‘‘(aa) the recipient of the written 
request does not agree to the request; 
or 
‘‘(bb) the Secretary does not re-
ceive a response as specified under 
section 505A(d)(4)(A); or 
‘‘(II) if the request was made under 
section 409I of the Public Health Service 
Act (42 U.S.C. 284m)—
‘‘(aa) the recipient of the written 
request does not agree to the request; 
or 
‘‘(bb) the Secretary does not re-
ceive a response as specified under 
section 409I(c)(2) of that Act; and 
‘‘(iii)(I) the Secretary certifies under 
subparagraph (B) that there are insuffi-
cient funds under sections 409I and 499 of 
the Public Health Service Act (42 U.S.C. 
284m, 290b) to conduct the study; or 
‘‘(II) the Secretary publishes in the 
Federal Register a certification that cer-
tifies that—
‘‘(aa) no contract or grant has 
been awarded under section 409I or
499 of the Public Health Service Act 
(42 U.S.C. 284m, 290b); and 
‘‘(bb) not less than 270 days 
have passed since the date of a certifi-
cation under subparagraph (B) that 
there are sufficient funds to conduct 
the study. 
‘‘(B) NO AGREEMENT TO REQUEST.—Not 
later than 60 days after determining that no 
holder will agree to the written request (includ-
ing a determination that the Secretary has not 
received a response specified under section 
505A(d) of this Act or section 409I of the Pub-
lic Health Service Act (42 U.S.C. 284m), the 
Secretary shall certify whether the Secretary 
has sufficient funds to conduct the study under 
section 409I or 499 of the Public Health Serv-
ice Act (42 U.S.C. 284m, 290b), taking into ac-
count the prioritization under section 409I. 
‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For 
the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) 
of 
subsection 
(a) 
and 
paragraphs 
(1)(B)(i) 
and 
(2)(B)(iii)(I)(aa) of subsection (b), a drug or biological 
product shall be considered to represent a meaningful
therapeutic benefit over existing therapies if the Secretary 
estimates that—
‘‘(1) if approved, the drug or biological product 
would represent a significant improvement in the 
treatment, diagnosis, or prevention of a disease, 
compared with marketed products adequately labeled 
for that use in the relevant pediatric population; or 
‘‘(2) the drug or biological product is in a class 
of products or for an indication for which there is 
a need for additional options. 
‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person 
fails to submit an assessment described in subsection 
(a)(2), or a request for approval of a pediatric formulation 
described in subsection (a) or (b), in accordance with ap-
plicable provisions of subsections (a) and (b)—
‘‘(1) the drug or biological product that is the 
subject of the assessment or request may be consid-
ered misbranded solely because of that failure and 
subject to relevant enforcement action (except that 
the drug or biological product shall not be subject to 
action under section 303); but 
‘‘(2) the failure to submit the assessment or re-
quest shall not be the basis for a proceeding—
‘‘(A) to withdraw approval for a drug 
under section 505(e); or
‘‘(B) to revoke the license for a biological 
product under section 351 of the Public Health 
Service Act (42 U.S.C. 262). 
‘‘(e) MEETINGS.—Before and during the investiga-
tional process for a new drug or biological product, the 
Secretary shall meet at appropriate times with the sponsor 
of the new drug or biological product to discuss—
‘‘(1) information that the sponsor submits on 
plans and timelines for pediatric studies; or 
‘‘(2) any planned request by the sponsor for 
waiver or deferral of pediatric studies.
‘‘(f) SCOPE OF AUTHORITY.—Nothing in this section 
provides to the Secretary any authority to require a pedi-
atric assessment of any drug or biological product, or any 
assessment regarding other populations or uses of a drug 
or biological product, other than the pediatric assessments 
described in this section. 
‘‘(g) ORPHAN DRUGS.—Unless the Secretary requires 
otherwise by regulation, this section does not apply to any 
drug for an indication for which orphan designation has 
been granted under section 526. 
‘‘(h) INTEGRATION WITH OTHER PEDIATRIC STUD-
IES.—The authority under this section shall remain in ef-
fect so long as an application subject to this section may
be accepted for filing by the Secretary on or before the 
date specified in section 505A(n).’’.
(b) CONFORMING AMENDMENTS.—
(1) Section 505(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) is 
amended in the second sentence—
(A) by striking ‘‘and (F)’’ and inserting 
‘‘(F)’’; and 
(B) by striking the period at the end and 
inserting ‘‘, and (G) any assessments required 
under section 505B.’’.
(2) Section 505A(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a(h)) is amended—
(A) in the subsection heading, by striking 
‘‘REGULATIONS’’ and inserting ‘‘PEDIATRIC RE-
SEARCH REQUIREMENTS’’; and 
(B) by striking ‘‘pursuant to regulations 
promulgated by the Secretary’’ and inserting 
‘‘by a provision of law (including a regulation) 
other than this section’’. 
