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







105th CONGRESS
  1st Session
                                 S. 830

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
  Service Act to improve the regulation of food, drugs, devices, and 
              biological products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 5, 1997

 Mr. Jeffords introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
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. Expedited access to investigational therapies.
Sec. 103. Expanded humanitarian use of devices.
         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

Sec. 201. Interagency collaboration.
Sec. 202. Sense of the committee regarding mutual recognition 
                            agreements and global harmonization 
                            efforts.
Sec. 203. Contracts for expert review.
Sec. 204. Accredited-party reviews.
Sec. 205. Device performance standards.
          TITLE III--IMPROVING COLLABORATION AND COMMUNICATION

Sec. 301. Collaborative determinations of device data requirements.
Sec. 302. Collaborative review process.
           TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES

Sec. 401. Policy statements.
Sec. 402. Product classification.
Sec. 403. Use of data relating to premarket approval.
Sec. 404. Consideration of labeling claims for product review.
Sec. 405. Definition of a day for purposes of product review.
Sec. 406. Certainty of review timeframes.
Sec. 407. Limitations on initial classification determinations.
Sec. 408. Clarification with respect to a general use and specific use 
                            of a device.
Sec. 409. Clarification of the number of required clinical 
                            investigations for approval.
Sec. 410. Prohibited acts.
                   TITLE V--IMPROVING ACCOUNTABILITY

Sec. 501. Agency plan for statutory compliance and annual report.
          TITLE VI--INCREASING RESOURCES BY SETTING PRIORITIES

Sec. 601. Minor modifications.
Sec. 602. Environmental impact review.
Sec. 603. Exemption of certain class devices from premarket 
                            notification requirement.
Sec. 604. Review of class I and class II devices.
Sec. 605. Evaluation of automatic class III designation.
Sec. 606. Secretary's discretion to track devices.
Sec. 607. Secretary's discretion to conduct postmarket surveillance.
Sec. 608. Reporting.
Sec. 609. Pilot and small-scale manufacture.
Sec. 610. Requirements for radiopharmaceuticals.
Sec. 611. Modernization of regulation of biological products.
Sec. 612. Supplemental new drug applications.
Sec. 613. Health care economic information.
Sec. 614. Expediting study and approval of fast track drugs.
Sec. 615. Manufacturing changes for drugs and biologics.
Sec. 616. Data requirements for drugs and biologics.
Sec. 617. Food contact substances.
Sec. 618. Health claims of food products.
Sec. 619. Pediatric studies marketing exclusivity.
                   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. Enforcement authority for special controls.
Sec. 806. Device samples.
Sec. 807. Interstate commerce.

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 adding after subsection (a) the following:
    ``(b) Mission.--
            ``(1) In general.--The Food and Drug Administration shall 
        protect the public health by ensuring that--
                    ``(A) foods are safe, wholesome, and sanitary;
                    ``(B) human and veterinary drugs are safe and 
                effective;
                    ``(C) there is reasonable assurance of safety and 
                effectiveness of devices intended for human use;
                    ``(D) cosmetics are safe; and
                    ``(E) public health and safety are protected from 
                electronic product radiation.
            ``(2) Special rules.--The Food and Drug Administration 
        shall promptly and efficiently review clinical research and 
        take appropriate action on the marketing of regulated products 
        in a manner that does not unduly impede innovation or product 
        availability. The Food and Drug Administration shall 
        participate with other countries to reduce the burden of 
        regulation, to harmonize regulatory requirements, and to 
        achieve appropriate reciprocal arrangements.''.

SEC. 102. EXPEDITED ACCESS TO INVESTIGATIONAL THERAPIES.

    Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end 
the following:

          ``Subchapter D--Unapproved Therapies and Diagnostics

``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.

    ``(a) In General.--Any person, acting through a medical 
practitioner licensed in accordance with State law, may request from a 
manufacturer or distributor, and any manufacturer or distributor may 
provide to a person after compliance with the provisions of this 
section, an investigational drug (including a biological product) or 
investigational device for the diagnosis, monitoring, or treatment of a 
serious disease or condition, or any other disease or condition 
designated by the Secretary as appropriate for expanded access under 
this section if--
            ``(1) the licensed medical practitioner determines that the 
        person has no comparable or satisfactory alternative therapy 
        available to diagnose, monitor, or treat the disease or 
        condition involved;
            ``(2) the licensed medical practioner determines that the 
        risk to the person from the investigational drug or 
        investigational device is not greater than the risk from the 
        disease or condition;
            ``(3) the Secretary determines that an exemption for the 
        investigational drug or investigational device is in effect 
        under a regulation promulgated pursuant to section 505(i) or 
        520(g) and the sponsor of the drug or device and investigators 
        comply with such regulation;
            ``(4) the Secretary determines that the manufacturer of the 
        investigational drug or investigational device is actively 
        pursuing marketing approval with due diligence; and
            ``(5) expanded access will not interfere with adequate 
        enrollment of patients by the investigator in the ongoing 
        clinical investigation authorized under section 505(i) or 
        520(g).
    ``(b) Protocols.--A manufacturer or distributor may submit to the 
Secretary 1 or more expanded access protocols covering expanded access 
use of a drug or device described in subsection (a). The protocols 
shall be subject to the provisions of section 505(i) or 520(g) and may 
include any form of use of the drug or device outside a clinical 
investigation, prior to approval of the drug or device for marketing, 
including protocols for treatment use, emergency use, or uncontrolled 
trials, and single patient protocols.
    ``(c) Notification of Availability.--The Secretary shall inform 
national, State, and local medical associations and societies, 
voluntary health associations, and other appropriate persons about the 
availability of an investigational drug or investigational device under 
expanded access protocols submitted under this section.''.
    (d) Termination.--FDA may at any time terminate expanded access 
under subsection (a) if the requirements under this section are no 
longer met.

SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.

    Section 520(m) (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (2), by adding at the end the following 
        flush sentences:
``The request shall be in the form of an application submitted to the 
Secretary. Not later than 60 days after the date of the receipt of the 
application, the Secretary shall issue an order approving or denying 
the application.'';
            (2) in paragraph (4)(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 after making a good faith 
        effort, the physician does not receive a timely response from 
        an institutional review committee on the physician's request 
        for approval to use the device.
            (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. 
Nothing in this section shall be construed to prevent the Secretary 
from using any of the controls authorized by or under section 501, 502, 
510, 516, 518, 519, or 520, any combination of such controls, or any of 
the special controls established under section 513(a)(1)(B), in 
connection with a device for which an exemption has been granted under 
paragraph (2).''.

         TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES

SEC. 201. INTERAGENCY COLLABORATION.

    Section 903(b) (21 U.S.C. 393(b)) 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 Secretary's duties 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 that--
            (1) the Secretary of Health and Human Services, in 
        consultation with the Secretary of Commerce, should 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, reached 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 of an article or made 
        under section 351(a) of the Public Health Service Act (42 
        U.S.C. 262(a)) with respect to a biological product. Any such 
        contract shall be subject to the requirements of section 708 
        relating to the confidentiality of information.
            ``(2) Increased efficiency and expertise through 
        contracts.--The Secretary shall use the authority granted in 
        paragraph (1) whenever the Secretary determines that a contract 
        described in paragraph (1) will improve the timeliness or 
        quality of the review of an application or submission described 
        in paragraph (1). Such improvement may include providing the 
        Secretary increased scientific or technical expertise that is 
        necessary to review or evaluate new therapies and technologies.
    ``(b) Review of Expert's Evaluation.--
            ``(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.
            ``(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, or the classification of an article 
        as a device under section 513(f)(1).''.

SEC. 204. ACCREDITED-PARTY REVIEWS.

    Subchapter A of chapter V (21 U.S.C. 351 et seq.) is amended by 
adding at the end the following:

``SEC. 523. ACCREDITED-PARTY PARTICIPATION.

    ``(a) Accreditation.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall accredit 
        persons, including any entity or individual who is not an 
        employee of United States Government, to review and make 
        recommendations regarding submissions made to the Secretary 
        under section 510(k) except that this paragraph does not apply 
        to submissions for devices that are--
                    ``(A) life-supporting;
                    ``(B) life sustaining; or
                    ``(C) intended for implantation in the human body 
                for a period of over 1 year.
            ``(2) Special rule.--The Secretary shall have the 
        discretion to accredit persons, including any entity or 
        individual who is not an employee of the United States 
        Government, to review and make recommendations regarding 
        devices described in subparagraphs (A) through (C) of paragraph 
        (1) or devices subject to premarket approval under section 515.
    ``(b) Accreditation.--Within 180 days after the date of enactment 
of this section, the Secretary shall adopt methods of accreditation 
that ensure that persons 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 person accredited under this section, 
after providing notice and an opportunity for an informal hearing, if 
such person acts in a manner that is substantially not in compliance 
with the requirements established by the Secretary, 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 submit a 
premarket submission for a device to the Secretary under subsection (a) 
shall have the option to select an accredited person to review such 
submission. Upon the request of a person intending to make a premarket 
submission for a device, the Secretary shall identify for the person no 
less than 2 accredited persons from whom the selection may be made. 
Compensation for an accredited person shall be determined by agreement 
between the accredited person and the person who engages the services 
of the accredited person and shall be paid by the person who engages 
such services.
    ``(e) Review by Secretary.--The Secretary shall require an 
accredited person, upon recommending a classification of a device or 
approval or disapproval of an application for a device, to report to 
the Secretary the reasons of the accredited person for such 
recommendation of classification or approval or disapproval. For 
devices reviewed and initially classified under section 513(f)(1) and 
subject to a report under section 510(k), the Secretary shall have not 
more than 30 days to review the submission. For applications submitted 
under section 515(c)(1), the Secretary shall have not more than 60 days 
to review the application. The Secretary may change the classification 
under section 513(f)(1), or the approval or disapproval of the 
application under section 515(d), that is recommended by the accredited 
person, and in such case shall notify in writing the person making the 
submission of the detailed reasons for the change.
    ``(f) Duration.--The authority provided by this section 
terminates--
            ``(1) 5 years after the date on which the Secretary 
        notifies Congress that at least 2 persons accredited under 
        subsection (b) are available to review devices in each of at 
        least 70 percent of generic types of devices required for 
        review under subsection (a); or
            ``(2) 4 years after the date on which the Secretary 
        notifies Congress that at least 35 percent of the devices 
        required for review under subsection (a) that were the subject 
        of final action by the Secretary in the fiscal year preceding 
        the date on which the Secretary notifies the Congress 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 
        persons 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 persons to conduct such reviews, and shall summarize 
        all relevant data, including data on the review of accredited 
        persons (including review times, recommendations, and 
        compensation), and data on the review of the Secretary 
        (including review times, changes, and reasons for changes).''.

