sion of protocols for review under section 
505(b)(5)(B); 
‘‘(E) feedback from the Secretary regard-
ing any gaps in scientific knowledge that will 
need resolution prior to approval, licensure, or 
clearance of the eligible countermeasure and 
plans for conducting the necessary scientific re-
search; 
‘‘(F) identification of the population for 
which the countermeasure sponsor or applicant 
seeks approval, licensure, or clearance and the 
population for which desired labeling would not 
be appropriate, if known; and 
‘‘(G) as necessary and appropriate, and to 
the extent practicable, a plan for demonstrating 
safety and effectiveness in pediatric popu-
lations, and for developing pediatric dosing, for-
mulation, and administration with respect to 
the eligible countermeasure, provided that such 
plan would not delay authorization under sec-
tion 564, approval, licensure, or clearance for 
adults. 
‘‘(6) PRIORITIZATION.— 
‘‘(A) PLANS
FOR
SECURITY
COUNTER-
MEASURES.—The Secretary shall establish reg-
ulatory management plans for all security coun-
termeasures for which a request is submitted 
under paragraph (3)(A). 
‘‘(B) PLANS FOR OTHER ELIGIBLE COUN-
TERMEASURES.—The Secretary shall determine 
whether resources are available to establish reg-
ulatory management plans for eligible counter-
measures 
that 
are 
not 
security 
counter-
measures. If resources are available to establish 
regulatory management plans for eligible coun-
termeasures that are not security counter-
measures, and if resources are not available to 
establish regulatory management plans for all 
eligible countermeasures for which requests 
have been submitted, the Director of the Bio-
medical Advanced Research and Development 
Authority, in consultation with the Commis-
sioner, shall prioritize which eligible counter-
measures may receive regulatory management 
plans.’’. 
SEC. 306. REPORT. 
Section 565 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–4), as amended by section 305, 
is further amended by adding at the end the following:
‘‘(g) ANNUAL REPORT.—Not later than 180 days 
after the date of enactment of this subsection, and annu-
ally thereafter, the Secretary shall make publicly available 
on the Web site of the Food and Drug Administration a 
report that details the countermeasure development and 
review activities of the Food and Drug Administration, in-
cluding— 
‘‘(1) with respect to the development of new 
tools, standards, and approaches to assess and 
evaluate countermeasures— 
‘‘(A) the identification of the priorities of 
the Food and Drug Administration and the 
progress made on such priorities; and 
‘‘(B) the identification of scientific gaps 
that impede the development, approval, licen-
sure, or clearance of countermeasures for popu-
lations with special clinical needs, including 
children and pregnant women, and the progress 
made on resolving these challenges; 
‘‘(2) with respect to countermeasures for which 
a regulatory management plan has been agreed upon 
under subsection (f), the extent to which the per-
formance targets and goals set forth in subsection 
(f)(4)(B) and the regulatory management plan have 
been met, including, for each such countermeasure—
‘‘(A) whether the regulatory management 
plan was completed within the required time-
frame, and the length of time taken to complete 
such plan; 
‘‘(B) whether the Secretary adhered to the 
timely and appropriate response times set forth 
in such plan; and 
‘‘(C) explanations for any failure to meet 
such performance targets and goals; 
‘‘(3) the number of regulatory teams estab-
lished pursuant to subsection (b)(4), the number of 
products, classes of products, or technologies as-
signed to each such team, and the number of, type 
of, and any progress made as a result of consulta-
tions carried out under subsection (b)(4)(A); 
‘‘(4) an estimate of resources obligated to coun-
termeasure development and regulatory assessment, 
including— 
‘‘(A) Center-specific objectives and accom-
plishments; and 
‘‘(B) the number of full-time equivalent 
employees of the Food and Drug Administra-
tion who directly support the review of counter-
measures;
‘‘(5) the number of countermeasure applications 
and submissions submitted, the number of counter-
measures approved, licensed, or cleared, the status 
of remaining submitted applications and submis-
sions, and the number of each type of authorization 
issued pursuant to section 564; 
‘‘(6) the number of written requests for a regu-
latory management plan submitted under subsection 
(f)(3)(A), the number of regulatory management 
plans developed, and the number of such plans de-
veloped for security countermeasures; and 
‘‘(7) the number, type, and frequency of meet-
ings between the Food and Drug Administration 
and— 
‘‘(A) sponsors of a countermeasure as de-
fined in subsection (a); or 
‘‘(B) another agency engaged in develop-
ment or management of portfolios for such 
countermeasures, including the Centers for Dis-
ease Control and Prevention, the Biomedical 
Advanced Research and Development Authority, 
the National Institutes of Health, and the ap-
propriate agencies of the Department of De-
fense.’’.
SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 
(a) PEDIATRIC STUDIES OF DRUGS.—Section 505A 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended— 
(1) in subsection (d), by adding at the end the 
following: 
‘‘(5) CONSULTATION.—With respect to a drug 
that is a qualified countermeasure (as defined in sec-
tion 319F–1 of the Public Health Service Act), a se-
curity countermeasure (as defined in section 319F– 
2 of the Public Health Service Act), or a qualified 
pandemic or epidemic product (as defined in section 
319F–3 of the Public Health Service Act), the Sec-
retary shall solicit input from the Assistant Sec-
retary for Preparedness and Response regarding the 
need for and, from the Director of the Biomedical 
Advanced Research and Development Authority re-
garding the conduct of, pediatric studies under this 
section.’’; and 
(2) in subsection (n)(1), by adding at the end 
the following: 
‘‘(C) For a drug that is a qualified coun-
termeasure (as defined in section 319F–1 of the 
Public Health Service Act), a security counter-
measure (as defined in section 319F–2 of the 
Public Health Service Act), or a qualified pan-