121 
the date of the enactment of this title, shall continue to 
be in effect with respect to human drug applications and 
supplements (as defined in such part as of such day) that 
were accepted by the Food and Drug Administration for 
filing on or after October 1, 2007, but before October 1, 
2012, with respect to assessing and collecting any fee re-
quired by such part for a fiscal year prior to fiscal year 
2013. 
SEC. 407. CONFORMING AMENDMENT. 
Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amend-
ed by striking ‘‘or (k)’’. 
TITLE V—REAUTHORIZATION OF 
BEST 
PHARMACEUTICALS 
FOR CHILDREN ACT AND PE-
DIATRIC RESEARCH EQUITY 
ACT 
SEC. 501. PERMANENT EXTENSION OF BEST PHARMA-
CEUTICALS FOR CHILDREN ACT AND PEDI-
ATRIC RESEARCH EQUITY ACT. 
(a) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 
Section 409I(c) of the Public Health Service Act (42 
U.S.C. 284m(c)) is amended— 
(1) in subsection (c)(1)— 
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(A) in the matter preceding subparagraph 
(A), by inserting ‘‘or section 351(m) of this 
Act,’’ after ‘‘Cosmetic Act,’’; 
(B) in subparagraph (A)(i), by inserting 
‘‘or section 351(k) of this Act’’ after ‘‘Cosmetic 
Act’’; and 
(C) by amending subparagraph (B) to read 
as follows: 
‘‘(B)(i) there remains no patent listed pur-
suant to section 505(b)(1) of the Federal Food, 
Drug, and Cosmetic Act; and 
‘‘(ii) every three-year and five-year period 
referred 
to 
in 
subsection 
(c)(3)(E)(ii), 
(c)(3)(E)(iii), 
(c)(3)(E(iv), 
(j)(5)(F)(ii), 
(j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of 
the Federal Food, Drug and Cosmetic Act, or 
applicable twelve-year period referred to in sec-
tion 351(k)(7) of this Act, and any seven-year 
period referred to in section 527 of the Federal 
Food, Drug, and Cosmetic Act, has ended for 
at least one form of the drug; and’’; 
(2) in subsection (c)(2)— 
(A) in the heading of paragraph (2), by 
striking ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; 
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123 
(B) by striking ‘‘under section 505 of the 
Federal Food, Drug, and Cosmetic Act’’; and 
(C) by striking ‘‘505A of such Act’’ and 
inserting ‘‘505A of the Federal Food, Drug, 
and Cosmetic Act or section 351(m) of this 
Act’’; and 
(3) in subsection (e)(1), by striking ‘‘to carry 
out this section’’ and all that follows through the 
end of paragraph (1) and inserting ‘‘$25,000,000 
for each of fiscal years 2013 through 2017.’’. 
(b) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 
Section 505A (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 
the subject of a written request and for which reports are 
submitted and accepted in accordance with subsection 
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124 
(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-
atric Therapeutics from providing for the review of 
adverse event reports by the Pediatric Advisory 
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125 
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 eligi-
ble for extension under subsection (b)(1) or 
(c)(1) of this section, or any exclusivity protec-
tion eligible for extension under subsection 
(m)(2) or (m)(3) of section 351 of the Public 
Health Service Act, the Secretary shall make a 
determination regarding whether an assessment 
shall be required to be submitted under section 
505B(b). 
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‘‘(B) For a drug that has no remaining 
listed patents or exclusivity protection eligible 
for extension under subsection (b)(1) or (c)(1) 
of this section, or any exclusivity protection eli-
gible for extension under subsection (m)(2) or 
(m)(3) of section 351 of the Public Health 
Service Act, the Secretary shall refer the drug 
for inclusion on the list established under sec-
tion 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 
(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)’’; 
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127 
(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 
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; 
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128 
‘‘(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 
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)— 
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129 
(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-
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; 
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130 
‘‘(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 
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 
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131 
(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: 
‘‘(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 
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132 
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. 
