I
105TH CONGRESS
1ST SESSION
H. R. 1411
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act to facilitate the development and approval of new drugs
and biological products, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
APRIL 23, 1997
Mr. BURR of North Carolina (for himself, Mr. GREENWOOD, Mr. BARTON of
Texas, Mr. KLUG, Mr. COBURN, and Mr. DEAL of Georgia) introduced
the following bill; which was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act and
the Public Health Service Act to facilitate the develop-
ment and approval of new drugs and biological products,
and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE, REFERENCE, AND TABLE OF
CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Drug and Biological Products Modernization Act of
1997’’.
(b) REFERENCE.—Except as otherwise specified,
whenever in this Act an amendment is expressed in terms
of an amendment to a section or other provision, the ref-
erence shall be considered to be made to that section or
other provision of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321 et seq.).
(c) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title, reference, and table of contents.
Sec. 2. FDA mission and annual report.
Sec. 3. Streamlining clinical research on drugs and biological products.
Sec. 4. The content and review of a new drug application.
Sec. 5. Effectiveness determination.
Sec. 6. Scientific review panels.
Sec. 7. Marketing approval.
Sec. 8. Accreditation of third parties.
Sec. 9. Dispute resolution.
Sec. 10. Good manufacturing practices.
Sec. 11. Pilot and small scale manufacture.
Sec. 12. Manufacturing changes.
Sec. 13. Insulin and antibiotics.
Sec. 14. Nonprescription drugs.
Sec. 15. Information system.
Sec. 16. Environmental impact review.
Sec. 17. Application of State and Federal law to the practice of pharmacy
compounding.
Sec. 18. Harmonization.
Sec. 19. Informal agency statements.
Sec. 20. Research and education; practice of medicine.
Sec. 21. Delegation of authority.
Sec. 22. Publication of notice of deviation.
Sec. 23. Modernization of regulation of biological products.
Sec. 24. Requirements for human tissue.
Sec. 25. Access to unapproved therapies.
Sec. 26. Radiopharmaceuticals.
Sec. 27. Protection of confidential information.
Sec. 28. National uniformity.
Sec. 29. Centers for education and research on drugs, devices, and biological
products.
SEC. 2. FDA MISSION AND ANNUAL REPORT.
(a) MISSION.—Section 903 (21 U.S.C. 393) is
amended by redesignating subsections (b) and (c) as sub-
sections (c) and (d), respectively, and by adding after sub-
section (a) the following:
‘‘(b) MISSION.—The Food and Drug Administration
shall protect the public health by ensuring that—
‘‘(1) foods are safe, wholesome, and sanitary;
‘‘(2) human and veterinary drugs are safe and
effective;
‘‘(3) there is reasonable assurance of safety and
effectiveness of devices intended for human use;
‘‘(4) cosmetics are safe; and
‘‘(5) public health and safety are protected
from electronic product radiation.
The Food and Drug Administration shall promptly and
efficiently review clinical research and take appropriate ac-
tion on the marketing of regulated products in a manner
that does not unduly impede innovation or product avail-
ability. The Food and Drug Administration shall partici-
pate with other countries to reduce the burden of regula-
tion, harmonize regulatory requirements, and achieve ap-
propriate reciprocal arrangements.’’
(b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),
as amended by subsection (a), is amended by adding at
the end the following:
‘‘(e) ANNUAL REPORT.—The Secretary shall, simul-
taneously with the submission each year of the budget for
the Food and Drug Administration, submit to the Com-
mittee on Commerce of the House of Representatives and
the Committee on Labor and Human Resources of the
Senate an annual report which shall—
‘‘(1) review the performance of the Food and
Drug Administration in meeting its mission and the
development of Food and Drug Administration poli-
cies to implement such mission;
‘‘(2) review the performance of the Food and
Drug Administration in meeting its own perform-
ance standards, including its own outcome measure-
ments and statutory deadlines for the approval of
products or for other purposes contained in this Act;
‘‘(3) describe the staffing and resources of the
Food and Drug Administration and list those per-
sons and organizations accredited to conduct inves-
tigations under sections 505(i) and 520(g), to review
drugs under section 505, to make initial classifica-
tion of devices under section 513, and to perform
good manufacturing practice reviews under sections
and 520(f); and
‘‘(4) describe the goals, activities, and accom-
plishments of the Food and Drug Administration in
bilateral and multinational meetings that addressed
methods and approaches to reduce the burden of
regulation, harmonize regulation, and to seek appro-
priate reciprocal arrangements, list each such meet-
ing, and list pending issues specifying those that are
not consistent with or are contrary to the provisions
of this Act.
‘‘(f) GAO ANNUAL REPORT.—The Comptroller Gen-
eral of the United States shall each January submit to
the Committee on Commerce of the House of Representa-
tives and the Committee on Labor and Human Resources
of the Senate a report which compares—
‘‘(1) the performance of the Food and Drug
Administration in approving innovative drug, device,
human tissue, and food products with that of agen-
cies performing similar functions in countries listed
in section 802(b); and
‘‘(2) the resources used by agencies in such
countries to approve such products.
In developing a methodology for the report, the Comptrol-
ler General shall consult with representatives of the Sec-
retary, the regulated industry, academic experts in the
field, and experts knowledgeable about information in such
other countries so that the approach accurately presents
the information in a fair and balanced manner.
SEC. 3. STREAMLINING CLINICAL RESEARCH ON DRUGS
AND BIOLOGICAL PRODUCTS.
Section 505(i) (21 U.S.C. 355(i)) is amended by add-
ing ‘‘(1)’’ prior to the first sentence, by redesignating
paragraphs (1), (2), and (3) as subparagraphs (A), (B),
and (C), respectively, and by adding the following new
paragraphs at the end thereof:
‘‘(2) A clinical investigation of a new drug may begin
30 days after the Secretary has received from the sponsor
of the investigation a submission containing information
about the drug and the clinical investigation as follows:
The submission shall contain—
‘‘(A) information on design of the investigation
and adequate reports of basic information, certified
by the applicant to be accurate reports, necessary to
assess the safety of the drug for use in clinical inves-
tigation; and
‘‘(B) adequate information on the chemistry of
the drug, manufacturing of the drug, controls avail-
able for the drug, and primary data tabulations for
the drug from animal or human studies, except that
for phase I clinical investigations detailed informa-
tion for drugs and well-characterized therapeutic,
biotechnology derived drugs shall not be required un-
less the director of the office responsible for the re-
view of the drug makes a request within 30 days
institution, accredited by the Secretary under subpara-
graph (B) to conduct the specific type of investigation
which is the subject of such research, has approved the
investigation and the sponsor of the investigation has sub-
mitted to the Secretary a notification setting forth the
name and address of the sponsor, the identity of the drug,
and the uses of the drug that the sponsor intends to inves-
tigate. Data and information developed through such an
investigation may be submitted in support of an applica-
tion for approval of a new drug and shall be considered
by the Secretary to the same extent as data and informa-
tion developed through an investigation under paragraph
(2). Paragraph (3) shall apply to such an investigation.
‘‘(B) The Secretary shall establish and provide an op-
portunity for public comment on the requirements and
qualifications that an accredited institution, which may in-
clude medical colleges and other organizations, shall meet
to be eligible to approve an investigation for purposes of
this paragraph.
‘‘(5) The Food and Drug Administration shall have
exclusive regulatory jurisdiction in the Department of
Health and Human Services over the use of a new drug
in any clinical investigation.’’.
SEC. 4. THE CONTENT AND REVIEW OF A NEW DRUG APPLI-
CATION.
(a) SECTION 505(b).—Section 505(b) (21 U.S.C.
355(b)) is amended by adding at the end the following:
‘‘(4)(A) Within 1 year after the date of the enactment
of the Drug and Biological Products Modernization Act
of 1997, the Secretary, in order to minimize the burden
of unnecessary information submissions and to better har-
monize international regulatory requirements, shall, after
consultation with patient advocacy groups and the regu-
lated industry, publish in the Federal Register criteria for
the type and amount of information relating to effective-
ness to be included in an application for the approval of
a new drug or a new use of an approved drug. In develop-
ing the criteria, the Secretary shall consider any rec-
ommendations of the International Conference on Harmo-
nization of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
‘‘(B) The Secretary shall establish standards for the
review of applications submitted under paragraph (1) re-
lating to promptness, technical excellence, lack of bias and
conflict of interest, and a knowledge of regulatory and sci-
entific standards which shall apply equally to outside re-
viewers and to employees of the Secretary who review such
applications.
‘‘(C) Food and Drug Administration employees shall
meet with a sponsor of an investigation or an applicant
under an application for a new drug or a new use of an
approved drug submitted under paragraph (1) within 30
days of any reasonable request for a meeting by the spon-
sor or applicant for the purpose of reaching agreement on
the design and size of clinical trials. Minutes of any such
meeting shall be exchanged. Advice provided to a sponsor
or applicant at its request by a Food and Drug Adminis-
tration employee, which is reduced to writing and made
part of the administrative record by the sponsor or appli-
cant or by the Food and Drug Administration, regarding
appropriate testing of a new drug shall not be changed
after such testing begins, except with the written agree-
ment of the sponsor or applicant or by a decision in writ-
ing, after an informal hearing, by the director of the office
in which the drug is reviewed where such change is needed
because there is a demonstrated need to protect the public
health or a valid safety consideration.
