicant immediately of any deficiency identified in the application that was not described as a deficiency in the written description provided by the Secretary under subparagraph (A).''. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES SEC. 401. POLICY STATEMENTS. Section 701(a) (21 U.S.C. 371(a)) is amended-- (1) by striking ``(a) The'' and inserting ``(a)(1) The''; and (2) by adding at the end the following: ``(2) Not later than February 27, 1999, the Secretary, after evaluating the effectiveness of the Good Guidance Practices document published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.''. SEC. 402. PRODUCT CLASSIFICATION. Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end the following: ``Subchapter D--Classification of Products and Environmental Impact Reviews ``SEC. 741. CLASSIFICATION OF PRODUCTS. ``(a) Request.--A person who submits an application or submission (including a petition, notification, and any other similar form of request) under this Act, may submit a request to the Secretary respecting the classification of an article (including an article that is a combination product subject to section 503(g)) as a drug, biological product, or device, or respecting the component of the Food and Drug Administration that will regulate the article. In submitting the request, the person shall recommend a classification for the article, or a component to regulate the article, as appropriate. ``(b) Statement.--Not later than 60 days after the receipt of the request described in subsection (a), the Secretary shall determine the classification of the article or the component of the Food and Drug Administration that will regulate the article and shall provide to the person a written statement that identifies the classification of the article or the component of the Food and Drug Administration that will regulate the article and the reasons for such determination. The Secretary may not modify such statement except with the written consent of the person or for public health reasons. ``(c) Inaction of Secretary.--If the Secretary does not provide the statement within the 60-day period described in subsection (b), the recommendation made by the person under subsection (a) shall be considered to be a final determination by the Secretary of the classification of the article or the component of the Food and Drug Administration that will regulate the article and may not be modified by the Secretary except with the written consent of the person or for public health reasons.''. SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL. (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows: ``(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in-- ``(i) approving another device; ``(ii) determining whether a product development protocol has been completed, under section 515 for another device; ``(iii) establishing a performance standard or special control under this Act; or ``(iv) classifying or reclassifying another device under section 513 and subsection (l)(2). ``(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency action described in subparagraph (A).''. (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 360g(a)) is amended-- (1) in paragraph (8), by adding ``or'' at the end; (2) in paragraph (9), by striking ``, or'' and inserting a comma; and (3) by striking paragraph (10). SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT REVIEW. (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 360e(d)(1)(A)) is amended by adding at the end the following flush sentences: ``In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.''. (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is amended by adding at the end the following: ``(C) Whenever the Secretary requests information to demonstrate that the devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to make a substantial equivalence determination. In making such a request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and shall request information accordingly. ``(D) The determinations of the Secretary under this section and section 513(f)(1) with respect to the intended use of a device shall be based on the intended use included in proposed labeling of the device submitted in a report under section 510(k).''. [[Page S9137]] SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: ``(ii) In any provision relating to a review of any application or submission (including a petition, notification, and any other similar form of request), made under this Act with respect to an article that is a new drug, device, biological product, new animal drug, an animal feed bearing or containing a new animal drug, color additive, or food additive, that is submitted to the Secretary to obtain marketing approval, to obtain classification of a device under section 513(f)(1), or to establish or clarify the regulatory status of the article-- ``(1) the term `day' means a calendar day in which the Secretary has responsibility to review such an application or submission; and ``(2) a reference to a date relating to the receipt of such an application or submission by the Secretary shall be deemed to be a reference to the date on which the Secretary receives a complete application or submission within the meaning of this Act and the regulations promulgated under this Act.''. SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES. (a) Clarification on the 90-Day Timeframe for Premarket Notification Reviews.--Section 510(k) (21 U.S.C. 360) is amended by adding at the end the following flush sentence: ``The Secretary shall review the notification required by this subsection and make a determination under section 513(f)(1) not later than 90 days after receiving the notification.''. (b) Certainty of 180-Day Review Timeframe.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is amended by inserting after paragraph (2) the following: ``(3) Except as provided in paragraph (1), the period for the review of an application by the Secretary under this subsection shall be not more than 180 days. Such period may not be restarted or extended even if the application is amended.''. SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION DETERMINATIONS. Section 510 (21 U.S.C. 360) is amended by adding at the end the following: ``(m) The Secretary may not withhold a determination of the initial classification of a device under section 513(f)(1) because of a failure to comply with any provision of this Act that is unrelated to a substantial equivalence decision, including a failure to comply with the requirements relating to good manufacturing practices under section 520(f).''. SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND SPECIFIC USE OF A DEVICE. Not later than 270 days after the date of enactment of this section, the Secretary of Health and Human Services shall promulgate a final regulation specifying the general principles that the Secretary of Health and Human Services will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)). SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL. (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking ``clinical investigations'' and inserting ``1 or more clinical investigations''. (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: ``Substantial evidence may, as appropriate, consist of data from 1 adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation), if the Secretary determines, based on relevant science, that such data and evidence are sufficient to establish effectiveness.''. SEC. 410. PROHIBITED ACTS. Section 301(l) (21 U.S.C. 331(l)) is repealed. TITLE V--IMPROVING ACCOUNTABILITY SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL REPORT. Section 903(b) (21 U.S.C. 393(b)), as amended by section 201, is further amended by adding at the end the following: ``(4) Agency plan for statutory compliance.-- ``(A) In general.--Not later than 180 days after the date of enactment of this paragraph, the Secretary, after consultation with relevant experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act and other relevant statutes. The Secretary shall biannually review the plan and shall revise the plan as necessary, in consultation with such persons. ``(B) Objectives of agency plan.--The plan required by subparagraph (A) shall establish objectives, and mechanisms to be used by the Secretary, acting through the Commissioner, including objectives and mechanisms that-- ``(i) minimize deaths of, and harm to, persons who use or may use an article regulated under this Act; ``(ii) maximize the clarity of, and the availability of information about, the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act, including information for potential consumers and patients concerning new products; ``(iii) implement all inspection and postmarket monitoring provisions of this Act by July 1, 1999; ``(iv) ensure access to the scientific and technical expertise necessary to ensure compliance by the Secretary with the statutory obligations described in subparagraph (A); ``(v) establish a schedule to bring the Administration into full compliance by July 1, 1999, with the time periods specified in this Act for the review of all applications and submissions described in clause (ii) and submitted after the date of enactment of this paragraph; and ``(vi) reduce backlogs in the review of all applications and submissions described in clause (ii) for any article with the objective of eliminating all backlogs in the review of the applications and submissions by January 1, 2000. ``(5) Annual report.-- ``(A) Contents.--The Secretary shall prepare and publish in the Federal Register and solicit public comment on an annual report that-- ``(i) provides detailed statistical information on the performance of the Secretary under the plan described in paragraph (4); ``(ii) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; ``(iii) analyzes any failure of the Secretary to achieve any objective of the plan or to meet any statutory obligation; ``(iv) identifies any regulatory policy that has a significant impact on compliance with any objective of the plan or any statutory obligation; and ``(v) sets forth any proposed revision to any such regulatory policy, or objective of the plan that has not been met. ``(B) Statistical information.--The statistical information described in subparagraph (A)(i) shall include a full statistical presentation relating to all applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act and approved or subject to final action by the Secretary during the year covered by the report. In preparing the statistical presentation, the Secretary shall take into account the date of-- ``(i) the submission of any investigational application; ``(ii) the application of any clinical hold; ``(iii) the submission of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for approval or clearance; ``(iv) the acceptance for filing of any application or submission described in clause (iii) for approval or clearance; ``(v) the occurrence of any unapprovable action; ``(vi) the occurrence of any approvable action; and ``(vii) the approval or clearance of any application or submission described in clause (iii).''. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES SEC. 601. MINOR MODIFICATIONS. (a) Action on Investigational Device Exemptions.--Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: ``(6)(A) The Secretary shall, not later than 120 days after the date of enactment of this paragraph, by regulation modify parts 812 and 813 of title 21, Code of Federal Regulations to update the procedures and conditions under which a device intended for human use may, upon application by the sponsor of the device, be granted an exemption from the requirements of this Act. ``(B) The regulation shall permit developmental changes in a device (including manufacturing changes) in response to information collected during an investigation without requiring an additional approval of an application for an investigational device exemption or the approval of a supplement to such application, if the sponsor of the investigation determines, based on credible information, prior to making any such changes, that the changes-- ``(i) do not affect the scientific soundness of an investigational plan submitted under paragraph (3)(A) or the rights, safety, or welfare of the human subjects involved in the investigation; and ``(ii) do not constitute a significant change in design, or a significant change in basic principles of operation, of the device.''. (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 360e(d)(1)(B)) is amended by adding at the end the following: ``(iii) The Secretary shall accept and review data and any other information from investigations conducted under the authority of regulations required by section 520(g), to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if-- ``(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or ``(II) the data or information relates to a device approved under this section, is available for use under this Act, and is relevant to the design and intended use of the device for which the application is pending.''. (c) Action on Supplements.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is further amended by adding at the end the following: ``(6)(A)(i) A supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 520(f). [[Page S9138]] ``(ii) The holder of an approved application who submits a notice under clause (i) with respect to a manufacturing change of a device shall not distribute the device for a period of 14 days after the date on which the Secretary receives the notice. ``(B)(i) Subject to clause (ii), in reviewing a supplement to an approved application, for an incremental change to the design of a device that affects safety or effectiveness, the Secretary shall approve such supplement if-- ``(I) nonclinical data demonstrate that the design modification creates the intended additional capacity, function, or performance of the device; and ``(II) clinical data from the approved application and any supplement to the approved application provide a reasonable assurance of safety and effectiveness for the changed device. ``(ii) The Secretary may require, when necessary, additional clinical data to evaluate the design modification to provide a reasonable assurance of safety and effectiveness.''. SEC. 602. ENVIRONMENTAL IMPACT REVIEW. Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is further amended by adding at the end the following: ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW. ``Notwithstanding any other provision of law, no action by the Secretary pursuant to this Act shall be subject to an environmental assessment, an environmental impact statement, or other environmental consideration unless the Secretary demonstrates, in writing-- ``(1) that there is a reasonable probability that the environmental impact of the action is sufficiently substantial and within the factors that the Secretary is authorized to consider under this Act; and ``(2) that consideration of the environmental impact will directly affect the decision on the action.''. SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM PREMARKET NOTIFICATION REQUIREMENT. (a) Class I and Class II Devices.--Section 510(k) (21 U.S.C. 360(k)) is amended by striking ``intended for human use'' and inserting ``intended for human use (except a device that is classified into class I under section 513 or 520 unless the Secretary determines such device is intended for a use that is of substantial importance in preventing impairment of human health or such device presents a potential unreasonable risk of illness or injury, or a device that is classified into class II under section 513 or 520 and is exempt from the requirements of this subsection under subsection (l))''. (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) is amended by inserting after subsection (k) the following: ``(l)(1) Not later than 30 days after the date of enactment of this subsection, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a notification under subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary not to require the notification shall be exempt from the requirement to provide notification under subsection (k) as of the date of the publication of the list in the Federal Register. ``(2) Beginning on the date that is 1 day after the date of the publication of a list under this subsection, the Secretary may exempt a class II device from the notification requirement of subsection (k), upon the Secretary's own initiative or a petition of an interested person, if the Secretary determines that such notification is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 30-day comment period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice.''. SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION. Section 513(f) (21 U.S.C. 360c(f)) is amended-- (1) in paragraph (1)-- (A) in subparagraph (B), by striking ``paragraph (2)'' and inserting ``paragraph (3)''; and (B) in the last sentence, by striking ``paragraph (2)'' and inserting ``paragraph (2) or (3)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A) Any person who submits a report under section 510(k) for a type of device that has not been previously classified under this Act, and that is classified into class III under paragraph (1), may request, within 30 days after receiving written notice of such a classification, the Secretary to classify the device into class I or II under the criteria set forth in subparagraphs (A) through (C) subsection (a)(1). The person may, in the request, recommend to the Secretary a classification for the device. The request shall describe the device and provide detailed information and reasons for the recommended classification. ``(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A) for classification of a device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1), the Secretary shall by written order classify the device. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph into class I or II shall be a predicate device for determining substantial equivalence under paragraph (1). ``(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 501(f)(1)(B) until approved under section 515 or exempted from such approval under section 520(g). ``(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.''. SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES. (a) Release of Information.--Section 519(e) (21 U.S.C. 360i(e)) is amended by adding at the end the following flush sentence: ``Any patient receiving a device subject to tracking under this section may refuse to release, or refuse permission to release, the patient's name, address, social security number, or other identifying information for the purpose of tracking.''. (b) Publication of Certain Devices.--Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall develop and publish in the Federal Register a list that identifies each type of device subject to tracking under section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each device not identified by the Secretary of Health and Human Services under this subsection or designated by the Secretary under section 519(e)(2) shall be deemed to be exempt from the mandatory tracking requirement under section 519 of such Act. The Secretary of Health and Human Services shall have authority to modify the list of devices exempted from the mandatory tracking requirements. SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET SURVEILLANCE. (a) In General.--Section 522 (21 U.S.C. 360l) is amended by striking ``Sec. 522.'' and all that follows through ``(2) Discretionary surveillance.--The'' and inserting the following: ``Sec. 522. (a) Discretionary Surveillance.--The''. (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 360l(b)) is amended to read as follows: ``(b) Surveillance Approval.-- ``(1) In general.--Each manufacturer that receives notice from the Secretary that the manufacturer is required to conduct surveillance of a device under subsection (a) shall, not later than 30 days after receiving the notice, submit for the approval of the Secretary, a plan for the required surveillance. ``(2) Determination.--Not later than 60 days after the receipt of the plan, the Secretary shall determine if a person proposed in the plan to conduct the surveillance has sufficient qualifications and experience to conduct the surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health and to provide safety and effectiveness information for the device. ``(3) Limitation on plan approval.--The Secretary may not approve the plan until the plan has been reviewed by a qualified scientific and technical review committee established by the Secretary.''. (c) Duration of Surveillance.--Section 522 (21 U.S.C. 360l), as amended by subsection (b), is further amended by adding at the end the following: ``(c) Duration of Surveillance.-- ``(1) In general.--Each manufacturer required to conduct surveillance of a device under subsection (a) shall be required to conduct such surveillance for not longer than 24 months. ``(2) Extension of the period of surveillance.--If the Secretary determines that additional surveillance is needed to identify the incidence of adverse events documented during the initial period of surveillance that were not foreseen at the time of approval or classification of the device, the Secretary may extend the period of surveillance for such time as may be necessary after providing the person required to conduct such surveillance an opportunity for an informal hearing to determine whether or not additional surveillance is appropriate and to determine the appropriate period, if any, for such surveillance.''. SEC. 607. REPORTING. (a) Reports.--Section 519 (21 U.S.C. 360i) is amended-- (1) in subsection (a)-- (A) in the first sentence by striking ``make such reports, and provide such information,'' and inserting ``and submit such samples and components of devices (as required by paragraph (10)),''; and (B) by inserting after the first sentence the following: ``Every person who is a manufacturer or importer of a device intended for human use shall make reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to assure the safety and effectiveness of such device.''; (C) in the last sentence by striking ``sentence'' and inserting ``sentences''; (D) in paragraph (8), by striking ``; and'' and inserting a semicolon; and (E) by striking paragraph (9) and inserting the following: ``(9) shall require distributors to keep records and make such records available to the Secretary upon request; and''; (2) by striking subsection (d); and (3) in subsection (f), by striking ``, importer, or distributor'' each place it appears and inserting ``or importer''. (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended-- (1) by redesignating paragraph (4) as paragraph (5); (2) by inserting after paragraph (3), the following: ``(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or''; and (3) by adding at the end the following flush sentence: [[Page S9139]] ``In this subsection, the term `wholesale distributor' means any person who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.''. SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE. Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end the following: ``(4) A new drug manufactured in a

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All articles in Senate section

FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997
(Senate - September 11, 1997)

Text of this article available as: TXT PDF [Pages S9133-S9157] FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997 The PRESIDING OFFICER. The clerk will report the bill. The legislative clerk read as follows: A bill (S. 830) to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes, which had been reported from to the Committee on Labor and Human Resources, with an amendment to strike all after the enacting clause and inserting in lieu thereof the following: SECTION 1. SHORT TITLE. This Act may be cited as the ``Food and Drug Administration Modernization and Accountability Act of 1997''. SEC. 2. TABLE OF CONTENTS. The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. References. TITLE I--IMPROVING PATIENT ACCESS Sec. 101. Mission of the Food and Drug Administration. Sec. 102. Expedited access to investigational therapies. Sec. 103. Expanded humanitarian use of devices. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES Sec. 201. Interagency collaboration. Sec. 202. Sense of the committee regarding mutual recognition agreements and global harmonization efforts. Sec. 203. Contracts for expert review. Sec. 204. Accredited-party reviews. Sec. 205. Device performance standards. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION Sec. 301. Collaborative determinations of device data requirements. Sec. 302. Collaborative review process. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES Sec. 401. Policy statements. Sec. 402. Product classification. Sec. 403. Use of data relating to premarket approval. Sec. 404. Consideration of labeling claims for product review. [[Page S9134]] Sec. 405. Definition of a day for purposes of product review. Sec. 406. Certainty of review timeframes. Sec. 407. Limitations on initial classification determinations. Sec. 408. Clarification with respect to a general use and specific use of a device. Sec. 409. Clarification of the number of required clinical investigations for approval. Sec. 410. Prohibited acts. TITLE V--IMPROVING ACCOUNTABILITY Sec. 501. Agency plan for statutory compliance and annual report. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES Sec. 601. Minor modifications. Sec. 602. Environmental impact review. Sec. 603. Exemption of certain classes of devices from premarket notification requirement. Sec. 604. Evaluation of automatic class III designation. Sec. 605. Secretary's discretion to track devices. Sec. 606. Secretary's discretion to conduct postmarket surveillance. Sec. 607. Reporting. Sec. 608. Pilot and small-scale manufacture. Sec. 609. Requirements for radiopharmaceuticals. Sec. 610. Modernization of regulation of biological products. Sec. 611. Approval of supplemental applications for approved products. Sec. 612. Health care economic information. Sec. 613. Expediting study and approval of fast track drugs. Sec. 614. Manufacturing changes for drugs and biologics. Sec. 615. Data requirements for drugs and biologics. Sec. 616. Food contact substances. Sec. 617. Health claims for food products. Sec. 618. Pediatric studies marketing exclusivity. Sec. 619. Positron emission tomography. TITLE VII--FEES RELATING TO DRUGS Sec. 701. Short title. Sec. 702. Findings. Sec. 703. Definitions. Sec. 704. Authority to assess and use drug fees. Sec. 705. Annual reports. Sec. 706. Effective date. Sec. 707. Termination of effectiveness. TITLE VIII--MISCELLANEOUS Sec. 801. Registration of foreign establishments. Sec. 802. Elimination of certain labeling requirements. Sec. 803. Clarification of seizure authority. Sec. 804. Intramural research training award program. Sec. 805. Device samples. Sec. 806. Interstate commerce. Sec. 807. National uniformity for nonprescription drugs and cosmetics. Sec. 808. Information program on clinical trials for serious or life- threatening diseases. Sec. 809. Application of Federal law to the practice of pharmacy compounding. SEC. 3. REFERENCES. Except as otherwise expressly provided, wherever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). TITLE I--IMPROVING PATIENT ACCESS SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION. Section 903 (21 U.S.C. 393) is amended-- (1) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (2) by inserting after subsection (a) the following: ``(b) Mission.-- ``(1) In general.--The Administration shall protect the public health by ensuring that-- ``(A) foods are safe, wholesome, sanitary, and properly labeled; ``(B) human and veterinary drugs are safe and effective; ``(C) there is reasonable assurance of safety and effectiveness of devices intended for human use; ``(D) cosmetics are safe; and ``(E) public health and safety are protected from electronic product radiation. ``(2) Special rules.--The Administration shall promptly and efficiently review clinical research and take appropriate action on the marketing of regulated products in a manner that does not unduly impede innovation or product availability. The Administration shall participate with other countries to reduce the burden of regulation, to harmonize regulatory requirements, and to achieve appropriate reciprocal arrangements with other countries.''. SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES. Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``Subchapter D--Unapproved Therapies and Diagnostics ``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS. ``(a) In General.--Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may provide to a person after compliance with the provisions of this section, an investigational drug (including a biological product) or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition, or any other disease or condition designated by the Secretary as appropriate for expanded access under this section if-- ``(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved; ``(2) the licensed physician determines that the risk to the person from the investigational drug or investigational device is not greater than the risk from the disease or condition; ``(3) the Secretary determines that an exemption for the investigational drug or investigational device is in effect under a regulation promulgated pursuant to section 505(i) or 520(g) and the sponsor of the drug or device and investigators comply with such regulation; ``(4) the Secretary determines that the manufacturer of the investigational drug or investigational device is actively pursuing marketing approval with due diligence; ``(5) the Secretary determines that expanded access to the investigational drug or investigational device will not interfere with adequate enrollment of patients by the investigator in the ongoing clinical investigation of the investigational drug or investigational device authorized under section 505(i) or 520(g); and ``(6) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the expanded use of the investigational drug or investigational device in accordance with this section. ``(b) Protocols.--A manufacturer or distributor may submit to the Secretary 1 or more expanded access protocols covering expanded access use of a drug or device described in subsection (a). The protocols shall be subject to the provisions of section 505(i) or 520(g) and may include any form of use of the drug or device outside a clinical investigation, prior to approval of the drug or device for marketing, including protocols for treatment use, emergency use, or uncontrolled trials, and single patient protocols. If the request for expanded access to an investigational drug or investigational device is intended for a single patient only, the Secretary may waive the requirements of paragraphs (3) and (4) of subsection (a) and accept a submission under section 505(i) or 520(g) for an exemption for the investigational drug or investigational device for the single patient use. In the case of an emergency that does not allow sufficient time for a submission under section 505(i) or 520(g), the Secretary may, prior to the submission, authorize the shipment of the investigational drug or investigational device for a single patient use. ``(c) Notification of Availability.--The Secretary shall inform national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this section, except that this subsection shall not apply to expanded access protocols for single patient use. ``(d) Termination.--The Secretary may at anytime terminate expanded access provided under subsection (a) for an investigational drug or investigational device if the requirements under this section are no longer met.''. SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES. Section 520(m) (21 U.S.C. 360j(m)) is amended-- (1) in paragraph (2), by adding at the end the following flush sentences: ``The request shall be in the form of an application submitted to the Secretary. Not later than 60 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.''; (2) in paragraph (4)-- (A) in subparagraph (B), by inserting after ``(2)(A)'' the following: ``, unless a physician determines that waiting for such an approval from an institutional review committee will cause harm or death to a patient, and makes a good faith effort to obtain the approval, and does not receive a timely response from an institutional review committee on the request of the physician for approval to use the device for such treatment or diagnosis''; and (B) by adding at the end the following flush sentences: ``In a case in which a physician described in subparagraph (B) uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.''; and (3) by striking paragraph (5) and inserting the following: ``(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met.''. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES SEC. 201. INTERAGENCY COLLABORATION. Section 903(b) (21 U.S.C. 393(b)), as added by section 101(2), is amended by adding at the end the following: ``(3) Interagency collaboration.--The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.''. [[Page S9135]] SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS. It is the sense of the Committee on Labor and Human Resources of the Senate that-- (1) the Secretary of Health and Human Services should support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States; (2) the Secretary of Health and Human Services should regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements; and (3) the Office of International Relations of the Department of Health and Human Services (as established under section 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383)) should have the responsibility of ensuring that the process of harmonizing international regulatory requirements is continuous. SEC. 203. CONTRACTS FOR EXPERT REVIEW. Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end the following: ``SEC. 906. CONTRACTS FOR EXPERT REVIEW. ``(a) In General.-- ``(1) Authority.--The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with expertise in a relevant discipline, to review, evaluate, and make recommendations to the Secretary on part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 708 relating to the confidentiality of information. ``(2) Increased efficiency and expertise through contracts.--The Secretary shall use the authority granted in paragraph (1) whenever the Secretary determines that a contract described in paragraph (1) will improve the timeliness or quality of the review of an application or submission described in paragraph (1). Such improvement may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies. ``(b) Review of Expert Review.-- ``(1) In general.--Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter within 60 days after receiving the recommendations. ``(2) Limitation.--A final decision under paragraph (1) shall be made within the applicable prescribed time period for review of the matter as set forth in this Act or in the Public Health Service Act (42 U.S.C. 201 et seq.). ``(3) Authority of secretary.--Notwithstanding subsection (a), the Secretary shall retain full authority to make determinations with respect to the approval or disapproval of an article under this Act, the approval or disapproval of a biologics license with respect to a biological product under section 351(a) of the Public Health Service Act, or the classification of an article as a device under section 513(f)(1).''. SEC. 204. ACCREDITED-PARTY REVIEWS. Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``SEC. 523. ACCREDITED-PARTY PARTICIPATION. ``(a) Accreditation.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall accredit entities or individuals who are not employees of the Federal Government, to review reports made to the Secretary under section 510(k) for devices and make recommendations to the Secretary regarding the initial classification of such devices under section 513(f)(1), except that this paragraph shall not apply to reports made to the Secretary under section 510(k) for devices that are-- ``(A) life-supporting; ``(B) life sustaining; or ``(C) intended for implantation in the human body for a period of over 1 year. ``(2) Special rule.--The Secretary shall have the discretion to accredit entities or individuals who are not employees of the Federal Government-- ``(A) to review reports made to the Secretary under section 510(k) for devices described in subparagraphs (A) through (C) of paragraph (1), and make recommendations of initial classification of such devices; or ``(B) to review applications for premarket approval for class III devices under section 515 and make recommendations with respect to the approval or disapproval of such applications. ``(b) Accreditation.--Within 180 days after the date of enactment of this section, the Secretary shall adopt methods of accreditation that ensure that entities or individuals who conduct reviews and make recommendations under this section are qualified, properly trained, knowledgeable about handling confidential documents and information, and free of conflicts of interest. The Secretary shall publish the methods of accreditation in the Federal Register on the adoption of the methods. ``(c) Withdrawal of Accreditation.--The Secretary may suspend or withdraw the accreditation of any entity or individual accredited under this section, after providing notice and an opportunity for an informal hearing, if such entity or individual acts in a manner that is substantially not in compliance with the requirements established by the Secretary under subsection (b), including the failure to avoid conflicts of interest, the failure to protect confidentiality of information, or the failure to competently review premarket submissions for devices. ``(d) Selection and Compensation.--Subject to subsection (a)(2), a person who intends to make a report described in subsection (a), or to submit an application described in subsection (a), to the Secretary shall have the option to select an accredited entity or individual to review such report or application. Upon the request by a person to have a report or application reviewed by an accredited entity or individual, the Secretary shall identify for the person no less than 2 accredited entities or individuals from whom the selection may be made. Compensation for an accredited entity or individual shall be determined by agreement between the accredited entity or individual and the person who engages the services of the accredited entity or individual and shall be paid by the person who engages such services. ``(e) Review by Secretary.-- ``(1) In general.--The Secretary shall require an accredited entity or individual, upon making a recommendation under this section with respect to an initial classification of a device or approval or disapproval of an application for premarket approval, to notify the Secretary in writing of the reasons for such recommendation. ``(2) Time period for review.-- ``(A) Initial classification.--Not later than 30 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. ``(B) Premarket approval.--Not later than 60 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an approval or disapproval of an application for a device, the Secretary shall make a determination with respect to the approval or disapproval. ``(3) Special rule.--The Secretary may change the initial classification under section 513(f)(1), or the approval or disapproval of the application under section 515(d), that is recommended by the accredited entity or individual under this section, and in such case shall notify in writing the person making the report or application described in subsection (a) of the detailed reasons for the change. ``(f) Duration.--The authority provided by this section terminates-- ``(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) are available to review devices for each of at least 70 percent of the generic types of devices subject to review under subsection (a); or ``(2) 4 years after the date on which the Secretary notifies Congress that at least 35 percent of the devices that are subject to review under subsection (a), and that were the subject of final action by the Secretary in the fiscal year preceding the date of such notification, were reviewed by the Secretary under subsection (e), whichever occurs first. ``(g) Report.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall contract with an independent research organization to prepare and submit to the Secretary a written report examining the use of accredited entities and individuals to conduct reviews under this section. The Secretary shall submit the report to Congress not later than 6 months prior to the conclusion of the applicable period described in subsection (f). ``(2) Contents.--The report by the independent research organization described in paragraph (1) shall identify the benefits or detriments to public and patient health of using accredited entities and individuals to conduct such reviews, and shall summarize all relevant data, including data on the review of accredited entities and individuals (including data on the review times, recommendations, and compensation of the entities and individuals), and data on the review of the Secretary (including data on the review times, changes, and reasons for changes of the Secretary).''. SEC. 205. DEVICE PERFORMANCE STANDARDS. (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended by adding at the end the following: ``Recognition of a Standard ``(c)(1)(A) In addition to establishing performance standards under this section, the Secretary may, by publication in the Federal Register, recognize all or part of a performance standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet premarket submission requirements or other requirements under this Act to which such standards are applicable. ``(B) If a person elects to use a performance standard recognized by the Secretary under subparagraph (A) to meet the requirements described in subparagraph (A), the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to fulfill or satisfy any requirement under this Act. ``(2) The Secretary may withdraw such recognition of a performance standard through publication of a notice in the Federal Register that the Secretary will no longer recognize the [[Page S9136]] standard, if the Secretary determines that the standard is no longer appropriate for meeting the requirements under this Act. ``(3)(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds-- ``(i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or ``(ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review. ``(B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1). ``(C) A person relying on a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of 2 years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.''. (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding at the end the following: ``(x) The falsification of a declaration of conformity submitted under subsection (c) of section 514 or the failure or refusal to provide data or information requested by the Secretary under section 514(c)(3).''. (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended-- (1) by striking ``(e)'' and inserting ``(e)(1)''; and (2) by inserting at the end the following: ``(2) If it is, declared to be, purports to be, or is represented as, a device that is in conformity with any performance standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.''. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA REQUIREMENTS. Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding at the end the following: ``(C)(i)(I) The Secretary, upon the written request of any person intending to submit an application under section 515, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate the effectiveness of a device for the conditions of use proposed by such person, to support an approval of an application. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, and, if available, information regarding the expected performance from the device. Within 30 days after such meeting, the Secretary shall specify in writing the type of valid scientific evidence that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person. ``(II) Any clinical data, including 1 or more well- controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary-- ``(aa) that such data are necessary to establish device effectiveness; and ``(bb) that no other less burdensome means of evaluating device effectiveness is available that would have a reasonable likelihood of resulting in an approval. ``(ii) The determination of the Secretary with respect to the specification of valid scientific evidence under clause (i) shall be binding upon the Secretary, unless-- ``(I) such determination by the Secretary would be contrary to the public health; or ``(II) based on new information (other than the information reviewed by the Secretary in making such determination) obtained by the Secretary prior to the approval of an application for an investigational device exemption under section 520(g), the Secretary finds that such determination is scientifically inappropriate.''. SEC. 302. COLLABORATIVE REVIEW PROCESS. Section 515(d) (21 U.S.C. 360e(d)) is amended-- (1) in paragraph (1)(A), by striking ``paragraph (2) of this subsection'' each place it appears and inserting ``paragraph (4)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A)(i) The Secretary shall, upon the written request of the applicant involved, meet with the applicant not later than 100 days after the receipt of an application, from the applicant, that has been filed as complete under subsection (c), to discuss the review status of the application. ``(ii) If the application does not appear in a form that would require an approval under this subsection, the Secretary shall in writing, and prior to the meeting, provide to the applicant a description of any deficiencies in the application identified by the Secretary and identify the information (other than information the Secretary needs to make a finding under paragraph (4)(C)) that is required to bring the application into an approvable form. ``(iii) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph. ``(B) The Secretary shall notify the applicant immediately of any deficiency identified in the application that was not described as a deficiency in the written description provided by the Secretary under subparagraph (A).''. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES SEC. 401. POLICY STATEMENTS. Section 701(a) (21 U.S.C. 371(a)) is amended-- (1) by striking ``(a) The'' and inserting ``(a)(1) The''; and (2) by adding at the end the following: ``(2) Not later than February 27, 1999, the Secretary, after evaluating the effectiveness of the Good Guidance Practices document published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.''. SEC. 402. PRODUCT CLASSIFICATION. Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end the following: ``Subchapter D--Classification of Products and Environmental Impact Reviews ``SEC. 741. CLASSIFICATION OF PRODUCTS. ``(a) Request.--A person who submits an application or submission (including a petition, notification, and any other similar form of request) under this Act, may submit a request to the Secretary respecting the classification of an article (including an article that is a combination product subject to section 503(g)) as a drug, biological product, or device, or respecting the component of the Food and Drug Administration that will regulate the article. In submitting the request, the person shall recommend a classification for the article, or a component to regulate the article, as appropriate. ``(b) Statement.--Not later than 60 days after the receipt of the request described in subsection (a), the Secretary shall determine the classification of the article or the component of the Food and Drug Administration that will regulate the article and shall provide to the person a written statement that identifies the classification of the article or the component of the Food and Drug Administration that will regulate the article and the reasons for such determination. The Secretary may not modify such statement except with the written consent of the person or for public health reasons. ``(c) Inaction of Secretary.--If the Secretary does not provide the statement within the 60-day period described in subsection (b), the recommendation made by the person under subsection (a) shall be considered to be a final determination by the Secretary of the classification of the article or the component of the Food and Drug Administration that will regulate the article and may not be modified by the Secretary except with the written consent of the person or for public health reasons.''. SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL. (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows: ``(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in-- ``(i) approving another device; ``(ii) determining whether a product development protocol has been completed, under section 515 for another device; ``(iii) establishing a performance standard or special control under this Act; or ``(iv) classifying or reclassifying another device under section 513 and subsection (l)(2). ``(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency action described in subparagraph (A).''. (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 360g(a)) is amended-- (1) in paragraph (8), by adding ``or'' at the end; (2) in paragraph (9), by striking ``, or'' and inserting a comma; and (3) by striking paragraph (10). SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT REVIEW. (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 360e(d)(1)(A)) is amended by adding at the end the following flush sentences: ``In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.''. (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is amended by adding at the end the following: ``(C) Whenever the Secretary requests information to demonstrate that the devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to make a substantial equivalence determination. In making such a request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and shall request information accordingly. ``(D) The determinations of the Secretary under this section and section 513(f)(1) with respect to the intended use of a device shall be based on the intended use included in proposed labeling of the device submitted in a report under section 510(k).''. [[Page S9137]] SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: ``(ii) In any provision relating to a review of any application or submission (including a petition, notification, and any other similar form of request), made under this Act with respect to an article that is a new drug, device, biological product, new animal drug, an animal feed bearing or containing a new animal drug, color additive, or food additive, that is submitted to the Secretary to obtain marketing approval, to obtain classification of a device under section 513(f)(1), or to establish or clarify the regulatory status of the article-- ``(1) the term `day' means a calendar day in which the Secretary has responsibility to review such an application or submission; and ``(2) a reference to a date relating to the receipt of such an application or submission by the Secretary shall be deemed to be a reference to the date on which the Secretary receives a complete application or submission within the meaning of this Act and the regulations promulgated under this Act.''. SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES. (a) Clarification on the 90-Day Timeframe for Premarket Notification Reviews.--Section 510(k) (21 U.S.C. 360) is amended by adding at the end the following flush sentence: ``The Secretary shall review the notification required by this subsection and make a determination under section 513(f)(1) not later than 90 days after receiving the notification.''. (b) Certainty of 180-Day Review Timeframe.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is amended by inserting after paragraph (2) the following: ``(3) Except as provided in paragraph (1), the period for the review of an application by the Secretary under this subsection shall be not more than 180 days. Such period may not be restarted or extended even if the application is amended.''. SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION DETERMINATIONS. Section 510 (21 U.S.C. 360) is amended by adding at the end the following: ``(m) The Secretary may not withhold a determination of the initial classification of a device under section 513(f)(1) because of a failure to comply with any provision of this Act that is unrelated to a substantial equivalence decision, including a failure to comply with the requirements relating to good manufacturing practices under section 520(f).''. SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND SPECIFIC USE OF A DEVICE. Not later than 270 days after the date of enactment of this section, the Secretary of Health and Human Services shall promulgate a final regulation specifying the general principles that the Secretary of Health and Human Services will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)). SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL. (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking ``clinical investigations'' and inserting ``1 or more clinical investigations''. (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: ``Substantial evidence may, as appropriate, consist of data from 1 adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation), if the Secretary determines, based on relevant science, that such data and evidence are sufficient to establish effectiveness.''. SEC. 410. PROHIBITED ACTS. Section 301(l) (21 U.S.C. 331(l)) is repealed. TITLE V--IMPROVING ACCOUNTABILITY SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL REPORT. Section 903(b) (21 U.S.C. 393(b)), as amended by section 201, is further amended by adding at the end the following: ``(4) Agency plan for statutory compliance.-- ``(A) In general.--Not later than 180 days after the date of enactment of this paragraph, the Secretary, after consultation with relevant experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act and other relevant statutes. The Secretary shall biannually review the plan and shall revise the plan as necessary, in consultation with such persons. ``(B) Objectives of agency plan.--The plan required by subparagraph (A) shall establish objectives, and mechanisms to be used by the Secretary, acting through the Commissioner, including objectives and mechanisms that-- ``(i) minimize deaths of, and harm to, persons who use or may use an article regulated under this Act; ``(ii) maximize the clarity of, and the availability of information about, the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act, including information for potential consumers and patients concerning new products; ``(iii) implement all inspection and postmarket monitoring provisions of this Act by July 1, 1999; ``(iv) ensure access to the scientific and technical expertise necessary to ensure compliance by the Secretary with the statutory obligations described in subparagraph (A); ``(v) establish a schedule to bring the Administration into full compliance by July 1, 1999, with the time periods specified in this Act for the review of all applications and submissions described in clause (ii) and submitted after the date of enactment of this paragraph; and ``(vi) reduce backlogs in the review of all applications and submissions described in clause (ii) for any article with the objective of eliminating all backlogs in the review of the applications and submissions by January 1, 2000. ``(5) Annual report.-- ``(A) Contents.--The Secretary shall prepare and publish in the Federal Register and solicit public comment on an annual report that-- ``(i) provides detailed statistical information on the performance of the Secretary under the plan described in paragraph (4); ``(ii) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; ``(iii) analyzes any failure of the Secretary to achieve any objective of the plan or to meet any statutory obligation; ``(iv) identifies any regulatory policy that has a significant impact on compliance with any objective of the plan or any statutory obligation; and ``(v) sets forth any proposed revision to any such regulatory policy, or objective of the plan that has not been met. ``(B) Statistical information.--The statistical information described in subparagraph (A)(i) shall include a full statistical presentation relating to all applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act and approved or subject to final action by the Secretary during the year covered by the report. In preparing the statistical presentation, the Secretary shall take into account the date of-- ``(i) the submission of any investigational application; ``(ii) the application of any clinical hold; ``(iii) the submission of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for approval or clearance; ``(iv) the acceptance for filing of any application or submission described in clause (iii) for approval or clearance; ``(v) the occurrence of any unapprovable action; ``(vi) the occurrence of any approvable action; and ``(vii) the approval or clearance of any application or submission described in clause (iii).''. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES SEC. 601. MINOR MODIFICATIONS. (a) Action on Investigational Device Exemptions.--Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: ``(6)(A) The Secretary shall, not later than 120 days after the date of enactment of this paragraph, by regulation modify parts 812 and 813 of title 21, Code of Federal Regulations to update the procedures and conditions under which a device intended for human use may, upon application by the sponsor of the device, be granted an exemption from the requirements of this Act. ``(B) The regulation shall permit developmental changes in a device (including manufacturing changes) in response to information collected during an investigation without requiring an additional approval of an application for an investigational device exemption or the approval of a supplement to such application, if the sponsor of the investigation determines, based on credible information, prior to making any such changes, that the changes-- ``(i) do not affect the scientific soundness of an investigational plan submitted under paragraph (3)(A) or the rights, safety, or welfare of the human subjects involved in the investigation; and ``(ii) do not constitute a significant change in design, or a significant change in basic principles of operation, of the device.''