‘‘(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 90 calendar days 
after receiving an initial pediatric plan under 
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133 
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 90 days after receiving an 
initial pediatric plan under paragraph (1)— 
‘‘(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 
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134 
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). 
‘‘(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 
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135 
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 
Food and Drug Administration Reform Act of 2012, 
the Secretary shall promulgate proposed regulations 
and guidance to implement the provisions of this 
subsection. 
‘‘(6) EFFECTIVE DATE.—The provisions of this 
subsection shall take effect 180 calendar days after 
the date of enactment of the Food and Drug Admin-
istration Reform Act of 2012, irrespective of wheth-
er 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 
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136 
(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)— 
(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)— 
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137 
(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 330 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)— 
(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’’; 
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138 
(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 
(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), (n), 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 
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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 
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’’. 
(g) PUBLIC MEETING ON PEDIATRIC CANCERS.— 
Not later than December 31, 2013, the Secretary of 
Health and Human Services shall hold a public meeting 
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140 
on the impact of sections 505A and 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) 
on the development of new therapies for children with can-
cer. 
SEC. 502. FOOD AND DRUG ADMINISTRATION REPORT. 
(a) IN GENERAL.—Not later than four years after 
the date of enactment of this Act and every five years 
thereafter, the Secretary of Health and Human Services 
shall prepare and submit to the Committee on Health, 
Education, Labor and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives, and make publicly available, including 
through posting on the Web site of the Food and Drug 
Administration, a report on the implementation of section 
505A and 505B. 
(b) CONTENTS.—The report described in paragraph 
(1) shall include— 
(1) an assessment of the effectiveness of sec-
tions 505A and 505B in improving information 
about pediatric uses for approved drugs and bio-
logics, including the number and type of labeling 
changes made since the date of enactment of this 
Act; 
(2) the number of waivers and partial waivers 
granted under section 505B since the date of enact-
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141 
ment of this Act, and the reasons such waivers and 
partial waivers were granted; 
(3) the number of deferrals and deferral exten-
sions granted under section 505B since the date of 
enactment of this Act, and the reasons such defer-
rals and deferral extensions were granted; 
(4) the number of letters issued under section 
505B(d); 
(5) an assessment of the timeliness and effec-
tiveness of pediatric study planning since the date of 
enactment of this Act, including the number of pedi-
atric plans not submitted in accordance with the re-
quirements of section 505B(e) and any resulting 
rulemaking; 
(6) the number of written requests issued, ac-
cepted, and declined under section 505A since the 
date of enactment of this Act, and a listing of any 
important gaps in pediatric information as a result 
of such declined requests; 
(7) a description and current status of referrals 
made under section 505A(n); 
(8) an assessment of the effectiveness of study-
ing drugs for rare diseases under 505A; 
(9) an assessment of the effectiveness of study-
ing drugs for children with cancer under 505A and 
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505B, and any recommendations for modifications 
to the programs under such sections that would lead 
to new and better therapies for children with cancer; 
(10) an assessment of the effectiveness of 
studying drugs in the neonate population under 
505A and 505B; 
(11) an assessment of the effectiveness of 
studying biological products in pediatric populations 
under 505A and 505B; 
(12) an assessment of the Secretary’s efforts to 
address the suggestions and options described in the 
report required under 505A(p); 
(13) any suggestions for modification to the 
programs that would improve pediatric drug re-
search and increase pediatric labeling of drugs and 
biologics that the Secretary determines to be appro-
priate. 
(c) STAKEHOLDER COMMENT.—At least 180 days 
prior to the submission of the report required in para-
graph (1), the Secretary shall consult with representatives 
of patient groups, including pediatric patient groups, con-
sumer groups, regulated industry, academia, and other in-
terested parties to obtain any recommendations or infor-
mation relevant to the study and report including sugges-
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143 
tions for modifications that would improve pediatric drug 
research and pediatric labeling of drugs and biologics. 