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 the 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 Secretary's 
classification or approval of the device or a time equal to the 
expected design life of a 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 under 
subsection (c)(3) of section 514 or the failure or refusal to provide 
data or information requested by the Secretary under such 
subsection.''.
    (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, purports to be, or is represented as, a device that 
is declared to be 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) 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. 
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. 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 that such 
data are necessary to establish device effectiveness and that no other 
less burdensome means of evaluating device effectiveness are available 
which would have a reasonable likelihood of resulting in an approval.
    ``(ii) The determination of the Secretary with respect to the 
specification of valid scientific evidence under clause (i) shall be 
binding upon the Secretary, unless--
            ``(I) such determination by the Secretary would be contrary 
        to the public health; or
            ``(II) based on new information obtained by the Secretary 
        prior to the approval of an application for an investigational 
        device exemption under section 520(g), the Secretary finds that 
such determination is scientifically inappropriate.''.

SEC. 302. COLLABORATIVE REVIEW PROCESS.

    Section 515(d) (21 U.S.C. 360e(d)) is amended--
            (1) in paragraph (1)(A), by striking ``paragraph (2) of 
        this subsection'' each place it appears and inserting 
        ``paragraph (4)'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (4) and (5), respectively; and
            (3) by inserting after paragraph (1) the following:
    ``(2)(A) The Secretary shall meet with an applicant not later than 
100 days after the receipt of an application that has been filed as 
complete under subsection (c) to discuss the review status of the 
application. If the application does not appear in a form that would 
require an approval under this subsection, the Secretary shall in 
writing, and prior to the meeting, provide to the applicant a 
description of any deficiencies in the application identified by the 
Secretary and identify the information (other than information the 
Secretary needs to making a finding under paragraph (4)(C)) that is 
required to bring the application into a form that would require an 
approval. 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 as a regulation in the Federal Register 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--Review of Applications and Environmental Impact Reviews

``SEC. 741. CONTENT AND REVIEW OF AN APPLICATION OR SUBMISSION.

    ``(a) Classification of a Product.--
            ``(1) Request.--A person who submits an application or 
        submission (including a petition, notification, and any other 
        similar form of request) under this Act, may submit a request 
        to the Secretary respecting the classification of an article 
        (including an article that is a combination product subject to 
        section 503(g)) as a drug, biological product, or device, or 
        respecting the component of the Food and Drug Administration 
        that will regulate the article. In submitting the request, the 
        person shall recommend a classification for the article, or the 
        component that should regulate the article, as appropriate.
            ``(2) Statement.--Not later than 60 days after the receipt 
        of the request described in paragraph (1), 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.
            ``(3) Inaction of secretary.--If the Secretary does not 
        provide the statement within the 60-day period described in 
        paragraph (2), the recommendation made by the person under 
        paragraph (1) 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.

    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 
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 devices;
            ``(ii) determining whether a product development protocol 
        has been completed, under section 515;
            ``(iii) establishing a performance standard or special 
        control under section 514; and
            ``(iv) classifying or reclassifying devices 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 regulatory action described in subparagraph 
(A).''.

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 an 
application, the Secretary shall rely on the conditions of use proposed 
in the labeling of a device as the basis for determining whether or not 
there is a reasonable assurance of safety and effectiveness. If, based 
on a fair evaluation of all material facts, the proposed labeling is 
neither false nor misleading in any particular, the Secretary, in 
making the determination, shall not consider conditions of use not 
included in 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) Any determinations of substantial equivalence by the 
Secretary shall be based upon the intended uses proposed in labeling 
submitted in a report under section 510(k).''.

SEC. 405. DEFINITION OF A DAY FOR PURPOSES OF PRODUCT REVIEW.

    Section 201 (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ii) In any provision relating to a review of any application or 
submission (including a petition, notification, and any other similar 
form of request), made under this Act with respect to an article that 
is a new drug, device, biological product, new animal drug, an animal 
feed bearing or containing a new animal drug, color additive, or food 
additive, that is submitted to the Secretary to obtain marketing 
approval, to obtain classification of a device under section 513(f)(1), 
or to establish or clarify the regulatory status of the article, the 
term `day' means a calendar day in which the Secretary has 
responsibility to review such an application or submission (excluding 
any calendar day between the date of receipt, by the person submitting 
the application or submission, of a written communication from the 
Secretary setting forth the action of the Secretary on the application 
or submission and the date of receipt by the Secretary of the written 
response of the person to the action).''.

SEC. 406. CERTAINTY OF REVIEW TIMEFRAMES.

    (a) Clarification on the 90-Day Timeframe for Premarket 
Notification Reviews.--Section 510(k) (21 U.S.C. 360) is amended by 
adding at the end the following flush sentence:
``The Secretary shall review the notification required by this 
subsection and make a determination under section 513(f)(1) not later 
than 90 days after receiving the notification.''.
    (b) Certainty of 180-Day Review Time Frame.--Section 515(d) (21 
U.S.C. 360e(d)), as amended by section 302, is amended by inserting 
after paragraph (2) the following:
    ``(3) The time for the review of an application by the Secretary 
under this subsection shall take not more than 180 days and such time 
may not be extended if the application is amended.''.

SEC. 407. LIMITATIONS ON INITIAL CLASSIFICATION DETERMINATIONS.

    Section 510 (21 U.S.C. 360) is amended by adding at the end the 
following:
    ``(m)(1) 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).
    ``(2) Nothing in this provision shall be construed to prevent the 
Secretary from using any of the controls authorized by or under section 
501, 502, 510, 516, 518, 519, or 520, or any combination of such 
controls, or any of the special controls established under section 
513(a)(1)(B) to regulate a marketed device.''.

SEC. 408. CLARIFICATION WITH RESPECT TO A GENERAL USE AND SPECIFIC USE 
              OF A DEVICE.

    Not later than 270 days after the date of enactment of this 
section, the Secretary shall promulgate a final regulation specifying 
the general principles that the Secretary 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. 360(f)(1)) .

