status of the subjects involved. Any response from the
sponsor to the director of such office requesting that the
clinical hold be removed shall receive a decision, in writing
and specifying the reasons therefor, within 15 days or the
clinical hold shall be deemed to be withdrawn. The director
may not delegate the authority to issue a clinical hold.
SEC. 9. CONTENT AND REVIEW OF NEW DRUG APPLICA-
TION.
(a) SUBSECTION
(B)(1) APPLICATION.—Section
505(b) (21 U.S.C. 355) is amended by adding at the end
the following:
‘‘(4)(A) An application submitted under paragraph
(1) shall include reports of studies on safety and effective-
ness certified by the applicant to be accurate summaries
which are supported by summary tables of the relevant
data. Such an application shall not be required to include
the primary data tabulations or case report forms or tab-
ulations. In extraordinary circumstances, the director of
the office of the Food and Drug Administration respon-
sible for review of the drug for which the application is
submitted may request, in writing and specifying the rea-
sons for the request, the submission of primary data tab-
ulations. The director may not delegate the authority to
make such a request.
‘‘(B) In reviewing an application submitted under
paragraph (1), the Secretary, after obtaining agreement
of the applicant, shall contract with outside organizations
or individuals with expertise in relevant disciplines for the
review of all or parts of such application.
‘‘(C) 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 apply equally to outside reviewers
and to employees of the Secretary who review such appli-
cations. The Secretary shall conduct and maintain records
of training programs for outside reviewers and employees
of the Secretary who review such applications to assure
their compliance with good review practices and good re-
view standards and shall monitor their compliance with
such practices and standards, the requirements of section
708, and the statutory time limits for action.
‘‘(D) Advice provided to a sponsor or applicant at its
request by a responsible Food and Drug Administration
employee regarding appropriate testing of a new drug
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 di-
rector of the office in which the drug is reviewed. The di-
rector may not delegate the authority to require such a
change.
‘‘(E) The written decisions of the center for drugs
and the center for biologics of the Food and Drug Admin-
istration on all aspects of matters relating to a new drug
or biologic shall be binding upon, and may not directly
or indirectly be changed by, the field personnel or the of-
fices of compliance in the centers.
‘‘(F) No action by the center for drugs or the center
for biologics on any matter relating to a new drug or bio-
logic may at any time or under any circumstance be de-
layed because of the unavailability of information or action
by the field personnel or because of issues relating to the
integrity of data, except on the basis of evidence presented
to the applicant, followed by an informal hearing, that
data in that particular application are false.’’.
(b) SUMMARIES.—Section 505(b)(1)(A) (21 U.S.C.
355(b)(1)(A)) is amended by inserting ‘‘(including de-
tailed summaries)‘‘ after ‘‘full reports and investigations’’.
SEC. 10. REVIEW BY INDEPENDENT TESTING ORGANIZA-
TIONS.
(a) PRIVATIZATION.—Chapter IX is amended by add-
ing after section 905 (21 U.S.C. 395) the following:
‘‘PRIVATIZATION OF APPROVAL FUNCTIONS
‘‘SEC. 906. (a) The Secretary, acting through the
Commissioner of Food and Drugs, may establish and im-
plement a program under which the Commissioner will
contract, in whole or in significant part, with individuals
and laboratories certified under subsection (b) to conduct,
under such conditions as the Secretary may specify to as-
sure unbiased scientifically valid results, the following ac-
tivities and responsibilities of the Food and Drug Adminis-
tration in connection with the approval of drugs and de-
vices under sections 505 and 515 and with reviewing noti-
fications required under section 510(k) and making writ-
ten recommendations of initial classification under section
513(f)(1) of devices:
‘‘(1) Toxicology reviews to determine if applica-
ble requirements are being met.
‘‘(2) Chemistry reviews to determine if applica-
ble requirements are being met.
‘‘(3) Statistical analysis to determine if applica-
ble requirements are being met.
‘‘(4) Preapproval manufacturing practice in-
spections to determine if applicable requirements are
being met.
‘‘(5) Clinical reviews to determine if applicable
requirements are being met.
