[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 830 Engrossed in Senate (ES)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
105th CONGRESS
  1st Session
                                 S. 830

_______________________________________________________________________

                                 AN ACT


 
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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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. Expanded 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.
Sec. 405. Certainty of review timeframes.
Sec. 406. Limitations on initial classification determinations.
Sec. 407. Clarification with respect to a general use and specific use 
                            of a device.
Sec. 408. Clarification of the number of required clinical 
                            investigations for approval.
Sec. 409. 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.
Sec. 620. Disclosure.
Sec. 621. Referral statements relating to food nutrients.
                   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. 810. Reports of postmarketing approval studies.
Sec. 811. Information exchange.
Sec. 812. Reauthorization of clinical pharmacology program.
Sec. 813. Monograph for sunburn products.
Sec. 814. Safety report disclaimers.

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 Secretary, acting through the 
        Commissioner, and in consultation, as determined appropriate by 
        the Secretary, with experts in science, medicine, and public 
        health, and in cooperation with consumers, users, 
        manufacturers, importers, packers, distributors, and retailers 
        of regulated products, shall protect the public health by 
        taking actions that help ensure that--
                    ``(A) foods are safe, wholesome, sanitary, and 
                properly labeled;
                    ``(B) human and veterinary drugs, including 
                biologics, 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 Secretary, acting through the 
        Commissioner, 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 Secretary, acting 
        through the Commissioner, 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. EXPANDED 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) Emergency Situations.--The Secretary may, under appropriate 
conditions determined by the Secretary, authorize the shipment of 
investigational drugs (including investigational biological products), 
or investigational devices, (as defined in regulations prescribed by 
the Secretary) for the diagnosis, monitoring, or treatment of a serious 
disease or condition in emergency situations.
    ``(b) Individual Patient Access to Investigational Products 
Intended for Serious Diseases.--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 such 
physician after compliance with the provisions of this subsection, an 
investigational drug (including an investigational biological product), 
or investigational device, (as defined in regulations prescribed by the 
Secretary) for the diagnosis, monitoring, or treatment of a serious 
disease or condition 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, 
        and that the risk to the person from the investigational drug 
        or investigational device is not greater than the risk from the 
        disease or condition;
            ``(2) the Secretary determines that there is sufficient 
        evidence of safety and effectiveness to support the use of the 
        investigational drug or investigational device in the case 
        described in paragraph (1);
            ``(3) the Secretary determines that provision of the 
        investigational drug or investigational device will not 
        interfere with the initiation, conduct, or completion of 
        clinical investigations to support marketing approval; and
            ``(4) the product sponsor, or clinical investigator, of the 
        investigational drug or investigational device submits to the 
        Secretary a clinical protocol consistent with the provisions of 
        section 505(i) or 520(g) and any regulations promulgated under 
        section 505(i) or 520(g) describing the use of investigational 
        drugs or investigational devices in a single patient or a small 
        group of patients.
    ``(c) Treatment INDs/IDEs.--Upon submission by a product sponsor or 
a physician of a protocol intended to provide widespread access to an 
investigational product for eligible patients, the Secretary shall 
permit an investigational drug (including an investigational biological 
product) or investigational device to be made available for expanded 
access under a treatment investigational new drug application or 
investigational device exemption (as the terms are described in 
regulations prescribed by the Secretary) if the Secretary determines 
that--
            ``(1) under the treatment investigational new drug 
        application or investigational device exemption, the 
        investigational drug or investigational device is intended for 
        use in the diagnosis, monitoring, or treatment of a serious or 
        immediately life-threatening disease or condition;
            ``(2) there is no comparable or satisfactory alternative 
        therapy available to diagnose, monitor, or treat that stage of 
        disease or condition in the population of patients to which the 
        investigational drug or investigational device is intended to 
        be administered;
            ``(3)(A) the investigational drug or investigational device 
        is under investigation in a controlled clinical trial for the 
        use described in paragraph (1) under an effective 
        investigational new drug application or investigational device 
        exemption; and
            ``(B) all clinical trials necessary for approval of that 
        use of the investigational drug or investigational device have 
        been completed;
            ``(4) the sponsor of the controlled clinical trials is 
        actively pursuing marketing approval of the investigational 
        drug or investigational device for the use described in 
        paragraph (1) with due diligence;
            ``(5) the provision of the investigational drug or 
        investigational device will not interfere with the enrollment 
        of patients in ongoing clinical investigations under section 
        505(i) or 520(g);
            ``(6) in the case of serious diseases, there is sufficient 
        evidence of safety and effectiveness to support the use 
        described in paragraph (1); and
            ``(7) in the case of immediately life-threatening diseases, 
        the available scientific evidence, taken as a whole, provides a 
        reasonable basis to conclude that the product may be effective 
        for its intended use and would not expose patients to an 
        unreasonable and significant risk of illness or injury.
A protocol submitted under this subsection shall be subject to the 
provisions of section 505(i) or 520(g) and regulations promulgated 
under section 505(i) or 520(g). The Secretary may 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 subsection. The information provided by 
the Secretary, in accordance with the preceding sentence, shall be of 
the same type of information that is required by section 402(j)(3).
    ``(d) Termination.--The Secretary may, at any time, with respect to 
a person, manufacturer, or distributor described in this section, 
terminate expanded access provided under this section for an 
investigational drug (including an investigational biological product) 
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 75 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.''.

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), unless using such authority would reduce the 
        quality, or unduly increase the cost, of such review. 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.

    (a) In General.--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.--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 a report made to the Secretary under section 510(k) 
for a device that is--
            ``(1) for a use in supporting or sustaining human life;
            ``(2) for implantation in the human body for more than 1 
        year; or
            ``(3) for a use that is of substantial importance in 
        preventing the impairment of human health.
    ``(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.--A person who intends to make a 
report described in subsection (a) to the Secretary shall have the 
option to select an accredited entity or individual to review such 
report. Upon the request by a person to have a report 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, to notify the Secretary in writing of the reasons for 
        such recommendation.
            ``(2) Time period for review.--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.
            ``(3) Special rule.--The Secretary may change the initial 
        classification under section 513(f)(1) 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 
        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 at least 60 percent of 
        the submissions under section 510(k); 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).''.
    (b) Recordkeeping.--Section 704 (21 U.S.C. 374) is amended by 
adding at the end the following:
    ``(f)(1) A person accredited under section 523 to review reports 
made under section 510(k) and make recommendations of initial 
classifications of devices to the Secretary shall maintain records 
documenting the training qualifications of the person and the employees 
of the person, the procedures used by the person for handling 
confidential information, the compensation arrangements made by the 
person in accordance with section 523(d), and the procedures used by 
the person to identify and avoid conflicts of interest. Upon the 
request of an officer or employee designated by the Secretary, the 
person shall permit the officer or employee, at all reasonable times, 
to have access to, to copy, and to verify, the records.
    ``(2) Within 15 days after the receipt of a written request from 
the Secretary to a person accredited under section 523 for copies of 
records described in paragraph (1), the person shall produce the copies 
of the records at the place designated by 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 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, a 
proposed plan for determining whether there is a reasonable assurance 
of effectiveness, 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 such determination by the Secretary 
could be contrary to the public health.''.

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 an 
applicant, 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 based on an interim review of the entire application and 
identify the information that is required to correct those 
deficiencies.
    ``(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 as a drug, biological 
product, device, or a combination product subject to section 503(g) 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 actions 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 determination of the Secretary under this subsection and 
section 513(f)(1) with respect to the intended use of a device shall be 
based on the intended use included in the proposed labeling of the 
device submitted in a report under section 510(k).''.
    (c) Rule of Construction.--Nothing in the amendments made by 
subsections (a) and (b) shall be construed to alter any authority of 
the Secretary of Health and Human Services to regulate any tobacco 
product, or any additive or ingredient of a tobacco product.

SEC. 405. 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 report required by this subsection and 
make a determination under section 513(f)(1) not later than 90 days 
after receiving the report.''.
    (b) One-Cycle Review.--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. The Secretary is not required to 
review a major amendment to an application, unless the amendment is 
made in response to a request by the Secretary for information.''.

SEC. 406. 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. 407. 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. 408. 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. 409. 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).
                    ``(C) Special rule.--If the Secretary provides 
                information in a report required by section 705 of the 
                Food and Drug Administration Modernization and 
                Accountability Act of 1997 or a report required by the 
                amendments made by the Government Performance and 
                Results Act of 1993 and that information is required by 
                this paragraph, the report shall be deemed to satisfy 
                the requirements of this paragraph relating to that 
                information.''.

     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).
    ``(ii) The holder of an approved application who submits a notice 
under clause (i) with respect to a manufacturing change of a device may 
distribute the device 30 days after the date on which the Secretary 
receives the notice, unless the Secretary within such 30-day period 
notifies the holder that the notice is not adequate and describes such 
further information or action that is required for acceptance of such 
change. If the Secretary notifies the holder that a premarket approval 
supplement is required, the Secretary shall review the supplement 
within 135 days after the receipt of the supplement. The time used by 
the Secretary to review the notice of the manufacturing change shall be 
deducted from the 135-day review period if the notice meets appropriate 
content requirements for premarket approval supplements.
    ``(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 of the device 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, an environmental 
impact statement prepared in accordance with the regulations published 
in part 25 of title 21, Code of Federal Regulations (as in effect on 
August 31, 1997) in connection with an action carried out under (or a 
recommendation or report relating to) this Act, shall be considered to 
meet the requirements for a detailed statement under section 102(2)(C) 
of the National Environmental Policy Act of 1969 (42 U.S.C. 
4332(2)(C)).''.

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 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 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. 
Any such 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 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.''.

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 each such manufacturer or importer shall make 
                such reports, provide such information, and submit such 
                samples and components of devices (as required by 
                paragraph (10)),'';
                    (B) in paragraph (8), by striking ``; and'' and 
                inserting a semicolon; and
                    (C) 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:
``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.

    (a) New Drugs.--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 other small facility 
may be used to demonstrate the safety and effectiveness of the new drug 
and to obtain approval of the new drug prior to scaling up to a larger 
facility, unless the Secretary determines that a full scale production 
facility is necessary to ensure the safety or effectiveness of the new 
drug.''.
    (b) New Animal Drugs.--Section 512(c) (21 U.S.C. 360b(c)) is 
amended by adding at the end the following:
    ``(4) A new animal drug manufactured in a pilot or other small 
facility may be used to demonstrate the safety and effectiveness of the 
new drug and to obtain approval of the new drug prior to scaling up to 
a larger facility, unless the Secretary determines that a full scale 
production facility is necessary to ensure the safety or effectiveness 
of the new drug.''.

SEC. 609. REQUIREMENTS FOR RADIOPHARMACEUTICALS.

    (a) Requirements.--
            (1) Regulations.--
                    (A) Proposed regulations.--Not later than 180 days 
                after the date of enactment of this Act, the Secretary 
                of Health and Human Services, after consultation with 
                patient advocacy groups, associations, physicians 
                licensed to use radiopharmaceuticals, and the regulated 
                industry, shall issue proposed regulations governing 
                the approval of radiopharmaceuticals designed for 
                diagnosis and monitoring of diseases and conditions. 
                The regulations shall provide that the determination of 
                the safety and effectiveness of such a 
                radiopharmaceutical under section 505 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 
                351 of the Public Health Service Act (42 U.S.C. 262) 
                shall include (but not be limited to) consideration of 
                the proposed use of the radiopharmaceutical in the 
                practice of medicine, the pharmacological and 
                toxicological activity of the radiopharmaceutical 
                (including any carrier or ligand component of the 
                radiopharmaceutical), and the estimated absorbed 
                radiation dose of the radiopharmaceutical.
                    (B) Final regulations.--Not later than 18 months 
                after the date of enactment of this Act, the Secretary 
                shall promulgate final regulations governing the 
                approval of the radiopharmaceuticals.
            (2) Special rule.--In the case of a radiopharmaceutical 
        intended to be used for diagnostic or monitoring purposes, the 
        indications for which such radiopharmaceutical is approved for 
        marketing may, in appropriate cases, refer to manifestations of 
        disease (such as biochemical, physiological, anatomic, or 
        pathological processes) common to, or present in, 1 or more 
        disease states.
    (b) Definition.--In this section, the term ``radiopharmaceutical'' 
means--
            (1) an article--
                    (A) that is intended for use in the diagnosis or 
                monitoring of a disease or a manifestation of a disease 
                in humans; and
                    (B) that exhibits spontaneous disintegration of 
                unstable nuclei with the emission of nuclear particles 
                or photons; or
            (2) any nonradioactive reagent kit or nuclide generator 
        that is intended to be used in the preparation of any such 
        article.

SEC. 610. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.