(3) Section 351(a)(2) of the Public Health 
Service Act (42 U.S.C. 262(a)(2)) is amended—
(A) by redesignating subparagraph (B) as 
subparagraph (C); and
(B) by inserting after subparagraph (A) 
the following: 
‘‘(B) PEDIATRIC STUDIES.—A person that 
submits an application for a license under this 
paragraph shall submit to the Secretary as part 
of the application any assessments required 
under section 505B of the Federal Food, Drug, 
and Cosmetic Act.’’. 
SEC. 3. TECHNICAL AND CONFORMING AMENDMENTS. 
(a) ABBREVIATED NEW DRUG APPLICATION.—Sec-
tion 505A of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355a) is amended in subparagraphs (A) and 
(B) of subsection (b)(2) and subparagraphs (A) and (B) 
of subsection (c)(2) by striking ‘‘505(j)(4)(B)’’ and insert-
ing ‘‘505(j)(5)(B)’’. 
(b) PEDIATRIC ADVISORY COMMITTEE.—
(1) Section 505A(i)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a(i)(2)) is 
amended by striking ‘‘Advisory Subcommittee of the 
Anti-Infective Drugs’’ each place it appears. 
(2) Section 14 of the Best Pharmaceuticals for 
Children Act (42 U.S.C. 284m note; Public Law 
107–109) is amended—
(A) in the section heading, by striking 
‘‘PHARMACOLOGY’’;
(B) in subsection (a), by striking ‘‘(42 
U.S.C. 217a),’’ and inserting (42 U.S.C. 217a) 
or other appropriate authority,’’; 
(C) in subsection (b)—
(i) in paragraph (1), by striking ‘‘and 
in consultation with the Director of the 
National Institutes of Health’’; and 
(ii) in paragraph (2), by striking ‘‘and 
505A’’ and inserting ‘‘505A, and 505B’’; 
and 
(D) by striking ‘‘pharmacology’’ each place 
it appears and inserting ‘‘therapeutics’’. 
(3) Section 15(a)(2)(A) of the Best Pharma-
ceuticals for Children Act (115 Stat. 1419) is 
amended by striking ‘‘Pharmacology’’. 
(4) Section 16(1)(C) of the Best Pharma-
ceuticals for Children Act (21 U.S.C. 355a note; 
Public Law 107–109) is amended by striking ‘‘Advi-
sory Subcommittee of the Anti-Infective Drugs’’. 
(5) Section 17(b)(1) of the Best Pharma-
ceuticals for Children Act (21 U.S.C. 355b(b)(1)) is 
amended in the second sentence by striking ‘‘Advi-
sory Subcommittee of the Anti-Infective Drugs’’. 
(6) Paragraphs (8), (9), and (11) of section 
409I(c) of the Public Health Service Act (42 U.S.C.
284m(c)) are amended by striking ‘‘Advisory Sub-
committee of the Anti-Infective Drugs’’ each place it 
appears. 
SEC. 4. EFFECTIVE DATE. 
(a) IN GENERAL.—Subject to subsection (b), this Act 
and the amendments made by this Act take effect on the 
date of enactment of this Act. 
(b) APPLICABILITY TO NEW DRUGS AND BIOLOGICAL 
PRODUCTS.—
(1) IN
GENERAL.—Subsection (a) of section 
505B of the Federal Food, Drug, and Cosmetic Act 
(as added by section 2) shall apply to an application 
described in paragraph (1) of that subsection sub-
mitted to the Secretary of Health and Human Serv-
ices on or after April 1, 1999. 
(2) WAIVERS AND DEFERRALS.—
(A) WAIVER OR DEFERRAL GRANTED.—If, 
with respect to an application submitted to the 
Secretary of Health and Human Services be-
tween April 1, 1999, and the date of enactment 
of this Act, a waiver or deferral of pediatric as-
sessments was granted under regulations of the 
Secretary then in effect, the waiver or deferral 
shall be a waiver or deferral under subsection 
(a) of section 505B of the Federal Food, Drug,
and Cosmetic Act, except that any date speci-
fied in such a deferral shall be extended by the 
number of days that is equal to the number of 
days between October 17, 2002, and the date of 
enactment of this Act. 
(B) WAIVER OR DEFERRAL NOT GRANT-
ED.—If, with respect to an application sub-
mitted to the Secretary of Health and Human 
Services between April 1, 1999, and the date of 
enactment of this Act, neither a waiver nor de-
ferral of pediatric assessments was granted 
under regulations of the Secretary then in ef-
fect, the person that submitted the application 
shall be required to submit assessments under 
subsection (a)(2) of section 505B of the Fed-
eral Food, Drug, and Cosmetic Act on the date 
that is the later of—
(i) the date that is 1 year after the 
date of enactment of this Act; or 
(ii) such date as the Secretary may 
specify under subsection (a)(3) of that sec-
tion; 
unless the Secretary grants a waiver under sub-
section (a)(4) of that section.
(c) NO LIMITATION OF AUTHORITY.—Neither the 
lack of guidance or regulations to implement this Act or 
the amendments made by this Act nor the pendency of 
the process for issuing guidance or regulations shall limit 
the authority of the Secretary of Health and Human Serv-
ices under, or defer any requirement under, this Act or 
those amendments.
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