‘‘(D) The written decisions of the office responsible
for the review of a drug on all aspects of scientific and
medical matters relating to a new drug shall be binding
upon, and may not directly or indirectly be changed by,
the field personnel of the offices of compliance of the office
responsible for the review unless in consultation with the
reviewing office, such field personnel demonstrate why
such decision should be modified.
‘‘(E) No action by the office responsible for the re-
view of a drug on any matter relating to a new drug for
which an application has been submitted under paragraph
(1) may at any time, or under any circumstance other
than a demonstrable extraordinary circumstance, be de-
layed because of the unavailability of information from or
action by field personnel unless the field personnel dem-
onstrate to the office that such a delay is necessary to
assure the marketing of a safe and effective drug.’’.
(b) SECTION 505(j).—
(1) AMENDMENT.—Section 505(j) (21 U.S.C
355(j) is amended by redesignating paragraphs (3)
through (8) as paragraphs (4) through (9), respec-
tively, and by adding after paragraph (2) the follow-
ing:
‘‘(3)(A) The Secretary shall establish standards for
the review of applications submitted under paragraph (1)
relating to promptness, technical excellence, lack of bias
and conflict of interest, and a knowledge of regulatory and
scientific standards which shall apply equally to outside
reviewers and to employees of the Secretary who review
such applications.
‘‘(B) Food and Drug Administration employees shall
meet with a sponsor of an investigation or an applicant
under an application submitted under paragraph (1) with-
in 30 days of any reasonable request for a meeting by the
sponsor or applicant for the purpose of reaching agree-
ment on the design and size of bioavailability or bioequiva-
lence studies. Minutes of any such meeting shall be ex-
changed. Advice provided to a sponsor or applicant at its
request by a Food and Drug Administration employee,
which is reduced to writing and made part of the adminis-
trative record by the sponsor or applicant or by the Food
and Drug Administration, regarding bioavailability or bio-
equivalence studies shall not be changed after such testing
begins, except with the written agreement of the sponsor
or applicant or by a decision in writing, after an informal
hearing, by the director of the office in which the drug
is reviewed where such change is needed because there is
a demonstrated need to protect the public health or a valid
safety consideration.
‘‘(C) The written decisions of the office responsible
for the review of a drug on all aspects of scientific and
medical matters relating to a new drug shall be binding
upon the field personnel of the offices of compliance of
the office responsible for the review unless in consultation
with the reviewing office, such field personnel demonstrate
why such decision should be modified.
‘‘(D) No action by the office responsible for the re-
view of a drug on any matter relating to a new drug for
which an application has been submitted under paragraph
(1) may at any time, or under any circumstance other
than a demonstrable extraordinary circumstance, be de-
layed because of the unavailability of information from or
action by field personnel unless the field personnel dem-
onstrate to the office that such a delay is necessary to
assure the marketing of a safe and effective drug.’’.
(2) 
CONFORMING
AMENDMENTS.—Section
505(j) (21 U.S.C. 355(j) is amended—
(A) in paragraph (2)(A)(i), by striking
‘‘(6)’’ and inserting ‘‘(7)’’;
(B) in paragraph (3), by striking ‘‘(4)’’
and inserting ‘‘(5)’’;
(C) in paragraph (3)(I), by striking ‘‘(5)’’
and inserting ‘‘(6)’’; and
(D) in paragraph (6)(C), by striking ‘‘(5)’’
each place it occurs and inserting ‘‘(6)’’.
SEC. 5. EFFECTIVENESS DETERMINATION.
Section 505(d) (21 U.S.C. 355(d)) is amended—
(1) by adding after the last sentence the follow-
ing: ‘‘Substantial evidence may, where there is a
high level of confidence in the scientific validity of
the results of an adequate and well-controlled inves-
tigation, consist of data from an adequate and well-
controlled investigation and adequate supportive sci-
entific evidence (obtained before or after such inves-
tigation).’’;
(2) by adding at the end the following: ‘‘For
purposes of the preceding sentence, a well-controlled
investigation shall only include methods of control
that are appropriate to the disease or condition for
which a drug is intended as prescribed, rec-
ommended, or suggested in its labeling. The Sec-
retary may waive the requirement to conduct any
well-controlled investigation, as defined in the pre-
ceding sentence.’’; and
(3) by inserting ‘‘(1)’’ after ‘‘(d)’’, by redesig-
nating clauses (1) through (7) as clauses (A)
through (G), by striking ‘‘(1) through (6)’’ and in-
serting ‘‘(A) through (G)’’, and by adding at the end
the following:
‘‘(2) For purposes of paragraph (1)—
‘‘(A) the Secretary shall, for the purpose of
making an evaluation of a new drug for a serious or
life-threatening condition, consider whether the ben-
efits of the drug outweigh the known and potential
risks of the drug and the need to answer remaining
questions about risks and benefits of the drug, tak-
ing into consideration the severity of the diseases
and the absence of no comparable or satisfactory al-
ternative therapy; and
‘‘(B) concurrent with the approval of a drug de-
scribed in clause (i), the Secretary may seek agree-
ment from the sponsor of such drug to conduct cer-
tain postmarketing studies to delineate additional in-
formation about such drug’s risks, benefits, and op-
timal use.
‘‘(3) For the purpose of making an evaluation of an
application submitted for a new use of a previously ap-
proved new drug, the Secretary shall consider whether the
new use is supported by adequate valid scientific informa-
tion from clinical investigation reports in peer reviewed
medical and scientific journals, patient registries or com-
pendia, and other sources recognized by the Secretary. In
carrying out the preceding sentence, the Secretary may,
as appropriate, consult with medical speciality societies.
‘‘(4) For purposes of paragraph (1), the determina-
tion of effectiveness shall not include any potential use not
explicitly included in the labeling, except for public health
reasons.
SEC. 6. SCIENTIFIC ADVISORY PANELS.
Section 505 (21 U.S.C. 355) is amended by adding
at the end the following:
‘‘(n)(1) For the purpose of providing expert scientific
advice and recommendations to the Secretary regarding
a clinical investigation of a drug or biological product or
the approval for marketing of a drug or biological product
under section 505, the Secretary shall establish panels of
experts or use panels of experts established before the date
of the enactment of this subsection, or both. Scientific ad-
visory panels shall consider scientific issues and shall not
include considerations of cost, economic aspects, compara-
tive effectiveness, or legal matters.
‘‘(2) The Secretary may delegate the appointment
and oversight authority granted under section 904 to a
director of a center or successor entity within the Food
and Drug Administration.
‘‘(3) The Secretary shall appoint to each panel estab-
lished under paragraph (1) persons who are qualified by
training and experience to evaluate the safety and effec-
tiveness of the drugs and biological products to be referred
to the panel and who, to the extent feasible, possess skill
in the use of, or experience in, the development, manufac-
ture, or utilization of, such drugs or biological products.
The Secretary shall make appointments to each panel so
that each panel shall consist of members with adequately
diversified expertise in such fields as clinical and adminis-
trative medicine, engineering, biological and physical
sciences, and other related professions. In addition, each
panel shall include as nonvoting members a representative
of consumer interests and a representative of interests of
the drug and biological product manufacturing industry.
Scientific, trade, and consumer organizations shall be af-
forded an opportunity to nominate individuals for appoint-
ment to the panels. No individual who is in the regular
full-time employ of the United States and engaged in the
administration of this Act may be a voting member of any
panel. The Secretary shall designate one of the members
of each panel to serve as chairman thereof.
‘‘(4) Each member of a panel shall publicly disclose
all conflicts of interest that member may have with the
work to be undertaken by the panel. No member of a panel
may vote on any matter where the member or the imme-
diate family of such member could gain financially from
the advice given to the Secretary. The Secretary may
grant a waiver of any conflict of interest upon public dis-
closure of such conflict of interest if such waiver contrib-
utes to the ability of a panel to contribute to the public
health, except that the Secretary may not grant a waiver
for a member of a panel when the member’s own scientific
work is involved.
‘‘(5) The Secretary shall provide education and train-
ing to each new panel member before such member partici-
pates in a panel’s activities. Such education and training
shall include a familiarization with certain requirements
under this Act and any related regulation of the Secretary
and the administrative process and procedures related to
panel meetings.
‘‘(6) Panel members (other than officers or employees
of the United States), while attending meetings or con-
ferences of a panel or otherwise engaged in its business,
shall be entitled to receive compensation at rates to be
fixed by the Secretary, but not at rates exceeding the daily
equivalent of the rate in effect for grade GS–18 of the
General Schedule, for each day so engaged, including trav-
eltime. While so serving away from their homes or regular
places of business, each member may be allowed travel ex-
penses (including per diem in lieu of subsistence) as au-
thorized by section 5703 of title 5, United States Code,
for persons in the Government service employed intermit-
tently.
‘‘(7) The Secretary shall take whatever action is nec-
essary to ensure that regular meetings are held by sci-
entific advisory panels, at appropriate intervals and for a
sufficient length of time, so that any matter to be reviewed
by any such panel shall be presented to the panel not more
than 60 days after the matter is ready for review by the
panel. Meetings of the panel may be held using electronic
communication to convene the meeting.
