132 
‘‘(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: 
‘‘(e) INITIAL PEDIATRIC PLAN.— 
‘‘(1) IN GENERAL.— 
‘‘(A) SUBMISSION.—An applicant who is 
required to submit an assessment under sub-
133 
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. 
‘‘(C) CONTENTS.—The initial pediatric 
plan shall include— 
‘‘(i) an outline of the pediatric studies 
that the applicant plans to conduct;
134 
‘‘(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 
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 INITIAL PEDIATRIC PLAN.—
135 
‘‘(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 initial pedi-
atric plan’). 
‘‘(B) CONFIRMATION.—Not later than 30 
days after receiving the agreed initial pediatric 
plan under subparagraph (A), the Secretary 
shall provide written confirmation to the appli-
cant that such plan reflects the agreement of 
the Secretary. 
‘‘(C) DEFERRAL
AND
WAIVER.—If the 
agreed initial pediatric plan contains a request 
from the applicant for a deferral, partial waiver, 
or waiver under this section, the written con-
firmation 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 initial pediatric plan may be amend-
ed at any time. The requirements of paragraph 
(2) shall apply to any such proposed amend-
137 
(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)— 
(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
138 
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 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)—
139 
(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 
(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)’’.
140 
(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 
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-
141 
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 
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-
142 
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-
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;
143 
(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 
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); and 
(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-
144 
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-
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:
145 
‘‘(2) one or more additional individuals with ex-
pertise in neonatology; 
‘‘(3) one or more additional individuals with ex-
pertise in pediatric epidemiology; and’’. 
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
146 
of 2007’’ and inserting ‘‘to carry out the Sub-
committee’s responsibilities under this section’’. 
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 ini-
tial interpretations of a statute or regulation, sets forth 
changes in interpretation or policy that are of more than 
a minor nature, includes complex scientific issues, or cov-
ers 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 
intent to prepare such guidance document; and 
‘‘(II) 
during 
preparation 
and 
before 
issuance of such guidance document, may meet 
with interested stakeholders, including industry, 
medical, and scientific experts and others, and 
solicit public comment;
147 
‘‘(ii) if the Secretary for good cause finds that, 
with respect to such guidance document, compliance 
with clause (i) is impracticable, unnecessary, or con-
trary to the public interest— 
‘‘(I) the Secretary shall publish such find-
ing 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 document; and 
‘‘(III) during a 90-day period beginning 
not later than the date of issuance of such guid-
ance document, the Secretary may meet with 
interested 
stakeholders, 
including 
industry, 
medical, and scientific experts and others, and 
shall solicit public comment; 
‘‘(iii) beginning on the date of enactment of the 
Food and Drug Administration Reform Act of 2012, 
upon issuance of 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);
148 
‘‘(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 Sec-
retary of a notification of such extension in the Fed-
eral Register; 
‘‘(v) if the Secretary issues a draft guidance 
document and fails to finalize the draft by the dead-
line 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 in accordance 
with clause (iii), the Secretary shall— 
‘‘(I) conduct a retrospective analysis of 
such guidance document to ensure it is not out-
moded, ineffective, insufficient, or excessively 
burdensome; and 
‘‘(II) based on such analysis, modify, 
streamline, expand, or repeal the guidance doc-
ument 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
149 
a statute or regulation or sets forth changes in interpreta-
tion 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 subparagraph (C): 
‘‘(i) Any document that does not set forth an 
initial interpretation or a reinterpretation of a stat-
ute or regulation. 
‘‘(ii) Any document that sets forth or changes 
a policy relating to internal procedures of the Food 
and Drug Administration. 
‘‘(iii) Agency reports, general information docu-
ments provided to consumers or health professionals, 
speeches, journal articles and editorials, media inter-
views, press materials, warning letters, memoranda 
of understanding, or communications directed to in-
dividual 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—
151 
the numbers of vacancies of the advisory com-
mittees. 
‘‘(2) RECRUITMENT ACTIVITIES.—The recruit-
ment activities under paragraph (1) may include— 
‘‘(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.
152 
‘‘(c) DISCLOSURE OF DETERMINATIONS AND CER-
TIFICATIONS.—Notwithstanding section 107(a)(2) of the 
Ethics in Government Act of 1978, the following shall 
apply: 
‘‘(1) 15 OR MORE DAYS IN ADVANCE.—As soon 
as practicable, but (except as provided in paragraph 
(2)) not later than 15 days prior to a meeting of an 
advisory committee to which a written determination 
as referred to in section 208(b)(1) of title 18, 
United States Code, or a written certification as re-
ferred to in section 208(b)(3) of such title, applies, 
the Secretary shall disclose (other than information 
exempted from disclosure under section 552 or sec-
tion 552a of title 5, United States Code (popularly 
known as the Freedom of Information Act and the 
Privacy Act of 1974, respectively)) on the Internet 
Website of the Food and Drug Administration— 
‘‘(A) the type, nature, and magnitude of 
the financial interests of the advisory committee 
member to which such determination or certifi-
cation applies; and 
‘‘(B) the reasons of the Secretary for such 
determination or certification, including, as ap-
propriate, the public health interest in having 
the expertise of the member with respect to the
153 
particular matter before the advisory com-
mittee. 