. (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 360e(d)(1)(B)) is amended by adding at the end the following: ``(iii) The Secretary shall accept and review data and any other information from investigations conducted under the authority of regulations required by section 520(g), to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if-- ``(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or ``(II) the data or information relates to a device approved under this section, is available for use under this Act, and is relevant to the design and intended use of the device for which the application is pending.''. (c) Action on Supplements.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is further amended by adding at the end the following: ``(6)(A)(i) A supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 520(f). [[Page S9138]] ``(ii) The holder of an approved application who submits a notice under clause (i) with respect to a manufacturing change of a device shall not distribute the device for a period of 14 days after the date on which the Secretary receives the notice. ``(B)(i) Subject to clause (ii), in reviewing a supplement to an approved application, for an incremental change to the design of a device that affects safety or effectiveness, the Secretary shall approve such supplement if-- ``(I) nonclinical data demonstrate that the design modification creates the intended additional capacity, function, or performance of the device; and ``(II) clinical data from the approved application and any supplement to the approved application provide a reasonable assurance of safety and effectiveness for the changed device. ``(ii) The Secretary may require, when necessary, additional clinical data to evaluate the design modification to provide a reasonable assurance of safety and effectiveness.''. SEC. 602. ENVIRONMENTAL IMPACT REVIEW. Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is further amended by adding at the end the following: ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW. ``Notwithstanding any other provision of law, no action by the Secretary pursuant to this Act shall be subject to an environmental assessment, an environmental impact statement, or other environmental consideration unless the Secretary demonstrates, in writing-- ``(1) that there is a reasonable probability that the environmental impact of the action is sufficiently substantial and within the factors that the Secretary is authorized to consider under this Act; and ``(2) that consideration of the environmental impact will directly affect the decision on the action.''. SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM PREMARKET NOTIFICATION REQUIREMENT. (a) Class I and Class II Devices.--Section 510(k) (21 U.S.C. 360(k)) is amended by striking ``intended for human use'' and inserting ``intended for human use (except a device that is classified into class I under section 513 or 520 unless the Secretary determines such device is intended for a use that is of substantial importance in preventing impairment of human health or such device presents a potential unreasonable risk of illness or injury, or a device that is classified into class II under section 513 or 520 and is exempt from the requirements of this subsection under subsection (l))''. (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) is amended by inserting after subsection (k) the following: ``(l)(1) Not later than 30 days after the date of enactment of this subsection, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a notification under subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary not to require the notification shall be exempt from the requirement to provide notification under subsection (k) as of the date of the publication of the list in the Federal Register. ``(2) Beginning on the date that is 1 day after the date of the publication of a list under this subsection, the Secretary may exempt a class II device from the notification requirement of subsection (k), upon the Secretary's own initiative or a petition of an interested person, if the Secretary determines that such notification is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 30-day comment period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice.''. SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION. Section 513(f) (21 U.S.C. 360c(f)) is amended-- (1) in paragraph (1)-- (A) in subparagraph (B), by striking ``paragraph (2)'' and inserting ``paragraph (3)''; and (B) in the last sentence, by striking ``paragraph (2)'' and inserting ``paragraph (2) or (3)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A) Any person who submits a report under section 510(k) for a type of device that has not been previously classified under this Act, and that is classified into class III under paragraph (1), may request, within 30 days after receiving written notice of such a classification, the Secretary to classify the device into class I or II under the criteria set forth in subparagraphs (A) through (C) subsection (a)(1). The person may, in the request, recommend to the Secretary a classification for the device. The request shall describe the device and provide detailed information and reasons for the recommended classification. ``(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A) for classification of a device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1), the Secretary shall by written order classify the device. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph into class I or II shall be a predicate device for determining substantial equivalence under paragraph (1). ``(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 501(f)(1)(B) until approved under section 515 or exempted from such approval under section 520(g). ``(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.''. SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES. (a) Release of Information.--Section 519(e) (21 U.S.C. 360i(e)) is amended by adding at the end the following flush sentence: ``Any patient receiving a device subject to tracking under this section may refuse to release, or refuse permission to release, the patient's name, address, social security number, or other identifying information for the purpose of tracking.''. (b) Publication of Certain Devices.--Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall develop and publish in the Federal Register a list that identifies each type of device subject to tracking under section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each device not identified by the Secretary of Health and Human Services under this subsection or designated by the Secretary under section 519(e)(2) shall be deemed to be exempt from the mandatory tracking requirement under section 519 of such Act. The Secretary of Health and Human Services shall have authority to modify the list of devices exempted from the mandatory tracking requirements. SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET SURVEILLANCE. (a) In General.--Section 522 (21 U.S.C. 360l) is amended by striking ``Sec. 522.'' and all that follows through ``(2) Discretionary surveillance.--The'' and inserting the following: ``Sec. 522. (a) Discretionary Surveillance.--The''. (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 360l(b)) is amended to read as follows: ``(b) Surveillance Approval.-- ``(1) In general.--Each manufacturer that receives notice from the Secretary that the manufacturer is required to conduct surveillance of a device under subsection (a) shall, not later than 30 days after receiving the notice, submit for the approval of the Secretary, a plan for the required surveillance. ``(2) Determination.--Not later than 60 days after the receipt of the plan, the Secretary shall determine if a person proposed in the plan to conduct the surveillance has sufficient qualifications and experience to conduct the surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health and to provide safety and effectiveness information for the device. ``(3) Limitation on plan approval.--The Secretary may not approve the plan until the plan has been reviewed by a qualified scientific and technical review committee established by the Secretary.''. (c) Duration of Surveillance.--Section 522 (21 U.S.C. 360l), as amended by subsection (b), is further amended by adding at the end the following: ``(c) Duration of Surveillance.-- ``(1) In general.--Each manufacturer required to conduct surveillance of a device under subsection (a) shall be required to conduct such surveillance for not longer than 24 months. ``(2) Extension of the period of surveillance.--If the Secretary determines that additional surveillance is needed to identify the incidence of adverse events documented during the initial period of surveillance that were not foreseen at the time of approval or classification of the device, the Secretary may extend the period of surveillance for such time as may be necessary after providing the person required to conduct such surveillance an opportunity for an informal hearing to determine whether or not additional surveillance is appropriate and to determine the appropriate period, if any, for such surveillance.''. SEC. 607. REPORTING. (a) Reports.--Section 519 (21 U.S.C. 360i) is amended-- (1) in subsection (a)-- (A) in the first sentence by striking ``make such reports, and provide such information,'' and inserting ``and submit such samples and components of devices (as required by paragraph (10)),''; and (B) by inserting after the first sentence the following: ``Every person who is a manufacturer or importer of a device intended for human use shall make reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to assure the safety and effectiveness of such device.''; (C) in the last sentence by striking ``sentence'' and inserting ``sentences''; (D) in paragraph (8), by striking ``; and'' and inserting a semicolon; and (E) by striking paragraph (9) and inserting the following: ``(9) shall require distributors to keep records and make such records available to the Secretary upon request; and''; (2) by striking subsection (d); and (3) in subsection (f), by striking ``, importer, or distributor'' each place it appears and inserting ``or importer''. (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended-- (1) by redesignating paragraph (4) as paragraph (5); (2) by inserting after paragraph (3), the following: ``(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or''; and (3) by adding at the end the following flush sentence: [[Page S9139]] ``In this subsection, the term `wholesale distributor' means any person who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.''. SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE. Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end the following: ``(4) A new drug manufactured in a pilot or o

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FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997
(Senate - September 11, 1997)

Text of this article available as: TXT PDF [Pages S9133-S9157] FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 1997 The PRESIDING OFFICER. The clerk will report the bill. The legislative clerk read as follows: A bill (S. 830) to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes, which had been reported from to the Committee on Labor and Human Resources, with an amendment to strike all after the enacting clause and inserting in lieu thereof the following: SECTION 1. SHORT TITLE. This Act may be cited as the ``Food and Drug Administration Modernization and Accountability Act of 1997''. SEC. 2. TABLE OF CONTENTS. The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. References. TITLE I--IMPROVING PATIENT ACCESS Sec. 101. Mission of the Food and Drug Administration. Sec. 102. Expedited access to investigational therapies. Sec. 103. Expanded humanitarian use of devices. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES Sec. 201. Interagency collaboration. Sec. 202. Sense of the committee regarding mutual recognition agreements and global harmonization efforts. Sec. 203. Contracts for expert review. Sec. 204. Accredited-party reviews. Sec. 205. Device performance standards. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION Sec. 301. Collaborative determinations of device data requirements. Sec. 302. Collaborative review process. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES Sec. 401. Policy statements. Sec. 402. Product classification. Sec. 403. Use of data relating to premarket approval. Sec. 404. Consideration of labeling claims for product review. [[Page S9134]] Sec. 405. Definition of a day for purposes of product review. Sec. 406. Certainty of review timeframes. Sec. 407. Limitations on initial classification determinations. Sec. 408. Clarification with respect to a general use and specific use of a device. Sec. 409. Clarification of the number of required clinical investigations for approval. Sec. 410. Prohibited acts. TITLE V--IMPROVING ACCOUNTABILITY Sec. 501. Agency plan for statutory compliance and annual report. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES Sec. 601. Minor modifications. Sec. 602. Environmental impact review. Sec. 603. Exemption of certain classes of devices from premarket notification requirement. Sec. 604. Evaluation of automatic class III designation. Sec. 605. Secretary's discretion to track devices. Sec. 606. Secretary's discretion to conduct postmarket surveillance. Sec. 607. Reporting. Sec. 608. Pilot and small-scale manufacture. Sec. 609. Requirements for radiopharmaceuticals. Sec. 610. Modernization of regulation of biological products. Sec. 611. Approval of supplemental applications for approved products. Sec. 612. Health care economic information. Sec. 613. Expediting study and approval of fast track drugs. Sec. 614. Manufacturing changes for drugs and biologics. Sec. 615. Data requirements for drugs and biologics. Sec. 616. Food contact substances. Sec. 617. Health claims for food products. Sec. 618. Pediatric studies marketing exclusivity. Sec. 619. Positron emission tomography. TITLE VII--FEES RELATING TO DRUGS Sec. 701. Short title. Sec. 702. Findings. Sec. 703. Definitions. Sec. 704. Authority to assess and use drug fees. Sec. 705. Annual reports. Sec. 706. Effective date. Sec. 707. Termination of effectiveness. TITLE VIII--MISCELLANEOUS Sec. 801. Registration of foreign establishments. Sec. 802. Elimination of certain labeling requirements. Sec. 803. Clarification of seizure authority. Sec. 804. Intramural research training award program. Sec. 805. Device samples. Sec. 806. Interstate commerce. Sec. 807. National uniformity for nonprescription drugs and cosmetics. Sec. 808. Information program on clinical trials for serious or life- threatening diseases. Sec. 809. Application of Federal law to the practice of pharmacy compounding. SEC. 3. REFERENCES. Except as otherwise expressly provided, wherever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). TITLE I--IMPROVING PATIENT ACCESS SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION. Section 903 (21 U.S.C. 393) is amended-- (1) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (2) by inserting after subsection (a) the following: ``(b) Mission.