‘‘(8)(A) Any person whose drug is the subject of a
scientific advisory panel shall have the same rights and
responsibilities as the Secretary regarding—
‘‘(i) the submission of written information to a
scientific advisory panel;
‘‘(ii) the participation of the persons at meet-
ings of the panel; and
‘‘(iii) access to data and information submitted
to a scientific advisory panel (except for data and in-
formation that are not available for public disclosure
under section 552 of title 5, United States Code).
‘‘(B) In a case in which a scientific advisory panel
reviews an application submitted under section 505 or sec-
tion 351 of the Public Health Service Act (including a pe-
tition, notification, or other similar request), all related
data and information that are not available for public dis-
closure under section 552 of title 5, United States Code,
shall be exchanged between the applicant and the Food
and Drug Administration at the time the data and infor-
mation are submitted to such panel but shall not otherwise
be publicly disclosed.
‘‘(C) Any meetings of a scientific advisory panel shall
provide adequate time for initial presentations and for re-
sponse to any differing views and shall encourage free and
open participation by all interested persons.
‘‘(9) Within 30 days after the date a scientific advi-
sory panel makes its conclusions and recommendations on
any matter under review by the panel, the Food and Drug
Administration official responsible for the matter shall re-
view the conclusions and recommendations of the panel,
shall make a final decision on the matter, and shall notify
the affected persons of the decision in writing and, if the
decision differs from the conclusions and recommendations
of the panel, shall include the reasons for the difference.
‘‘(10) A scientific advisory panel under this sub-
section shall not be subject to the annual chartering and
annual report requirements of the Federal Advisory Com-
mittee Act. Such a panel shall make an annual report of
its activities to the Secretary.’’.
SEC. 7. MARKETING APPROVAL.
(a) SECTION 505.—
(1) SUBSECTION
(b).—Section 505(b) (21
U.S.C. 355(b)), as amended by section 4(a), is
amended—
(A) in the first sentence of paragraph (1),
by inserting immediately before the period the
following: ‘‘or and the Secretary may request a
review of all or part of such application by an
accredited person authorized to review applica-
tions for marketing approval , upon concurrence
of the sponsor, and the Secretary shall pay for
such review with fees authorized by section
736’’; and
(B) by adding after paragraph (4) the fol-
lowing:
‘‘(5) The scope of review responsibilities of an accred-
ited person authorized to conduct reviews of marketing ap-
proval applications shall include the review of all or part
of an application as requested by the Secretary . The ac-
credited person shall submit a report of its review, includ-
ing the basis for any recommendation to the Secretary.
(2) SUBSECTION (j).—Section 505(j)(1) (21
U.S.C. 355(j)(1)) is amended by adding at the end
the following: ‘‘The Secretary may request a review
of all or part of such an application by an accredited
person authorized to review applications for market-
ing approval upon concurrence of the sponsor. The
scope of review responsibilities of such an accredited
person shall include the review of all or part of such
an application as requested by the Secretary. The
accredited person shall submit a report of its review,
including the basis for any recommendation to the
Secretary.’’.
(b) SECTION 735(7).—Section 735(7) is amended—
(1) by striking ‘‘applications for’’ and inserting
‘‘applications’’ and by inserting ‘‘for’’ after ‘‘(A)’’,
‘‘(B)’’, and ‘‘(C)’’;
(2) by striking ‘‘and’’ at the end of subpara-
graph (C),
(3) by striking the period at the end of sub-
paragraph (D) and inserting ‘‘, and’’, and
(4) by inserting the following after subpara-
graph (D):
‘‘(E) by outside organizations and individ-
uals.’’.
SEC. 8. ACCREDITATION OF THIRD PARTIES.
(a) AMENDMENT.—Subchapter A of chapter VII is
amended by adding at the end the following:
‘‘SEC. 712. ACCREDITED PERSONS.
‘‘(a) IN GENERAL.—The Secretary shall, within 180
days of the date of the enactment of this section, by regu-
lation establish procedures for the accreditation of persons
for the purposes of reviewing applications under section
505(b), or under section 351 of the Public Health Service
Act, providing written reviews to the Secretary for the
Secretary’s consideration, and making recommendations
on whether or not such applications should be approved.
‘‘(b) ACCREDITATION.—
‘‘(1) PROGRAMS.—The Secretary shall provide
for such accreditation through programs adminis-
tered by the Food and Drug Administration, other
government agencies, or by other qualified non-gov-
ernment organizations.
‘‘(2) ACCREDITATION.—
‘‘(A) GENERAL RULE.—Within 180 days
of the date of the enactment of this section, the
Secretary shall establish and publish in the
Federal Register requirements to accredit or
deny accreditation to persons who request to
perform the duties specified in subsection (a).
The Secretary shall respond to a request for ac-
creditation within 60 days of the receipt of the
request. The accreditation of such person shall
specify the particular activities under subsection
(a) for which such person is accredited.
‘‘(B) WITHDRAWAL OF ACCREDITATION.—
The Secretary may withdraw accreditation of
any person accredited under this paragraph,
after providing notice and an opportunity for an
informal hearing when such person acts or fails
to act in a manner that is inconsistent with the
purposes of this section or poses a threat to
public health.
‘‘(C) PERFORMANCE
AUDITING.—To en-
sure that persons accredited under this section
will continue to meet the standards of accredi-
tation, the Secretary shall—
‘‘(i) make onsite visits on a periodic
basis to each accredited person to audit
the performance of such person; and
‘‘(ii) take such additional measures as
the Secretary determines to be appropriate.
‘‘(D) ANNUAL
REPORT.—The Secretary
shall include in the annual report required
under section 903(e)(2) the names of all accred-
ited persons and the particular activities under
subsection (a) for which each such person is ac-
credited and the name of each accredited per-
son whose accreditation has been withdrawn
during the year.
‘‘(3) QUALIFICATIONS.—An accredited person
shall, at a minimum, meet the following require-
ments:
‘‘(A) Such person shall be an independent
organization which is not owned or controlled
by manufacturer, supplier or vendor of drugs
and which has no organizational, material, or
financial affiliation with such a manufacturer,
supplier, or vendor.
‘‘(B) Such person shall be a legally con-
stituted entity permitted to conduct the activi-
ties for which it seeks accreditation.
‘‘(C) Such person shall not engage in the
development, manufacture, promotion, or sale
of drugs.
‘‘(D) Such person shall be operated in ac-
cordance with generally accepted professional
and ethical business practices and shall agree in
writing that as a minimum it will—
‘‘(i) certify that reported information
accurately reflects data reviewed;
‘‘(ii) limit work to that for which com-
petence and capacity are available;
‘‘(iii) 
treat 
information 
received,
records, reports, and recommendations as
proprietary information; and
‘‘(iv) promptly respond and attempt to
resolve complaints regarding its activities
for which it is accredited.’’.
(b) CONFORMING AMENDMENT.—Section 301 (21
U.S.C. 321) is amended by redesignating the second para-
graph (u) as paragraph (v) and by adding after that para-
graph the following:
‘‘(w) in the case of a drug, device, or food—
‘‘(A) the submission of a report or rec-
ommendation by a person accredited under section
712 that is false or misleading in any material re-
spect;
‘‘(B) the disclosure by a person accredited
under section 712 of confidential commercial infor-
mation or any trade secret without the express writ-
ten consent of the person who submitted such infor-
mation or secret to such person; or
‘‘(C) the receipt by a person accredited under
section 712 of a bribe in any form or the doing of
any corrupt act by such person associated with a re-
sponsibility delegated to such person under this
Act.’’.
SEC. 9. DISPUTE RESOLUTION.
Chapter V is amended by adding after section 505
the following:
‘‘DISPUTE RESOLUTION
‘‘SEC. 506. (a) In instances in which there is a sci-
entific controversy between a regulated person and the
Secretary regarding an obligation under this Act, and no
specific provision of this Act or regulations promulgated
under this Act by the Secretary provides a right to review
of the subject matter of the dispute, the Secretary, upon
receipt of a request for review of the controversy from
such a regulated person, shall refer the disputed issue—
‘‘(1) to an existing (as of the date of the notifi-
cation) scientific advisory panel having expertise re-
lated to the issue; or
‘‘(2) to a special Government employee, as de-
fined in section 202(a) of title 18, United States
Code, or to a non-governmental person qualified to
mediate or arbitrate the substance of such impasse
who is acceptable to the Secretary and the applicant.
‘‘(b) The applicant and representatives of the Sec-
retary may consult with the panel, special Government em-
ployee, or non-governmental person on the matter re-
ferred. The panel, special Governmental employee, or non-
governmental person shall submit to the Secretary and the
applicant a report containing recommendations (including
a statement of reasons for the recommendations) regard-
ing the matter not later than 60 days after the date of
the referral, or not later than 90 days after the date of
the referral if the panel, special Governmental employee,
or non-governmental person considers the additional 30
days to be necessary. Not later than 30 days after the
date of receiving the report, the Secretary shall, in writing,
confirm or modify the recommendations received, provid-
ing reasons and reference to data before the panel, special
Governmental employee, or non-governmental person for
any modification. If the Secretary fails to act on such a
recommendation within 30 days of its receipt, the rec-
ommendation of the panel, special Government employee,
or non-governmental person shall be deemed to be the rec-
ommendation of the Secretary.
‘‘(c) Whenever the Secretary fails to complete a pre-
market submission review under section 505 in a timely
manner as prescribed by this Act and the regulations of
the Secretary under this Act, the person who made the
submission may request that the director of the office re-
sponsible for the review (or any successor entity) evaluate
the failure to timely complete the review of the submission
and issue an explanation for such failure and a new date
for completion of the review. Such director shall complete
such an evaluation within 14 days of the date a request
is made for it.