    (a) Licenses.--
            (1) In general.--Section 351(a) of the Public Health 
        Service (42 U.S.C. 262(a)) is amended to read as follows:
    ``(a)(1) Except as provided in paragraph (4), no person shall 
introduce or deliver for introduction into interstate commerce any 
biological product unless--
            ``(A) a biologics license is in effect for the biological 
        product; and
            ``(B) each package of the biological product is plainly 
        marked with--
                    ``(i) the proper name of the biological product 
                contained in the package;
                    ``(ii) the name, address, and applicable license 
                number of the manufacturer of the biological product; 
                and
                    ``(iii) the expiration date of the biological 
                product.
    ``(2)(A) The Secretary shall establish, by regulation, requirements 
for the approval, suspension, and revocation of biologics licenses.
    ``(B) The Secretary shall approve a biologics license application 
on the basis of a demonstration that--
            ``(i) the biological product that is the subject of the 
        application is safe, pure, and potent; and
            ``(ii) the facility in which the biological product is 
        manufactured, processed, packed, or held meets standards 
        designed to assure that the biological product continues to be 
        safe, pure, and potent.
    ``(3) A biologics license application shall be approved only if the 
applicant (or other appropriate person) consents to the inspection of 
the facility that is the subject of the application, in accordance with 
subsection (c).
    ``(4) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt from the 
requirements of paragraph (1).''.
            (2) Elimination of existing license requirement.--Section 
        351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is 
        amended--
                    (A) by striking ``(d)(1)'' and all that follows 
                through ``of this section.'';
                    (B) in paragraph (2)--
                            (i) by striking ``(2)(A) Upon'' and 
                        inserting ``(d)(1) Upon;'' and
                            (ii) by redesignating subparagraph (B) as 
                        paragraph (2); and
                    (C) in paragraph (2) (as so redesignated by 
                subparagraph (B)(ii))--
                            (i) by striking ``subparagraph (A)'' and 
                        inserting ``paragraph (1)''; and
                            (ii) by striking ``this subparagraph'' each 
                        place it appears and inserting ``this 
                        paragraph''.
    (b) Labeling.--Section 351(b) of the Public Health Service Act (42 
U.S.C. 262(b)) is amended to read as follows:
    ``(b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark on the 
package or container of the biological product so as to falsify the 
label or mark.''.
    (c) Inspection.--Section 351(c) of the Public Health Service Act 
(42 U.S.C. 262(c)) is amended by striking ``virus, serum,'' and all 
that follows and inserting ``biological product.''.
    (d) Definition; Application.--Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the end the 
following:
    ``(i) In this section, the term `biological product' means a virus, 
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or 
derivative, allergenic product, or analogous product, or arsphenamine 
or derivative of arsphenamine (or any other trivalent organic arsenic 
compound), applicable to the prevention, treatment, or cure of a 
disease or condition of human beings.''.
    (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 353(g)(4)) 
is amended--
            (1) in subparagraph (A)--
                    (A) by striking ``section 351(a)'' and inserting 
                ``section 351(i)''; and
                    (B) by striking ``262(a)'' and inserting 
                ``262(i)''; and
            (2) in subparagraph (B)(iii), by striking ``product or 
        establishment license under subsection (a) or (d)'' and 
        inserting ``biologics license application under subsection 
        (a)''.
    (f) Special Rule.--The Secretary of Health and Human Services shall 
take measures to minimize differences in the review and approval of 
products required to have approved biologics license applications under 
section 351 of the Public Health Service Act (42 U.S.C. 262) and 
products required to have approved full new drug applications under 
section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)).

SEC. 611. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.

    (a) Performance Standards.--Not later than 180 days after the date 
of enactment of this section, the Secretary of Health and Human 
Services shall publish in the Federal Register performance standards 
for the prompt review of supplemental applications submitted for 
approved articles under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq.).
    (b) Guidance to Industry.--Not later than 180 days after the date 
of enactment of this section, the Secretary of Health and Human 
Services shall issue final guidances to clarify the requirements for, 
and facilitate the submission of data to support, the approval of 
supplemental applications for the approved articles described in 
subsection (a). The guidances shall--
            (1) clarify circumstances in which published matter may be 
        the basis for approval of a supplemental application;
            (2) specify data requirements that will avoid duplication 
        of previously submitted data by recognizing the availability of 
        data previously submitted in support of an original 
        application; and
            (3) define supplemental applications that are eligible for 
        priority review.
    (c) Responsibilities of Centers.--The Secretary of Health and Human 
Services shall designate an individual in each center within the Food 
and Drug Administration (except the Center for Food Safety and Applied 
Nutrition) to be responsible for--
            (1) encouraging the prompt review of supplemental 
        applications for approved articles; and
            (2) working with sponsors to facilitate the development and 
        submission of data to support supplemental applications.
    (d) Collaboration.--The Secretary of Health and Human Services 
shall implement programs and policies that will foster collaboration 
between the Food and Drug Administration, the National Institutes of 
Health, professional medical and scientific societies, and other 
persons, to identify published and unpublished studies that may support 
a supplemental application, and to encourage sponsors to make 
supplemental applications or conduct further research in support of a 
supplemental application based, in whole or in part, on such studies.

SEC. 612. HEALTH CARE ECONOMIC INFORMATION.

    (a) In General.--Section 502(a) (21 U.S.C. 352(a)) is amended by 
adding at the end the following: ``Health care economic information 
provided to a formulary committee, or other similar entity, in the 
course of the committee or the entity carrying out its responsibilities 
for the selection of drugs for managed care or other similar 
organizations, shall not be considered to be false or misleading if the 
health care economic information directly relates to an indication 
approved under section 505 or 507 or section 351(a) of the Public 
Health Service Act (42 U.S.C. 262(a)) for such drug and is based on 
competent and reliable scientific evidence. The requirements set forth 
in section 505(a), 507, or section 351(a) of the Public Health Service 
Act (42 U.S.C. 262(a)) shall not apply to health care economic 
information provided to such a committee or entity in accordance with 
this paragraph. Information that is relevant to the substantiation of 
the health care economic information presented pursuant to this 
paragraph shall be made available to the Secretary upon request. In 
this paragraph, the term `health care economic information' means any 
analysis that identifies, measures, or compares the economic 
consequences, including the costs of the represented health outcomes, 
of the use of a drug to the use of another drug, to another health care 
intervention, or to no intervention.''.
    (b) Study and Report.--The Comptroller General of the United States 
shall conduct a study of the implementation of the provisions added by 
the amendment made by subsection (a). Not later than 4 years and 6 
months after the date of enactment of this Act, the Comptroller General 
of the United States shall prepare and submit to Congress a report 
containing the findings of the study.

SEC. 613. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

    (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as amended by 
section 102, is further amended by adding at the end the following:

 ``Subchapter E--Fast Track Drugs and Reports of Post-Market Approval 
                                Studies

``SEC. 561. FAST TRACK DRUGS.

    ``(a) Designation of Drug as a Fast Track Drug.--
            ``(1) In general.--The Secretary shall facilitate 
        development, and expedite review and approval of new drugs and 
        biological products that are intended for the treatment of 
        serious or life-threatening conditions and that demonstrate the 
        potential to address unmet medical needs for such conditions. 
        In this Act, such products shall be known as `fast track 
        drugs'.
            ``(2) Request for designation.--The sponsor of a drug 
        (including a biological product) may request the Secretary to 
        designate the drug as a fast track drug. A request for the 
        designation may be made concurrently with, or at any time 
        after, submission of an application for the investigation of 
        the drug under section 505(i) or section 351(a)(4) of the 
        Public Health Service Act.
            ``(3) Designation.--Within 30 calendar days after the 
        receipt of a request under paragraph (2), the Secretary shall 
        determine whether the drug that is the subject of the request 
        meets the criteria described in paragraph (1). If the Secretary 
        finds that the drug meets the criteria, the Secretary shall 
        designate the drug as a fast track drug and shall take such 
        actions as are appropriate to expedite the development and 
        review of the drug.
    ``(b) Approval of Application for a Fast Track Drug.--
            ``(1) In general.--The Secretary may approve an application 
        for approval of a fast track drug under section 505(b) or 
        section 351 of the Public Health Service Act (21 U.S.C. 262) 
        upon a determination that the drug has an effect on a surrogate 
        endpoint that is reasonably likely to predict clinical benefit.
            ``(2) Limitation.--Approval of a fast track drug under this 
        subsection may be subject to the requirements--
                    ``(A) that the sponsor conduct appropriate post-
                approval studies to validate the surrogate endpoint or 
                otherwise confirm the clinical benefit of the drug; and
                    ``(B) that the sponsor submit copies of all 
                promotional materials related to the fast track drug 
                during the preapproval review period and following 
                approval, at least 30 days prior to dissemination of 
                the materials for such period of time as the Secretary 
                deems appropriate.
            ``(3) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a fast track drug using expedited 
        procedures (as prescribed by the Secretary in regulations) 
        including a procedure that provides an opportunity for an 
        informal hearing, if--
                    ``(A) the sponsor fails to conduct any required 
                post-approval study of the fast track drug with due 
                diligence;
                    ``(B) a post-approval study of the fast track drug 
                fails to verify clinical benefit of the fast track 
                drug;
                    ``(C) other evidence demonstrates that the fast 
                track drug is not safe or effective under conditions of 
                use of the drug; or
                    ``(D) the sponsor disseminates false or misleading 
                promotional materials with respect to the fast track 
                drug.
    ``(c) Review of Incomplete Applications for Approval of a Fast 
Track Drug.--
            ``(1) In general.--If preliminary evaluation by the 
        Secretary of clinical efficacy data for a fast track drug under 
        investigation shows evidence of effectiveness, the Secretary 
        shall evaluate for filing, and may commence review of, portions 
        of an application for the approval of the drug if the applicant 
        provides a schedule for submission of information necessary to 
        make the application complete and any fee that may be required 
        under section 736.
            ``(2) Exception.--Any time period for review of human drug 
        applications that has been agreed to by the Secretary and that 
        has been set forth in goals identified in letters of the 
        Secretary (relating to the use of fees collected under section 
        736 to expedite the drug development process and the review of 
        human drug applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which the 
        application is complete.
    ``(d) Awareness Efforts.--The Secretary shall--
            ``(1) develop and widely disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology companies, and 
        other appropriate persons a comprehensive description of the 
        provisions applicable to fast track drugs established under 
        this section; and
            ``(2) establish an ongoing program to encourage the 
        development of surrogate endpoints that are reasonably likely 
        to predict clinical benefit for serious or life-threatening 
        conditions for which there exist significant unmet medical 
        needs.''.
    (b) Guidance.--Within 1 year after the date of enactment of this 
Act, the Secretary of Health and Human Services shall issue guidance 
for fast track drugs that describes the policies and procedures that 
pertain to section 561 of the Federal Food, Drug, and Cosmetic Act.

SEC. 614. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.

    (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as amended by 
section 602, is further amended by adding at the end the following:

                 ``Subchapter E--Manufacturing Changes

``SEC. 751. MANUFACTURING CHANGES.

    ``(a) In General.--A change in the manufacture of a new drug, 
including a biological product, or a new animal drug may be made in 
accordance with this section.
    ``(b) Changes.--
            ``(1) Validation.--Before distributing a drug made after a 
        change in the manufacture of the drug from the manufacturing 
        process established in the approved new drug application under 
        section 505, the approved new animal drug application under 
        section 512, or the license application under section 351 of 
        the Public Health Service Act, the applicant shall validate the 
        effect of the change on the identity, strength, quality, 
        purity, and potency of the drug as the identity, strength, 
        quality, purity, and potency may relate to the safety or 
        effectiveness of the drug.
            ``(2) Reports.--The applicant shall report the change 
        described in paragraph (1) to the Secretary and may distribute 
        a drug made after the change as follows:
                    ``(A) Major manufacturing changes.--
                            ``(i) In general.--Major manufacturing 
                        changes, which are of a type determined by the 
                        Secretary to have substantial potential to 
                        adversely affect the identity, strength, 
                        quality, purity, or potency of the drug as the 
                        identity, strength, quality, purity, and 
                        potency may relate to the safety or 
                        effectiveness of a drug, shall be submitted to 
                        the Secretary in a supplemental application and 
                        drugs made after such changes may not be 
                        distributed until the Secretary approves the 
                        supplemental application.
                            ``(ii) Definition.--In this subparagraph, 
                        the term `major manufacturing changes' means--
                                    ``(I) changes in the qualitative or 
                                quantitative formulation of a drug or 
                                the specifications in the approved 
                                marketing application for the drug 
                                (unless exempted by the Secretary from 
                                the requirements of this subparagraph);
                                    ``(II) changes that the Secretary 
                                determines by regulation or issuance of 
                                guidance require completion of an 
                                appropriate human study demonstrating 
                                equivalence of the drug to the drug 
                                manufactured before such changes; and
                                    ``(III) other changes that the 
                                Secretary determines by regulation or 
                                issuance of guidance have a substantial 
                                potential to adversely affect the 
                                safety or effectiveness of the drug.
                    ``(B) Other manufacturing changes.--
                            ``(i) In general.--As determined by the 
                        Secretary, manufacturing changes other than 
                        major manufacturing changes shall--
                                    ``(I) be made at any time and 
                                reported annually to the Secretary, 
                                with supporting data; or
                                    ``(II) be reported to the Secretary 
                                in a supplemental application.
                            ``(ii) Distribution of the drug.--In the 
                        case of changes reported in accordance with 
                        clause (i)(II)--
                                    ``(I) the applicant may distribute 
                                the drug 30 days after the Secretary 
                                receives the supplemental application 
                                unless the Secretary notifies the 
                                applicant within such 30-day period 
                                that prior approval of such 
                                supplemental application is required;
                                    ``(II) the Secretary shall approve 
                                or disapprove each such supplemental 
                                application; and
                                    ``(III) the Secretary may determine 
                                types of manufacturing changes after 
                                which distribution of a drug may 
                                commence at the time of submission of 
                                such supplemental application.''.
    (b) Existing Law.--The requirements of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 et seq.) and the Public Health Service Act 
(42 U.S.C. 201 et seq.) that are in effect on the date of enactment of 
this Act with respect to manufacturing changes shall remain in effect--
            (1) for a period of 24 months after the date of enactment 
        of this Act; or
            (2) until the effective date of regulations promulgated by 
        the Secretary of Health and Human Services implementing section 
        751 of the Federal Food, Drug, and Cosmetic Act,
whichever is sooner.

SEC. 615. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.

    Within 12 months after the date of enactment of this Act, the 
Secretary of the Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall issue guidance that describes 
when abbreviated study reports may be submitted, in lieu of full 
reports, with a new drug application under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) and with a biologics 
license application under section 351 of the Public Health Service Act 
(42 U.S.C. 262) for certain types of studies. Such guidance shall 
describe the kinds of studies for which abbreviated reports are 
appropriate and the appropriate abbreviated report formats.

SEC. 616. FOOD CONTACT SUBSTANCES.