‘‘(6) Any other function of the Food and Drug
Administration relating to the review and approval
of drugs or devices that the Secretary determines
can be adequately performed under contract with
qualified individuals and laboratories.
‘‘(b) The Secretary, acting through the Commissioner
of Food and Drugs, shall certify individuals and labora-
tories as qualified to carry out the functions described in
paragraphs (1) through (6) of subsection (a) under a con-
tract with the Commissioner of Food and Drugs.
‘‘(c) The Secretary shall provide that drugs and de-
vices which are subject to review under subsection (a) shall
be approved under sections 505 and 515 if the review de-
termines that the drugs and devices meet all applicable
approval requirements.
‘‘(d)(1) Information otherwise protected from disclo-
sure to the public under section 301(j) or 520(c) may be
disclosed to—
‘‘(A) contractors certified under subsection (b),
and
‘‘(B) employees of such contractors,
if, in the opinion of the Secretary, such disclosure is nec-
essary for the satisfactory performance by the contractor
of work under a contract under subsection (a).
‘‘(2) The Secretary shall, in writing, require as a con-
dition to the disclosure of information under paragraph
(1) that the person receiving such information take such
security precautions respecting the information as the Sec-
retary shall by regulation prescribe. Disclosure by such
person of such information to a person not authorized to
receive it shall constitute a violation of section 301(j) and
of section 1905 of title 18, United States Code.
‘‘(e) The review of an application for approval of a
new drug or device under this Act or a biological product
under section 351 of the Public Health Service Act shall
not include the review of the environmental impact of such
drug, device, or biological product under the Environ-
mental Quality Improvement Act of 1970 (42 U.S.C. 4371
et seq.).’’.
(b) REPORT.—Not later than the expiration of one
year from the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall report to the
Congress on—
(1) the use the Secretary has made under sec-
tion 906 of the Federal Food, Drug, and Cosmetic
Act of the authority to contract for individuals and
laboratories to perform duties of the Food and Drug
Administration, and
(2) any difficulties encountered in contracting
under such section 906.
SEC. 11. RESEARCH ACTIVITIES.
(a) ACTIVITIES.—Chapter IX, as amended by section
10, is amended by adding after section 906 the following:
‘‘RESEARCH ACTIVITIES
‘‘SEC. 907. Research activities of the Food and Drug
Administration relating to drugs, devices, and biological
products, 
which 
are 
authorized 
under 
section
903(b)(2)(D) and section 352 of the Public Health Service
Act, shall directly relate to the review and approval of
drugs, devices, and biological products. In conducting such
research activities, the Food and Drug Administration
may collaborate with the National Institutes of Health,
academic health centers, and other scientific institutions
and the drug and device industry.’’.
(b) PURPOSE.—Section 903 (21 U.S.C. 393), as
amended by section 2, is amended by adding at the end
the following:
‘‘(e) Any research conducted by or for the Food and
Drug Administration shall be solely related directly to (1)
the regulatory mission or (2) professional staff develop-
ment related to that mission and shall be limited to the
minimum necessary to achieve such purposes.’’.
SEC. 12. POLICY AND PERFORMANCE REVIEW.
Section 903 (21 U.S.C. 393), as amended by section
11(b), is amended by adding at the end the following:
‘‘(f)(1) The Secretary shall establish, in the office of
the Assistant Secretary for Health, a permanent commis-
sion responsible for broad oversight of the policy and per-
formance of the Food and Drug Administration. The com-
mission, which shall be subject to the provisions of sub-
section (c) of this section, shall review the performance
of individuals and groups in meeting the mission of the
Food and Drug Administration and the development of
appropriate agency policy to implement that mission and
shall include outcomes measurements and performance as-
sessments in evaluating agency activities. Such review
shall also include a comparison of the performance of the
Food and Drug Administration with that of agencies per-
forming similar functions for other countries and an eval-
uation of the effect of the Food and Drug Administra-
tion’s performance on the competitiveness of the regulated
American industries.
‘‘(2)(A) The members of the commission shall include
the nation’s leading medical experts, medical society rep-
resentatives, scientific and health policy authorities, and
representatives from the trade associations for the regu-
lated industries and from voluntary health associations.
‘‘(B) Members of the commission shall serve at the
discretion of the Secretary from year to year with no fixed
term.
‘‘(C) The Secretary shall pay members of the com-
mission at an appropriate level commensurate with the
services they provide.
‘‘(3)(A) The commission shall issue a report to the
Secretary and the Congress annually on the performance
of the Food and Drug Administration. The Food and
Drug Administration shall be given an opportunity to re-
view and respond to the report before it is submitted to
the Secretary and the Congress.
‘‘(B) As part of its annual report under subparagraph
(A), the commission shall recommend personnel and policy
changes to improve the performance of the Food and Drug
Administration in order to meet its mission as set forth
in subsection (d).’’.
SEC. 13. APPEALS.
Section 903 (21 U.S.C. 393), as amended by section
12, is amended by adding the following new subsection
at the end thereof:
‘‘(g)(1) The Secretary shall establish within the Food
and Drug Administration a drug and biologics policy ap-
peals committee consisting of the director and deputy di-
rector of the center for drugs and the director and deputy
director of the center for biologics. The appeals committee
shall meet to hear and consider any dispute raised by an
individual who wishes to contest a policy matter relating
to drugs or biologics. The appeals committee shall meet
to hear the individual within 15 days of receiving the re-
quest from the individual and shall decide the matter with-
in 10 days after the hearing.
‘‘(2) The Secretary shall establish standing panels of
qualified experts who are not employees of the United
States Government or of any State or local government
for the purpose of hearing appeals by individuals who have
exhausted their informal appeals within the Food and
Drug Administration and who wish to contest the action
or failure to act by the Food and Drug Administration
in a particular matter. The Secretary shall establish an
appeal procedure that assures immediate access to such
a panel and prompt conclusions and recommendations by
the panel. Following the conclusions and recommendations
of the panel, the official of the Food and Drug Adminis-
tration who reports to the Commissioner of Food and
Drugs and is the director of the component responsible
for regulation of the matter shall personally review the
matter, in light of such conclusions and recommendations,
and shall make a final decision within 15 days after receiv-
ing the conclusions and recommendations. Such official
may not delegate the requirement to review and make a
final decision. The decision of that official shall imme-
diately be implemented. If that official fails to make a de-
cision within 15 days, or if the decision is not immediately
implemented, the conclusions and recommendations of the
panel shall be deemed to be the decision of the Food and
Drug Administration and shall be implemented imme-
diately. The failure of the Secretary to take action to im-
plement that decision immediately shall constitute final
agency action for purposes of judicial review.’’.
SEC. 14. EXPORT OF NEW DRUGS.
Section 801(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(e) is amended—
(1) in paragraph (1), by inserting after ‘‘under
this Act’’ the following: ‘‘or in violation of section
505 or section 351 of the Public Health Service
Act’’,
(2) in paragraph (1), by striking the last sen-
tence, and
(3) by amending paragraph (2) to read as fol-
lows:
‘‘(2) Paragraph (1) does not apply to the export of—
‘‘(A) any device—
‘‘(i) which does not comply with an appli-
cable requirement under section 514 or 515,
‘‘(ii) which under section 520(g) is exempt
from either such section, or
‘‘(iii) which is a banned device under sec-
tion 516, or
‘‘(B) any drug (including a biological product)
which does not comply with an applicable require-
ment under section 505 or 512 or section 351 of the
Public Health Service Act,
unless the device or drug is in compliance with the require-
ments of paragraph (1). In the case of a device or drug
for which an export notice is required under this para-
graph, the Secretary may prohibit the export of such de-
vice or drug if the Secretary determines that the possibil-
ity of the reimportation of the device or drug into the
United States presents an imminent hazard to the public
health and safety of the United States and the only means
of limiting the hazard is to prohibit the export of the de-
vice or drug.’’.
SEC. 15. EXPORT OF CERTAIN UNAPPROVED PRODUCTS.
Section 802 (21 U.S.C. 382) is repealed.
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HR 1995 IH——2
HR 1995 IH——3