‘‘(d) The Federal Advisory Committee Act shall not
apply to any scientific advisory panel acting under this
section.’’.
SEC. 10. GOOD MANUFACTURING PRACTICES.
(a) AMENDMENT.—Section 501(a) (21 U.S.C.
351(a)) is amended—
(1) 
by 
striking 
‘‘(a)(1)’’ 
and 
inserting
‘‘(a)(1)(A)’’;
(2) by redesignating subclauses (A) and (B) in
clauses (2) and (4) as subclauses (i) and (ii), respec-
tively; and
(3) by redesignating clauses (2) through (6) as
clauses (B) through (F), respectively;
(4) by adding at the end the following:
‘‘(2) All chemistry, manufacturing, and controls
which comply with an approved new drug application
under section 505 or a license application under section
351 of the Public Health Service Act or with the opinion
of an appropriate official in the component of the Food
and Drug Administration responsible for the review of
such chemistry, manufacturing, or controls and which is
reduced to writing and made part of the administrative
record shall be deemed to comply with current good manu-
facturing practice. The Secretary shall not take action to
delay or prevent the manufacture or marketing of a drug
under section 505 or section 351 of the Public Health
Service Act for failure to conform to current good manu-
facturing practice unless there is reasonable probability of
harm to the public health or the Secretary determines in
writing that the drug is—
‘‘(A) not bioequivalent,
‘‘(B) deviates from the specifications for the
drug established in the approved new drug applica-
tion from the specifications for the drug established
by the manufacturer,
‘‘(C) lacks adequate assurance that it will meet
the represented sterility, or
‘‘(D) has been rendered unsafe or ineffective.’’.
(b) CONFORMING AMENDMENTS.—
(1) SECTION
303.—Section 303(g)(1)(B)(iii)
(21 U.S.C. 333(g)(1)(B)(iii)) is amended by striking
‘‘501(a)(2)(A)’’ and inserting ‘‘501(a)(1)(B)(i)’’.
(2) SECTION
304.—Section 304(d)(1) (21
U.S.C. 
334(d)(1)) 
is 
amended 
by 
striking
‘‘501(a)(3)’’ and inserting ‘‘501(a)(1)(C)’’.
(3) SECTION
512.—Section 512(a)(1) (21
U.S.C. 
360c(a)(1)) 
is 
amended 
by 
striking
‘‘501(a)(5)’’ and inserting ‘‘501(a)(1)(E)’’, section
512(a)(2) (21 U.S.C. 360c(a)(2)) is amended by
striking ‘‘501(a)(6)’’ and inserting ‘‘501(a)(1)(F)’’,
and section 512(a)(3) (21 U.S.C. 360c(a)(3)) is
amended by striking ‘‘501(a)(5) or (6)’’ and insert-
ing ‘‘501(a)(1)(E) or 501(a)(1)(F)’’.
(4) SECTION 721.—Section 721(a) (21 U.S.C
379e(a)) is amended by striking ‘‘501(a)(4)’’ and in-
serting ‘‘501(a)(1)(D)’’.
(5) SECTION 802.—Sections 802(b)(1)(D) and
802(f)(1)(B) (21 U.S.C.382(b)(1)(D), 382(f)(1)(B))
are each amended by striking ‘‘(a)(1), (a)(2)(A),
(a)(3)’’ 
and 
inserting 
‘‘(a)(1)(A), 
(a)(1)(B)(i),
(a)(1)(C)’’ .
SEC. 11. PILOT AND SMALL SCALE MANUFACTURE.
Section 505(c) (21 U.S.C. 355(c)) is amended by
adding at the end thereof the following:
‘‘(4) A new drug manufactured in a pilot or other
small facility may be used to demonstrate the safety and
effectiveness of the drug and to obtain approval prior to
scaling up to a larger facility, unless the Secretary dem-
onstrates in writing and specifying in detail the reasons
that a full scale production facility is necessary to ensure
the safety or effectiveness of the drug.’’.
SEC. 12. MANUFACTURING CHANGES.
Chapter VII (21 U.S.C. 371 et seq.) is amended by
adding at the end thereof the following:
made at any time and shall be reported annu-
ally with supporting data to the Secretary.
‘‘(B) 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, or po-
tency as they may relate to the safety or effec-
tiveness of a drug, shall be submitted to the
Secretary in a supplemental application and
drugs made after such changes may not be dis-
tributed until the Secretary approves the sup-
plemental application. Major manufacturing
changes are (i) changes in the qualitative or
quantitative formulation or the specifications in
the approved marketing application (unless ex-
empted by the Secretary); (ii) changes which
the Secretary determines by regulation or guid-
ance require completion of an appropriate
human study demonstrating equivalence to the
drug manufactured before such changes; and
(iii) other changes which the Secretary deter-
mines by regulation or guidance have a sub-
stantial potential to adversely affect the safety
or effectiveness of the drug.
‘‘(C) All other manufacturing changes shall
be reported to the Secretary in a supplemental
application. Unless the Secretary notifies the
applicant within 30 days that preapproval of
the supplement is required, the applicant may
distribute the drug before the application is ap-
proved. The Secretary will subsequently approve
or disapprove the supplemental application. The
Secretary may determine types of manufactur-
ing changes after which distribution of a drug
may commence at the time of submission of the
supplemental application.’’.
(b) EXISTING LAW.—The requirements of the Fed-
eral Food, Drug, and Cosmetic Act with respect to manu-
facturing changes shall remain in effect for—
(1) a period of 12 months after the date of the
enactment of this section, or
(2) until the Secretary’s regulations implement-
ing section 741 of such Act take effect,
whichever is sooner.
SEC. 13. INSULIN AND ANTIBIOTICS.
(a) CERTIFICATION OF DRUGS CONTAINING INSU-
LIN.—
(1) AMENDMENT.—Section 506 (21 U.S.C.
356) is repealed.
(2) CONFORMING AMENDMENTS.—
(A) Sections 301(i)(1) and 301(j)(1) (21
U.S.C. 321(i)(1), 321(j)(1)) are each amended
by striking ‘‘506, 507,’’.
(B) Section 501(k) (21 U.S.C. 351(k)) is
repealed
(C) Section 502(k) (21 U.S.C. 352(k) is
repealed.
(D) 
Sections 
510(j)(1)(A) 
and
510(j)(1)(D) 
(21 
U.S.C. 
360(j)(1)(A),
360(j)(1)(D)) are each amended by striking
‘‘506, 507,’’.
(E) Section 8126(h)(2) of title 38, United
States Code, is amended by inserting ‘‘or’’ at
the end of subparagraph (B), by striking ‘‘; or’’
at the end of subparagraph (C) and inserting a
period, and by striking subparagraph (D).
(F) Section 1927(k)(2) of the Social Secu-
rity Act (42 U.S.C. 1396r–8(k)(2)) is amended
by striking ‘‘; and’’ at the end of subparagraph
(B) and inserting a period and by striking sub-
paragraph (C).
(b) CERTIFICATION OF ANTIBIOTICS.—
(1) AMENDMENT.—Section 507 (21 U.S.C.
357), as in effect on the date of the enactment of
this Act, is repealed.
(2) CONFORMING AMENDMENTS.—
(A) Section 201(aa) (21 U.S.C. 321(aa)) is
amended by striking out ‘‘or 507’’, section
201(dd) (21 U.S.C. 321(dd)) is amended by
striking ‘‘507,’’, and sections 201(ff)(2)(B) and
201(ff)(3) (21 U.S.C. 321(ff)(2)(B), 321(ff)(3))
are each amended by striking ‘‘, certified as an
antibiotic under section 507,’’.
(B) Section 301(e) (21 U.S.C. 331(e)) is
amended by striking ‘‘507(d) or (g),’’.
(C) Sections 301(i)(1) and 301(j) (21
U.S.C. 321(i)(1), 321(j)) are each amended by
striking ‘‘507,’’.
(D) Section 306(d)(4)(B)(ii) (21 U.S.C.
335a(d)(4)(B)(ii)) is amended by striking ‘‘or
507’’.
(E) Section 502 (21 U.S.C. 352) is
amended by striking subsection (l).
(F) Section 510(j)(1)(D) (21 U.S.C.
360(j)(1)(D)) is amended by striking ‘‘507,’’.
(G) Section 520(l) is amended by striking
paragraph (4) and by striking ‘‘or Antibiotic
Drugs’’ in the subsection heading.
(H) Section 525(a) (21 U.S.C. 360aa(a))
is amended by inserting ‘‘or’’ at the end of
paragraph (1), by striking paragraph (2), and
by redesignating paragraph (3) as paragraph
(2).
(I) Section 525(a) (21 U.S.C. 360aa(a)) is
amended by striking ‘‘, certification of such
drug for such disease or condition under section
507,’’.
(J) Section 526(a)(1) (21 U.S.C. 360bb) is
amended by striking ‘‘the submission of an ap-
plication for certification of the drug under sec-
tion 507,’’, by inserting ‘‘or’’ at the end of sub-
paragraph (A), by striking subparagraph (B),
and by redesignating subparagraph (C) as sub-
paragraph (B).