    (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 348(a)) is 
amended--
            (1) in paragraph (1)--
                    (A) by striking ``subsection (i)'' and inserting 
                ``subsection (j)''; and
                    (B) by striking at the end ``or'';
            (2) by striking the period at the end of paragraph (2) and 
        inserting ``; or'';
            (3) by inserting after paragraph (2) the following:
            ``(3) in the case of a food additive as defined in this Act 
        that is a food contact substance, there is--
                    ``(A) in effect, and such substance and the use of 
                such substance are in conformity with, a regulation 
                issued under this section prescribing the conditions 
                under which such additive may be safely used; or
                    ``(B) a notification submitted under subsection (h) 
                that is effective.''; and
            (4) by striking the matter following paragraph (3) (as 
        added by paragraph (2)) and inserting the following flush 
        sentence:
``While such a regulation relating to a food additive, or such a 
notification under subsection (h) relating to a food additive that is a 
food contact substance, is in effect, and has not been revoked pursuant 
to subsection (i), a food shall not, by reason of bearing or containing 
such a food additive in accordance with the regulation or notification, 
be considered adulterated under section 402(a)(1).''.
    (b) Notification for Food Contact Substances.--Section 409 (21 
U.S.C. 348), as amended by subsection (a), is further amended--
            (1) by redesignating subsections (h) and (i), as 
        subsections (i) and (j), respectively;
            (2) by inserting after subsection (g) the following:

          ``Notification Relating to a Food Contact Substance

    ``(h)(1) Subject to such regulations as may be promulgated under 
paragraph (3), a manufacturer or supplier of a food contact substance 
may, at least 120 days prior to the introduction or delivery for 
introduction into interstate commerce of the food contact substance, 
notify the Secretary of the identity and intended use of the food 
contact substance, and of the determination of the manufacturer or 
supplier that the intended use of such food contact substance is safe 
under the standard described in subsection (c)(3)(A). The notification 
shall contain the information that forms the basis of the 
determination, the fee required under paragraph (5), and all 
information required to be submitted by regulations promulgated by the 
Secretary.
    ``(2)(A) A notification submitted under paragraph (1) shall become 
effective 120 days after the date of receipt by the Secretary and the 
food contact substance may be introduced or delivered for introduction 
into interstate commerce, unless the Secretary makes a determination 
within the 120-day period that, based on the data and information 
before the Secretary, such use of the food contact substance has not 
been shown to be safe under the standard described in subsection 
(c)(3)(A), and informs the manufacturer or supplier of such 
determination.
    ``(B) A decision by the Secretary to object to a notification shall 
constitute final agency action subject to judicial review.
    ``(C) In this paragraph, the term `food contact substance' means 
the substance that is the subject of a notification submitted under 
paragraph (1), and does not include a similar or identical substance 
manufactured or prepared by a person other than the manufacturer 
identified in the notification.
    ``(3)(A) The process in this subsection shall be utilized for 
authorizing the marketing of a food contact substance except where the 
Secretary determines that submission and review of a petition under 
subsection (b) is necessary to provide adequate assurance of safety, or 
where the Secretary and any manufacturer or supplier agree that such 
manufacturer or supplier may submit a petition under subsection (b).
    ``(B) The Secretary is authorized to promulgate regulations to 
identify the circumstances in which a petition shall be filed under 
subsection (b), and shall consider criteria such as the probable 
consumption of such food contact substance and potential toxicity of 
the food contact substance in determining the circumstances in which a 
petition shall be filed under subsection (b).
    ``(4) The Secretary shall keep confidential any information 
provided in a notification under paragraph (1) for 120 days after 
receipt by the Secretary of the notification. After the expiration of 
such 120 days, the information shall be available to any interested 
party except for any matter in the notification that is a trade secret 
or confidential commercial information.
    ``(5)(A) Each person that submits a notification regarding a food 
contact substance under this section shall be subject to the payment of 
a reasonable fee. The fee shall be based on the resources required to 
process the notification including reasonable administrative costs for 
such processing.
    ``(B) The Secretary shall conduct a study of the costs of 
administering the notification program established under this section 
and, on the basis of the results of such study, shall, within 18 months 
after the date of enactment of the Food and Drug Administration 
Modernization and Accountability Act of 1997, promulgate regulations 
establishing the fee required by subparagraph (A).
    ``(C) A notification submitted without the appropriate fee is not 
complete and shall not become effective for the purposes of subsection 
(a)(3) until the appropriate fee is paid.
    ``(D) Fees collected pursuant to this subsection--
            ``(i) shall not be deposited as an offsetting collection to 
        the appropriations for the Department of Health and Human 
        Services;
            ``(ii) shall be credited to the appropriate account of the 
        Food and Drug Administration; and
            ``(iii) shall be available in accordance with appropriation 
        Acts until expended, without fiscal year limitation.
    ``(6) In this section, the term `food contact substance' means any 
substance intended for use as a component of materials used in 
manufacturing, packing, packaging, transporting, or holding food if 
such use is not intended to have any technical effect in such food.'';
            (3) in subsection (i), as so redesignated by paragraph (1), 
        by adding at the end the following: ``The Secretary shall by 
        regulation prescribe the procedure by which the Secretary may 
        deem a notification under subsection (h) to no longer be 
        effective.''; and
            (4) in subsection (j), as so redesignated by paragraph (1), 
        by striking ``subsections (b) to (h)'' and inserting 
        ``subsections (b) to (i)''.
    (c) Effective Date.--Notifications under section 409(h) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (b), may 
be submitted beginning 18 months after the date of enactment of this 
Act.

SEC. 617. HEALTH CLAIMS FOR FOOD PRODUCTS.

    Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by adding at the 
end the following:
    ``(C) Notwithstanding the provisions of clauses (A)(i) and (B), a 
claim of the type described in subparagraph (1)(B) that is not 
authorized by the Secretary in a regulation promulgated in accordance 
with clause (B) shall be authorized and may be made if--
            ``(i) an authoritative scientific body of the Federal 
        Government with official responsibility for public health 
        protection or research directly relating to human nutrition 
        (such as the National Institutes of Health or the Centers for 
        Disease Control and Prevention), the National Academy of 
        Sciences, or a subdivision of the scientific body or the 
        National Academy of Sciences, has published an authoritative 
        statement, which is currently in effect, about the relationship 
        between a nutrient and a disease or health-related condition to 
        which the claim refers;
            ``(ii) a person has submitted to the Secretary at least 120 
        days before the first introduction of a food into interstate 
        commerce a notice of the claim, including a concise description 
        of the basis upon which such person relied for determining that 
        the requirements of subclause (i) have been satisfied;
            ``(iii) the claim and the food for which the claim is made 
        are in compliance with clause (A)(ii), and are otherwise in 
        compliance with paragraph (a) and section 201(n); and
            ``(iv) the claim is stated in a manner so that the claim is 
        an accurate representation of the authoritative statement 
        referred to in subclause (i) and so that the claim enables the 
        public to comprehend the information provided in the claim and 
        to understand the relative significance of such information in 
        the context of a total daily diet.
For purposes of this paragraph, a statement shall be regarded as an 
authoritative statement of such a scientific body described in 
subclause (i) only if the statement is published by the scientific body 
and shall not include a statement of an employee of the scientific body 
made in the individual capacity of the employee.
    ``(D) A claim submitted under the requirements of clause (C), may 
be made until--
            ``(i) such time as the Secretary issues an interim final 
        regulation--
                    ``(I) under the standard in clause (B)(i), 
                prohibiting or modifying the claim; or
                    ``(II) finding that the requirements of clause (C) 
                have not been met; or
            ``(ii) a district court of the United States in an 
        enforcement proceeding under chapter III has determined that 
        the requirements of clause (C) have not been met.
Where the Secretary issues a regulation under subclause (i), good cause 
shall be deemed to exist for the purposes of subsections (b)(B) and 
(d)(3) of section 553 of title 5, United States Code. The Secretary 
shall solicit comments in response to a regulation promulgated under 
subclause (i) and shall publish a response to such comments.''.

SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

    (a) General Authority.--Chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505 the following:

``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

    ``(a) Market Exclusivity for New Drugs.--If, prior to approval of 
an application that is submitted under section 505(b)(1), the Secretary 
determines that information relating to the use of a drug in the 
pediatric population may produce health benefits in that population, 
the Secretary makes a written request for pediatric studies (which may 
include a timeframe for completing such studies), and such studies are 
completed within any such timeframe and the reports thereof submitted 
in accordance with subsection (d)(2) or completed within any such 
timeframe and the reports thereof are accepted in accordance with 
subsection (d)(3)--
            ``(1)(A) the period during which an application may not be 
        submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 shall be five years and six months rather than five 
        years, and the references in subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(B) the period of market exclusivity under subsections 
        (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
        section 505 shall be three years and six months rather than 
        three years; and
            ``(2)(A) if the drug is the subject of--
                    ``(i) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) of section 505 and for which 
                pediatric studies were submitted prior to the 
                expiration of the patent (including any patent 
                extensions); or
                    ``(ii) a listed patent for which a certification 
                has been submitted under subsection (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be approved 
        under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
        extended by a period of six months after the date the patent 
        expires (including any patent extensions); or
            ``(B)  if  the  drug  is  the  subject  of  a  listed   
        patent   for   which   a   certification has been submitted 
        under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 
        505, and in the patent infringement litigation resulting from 
        the certification the court determines that the patent is valid 
        and would be infringed, the period during which an application 
        may not be approved under subsection (c)(3) or (j)(4)(B) of 
        section 505 shall be extended by a period of six months after 
        the date the patent expires (including any patent extensions).
    ``(b) Secretary To Develop List of Drugs for Which Additional 
Pediatric Information May Be Beneficial.--Not later than 180 days after 
the date of enactment of this section, the Secretary, after 
consultation with experts in pediatric research (such as the American 
Academy of Pediatrics, the Pediatric Pharmacology Research Unit 
Network, and the United States Pharmacopoeia) shall develop, 
prioritize, and publish an initial list of approved drugs for which 
additional pediatric information may produce health benefits in the 
pediatric population. The Secretary shall annually update the list.
    ``(c) Market Exclusivity for Already-Marketed Drugs.--If the 
Secretary makes a written request for pediatric studies (which may 
include a timeframe for completing such studies) concerning a drug 
identified in the list described in subsection (b) to the holder of an 
approved application under section 505(b)(1) for the drug, the holder 
agrees to the request, and the studies are completed within any such 
timeframe and the reports thereof submitted in accordance with 
subsection (d)(2) or completed within any such timeframe and the 
reports thereof accepted in accordance with subsection (d)(3)--
            ``(1)(A) the period during which an application may not be 
        submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 shall be five years and six months rather than five 
        years, and the references in subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
            ``(B) the period of market exclusivity under subsections 
        (c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of 
        section 505 shall be three years and six months rather than 
        three years; and
            ``(2)(A) if the drug is the subject of--
                    ``(i) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) of section 505 and for which 
                pediatric studies were submitted prior to the 
                expiration of the patent (including any patent 
                extensions); or
                    ``(ii) a listed patent for which a certification  
                has  been  submitted  under subsection (b)(2)(A)(iii) 
                or (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be approved 
        under subsection (c)(3) or (j)(4)(B) of section 505 shall be 
        extended by a period of six months after the date the patent 
        expires (including any patent extensions); or
            ``(B)  if  the  drug  is  the  subject  of  a  listed 
        patent   for   which   a   certification   has   been submitted 
        under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 
        505, and in the patent infringement litigation resulting from 
        the certification the court determines that the patent is valid 
        and would be infringed, the period during which an application 
        may not be approved under subsection (c)(3) or (j)(4)(B) of 
        section 505 shall be extended by a period of six months after 
        the date the patent expires (including any patent extensions).
    ``(d) Conduct of Pediatric Studies.--
            ``(1) Agreement for studies.--The Secretary may, pursuant 
        to a written request for studies, after consultation with--
                    ``(A) the sponsor of an application for an 
                investigational new drug under section 505(i);
                    ``(B) the sponsor of an application for a drug 
                under section 505(b)(1); or
                    ``(C) the holder of an approved application for a 
                drug under section 505(b)(1),
        agree with the sponsor or holder for the conduct of pediatric 
        studies for such drug.
            ``(2) Written protocols to meet the studies requirement.--
        If the sponsor or holder and the Secretary agree upon written 
        protocols for the studies, the studies requirement of 
        subsection (a) or (c) is satisfied upon the completion of the 
        studies and submission of the reports thereof in accordance 
        with the original written request and the written agreement 
        referred to in paragraph (1). Not later than 60 days after the 
        submission of the report of the studies, the Secretary shall 
        determine if such studies were or were not conducted in 
        accordance with the original written request and the written 
        agreement and reported in accordance with the requirements of 
        the Secretary for filing and so notify the sponsor or holder.
            ``(3) Other methods to meet the studies requirement.--If 
        the sponsor or holder and the Secretary have not agreed in 
        writing on the protocols for the studies, the studies 
        requirement of subsection (a) or (c) is satisfied when such 
        studies have been completed and the reports accepted by the 
        Secretary. Not later than 90 days after the submission of the 
        reports of the studies, the Secretary shall accept or reject 
        such reports and so notify the sponsor or holder. The 
        Secretary's only responsibility in accepting or rejecting the 
        reports shall be to determine, within the 90 days, whether the 
        studies fairly respond to the written request, whether such 
        studies have been conducted in accordance with commonly 
        accepted scientific principles and protocols, and whether such 
        studies have been reported in accordance with the requirements 
        of the Secretary for filing.
    ``(e) Delay of Effective Date for Certain Applications; Period of 
Market Exclusivity.--If the Secretary determines that the acceptance or 
approval of an application under subsection (b)(2) or (j) of section 
505 for a drug may occur after submission of reports of pediatric 
studies under this section, which were submitted prior to the 
expiration of the patent (including any patent extension) or market 
exclusivity protection, but before the Secretary has determined whether 
the requirements of subsection (d) have been satisfied, the Secretary 
shall delay the acceptance or approval under subsection (b)(2) or (j), 
respectively, of section 505 until the determination under subsection 
(d) is made, but such delay shall not exceed 90 days. In the event that 
requirements of this section are satisfied, the applicable period of 
market exclusivity referred to in subsection (a) or (c) shall be deemed 
to have been running during the period of delay.
    ``(f) Notice of Determinations on Studies Requirement.--The 
Secretary shall publish a notice of any determination that the 
requirements of subsection (d) have been met and that submissions and 
approvals under subsection (b)(2) or (j) of section 505 for a drug will 
be subject to the provisions of this section.
    ``(g) Limitation.--The holder of an approved application for a new 
drug that has already received six months of market exclusivity under 
subsection (a) or (c) may, if otherwise eligible, obtain six months of 
market exclusivity under subsection (c)(1)(B) for a supplemental 
application, except that the holder is not eligible for exclusivity 
under subsection (c)(2).
    ``(h) Study and Report.--The Secretary shall conduct a study and 
report to Congress not later than January 1, 2003 based on the 
experience under the program. The study and report shall examine all 
relevant issues, including--
            ``(1) the effectiveness of the program in improving 
        information about important pediatric uses for approved drugs;
            ``(2) the adequacy of the incentive provided under this 
        section;
            ``(3) the economic impact of the program; and
            ``(4) any suggestions for modification that the Secretary 
        deems appropriate.
    ``(i) Termination of Market Exclusivity Extension Authority for New 
Drugs.--Except as provided in section 618(b) of the Food and Drug 
Administration Modernization and Accountability Act of 1997, no period 
of market exclusivity shall be extended under subsection (a) for a drug 
if--
            ``(1) the extension would be based on studies commenced 
        after January 1, 2004; and
            ``(2) the application submitted for the drug under section 
        505(b)(1) was not approved by January 1, 2004.
    ``(j) Definitions.--In this section, the term `pediatric studies' 
or `studies' means at least 1 clinical investigation (that, at the 
Secretary's discretion, may include pharmacokinetic studies) in 
pediatric age-groups in which a drug is anticipated to be used.''.
    (b) Market Exclusivity Under Other Authority.--
            (1) Through calendar year 2003.--
                    (A) Determination.--If the Secretary requests or 
                requires pediatric studies, prior to January 1, 2004, 
                under Federal law other than section 505A of the 
                Federal Food, Drug, and Cosmetic Act (as added by 
                subsection (a)), from the sponsor of an application, or 
                the holder of an approved application, for a drug under 
                section 505(b) of such Act (21 U.S.C. 355(b)), the 
                Secretary shall determine whether the studies meet the 
                completeness, timeliness, and other submission 
                requirements of the Federal law involved.
                    (B) Market exclusivity.--If the Secretary 
                determines that the studies meet the requirements 
                involved, the Secretary shall ensure that the period of 
                market exclusivity for the drug involved is extended 
                for 6 months in accordance with the requirements of 
                subsection (a), (c), (e), and (g) (as appropriate) of 
                section 505A of such Act (as in effect on the date of 
                enactment of this Act.).
            (2) Calendar year 2004 and subsequent years.--
                    (A) New drugs.--Effective January 1, 2004, if the 
                Secretary requests or requires pediatric studies, under 
                Federal law other than section 505A of the Federal 
                Food, Drug, and Cosmetic Act, from the sponsor of an 
                application for a drug under section 505(b) of such 
                Act, nothing in such law shall be construed to permit 
                or require the Secretary to ensure that the period of 
                market exclusivity for the drug is extended.
                    (B) Already marketed drugs.--
                            (i) Determination.--Effective January 1, 
                        2004, if the Secretary requests or requires 
                        pediatric studies, under Federal law other than 
                        section 505A of the Federal Food, Drug, and 
                        Cosmetic Act (as added by subsection (a)), from 
                        the holder of an approved application for a 
                        drug under section 505(b) of such Act, the 
                        Secretary shall determine whether the studies 
                        meet the completeness, timeliness, and other 
                        submission requirements of the Federal law 
                        involved.
                            (ii) Market exclusivity.--If the Secretary 
                        determines that the studies meet the 
                        requirements involved, the Secretary shall 
                        ensure that the period of market exclusivity 
                        for the drug involved is extended for 6 months 
                        in accordance with the requirements of 
                        subsection (a), (c), (e), and (g) (as 
                        appropriate) of section 505A of such Act (as in 
                        effect on the date of enactment of this Act.).
            (3) Definitions.--In this subsection:
                    (A) Drug.--The term ``drug'' has the meaning given 
                the term in section 201 of such Act.
                    (B) Pediatric studies.--The term ``pediatric 
                studies'' has the meaning given the term in section 
                505A of such Act.
                    (C) Secretary.--The term ``Secretary'' means the 
                Secretary of Health and Human Services.