SEC. 409. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL 
              INVESTIGATIONS FOR APPROVAL.

    (a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) 
is amended by striking ``clinical investigations'' and inserting ``one 
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: ``If the Secretary determines that 
only one investigation is required, then the Secretary may require 
appropriate supporting scientific evidence obtained prior to or after 
such investigation. The Secretary shall establish a mechanism to ensure 
the fair and consistent application of this provision to new drugs''.

SEC. 410. PROHIBITED ACTS.

    Section 301(l) (21 U.S.C. 331(l) is repealed.

                   TITLE V--IMPROVING ACCOUNTABILITY

SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL REPORT.

    Section 903(b) (21 U.S.C. 393(b)), as amended by section 201, is 
further amended by adding at the end the following:
            ``(4) Agency plan for statutory compliance.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of this paragraph, the Secretary, 
                after consultation with relevant experts, health care 
                professionals, and 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 for and 
                mechanisms to be used by the Secretary, acting through 
                the Commissioner, including objectives and mechanisms 
                that--
                            ``(i) minimize deaths of, and harm to, 
                        persons who use or may use an article regulated 
                        under this Act;
                            ``(ii) maximize the clarity of, and the 
                        availability of information about, the process 
                        for review of applications and submissions 
                        (including petitions, notifications, and any 
                        other similar forms of request) made under this 
                        Act, including information for potential 
                        consumers and patients concerning new products;
                            ``(iii) implement all inspection and 
                        postmarket monitoring provisions of this Act by 
                        July 1, 1999;
                            ``(iv) ensure access to the scientific and 
                        technical expertise necessary to ensure 
                        compliance by the Secretary with the statutory 
                        obligations described in subparagraph (A);
                            ``(v) establish a schedule to bring the 
                        Administration into full compliance by July 1, 
                        1999, with the time periods specified in this 
                        Act for the review of all applications and 
                        submissions described in clause (ii) and 
                        submitted after the date of enactment of this 
                        paragraph; and
                            ``(vi) reduce backlogs in the review of all 
                        applications and submissions described in 
                        clause (ii) for any article with the objective 
                        of eliminating all backlogs in the review of 
                        the applications and submissions by January 1, 
                        2000.
            ``(5) Annual report.--
                    ``(A) Contents.--The Secretary shall prepare and 
                publish in the Federal Register and solicit public 
                comment on an annual report that--
                            ``(i) provides detailed statistical 
                        information on the performance of the Secretary 
                        under the plan described in paragraph (4);
                            ``(ii) compares such performance of the 
                        Secretary with the objectives of the plan and 
                        with the statutory obligations of the 
                        Secretary;
                            ``(iii) analyzes any failure of the 
                        Secretary to achieve any objective of the plan 
                        or to meet any statutory obligation;
                            ``(iv) identifies any regulatory policy 
                        that has a significant impact on compliance 
                        with any objective of the plan or any statutory 
                        obligation; and
                            ``(v) sets forth any proposed revision to 
                        any such regulatory policy, or objective of the 
                        plan that has not been met.
                    ``(B) Statistical information.--The statistical 
                information described in subparagraph (A)(i) shall 
                include a full statistical presentation relating to all 
                applications and submissions (including petitions, 
                notifications, and any other similar forms of request) 
                made under this Act and approved or subject to final 
                action by the Secretary during the year covered by the 
                report. In preparing the statistical presentation, the 
                Secretary shall take into account the date of--
                            ``(i) the submission of any investigational 
                        application;
                            ``(ii) the application of any clinical 
                        hold;
                            ``(iii) the submission of any application 
                        or submission (including a petition, 
                        notification, and any other similar form of 
                        request) made under this Act for approval or 
                        clearance;
                            ``(iv) the acceptance for filing of any 
                        application or submission described in clause 
                        (iii) for approval or clearance;
                            ``(v) the occurrence of any unapprovable 
                        action;
                            ``(vi) the occurrence of any approvable 
                        action; and
                            ``(vii) the approval or clearance of any 
                        application or submission described in clause 
                        (iii).''.

          TITLE VI--INCREASING RESOURCES BY SETTING PRIORITIES

SEC. 601. MINOR MODIFICATIONS.

    (a) Procedures and Conditions.--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 
certain requirements under this Act.
    ``(B) The regulation shall permit developmental changes in devices 
(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, prior to making any 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 section 515(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 subject to the 
pending application.''.
    (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) 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 an approved application submits a written notice to 
the Secretary that describes the change and informs the Secretary that 
the change has been made under the requirements of section 520(f).
    ``(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 a 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.
    ``(ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification to provide a 
reasonable assurance of safety and effectiveness.''.

SEC. 602. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII (21 U.S.C. 371 et seq.), as amended by section 402, is 
further amended by adding at the end the following:

``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

    ``Notwithstanding any other provision of law, no action by the 
Secretary pursuant to this Act shall be subject to an environmental 
assessment, an environmental impact statement, or other environmental 
consideration unless the Secretary demonstrates, in writing--
            ``(1) that there is a reasonable probability that the 
        environmental impact of the action is sufficiently substantial 
        and within the factors that the Secretary is authorized to 
        consider under this Act; and
            ``(2) that consideration of the environmental impact will 
        directly affect the decision on the action.''.

SEC. 603. EXEMPTION OF CERTAIN CLASS DEVICES FROM PREMARKET 
              NOTIFICATION REQUIREMENT.

    Section 510 (21 U.S.C. 360) is amended 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, any person may petition 
the Secretary to exempt a type of class II device from the notification 
requirement of subsection (k). The Secretary shall publish notice of 
the petition in the Federal Register and provide a 30-day period for 
public comment. The Secretary shall respond to the petition within 120 
days after the receipt of the petition and determine whether or not to 
grant the petition in whole or in part.''.