(K) Section 526(b) (21 U.S.C. 360bb(b))
is amended by striking ‘‘, a certificate was is-
sued for the drug under section 507,’’ each time
it appears and by striking ‘‘, approval of an ap-
plication for certification under section 507,’’.
(L) Section 527(a) (21 U.S.C. 360cc(a)) is
amended by inserting ‘‘or’’ at the end of para-
graph (1), by striking paragraph (2), by redes-
ignating paragraph (3) as paragraph (2), and
by striking ‘‘, issue another certificate under
section 507,’’.
(M) Section 527(b) (21 U.S.C. 360cc(b))
is amended by striking ‘‘, if a certification is is-
sued under section 507 for such a drug,’’, and
‘‘, of the issuance of the certification under sec-
tion 507,’’.
(N) Section 704(a)(1) (21 U.S.C. 374) is
amended by striking ‘‘, section 507 (d) or (g)’’.
(O) Section 735(1) (21 U.S.C. 379g(1)(C))
is amended by inserting ‘‘or’’ at the end of sub-
paragraph (B), by striking subparagraph (C),
and by redesignating subparagraph (D) as sub-
paragraph (C).
(P) Sections 5(b)(1)(A) and 5(b)(1)(B) of
the 
Orphan 
Drug 
Act 
(21 
U.S.C.
360ee(b)(1)(A), 
360ee(b)(1)(B)) 
are 
each
amended by striking ‘‘or 507’’.
(Q) Section 28(b)(2)(A)(ii)(II) of the In-
ternal Revenue Code of 1986 is amended by
striking ‘‘or 507’’.
(R) Section 156(f)(4)(B) of title 35,
United States Code, is amended by striking
‘‘507,’’ each place it occurs.
(S) Section 1927(k)(2)(A)(i) of the Social
Security 
Act 
(42 
U.S.C. 
1396r–
8(k)(2)(A)(ii)(II)) is amended by striking ‘‘or
507’’.
(c) EXPORTATION.—Section 802 (21 U.S.C. 382) is
amended by adding at the end thereof the following:
‘‘(h) EXPORTATION OF INSULIN AND ANTIBIOTICS.—
Insulin and antibiotics may be exported without regard to
the requirements in this section if the insulin and anti-
biotics meet the requirements of section 801(e)(1).’’.
SEC. 14. NONPRESCRIPTION DRUGS.
Chapter V is amended by adding after section 510
(21 U.S.C. 360) the following:
‘‘NONPRESCRIPTION DRUGS
‘‘SEC. 511. All applications or petitions requesting
that a drug be switched from prescription to nonprescrip-
tion status and all other matters relating to nonprescrip-
tion drugs shall be reviewed and acted upon solely by a
single office in the Center for Drug Evaluation and Re-
search or a successor entity, and that office shall report
directly to the Director of the Center. A single scientific
advisory panel may provide conclusions and recommenda-
tions regarding any such matter.’’.
SEC. 15. INFORMATION SYSTEM.
Chapter IX is amended by adding at the end the fol-
lowing section:
‘‘SEC. 906. INFORMATION SYSTEM.
‘‘The Secretary shall establish and maintain an infor-
mation system to track the status and progress of each
application or submission (including a petition, notifica-
tion, or other similar form of request) submitted to the
Food and Drug Administration requesting agency action.
The system shall permit access by the applicant.’’.
SEC. 16. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII, as amended by section 12, is amended
by adding at the end the following:
‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW
‘‘SEC. 744. ENVIRONMENTAL IMPACT REVIEW
‘‘No action by the Secretary proposed to be taken
pursuant to this Act shall require the preparation of an
environmental assessment or environmental impact state-
ment under the National Environmental Policy Act of
1969 unless the Secretary finds that because of extraor-
dinary circumstances the proposed action may have a sig-
nificant effect, either directly or cumulatively, on the
human environment.’’.
SEC. 17. APPLICATION OF FEDERAL LAW TO THE PRACTICE
OF PHARMACY COMPOUNDING.
(a) IN GENERAL.—Section 503 (21 U.S.C. 353) is
amended by adding at the end the following:
‘‘(h)(1) Sections 501(a)(2)(B), 501(f), 501(h),
502(f)(1), 502(l), 502(o), 502(s), 502(t), 505, and sec-
tions 510 through 520 shall not apply to a drug or device
that is compounded by a licensed pharmacist or licensed
physician or other licensed practitioner authorized by
State law to prescribe drugs or devices or both—
‘‘(A) on the order of such a licensed physician
or other licensed practitioner for an individual pa-
tient; or
‘‘(B) in limited quantities, as determined by the
principal State agency of jurisdiction which regulates
the practice of pharmacy for that pharmacist, before
receiving a valid order for an individual patient if
the compounding of the drug or device is based on
a history of receiving valid orders that have been
generated solely within an established relationship
between the pharmacist, and (i) the patient for
whom the order will be given, or (ii) the physician
or other licensed practitioner who will write such
order.
Such sections shall not apply to a drug or device if such
pharmacist or physician or other licensed practitioner does
no more than advertise or otherwise promote the
compounding service and does not advertise or otherwise
promote the compounding of a particular drug or device.
‘‘(2) None of the provisions of this Act referred to
in paragraph (1) shall apply to a bulk drug product or
other drug, including an imported drug, that is intended
for use by a licensed pharmacist or licensed physician or
other licensed practitioner in compounding a drug or de-
vice on the order of a licensed physician or other licensed
practitioner for an individual patient, except to the extent
that the provision relates directly to the quality, purity,
potency, or identity of such drug.’’.
(b) WITHDRAWAL OF PROPOSED RULE AND GUIDE-
LINE.—The proposed rule of the Secretary of Health and
Human Services concerning exceptions to the current good
manufacturing practices for makers of positron emission
tomography drug products and the draft guideline on the
manufacture of positron emission tomography drug prod-
ucts published in the Federal Register of February 27,
1995 (at 60 FR 10517-10520 and 60 FR 10593-10594)
are null and void and the Secretary of Health and Human
Services may not propose another proposed regulation or
guideline respecting the same matters covered by the pro-
posed regulation and guideline described in this sub-
section.
SEC. 18. HARMONIZATION.
Section 803 (21 U.S.C. 383) is amended by adding
at the end the following:
‘‘(c)(1) The Secretary shall participate in meetings
with other countries to discuss methods and approaches
to reduce the burden of regulation, harmonize regulatory
requirements, and seek appropriate reciprocal arrange-
ments. The Secretary shall, within 180 days of the date
of enactment of this subsection, make public a plan that
establishes a framework for achieving mutual recognition
of good manufacturing practices.
‘‘(2) The Secretary shall report to the Committee on
Commerce of the House of Representatives and the Com-
mittee on Labor and Human Resources of the Senate at
least 60 days before executing any bilateral or multilateral
agreement under paragraph (1).’’.
SEC. 19. INFORMAL AGENCY STATEMENTS.
Section 701 (21 U.S.C. 371) is amended by adding
at the end the following:
‘‘(h)(1) The Secretary shall not rely upon informal
agency statements, including guidance documents, policy
statements, points to consider documents, or any other
statements that have not been promulgated in accordance
with the rulemaking requirements of chapter V of title 5,
United States Code, to require any action be taken to sat-
isfy a requirement of this Act.
‘‘(2) The Secretary shall publish notice in the Federal
Register of the availability to the public of each type of
statement identified in paragraph (1). Additionally, the
Secretary shall undertake to make available all such state-
ments by electronic or other similar means.’’.
SEC. 20. EDUCATION AND RESEARCH; PRACTICE OF MEDI-
CINE.
Chapter IX, as amended by section 15, is amended
by adding at the end the following sections:
‘‘SEC. 907. EDUCATION AND RESEARCH.
‘‘(a) EDUCATION.—The Secretary shall conduct
training and education programs for the employees of the
Food and Drug Administration relating to the regulatory
responsibilities and policies established by this Act, includ-
ing programs for scientific training, administrative process
and procedure, and integrity issues.
‘‘(b) RESEARCH.—The Secretary, acting through the
Food and Drug Administration, may conduct or contract
for scientific research only if it is directly related to the
implementation of this Act.
‘‘SEC. 908. PRACTICE OF MEDICINE.
‘‘Nothing in this Act shall be construed to limit or
interfere with the authority of a health care practitioner,
licensed by law to administer drugs and devices, to pre-
scribe or administer any legally marketed drug or device
to a patient for any condition or disease within a legiti-
mate health care practitioner-patient relationship.’’.
SEC. 21. DELEGATION OF AUTHORITY.
Section 903 (21 U.S.C. 393), as amended by section
2(b), is amended by adding at the end the following:
‘‘(f) DELEGATION OF AUTHORITY.—The reference in
sections 
505(b)(4)(A), 
505(b)(4)(C), 
505(i)(2)(B),
505(n)(1), 701(n), and 505(a)(4)(E) to the authority of
a specific official or position in the Food and Drug Admin-
istration to perform a particular function is an authority
which shall be only exercised by such official or individual
in such position and the authority to exercise such author-
ity may not be delegated.’’.
SEC. 22. PUBLICATION OF NOTICE OF DEVIATION.
Section 705 (21 U.S.C. 375) is amended by adding
at the end the following:
‘‘(c) The Secretary may make public or communicate
to any person outside the Food and Drug Administration
any information regarding a notice which informs a regu-
lated person of a purported deviation from a requirement
of this Act only after the Secretary has completed the in-
vestigation of such deviation, except as provided in sub-
section (b).’’.