SEC. 619. POSITRON EMISSION TOMOGRAPHY.

    (a) Regulation of Compounded Positron Emission Tomography Drugs 
Under the Federal Food, Drug, and Cosmetic Act.--
            (1) Definition.--Section 201 (21 U.S.C. 321) is amended by 
        adding at the end the following:
    ``(ii) The term `compounded positron emission tomography drug'--
            ``(1) means a drug that--
                    ``(A) exhibits spontaneous disintegration of 
                unstable nuclei by the emission of positrons and is 
                used for the purpose of providing dual photon positron 
                emission tomographic diagnostic images; and
                    ``(B) has been compounded by or on the order of a 
                practitioner who is licensed by a State to compound or 
                order compounding for a drug described in subparagraph 
                (A), and is compounded in accordance with that State's 
                law, for a patient or for research, teaching, or 
                quality control; and
            ``(2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target material, 
        electronic synthesizer, or other apparatus or computer program 
        to be used in the preparation of such a drug.''.
    (b) Adulteration.--
            (1) In general.--Section 501(a)(2) (21 U.S.C. 351(a)(2)) is 
        amended by striking ``; or (3)'' and inserting the following: 
        ``; or (C) if it is a compounded positron emission tomography 
        drug and the methods used in, or the facilities and controls 
        used for, its compounding, processing, packing, or holding do 
        not conform to or are not operated or administered in 
        conformity with the positron emission tomography compounding 
        standards and the official monographs of the United States 
        Pharmacopeia to assure that such drug meets the requirements of 
        this Act as to safety and has the identity and strength, and 
        meets the quality and purity characteristics, that it purports 
        or is represented to possess; or (3)''.
            (2) Sunset.--Section 501(a)(2)(C) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 
        4 years after the date of enactment of this Act or 2 years 
        after the date or which the Secretary of Health and Human 
        Services establishes the requirements described in subsection 
        (c)(1)(B), whichever is later.
    (c) Requirements for Review of Approval Procedures and Current Good 
Manufacturing Practices for Positron Emission Tomography.--
            (1) Procedures and requirements.--
                    (A) In general.--In order to take account of the 
                special characteristics of compounded positron emission 
                tomography drugs and the special techniques and 
                processes required to produce these drugs, not later 
                than 2 years after the date of enactment of this Act, 
                the Secretary of Health and Human Services shall 
                establish--
                            (i) appropriate procedures for the approval 
                        of compounded positron emission tomography 
                        drugs pursuant to section 505 of the Federal 
                        Food, Drug, and Cosmetic Act (21 U.S.C. 355); 
                        and
                            (ii) appropriate current good manufacturing 
                        practice requirements for such drugs.
                    (B) Considerations and consultation.--In 
                establishing the procedures and requirements required 
                by subparagraph (A), the Secretary of Health and Human 
                Services shall take due account of any relevant 
                differences between not-for-profit institutions that 
                compound the drugs for their patients and commercial 
                manufacturers of the drugs. Prior to establishing the 
                procedures and requirements, the Secretary of Health 
                and Human Services shall consult with patient advocacy 
                groups, professional associations, manufacturers, and 
                physicians and scientists licensed to make or use 
                compounded positron emission tomography drugs.
            (2) Submission of new drug applications and abbreviated new 
        drug applications.--
                    (A) In general.--Except as provided in subparagraph 
                (B), the Secretary of Health and Human Services shall 
                not require the submission of new drug applications or 
                abbreviated new drug applications under subsection (b) 
                or (j) of section 505 (21 U.S.C. 355), for compounded 
                positron emission tomography drugs that are not 
                adulterated drugs described in section 501(a)(2)(C) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                351(a)(2)(C)) (as amended by subsection (b)), for a 
                period of 4 years after the date of enactment of this 
                Act, or for 2 years after the date or which the 
                Secretary establishes procedures and requirements under 
                paragraph (1), whichever is later.
                    (B) Exception.--Nothing in this Act shall prohibit 
                the voluntary submission of such applications or the 
                review of such applications by the Secretary of Health 
                and Human Services. Nothing in this Act shall 
                constitute an exemption for a compounded positron 
                emission tomography drug from the requirements of 
                regulations issued under section 505(i) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) for 
                such drugs.
    (d) Revocation of Certain Inconsistent Documents.--Within 30 days 
after the date of enactment of this Act, the Secretary of Health and 
Human Services shall publish in the Federal Register a notice 
terminating the application of the following notices and rule, to the 
extent the notices and rule relate to compounded positron emission 
tomography drugs:
            (1) A notice entitled ``Regulation of Positron Emission 
        Tomographic Drug Products: Guidance; Public Workshop'', 
        published in the Federal Register on February 27, 1995.
            (2) A notice entitled ``Guidance for Industry: Current Good 
        Manufacturing Practices for Positron Emission Tomographic (PET) 
        Drug Products; Availability'', published in the Federal 
        Register on April 22, 1997.
            (3) A final rule entitled ``Current Good Manufacturing 
        Practice for Finished Pharmaceuticals; Positron Emission 
        Tomography'', published in the Federal Register on April 22, 
        1997.
    (e) Definition.--As used in this section, the term ``compounded 
positron emission tomography drug'' has the meaning given the term in 
section 201 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321).

SEC. 620. DISCLOSURE.

    Chapter IV (21 U.S.C. 341 et seq.) is amended by adding after 
section 403B the following:

                              ``disclosure

    ``Sec. 403C. (a) No provision of section 403(a), 201(n), or 409 
shall be construed to require on the label or labeling of a food a 
separate radiation disclosure statement that is more prominent than the 
declaration of ingredients required by section 403(i)(2).
    ``(b) In this section, the term `radiation disclosure statement' 
means a written statement that discloses that a food or a component of 
the food has been intentionally subject to radiation.''.

SEC. 621. REFERRAL STATEMENTS RELATING TO FOOD NUTRIENTS.

    Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to read as 
follows:
    ``(B) If a claim described in subparagraph (1)(A) is made with 
respect to a nutrient in a food, and the Secretary makes a 
determination that the food contains a nutrient at a level that 
increases to persons in the general population the risk of a disease or 
health-related condition that is diet related, then the label or 
labeling of such food shall contain, prominently and in immediate 
proximity to such claim, the following statement: `See nutrition 
information panel for ____ content.' The blank shall identify the 
nutrient associated with the increased disease or health-related 
condition risk. In making the determination described in this clause, 
the Secretary shall take into account the significance of the food in 
the total daily diet.''.

                   TITLE VII--FEES RELATING TO DRUGS

SEC. 701. SHORT TITLE.

    This title may be cited as the ``Prescription Drug User Fee 
Reauthorization Act of 1997''.

SEC. 702. FINDINGS.

    Congress finds that--
            (1) prompt approval of safe and effective new drugs and 
        other therapies is critical to the improvement of the public 
        health so that patients may enjoy the benefits provided by 
        these therapies to treat and prevent illness and disease;
            (2) the public health will be served by making additional 
        funds available for the purpose of augmenting the resources of 
        the Food and Drug Administration that are devoted to the 
        process for review of human drug applications;
            (3) the provisions added by the Prescription Drug User Fee 
        Act of 1992 have been successful in substantially reducing 
        review times for human drug applications and should be--
                    (A) reauthorized for an additional 5 years, with 
                certain technical improvements; and
                    (B) carried out by the Food and Drug Administration 
                with new commitments to implement more ambitious and 
                comprehensive improvements in regulatory processes of 
                the Food and Drug Administration; and
            (4) the fees authorized by amendments made in this title 
        will be dedicated toward expediting the drug development 
        process and the review of human drug applications as set forth 
        in the goals identified in appropriate letters from the 
        Secretary of Health and Human Services to the chairman of the 
        Committee on Commerce of the House of Representatives and the 
        chairman of the Committee on Labor and Human Resources of the 
        Senate.

SEC. 703. DEFINITIONS.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) in the second sentence of paragraph (1)--
                    (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                    (B) by striking ``September 1, 1992.'' and 
                inserting the following: ``September 1, 1992, does not 
                include an application for a licensure of a biological 
                product for further manufacturing use only, and does 
                not include an application or supplement submitted by a 
                State or Federal Government entity for a drug or 
                biological product that is not distributed 
                commercially. Such term does include an application for 
                licensure, as described in subparagraph (D), of a large 
                volume biological product intended for single dose 
                injection for intravenous use or infusion.'';
            (2) in the second sentence of paragraph (3)--
                    (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                    (B) by striking ``September 1, 1992.'' and 
                inserting the following: ``September 1, 1992, does not 
                include a biological product that is licensed for 
                further manufacturing use only, and does not include a 
                drug or biological product that is not distributed 
                commercially and is the subject of an application or 
                supplement submitted by a State or Federal Government 
                entity. Such term does include a large volume 
                biological product intended for single dose injection 
                for intravenous use or infusion.'';
            (3) in paragraph (4), by striking ``without'' and inserting 
        ``without substantial'';
            (4) by striking paragraph (5) and inserting the following:
            ``(5) The term `prescription drug establishment' means a 
        foreign or domestic place of business which is at 1 general 
        physical location consisting of 1 or more buildings all of 
        which are within 5 miles of each other, at which 1 or more 
        prescription drug products are manufactured in final dosage 
        forms.'';
            (5) in paragraph (7)(A)--
                    (A) by striking ``employees under contract'' and 
                all that follows through ``Administration,'' and 
                inserting ``contractors of the Food and Drug 
                Administration,''; and
                    (B) by striking ``and committees,'' and inserting 
                ``and committees and to contracts with such 
                contractors,'';
            (6) in paragraph (8)--
                    (A) in subparagraph (A)--
                            (i) by striking ``August of'' and inserting 
                        ``April of''; and
                            (ii) by striking ``August 1992'' and 
                        inserting ``April 1997'';
                    (B) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) 1 plus the decimal expression of the total 
                percentage increase for such fiscal year since fiscal 
                year 1997 in basic pay under the General Schedule in 
                accordance with section 5332 of title 5, United States 
                Code, as adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title for 
                Federal employees stationed in the District of 
                Columbia.''; and
                    (C) by striking the second sentence; and
            (7) by adding at the end the following:
            ``(9) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) 1 business entity controls, or has the power 
                to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control both of the business entities.''.

