search and development conducted or supported by 
the Agency in the same manner and the to same ex-
tent as such requirements apply to research and de-
velopment conducted or supported by the National 
Institutes of Health. 
‘‘(2) TECHNICAL AND SCIENTIFIC PEER REVIEW 
GROUPS.—The Director for Vaccine Safety Evalua-
tion may, without regard to the provisions of title 5, 
United States Code, governing appointments in the 
competitive service, and without regard to the provi-
sions of chapter 51 and subchapter III of chapter 53 
of such title relating to classification and General 
Schedule pay rates, establish such technical and sci-
entific peer review groups as are needed to carry out 
the requirements of this subtitle and appoint and 
pay the members of such groups, except that officers 
and employees of the United States shall not receive 
additional compensation for service as members of 
such groups. 
‘‘(h) FDA INFORMATION.—At the request of the Di-
rector for Vaccine Safety Evaluation, the Commissioner 
of Food and Drugs shall provide the Director with com-
plete access to all vaccine-related information submitted 
to the Food and Drug Administration by vaccine manufac-
turers, irrespective of whether the information was sub-
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mitted before or after approval of the vaccine under sec-
tion 351. The Director shall keep such information con-
fidential to the same extent as the Commissioner of Food 
and Drugs is required to keep such information confiden-
tial, and the Director shall not disclose such information 
under section 552 of title 5, United States Code. 
‘‘(i) REPORT.— 
‘‘(1) SUBMISSION.—Not less than twice each 
year, the Director for Vaccine Safety Evaluation 
shall submit a report on the Agency’s activities 
under this section to the Advisory Committee on Im-
munization Practices, the National Vaccine Advisory 
Committee, the National Vaccine Program Office, 
the National Vaccine Injury Compensation Program, 
the Health Resources and Services Administration, 
and any other entity deemed appropriate by the Di-
rector or by the Secretary of Health and Human 
Services. 
‘‘(2) PUBLIC AVAILABILITY.—The Director for 
Vaccine Safety Evaluation shall make each report 
under this subsection publicly available. 
‘‘SEC. 2143. POSTMARKETING VACCINE SAFETY. 
‘‘(a) SURVEILLANCE AND CLINICAL TRIALS.— 
‘‘(1) IN GENERAL.—The Director for Vaccine 
Safety Evaluation, in consultation with the Commis-
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sioner of Food and Drugs, shall require the manu-
facturer of each covered vaccine to provide for post-
marketing surveillance and clinical testing for any 
acute or chronic adverse reactions associated with 
the vaccine. 
‘‘(2) REQUIREMENTS.—The Director for Vac-
cine Safety Evaluation shall require the following: 
‘‘(A) Postmarketing surveillance and clin-
ical testing under paragraph (1) shall be con-
ducted— 
‘‘(i) by one or more individuals re-
ferred to the advisory council by the manu-
facturer or by the Agency, recommended 
by the advisory council under section 
2145(b)(3), and approved by the Director 
for Vaccine Safety Evaluation under para-
graph (3); and 
‘‘(ii) in accordance with a research 
protocol referred to the advisory council by 
the manufacturer or by the Agency, rec-
ommended by the advisory council under 
section 2145(b)(3), and approved by the 
Director for Vaccine Safety Evaluation. 
‘‘(B) The data and analysis of post-
marketing surveillance and clinical testing 
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