SEC. 23. MODERNIZATION OF REGULATION OF BIOLOGICAL
PRODUCTS.
(a) IN GENERAL.—Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by striking ‘‘SEC.
351. (a)’’ and all that follows through ‘‘barter, or ex-
change the same.’’ and inserting the following:
‘‘SEC. 351. (a)(1) Except as provided in paragraph
(6), no person shall introduce or deliver for introduction
into interstate commerce any biological product unless—
‘‘(A) a 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 biologi-
cal product contained therein, the name, address,
and applicable license number of the manufacturer
of the biological product, and the expiration date of
the biological product.
‘‘(2) The license required under paragraph (1)(A)
shall, as determined by the Secretary, cover the biological
product, any facility in which the biological product is
manufactured, processed, packed, or held, or both the
product and facility.
‘‘(3)(A) The Secretary shall establish, by regulation,
requirements for license applications for biological prod-
ucts.
‘‘(B) Except as provided in subparagraph (D), a li-
cense application that covers a biological product shall be
approved based upon a demonstration that—
‘‘(i) the product that is the subject of the appli-
cation is safe and effective in accordance with sub-
sections (c) and (d) of section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355), or
meets standards designed to ensure that the product
is safe, pure, and where appropriate, potent; and
‘‘(ii) the methods used in, and the facilities and
control used for, the manufacture, processing, pack-
ing, and holding of such product meet standards de-
signed to ensure that the product meets the require-
ments of clause (i).
‘‘(C) A license application that covers a facility shall
ensure that the product and the facility meet standards
designed to ensure that the product meets applicable re-
quirements of subparagraph (B).
‘‘(D) A license application for blood or a blood com-
ponent (including plasma) shall be approved based on a
demonstration that the product meets standards designed
to assure that such product is safe, pure, and where ap-
propriate, potent, and that the facility in which the prod-
uct is manufactured, processed, packed, or held meets
standards designed to ensure that such product is safe,
pure, and where appropriate, potent.
‘‘(4)(A) Requirements prescribed under paragraph
(3) shall include a requirement for preapproval inspection
under subsection (c).
‘‘(B) A license shall be approved only on condition
that the licensee agrees to permit inspection of the facility
of the licensee in accordance with subsection (c).
‘‘(5)(A) Except as provided in subparagraph (C), an
approved license for a biological product may be revoked
if the Secretary determines, on the record after providing
an opportunity for a hearing in accordance with section
554 of title 5, United States Code, that the requirements
for approval as specified in paragraph (3) are no longer
met with respect to such product, or that other public
health reasons, prescribed by regulation, exist. No action
to revoke a license based on the findings of an inspection
shall be initiated prior to the submission and review by
the Secretary of a written response submitted by the li-
censee to a notice of inspection findings so long as such
written response is received within 30 days after the date
of receipt by the licensee of the findings. The revocation
of any product license shall not prevent the continued use
of any licensed biological product that has been sold and
delivered by the licensee unless the biological product is
subject to recall under subsection (d).
‘‘(B) If at any time before the Secretary has taken
final action to revoke a license, the licensee requests an
inspection by the Secretary to determine whether the li-
censee is in compliance with applicable standards, the Sec-
retary shall conduct an inspection within 30 days after
the date of the request. If the inspection confirms that
the licensee is not in compliance with applicable standards,
the 30-day requirement for inspection shall not apply to
any subsequent request by the licensee under this subpara-
graph for inspection. If the inspection confirms that the
licensee is in compliance with all applicable requirements,
the Secretary shall withdraw any proposed action within
30 days after the inspection.
‘‘(C) If the Secretary determines that conditions exist
that constitute a danger to health, the Secretary shall sus-
pend the license, notify the licensee that the licensee’s li-
cense is suspended, and require notification of the suspen-
sion to any consignee. Within 30 days thereafter, the Sec-
retary shall initiate the hearing process under subpara-
graph (A).
‘‘(6) The requirements of paragraph (1) do not apply
to a biological product for which there is in effect an inves-
tigational new drug application under section 505(i) of the
Federal Food, Drug, and Cosmetic Act.’’.
(b) DELETION
OF ELA REQUIREMENT.—Section
351(d) of the Public Health Service Act (42 U.S.C.
262(d)) is amended—
(1) by striking ‘‘(d)(1)’’ and all that follows
through ‘‘of this section.’’;
(2) by redesignating paragraph (2)(A) as sub-
section (d)(1);
(3) by redesignating subparagraph (B) as para-
graph (2); and
(4) in paragraph (2) (as so redesignated), by
striking ‘‘subparagraph (A)’’ and inserting ‘‘para-
graph (1)’’.
(c) LABELING.—Section 351(b) of the Public Health
Service Act (42 U.S.C. 262(b)) is amended to read as fol-
lows:
‘‘(b) No person shall falsely label or mark any pack-
age or container of any biological product or alter any
label or mark on the package so as to falsify the label
or mark.’’.
(d) 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 through
‘‘other product aforesaid’’ and inserting ‘‘biological prod-
uct’’.
(e) DEFINITION; APPLICATION.—Section 351 of the
Public Health Service Act (42 U.S.C. 262) is amended
by adding at the end thereof the following new sub-
sections:
‘‘(i)(1) For purposes of this section, the term ‘biologi-
cal product’ means a virus, therapeutic serum, toxin, anti-
toxin, vaccine, blood, blood component or derivative, aller-
genic biologic product (except for topically applied aller-
genic products used for the diagnosis of Type IV aller-
gies), or arsphenamine or its derivative (or any other anal-
ogous biological product) applicable to the prevention,
treatment, or cure of diseases or conditions of human
beings.
‘‘(2) The Secretary shall promulgate regulations
under section 513(d) of the Federal Food, Drug, and Cos-
metic Act to provide for the regulation of diagnostic test-
ing kits using topically applied allergenic products as de-
vices within the meaning of section 201(h) of such Act.
Such regulations shall take into account the following—
‘‘(A) topically applied allergenic products used
for diagnostic testing elicit a biological response, not
a chemical response, on the body;
‘‘(B) diagnostic testing kits using topically ap-
plied allergenic products were commercially mar-
keted prior to May 28, 1976;
‘‘(C) diagnostic testing kits using topically ap-
plied allergenic products are appropriately classified
as class II devices pursuant to section 513(a)(1)(B)
of such Act, without need for a review by or rec-
ommendation from a classification panel under sec-
tion 513(c) of such Act; and
‘‘(D) clinical data are not required for purposes
of determining substantial equivalence of diagnostic
testing kits using topically applied allergenic prod-
ucts under section 513(i) of such Act.
‘‘(3) Not later than 12 months after the date of the
enactment of this Act, the Secretary shall issue proposed
regulations under paragraph (2). Not later than 24
months after the date of enactment of this Act, the Sec-
retary shall issue final regulations under paragraph (2).
‘‘(j)(1) Sections 505(i), 903, and 904 of the Federal
Food, Drug, and Cosmetic Act shall apply to all biological
products, and references in such sections to new drug ap-
plications shall be deemed to include product license appli-
cations for biological products.
‘‘(2) Requirements involving labeling or advertising
for biological products shall be established in accordance
with sections 201(m) and 502(n) of the Federal Food,
Drug, and Cosmetic Act.’’.
(f) STRENGTHENING REGULATION OF BLOOD AND
BLOOD PRODUCTS.—The Secretary of Health and Human
Services, in order to strengthen and streamline the regula-
tion of blood and blood products, shall, after consultation
with patient advocacy groups and the regulated industry,
develop the concept of a single license for the regulation
of blood and blood products that would, as appropriate,
cover multiple individual locations that fall under a single
management. The Secretary shall report the progress on
achieving a single license to the Committee on Commerce
of the House of Representatives and the Committee on
Labor and Human Resources of the Senate by March 31,
1997.
SEC. 24. REQUIREMENTS FOR HUMAN TISSUE.
(a) IN GENERAL.—Section 201 is amended by adding
at the end the following:
‘‘(gg)(1) The term ‘human tissue’ means a collection
of similar human cells which—
‘‘(A) is intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of a disease or
condition in man or for reproduction,
‘‘(B) achieves its primary intended purpose
through repair or replacement by structural support
or cellular function and not systemic action,
‘‘(C) may have been propagated or otherwise
processed before use, and
‘‘(D) may be combined with substances that are
safe under conditions of intended use and not in-
tended to provide a therapeutic effect.
‘‘(2) The term human tissue does not include
vascularized human organs, gene therapy, blood, blood
components, milk, or human tissue combined with bio-
materials.
‘‘(3) Human tissue is not a drug, biological product,
or device unless reclassified by the Secretary pursuant to
355 of the Public Health Service Act.
(b) REGULATION OF HUMAN TISSUE.—Subpart 1 of
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 section:
‘‘REGULATION OF HUMAN TISSUE
‘‘SEC. 352A. (a)(1) Human tissue shall be subject to
regulation under this section only if the Secretary pub-
lishes a finding in the Federal Register, after a hearing
before the Commissioner, that voluntary regulation under
generally accepted scientific standards is inadequate to
protect the public health with respect to any particular
type of human tissue or human tissue generally.
‘‘(2) Human tissue shall not be subject to regulation
as a drug, biological product, or device unless it is reclassi-
fied under subsection (e).
