Sec. 1. Short title; table of contents. 
Sec. 2. Permanent extension of Best Pharmaceuticals for Children Act and Pe-
diatric Research Equity Act. 
Sec. 3. Government Accountability Office report. 
Sec. 4. Internal Committee for Review of Pediatric Plans, Assessments, Defer-
rals, Deferral Extensions, and Waivers. 
Sec. 5. Staff of Office of Pediatric Therapeutics. 
Sec. 6. Continuation of operation of Pediatric Advisory Committee. 
Sec. 7. Pediatric Subcommittee of the Oncologic Drugs Advisory Committee. 
SEC. 
2. 
PERMANENT 
EXTENSION 
OF 
BEST 
PHARMA-
CEUTICALS FOR CHILDREN ACT AND PEDI-
ATRIC RESEARCH EQUITY ACT. 
(a) PROGRAM FOR PEDIATRIC STUDY OF DRUGS IN 
PHSA.—Section 409I(e)(1)(B) of the Public Health Serv-
ice Act (42 U.S.C. 284m(e)(1)(B)) is amended by striking 
‘‘of the four succeeding fiscal years’’ and inserting ‘‘suc-
ceeding fiscal year’’. 
(b) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 
Section 505A of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355a) is amended— 
(1) in subsection (d)(1)(A), by adding at the 
end the following: ‘‘If a request under this subpara-
graph does not request studies in neonates, such re-
quest shall include a statement describing the ra-
tionale for not requesting studies in neonates.’’; 
(2) by amending subsection (h) to read as fol-
lows: 
‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE-
QUIREMENTS.—Exclusivity under this section shall only be 
granted for the completion of a study or studies that are 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
the subject of a written request and for which reports are 
submitted and accepted in accordance with subsection 
(d)(3). Written requests under this section may consist of 
a study or studies required under section 505B.’’; 
(3) in subsection (k)(2), by striking ‘‘subsection 
(f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 
(4) in subsection (l)— 
(A) in paragraph (1)— 
(i) in the paragraph heading, by strik-
ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 
MONTH PERIOD’’; and 
(ii) by striking ‘‘one-year’’ and insert-
ing ‘‘18-month’’; 
(B) in paragraph (2)— 
(i) in the paragraph heading, by strik-
ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; 
and 
(ii) by striking ‘‘one-year period’’ and 
inserting ‘‘18-month period’’; 
(C) by redesignating paragraph (3) as 
paragraph (4); and 
(D) by inserting after paragraph (2) the 
following: 
‘‘(3) PRESERVATION OF AUTHORITY.—Nothing 
in this subsection shall prohibit the Office of Pedi-
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
atric Therapeutics from providing for the review of 
adverse event reports by the Pediatric Advisory 
Committee prior to the 18-month period referred to 
in paragraph (1), if such review is necessary to en-
sure safe use of a drug in a pediatric population.’’; 
(5) in subsection (n)— 
(A) in the subsection heading, by striking 
‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 
and 
(B) in paragraph (1)— 
(i) in the text preceding subparagraph 
(A), by striking ‘‘have not been completed’’ 
and inserting ‘‘have not been submitted by 
the date specified in the written request 
issued and agreed upon’’; and 
(ii) by revising subparagraphs (A) and 
(B) to read as follows: 
‘‘(A) For a drug for which there remains 
any listed patent or exclusivity protection, make 
a determination regarding whether an assess-
ment shall be required to be submitted under 
section 505B(b). 
‘‘(B) For a drug that has no remaining 
listed patents or exclusivity protection, the Sec-
retary shall refer the drug for inclusion on the 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
list established under section 409I of the Public 
Health Service Act for the conduct of studies.’’; 
(6) in subsection (o)(2), by amending subpara-
graph (B) to read as follows: 
‘‘(B) a statement of any appropriate pedi-
atric contraindications, warnings, precautions, 
or other information that the Secretary con-
siders necessary to assure safe use.’’; and 
(7) by striking subsection (q) (relating to a sun-
set). 
(c) RESEARCH INTO PEDIATRIC USES FOR DRUGS 
AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), in the matter before 
subparagraph (A), by inserting ‘‘for a drug’’ 
after ‘‘(or supplement to an application)’’; 
(B) in paragraph (3)— 
(i) by redesignating subparagraph (B) 
as subparagraph (D); and 
(ii) by inserting after subparagraph 
(A) the following: 
‘‘(B) DEFERRAL EXTENSION.—On the ini-
tiative of the Secretary or at the request of the 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
applicant, the Secretary may grant an extension 
of a deferral under subparagraph (A) if— 
‘‘(i) the Secretary finds that the cri-
teria specified in subclause (II) or (III) of 
subparagraph (A)(i) continue to be met; 
and 
‘‘(ii) the applicant submits the mate-
rials required under subparagraph (A)(ii). 
‘‘(C) CONSIDERATION DURING DEFERRAL 
PERIOD.—If the Secretary has under this para-
graph deferred the date by which an assessment 
must be submitted, then until the date specified 
in the deferral under subparagraph (A) (includ-
ing any extension of such date under subpara-
graph (B))— 
‘‘(i) the assessment shall not be con-
sidered late or delayed; 
‘‘(ii) the Secretary shall not classify 
the assessment as late or delayed in any 
report, database, or public posting.’’; and 
(iii) in subparagraph (D), as redesig-
nated, by amending clause (ii) to read as 
follows: 
‘‘(ii) 
PUBLIC
AVAILABILITY.—Not 
later than 60 days after the submission to 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
the Secretary of the information submitted 
through the annual review under clause (i), 
the Secretary shall make available to the 
public in an easily accessible manner, in-
cluding through the Web site of the Food 
and Drug Administration— 
‘‘(I) such information; 
‘‘(II) the name of the applicant 
for the product subject to the assess-
ment; 
‘‘(III) the date on which the 
product was approved; and 
‘‘(IV) the date of each deferral or 
deferral extension under this para-
graph for the product.’’; and 
(C) in paragraph (4)(C)— 
(i) in the first sentence, by inserting 
‘‘partial’’ before ‘‘waiver is granted’’; and 
(ii) in the second sentence, by striking 
‘‘either a full or partial waiver’’ and insert-
ing ‘‘a partial waiver’’; 
(2) in subsection (b)(1), by striking ‘‘After pro-
viding notice in the form of a letter (that, for a drug 
approved under section 505, references a declined 
written request under section 505A for a labeled in-
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
dication which written request is not referred under 
section 505A(n)(1)(A) to the Foundation of the Na-
tional Institutes of Health for the pediatric studies), 
the Secretary’’ and inserting ‘‘The Secretary’’; 
(3) by amending subsection (d) to read as fol-
lows: 
‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a per-
son fails to submit a required assessment described in sub-
section (a)(2), fails to meet the applicable requirements 
in subsection (a)(3), or fails to submit a request for ap-
proval of a pediatric formulation described in subsection 
(a) or (b), in accordance with applicable provisions of sub-
sections (a) and (b)— 
‘‘(1)(A) the Secretary shall issue a letter to 
such person informing such person of such failure; 
‘‘(B) not later than 30 calendar days after the 
issuance of a letter under subparagraph (A), the 
person who receives such letter shall submit to the 
Secretary a written response to such letter; and 
‘‘(C) not later than 45 calendar days after the 
issuance of a letter under subparagraph (A), the 
Secretary shall make such letter, and any response 
to such letter under subparagraph (B), available to 
the public on the Web site of the Food and Drug 
Administration, with appropriate redactions made to 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
protect trade secrets and confidential commercial in-
formation, except that, if the Secretary determines 
that the letter under subparagraph (A) was issued 
in error, the requirements of this subparagraph shall 
not apply with respect to such letter; and 
‘‘(2)(A) the drug or biological product that is 
the subject of the required assessment, applicable re-
quirements in subsection (a)(3), or required request 
for approval of a pediatric formulation may be con-
sidered 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 
‘‘(B) the failure to submit the required assess-
ment, meet the applicable requirements in subsection 
(a)(3), or submit the required request for approval 
of a pediatric formulation shall not be the basis for 
a proceeding— 
‘‘(i) to withdraw approval for a drug under 
section 505(e); or 
‘‘(ii) to revoke the license for a biological 
product under section 351 of the Public Health 
Service Act.’’; 
(4) by amending subsection (e) to read as fol-
lows: 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
‘‘(e) INITIAL PEDIATRIC PLAN.— 
‘‘(1) IN GENERAL.— 
‘‘(A) SUBMISSION.—An applicant who is 
required to submit an assessment under sub-
section (a)(1) shall submit an initial pediatric 
plan. 
‘‘(B) TIMING.—An applicant shall submit 
the initial pediatric plan under paragraph (1)— 
‘‘(i) before the date on which the ap-
plicant submits the assessments under sub-
section (a)(2); and 
‘‘(ii) not later than— 
‘‘(I) 60 calendar days after the 
date of end-of-Phase 2 meeting (as 
such term is used in section 312.47 of 
title 21, Code of Federal Regulations, 
or successor regulations); or 
‘‘(II) such other time as may be 
agreed upon between the Secretary 
and the applicant. 
Nothing in this section shall preclude the Sec-
retary from accepting the submission of an ini-
tial pediatric plan earlier than the date other-
wise applicable under this subparagraph. 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
‘‘(C) CONTENTS.—The initial pediatric 
plan shall include— 
‘‘(i) an outline of the pediatric studies 
that the applicant plans to conduct; 
‘‘(ii) any request for a deferral, partial 
waiver, or waiver under this section, along 
with supporting information; and 
‘‘(iii) other information the Secretary 
determines necessary, including any infor-
mation specified in regulations under para-
graph (5). 
‘‘(2) MEETING.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), not later than 60 calendar days 
after receiving an initial pediatric plan under 
paragraph (1), the Secretary shall meet with 
the applicant to discuss the plan. 
‘‘(B) WRITTEN
RESPONSE.—If the Sec-
retary determines that a written response to the 
initial pediatric plan is sufficient to commu-
nicate comments on the initial pediatric plan, 
and that no meeting is necessary the Secretary 
shall, not later than 60 days after receiving an 
initial pediatric plan under paragraph (1)— 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
‘‘(i) notify the applicant of such deter-
mination; and 
‘‘(ii) provide to the applicant the Sec-
retary’s written comments on the plan. 
‘‘(3) AGREED PEDIATRIC PLAN.— 
‘‘(A) SUBMISSION.—The applicant shall 
submit to the Secretary a document reflecting 
the agreement between the Secretary and the 
applicant on the initial pediatric plan (referred 
to in this subsection as an ‘agreed pediatric 
plan’). 
‘‘(B) CONFIRMATION.—Not later than 30 
days after receiving the agreed pediatric plan 
under subparagraph (A), the Secretary shall 
provide written confirmation to the applicant 
that such plan reflects the agreement of the 
Secretary. 
‘‘(C) DEFERRAL
AND
WAIVER.—If the 
agreed pediatric plan contains a request from 
the applicant for a deferral, partial waiver, or 
waiver under this section, the written confirma-
tion under subparagraph (B) shall include a 
recommendation from the Secretary as to 
whether such request meets the standards 
under paragraphs (3) or (4) of subsection (a). 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
‘‘(D) AMENDMENTS
TO
THE
PLAN.—At 
the initiative of the Secretary or the applicant, 
the agreed pediatric plan may be amended at 
any time. The requirements of paragraph (2) 
shall apply to any such proposed amendment in 
the same manner and to the same extent as 
such requirements apply to an initial pediatric 
plan under paragraph (1). The requirements of 
subparagraphs (A) through (C) of this para-
graph shall apply to any agreement resulting 
from such proposed amendment in the same 
manner and to the same extent as such require-
ments apply to an agreed pediatric plan. 
‘‘(4) INTERNAL
COMMITTEE.—The Secretary 
shall consult the internal committee under section 
505C on the review of the initial pediatric plan, 
agreed pediatric plan, and any amendments to such 
plans. 
‘‘(5) MANDATORY
RULEMAKING.—Not later 
than one year after the date of enactment of the 
BPCA and PREA Reauthorization Act of 2012, the 
Secretary shall promulgate proposed regulations and 
guidance to implement the provisions of this sub-
section. 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
‘‘(6) EFFECTIVE DATE.—The provisions of this 
subsection shall take effect 180 calendar days after 
the date of enactment of the BPCA and PREA Re-
authorization Act of 2012, irrespective of whether 
the Secretary has promulgated final regulations to 
carry out this subsection by such date.’’; 
(5) in subsection (f)— 
(A) in the subsection heading, by inserting 
‘‘DEFERRAL
EXTENSIONS,’’ after ‘‘DEFER-
RALS,’’; 
(B) in paragraph (4)— 
(i) in the paragraph heading, by in-
serting ‘‘DEFERRAL
EXTENSIONS,’’ after 
‘‘DEFERRALS,’’; and 
(ii) in the second sentence, by insert-
ing ‘‘, deferral extensions,’’ after ‘‘defer-
rals’’; and 
(C) in paragraph (6)(D)— 
(i) by inserting ‘‘and deferral exten-
sions’’ before ‘‘requested and granted’’; 
and 
(ii) by inserting ‘‘and deferral exten-
sions’’ after ‘‘the reasons for such defer-
rals’’; 
(6) in subsection (g)— 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
(A) in paragraph (1)(A), by striking ‘‘after 
the date of the submission of the application or 
supplement’’ and inserting ‘‘after the date of 
the submission of an application or supplement 
that receives a priority review or 330 days after 
the date of the submission of an application or 
supplement that receives a standard review’’; 
and 
(B) in paragraph (2), by striking ‘‘the 
label of such product’’ and inserting ‘‘the label-
ing of such product’’; 
(7) in subsection (h)(1)— 
(A) by inserting ‘‘an application (or sup-
plement to an application) that contains’’ after 
‘‘date of submission of’’; and 
(B) by inserting ‘‘if the application (or 
supplement) receives a priority review, or not 
later than 300 days after the date of submis-
sion of an application (or supplement to an ap-
plication) that contains a pediatric assessment 
under this section, if the application (or supple-
ment) receives a standard review,’’ after ‘‘under 
this section,’’; 
(8) in subsection (i)— 
(A) in paragraph (1)— 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
(i) in the paragraph heading, by strik-
ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 
MONTH PERIOD’’; and 
(ii) by striking ‘‘one-year’’ and insert-
ing ‘‘18-month’’; 
(B) in paragraph (2)— 
(i) in the paragraph heading, by strik-
ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; 
and 
(ii) by striking ‘‘one-year period’’ and 
inserting ‘‘18-month period’’; 
(C) by redesignating paragraph (3) as 
paragraph (4); and 
(D) by inserting after paragraph (2) the 
following: 
‘‘(3) PRESERVATION OF AUTHORITY.—Nothing 
in this subsection shall prohibit the Office of Pedi-
atric Therapeutics from providing for the review of 
adverse event reports by the Pediatric Advisory 
Committee prior to the 18-month period referred to 
in paragraph (1), if such review is necessary to en-
sure safe use of a drug in a pediatric population.’’; 
(9) by striking subsection (m) (relating to inte-
gration with other pediatric studies); and 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
(10) by redesignating subsection (n) as sub-
section (m). 
(d) PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS 
IN PHSA.—Section 351(m)(1) of the Public Health Serv-
ice Act (42 U.S.C. 262(m)(1)) is amended by striking ‘‘(f), 
(i), (j), (k), (l), (p), and (q)’’ and inserting ‘‘(f), (h), (i), 
(j), (k), (l), and (p)’’. 
(e) APPLICATION; TRANSITION RULE.— 
(1) APPLICATION.—Notwithstanding any provi-
sion of section 505A and 505B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) 
stating that a provision applies beginning on the 
date of the enactment of the Best Pharmaceuticals 
for Children Act of 2007 or the date of the enact-
ment of the Pediatric Research Equity Act of 2007, 
any amendment made by this Act to such a provi-
sion applies beginning on the date of the enactment 
of this Act. 
(2) TRANSITIONAL RULE FOR ADVERSE EVENT 
REPORTING.—With respect to a drug for which a la-
beling change described under section 505A(l)(1) or 
505B(i)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved 
or made, respectively, during the one-year period 
that ends on the day before the date of enactment 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
of this Act, the Secretary shall apply section 505A(l) 
and section 505B(i), as applicable, to such drug, as 
such sections were in effect on such day. 
(f) 
CONFORMING
AMENDMENT.—Section 
499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
290b(c)(1)(C)) is amended by striking ‘‘for which the Sec-
retary issues a certification in the affirmative under sec-
tion 505A(n)(1)(A) of the Federal Food, Drug, and Cos-
metic Act’’. 
SEC. 3. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. 
(a) IN GENERAL.—Not later than January 1, 2016, 
and the end of each subsequent 5-year period, the Comp-
troller General of the United States, in consultation with 
the Secretary of Health and Human Services, shall submit 
to the Congress a report that evaluates the effectiveness 
of sections 505A and 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a, 355c) and section 
409I of the Public Health Service Act (42 U.S.C. 284m) 
in ensuring that medicines used by children are tested in 
pediatric populations and properly labeled for use in chil-
dren. 
(b) CONTENTS.—The report under subsection (a) 
shall include— 
(1) the number and importance of drugs and 
biological products for children that are being tested 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
as a result of the programs established under sec-
tions 505A and 505B of the Federal Food, Drug, 
and Cosmetic Act and section 409I of the Public 
Health Service Act; 
(2) a description of the importance for children, 
health care providers, parents, and others of labeling 
changes made as a result of such testing; 
(3) the number and importance of drugs and 
biological products for children that are not being 
tested for their use in pediatric populations, notwith-
standing the existence of such programs; 
(4) the possible reasons for the lack of testing 
reported under paragraph (3); 
(5) the number of drugs and biological products 
for which testing is being done and labeling changes 
are required under the programs established by this 
Act, including— 
(A) the date labeling changes are made; 
(B) which labeling changes required the 
use of the dispute resolution process; and 
(C) for labeling changes that required such 
dispute resolution process, a description of— 
(i) the disputes; 
(ii) the recommendations of the Pedi-
atric Advisory Committee; and 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
(iii) the outcomes of such process; 
(6) any recommendations for modifications to 
the programs established under sections 505A and 
505B of the Federal Food, Drug, and Cosmetic Act 
and section 409I of the Public Health Service Act 
that the Secretary determines to be appropriate, in-
cluding a detailed rationale for each recommenda-
tion; 
(7)(A) the efforts made by the Secretary to in-
crease the number of studies conducted in the 
neonate population (including efforts made to en-
courage the conduct of appropriate studies in neo-
nates by companies with products that have suffi-
cient safety and other information to make the con-
duct of the studies ethical and safe); and 
(B) the results of such efforts; and 
(8)(A) the number and importance of drugs and 
biological products for children with cancer that are 
being tested as a result of the programs established 
under sections 505A and 505B of the Federal Food, 
Drug, and Cosmetic Act and section 409I of the 
Public Health Service Act; and 
(B) any recommendations for modifications to 
the programs under such sections that would lead to 
new and better therapies for children with cancer, 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
including a detailed rationale for each recommenda-
tion. 
SEC. 4. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC 
PLANS, ASSESSMENTS, DEFERRALS, DEFER-
RAL EXTENSIONS, AND WAIVERS. 
Section 505C of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355d) is amended— 
(1) in the section heading, by inserting ‘‘DE-
FERRAL
EXTENSIONS,’’ after ‘‘DEFERRALS,’’; 
and 
(2) by inserting ‘‘neonatology’’ after ‘‘pediatric 
ethics’’. 
SEC. 5. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS. 
Section 6(c) of the Best Pharmaceuticals for Children 
Act (21 U.S.C. 393a(c)) is amended— 
(1) in paragraph (1), by striking ‘‘and’’ at the 
end; 
(2) by redesignating paragraph (2) as para-
graph (4); 
(3) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) one or more additional individuals with ex-
pertise in neonatology; 
‘‘(3) one or more additional individuals with ex-
pertise in pediatric epidemiology; and’’. 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS
SEC. 6. CONTINUATION OF OPERATION OF PEDIATRIC AD-
VISORY COMMITTEE. 
Section 14(d) of the Best Pharmaceuticals for Chil-
dren Act (42 U.S.C. 284m note) is amended by striking 
‘‘during the five-year period beginning on the date of the 
enactment of the Best Pharmaceuticals for Children Act 
of 2007’’ and inserting ‘‘to carry out the advisory commit-
tee’s responsibilities under sections 505A, 505B, and 
520(m) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a, 355c, and 360j(m))’’. 
SEC. 7. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC 
DRUGS ADVISORY COMMITTEE. 
Section 15(a) of the Best Pharmaceuticals for Chil-
dren Act (Public Law 107–109), as amended by section 
502(e) of the Food and Drug Administration Amendments 
Act of 2007 (Public Law 110–85), is amended— 
(1) in paragraph (1)(D), by striking ‘‘section 
505B(f)’’ and inserting ‘‘section 505C’’; and 
(2) in paragraph (3), by striking ‘‘during the 
five-year period beginning on the date of the enact-
ment of the Best Pharmaceuticals for Children Act 
of 2007’’ and inserting ‘‘to carry out the Sub-
committee’s responsibilities under this section’’. 
Æ 
VerDate Mar 15 2010 
22:39 Apr 04, 2012
Jkt 099200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6301
E:\BILLS\H4274.IH
H4274
sroberts on DSK5SPTVN1PROD with BILLS