SEC. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
            (1) by striking ``Beginning in fiscal year 1993'' and 
        inserting ``Beginning in fiscal year 1998'';
            (2) in paragraph (1)--
                    (A) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) Payment.--The fee required by subparagraph 
                (A) shall be due upon submission of the application or 
                supplement.'';
                    (B) in subparagraph (D)--
                            (i) in the subparagraph heading, by 
                        striking ``not accepted'' and inserting 
                        ``refused'';
                            (ii) by striking ``50 percent'' and 
                        inserting ``75 percent'';
                            (iii) by striking ``subparagraph (B)(i)'' 
                        and inserting ``subparagraph (B)''; and
                            (iv) by striking ``not accepted'' and 
                        inserting ``refused''; and
                    (C) by adding at the end the following:
                    ``(E) Exception for designated orphan drug or 
                indication.--A human drug application for a 
                prescription drug product that has been designated as a 
                drug for a rare disease or condition pursuant to 
                section 526 shall not be subject to a fee under 
                subparagraph (A), unless the human drug application 
                includes indications for other than rare diseases or 
                conditions. A supplement proposing to include a new 
                indication for a rare disease or condition in a human 
                drug application shall not be subject to a fee under 
                subparagraph (A), provided that the drug has been 
                designated pursuant to section 526 as a drug for a rare 
                disease or condition with regard to the indication 
                proposed in such supplement.
                    ``(F) Exception for supplements for pediatric 
                indications.--A supplement to a human drug application 
                for an indication for use in pediatric populations 
                shall not be assessed a fee under subparagraph (A).
                    ``(G) Refund of fee if application withdrawn.--If 
                an application or supplement is withdrawn after the 
                application or supplement is filed, the Secretary may 
                waive and refund the fee or a portion of the fee if no 
                substantial work was performed on the application or 
                supplement after the application or supplement was 
                filed. The Secretary shall have the sole discretion to 
                waive and refund a fee or a portion of the fee under 
                this subparagraph. A determination by the Secretary 
                concerning a waiver or refund under this paragraph 
                shall not be reviewable.'';
            (3) by striking paragraph (2) and inserting the following:
            ``(2) Prescription drug establishment fee.--
                    ``(A) In general.--Each person that--
                            ``(i) is named as the applicant in a human 
                        drug application; and
                            ``(ii) after September 1, 1992, had pending 
                        before the Secretary a human drug application 
                        or supplement;
                shall be assessed an annual fee established in 
                subsection (b) for each prescription drug establishment 
                listed in its approved human drug application as an 
                establishment that manufactures the prescription drug 
                product named in the application. The annual 
                establishment fee shall be assessed in each fiscal year 
                in which the prescription drug product named in the 
                application is assessed a fee under paragraph (3) 
                unless the prescription drug establishment listed in 
                the application does not engage in the manufacture of 
                the prescription drug product during the fiscal year. 
                The establishment fee shall be payable on or before 
                January 31 of each year. Each such establishment shall 
                be assessed only 1 fee per establishment, 
                notwithstanding the number of prescription drug 
                products manufactured at the establishment. In the 
                event an establishment is listed in a human drug 
                application by more than 1 applicant, the establishment 
                fee for the fiscal year shall be divided equally and 
                assessed among the applicants whose prescription drug 
                products are manufactured by the establishment during 
                the fiscal year and assessed product fees under 
                paragraph (3).
                    ``(B) Exception.--If, during the fiscal year, an 
                applicant initiates or causes to be initiated the 
                manufacture of a prescription drug product at an 
                establishment listed in its human drug application--
                            ``(i) that did not manufacture the product 
                        in the previous fiscal year; and
                            ``(ii) for which the full establishment fee 
                        has been assessed in the fiscal year at a time 
                        before manufacture of the prescription drug 
                        product was begun;
                the applicant will not be assessed a share of the 
                establishment fee for the fiscal year in which 
                manufacture of the product began.''; and
            (4) in paragraph (3)--
                    (A) in subparagraph (A)--
                            (i) in clause (i), by striking ``is 
                        listed'' and inserting ``has been submitted for 
                        listing''; and
                            (ii) by striking ``Such fee shall be 
                        payable'' and all that follows through 
                        ``section 510.'' and inserting the following: 
                        ``Such fee shall be payable for the fiscal year 
                        in which the product is first submitted for 
                        listing under section 510, or for relisting 
                        under section 510 if the product has been 
                        withdrawn from listing and relisted. After such 
                        fee is paid for that fiscal year, such fee 
                        shall be payable on or before January 31 of 
                        each year. Such fee shall be paid only once for 
                        each product for a fiscal year in which the fee 
                        is payable.''; and
                    (B) in subparagraph (B), by striking ``505(j).'' 
                and inserting the following: ``505(j), or under an 
                abbreviated new drug application pursuant to 
                regulations in effect prior to the implementation of 
                the Drug Price Competition and Patent Term Restoration 
                Act of 1984, or is a product approved under an 
                application filed under section 507 that is 
                abbreviated.''.
    (b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is amended to 
read as follows:
    ``(b) Fee Amounts.--Except as provided in subsections (c), (d), 
(f), and (g), the fees required under subsection (a) shall be 
determined and assessed as follows:
            ``(1) Application and supplement fees.--
                    ``(A) Full fees.--The application fee under 
                subsection (a)(1)(A)(i) shall be $250,704 in fiscal 
                year 1998, $256,338 in each of fiscal years 1999 and 
                2000, $267,606 in fiscal year 2001, and $258,451 in 
                fiscal year 2002.
                    ``(B) Other fees.--The fee under subsection 
                (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998, 
                $128,169 in each of fiscal years 1999 and 2000, 
                $133,803 in fiscal year 2001, and $129,226 in fiscal 
                year 2002.
            ``(2) Fee revenues for establishment fees.--The total fee 
        revenues to be collected in establishment fees under subsection 
        (a)(2) shall be $35,600,000 in fiscal year 1998, $36,400,000 in 
        each of fiscal years 1999 and 2000, $38,000,000 in fiscal year 
        2001, and $36,700,000 in fiscal year 2002.
            ``(3) Total fee revenues for product fees.--The total fee 
        revenues to be collected in product fees under subsection 
        (a)(3) in a fiscal year shall be equal to the total fee 
        revenues collected in establishment fees under subsection 
        (a)(2) in that fiscal year.''.
    (c) Increases and Adjustments.--Section 736(c) (21 U.S.C. 379h(c)) 
is amended--
            (1) in the subsection heading, by striking ``Increases 
        and'';
            (2) in paragraph (1)--
                    (A) by striking ``(1) Revenue'' and all that 
                follows through ``increased by the Secretary'' and 
                inserting the following: ``(1) Inflation adjustment.--
                The fees and total fee revenues established in 
                subsection (b) shall be adjusted by the Secretary'';
                    (B) in subparagraph (A), by striking ``increase'' 
                and inserting ``change'';
                    (C) in subparagraph (B), by striking ``increase'' 
                and inserting ``change''; and
                    (D) by adding at the end the following flush 
                sentence:
        ``The adjustment made each fiscal year by this subsection will 
        be added on a compounded basis to the sum of all adjustments 
        made each fiscal year after fiscal year 1997 under this 
        subsection.'';
            (3) in paragraph (2), by striking ``October 1, 1992,'' and 
        all that follows through ``such schedule.'' and inserting the 
        following: ``September 30, 1997, adjust the establishment and 
        product fees described in subsection (b) for the fiscal year in 
        which the adjustment occurs so that the revenues collected from 
        each of the categories of fees described in paragraphs (2) and 
        (3) of subsection (b) shall be set to be equal to the revenues 
        collected from the category of application and supplement fees 
        described in paragraph (1) of subsection (b).''; and
            (4) in paragraph (3), by striking ``paragraph (2)'' and 
        inserting ``this subsection''.
    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is 
amended--
            (1) by redesignating paragraphs (1), (2), (3), and (4) as 
        subparagraphs (A), (B), (C), and (D), respectively, and 
        indenting appropriately;
            (2) by striking ``The Secretary shall grant a'' and all 
        that follows through ``finds that--'' and inserting the 
        following:
            ``(1) In general.--The Secretary shall grant a waiver from 
        or a reduction of 1 or more fees assessed under subsection (a) 
        where the Secretary finds that--'';
            (3) in subparagraph (C) (as so redesignated by paragraph 
        (1)), by striking ``, or'' and inserting a comma;
            (4) in subparagraph (D) (as so redesignated by paragraph 
        (1)), by striking the period and inserting ``, or'';
            (5) by inserting after subparagraph (D) (as so redesignated 
        by paragraph (1)) the following:
                    ``(E) the applicant is a small business submitting 
                its first human drug application to the Secretary for 
                review.''; and
            (6) by striking ``In making the finding in paragraph (3),'' 
        and all that follows through ``standard costs.'' and inserting 
        the following:
            ``(2) Use of standard costs.--In making the finding in 
        paragraph (1)(C), the Secretary may use standard costs.
            ``(3) Rules relating to small businesses.--
                    ``(A) Definition.--In paragraph (1)(E), the term 
                `small business' means an entity that has fewer than 
                500 employees, including employees of affiliates.
                    ``(B) Waiver of application fee.--The Secretary 
                shall waive under paragraph (1)(E) the application fee 
                for the first human drug application that a small 
                business or its affiliate submits to the Secretary for 
                review. After a small business or its affiliate is 
                granted such a waiver, the small business or its 
                affiliate shall pay--
                            ``(i) application fees for all subsequent 
                        human drug applications submitted to the 
                        Secretary for review in the same manner as an 
                        entity that does not qualify as a small 
                        business; and
                            ``(ii) all supplement fees for all 
                        supplements to human drug applications 
                        submitted to the Secretary for review in the 
                        same manner as an entity that does not qualify 
                        as a small business.''.
    (e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C. 379h(f)(1)) 
is amended--
            (1) by striking ``fiscal year 1993'' and inserting ``fiscal 
        year 1997''; and
            (2) by striking ``fiscal year 1992'' and inserting ``fiscal 
        year 1997 (excluding the amount of fees appropriated for such 
        fiscal year)''.
    (f) Crediting and Availability of Fees.--Section 736(g) (21 U.S.C. 
379h(g)) is amended--
            (1) in paragraph (1), by adding at the end the following: 
        ``Such sums as may be necessary may be transferred from the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the process for the review of human drug 
        applications within the meaning of section 735(6).'';
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``Acts'' and 
                inserting ``Acts, or otherwise made available for 
                obligation,''; and
                    (B) in subparagraph (B), by striking ``over such 
                costs for fiscal year 1992'' and inserting ``over such 
                costs, excluding costs paid from fees collected under 
                this section, for fiscal year 1997''; and
            (3) by striking paragraph (3) and inserting the following:
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated for fees under this section--
                    ``(A) $106,800,000 for fiscal year 1998;
                    ``(B) $109,200,000 for fiscal year 1999;
                    ``(C) $109,200,000 for fiscal year 2000;
                    ``(D) $114,000,000 for fiscal year 2001; and
                    ``(E) $110,100,000 for fiscal year 2002,
        as adjusted to reflect adjustments in the total fee revenues 
        made under this section and changes in the total amounts 
        collected by application, supplement, establishment, and 
        product fees.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year which exceeds the amount of fees specified in 
        appropriation Acts for such fiscal year, shall be credited to 
        the appropriation account of the Food and Drug Administration 
        as provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under appropriation Acts for a subsequent fiscal 
        year.''.
    (g) Requirement for Written Requests for Waivers, Reductions, and 
Fees.--Section 736 (21 U.S.C. 379h) is amended--
            (1) by redesignating subsection (i) as subsection (j); and
            (2) by inserting after subsection (h) the following:
    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund, of any fee collected in accordance with 
subsection (a), a person shall submit to the Secretary a written 
request for such waiver, reduction, or refund not later than 180 days 
after such fee is due.''.
    (h) Special Rule for Waiver, Refunds, and Exceptions.--Any requests 
for waivers, refunds, or exceptions for fees paid prior to the date of 
enactment of this Act shall be submitted in writing to the Secretary of 
Health and Human Services within 1 year after the date of enactment of 
this Act.

SEC. 705. ANNUAL REPORTS.

    (a) First Report.--Beginning with fiscal year 1998, not later than 
60 days after the end of each fiscal year during which fees are 
collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report concerning the progress of the 
Food and Drug Administration in achieving the goals identified in the 
letter described in section 702(4) during such fiscal year and the 
future plans of the Food and Drug Administration for meeting the goals.
    (b) Second Report.--Beginning with fiscal year 1998, not later than 
120 days after the end of each fiscal year during which fees are 
collected under the part described in subsection (a), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report on the implementation of the 
authority for such fees during such fiscal year and the use, by the 
Food and Drug Administration, of the fees collected during such fiscal 
year for which the report is made.

SEC. 706. EFFECTIVE DATE.

    The amendments made by this title shall take effect October 1, 
1997.

SEC. 707. TERMINATION OF EFFECTIVENESS.

    The amendments made by sections 703 and 704 cease to be effective 
October 1, 2002 and section 705 ceases to be effective 120 days after 
such date.

                       TITLE VIII--MISCELLANEOUS

SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.

    Section 510(i) (21 U.S.C. 360(i)) is amended to read as follows:
    ``(i)(1) Any establishment within any foreign country engaged in 
the manufacture, preparation, propagation, compounding, or processing 
of a drug or a device that is imported or offered for import into the 
United States shall register with the Secretary the name and place of 
business of the establishment and the name of the United States agent 
for the establishment.
    ``(2) The establishment shall also provide the information required 
by subsection (j).
    ``(3) The Secretary is authorized to enter into cooperative 
arrangements with foreign countries to ensure that adequate and 
effective means are available for purposes of determining, from time to 
time, whether drugs or devices manufactured, prepared, propagated, 
compounded, or processed by an establishment described in paragraph 
(1), if imported or offered for import into the United States, shall be 
refused admission on any of the grounds set forth in section 801(a).''.

SEC. 802. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.

    (a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C. 353(b)(4)) is 
amended to read as follows:
    ``(4)(A) A drug that is subject to paragraph (1) shall be deemed to 
be misbranded if at any time prior to dispensing the label of the drug 
fails to bear, at a minimum, the symbol `Rx only'.
    ``(B) A drug to which paragraph (1) does not apply shall be deemed 
to be misbranded if at any time prior to dispensing the label of the 
drug bears the symbol described in subparagraph (A).''.
    (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is 
repealed.
    (c) Conforming Amendments.--
            (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
                    (A) by striking subparagraph (A); and
                    (B) by redesignating subparagraphs (B) and (C) as 
                subparagraphs (A) and (B), respectively.
            (2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by 
        striking ``section 502(d) and''.
            (3) Section 102(9)(A) of the Controlled Substances Act (21 
        U.S.C. 802(9)(A)) is amended--
                    (A) in clause (i), by striking ``(i)''; and
                    (B) by striking ``(ii)'' and all that follows.

SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.

    Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
            (1) in the fifth sentence, by striking ``paragraphs (1) and 
        (2) of section 801(e)'' and inserting ``subparagraphs (A) and 
        (B) of section 801(e)(1)''; and
            (2) by inserting after the fifth sentence the following: 
        ``Any person seeking to export an imported article pursuant to 
        any of the provisions of this subsection shall establish that 
        the article was intended for export at the time the article 
        entered commerce.''.

SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 203, is 
further amended by adding at the end the following:

``SEC. 907. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.

    ``(a) In General.--The Secretary, acting through the Commissioner 
of Food and Drugs, may, directly or through grants, contracts, or 
cooperative agreements, conduct and support intramural research 
training in regulatory scientific programs by predoctoral and 
postdoctoral scientists and physicians, including support through the 
use of fellowships.
    ``(b) Limitation on Participation.--A recipient of a fellowship 
under subsection (a) may not be an employee of the Federal Government.
    ``(c) Special Rule.--The Secretary, acting through the Commissioner 
of Food and Drugs, may support the provision of assistance for 
fellowships described in subsection (a) through a Cooperative Research 
and Development Agreement.''.

SEC. 805. DEVICE SAMPLES.

    (a) Recall Authority.--
            (1) In general.--Section 518(e)(2) (21 U.S.C. 360h(e)(2)) 
        is amended by adding at the end the following:
    ``(C) If the Secretary issues an amended order under subparagraph 
(A), the Secretary may require the person subject to the order to 
submit such samples of the device and of components of the device as 
the Secretary may reasonably require. If the submission of such samples 
is impracticable or unduly burdensome, the requirement of this 
subparagraph may be met by the submission of complete information 
concerning the location of 1 or more such devices readily available for 
examination and testing.''.
            (2) Technical amendment.--Section 518(e)(2)(A) (21 U.S.C. 
        360h(e)(2)(A)) is amended by striking ``subparagraphs (B) and 
        (C)'' and inserting ``subparagraph (B)''.
    (b) Records and Reports on Devices.--Section 519(a) (21 U.S.C. 
360i(a)) is amended by inserting after paragraph (9) the following:
            ``(10) may reasonably require a manufacturer or importer to 
        submit samples of a device and of components of the device that 
        may have caused or contributed to a death or serious injury, 
        except that if the submission of such samples is impracticable 
        or unduly burdensome, the requirement of this paragraph may be 
        met by the submission of complete information concerning the 
        location of 1 or more such devices readily available for 
        examination and testing.''.

SEC. 806. INTERSTATE COMMERCE.

    Section 709 (21 U.S.C. 379a) is amended by striking ``a device'' 
and inserting ``a device, food, drug, or cosmetic''.

SEC. 807. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS.

    (a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et seq.), as 
amended by section 614(a), is further amended by adding at the end the 
following:

   ``Subchapter F--National Uniformity for Nonprescription Drugs and 
           Preemption for Labeling or Packaging of Cosmetics

``SEC. 761. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.

    ``(a) In General.--Except as provided in subsection (b), (c)(1), 
(d), (e), or (f), no State or political subdivision of a State may 
establish or continue in effect any requirement--
            ``(1) that relates to the regulation of a drug that is not 
        subject to the requirements of section 503(b)(1) or 
        503(f)(1)(A); and
            ``(2) that is different from or in addition to, or that is 
        otherwise not identical with, a requirement under this Act, the 
        Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
        seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 
        et seq.).
    ``(b) Exemption.--
            ``(1) In general.--Upon application of a State or political 
        subdivision thereof, the Secretary may by regulation, after 
        notice and opportunity for written and oral presentation of 
        views, exempt from subsection (a), under such conditions as may 
        be prescribed in such regulation, a State or political 
        subdivision requirement that--
                    ``(A) protects an important public interest that 
                would otherwise be unprotected, including the health 
                and safety of children;
                    ``(B) would not cause any drug to be in violation 
                of any applicable requirement or prohibition under 
                Federal law; and
                    ``(C) would not unduly burden interstate commerce.
            ``(2) Timely action.--The Secretary shall make a decision 
        on the exemption of a State or political subdivision 
        requirement under paragraph (1) not later than 120 days after 
        receiving the application of the State or political subdivision 
        under paragraph (1).
    ``(c) Scope.--
            ``(1) In general.--This section shall not apply to--
                    ``(A) any State or political subdivision 
                requirement that relates to the practice of pharmacy; 
                or
                    ``(B) any State or political subdivision 
                requirement that a drug be dispensed only upon the 
                prescription of a practitioner licensed by law to 
                administer such drug.
            ``(2) Safety or effectiveness.--For purposes of subsection 
        (a), a requirement that relates to the regulation of a drug 
        shall be deemed to include any requirement relating to public 
        information or any other form of public communication relating 
        to a warning of any kind for a drug.
    ``(d) Exceptions.--
            ``(1) In general.--In the case of a drug described in 
        subsection (a)(1) that is not the subject of an application 
        approved under section 505 or 507 or a final regulation 
        promulgated by the Secretary establishing conditions under 
        which the drug is generally recognized as safe and effective 
        and not misbranded, subsection (a) shall apply only with 
        respect to a requirement of a State or political subdivision of 
        a State that relates to the same subject as, but is different 
        from or in addition to, or that is otherwise not identical 
        with--
                    ``(A) a regulation in effect with respect to the 
                drug pursuant to a statute described in subsection 
                (a)(2); or
                    ``(B) any other requirement in effect with respect 
                to the drug pursuant to an amendment to such a statute 
                made on or after the date of enactment of this section.
            ``(2) State initiatives.--This section shall not apply to a 
        State public initiative enacted prior to the date of enactment 
        of this section.
    ``(e) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any State.
    ``(f) State Enforcement Authority.--Nothing in this section shall 
prevent a State or political subdivision thereof from enforcing, under 
any relevant civil or other enforcement authority, a requirement that 
is identical to a requirement of this Act.''.
    (b) Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) is 
amended by striking ``prescription drugs'' each place it appears and 
inserting ``prescription drugs, nonprescription drugs intended for 
human use,''.
    (c) Misbranding.--Paragraph (1) of section 502(e) (21 U.S.C. 
352(e)(1)) is amended to read as follows:
    ``(1)(A) If it is a drug, unless its label bears, to the exclusion 
of any other nonproprietary name (except the applicable systematic 
chemical name or the chemical formula)--
            ``(i) the established name (as defined in subparagraph (3)) 
        of the drug, if there is such a name;
            ``(ii) the established name and quantity or, if deemed 
        appropriate by the Secretary, the proportion of each active 
        ingredient, including the quantity, kind, and proportion of any 
        alcohol, and also including whether active or not the 
        established name and quantity or if deemed appropriate by the 
        Secretary, the proportion of any bromides, ether, chloroform, 
        acetanilide, acetophenetidin, amidopyrine, antipyrine, 
        atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis 
        glucosides, mercury, ouabain, strophanthin, strychnine, 
        thyroid, or any derivative or preparation of any such 
        substances, contained therein: Provided, That the requirement 
        for stating the quantity of the active ingredients, other than 
        the quantity of those specifically named in this paragraph, 
        shall not apply to nonprescription drugs not intended for human 
        use; and
            ``(iii) the established name of each inactive ingredient 
        listed in alphabetical order on the outside container of the 
        retail package and, if deemed appropriate by the Secretary, on 
        the immediate container, as prescribed in regulation 
        promulgated by the Secretary, but nothing in this clause shall 
        be deemed to require that any trade secret be divulged: 
        Provided, That the requirements of this clause with respect to 
        alphabetical order shall apply only to nonprescription drugs 
        that are not also cosmetics: and Provided further, That this 
        clause shall not apply to nonprescription drugs not intended 
        for human use.
    ``(B) For any prescription drug the established name of such drug 
or ingredient, as the case may be, on such label (and on any labeling 
on which a name for such drug or ingredient is used) shall be printed 
prominently and in type at least half as large as that used thereon for 
any proprietary name or designation for such drug or ingredient: 
Provided, That to the extent that compliance with the requirements of 
clause (A)(ii) or (iii) or this clause of this subparagraph is 
impracticable, exemptions shall be established by regulations 
promulgated by the Secretary.''.
    (d) Cosmetics.--Subchapter F of chapter VII, as amended by 
subsection (a), is further amended by adding at the end the following:

``SEC. 762. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS.

    ``(a) In General.--Except as provided in subsection (b), (d), or 
(e), a State or political subdivision of a State shall not impose or 
continue in effect any requirement for labeling or packaging of a 
cosmetic that is different from or in addition to, or that is otherwise 
not identical with a requirement specifically applicable to a 
particular cosmetic or class of cosmetics under this Act, the Poison 
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair 
Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
    ``(b) Exemption.--Upon application of a State or political 
subdivision thereof, the Secretary may by regulation after notice and 
opportunity for written and oral presentation of views, exempt from 
subsection (a), under such conditions as may be prescribed in such 
regulation, a State or political subdivision requirement for labeling 
and packaging that--
            ``(1) protects an important public interest that would 
        otherwise be unprotected;
            ``(2) would not cause a cosmetic to be in violation of any 
        applicable requirements or prohibition under Federal law; and
            ``(3) would not unduly burden interstate commerce.
    ``(c) Scope.--For purposes of subsection (a), a reference to a 
State requirement that relates to the packaging or labeling of a 
cosmetic means any specific requirement relating to the same aspect of 
such cosmetic as a requirement specifically applicable to that 
particular cosmetic or class of cosmetics under this Act for packaging 
or labeling, including any State requirement relating to public 
information or any other form of public communication.
    ``(d) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any State.
    ``(e) State Initiative.--This section shall not apply to a State 
requirement adopted by a State public initiative or referendum enacted 
prior to September 1, 1997.''.

SEC. 808. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS OR LIFE-
              THREATENING DISEASES.

    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended--
            (1) by redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and
            (2) by inserting after subsection (i), the following:
    ``(j)(1) The Secretary, acting through the Director of the National 
Institutes of Health and subject to the availability of appropriations, 
shall establish, maintain, and operate a program with respect to 
information on research relating to the treatment, detection, and 
prevention of serious or life-threatening diseases and conditions. The 
program shall, with respect to the agencies of the Department of Health 
and Human Services, be integrated and coordinated, and, to the extent 
practicable, coordinated with other data banks containing similar 
information.
    ``(2)(A) After consultation with the Commissioner of Food and 
Drugs, the directors of the appropriate agencies of the National 
Institutes of Health (including the National Library of Medicine), and 
the Director of the Centers for Disease Control and Prevention, the 
Secretary shall, in carrying out paragraph (1), establish a data bank 
of information on clinical trials for drugs, and biologicals, for 
serious or life-threatening diseases and conditions.
    ``(B) In carrying out subparagraph (A), the Secretary shall 
collect, catalog, store, and disseminate the information described in 
such subparagraph. The Secretary shall disseminate such information 
through information systems, which shall include toll-free telephone 
communications, available to individuals with serious or life-
threatening diseases and conditions, to other members of the public, to 
health care providers, and to researchers.
    ``(3) The data bank shall include the following:
            ``(A) A registry of clinical trials (whether federally or 
        privately funded) of experimental treatments for serious or 
        life-threatening diseases and conditions under regulations 
        promulgated pursuant to sections 505 and 520 of the Federal 
        Food, Drug, and Cosmetic Act that provides a description of the 
        purpose of each experimental drug or biological protocol, 
        either with the consent of the protocol sponsor, or when a 
        trial to test efficacy begins. Information provided shall 
        consist of eligibility criteria, a description of the location 
        of trial sites, and a point of contact for those wanting to 
        enroll in the trial, and shall be in a form that can be readily 
        understood by members of the public. Such information must be 
        forwarded to the data bank by the sponsor of the trial not 
        later than 21 days after the approval by the Food and Drug 
        Administration.
            ``(B) Information pertaining to experimental treatments for 
        serious or life-threatening diseases and conditions that may be 
        available--
                    ``(i) under a treatment investigational new drug 
                application that has been submitted to the Food and 
                Drug Administration pursuant to part 312 of title 21, 
                Code of Federal Regulations; or
                    ``(ii) as a Group C cancer drug.
        The data bank may also include information pertaining to the 
        results of clinical trials of such treatments, with the consent 
        of the sponsor, including information concerning potential 
        toxicities or adverse effects associated with the use or 
        administration of such experimental treatments.
    ``(4) The data bank shall not include information relating to an 
investigation if the sponsor has provided a detailed certification to 
the Secretary that disclosure of such information would substantially 
interfere with the timely enrollment of subjects in the investigation, 
unless the Secretary, after the receipt of the certification, provides 
the sponsor with a detailed written determination that finds that such 
disclosure would not substantially interfere with such enrollment.
    ``(5) For the purpose of carrying out this subsection, there are 
authorized to be appropriated such sums as may be necessary. Fees 
collected under section 736 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h) shall not be authorized or appropriated for use in 
carrying out this subsection.''.
    (b) Collaboration and Report.--
            (1) In general.--The Secretary of Health and Human 
        Services, the Director of the National Institutes of Health, 
        and the Commissioner of Food and Drugs shall collaborate to 
        determine the feasibility of including device investigations 
        within the scope of the registry requirements set forth in 
        subsection (j) of section 402 of the Public Health Service Act.
            (2) Report.--Not later than 2 years after the date of 
        enactment of this section, the Secretary of Health and Human 
        Services shall prepare and submit to the Committee on Labor and 
        Human Resources of the Senate and the Committee on Commerce of 
        the House of Representatives a report that shall consider, 
        among other things--
                    (A) the public health need, if any, for inclusion 
                of device investigations within the scope of the 
                registry requirements set forth in subsection (j) of 
                section 402 of the Public Health Service Act; and
                    (B) the adverse impact, if any, on device 
                innovation and research in the United States if 
                information relating to such device investigation is 
                required to be publicly disclosed.

SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF PHARMACY 
              COMPOUNDING.