‘‘(b)(1) Any person subject to regulation under this
section who recovers, processes, stores, or distributes
human tissue for transplantation or implantation in the
United States shall register in accordance with the reg-
istration procedures established for drugs under section
510 of the Federal Food, Drug, and Cosmetic Act. Such
registration shall contain the name of the person, the loca-
tion of the facilities of the person, a list of the types of
human tissue recovered, processed, stored, or distributed
by the person, and a brief description of the basic method
or methods of processing of such tissue.
‘‘(2) A registered person shall be deemed to be au-
thorized to conduct human tissue recovery, processing,
storage, and distribution activities identified in its reg-
istration unless—
‘‘(A)(i) the Secretary determines, upon inspec-
tion, that such person fails to meet applicable oper-
ating standards under subsection (c);
‘‘(ii) the Secretary so notifies such person, ad-
vises the person of the steps necessary to meet such
standards, and provides the person with a reason-
able opportunity to establish compliance with the
standards;
‘‘(iii) the Secretary determines, after an oppor-
tunity for an informal hearing, that the person has
failed to establish such compliance within the appli-
cable period and such failure constitutes a threat to
the public health; and
‘‘(iv) the Secretary suspends or revokes the au-
thority to conduct such activities;
‘‘(B) the Secretary determines, after an oppor-
tunity for an informal hearing, that such person has
failed to comply with any patient registry or other
retrospective patient data requirement, and the Sec-
retary suspends or revokes the authority to conduct
such activities; or
‘‘(C) the Secretary determines that such person
presents an immediate or substantial danger to the
public health, and the Secretary suspends or revokes
the authority to conduct such activities.
‘‘(c) The Secretary may establish operating standards
for human tissue that shall be limited to the following gen-
eral requirements for the recovery, processing, storage,
and shipment of human tissue:
‘‘(1) Requirements for infection control de-
signed to prevent transmission of disease.
‘‘(2) Requirements for processing practices that
assure the safety of, and prevent damage to, human
tissue.
‘‘(3) Requirements for labeling and record keep-
ing to identify the type of tissue and any added for-
eign substance and to permit tracing.
‘‘(d) A registered person may be required by the Sec-
retary to maintain a patient registry or meet other retro-
spective patient data requirements if, after notice and an
opportunity for comment, the Secretary finds that such
tissue has been commercially available within the United
States for a period of less than 5 years and that such
data requirement is necessary to protect the public health.
‘‘(e)(1) The Secretary may reclassify a particular
type of human tissue as a drug, biological product or de-
vice if, after notice and an opportunity for comment, the
Secretary finds that—
‘‘(A) the particular type of human tissue is—
‘‘(i) subject to a patient registry or other
retrospective data requirement under which the
collection of information has been required for
at least 5 years (or such other time period as
agreed to by the Secretary and the registered
person); and
‘‘(ii) the information received from such
patient registry or other retrospective data re-
quirement is insufficient to confirm the safety
and clinical benefit from the use of such tissue;
or
‘‘(B) a particular type of human tissue should
be reclassified because it presents an imminent haz-
ard to public health.
‘‘(2) The Secretary may reclassify a human drug, bio-
logical product or medical device as human tissue if, after
notice and an opportunity for comment, the Secretary
finds that such previous classification is not necessary to
protect public health.
‘‘(3) The Secretary may reclassify a drug, biological
product, device, or human tissue upon the petition of the
sponsor of such drug, biological product, or device, or the
registered person of such human tissue, if, after notice and
an opportunity for comment, the Secretary finds that such
reclassification is consistent with the protection of the
public health.
‘‘(f)(1) If the Secretary finds that a person violates
any provision of this section or any regulations promul-
gated thereunder, and the Secretary finds the violation
constitutes a significant risk to the public health, the Sec-
retary may issue an order that such person cease distribu-
tion of human tissue, or that human tissue recovered,
processed, stored or distributed by such person be re-
tained, recalled, or destroyed. After receipt of such an
order, the person in possession of the human tissue shall
not distribute or dispose of the human tissue in any man-
ner inconsistent with the provisions of the order.
‘‘(2) A person subject to an order under paragraph
(1) may obtain an informal hearing regarding the order
if the person requests such a hearing not later than 5 days
after receiving the order. If the person makes such a re-
quest within such period, the Secretary shall conduct the
hearing not later than 30 days after receiving the request
and shall issue an order not later than 15 days after the
hearing is conducted. Such order shall be considered a
final order of the Secretary.
‘‘(g) Each registered person shall be subject to in-
spection under section 704 of the Federal Food, Drug,
and Cosmetic Act. The Secretary may, with the concur-
rence of the registered person, authorize an inspection to
be conducted by a person specifically accredited by the
Secretary to conduct such inspection under section 712
of such Act.
‘‘(i) This section (including provisions regarding re-
classification) shall apply with respect to cord blood to the
same extent and in the same manner as this section ap-
plies with respect to human tissue.’’.
(c) TRANSITION—The requirements of the interim
regulation promulgated by the Secretary of Health and
Human Services on December 11, 1993, shall remain in
effect until amended or withdrawn by the Secretary. Any
changes to such regulations after the date of the enact-
ment of this Act are subject to this Act and the amend-
ments made by this Act.
(d) EFFECTIVE DATE.—Section 352A of the Public
Health Service Act shall take effect on June 30, 1997.
(e) CONFORMING AMENDMENTS.—
(1) ADULTERATION
PROVISION.—Section 501
(21 U.S.C. 351) is amended—
(A) in the first sentence, by striking ‘‘drug
or device’’ and inserting ‘‘drug, device or
human tissue’’; and
(B) by inserting at the end thereof the fol-
lowing:
‘‘(j) If it is human tissue and is recovered, processed,
stored, or distributed by—
‘‘(1) a registered person under section 352A of
the Public Health Service Act whose failure to com-
ply with operating standards for human tissue con-
sistent with such section constitutes a threat to the
public health; or
‘‘(2) a person who is required under such sec-
tion to register but has failed to do so.’’.
(2) MISBRANDING
PROVISIONS.—Section 502
(21 U.S.C. 352) is amended—
(A) in the heading for the section, by strik-
ing ‘‘MISBRANDED’’ and all that follows and in-
serting the following: ‘‘MISBRANDED
DRUGS,
DEVICES, AND HUMAN TISSUE’’; and
(B) in the first sentence, by striking ‘‘drug
or device’’ and inserting ‘‘drug, device or
human tissue’’.
(3) 
PROHIBITED
ACTS.—Section 
301 
(21
U.S.C. 331) is amended by inserting the following
new section:
‘‘(v) The adulteration or misbranding of any
human tissue.’’.
(4) SEIZURE.—
(A) Section 304 (a)(2)(D) (21 U.S.C. 334
(a)) is amended by inserting ‘‘or human tissue’’
after ‘‘device.’’
((B) Section 304(d)(1) is amended by de-
leting the ‘‘or’’ before ‘‘cosmetic’’ and inserting
‘‘, or human tissue’’ after ‘‘cosmetic’’ in the
first sentence.
(5) INSPECTION.—Section 704(a)(1) (21 US.C.
374(a)(1)) is amended—
(A) in the first sentence, by inserting
‘‘human tissue,’’ after ‘‘device,’’ each place such
term appears; and
(B) in the second sentence, by inserting
‘‘human tissue,’’ after ‘‘drugs,’’ each place such
term appears.
SEC. 25. ACCESS TO UNAPPROVED THERAPIES.
Chapter V (21 U.S.C. 351 et seq.) is amended by
adding at the end thereof the following:
‘‘SUBCHAPTER D—ACCESS TO UNAPPROVED THERAPIES
AND DIAGNOSTICS
‘‘EXPANDED ACCESS TO UNAPPROVED THERAPIES AND
DIAGNOSTICS
‘‘SEC. 543. (a) Any physician acting on behalf of a
patient or a patient may request from a manufacturer or
distributor, and any manufacturer or distributor may pro-
vide to such a physician or patient after compliance with
this section, an investigational drug for the diagnosis,
monitoring, or treatment of a serious disease or condition,
life-threatening or seriously debilitating disease or condi-
tion, and any other disease or condition designated by the
Secretary as appropriate for expanded access under this
section by the physician or patient making the request if—
‘‘(1) in the case of a physician acting on behalf
of a patient the physician has no comparable or sat-
isfactory alternative therapy available to treat, diag-
nose, or monitor the disease or condition; or
‘‘(2) in the case of such a physician or patient,
the risk to the physician or patient from the inves-
tigational drug or device is not greater than the risk
from the disease or condition.
‘‘(b) A manufacturer or distributor may submit to the
Secretary one or more expanded access protocols covering
expanded access use of a drug described in subsection (a).
The protocols shall be subject to the provisions of section
505(i) for a drug and may include any form of use of the
drug outside a clinical investigation, prior to approval of
the drug for marketing, including protocols for treatment,
use, emergency use, and uncontrolled trials and single pa-
tient protocols.
‘‘(c) A manufacturer or distributor may charge for
an investigational drug under an expanded access proto-
col, but the price of the drug or device may not be more
than that necessary to recover the costs of manufacture,
research, development, and handling for the drug or de-
vice.
