[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''.
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