SEC. 604. REVIEW OF CLASS I AND CLASS II DEVICES.

    (a) Exemption From Premarket Notification.--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 such device is intended 
for a use which is of substantial importance in preventing impairment 
of human health, or 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))''.

SEC. 605. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.

    Section 513(f) (21 U.S.C. 360c(f)) is amended--
            (1) in paragraph (1) 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 which is classified into class III under paragraph (1), may 
request, within 30 days after receiving written notice of such a 
classification, the Secretary to classify the device into class I or II 
under the criteria set forth in subsection (a)(1). The person may, in 
the request, recommend to the Secretary the classification for the 
device. The request shall describe the device and provide detailed 
information and reasons for the recommended classification.
    ``(B)(i) Not later than 60 days after the date of the request under 
subparagraph (A) for classification of a device under the criteria set 
forth in subparagraphs (A) through (C) of section 513(a)(1), the 
Secretary shall by written order classify the device. Such 
classification shall be the initial classification of the device for 
purposes of paragraph (1) and any device classified under this 
paragraph into class I or II shall be a predicate device for 
determining substantial equivalence under paragraph (1).
    ``(ii) A device that remains in class III under this subparagraph 
shall be deemed 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) Following the issuance of an order classifying a device under 
this paragraph, the Secretary shall, within 30 days after the date of 
the issuance of the order, publish a notice in the Federal Register 
announcing such classification.''.

SEC. 606. 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 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)). Each device not identified 
by the Secretary under this subsection shall be deemed to be exempt 
from the mandatory tracking requirement under section 519 of such Act.

SEC. 607. 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 required to conduct a 
        surveillance of a device under subsection (a) shall, not later 
        than 30 days after receiving notice from the Secretary that the 
        manufacturer is required under this section to conduct the 
        surveillance, 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 to be used to conduct the surveillance has sufficient 
        qualifications and experience to conduct the surveillance and 
        if the plan will result in the collection of useful data that 
        can reveal unforeseen adverse events or other information 
        necessary to protect the public health and to provide safety 
        and effectiveness information for the device.
            ``(3) Limitation on plan approval.--The Secretary may not 
        approve the plan until the plan has been reviewed by a 
        qualified scientific and technical review committee established 
        by the Secretary.''.
    (c) Duration of Surveillance.--Section 522 (21 U.S.C. 360l), as 
amended by subsection (b), is further amended by adding at the end the 
following:
    ``(c) Duration of Surveillance.--
            ``(1) In general.--Each manufacturer required to conduct a 
        surveillance of a device under subsection (a) shall be required 
        to conduct such surveillance for not longer than 24 months.
            ``(2) Extension of the period of surveillance.--If the 
        Secretary determines that additional surveillance is needed to 
        identify the incidence of adverse events documented during the 
        initial period of surveillance that were not foreseen at the 
        time of approval or classification of the device, the Secretary 
        may extend the period of surveillance for such time as may be 
        necessary after providing the person required to conduct such 
        surveillance an opportunity for an informal hearing to 
        determine whether or not additional surveillance is appropriate 
        and to determine the appropriate period, if any, for such 
        surveillance.''.

SEC. 608. REPORTING.

    Section 519 (21 U.S.C. 360i) is amended--
            (1) by striking ``, importer, or distributor'' each place 
        it appears and inserting ``or importer'';
            (2) in subsection (a)--
                    (A) in paragraph (7), by striking the semicolon at 
                the end and inserting ``; and'';
                    (B) in paragraph (8), by striking ``; and'' and 
                inserting a period; and
                    (C) by striking paragraph (9); and
            (3) by striking subsection (d).

SEC. 609. PILOT AND SMALL-SCALE MANUFACTURE.

    Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end 
the following:
    ``(4) An application shall be approved based on information 
obtained from products manufactured in a pilot or other small facility 
so long as the commercial manufacturing process is validated prior to 
product distribution pursuant to a protocol submitted with the 
application, unless the Secretary specifies in writing the reasons why 
information from a full scale production facility is necessary to 
ensure the safety or effectiveness of the drug.''.

SEC. 610. REQUIREMENTS FOR RADIOPHARMACEUTICALS.

    (a) Requirements.--
            (1) 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 establish proposed 
        regulations governing the approval of radiopharmaceutical 
        articles designed for diagnosis and monitoring of diseases and 
        conditions. The regulations shall provide that the safety and 
        effectiveness of a radiopharmaceutical shall be evaluated 
        taking into account the appropriate use of radiopharmaceutical 
        in the practice of medicine, the pharmacological and 
        toxicological activity of the radiopharmaceutical, and the 
        estimated absorbed radiation dose of the radiopharmaceutical. 
        Not later than 1 year after the date of enactment of this Act, 
        the Secretary shall promulgate the final regulations governing 
        the approval of the radiopharmaceutical.
            (2) Special Rule.--In the case of a radiopharmaceutical 
        intended to be used for diagnostic purposes, the indications 
        for which such radiopharmaceutical is approved for marketing 
        may refer to manifestations of disease (such as biochemical, 
        physiological, anatomic, or pathological processes) common to 
        or present in 1 or more disease states, or may refer to a 
        diagnostic procedure used in the diagnosis of 1 or more 
        diseases or conditions.
    (b) Definition.--In this section, the term ``radiopharmaceutical'' 
means--
            (1) an article--
                    (A) that is intended for use in vivo in the 
                diagnosis, cure, mitigation, treatment, or prevention 
                of a disease or a manifestation of disease in man; and
                    (B) that exerts its primary effect through its 
                pharmacokinetics and the spontaneous disintegration of 
                unstable nuclei with the emission of ionizing 
                radiation; or
            (2) a reagent kit or nuclide generator that is intended to 
        be used in the preparation of any such article.