‘‘(d) The manufacturer or distributor may inform na-
tional, State, and local medical associations and societies,
and voluntary health associations, about the availability
of an investigational drug for expanded access use pursu-
ant to this section but—
‘‘(1) shall state that the drug is investigational;
‘‘(2) shall not represent that the drug is safe or
effective for any use; and
‘‘(3) shall not otherwise promote or advertise
the availability of the product for expanded access
use.
SEC. 26. RADIOPHARMACEUTICALS.
Section 505(d) (21 U.S.C. 355(d)), as amended by
section 5, is amended by adding at the end the following:
‘‘(4)(A) For purposes of paragraph (1), the
safety and effectiveness of a radiopharmaceutical in-
tended to be used for purposes of diagnosis or mon-
itoring shall be determined by—
‘‘(i) weighing the probable benefit from the
use of the radiopharmaceutical against any
probable risk of injury or illness from such use;
and
‘‘(ii) taking into account the appropriate
use of the radiopharmaceutical in the practice
of medicine, the level of pharmacological and
toxicological activity of the radiopharmaceutical,
and the estimated absorbed radiation dose of
the radiopharmaceutical.
‘‘(B) In the case of a radiopharmaceutical in-
tended to be used for purposes of diagnosis or mon-
itoring, 
the 
indications 
for 
which 
such 
a
radiopharmaceutical is approved under this section
may refer to manifestations of disease (such as bio-
chemical, physiological, anatomical, or pathological
processes) common to or present in one or more dis-
ease states or may refer to a diagnostic procedure
used in the diagnosis of one or more diseases or con-
ditions.
‘‘(C) Within 180 days after the date of the en-
actment of this paragraph, the Secretary shall, after
consultation with patient advocacy groups, associa-
tions, 
physicians 
licensed 
to 
use
radiopharmaceuticals, and the regulated industry,
issue guidelines pertaining to the evaluation, in ac-
cordance with this paragraph, of the safety and ef-
fectiveness of radiopharmaceuticals.
‘‘(D) As used in this paragraph, the term
‘radiopharmaceutical’ means—
‘‘(i) an article that is intended for use in
vivo in the diagnosis, cure, mitigation, treat-
ment, or prevention of disease or a manifesta-
tion of disease in man, and that exerts its pri-
mary effect by the spontaneous disintegration
of unstable nuclei with the emission of ionizing
radiation; or
‘‘(ii) a reagent kit or nuclide generator
that is intended to be used in the preparation
of any such article.’’.
SEC. 27. PROTECTION OF CONFIDENTIAL INFORMATION.
Section 301, as amended by section 8(b), is amended
by adding after paragraph (w) the following:
‘‘(x) The release to the public of confidential patient
and donor identifying information from establishments li-
censed or registered by the Secretary unless the release
of such information is critical to a public health purpose.’’.
SEC. 28. NATIONAL UNIFORMITY.
(a) Chapter VII is amended by adding at the end
thereof the following:
‘‘SUBCHAPTER D—NATIONAL UNIFORMITY
‘‘SEC. 741. (a)(1) Except as provided in subsection
(d)(1) or (e), no State or political subdivision of a State
may establish or continue in effect any requirement—
‘‘(A) that relates to the regulation of a drug or
cosmetic, and
‘‘(B) that is not identical with a requirement of
this Act, section 351 of the Public Health Service
Act (42 U.S.C. 262), or the Fair Packaging and La-
beling Act (15 U.S.C. 1451 et seq.), and the admin-
istrative implementation of such Acts.
‘‘(2) Except as provided in subsection (d)(2) or (e),
no State or political subdivision of a State may establish
any requirement after the date of enactment of this sec-
tion or continue in effect any requirement established after
such date—
‘‘(A) that relates to the regulation of food, and
‘‘(B) that is not identical with a requirement of
this Act or the Fair Packaging and Labeling Act
(15 U.S.C. 1451 et seq.) and the administrative im-
plementation of such Acts.
‘‘(b) For purposes of subsection (a)(1), a requirement
that relates to the regulation of a drug or cosmetic shall
be deemed to include any requirement that relates to the
subject matter in any provision of this Act, section 351
of the Public Health Service Act (42 U.S.C. 262), or the
Fair Packaging and Labeling Act (15 U.S.C. 1451 et
seq.), including any notification requirement for a drug
or cosmetic that provides for a warning concerning the
safety of the drug or cosmetic or any component or pack-
age thereof, but shall not include any requirement that
relates to the practice of pharmacy or any requirement
that a drug be dispensed only upon the prescription of
a practitioner licensed by law to administer such drug.
‘‘(c) For purposes of subsections (b)—
‘‘(1) the term ‘warning’ with respect to a drug
or cosmetic means any statement, vignette, or other
representation which indicates, directly or by impli-
cation, that the drug or cosmetic presents or may
present a hazard to human health or safety; and
‘‘(2) the term ‘notification requirement’ in-
cludes any mandatory disclosure requirement that
relates to the dissemination of information about a
drug or cosmetic in any manner, such as labels, la-
beling, posters, public notices, advertising, or any
other means of communication.
‘‘(d)(1) Upon application of a State, the Secretary
may by regulation, after notice and opportunity for writ-
ten and oral presentation of views, exempt from subsection
(a)(1), under such conditions as the Secretary may im-
pose, a State requirement which—
‘‘(A) is justified by compelling and unique local
conditions,
‘‘(B) protects an important public interest that
would otherwise be unprotected,
‘‘(C) would not cause any drug or cosmetic to
be in violation of any applicable requirement or pro-
hibition under Federal law, and
‘‘(D) would not unduly burden interstate com-
merce.
‘‘(2)(A) A State may establish a warning notification
requirement for food that would otherwise violate sub-
section (a)(2) if—
‘‘(i) the warning is needed to address an immi-
nent hazard to health that is likely to result in seri-
ous adverse health consequences or death, and
‘‘(ii) a petition for an exemption is submitted
by the State no later than 7 days after the warning
notification requirement is established and is not
subsequently denied by the Secretary.
The Secretary shall take action on a petition no later than
30 days after its submittal.
‘‘(B) For purposes of subparagraph (A)—
‘‘(i) the term ‘warning’ with respect to a food
means any statement, vignette, or other representa-
tion which indicates, directly or by implication, that
the food presents or may present a hazard to human
health; and
‘‘(ii) the term ‘notification requirement’ in-
cludes any mandatory disclosure requirement that
relates to the dissemination of information about a
food in any manner, such as labels, labeling, posters,
public notices, advertising, or any other means of
communication.
‘‘(e) An application described in paragraph (1) or a
petition described in paragraph (2) of subsection (d) that
demonstrates that a drug, cosmetic, or food during the
period of its likely availability in the State will pose a sig-
nificant public health threat from acute exposure shall be
considered an urgent application or petition. If an order
by the Secretary to grant or deny the requested authoriza-
tion in an urgent application or petition is not made within
30 days of receipt of the application or petition, the State
may establish and enforce a temporary requirement. The
temporary requirement shall be validated or terminated by
the Secretary’s final order on the application or petition.
‘‘(f) Nothing in this section shall be construed to
modify or otherwise affect any action or the liability of
any person under the product liability law of any State.’’.
SEC. 29. CENTERS FOR EDUCATION AND RESEARCH ON
DRUGS, DEVICES, AND BIOLOGICAL PROD-
UCTS.
Chapter IX is amended by adding at the end the fol-
lowing section:
‘‘SEC. 909. DEMONSTRATION PROGRAM REGARDING CEN-
TERS FOR EDUCATION AND RESEARCH ON
DRUGS, DEVICES, AND BIOLOGICAL PROD-
UCTS.
‘‘(a) IN GENERAL.—The Secretary, acting through
the Commissioner, shall establish a demonstration pro-
gram for the purpose of making 1 or more grants for the
establishment and operation of 1 or more centers to carry
out the activities specified in subsection (b).
‘‘(b) REQUIRED ACTIVITIES.—The activities referred
to in subsection (a) are the following:
‘‘(1) The conduct of state-of-the-art clinical and
laboratory research for the following purposes:
‘‘(A) To increase awareness of new uses of
drugs, devices, or biological products and the
unforeseen risks of new uses of drugs, devices,
or biological products.
‘‘(B) To provide objective clinical informa-
tion to the following entities:
‘‘(i) Health care practitioners or other
providers of health care goods or services.
‘‘(ii) Pharmacy benefit managers.
‘‘(iii) Health maintenance organiza-
tions or other managed health care organi-
zations.
‘‘(iv) Health care insurers or govern-
mental agencies; and
‘‘(C) To improve the quality of health care
while reducing the cost of health care through
the prevention of adverse effects of drugs, de-
vices, or biological products and the con-
sequences of such effects, such as unnecessary
hospitalizations.
‘‘(2) The conduct of research on the compara-
tive effectiveness and safety of drugs, devices, or bio-
logical products.
‘‘(3) Such other activities as the Secretary de-
termines to be appropriate, except that the grant
may not be expended to assist the Secretary in the
review of new drugs.
‘‘(c) APPLICATION FOR GRANT.—A grant under sub-
section (a) may be made only if an application for the
grant is submitted to the Secretary and the application
is in such form, is made in such manner, and contains
such agreements, assurances, and information as the Sec-
retary determines to be necessary to carry out this section.
‘‘(d) PEER REVIEW.—A grant under subsection (a)
may be made only if the application for the grant has un-
dergone appropriate technical and scientific peer review.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $2,000,000 for fiscal year 1997 and
$3,000,000 for fiscal year 1998.’’.
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