    Section 503 (21 U.S.C. 353) is amended by adding at the end the 
following:
    ``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and 507 
shall not apply to a drug product if--
            ``(A) the drug product is compounded for an identified 
        individual patient, based on a medical need for a compounded 
        product--
                    ``(i) by a licensed pharmacist in a State licensed 
                pharmacy or a Federal facility, or a licensed 
                physician, on the prescription order of a licensed 
                physician or other licensed practitioner authorized by 
                State law to prescribe drugs; or
                    ``(ii) by a licensed pharmacist or licensed 
                physician in limited quantities, prior to the receipt 
                of a valid prescription order for the identified 
                individual patient, and is compounded based on a 
                history of the licensed pharmacist or licensed 
                physician receiving valid prescription orders for the 
                compounding of the drug product that have been 
                generated solely within an established relationship 
                between the licensed pharmacist, or licensed physician, 
                and--
                            ``(I) the individual patient for whom the 
                        prescription order will be provided; or
                            ``(II) the physician or other licensed 
                        practitioner who will write such prescription 
                        order; and
            ``(B) the licensed pharmacist or licensed physician--
                    ``(i) compounds the drug product using bulk drug 
                substances--
                            ``(I) that--
                                    ``(aa) comply with the standards of 
                                an applicable United States 
                                Pharmacopeia or National Formulary 
                                monograph; or
                                    ``(bb) in a case in which such a 
                                monograph does not exist, are drug 
                                substances that are covered by 
                                regulations issued by the Secretary 
                                under paragraph (3);
                            ``(II) that are manufactured by an 
                        establishment that is registered under section 
                        510 (including a foreign establishment that is 
                        registered under section 510(i)); and
                            ``(III) that are accompanied by valid 
                        certificates of analysis for each bulk drug 
                        substance;
                    ``(ii) compounds the drug product using ingredients 
                (other than bulk drug substances) that comply with the 
                standards of an applicable United States Pharmacopeia 
                or National Formulary monograph and the United States 
                Pharmacopeia chapter on pharmacy compounding;
                    ``(iii) only advertises or promotes the compounding 
                service provided by the licensed pharmacist or licensed 
                physician and does not advertise or promote the 
                compounding of any particular drug, class of drug, or 
                type of drug;
                    ``(iv) does not compound a drug product that 
                appears on a list published by the Secretary in the 
                Federal Register of drug products that have been 
                withdrawn or removed from the market because such drug 
                products or components of such drug products have been 
                found to be unsafe or not effective;
                    ``(v) does not compound a drug product that is 
                identified by the Secretary in regulation as presenting 
                demonstrable difficulties for compounding that 
                reasonably demonstrate an adverse effect on the safety 
                or effectiveness of that drug product; and
                    ``(vi) does not distribute compounded drugs outside 
                of the State in which the drugs are compounded, unless 
                the principal State agency of jurisdiction that 
                regulates the practice of pharmacy in such State has 
                entered into a memorandum of understanding with the 
                Secretary regarding the regulation of drugs that are 
                compounded in the State and are distributed outside of 
                the State, that provides for appropriate investigation 
                by the State agency of complaints relating to 
                compounded products distributed outside of the State.
    ``(2)(A) The Secretary shall, after consultation with the National 
Association of Boards of Pharmacy, develop a standard memorandum of 
understanding for use by States in complying with paragraph (1)(B)(vi).
    ``(B) Paragraph (1)(B)(vi) shall not apply to a licensed pharmacist 
or licensed physician, who does not distribute inordinate amounts of 
compounded products outside of the State, until--
            ``(i) the date that is 180 days after the development of 
        the standard memorandum of understanding; or
            ``(ii) the date on which the State agency enters into a 
        memorandum of understanding under paragraph (1)(B)(vi),
whichever occurs first.
    ``(3) The Secretary, after consultation with the United States 
Pharmacopeia Convention Incorporated, shall promulgate regulations 
limiting compounding under paragraph (1)(B)(i)(I)(bb) to drug 
substances that are components of drug products approved by the 
Secretary and to other drug substances as the Secretary may identify.
    ``(4) The provisions of paragraph (1) shall not apply--
            ``(A) to compounded positron emission tomography drugs as 
        defined in section 201(ii); or
            ``(B) to radiopharmaceuticals.
    ``(5) In this subsection, the term `compound' does not include to 
mix, reconstitute, or perform another similar act, in accordance with 
directions contained in approved drug labeling provided by a drug 
manufacturer and other drug manufacturer directions consistent with 
that labeling.''.

SEC. 810. REPORTS OF POSTMARKETING APPROVAL STUDIES.

    (a) In General.--Chapter V (21 U.S.C. 351 et seq.), as amended by 
section 613(a), is further amended by adding at the end the following:

``SEC. 562. REPORTS OF POSTMARKETING STUDIES.

    ``(a) Submission.--
            ``(1) In general.--A sponsor of a drug that has entered 
        into an agreement with the Secretary to conduct a postmarketing 
        study of a drug shall submit to the Secretary, within 1 year 
        after the approval of such drug and annually thereafter until 
        the study is completed or terminated, a report of the progress 
        of the study or the reasons for the failure of the sponsor to 
        conduct the study. The report shall be submitted in such form 
        as prescribed by the Secretary in regulations issued by the 
        Secretary.
            ``(2) Agreements prior to effective date.--An agreement 
        entered into between the Secretary and a sponsor of a drug, 
        prior to the date of enactment of this section, to conduct a 
        postmarketing study of a drug shall be subject to the 
        requirements of paragraph (1). An initial report for such an 
        agreement shall be submitted within 6 months after the date of 
        the issuance of the regulations under paragraph (1).
    ``(b) Consideration of Information as Public Information.--Any 
information pertaining to a report described in paragraph (1) shall be 
considered to be public information to the extent that the information 
is necessary--
            ``(1) to identify the sponsor; and
            ``(2) to establish the status of a study described in 
        subsection (a) and the reasons, if any, for any failure to 
        carry out the study.
    ``(c) Status of Studies and Reports.--The Secretary shall annually 
develop and publish in the Federal Register a report that provides a 
status of the postmarketing studies--
            ``(1) that sponsors have entered into agreements to 
        conduct; and
            ``(2) for which reports have been submitted under 
        subsection (a)(1).''.
    (b) Report to Congressional Committees.--Not later than October 1, 
2001, the Secretary shall prepare and submit to the Committee on Labor 
and Human Resources of the Senate and the Committee on Commerce of the 
House of Representatives a report containing--
            (1) a summary of the reports submitted under section 562 of 
        the Federal Food, Drug, and Cosmetic Act; and
            (2) an evaluation of--
                    (A) the performance of the sponsors in fulfilling 
                the agreements with respect to the conduct of 
                postmarketing studies described in such section of such 
                Act;
                    (B) the timeliness of the Secretary's review of the 
                postmarketing studies; and
                    (C) any legislative recommendations respecting 
                postmarketing studies.

 SEC. 811. INFORMATION EXCHANGE.

    (a) In General.--Chapter VII (2 U.S.C. 371 et seq.), as amended by 
section 807, is further amended by adding at the end the following:

        ``Subchapter G--Dissemination of Treatment Information 

``SEC. 771. DISSEMINATION OF TREATMENT INFORMATION ON DRUGS, BIOLOGICAL 
              PRODUCTS, AND DEVICES.