SEC. 503. INTERNAL COMMITTEE FOR REVIEW OF PEDI-
ATRIC PLANS, ASSESSMENTS, DEFERRALS, 
DEFERRAL EXTENSIONS, AND WAIVERS. 
Section 505C (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. 504. 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’’. 
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144 
SEC. 505. CONTINUATION OF OPERATION OF PEDIATRIC 
ADVISORY 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. 506. 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’’. 
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145 
TITLE VI—FOOD AND DRUG AD-
MINISTRATION ADMINISTRA-
TIVE REFORMS 
SEC. 601. PUBLIC PARTICIPATION IN ISSUANCE OF FDA 
GUIDANCE DOCUMENTS. 
Section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended 
by striking subparagraph (C) and inserting the following: 
‘‘(C) For any guidance document that sets 
forth initial interpretations of a statute or regu-
lation, sets forth changes in interpretation or 
policy that are of more than a minor nature, in-
cludes complex scientific issues, or covers highly 
controversial issues— 
‘‘(i) the Secretary— 
‘‘(I) at least 30 days before 
issuance of a draft of such guidance 
document, shall publish notice in the 
Federal Register of the Secretary’s in-
tent to prepare such guidance docu-
ment; and 
‘‘(II) during preparation and be-
fore issuance of such guidance docu-
ment, may meet with interested stake-
holders, including industry, medical, 
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146 
and scientific experts and others, and 
solicit public comment; 
‘‘(ii) if the Secretary for good cause 
finds that, with respect to such guidance 
document, compliance with clause (i) is im-
practicable, unnecessary, or contrary to the 
public interest— 
‘‘(I) the Secretary shall publish 
such finding and a brief statement of 
the reasons for such finding in the 
Federal Register; 
‘‘(II) clause (i) shall not apply 
with respect to such guidance docu-
ment; and 
‘‘(III) during a 90-day period be-
ginning not later than the date of 
issuance of the draft of such guidance 
document, the Secretary may meet 
with interested stakeholders, including 
industry, medical, and scientific ex-
perts and others, and shall solicit pub-
lic comment; 
‘‘(iii) beginning on the date of enact-
ment of the Food and Drug Administra-
tion Reform Act of 2012, upon issuance of 
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a draft guidance document under clause (i) 
or (ii), the Secretary shall— 
‘‘(I) designate the document as 
draft or final; and 
‘‘(II) not later than 18 months 
after the close of the comment period 
for such guidance, issue a final 
version of such guidance document in 
accordance with clauses (i) and (ii); 
‘‘(iv) the Secretary may extend the 
deadline for issuing final guidance under 
clause (iii)(II) by not more than 180 days 
upon submission by the Secretary of a no-
tification of such extension in the Federal 
Register; 
‘‘(v) if the Secretary issues a draft 
guidance document and fails to finalize the 
draft by the deadline determined under 
clause (iii)(II), as extended under clause 
(iv), the Secretary shall, beginning on the 
date of such deadline, treat the draft as 
null and void; and 
‘‘(vi) not less than every 5 years after 
the issuance of a final guidance document 
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in accordance with clause (iii), the Sec-
retary shall— 
‘‘(I) conduct a retrospective anal-
ysis of such guidance document to en-
sure it is not outmoded, ineffective, 
insufficient, or excessively burden-
some; and 
‘‘(II) based on such analysis, 
modify, streamline, expand, or repeal 
the guidance document in accordance 
with what has been learned. 
‘‘(D) With respect to devices, a notice to 
industry guidance letter, a notice to industry 
advisory letter, and any similar notice that sets 
forth initial interpretations of a statute or regu-
lation or sets forth changes in interpretation or 
policy shall be treated as a guidance document 
for purposes of subparagraph (C). 
‘‘(E) The following shall not be treated as 
a guidance document for purposes of subpara-
graph (C): 
‘‘(i) Any document that does not set 
forth an initial interpretation or a reinter-
pretation of a statute or regulation. 