-- ``(1) In general.--The Administration shall protect the public health by ensuring that-- ``(A) foods are safe, wholesome, sanitary, and properly labeled; ``(B) human and veterinary drugs are safe and effective; ``(C) there is reasonable assurance of safety and effectiveness of devices intended for human use; ``(D) cosmetics are safe; and ``(E) public health and safety are protected from electronic product radiation. ``(2) Special rules.--The Administration shall promptly and efficiently review clinical research and take appropriate action on the marketing of regulated products in a manner that does not unduly impede innovation or product availability. The Administration shall participate with other countries to reduce the burden of regulation, to harmonize regulatory requirements, and to achieve appropriate reciprocal arrangements with other countries.''. SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES. Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``Subchapter D--Unapproved Therapies and Diagnostics ``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS. ``(a) In General.--Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may provide to a person after compliance with the provisions of this section, an investigational drug (including a biological product) or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition, or any other disease or condition designated by the Secretary as appropriate for expanded access under this section if-- ``(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved; ``(2) the licensed physician determines that the risk to the person from the investigational drug or investigational device is not greater than the risk from the disease or condition; ``(3) the Secretary determines that an exemption for the investigational drug or investigational device is in effect under a regulation promulgated pursuant to section 505(i) or 520(g) and the sponsor of the drug or device and investigators comply with such regulation; ``(4) the Secretary determines that the manufacturer of the investigational drug or investigational device is actively pursuing marketing approval with due diligence; ``(5) the Secretary determines that expanded access to the investigational drug or investigational device will not interfere with adequate enrollment of patients by the investigator in the ongoing clinical investigation of the investigational drug or investigational device authorized under section 505(i) or 520(g); and ``(6) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the expanded use of the investigational drug or investigational device in accordance with this section. ``(b) Protocols.--A manufacturer or distributor may submit to the Secretary 1 or more expanded access protocols covering expanded access use of a drug or device described in subsection (a). The protocols shall be subject to the provisions of section 505(i) or 520(g) and may include any form of use of the drug or device outside a clinical investigation, prior to approval of the drug or device for marketing, including protocols for treatment use, emergency use, or uncontrolled trials, and single patient protocols. If the request for expanded access to an investigational drug or investigational device is intended for a single patient only, the Secretary may waive the requirements of paragraphs (3) and (4) of subsection (a) and accept a submission under section 505(i) or 520(g) for an exemption for the investigational drug or investigational device for the single patient use. In the case of an emergency that does not allow sufficient time for a submission under section 505(i) or 520(g), the Secretary may, prior to the submission, authorize the shipment of the investigational drug or investigational device for a single patient use. ``(c) Notification of Availability.--The Secretary shall inform national, State, and local medical associations and societies, voluntary health associations, and other appropriate persons about the availability of an investigational drug or investigational device under expanded access protocols submitted under this section, except that this subsection shall not apply to expanded access protocols for single patient use. ``(d) Termination.--The Secretary may at anytime terminate expanded access provided under subsection (a) for an investigational drug or investigational device if the requirements under this section are no longer met.''. SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES. Section 520(m) (21 U.S.C. 360j(m)) is amended-- (1) in paragraph (2), by adding at the end the following flush sentences: ``The request shall be in the form of an application submitted to the Secretary. Not later than 60 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.''; (2) in paragraph (4)-- (A) in subparagraph (B), by inserting after ``(2)(A)'' the following: ``, unless a physician determines that waiting for such an approval from an institutional review committee will cause harm or death to a patient, and makes a good faith effort to obtain the approval, and does not receive a timely response from an institutional review committee on the request of the physician for approval to use the device for such treatment or diagnosis''; and (B) by adding at the end the following flush sentences: ``In a case in which a physician described in subparagraph (B) uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.''; and (3) by striking paragraph (5) and inserting the following: ``(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met.''. TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES SEC. 201. INTERAGENCY COLLABORATION. Section 903(b) (21 U.S.C. 393(b)), as added by section 101(2), is amended by adding at the end the following: ``(3) Interagency collaboration.--The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.''. [[Page S9135]] SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS. It is the sense of the Committee on Labor and Human Resources of the Senate that-- (1) the Secretary of Health and Human Services should support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States; (2) the Secretary of Health and Human Services should regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements; and (3) the Office of International Relations of the Department of Health and Human Services (as established under section 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 383)) should have the responsibility of ensuring that the process of harmonizing international regulatory requirements is continuous. SEC. 203. CONTRACTS FOR EXPERT REVIEW. Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at the end the following: ``SEC. 906. CONTRACTS FOR EXPERT REVIEW. ``(a) In General.-- ``(1) Authority.--The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with expertise in a relevant discipline, to review, evaluate, and make recommendations to the Secretary on part or all of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for the approval or classification of an article or made under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with respect to a biological product. Any such contract shall be subject to the requirements of section 708 relating to the confidentiality of information. ``(2) Increased efficiency and expertise through contracts.--The Secretary shall use the authority granted in paragraph (1) whenever the Secretary determines that a contract described in paragraph (1) will improve the timeliness or quality of the review of an application or submission described in paragraph (1). Such improvement may include providing the Secretary increased scientific or technical expertise that is necessary to review or evaluate new therapies and technologies. ``(b) Review of Expert Review.-- ``(1) In general.--Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or individual who conducted the expert review and shall make a final decision regarding the matter within 60 days after receiving the recommendations. ``(2) Limitation.--A final decision under paragraph (1) shall be made within the applicable prescribed time period for review of the matter as set forth in this Act or in the Public Health Service Act (42 U.S.C. 201 et seq.). ``(3) Authority of secretary.--Notwithstanding subsection (a), the Secretary shall retain full authority to make determinations with respect to the approval or disapproval of an article under this Act, the approval or disapproval of a biologics license with respect to a biological product under section 351(a) of the Public Health Service Act, or the classification of an article as a device under section 513(f)(1).''. SEC. 204. ACCREDITED-PARTY REVIEWS. Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the following: ``SEC. 523. ACCREDITED-PARTY PARTICIPATION. ``(a) Accreditation.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall accredit entities or individuals who are not employees of the Federal Government, to review reports made to the Secretary under section 510(k) for devices and make recommendations to the Secretary regarding the initial classification of such devices under section 513(f)(1), except that this paragraph shall not apply to reports made to the Secretary under section 510(k) for devices that are-- ``(A) life-supporting; ``(B) life sustaining; or ``(C) intended for implantation in the human body for a period of over 1 year. ``(2) Special rule.--The Secretary shall have the discretion to accredit entities or individuals who are not employees of the Federal Government-- ``(A) to review reports made to the Secretary under section 510(k) for devices described in subparagraphs (A) through (C) of paragraph (1), and make recommendations of initial classification of such devices; or ``(B) to review applications for premarket approval for class III devices under section 515 and make recommendations with respect to the approval or disapproval of such applications. ``(b) Accreditation.--Within 180 days after the date of enactment of this section, the Secretary shall adopt methods of accreditation that ensure that entities or individuals who conduct reviews and make recommendations under this section are qualified, properly trained, knowledgeable about handling confidential documents and information, and free of conflicts of interest. The Secretary shall publish the methods of accreditation in the Federal Register on the adoption of the methods. ``(c) Withdrawal of Accreditation.--The Secretary may suspend or withdraw the accreditation of any entity or individual accredited under this section, after providing notice and an opportunity for an informal hearing, if such entity or individual acts in a manner that is substantially not in compliance with the requirements established by the Secretary under subsection (b), including the failure to avoid conflicts of interest, the failure to protect confidentiality of information, or the failure to competently review premarket submissions for devices. ``(d) Selection and Compensation.--Subject to subsection (a)(2), a person who intends to make a report described in subsection (a), or to submit an application described in subsection (a), to the Secretary shall have the option to select an accredited entity or individual to review such report or application. Upon the request by a person to have a report or application reviewed by an accredited entity or individual, the Secretary shall identify for the person no less than 2 accredited entities or individuals from whom the selection may be made. Compensation for an accredited entity or individual shall be determined by agreement between the accredited entity or individual and the person who engages the services of the accredited entity or individual and shall be paid by the person who engages such services. ``(e) Review by Secretary.-- ``(1) In general.--The Secretary shall require an accredited entity or individual, upon making a recommendation under this section with respect to an initial classification of a device or approval or disapproval of an application for premarket approval, to notify the Secretary in writing of the reasons for such recommendation. ``(2) Time period for review.-- ``(A) Initial classification.--Not later than 30 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. ``(B) Premarket approval.--Not later than 60 days after the date on which the Secretary is notified under paragraph (1) by an accredited entity or individual with respect to a recommendation of an approval or disapproval of an application for a device, the Secretary shall make a determination with respect to the approval or disapproval. ``(3) Special rule.--The Secretary may change the initial classification under section 513(f)(1), or the approval or disapproval of the application under section 515(d), that is recommended by the accredited entity or individual under this section, and in such case shall notify in writing the person making the report or application described in subsection (a) of the detailed reasons for the change. ``(f) Duration.--The authority provided by this section terminates-- ``(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) are available to review devices for each of at least 70 percent of the generic types of devices subject to review under subsection (a); or ``(2) 4 years after the date on which the Secretary notifies Congress that at least 35 percent of the devices that are subject to review under subsection (a), and that were the subject of final action by the Secretary in the fiscal year preceding the date of such notification, were reviewed by the Secretary under subsection (e), whichever occurs first. ``(g) Report.-- ``(1) In general.