SEC. 611. 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:

                   regulation of biological products

    ``Sec. 351. (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 the proper name of the biological product contained 
        in the package, the name, address, and applicable license 
        number of the manufacturer of the biological product, and 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) A biologics license application shall be approved based upon 
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 demonstration under paragraph (2)(B)(i) may be made on the 
basis of 1 or more clinical trials, or other requirements established 
by the Secretary under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355).
    ``(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)), by striking ``subparagraph (A)'' and inserting 
        ``paragraph (1)''.
    (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 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.--Part F of title III of the Public 
Health Service Act (42 U.S.C. 262 et seq.) is amended by adding at the 
end the following:
    ``(i) For purposes of this section, the term ``biological product'' 
means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, 
blood component or derivative, allergenic product, analogous product, 
or arsphenamine or its derivatives (or any other trivalent organic 
arsenic compound) applicable to the prevention, treatment, or cure of 
diseases or conditions of human beings.''.
    (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 353(g)(4)) 
is amended--
            (1) in subparagraph (A), by striking ``section 351(a)'' and 
        inserting ``section 351(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 biological license applications under section 
351 of the Public Health Service Act (42 U.S.C. 262) and products 
required to have full new drug applications under section 505(b)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).

SEC. 612. SUPPLEMENTAL NEW DRUG APPLICATIONS.

    Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end 
the following:
    ``(7) The Secretary may approve a supplement to an approved 
application for an additional use for the drug on the basis of 
literature reports, reliable clinical experience, or persuasive 
scientific evidence, the totality of which is sufficient to demonstrate 
the effectiveness of the drug for the use involved.''.

SEC. 613. HEALTH CARE ECONOMIC INFORMATION.

    Section 502 (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(u) In the case of a health care economic statement that is 
included in labeling or advertising provided to a formulary committee, 
managed care organization, or similar entity with responsibility for 
drug selection decisions (other than the label or approved physician 
package insert relating to an indication approved under section 505 or 
351 of the Public Health Service Act) if the health care economic 
statement is not competent and reliable. Any such statement shall be 
subject solely to this paragraph. In this paragraph, the term `health 
care economic statement' means any statement that identifies, measures, 
or compares the costs (direct, indirect, and intangible) and health 
care consequences of a drug to another drug or to another health care 
intervention for the same indication, or to no intervention, where the 
primary endpoint is an economic outcome.''.

SEC. 614. 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

``SEC. 561. FAST TRACK DRUGS.

    ``(a) Designation of Drug as a Fast Track Drug.--
            ``(1) In general.--The Secretary shall facilitate 
        development, and expedite 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. For 
        purposes of this Act, such products shall be known as `fast 
        track drugs'.
            ``(2) Request for designation.--The sponsor of a drug may 
        request the Secretary to designate the drug as a fast track 
        drug. A request for 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).
            ``(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 
        is being, or will be, investigated for treatment of a condition 
        described in paragraph (1). If the Secretary finds that the 
        drug is intended for such treatment, 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 upon a 
        determination that the drug has an effect on a surrogate 
        endpoint that is reasonably likely to predict clinical benefit.
            ``(2) Limitation.--Approval under this subsection may be 
        subject to the requirement that the sponsor conduct appropriate 
        post-approval studies to validate the surrogate endpoint or 
        otherwise confirm the clinical benefit of the drug.
    ``(c) Review of Incomplete Applications for Approval of a Fast 
Track Drug.--
            ``(1) In general.--The Secretary shall, after completion of 
        the pivotal clinical trial for a fast track drug under 
        investigation, accept for filing and commence review of an 
        incomplete application for the drug's approval if the 
        application includes 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 agreed to by the Secretary under section 736 shall 
        not apply to applications submitted under paragraph (1) until a 
        completed application is submitted.
    ``(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 and use of surrogate endpoints that are reasonably 
        likely to predict clinical benefit for all serious and life-
        threatening conditions for which there exist significant unmet 
        medical needs.''.
    (b) Regulations.--Within 90 days after the date of enactment of 
this Act, the Secretary shall issue guidelines for fast track drugs 
that implement the requirements of section 561 of the Federal Food, 
Drug, and Cosmetic Act.

SEC. 615. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.

    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, 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, or 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 as the identity, strength, quality, purity, 
        and potency may relate to the safety or effectiveness of the 
        drug.
            ``(2) Reports.--The applicant shall report a change 
        described in paragraph (1) to the Secretary and may distribute 
        a drug made after the change as follows:
                    ``(A)(i) Major manufacturing changes, which are of 
                a type determined by the Secretary to have a 
                substantial potential to adversely affect the identity, 
                strength, quality, purity, and potency 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) In this subparagraph, the term `major 
                manufacturing changes' means--
                            ``(I) changes in the qualitative or 
                        quantitative formulation or the specifications 
                        in the approved marketing application (unless 
                        exempted by the Secretary);
                            ``(II) changes which the Secretary 
                        determines by regulation or guidance require 
                        completion of an appropriate human study 
                        demonstrating equivalence to the drug 
                        manufactured before such changes; and
                            ``(III) other changes which the Secretary 
                        determines by regulation or guidance have a 
                        substantial potential to adversely affect the 
                        safety or effectiveness of the drug.
                    ``(B)(i) 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) In the case of changes made in accordance 
                with clause (i)(II);
                            ``(I) the applicant may distribute the drug 
                        30 days after the supplemental application is 
                        received by the Secretary unless the Secretary 
                        notifies the applicant within such 30-day 
                        period that prior approval of such supplemental 
                        application is required; and
                            ``(II) the Secretary shall, after the 
                        notification to an applicant under subclause 
                        (I), approve or disapprove each such 
                        supplemental application.
                    ``(ii) 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 and the Public Health Service Act in effect on the date of 
enactment of this Act with respect to manufacturing changes shall 
remain in effect for--
            (1) a period of 24 months after the date of the enactment 
        of this Act; or
            (2) until the effective date of regulations promulgated by 
        the Secretary implementing section 751 of the Federal Food, 
        Drug, and Cosmetic Act,
whichever is sooner.