    ``(a) Dissemination of Treatment Information.--
            ``(1) In general.--Notwithstanding sections 301(d), 502(f), 
        505, and 507 and section 351 of the Public Health Service Act 
        (42 U.S.C. 262), and subject to the requirements of paragraphs 
        (2) through (6) and subsection (b), a manufacturer may 
        disseminate to a health care practitioner, a pharmacy benefit 
        manager, a health maintenance organization or other managed 
        health care organization, or a health care insurer or 
        governmental agency, written information concerning the safety, 
        effectiveness, or benefit (whether or not such information is 
        contained in the official labeling) of a drug, biological 
        product, or device for which--
                    ``(A) an approval of an application filed under 
                section 505(b), 505(j), or 515, a clearance in 
                accordance with section  510(k), an approval in 
                accordance with section 507, or a biologics license 
                issued under section 351 of the Public Health Service 
                Act, is in effect; and
                    ``(B) if the use is not described in the approved 
                labeling of the product, the manufacturer has submitted 
                to the Secretary a certification that a supplemental 
                application for that use will be submitted to the 
                Secretary pursuant to paragraph (3) or the manufacturer 
                has received an exemption under paragraph (3)(C).
            ``(2) Authorized information.--A manufacturer may 
        disseminate the written information under paragraph (1) only if 
        the information--
                    ``(A) is in the form of an unabridged--
                            ``(i) reprint or copy of a peer-reviewed 
                        article from a scientific or medical journal 
                        (as defined in subsection (c)(5)) of a clinical 
                        investigation, with respect to a drug, 
                        biological product or device, that would be 
                        considered to be scientifically sound by 
                        experts qualified by scientific training or 
                        experience to evaluate the safety or 
                        effectiveness of the drug, biological product, 
                        or device that is the subject of such clinical 
                        investigation; or
                            ``(ii) reference textbook (as defined in 
                        subsection (c)(4)) that includes information 
                        about a clinical investigation with respect to 
                        a drug, biological product, or device, that 
                        would be considered to be scientifically sound 
                        by experts qualified by scientific training or 
                        experience to evaluate the safety or 
                        effectiveness of the drug, biological product, 
                        or device that is the subject of such clinical 
                        investigation; and
                    ``(B) is not false, not misleading, and would not 
                pose a significant risk to the public health.
            ``(3) Commitment to file a supplemental application; 
        incentives for research.--
                    ``(A) In general.--A manufacturer may disseminate 
                information about a use not described in the approved 
                labeling of a drug, biological product, or device 
                pursuant to paragraph (1) only if--
                            ``(i) the manufacturer has submitted to the 
                        Secretary a certification that the studies 
                        needed to file a supplemental application for 
                        such use have been completed and such 
                        supplement will be filed within 6 months after 
                        the date of the initial dissemination of 
                        information under paragraph (1); or
                            ``(ii)(I) the manufacturer has submitted to 
                        the Secretary a proposed protocol and schedule 
                        for conducting the studies needed to submit a 
                        supplemental application for such use and has 
                        certified that the supplement will be submitted 
                        within 36 months after the date of the initial 
                        dissemination of information under paragraph 
                        (1); and
                            ``(II) the Secretary has determined that 
                        the protocol for conducting such studies is 
                        adequate and that the schedule for completing 
                        such studies is reasonable.
                    ``(B) Extension.--
                            ``(i) Longer period of time.--The Secretary 
                        may grant a longer period of time for a 
                        manufacturer to submit a supplemental 
                        application pursuant to subparagraph (A) if the 
                        Secretary determines that the studies needed to 
                        submit a supplemental application cannot be 
                        completed and submitted within 36 months.
                            ``(ii) Extension of 3-year period.--The 
                        Secretary may extend the time within which a 
                        manufacturer must submit a supplemental 
                        application pursuant to subparagraph (A) if the 
                        manufacturer demonstrates that the manufacturer 
                        has acted with due diligence to conduct the 
                        studies in a timely manner. Such extension 
                        shall not exceed a period of 24 months.
                    ``(C) Exemptions.--A manufacturer may file a 
                request for an exemption from the requirements set 
                forth in subparagraph (A). Such request shall be 
                submitted in the form and manner prescribed by the 
                Secretary and shall demonstrate that--
                            ``(i) due to the size of the patient 
                        population or the lack of potential benefit to 
                        the sponsor, the cost of obtaining clinical 
                        information and submitting a supplemental 
                        application is economically prohibitive; or
                            ``(ii) it would be unethical to conduct the 
                        studies necessary to obtain adequate evidence 
                        for approval of a supplemental application.
                The Secretary shall act on a request for an exemption 
                under this subparagraph within 60 days after the 
                receipt of the request. If the Secretary fails to act 
                within 60 days, the manufacturer may begin to 
                disseminate information pursuant to paragraph (1) 
                without complying with subparagraph (A). If the 
                Secretary subsequently denies the request for an 
                exemption, the manufacturer either shall cease 
                dissemination or shall comply with the requirements of 
                subparagraph (A) within 60 days after such denial. If 
                the manufacturer ceases dissemination pursuant to this 
                subparagraph solely on the basis that the manufacturer 
                does not comply with subparagraph (A), the Secretary 
                may take appropriate corrective action, but may not 
                order the manufacturer to take corrective action.
                    ``(D) Report.--A manufacturer who submits a 
                certification to the Secretary under subparagraph (A) 
                shall provide the Secretary periodic reports that 
                describe the status of the studies being conducted to 
                obtain adequate evidence for approval of a supplemental 
                application.
            ``(4) Information on new uses.--
                    ``(A) In general.--If the information being 
                disseminated under paragraph (1) meets the requirements 
                of this section, a manufacturer may disseminate 
                information under paragraph (1) concerning the new use 
                of a drug, biological product, or device (described in 
                paragraph (1)) 60 calendar days after the manufacturer 
                has submitted to the Secretary--
                            ``(i) a copy of the information; and
                            ``(ii) any clinical trial information the 
                        manufacturer has relating to the safety or 
                        efficacy of the new use, any reports of 
                        clinical experience pertinent to the safety of 
                        the new use, and a summary of such information.
                If any of the information required to be provided under 
                clause (ii) has already been provided to the Secretary, 
                the manufacturer may meet the requirements of clause 
                (ii) by providing any such information obtained by the 
                manufacturer since the manufacturer's last submission 
                to the Secretary and a summary that identifies the 
                information previously provided.
                    ``(B) Additional information.--If the Secretary 
                determines that the information submitted by a 
                manufacturer under subparagraph (A)(i) with respect to 
                a new use of a drug, biological product, or device 
                fails to provide data, analyses, or other written 
                matter, that is objective and balanced, the Secretary 
                may require the manufacturer to disseminate along with 
                the information described in subparagraph (A)--
                            ``(i) additional information with respect 
                        to the new use of the drug,  biological 
                        product, or device that--
                                    ``(I) is in the form of an article 
                                described in paragraph (2)(A); and
                                    ``(II) provides data, analyses, or 
                                other written matter, that is 
                                scientifically sound;
                            ``(ii) additional objective and 
                        scientifically sound information that pertains 
                        to the safety or efficacy of the use and is 
                        necessary to provide objectivity and balance, 
                        including any information that the manufacturer 
                        has submitted to the Secretary, or where 
                        appropriate, a summary of such information, or 
                        any other information that the Secretary has 
                        authority to make available to the public;
                            ``(iii) an objective statement prescribed 
                        by the Secretary based on information described 
                        in clause (i) or (ii), provided the 
                        manufacturer has access to the data that forms 
                        the basis of such statement unless the 
                        Secretary is prohibited from making such data 
                        available to the manufacturer; and
                            ``(iv) a statement that describes any 
                        previous public announcements by the Secretary 
                        relevant to the new use.
            ``(5) New information.--If a manufacturer that is 
        disseminating information pursuant to paragraph (1) becomes 
        aware of new information relating to the safety or efficacy of 
        a new use of a drug, biological product, or device for which 
        information was disseminated under paragraph (1), the 
        manufacturer shall notify the Secretary with respect to the new 
        information. If the Secretary determines that the new 
        information demonstrates that a drug, biological product, or 
        device may not be effective or may present a significant risk 
        to public health, the Secretary shall, in consultation with the 
        manufacturer, take such appropriate action as the Secretary 
        determines necessary to ensure public health and safety. The 
        Secretary may limit the types of new information that must be 
        submitted under this paragraph.
            ``(6) Cessation of dissemination; corrective action.--The 
        Secretary may order a manufacturer to cease the dissemination 
        of all information being disseminated pursuant to paragraph (1) 
        if--
                    ``(A) the Secretary finds that a supplemental 
                application does not contain adequate information for 
                approval for the use that is the subject of the 
                information;
                    ``(B) the Secretary determines, after an informal 
                hearing, that the manufacturer is not acting with due 
                diligence to complete the studies necessary to file a 
                supplemental application for the use that is the 
                subject of the information being disseminated; or
                    ``(C) the Secretary determines that the information 
                being disseminated does not comply with the 
                requirements set forth in this section, after providing 
                notice, an opportunity for a meeting, and for minor 
                violations of this section (if there has been 
                substantial compliance with this section), an 
                opportunity to correct such information.
        If the Secretary orders cessation of dissemination pursuant to 
        this paragraph, the Secretary may order the manufacturer to 
        take appropriate corrective action.
            ``(7) Sponsored research.--If a manufacturer has sponsored 
        research that results in information as described in paragraph 
        (2)(A), another manufacturer may not distribute the information 
        under this section, unless such manufacturer is required by the 
        Secretary to distribute the information.
    ``(b) Disclosure Statement.--In order to afford a full and fair 
evaluation of the information described in subsection (a), a 
manufacturer disseminating the information shall include along with the 
information--
            ``(1) a prominently displayed statement that discloses--
                    ``(A) that the information concerns a use of a 
                drug, biological product, or device or other attribute 
                of a drug, biological product, or device that has not 
                been approved by the Food and Drug Administration;
                    ``(B) if applicable, that the information is being 
                disseminated at the expense of the manufacturer;
                    ``(C) if applicable, the name of any authors of the 
                information who are employees of, or consultants to, or 
                have received compensation from, the manufacturer, or 
                who have a significant financial interest in the 
                manufacturer;
                    ``(D) the official labeling for the drug, 
                biological product, or device and all updates with 
                respect to the labeling;
                    ``(E) if applicable, a statement that there are 
                products or treatments that have been approved for the 
                use that is the subject of the information being 
                disseminated pursuant to subsection (a)(1); and
                    ``(F) the identification of any person that has 
                provided funding for the conduct of a study relating to 
                a new use of a drug, biological product, or device for 
                which such information is being disseminated; and
            ``(2) a bibliography of other articles from a scientific 
        reference textbook or scientific or medical journal that have 
        been previously published about the new use of a drug, 
        biological product, or device covered by the information 
        disseminated (unless the information already includes such 
        bibliography).
    ``(c) Definitions.--As used in this section:
            ``(1) Health care practitioner.--The term `health care 
        practitioner' means a medical provider that is licensed to 
        prescribe a drug or biological product, or to prescribe or use 
        a device, for the treatment of a disease or other medical 
        condition.
            ``(2) Manufacturer.--The term `manufacturer' includes a 
        person who manufactures, distributes, or markets a drug, 
        biological product, or device.
            ``(3) New use.--The term `new use' used with respect to a 
        drug, biological product, or device means a use of a drug, 
        biological product, or device not included in the approved 
        labeling of such drug, biological product, or device.
            ``(4) Reference textbook.--The term `reference textbook' 
        means a reference publication that--
                    ``(A) has not been written, edited, excerpted, or 
                published specifically for, or at the request of a 
                manufacturer of a drug, biological product, or device;
                    ``(B) has not been edited or significantly 
                influenced by a manufacturer of a drug, biological 
                product, or device;
                    ``(C) is not solely distributed through a 
                manufacturer of a drug, biological product, or device 
                but is generally available in bookstores or other 
                distribution channels where medical textbooks are sold;
                    ``(D) does not focus on any particular drug, 
                biological product, or device of a manufacturer that 
                disseminates information under subsection (a), and does 
                not have a primary focus on new uses of drugs, 
                biological products, or devices that are marketed or 
                under investigation by a manufacturer supporting the 
                dissemination of information; and
                    ``(E) presents materials that are not false or 
                misleading.
            ``(5) Scientific or medical journal.--The term `scientific 
        or medical journal' means a scientific or medical publication--
                    ``(A) that is published by an organization--
                            ``(i) that has an editorial board;
                            ``(ii) that utilizes experts, who have 
                        demonstrated expertise in the subject of an 
                        article under review by the organization and 
                        who are independent of the organization, to 
                        review and objectively select, reject, or 
                        provide comments about proposed articles; and
                            ``(iii) that has a publicly stated policy, 
                        to which the organization adheres, of full 
                        disclosure of any conflict of interest or 
                        biases for all authors or contributors involved 
                        with the journal or organization;
                    ``(B) whose articles are peer-reviewed and 
                published in accordance with the regular peer-review 
                procedures of the organization;
                    ``(C) that is generally recognized to be of 
                national scope and reputation;
                    ``(D) that is indexed in the Index Medicus of the 
                National Library of Medicine of the National Institutes 
                of Health;
                    ``(E) that presents materials that are not false or 
                misleading; and
                    ``(F) that is not in the form of a special 
                supplement that has been funded in whole or in part by 
                1 or more manufacturers.
    ``(d) Construction.--Nothing in this section shall be construed as 
prohibiting a manufacturer from disseminating information in response 
to an unsolicited request from a health care practitioner.
    ``(e) Studies and Reports.--
            ``(1) General accounting office.--
                    ``(A) In general.--The Comptroller General of the 
                United States shall conduct a study to determine the 
                impact of this section on the resources of the 
                Department of Health and Human Services.
                    ``(B) Report.--Not later than January 1, 2002, the 
                Comptroller General of the United States shall prepare 
                and submit to the Committee on Labor and Human 
                Resources of the Senate and the Committee on Commerce 
                of the House of Representatives a report of the results 
                of the study.
            ``(2) Department of health and human services.--
                    ``(A) In general.--In order to assist Congress in 
                determining whether the provisions of this section 
                should be extended beyond the termination date 
                specified in section 811(e) of the Food and Drug 
                Administration Modernization and Accountability Act of 
                1997, the Secretary of Health and Human Services shall, 
                in accordance with subparagraph (B), arrange for the 
                conduct of a study of the scientific issues raised as a 
                result of the enactment of this section, including 
                issues relating to--
                            ``(i) the effectiveness of this section 
                        with respect to the provision of useful 
                        scientific information to health care 
                        practitioners;
                            ``(ii) the quality of the information being 
                        disseminated pursuant to the provisions of this 
                        section;
                            ``(iii) the quality and usefulness of the 
                        information provided, in accordance with this 
                        section, by the Secretary or by the 
                        manufacturer at the request of the Secretary; 
                        and
                            ``(iv) the impact of this section on 
                        research in the area of new uses, indications, 
                        or dosages, particularly the impact on 
                        pediatric indications and rare diseases.
            ``(3) Procedure for study.--
                    ``(A) In general.--The Secretary shall request the 
                Institute of Medicine of the National Academy of 
                Sciences to conduct the study required by paragraph 
                (2), and to prepare and submit the report required by 
                subparagraph (B), under an arrangement by which the 
                actual expenses incurred by the Institute of Medicine 
                in conducting the study and preparing the report will 
                be paid by the Secretary. If the Institute of Medicine 
                is unwilling to conduct the study under such an 
                arrangement, the Secretary shall enter into a similar 
                arrangement with another appropriate nonprofit private 
                group or association under which the group or 
                association will conduct the study and prepare and 
                submit the report.
                    ``(B) Report.--Not later than September 30, 2005, 
                the Institute of Medicine, the group, or association, 
                as appropriate, shall prepare and submit to the 
                Committee on Labor and Human Resources of the Senate, 
                the Committee on Commerce of the House of 
                Representatives, and the Secretary a report of the 
                results of the study required by paragraph (2). The 
                Secretary, after the receipt of the report, shall make 
                the report available to the public.
            ``(4) Authorization of appropriation.--There are authorized 
        to be appropriated such sums as are necessary to carry out this 
        subsection.

``SEC. 772. ESTABLISHMENT OF LIST OF ARTICLES AND TEXTBOOKS 
              DISSEMINATED AND LIST OF PROVIDERS THAT RECEIVED ARTICLES 
              AND REFERENCE TEXTBOOKS.

    ``(a) In General.--A manufacturer that disseminates information in 
the form of articles or reference textbooks under section 771 shall 
prepare and submit to the Secretary biannually--
            ``(1) a list containing the titles of the articles and 
        reference textbooks relating to the new use of drugs, 
        biological products, and devices that were disseminated by the 
        manufacturer to a person described in section 771(a)(1) for the 
        6-month period preceding the date on which the manufacturer 
        submits the list to the Secretary; and
            ``(2) a list that identifies the categories of providers 
        (as described in section 771(a)(1)) that received the articles 
        and reference textbooks for the 6-month period described in 
        paragraph (1).
    ``(b) Records.--A manufacturer that disseminates information under 
section 771 shall keep records that identify the recipients of articles 
and textbooks provided pursuant to section 771. Such records are to be 
used by the manufacturer when, pursuant to section 771(a)(6), such 
manufacturer is required to take corrective action and shall be made 
available to the Secretary, upon request, for purposes of ensuring or 
taking corrective action pursuant to paragraph (3), (5), or (6) of 
section 771(a).

``SEC. 773. CONSTRUCTION.

    ``(a) Dissemination of Information on Drugs or Devices Not Evidence 
of Intended Use.--Notwithstanding subsection (a), (f), or (o) of 
section 502, or any other provision of law, the dissemination of 
information relating to a new use of a drug or device, in accordance 
with section 771, shall not be construed by the Secretary as evidence 
of a new intended use of the drug or device that is different from the 
intended use of the drug or device set forth in the official labeling 
of the drug or device. Such dissemination shall not be considered by 
the Secretary as labeling, adulteration, or misbranding of the drug or 
device.
    ``(b) Patent Protection.--Nothing in section 771 shall affect 
patent rights in any manner.
    ``(c) Authorization for Dissemination of Articles and Fees for 
Reprints of Articles.--Nothing in section 771 shall be construed as 
prohibiting an entity that publishes a scientific journal (as defined 
in section 771(c)(5)) from requiring authorization from the entity to 
disseminate an article published by such entity and from charging fees 
for the purchase of reprints of published articles from such entity.''.
    (b) Prohibited Act.--Section 301 (21 U.S.C. 331), as amended by 
section 205(b), is further amended by adding at the end the following:
    ``(y) The dissemination of information pursuant to section 771 by a 
manufacturer who fails to comply with the requirements of such 
section.''.
    (c) Regulations.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall 
promulgate regulations to implement the amendments made by this 
section.
    (d) Effective Date.--The amendments made by this section shall take 
effect 1 year after the date of enactment of this Act, or upon the 
Secretary's issuance of final regulations pursuant to subsection (c), 
whichever is sooner.
    (e) Termination of Effectiveness.--The amendments made by this 
section cease to be effective September 30, 2006, or 7 years after the 
date on which the Secretary promulgates the regulations described in 
subsection (c), whichever is later.

SEC. 812. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.

    Section 2 of Public Law 102-222 (105 Stat. 1677) is amended--
            (1) in subsection (a), by striking ``a grant'' and all that 
        follows through ``Such grant'' and inserting the following: 
        ``grants for a pilot program for the training of individuals in 
        clinical pharmacology at appropriate medical schools. Such 
        grants''; and
            (2) in subsection (b), by striking ``to carry out this 
        section'' and inserting ``, and for fiscal years 1998 through 
        2002 $3,000,000 for each fiscal year, to carry out this 
        section''.

SEC. 813. MONOGRAPH FOR SUNBURN PRODUCTS.

    Not later than 18 months after the date of enactment of this Act, 
the Secretary of Health and Human Services shall issue a final 
monograph for over-the-counter sunburn products for prevention or 
treatment of sunburn.

SEC. 814. SAFETY REPORT DISCLAIMERS.

    Chapter IX (21 U.S.C. 391 et seq.), as amended by section 804, is 
further amended by adding at the end the following:

``SEC. 908. SAFETY REPORT DISCLAIMERS.

    ``With respect to any entity that submits or is required to submit 
a safety report or other information in connection with the safety of a 
product (including a product which is a food, drug, new drug, device, 
dietary supplement, or cosmetic) under this Act (and any release by the 
Secretary of that report or information), such report or information 
shall not be construed to necessarily reflect a conclusion by the 
entity or the Secretary that the report or information constitutes an 
admission that the product involved caused or contributed to an adverse 
experience, or otherwise caused or contributed to a death, serious 
injury, serious illness, or malfunction. Such an entity need not admit, 
and may deny, that the report or information submitted by the entity 
constitutes an admission that the product involved caused or 
contributed to an adverse experience or caused or contributed to a 
death, serious injury, serious illness, or malfunction.''.

            Passed the Senate September 24, 1997.

            Attest:

                                                             Secretary.
105th CONGRESS

  1st Session

                                 S. 830

_______________________________________________________________________

                                 AN ACT

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.

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