‘‘(2) LESS THAN 30 DAYS IN ADVANCE.—In the 
case of a financial interest that becomes known to 
the Secretary less than 30 days prior to a meeting 
of an advisory committee to which a written deter-
mination as referred to in section 208(b)(1) of title 
18, United States Code, or a written certification as 
referred to in section 208(b)(3) of such title applies, 
the Secretary shall disclose (other than information 
exempted from disclosure under section 552 or 552a 
of title 5, United States Code) on the Internet 
Website of the Food and Drug Administration, the 
information described in subparagraphs (A) and (B) 
of paragraph (1) as soon as practicable after the 
Secretary makes such determination or certification, 
but in no case later than the date of such meeting.’’; 
(2) in subsection (d), by striking ‘‘subsection 
(c)(3)’’ and inserting ‘‘subsection (c)’’; 
(3) by amending subsection (e) to read as fol-
lows: 
‘‘(e) ANNUAL REPORT.— 
‘‘(1) IN GENERAL.—Not later than February 1 
of each year, the Secretary shall submit to the Com-
mittee on Appropriations and the Committee on
154 
Health, Education, Labor, and Pensions of the Sen-
ate, and the Committee on Appropriations and the 
Committee on Energy and Commerce of the House 
of Representatives, a report that describes— 
‘‘(A) with respect to the fiscal year that 
ended on September 30 of the previous year, 
the number of persons nominated for participa-
tion at meetings for each advisory committee, 
the number of persons so nominated, and will-
ing to serve, the number of vacancies on each 
advisory committee, and the number of persons 
contacted for service as members on each advi-
sory committee meeting for each advisory com-
mittee who did not participate because of the 
potential for such participation to constitute a 
disqualifying financial interest under section 
208 of title 18, United States Code; 
‘‘(B) with respect to such year, the number 
of persons contacted for services as members 
for each advisory committee meeting for each 
advisory committee who did not participate be-
cause of reasons other than the potential for 
such participation to constitute a disqualifying 
financial interest under section 208 of title 18, 
United States Code;
155 
‘‘(C) with respect to such year, the number 
of members attending meetings for each advi-
sory committee; and 
‘‘(D) with respect to such year, the aggre-
gate number of disclosures required under sub-
section (d) and the percentage of individuals to 
whom such disclosures did not apply who served 
on such committee. 
‘‘(2) PUBLIC AVAILABILITY.—Not later than 30 
days after submitting any report under paragraph 
(1) to the committees specified in such paragraph, 
the Secretary shall make each such report available 
to the public.’’; and 
(4) in subsection (f), by striking ‘‘shall review 
guidance’’ and all that follows through the end of 
the subsection and inserting the following: ‘‘shall— 
‘‘(1) review guidance of the Food and Drug Ad-
ministration with respect to advisory committees re-
garding disclosure of conflicts of interest and the ap-
plication of section 208 of title 18, United States 
Code; and 
‘‘(2) update such guidance as necessary to en-
sure that the Food and Drug Administration re-
ceives appropriate access to needed scientific exper-
156 
tise, with due consideration of the requirements of 
such section 208.’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) apply beginning on October 1, 2012. 
SEC. 603. ELECTRONIC SUBMISSION OF APPLICATIONS. 
Subchapter D of chapter VII (21 U.S.C. 379k et 
seq.) is amended by inserting after section 745 the fol-
lowing: 
‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 
‘‘(a) DRUGS AND BIOLOGICS.— 
‘‘(1) IN GENERAL.—Beginning no earlier than 
24 months after the issuance of a final guidance 
issued after public notice and opportunity for com-
ment, submissions under subsection (b), (i), or (j) of 
section 505 of this Act or subsection (a) or (k) of 
section 351 of the Public Health Service Act shall 
be submitted in such electronic format as specified 
by the Secretary in such guidance. 
‘‘(2) GUIDANCE CONTENTS.—In the guidance 
under paragraph (1), the Secretary may— 
‘‘(A) provide a timetable for establishment 
by the Secretary of further standards for elec-
tronic submission as required by such para-
graph; and
157 
‘‘(B) set forth criteria for waivers of and 
exemptions from the requirements of this sub-
section. 
‘‘(3) EXCEPTION.—This subsection shall not 
apply to submissions described in section 561. 
‘‘(b) DEVICES.— 
‘‘(1) 
IN
GENERAL.—Beginning 
after 
the 
issuance of final guidance implementing this para-
graph, pre-submissions and submissions for devices 
under section 510(k), 513(f)(2)(A), 515(c), 515(d), 
515(f), 520(g), 520(m), or 564 of this Act or section 
351 of the Public Health Service Act, and any sup-
plements to such pre-submissions or submissions, 
shall include an electronic copy of such pre-submis-
sions or submissions. 
‘‘(2) GUIDANCE CONTENTS.—In the guidance 
under paragraph (1), the Secretary may— 
‘‘(A) provide standards for the electronic 
copy required under such paragraph; and 
‘‘(B) set forth criteria for waivers of and 
exemptions from the requirements of this sub-
section.’’.