SEC. 616. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.

    Within 12 months after the date of enactment of this Act, the 
Secretary, through the Commissioner of Food and Drugs, shall issue 
guidance that describes when abbreviated study reports in lieu of full 
reports may be submitted with a new drug application for certain types 
of studies. Such guidance will describe the kinds of studies for which 
abbreviated reports are appropriate and the appropriate abbreviated 
report formats.

SEC. 617. FOOD CONTACT SUBSTANCES.

    (a) Food Contact Substances.--Section 409(a) (21 U.S.C. 348(a)) is 
amended--
            (1) in paragraph (1), 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) 
                which 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 (j), 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) For purposes of this paragraph, `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 matters 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 this subsection, 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 paragraph 
(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.
            (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 the enactment of 
this Act.

SEC. 618. HEALTH CLAIMS OF 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) which is not 
authorized by the Secretary in a regulation promulgated in accordance 
with clause shall be authorized and may be made if--
            ``(i) an authoritative scientific body of the United States 
        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 subdivisions of the scientific body or the 
        National Academy of Sciences, has published statements, 
        conclusions, or recommendations in effect recognizing that the 
        relationship between the nutrient and disease or health-related 
        condition to which the claim refers is supported by pertinent 
        scientific evidence; and
            ``(ii) the manufacturer or distributor of the food for 
        which such claim is made has submitted to the Secretary at 
        least 90 days before the first introduction of such food into 
        interstate commerce a notice of claim, including a concise 
        description of the basis upon which such manufacturer or 
        distributor relied for determining that the requirements of 
        clause (i) have been satisfied.''.

SEC. 619. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

    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 time frame for completing such studies), and such studies are 
completed within any such time frame and the reports thereof submitted 
in accordance with subsection (d)(2) or completed within any such time 
frame 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 section 505(b)(2)(A)(ii) or 
                section (j)(2)(A)(vii)(II) 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 section 505(b)(2)(A)(iii) or 
                section 505(j)(2)(A)(vii)(III),
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) 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 section 
        505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), 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 section 505(c)(3) or section 505(j)(4)(B) 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 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 time frame 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 
time frame and the reports thereof submitted in accordance with 
subsection (d)(2) or completed within any such time frame 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 section 505(b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) 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 section 505(b)(2)(A)(iii) or 
                section 505(j)(2)(A)(vii)(III),
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) 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 section 
        505(b)(2)(A)(iv) or section 505(j)(2)(A)(vii)(IV), 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 section 505(c)(3) or section 505(j)(4)(B) 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 section 505(b)(2) or 505(j) 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 section 505(b)(2) or 505(j), respectively, 
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 section 505(b)(2) or (j) for a drug will be subject to 
the provisions of this section.
    ``(g) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least one 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.
    ``(h) Limitation.--The holder of an approved application for a new 
drug that has already received six months of market exclusivity under 
subsection (a) or subsection (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).''
    ``(i) Sunset.--No period of market exclusivity shall be granted 
under this section based on studies commenced after January 1, 2004. 
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.''.

                   TITLE VII--FEES RELATING TO DRUGS

SEC. 701. SHORT TITLE.

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

SEC. 702. FINDINGS.

    Congress finds that--
            (1) prompt approval of safe and effective new drugs is 
        critical to the improvement of the public health so that 
        patients may enjoy the benefits provided by the drugs 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 review 
        of human drug applications;
            (3) the provisions added by the Prescription Drug User Fee 
        Act of 1992, has 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 the letters of ______________, and 
        ______________, 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 Committee on Labor and 
        Human Resources Committee of the Senate, as set forth at ____ 
        Cong. Rec. ________ (daily ed. __________, 1997).

SEC. 703. DEFINITIONS.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) in 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 biological product that is 
                licensed 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 
                a large volume biological product intended for single 
                dose injection for intravenous use or infusion.'';
            (2) in 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 
                biological product that is not distributed commercially 
                and is the subject of a supplement or application 
                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) in paragraph (7)(A), by striking ``employees under 
        contract'' and all that follows through ``Administration,'' and 
        inserting ``contractors of the Food and Drug Administration,'';
            (5) 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 1992''; and
                    (B) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) 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
            (6) by adding at the end the following:
            ``(9) The term `affiliate' means, 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 described in 
                subparagraph (A).''.