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‘‘(ii) Any document that sets forth or 
changes a policy relating to internal proce-
dures of the Food and Drug Administra-
tion. 
‘‘(iii) Agency reports, general informa-
tion documents provided to consumers or 
health professionals, speeches, journal arti-
cles and editorials, media interviews, press 
materials, warning letters, memoranda of 
understanding, or communications directed 
to individual persons or firms.’’. 
SEC. 602. CONFLICTS OF INTEREST. 
(a) IN GENERAL.—Section 712 (21 U.S.C. 379d–1) 
is amended— 
(1) by striking subsections (b) and (c) and in-
serting the following subsections: 
‘‘(b) RECRUITMENT FOR ADVISORY COMMITTEES.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) develop and implement strategies on 
effective outreach to potential members of advi-
sory committees at universities, colleges, other 
academic research centers, professional and 
medical societies, and patient and consumer 
groups; 
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‘‘(B) seek input from professional medical 
and scientific societies to determine the most ef-
fective informational and recruitment activities; 
‘‘(C) at least every 180 days, request refer-
rals for potential members of advisory commit-
tees from a variety of stakeholders, including— 
‘‘(i) 
product 
developers, 
patient 
groups, and disease advocacy organiza-
tions; and 
‘‘(ii) relevant— 
‘‘(I) professional societies; 
‘‘(II) medical societies; 
‘‘(III) 
academic 
organizations; 
and 
‘‘(IV) 
governmental 
organiza-
tions; and 
‘‘(D) in carrying out subparagraphs (A) 
and (B), take into account the levels of activity 
(including the numbers of annual meetings) and 
the numbers of vacancies of the advisory com-
mittees. 
‘‘(2) RECRUITMENT ACTIVITIES.—The recruit-
ment activities under paragraph (1) may include— 
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‘‘(A) advertising the process for becoming 
an advisory committee member at medical and 
scientific society conferences; 
‘‘(B) making widely available, including by 
using existing electronic communications chan-
nels, the contact information for the Food and 
Drug Administration point of contact regarding 
advisory committee nominations; and 
‘‘(C) developing a method through which 
an entity receiving funding from the National 
Institutes of Health, the Agency for Healthcare 
Research and Quality, the Centers for Disease 
Control and Prevention, or the Veterans Health 
Administration can identify a person whom the 
Food and Drug Administration can contact re-
garding the nomination of individuals to serve 
on advisory committees. 
‘‘(3) EXPERTISE.—In carrying out this sub-
section, the Secretary shall seek to ensure that the 
Secretary has access to the most current expert ad-
vice. 
‘‘(c) DISCLOSURE OF DETERMINATIONS AND CER-
TIFICATIONS.—Notwithstanding section 107(a)(2) of the 
Ethics in Government Act of 1978, the following shall 
apply: 
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opment of the device for such patients is impos-
sible, highly impracticable, or unsafe.’’; 
(iii) by striking clause (ii) and insert-
ing the following: 
‘‘(ii) During any calendar year, the number of 
such devices distributed during that year under each 
exemption granted under this subsection does not 
exceed the number of such devices needed to treat, 
diagnose, or cure a population of 4,000 individuals 
in the United States (referred to in this paragraph 
as the ‘annual distribution number’).’’; and 
(iv) in clause (iv), by striking ‘‘2012’’ 
and inserting ‘‘2017’’; 
(B) by striking subparagraph (C); 
(C) by redesignating subparagraphs (D) 
and (E) as subparagraphs (C) and (D), respec-
tively; and 
(D) in subparagraph (C), as so redesig-
nated, by striking ‘‘and modified under sub-
paragraph (C), if applicable,’’; 
(2) in paragraph (7), by striking ‘‘regarding a 
device’’ and inserting ‘‘regarding a device described 
in paragraph (6)(A)(i)(I)’’; and 
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