--Not later than 1 year after the date of enactment of this section, the Secretary shall contract with an independent research organization to prepare and submit to the Secretary a written report examining the use of accredited entities and individuals to conduct reviews under this section. The Secretary shall submit the report to Congress not later than 6 months prior to the conclusion of the applicable period described in subsection (f). ``(2) Contents.--The report by the independent research organization described in paragraph (1) shall identify the benefits or detriments to public and patient health of using accredited entities and individuals to conduct such reviews, and shall summarize all relevant data, including data on the review of accredited entities and individuals (including data on the review times, recommendations, and compensation of the entities and individuals), and data on the review of the Secretary (including data on the review times, changes, and reasons for changes of the Secretary).''. SEC. 205. DEVICE PERFORMANCE STANDARDS. (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended by adding at the end the following: ``Recognition of a Standard ``(c)(1)(A) In addition to establishing performance standards under this section, the Secretary may, by publication in the Federal Register, recognize all or part of a performance standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet premarket submission requirements or other requirements under this Act to which such standards are applicable. ``(B) If a person elects to use a performance standard recognized by the Secretary under subparagraph (A) to meet the requirements described in subparagraph (A), the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to fulfill or satisfy any requirement under this Act. ``(2) The Secretary may withdraw such recognition of a performance standard through publication of a notice in the Federal Register that the Secretary will no longer recognize the [[Page S9136]] standard, if the Secretary determines that the standard is no longer appropriate for meeting the requirements under this Act. ``(3)(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds-- ``(i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or ``(ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review. ``(B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1). ``(C) A person relying on a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of 2 years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.''. (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding at the end the following: ``(x) The falsification of a declaration of conformity submitted under subsection (c) of section 514 or the failure or refusal to provide data or information requested by the Secretary under section 514(c)(3).''. (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended-- (1) by striking ``(e)'' and inserting ``(e)(1)''; and (2) by inserting at the end the following: ``(2) If it is, declared to be, purports to be, or is represented as, a device that is in conformity with any performance standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.''. TITLE III--IMPROVING COLLABORATION AND COMMUNICATION SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA REQUIREMENTS. Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding at the end the following: ``(C)(i)(I) The Secretary, upon the written request of any person intending to submit an application under section 515, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate the effectiveness of a device for the conditions of use proposed by such person, to support an approval of an application. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, and, if available, information regarding the expected performance from the device. Within 30 days after such meeting, the Secretary shall specify in writing the type of valid scientific evidence that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person. ``(II) Any clinical data, including 1 or more well- controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary-- ``(aa) that such data are necessary to establish device effectiveness; and ``(bb) that no other less burdensome means of evaluating device effectiveness is available that would have a reasonable likelihood of resulting in an approval. ``(ii) The determination of the Secretary with respect to the specification of valid scientific evidence under clause (i) shall be binding upon the Secretary, unless-- ``(I) such determination by the Secretary would be contrary to the public health; or ``(II) based on new information (other than the information reviewed by the Secretary in making such determination) obtained by the Secretary prior to the approval of an application for an investigational device exemption under section 520(g), the Secretary finds that such determination is scientifically inappropriate.''. SEC. 302. COLLABORATIVE REVIEW PROCESS. Section 515(d) (21 U.S.C. 360e(d)) is amended-- (1) in paragraph (1)(A), by striking ``paragraph (2) of this subsection'' each place it appears and inserting ``paragraph (4)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A)(i) The Secretary shall, upon the written request of the applicant involved, meet with the applicant not later than 100 days after the receipt of an application, from the applicant, that has been filed as complete under subsection (c), to discuss the review status of the application. ``(ii) If the application does not appear in a form that would require an approval under this subsection, the Secretary shall in writing, and prior to the meeting, provide to the applicant a description of any deficiencies in the application identified by the Secretary and identify the information (other than information the Secretary needs to make a finding under paragraph (4)(C)) that is required to bring the application into an approvable form. ``(iii) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph. ``(B) The Secretary shall notify the applicant immediately of any deficiency identified in the application that was not described as a deficiency in the written description provided by the Secretary under subparagraph (A).''. TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES SEC. 401. POLICY STATEMENTS. Section 701(a) (21 U.S.C. 371(a)) is amended-- (1) by striking ``(a) The'' and inserting ``(a)(1) The''; and (2) by adding at the end the following: ``(2) Not later than February 27, 1999, the Secretary, after evaluating the effectiveness of the Good Guidance Practices document published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.''. SEC. 402. PRODUCT CLASSIFICATION. Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end the following: ``Subchapter D--Classification of Products and Environmental Impact Reviews ``SEC. 741. CLASSIFICATION OF PRODUCTS. ``(a) Request.--A person who submits an application or submission (including a petition, notification, and any other similar form of request) under this Act, may submit a request to the Secretary respecting the classification of an article (including an article that is a combination product subject to section 503(g)) as a drug, biological product, or device, or respecting the component of the Food and Drug Administration that will regulate the article. In submitting the request, the person shall recommend a classification for the article, or a component to regulate the article, as appropriate. ``(b) Statement.--Not later than 60 days after the receipt of the request described in subsection (a), the Secretary shall determine the classification of the article or the component of the Food and Drug Administration that will regulate the article and shall provide to the person a written statement that identifies the classification of the article or the component of the Food and Drug Administration that will regulate the article and the reasons for such determination. The Secretary may not modify such statement except with the written consent of the person or for public health reasons. ``(c) Inaction of Secretary.--If the Secretary does not provide the statement within the 60-day period described in subsection (b), the recommendation made by the person under subsection (a) shall be considered to be a final determination by the Secretary of the classification of the article or the component of the Food and Drug Administration that will regulate the article and may not be modified by the Secretary except with the written consent of the person or for public health reasons.''. SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL. (a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows: ``(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in-- ``(i) approving another device; ``(ii) determining whether a product development protocol has been completed, under section 515 for another device; ``(iii) establishing a performance standard or special control under this Act; or ``(iv) classifying or reclassifying another device under section 513 and subsection (l)(2). ``(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency action described in subparagraph (A).''. (b) Conforming Amendment.--Section 517(a) (21 U.S.C. 360g(a)) is amended-- (1) in paragraph (8), by adding ``or'' at the end; (2) in paragraph (9), by striking ``, or'' and inserting a comma; and (3) by striking paragraph (10). SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT REVIEW. (a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C. 360e(d)(1)(A)) is amended by adding at the end the following flush sentences: ``In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.''. (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is amended by adding at the end the following: ``(C) Whenever the Secretary requests information to demonstrate that the devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to make a substantial equivalence determination. In making such a request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and shall request information accordingly. ``(D) The determinations of the Secretary under this section and section 513(f)(1) with respect to the intended use of a device shall be based on the intended use included in proposed labeling of the device submitted in a report under section 510(k).''. [[Page S9137]] SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: ``(ii) In any provision relating to a review of any application or submission (including a petition, notification, and any other similar form of request), made under this Act with respect to an article that is a new drug, device, biological product, new animal drug, an animal feed bearing or containing a new animal drug, color additive, or food additive, that is submitted to the Secretary to obtain marketing approval, to obtain classification of a device under section 513(f)(1), or to establish or clarify the regulatory status of the article-- ``(1) the term `day' means a calendar day in which the Secretary has responsibility to review such an application or submission; and ``(2) a reference to a date relating to the receipt of such an application or submission by the Secretary shall be deemed to be a reference to the date on which the Secretary receives a complete application or submission within the meaning of this Act and the regulations promulgated under this Act.''. SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES. (a) Clarification on the 90-Day Timeframe for Premarket Notification Reviews.--Section 510(k) (21 U.S.C. 360) is amended by adding at the end the following flush sentence: ``The Secretary shall review the notification required by this subsection and make a determination under section 513(f)(1) not later than 90 days after receiving the notification.''. (b) Certainty of 180-Day Review Timeframe.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is amended by inserting after paragraph (2) the following: ``(3) Except as provided in paragraph (1), the period for the review of an application by the Secretary under this subsection shall be not more than 180 days. Such period may not be restarted or extended even if the application is amended.''. SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION DETERMINATIONS. Section 510 (21 U.S.C. 360) is amended by adding at the end the following: ``(m) The Secretary may not withhold a determination of the initial classification of a device under section 513(f)(1) because of a failure to comply with any provision of this Act that is unrelated to a substantial equivalence decision, including a failure to comply with the requirements relating to good manufacturing practices under section 520(f).''. SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND SPECIFIC USE OF A DEVICE. Not later than 270 days after the date of enactment of this section, the Secretary of Health and Human Services shall promulgate a final regulation specifying the general principles that the Secretary of Health and Human Services will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)). SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL. (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking ``clinical investigations'' and inserting ``1 or more clinical investigations''. (b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: ``Substantial evidence may, as appropriate, consist of data from 1 adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation), if the Secretary determines, based on relevant science, that such data and evidence are sufficient to establish effectiveness.''. SEC. 410. PROHIBITED ACTS. Section 301(l) (21 U.S.C. 331(l)) is repealed. TITLE V--IMPROVING ACCOUNTABILITY SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL REPORT. Section 903(b) (21 U.S.C. 393(b)), as amended by section 201, is further amended by adding at the end the following: ``(4) Agency plan for statutory compliance.-- ``(A) In general.--Not later than 180 days after the date of enactment of this paragraph, the Secretary, after consultation with relevant experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this Act and other relevant statutes. The Secretary shall biannually review the plan and shall revise the plan as necessary, in consultation with such persons. ``(B) Objectives of agency plan.