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) 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, or a supplement proposing to include a new 
                indication for a rare disease or condition pursuant to 
                section 526, shall not be assessed a fee under 
                subparagraph (A), unless the human drug application 
                includes indications for other than rare diseases or 
                conditions.
                    ``(F) Exception for applications and supplements 
                for pediatric indications.--A human drug application or 
                supplement that includes an indication for use in 
                pediatric populations shall be assessed a fee under 
                subparagraph (A) only if--
                            ``(i) the application is for initial 
                        approval for use in a pediatric population; or
                            ``(ii) the application or supplement is for 
                        approval for use in pediatric and non-pediatric 
                        populations.
                    ``(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.'';
            (2) in paragraph (2)(A), by striking ``505(j), and'' 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 a product approved under an 
        application under section 507 that is abbreviated, and''; and
            (3) 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 if 
                        the product has been withdrawn from listing or 
                        relisted and 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 the 
                        fiscal year in which a 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 implementation of the 
                Drug Price Competition and Patent Term Restoration Act 
                of 1984, or a product approved under an application 
                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 fee.--The application fee under 
        subsection (a)(1)(A)(i) shall be $250,704 in fiscal year 1998, 
        $256,338 in fiscal years 1999 and 2000, $267,606 in fiscal year 
        2001, and $258,451 in fiscal year 2002.
            ``(2) Supplement fee.--The supplement fee under subsection 
        (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998, $128,169 
        in fiscal years 1999 and 2000, $133,803 in fiscal year 2001, 
        and $129,226 in fiscal year 2002.
            ``(3) 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 
        fiscal years 1999 and 2000, $38,000,000 in fiscal year 2001, 
        and $36,700,000 in fiscal year 2002.
            ``(4) 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 for 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 
        provision.'';
            (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) so that the revenues 
        collected from each such fee category shall be set to be equal 
        to the revenues collected from the application and supplement 
        fee category.''; 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 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 ``, and'';
            (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.'' inserting the 
        following:
            ``(2) Use of standard costs.--In making the finding in 
        subparagraph (C), the Secretary may use standard costs.
            ``(3) Rules relating to small businesses.--
                    ``(A) Definition.--For the purpose of paragraph 
                (1)(E), a small business is 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. 379g(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. 
379g(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 subsection 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 
        products fees.''.
    (g) Requirement for Written Requests for Waivers and Fees.--Section 
736 (21 U.S.C. 379h) is amended by--
            (1) redesignating subsection (i) as subsection (j); and
            (2) by inserting after subsection (h) the following:
    ``(i) Written Requests for waivers and refunds.--To qualify for 
consideration for a waiver under subsection (d), or for a refund of any 
fee collected in accordance with subsection (a), a person must submit 
to the Secretary a written request for such waiver or refund not later 
than 180 days after such fee is due. Any requests for waivers, refunds, 
or exceptions must be submitted in writing to the Secretary within 1 
year after the date of enactment of this subsection.''.

SEC. 705. ANNUAL REPORTS.

    (a) First Report.--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.--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 4 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 drugs or a device or devices that are imported or offered 
for the 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 in an establishment 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) of this 
Act.

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 which 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 (B).
    (b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is 
repealed.

SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.

    Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
            (1) in paragraph (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 206, is 
further amended by adding at the end the following:

``SEC. 908. 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 research training in 
regulatory scientific programs by predoctoral and postdoctoral 
scientists and physicians, including 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 through a Cooperative Research and Development 
Agreement.''.

SEC. 805. ENFORCEMENT AUTHORITY FOR SPECIAL CONTROLS.

    (a) Adulterated Provisions.--Section 501(e) as amended by section 
205, is amended by striking subparagraph (1) and inserting the 
following: ``(1) If it is, or purports to be or is represented as, a 
device which is subject to a performance standard or a special control 
established under section 514, unless such device is in all respects in 
conformity with such standard or special control.''.
    (b) Misbranded Provisions.--Section 502(s) (21 U.S.C. 352(s)) is 
amended to read as follows:
    ``(s) If it is a device subject to a performance standard or a 
special control established or recognized under section 514, unless the 
device bears such labeling as may be prescribed in such standard or 
special control.''.

SEC. 806. 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 samples of such device and of components of the device as the 
Secretary may reasonably require, except that where 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)) 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. 
360(a)) is amended--
            (1) in paragraph (8), by striking ``; and'' and inserting a 
        semicolon;
            (2) in paragraph (9), by striking ``made.'' and inserting 
        ``made; and'';
            (3) by inserting after paragraph (9) the following:
            ``(10) may reasonably require a manufacturer, importer, or 
        distributor 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 where 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. 807. INTERSTATE COMMERCE.

    (a) Findings.--Congress finds that--
            (1) in order to make effective the regulation of interstate 
        commerce involving devices, foods, drugs, and cosmetics, it is 
        necessary to impose equivalent requirements on intrastate 
        commerce involving adulterated and misbranded devices, foods, 
        drugs, and cosmetics as imposed on interstate commerce in such 
        articles;
            (2) without the presumption of a connection with interstate 
        commerce, intrastate commerce involving adulterated and 
        misbranded devices, foods, drugs, and cosmetics would 
        discriminate against and depress interstate commerce in 
        devices, foods, drugs, and cosmetics, and adversely burden, 
        obstruct, and affect such interstate commerce; and
            (3) transactions involving adulterated and misbranded 
        devices, foods, drugs, and cosmetics constitute a class of 
        activities that have a deleterious effect on the public health 
        and welfare.
    (b) Definition.--Section 201(b) (21 U.S.C. 321(b)) is amended--
            (1) by striking ``and (2) commerce'' and inserting ``(2) 
        commerce'';
            (2) by inserting before the period the following: ``, and 
        (3) commerce involving any article or class of activities that 
        directly or indirectly affects interstate commerce pursuant to 
        section 709''.
    (c) Seizure.--Section 304(a)(2)(D) (21 U.S.C. 334(a)(2)(D)) is 
amended to read as follows: ``(D) Any adulterated or misbranded device, 
food, drug, or cosmetic.''.
    (d) Presumption.--Section 709 (21 U.S.C. 379a) is amended by 
striking ``a device'' and inserting ``a device, food, drug, or 
cosmetic''.
                                 <all>