158 
SEC. 604. NOTIFICATION OF FDA INTENT TO REGULATE 
LABORATORY-DEVELOPED TESTS. 
The Food and Drug Administration may not issue 
any draft or final guidance on the regulation of laboratory- 
developed tests under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) without, at least 60 
days prior to such issuance— 
(1) notifying the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate of the Administration’s intent to 
take such action; and 
(2) including in such notification the antici-
pated details of such action. 
TITLE VII—MEDICAL DEVICE 
REGULATORY IMPROVEMENTS 
Subtitle A—Premarket 
Predictability 
SEC. 701. INVESTIGATIONAL DEVICE EXEMPTIONS. 
Section 520(g) (21 U.S.C. 360j(g)) is amended— 
(1) in paragraph (2)(B)(ii), by inserting ‘‘safety 
or effectiveness’’ before ‘‘data obtained’’; and 
(2) in paragraph (4), by adding at the end the 
following:
159 
‘‘(C) Consistent with paragraph (1), the Secretary 
shall not disapprove an application under this subsection 
because the Secretary determines that— 
‘‘(i) the investigation may not support a sub-
stantial equivalence or de novo classification deter-
mination or approval of the device; 
‘‘(ii) the investigation may not meet a require-
ment, including a data requirement, relating to the 
approval or clearance of a device; or 
‘‘(iii) an additional or different investigation 
may be necessary to support clearance or approval 
of the device.’’. 
SEC. 702. CLARIFICATION OF LEAST BURDENSOME STAND-
ARD. 
(a) PREMARKET APPROVAL.—Section 513(a)(3)(D) 
(21 U.S.C. 360c(a)(3)(D)) is amended— 
(1) by redesignating clause (iii) as clause (v); 
and 
(2) by inserting after clause (ii) the following: 
‘‘(iii) For purposes of clause (ii), the term ‘necessary’ 
means the minimum required information that would sup-
port a determination by the Secretary that an application 
provides reasonable assurance of the effectiveness of the 
device.
160 
‘‘(iv) Nothing in this subparagraph shall alter the cri-
teria for evaluating an application for premarket approval 
of a device.’’. 
(b) PREMARKET NOTIFICATION UNDER SECTION 
510(k).—Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) 
is amended— 
(1) by striking ‘‘(D) Whenever’’ and inserting 
‘‘(D)(i) Whenever’’; and 
(2) by adding at the end the following: 
‘‘(ii) For purposes of clause (i), the term ‘necessary’ 
means the minimum required information that would sup-
port a determination of substantial equivalence between 
a new device and a predicate device. 
‘‘(iii) Nothing in this subparagraph shall alter the 
standard for determining substantial equivalence between 
a new device and a predicate device.’’. 
SEC. 703. AGENCY DOCUMENTATION AND REVIEW OF SIG-
NIFICANT DECISIONS. 
Chapter V is amended by inserting after section 517 
(21 U.S.C. 360g) the following: 
‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF 
SIGNIFICANT 
DECISIONS 
REGARDING 
DE-
VICES. 
‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFI-
CANT DECISIONS.—
161 
‘‘(1) IN GENERAL.—The Secretary shall com-
pletely document the scientific and regulatory ration-
ale for any significant decision of the Center for De-
vices and Radiological Health regarding submission 
or review of a report under section 510(k), an appli-
cation under section 515, or an application for an 
exemption under section 520(g), including docu-
mentation of significant controversies or differences 
of opinion and the resolution of such controversies 
or differences of opinion. 
‘‘(2) PROVISION
OF
DOCUMENTATION.—Upon 
request, the Secretary shall furnish such complete 
documentation to the person who is seeking to sub-
mit, or who has submitted, such report or applica-
tion. 
‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 
‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF 
SIGNIFICANT DECISION.—Any person may request a 
supervisory review of the significant decision de-
scribed in subsection (a)(1). Such review may be 
conducted at the next supervisory level or higher 
above the individual who made the significant deci-
sion. 
‘‘(2) SUBMISSION OF REQUEST.—A person re-
questing a supervisory review under paragraph (1)
162 
shall submit such request to the Secretary not later 
than 30 days after such decision and shall indicate 
in the request whether such person seeks an in-per-
son meeting or a teleconference review. 
‘‘(3) TIMEFRAME.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Secretary shall schedule 
an in-person or teleconference review, if so re-
quested, not later than 30 days after such re-
quest is made. The Secretary shall issue a deci-
sion to the person requesting a review under 
this subsection not later than 45 days after the 
request is made under paragraph (1), or, in the 
case of a person who requests an in-person 
meeting or teleconference, 30 days after such 
meeting or teleconference. 
‘‘(B) 
EXCEPTION.—Subparagraph 
(A) 
shall not apply in cases that are referred to ex-
perts outside of the Food and Drug Adminis-
tration.’’. 
SEC. 704. TRANSPARENCY IN CLEARANCE PROCESS. 
(a) PUBLICATION
OF DETAILED DECISION SUM-
MARIES.—Section 520(h) (21 U.S.C. 360j(h)) is amended 
by adding at the end the following: