I 

112TH CONGRESS 

2D SESSION H. R. 4274 

To amend title IV of the Public Health Service Act and title V of the 

Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric 

Research Equity Act of 2003. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 28, 2012 

Mr. ROGERS of Michigan (for himself, Ms. ESHOO, and Mr. MARKEY) introduced the following bill; which was referred to the Committee on Energy 

and Commerce 

A BILL 

To amend title IV of the Public Health Service Act and 

title V of the Federal Food, Drug, and Cosmetic Act 

to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research 

Equity Act of 2003. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘BPCA and PREA Reauthorization Act of 2012’’. 

6 (b) TABLE OF CONTENTS.—The table of contents of 

7 this Act is as follows: 


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Sec. 1. Short title; table of contents. 

Sec. 2. Permanent extension of Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. 

Sec. 3. Government Accountability Office report. 

Sec. 4. Internal Committee for Review of Pediatric Plans, Assessments, Deferrals, 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. 

1 SEC. 2. PERMANENT EXTENSION OF BEST PHARMA2 CEUTICALS FOR CHILDREN ACT AND PEDI3 ATRIC RESEARCH EQUITY ACT. 

4 (a) PROGRAM FOR PEDIATRIC STUDY OF DRUGS IN

5 PHSA.—Section 409I(e)(1)(B) of the Public Health Serv6 ice Act (42 U.S.C. 284m(e)(1)(B)) is amended by striking 

7 ‘‘of the four succeeding fiscal years’’ and inserting ‘‘suc8 ceeding fiscal year’’. 

9 (b) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 

10 Section 505A of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 355a) is amended— 

12 (1) in subsection (d)(1)(A), by adding at the 

13 end the following: ‘‘If a request under this subpara14 graph does not request studies in neonates, such re15 quest shall include a statement describing the ra16 tionale for not requesting studies in neonates.’’; 

17 (2) by amending subsection (h) to read as fol18 lows: 

19 ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE20 QUIREMENTS.—Exclusivity under this section shall only be 

21 granted for the completion of a study or studies that are 


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1 the subject of a written request and for which reports are 

2 submitted and accepted in accordance with subsection 

3 (d)(3). Written requests under this section may consist of 

4 a study or studies required under section 505B.’’; 

5 (3) in subsection (k)(2), by striking ‘‘subsection 

6 (f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 

7 (4) in subsection (l)— 

8 (A) in paragraph (1)— 

9 (i) in the paragraph heading, by strik10 ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 

11 MONTH PERIOD’’; and 

12 (ii) by striking ‘‘one-year’’ and insert13 ing ‘‘18-month’’; 

14 (B) in paragraph (2)— 

15 (i) in the paragraph heading, by strik16 ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; 

17 and 

18 (ii) by striking ‘‘one-year period’’ and 

19 inserting ‘‘18-month period’’; 

20 (C) by redesignating paragraph (3) as 

21 paragraph (4); and 

22 (D) by inserting after paragraph (2) the 

23 following: 

24 ‘‘(3) PRESERVATION OF AUTHORITY.—Nothing 

25 in this subsection shall prohibit the Office of PediVerDate Mar 15 2010 22:39 Apr 04, 2012 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4274.IH H4274

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1 atric Therapeutics from providing for the review of 

2 adverse event reports by the Pediatric Advisory 

3 Committee prior to the 18-month period referred to 

4 in paragraph (1), if such review is necessary to en5 sure safe use of a drug in a pediatric population.’’; 

6 (5) in subsection (n)— 

7 (A) in the subsection heading, by striking 

8 ‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 

9 and 

10 (B) in paragraph (1)— 

11 (i) in the text preceding subparagraph 

12 (A), by striking ‘‘have not been completed’’ 

13 and inserting ‘‘have not been submitted by 

14 the date specified in the written request 

15 issued and agreed upon’’; and 

16 (ii) by revising subparagraphs (A) and 

17 (B) to read as follows: 

18 ‘‘(A) For a drug for which there remains 

19 any listed patent or exclusivity protection, make 

20 a determination regarding whether an assess21 ment shall be required to be submitted under 

22 section 505B(b). 

23 ‘‘(B) For a drug that has no remaining 

24 listed patents or exclusivity protection, the Sec25 retary shall refer the drug for inclusion on the 


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1 list established under section 409I of the Public 

2 Health Service Act for the conduct of studies.’’; 

3 (6) in subsection (o)(2), by amending subpara4 graph (B) to read as follows: 

5 ‘‘(B) a statement of any appropriate pedi6 atric contraindications, warnings, precautions, 

7 or other information that the Secretary con8 siders necessary to assure safe use.’’; and 

9 (7) by striking subsection (q) (relating to a sun10 set). 

11 (c) RESEARCH INTO PEDIATRIC USES FOR DRUGS

12 AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B 

13 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 355c) is amended— 

15 (1) in subsection (a)— 

16 (A) in paragraph (1), in the matter before 

17 subparagraph (A), by inserting ‘‘for a drug’’ 

18 after ‘‘(or supplement to an application)’’; 

19 (B) in paragraph (3)— 

20 (i) by redesignating subparagraph (B) 

21 as subparagraph (D); and 

22 (ii) by inserting after subparagraph 

23 (A) the following: 

24 ‘‘(B) DEFERRAL EXTENSION.—On the ini25 tiative of the Secretary or at the request of the 


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1 applicant, the Secretary may grant an extension 

2 of a deferral under subparagraph (A) if— 

3 ‘‘(i) the Secretary finds that the cri4 teria specified in subclause (II) or (III) of 

5 subparagraph (A)(i) continue to be met; 

6 and 

7 ‘‘(ii) the applicant submits the mate8 rials required under subparagraph (A)(ii). 

9 ‘‘(C) CONSIDERATION DURING DEFERRAL

10 PERIOD.—If the Secretary has under this para11 graph deferred the date by which an assessment 

12 must be submitted, then until the date specified 

13 in the deferral under subparagraph (A) (includ14 ing any extension of such date under subpara15 graph (B))— 

16 ‘‘(i) the assessment shall not be con17 sidered late or delayed; 

18 ‘‘(ii) the Secretary shall not classify 

19 the assessment as late or delayed in any 

20 report, database, or public posting.’’; and 

21 (iii) in subparagraph (D), as redesig22 nated, by amending clause (ii) to read as 

23 follows: 

24 ‘‘(ii) PUBLIC AVAILABILITY.—Not 

25 later than 60 days after the submission to 


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1 the Secretary of the information submitted 

2 through the annual review under clause (i), 

3 the Secretary shall make available to the 

4 public in an easily accessible manner, in5 cluding through the Web site of the Food 

6 and Drug Administration— 

7 ‘‘(I) such information; 

8 ‘‘(II) the name of the applicant 

9 for the product subject to the assess10 ment; 

11 ‘‘(III) the date on which the 

12 product was approved; and 

13 ‘‘(IV) the date of each deferral or 

14 deferral extension under this para15 graph for the product.’’; and 

16 (C) in paragraph (4)(C)— 

17 (i) in the first sentence, by inserting 

18 ‘‘partial’’ before ‘‘waiver is granted’’; and 

19 (ii) in the second sentence, by striking 

20 ‘‘either a full or partial waiver’’ and insert21 ing ‘‘a partial waiver’’; 

22 (2) in subsection (b)(1), by striking ‘‘After pro23 viding notice in the form of a letter (that, for a drug 

24 approved under section 505, references a declined 

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1 dication which written request is not referred under 

2 section 505A(n)(1)(A) to the Foundation of the Na3 tional Institutes of Health for the pediatric studies), 

4 the Secretary’’ and inserting ‘‘The Secretary’’; 

5 (3) by amending subsection (d) to read as fol6 lows: 

7 ‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a per8 son fails to submit a required assessment described in sub9 section (a)(2), fails to meet the applicable requirements 

10 in subsection (a)(3), or fails to submit a request for ap11 proval of a pediatric formulation described in subsection 

12 (a) or (b), in accordance with applicable provisions of sub13 sections (a) and (b)— 

14 ‘‘(1)(A) the Secretary shall issue a letter to 

15 such person informing such person of such failure; 

16 ‘‘(B) not later than 30 calendar days after the 

17 issuance of a letter under subparagraph (A), the 

18 person who receives such letter shall submit to the 

19 Secretary a written response to such letter; and 

20 ‘‘(C) not later than 45 calendar days after the 

21 issuance of a letter under subparagraph (A), the 

22 Secretary shall make such letter, and any response 

23 to such letter under subparagraph (B), available to 

24 the public on the Web site of the Food and Drug 

25 Administration, with appropriate redactions made to 


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1 protect trade secrets and confidential commercial in2 formation, except that, if the Secretary determines 

3 that the letter under subparagraph (A) was issued 

4 in error, the requirements of this subparagraph shall 

5 not apply with respect to such letter; and 

6 ‘‘(2)(A) the drug or biological product that is 

7 the subject of the required assessment, applicable re8 quirements in subsection (a)(3), or required request 

9 for approval of a pediatric formulation may be con10 sidered misbranded solely because of that failure and 

11 subject to relevant enforcement action (except that 

12 the drug or biological product shall not be subject to 

13 action under section 303); but 

14 ‘‘(B) the failure to submit the required assess15 ment, meet the applicable requirements in subsection 

16 (a)(3), or submit the required request for approval 

17 of a pediatric formulation shall not be the basis for 

18 a proceeding— 

19 ‘‘(i) to withdraw approval for a drug under 

20 section 505(e); or 

21 ‘‘(ii) to revoke the license for a biological 

22 product under section 351 of the Public Health 

23 Service Act.’’; 

24 (4) by amending subsection (e) to read as fol25 lows: 


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1 ‘‘(e) INITIAL PEDIATRIC PLAN.— 

2 ‘‘(1) IN GENERAL.— 

3 ‘‘(A) SUBMISSION.—An applicant who is 

4 required to submit an assessment under sub5 section (a)(1) shall submit an initial pediatric 

6 plan. 

7 ‘‘(B) TIMING.—An applicant shall submit 

8 the initial pediatric plan under paragraph (1)— 

9 ‘‘(i) before the date on which the ap10 plicant submits the assessments under sub11 section (a)(2); and 

12 ‘‘(ii) not later than— 

13 ‘‘(I) 60 calendar days after the 

14 date of end-of-Phase 2 meeting (as 

15 such term is used in section 312.47 of 

16 title 21, Code of Federal Regulations, 

17 or successor regulations); or 

18 ‘‘(II) such other time as may be 

19 agreed upon between the Secretary 

20 and the applicant. 

21 Nothing in this section shall preclude the Sec22 retary from accepting the submission of an ini23 tial pediatric plan earlier than the date other24 wise applicable under this subparagraph. 


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1 ‘‘(C) CONTENTS.—The initial pediatric 

2 plan shall include— 

3 ‘‘(i) an outline of the pediatric studies 

4 that the applicant plans to conduct; 

5 ‘‘(ii) any request for a deferral, partial 

6 waiver, or waiver under this section, along 

7 with supporting information; and 

8 ‘‘(iii) other information the Secretary 

9 determines necessary, including any infor10 mation specified in regulations under para11 graph (5). 

12 ‘‘(2) MEETING.— 

13 ‘‘(A) IN GENERAL.—Subject to subpara14 graph (B), not later than 60 calendar days 

15 after receiving an initial pediatric plan under 

16 paragraph (1), the Secretary shall meet with 

17 the applicant to discuss the plan. 

18 ‘‘(B) WRITTEN RESPONSE.—If the Sec19 retary determines that a written response to the 

20 initial pediatric plan is sufficient to commu21 nicate comments on the initial pediatric plan, 

22 and that no meeting is necessary the Secretary 

23 shall, not later than 60 days after receiving an 

24 initial pediatric plan under paragraph (1)— 


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1 ‘‘(i) notify the applicant of such deter2 mination; and 

3 ‘‘(ii) provide to the applicant the Sec4 retary’s written comments on the plan. 

5 ‘‘(3) AGREED PEDIATRIC PLAN.— 

6 ‘‘(A) SUBMISSION.—The applicant shall 

7 submit to the Secretary a document reflecting 

8 the agreement between the Secretary and the 

9 applicant on the initial pediatric plan (referred 

10 to in this subsection as an ‘agreed pediatric 

11 plan’). 

12 ‘‘(B) CONFIRMATION.—Not later than 30 

13 days after receiving the agreed pediatric plan 

14 under subparagraph (A), the Secretary shall 

15 provide written confirmation to the applicant 

16 that such plan reflects the agreement of the 

17 Secretary. 

18 ‘‘(C) DEFERRAL AND WAIVER.—If the 

19 agreed pediatric plan contains a request from 

20 the applicant for a deferral, partial waiver, or 

21 waiver under this section, the written confirma22 tion under subparagraph (B) shall include a 

23 recommendation from the Secretary as to 

24 whether such request meets the standards 

25 under paragraphs (3) or (4) of subsection (a). 


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1 ‘‘(D) AMENDMENTS TO THE PLAN.—At 

2 the initiative of the Secretary or the applicant, 

3 the agreed pediatric plan may be amended at 

4 any time. The requirements of paragraph (2) 

5 shall apply to any such proposed amendment in 

6 the same manner and to the same extent as 

7 such requirements apply to an initial pediatric 

8 plan under paragraph (1). The requirements of 

9 subparagraphs (A) through (C) of this para10 graph shall apply to any agreement resulting 

11 from such proposed amendment in the same 

12 manner and to the same extent as such require13 ments apply to an agreed pediatric plan. 

14 ‘‘(4) INTERNAL COMMITTEE.—The Secretary 

15 shall consult the internal committee under section 

16 505C on the review of the initial pediatric plan, 

17 agreed pediatric plan, and any amendments to such 

18 plans. 

19 ‘‘(5) MANDATORY RULEMAKING.—Not later 

20 than one year after the date of enactment of the 

21 BPCA and PREA Reauthorization Act of 2012, the 

22 Secretary shall promulgate proposed regulations and 

23 guidance to implement the provisions of this sub24 section. 


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1 ‘‘(6) EFFECTIVE DATE.—The provisions of this 

2 subsection shall take effect 180 calendar days after 

3 the date of enactment of the BPCA and PREA Re4 authorization Act of 2012, irrespective of whether 

5 the Secretary has promulgated final regulations to 

6 carry out this subsection by such date.’’; 

7 (5) in subsection (f)— 

8 (A) in the subsection heading, by inserting 

9 ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFER10 RALS,’’; 

11 (B) in paragraph (4)— 

12 (i) in the paragraph heading, by in13 serting ‘‘DEFERRAL EXTENSIONS,’’ after 

14 ‘‘DEFERRALS,’’; and 

15 (ii) in the second sentence, by insert16 ing ‘‘, deferral extensions,’’ after ‘‘defer17 rals’’; and 

18 (C) in paragraph (6)(D)— 

19 (i) by inserting ‘‘and deferral exten20 sions’’ before ‘‘requested and granted’’; 

21 and 

22 (ii) by inserting ‘‘and deferral exten23 sions’’ after ‘‘the reasons for such defer24 rals’’; 

25 (6) in subsection (g)— 


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1 (A) in paragraph (1)(A), by striking ‘‘after 

2 the date of the submission of the application or 

3 supplement’’ and inserting ‘‘after the date of 

4 the submission of an application or supplement 

5 that receives a priority review or 330 days after 

6 the date of the submission of an application or 

7 supplement that receives a standard review’’; 

8 and 

9 (B) in paragraph (2), by striking ‘‘the 

10 label of such product’’ and inserting ‘‘the label11 ing of such product’’; 

12 (7) in subsection (h)(1)— 

13 (A) by inserting ‘‘an application (or sup14 plement to an application) that contains’’ after 

15 ‘‘date of submission of’’; and 

16 (B) by inserting ‘‘if the application (or 

17 supplement) receives a priority review, or not 

18 later than 300 days after the date of submis19 sion of an application (or supplement to an ap20 plication) that contains a pediatric assessment 

21 under this section, if the application (or supple22 ment) receives a standard review,’’ after ‘‘under 

23 this section,’’; 

24 (8) in subsection (i)— 

25 (A) in paragraph (1)— 


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1 (i) in the paragraph heading, by strik2 ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 

3 MONTH PERIOD’’; and 

4 (ii) by striking ‘‘one-year’’ and insert5 ing ‘‘18-month’’; 

6 (B) in paragraph (2)— 

7 (i) in the paragraph heading, by strik8 ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; 

9 and 

10 (ii) by striking ‘‘one-year period’’ and 

11 inserting ‘‘18-month period’’; 

12 (C) by redesignating paragraph (3) as 

13 paragraph (4); and 

14 (D) by inserting after paragraph (2) the 

15 following: 

16 ‘‘(3) PRESERVATION OF AUTHORITY.—Nothing 

17 in this subsection shall prohibit the Office of Pedi18 atric Therapeutics from providing for the review of 

19 adverse event reports by the Pediatric Advisory 

20 Committee prior to the 18-month period referred to 

21 in paragraph (1), if such review is necessary to en22 sure safe use of a drug in a pediatric population.’’; 

23 (9) by striking subsection (m) (relating to inte24 gration with other pediatric studies); and 


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1 (10) by redesignating subsection (n) as sub2 section (m). 

3 (d) PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS

4 IN PHSA.—Section 351(m)(1) of the Public Health Serv5 ice Act (42 U.S.C. 262(m)(1)) is amended by striking ‘‘(f), 

6 (i), (j), (k), (l), (p), and (q)’’ and inserting ‘‘(f), (h), (i), 

7 (j), (k), (l), and (p)’’. 

8 (e) APPLICATION; TRANSITION RULE.— 

9 (1) APPLICATION.—Notwithstanding any provi10 sion of section 505A and 505B of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) 

12 stating that a provision applies beginning on the 

13 date of the enactment of the Best Pharmaceuticals 

14 for Children Act of 2007 or the date of the enact15 ment of the Pediatric Research Equity Act of 2007, 

16 any amendment made by this Act to such a provi17 sion applies beginning on the date of the enactment 

18 of this Act. 

19 (2) TRANSITIONAL RULE FOR ADVERSE EVENT

20 REPORTING.—With respect to a drug for which a la21 beling change described under section 505A(l)(1) or 

22 505B(i)(1) of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved 

24 or made, respectively, during the one-year period 

25 that ends on the day before the date of enactment 


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1 of this Act, the Secretary shall apply section 505A(l) 

2 and section 505B(i), as applicable, to such drug, as 

3 such sections were in effect on such day. 

4 (f) CONFORMING AMENDMENT.—Section 

5 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 

6 290b(c)(1)(C)) is amended by striking ‘‘for which the Sec7 retary issues a certification in the affirmative under sec8 tion 505A(n)(1)(A) of the Federal Food, Drug, and Cos9 metic Act’’. 

10 SEC. 3. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. 

11 (a) IN GENERAL.—Not later than January 1, 2016, 

12 and the end of each subsequent 5-year period, the Comp13 troller General of the United States, in consultation with 

14 the Secretary of Health and Human Services, shall submit 

15 to the Congress a report that evaluates the effectiveness 

16 of sections 505A and 505B of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 355a, 355c) and section 

18 409I of the Public Health Service Act (42 U.S.C. 284m) 

19 in ensuring that medicines used by children are tested in 

20 pediatric populations and properly labeled for use in chil21 dren. 

22 (b) CONTENTS.—The report under subsection (a) 

23 shall include— 

24 (1) the number and importance of drugs and 

25 biological products for children that are being tested 


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1 as a result of the programs established under sec2 tions 505A and 505B of the Federal Food, Drug, 

3 and Cosmetic Act and section 409I of the Public 

4 Health Service Act; 

5 (2) a description of the importance for children, 

6 health care providers, parents, and others of labeling 

7 changes made as a result of such testing; 

8 (3) the number and importance of drugs and 

9 biological products for children that are not being 

10 tested for their use in pediatric populations, notwith11 standing the existence of such programs; 

12 (4) the possible reasons for the lack of testing 

13 reported under paragraph (3); 

14 (5) the number of drugs and biological products 

15 for which testing is being done and labeling changes 

16 are required under the programs established by this 

17 Act, including— 

18 (A) the date labeling changes are made; 

19 (B) which labeling changes required the 

20 use of the dispute resolution process; and 

21 (C) for labeling changes that required such 

22 dispute resolution process, a description of— 

23 (i) the disputes; 

24 (ii) the recommendations of the Pedi25 atric Advisory Committee; and 


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1 (iii) the outcomes of such process; 

2 (6) any recommendations for modifications to 

3 the programs established under sections 505A and 

4 505B of the Federal Food, Drug, and Cosmetic Act 

5 and section 409I of the Public Health Service Act 

6 that the Secretary determines to be appropriate, in7 cluding a detailed rationale for each recommenda8 tion; 

9 (7)(A) the efforts made by the Secretary to in10 crease the number of studies conducted in the 

11 neonate population (including efforts made to en12 courage the conduct of appropriate studies in neo13 nates by companies with products that have suffi14 cient safety and other information to make the con15 duct of the studies ethical and safe); and 

16 (B) the results of such efforts; and 

17 (8)(A) the number and importance of drugs and 

18 biological products for children with cancer that are 

19 being tested as a result of the programs established 

20 under sections 505A and 505B of the Federal Food, 

21 Drug, and Cosmetic Act and section 409I of the 

22 Public Health Service Act; and 

23 (B) any recommendations for modifications to 

24 the programs under such sections that would lead to 

25 new and better therapies for children with cancer, 


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1 including a detailed rationale for each recommenda2 tion. 

3 SEC. 4. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC 

4 PLANS, ASSESSMENTS, DEFERRALS, DEFER5 RAL EXTENSIONS, AND WAIVERS. 

6 Section 505C of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 355d) is amended— 

8 (1) in the section heading, by inserting ‘‘DE9 FERRAL EXTENSIONS,’’ after ‘‘DEFERRALS,’’; 

10 and 

11 (2) by inserting ‘‘neonatology’’ after ‘‘pediatric 

12 ethics’’. 

13 SEC. 5. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS. 

14 Section 6(c) of the Best Pharmaceuticals for Children 

15 Act (21 U.S.C. 393a(c)) is amended— 

16 (1) in paragraph (1), by striking ‘‘and’’ at the 

17 end; 

18 (2) by redesignating paragraph (2) as para19 graph (4); 

20 (3) by inserting after paragraph (1) the fol21 lowing: 

22 ‘‘(2) one or more additional individuals with ex23 pertise in neonatology; 

24 ‘‘(3) one or more additional individuals with ex25 pertise in pediatric epidemiology; and’’. 


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1 SEC. 6. CONTINUATION OF OPERATION OF PEDIATRIC AD2 VISORY COMMITTEE. 

3 Section 14(d) of the Best Pharmaceuticals for Chil4 dren Act (42 U.S.C. 284m note) is amended by striking 

5 ‘‘during the five-year period beginning on the date of the 

6 enactment of the Best Pharmaceuticals for Children Act 

7 of 2007’’ and inserting ‘‘to carry out the advisory commit8 tee’s responsibilities under sections 505A, 505B, and 

9 520(m) of the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 355a, 355c, and 360j(m))’’. 

11 SEC. 7. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC 

12 DRUGS ADVISORY COMMITTEE. 

13 Section 15(a) of the Best Pharmaceuticals for Chil14 dren Act (Public Law 107–109), as amended by section 

15 502(e) of the Food and Drug Administration Amendments 

16 Act of 2007 (Public Law 110–85), is amended— 

17 (1) in paragraph (1)(D), by striking ‘‘section 

18 505B(f)’’ and inserting ‘‘section 505C’’; and 

19 (2) in paragraph (3), by striking ‘‘during the 

20 five-year period beginning on the date of the enact21 ment of the Best Pharmaceuticals for Children Act 

22 of 2007’’ and inserting ‘‘to carry out the Sub23 committee’s responsibilities under this section’’. 

Æ 


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