--The plan required by subparagraph (A) shall establish objectives, and mechanisms to be used by the Secretary, acting through the Commissioner, including objectives and mechanisms that-- ``(i) minimize deaths of, and harm to, persons who use or may use an article regulated under this Act; ``(ii) maximize the clarity of, and the availability of information about, the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act, including information for potential consumers and patients concerning new products; ``(iii) implement all inspection and postmarket monitoring provisions of this Act by July 1, 1999; ``(iv) ensure access to the scientific and technical expertise necessary to ensure compliance by the Secretary with the statutory obligations described in subparagraph (A); ``(v) establish a schedule to bring the Administration into full compliance by July 1, 1999, with the time periods specified in this Act for the review of all applications and submissions described in clause (ii) and submitted after the date of enactment of this paragraph; and ``(vi) reduce backlogs in the review of all applications and submissions described in clause (ii) for any article with the objective of eliminating all backlogs in the review of the applications and submissions by January 1, 2000. ``(5) Annual report.-- ``(A) Contents.--The Secretary shall prepare and publish in the Federal Register and solicit public comment on an annual report that-- ``(i) provides detailed statistical information on the performance of the Secretary under the plan described in paragraph (4); ``(ii) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; ``(iii) analyzes any failure of the Secretary to achieve any objective of the plan or to meet any statutory obligation; ``(iv) identifies any regulatory policy that has a significant impact on compliance with any objective of the plan or any statutory obligation; and ``(v) sets forth any proposed revision to any such regulatory policy, or objective of the plan that has not been met. ``(B) Statistical information.--The statistical information described in subparagraph (A)(i) shall include a full statistical presentation relating to all applications and submissions (including petitions, notifications, and any other similar forms of request) made under this Act and approved or subject to final action by the Secretary during the year covered by the report. In preparing the statistical presentation, the Secretary shall take into account the date of-- ``(i) the submission of any investigational application; ``(ii) the application of any clinical hold; ``(iii) the submission of any application or submission (including a petition, notification, and any other similar form of request) made under this Act for approval or clearance; ``(iv) the acceptance for filing of any application or submission described in clause (iii) for approval or clearance; ``(v) the occurrence of any unapprovable action; ``(vi) the occurrence of any approvable action; and ``(vii) the approval or clearance of any application or submission described in clause (iii).''. TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES SEC. 601. MINOR MODIFICATIONS. (a) Action on Investigational Device Exemptions.--Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: ``(6)(A) The Secretary shall, not later than 120 days after the date of enactment of this paragraph, by regulation modify parts 812 and 813 of title 21, Code of Federal Regulations to update the procedures and conditions under which a device intended for human use may, upon application by the sponsor of the device, be granted an exemption from the requirements of this Act. ``(B) The regulation shall permit developmental changes in a device (including manufacturing changes) in response to information collected during an investigation without requiring an additional approval of an application for an investigational device exemption or the approval of a supplement to such application, if the sponsor of the investigation determines, based on credible information, prior to making any such changes, that the changes-- ``(i) do not affect the scientific soundness of an investigational plan submitted under paragraph (3)(A) or the rights, safety, or welfare of the human subjects involved in the investigation; and ``(ii) do not constitute a significant change in design, or a significant change in basic principles of operation, of the device.''. (b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C. 360e(d)(1)(B)) is amended by adding at the end the following: ``(iii) The Secretary shall accept and review data and any other information from investigations conducted under the authority of regulations required by section 520(g), to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if-- ``(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or ``(II) the data or information relates to a device approved under this section, is available for use under this Act, and is relevant to the design and intended use of the device for which the application is pending.''. (c) Action on Supplements.--Section 515(d) (21 U.S.C. 360e(d)), as amended by section 302, is further amended by adding at the end the following: ``(6)(A)(i) A supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 520(f). [[Page S9138]] ``(ii) The holder of an approved application who submits a notice under clause (i) with respect to a manufacturing change of a device shall not distribute the device for a period of 14 days after the date on which the Secretary receives the notice. ``(B)(i) Subject to clause (ii), in reviewing a supplement to an approved application, for an incremental change to the design of a device that affects safety or effectiveness, the Secretary shall approve such supplement if-- ``(I) nonclinical data demonstrate that the design modification creates the intended additional capacity, function, or performance of the device; and ``(II) clinical data from the approved application and any supplement to the approved application provide a reasonable assurance of safety and effectiveness for the changed device. ``(ii) The Secretary may require, when necessary, additional clinical data to evaluate the design modification to provide a reasonable assurance of safety and effectiveness.''. SEC. 602. ENVIRONMENTAL IMPACT REVIEW. Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is further amended by adding at the end the following: ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW. ``Notwithstanding any other provision of law, no action by the Secretary pursuant to this Act shall be subject to an environmental assessment, an environmental impact statement, or other environmental consideration unless the Secretary demonstrates, in writing-- ``(1) that there is a reasonable probability that the environmental impact of the action is sufficiently substantial and within the factors that the Secretary is authorized to consider under this Act; and ``(2) that consideration of the environmental impact will directly affect the decision on the action.''. SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM PREMARKET NOTIFICATION REQUIREMENT. (a) Class I and Class II Devices.--Section 510(k) (21 U.S.C. 360(k)) is amended by striking ``intended for human use'' and inserting ``intended for human use (except a device that is classified into class I under section 513 or 520 unless the Secretary determines such device is intended for a use that is of substantial importance in preventing impairment of human health or such device presents a potential unreasonable risk of illness or injury, or a device that is classified into class II under section 513 or 520 and is exempt from the requirements of this subsection under subsection (l))''. (b) Publication of Exemption.--Section 510 (21 U.S.C. 360) is amended by inserting after subsection (k) the following: ``(l)(1) Not later than 30 days after the date of enactment of this subsection, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a notification under subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary not to require the notification shall be exempt from the requirement to provide notification under subsection (k) as of the date of the publication of the list in the Federal Register. ``(2) Beginning on the date that is 1 day after the date of the publication of a list under this subsection, the Secretary may exempt a class II device from the notification requirement of subsection (k), upon the Secretary's own initiative or a petition of an interested person, if the Secretary determines that such notification is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 30-day comment period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice.''. SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION. Section 513(f) (21 U.S.C. 360c(f)) is amended-- (1) in paragraph (1)-- (A) in subparagraph (B), by striking ``paragraph (2)'' and inserting ``paragraph (3)''; and (B) in the last sentence, by striking ``paragraph (2)'' and inserting ``paragraph (2) or (3)''; (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and (3) by inserting after paragraph (1) the following: ``(2)(A) Any person who submits a report under section 510(k) for a type of device that has not been previously classified under this Act, and that is classified into class III under paragraph (1), may request, within 30 days after receiving written notice of such a classification, the Secretary to classify the device into class I or II under the criteria set forth in subparagraphs (A) through (C) subsection (a)(1). The person may, in the request, recommend to the Secretary a classification for the device. The request shall describe the device and provide detailed information and reasons for the recommended classification. ``(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A) for classification of a device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1), the Secretary shall by written order classify the device. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph into class I or II shall be a predicate device for determining substantial equivalence under paragraph (1). ``(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 501(f)(1)(B) until approved under section 515 or exempted from such approval under section 520(g). ``(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.''. SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES. (a) Release of Information.--Section 519(e) (21 U.S.C. 360i(e)) is amended by adding at the end the following flush sentence: ``Any patient receiving a device subject to tracking under this section may refuse to release, or refuse permission to release, the patient's name, address, social security number, or other identifying information for the purpose of tracking.''. (b) Publication of Certain Devices.--Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall develop and publish in the Federal Register a list that identifies each type of device subject to tracking under section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each device not identified by the Secretary of Health and Human Services under this subsection or designated by the Secretary under section 519(e)(2) shall be deemed to be exempt from the mandatory tracking requirement under section 519 of such Act. The Secretary of Health and Human Services shall have authority to modify the list of devices exempted from the mandatory tracking requirements. SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET SURVEILLANCE. (a) In General.--Section 522 (21 U.S.C. 360l) is amended by striking ``Sec. 522.'' and all that follows through ``(2) Discretionary surveillance.--The'' and inserting the following: ``Sec. 522. (a) Discretionary Surveillance.--The''. (b) Surveillance Approval.--Section 522(b) (21 U.S.C. 360l(b)) is amended to read as follows: ``(b) Surveillance Approval.-- ``(1) In general.--Each manufacturer that receives notice from the Secretary that the manufacturer is required to conduct surveillance of a device under subsection (a) shall, not later than 30 days after receiving the notice, submit for the approval of the Secretary, a plan for the required surveillance. ``(2) Determination.--Not later than 60 days after the receipt of the plan, the Secretary shall determine if a person proposed in the plan to conduct the surveillance has sufficient qualifications and experience to conduct the surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health and to provide safety and effectiveness information for the device. ``(3) Limitation on plan approval.--The Secretary may not approve the plan until the plan has been reviewed by a qualified scientific and technical review committee established by the Secretary.''. (c) Duration of Surveillance.--Section 522 (21 U.S.C. 360l), as amended by subsection (b), is further amended by adding at the end the following: ``(c) Duration of Surveillance.-- ``(1) In general.--Each manufacturer required to conduct surveillance of a device under subsection (a) shall be required to conduct such surveillance for not longer than 24 months. ``(2) Extension of the period of surveillance.--If the Secretary determines that additional surveillance is needed to identify the incidence of adverse events documented during the initial period of surveillance that were not foreseen at the time of approval or classification of the device, the Secretary may extend the period of surveillance for such time as may be necessary after providing the person required to conduct such surveillance an opportunity for an informal hearing to determine whether or not additional surveillance is appropriate and to determine the appropriate period, if any, for such surveillance.''. SEC. 607. REPORTING. (a) Reports.--Section 519 (21 U.S.C. 360i) is amended-- (1) in subsection (a)-- (A) in the first sentence by striking ``make such reports, and provide such information,'' and inserting ``and submit such samples and components of devices (as required by paragraph (10)),''; and (B) by inserting after the first sentence the following: ``Every person who is a manufacturer or importer of a device intended for human use shall make reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to assure the safety and effectiveness of such device.''; (C) in the last sentence by striking ``sentence'' and inserting ``sentences''; (D) in paragraph (8), by striking ``; and'' and inserting a semicolon; and (E) by striking paragraph (9) and inserting the following: ``(9) shall require distributors to keep records and make such records available to the Secretary upon request; and''; (2) by striking subsection (d); and (3) in subsection (f), by striking ``, importer, or distributor'' each place it appears and inserting ``or importer''. (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended-- (1) by redesignating paragraph (4) as paragraph (5); (2) by inserting after paragraph (3), the following: ``(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or''; and (3) by adding at the end the following flush sentence: [[Page S9139]] ``In this subsection, the term `wholesale distributor' means any person who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.''. SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE. Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end the following: ``(4) A new drug manufactured in a