IB 
Union Calendar No. 418 
113TH CONGRESS 
2D SESSION 
H. R. 4250 
[Report No. 113–558] 
To amend the Federal Food, Drug, and Cosmetic Act to provide an alternative 
process for review of safety and effectiveness of nonprescription sunscreen 
active ingredients and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 13, 2014 
Mr. WHITFIELD (for himself and Mr. DINGELL) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
JULY 24, 2014 
Additional sponsors: Mr. FARR, Mr. GUTHRIE, Mr. TIBERI, Mr. STIVERS, Mr. 
ROGERS of Kentucky, Mr. BARR, Mr. FORBES, Mr. CARNEY, Mr. LANCE, 
Mrs. ELLMERS, Mrs. BLACKBURN, Mrs. CAROLYN B. MALONEY of New 
York, Mr. GRIFFIN of Arkansas, Mr. CRENSHAW, Mr. LANKFORD, Mr. 
DENT, Mr. ROONEY, Mr. BARROW of Georgia, Mr. KINGSTON, Mrs. 
NOEM, Mr. LATTA, Mr. GRAVES of Georgia, Mr. ROSS, Mr. BISHOP of 
New York, Mr. PERLMUTTER, Mr. MURPHY of Pennsylvania, Mr. DIAZ- 
BALART, Mr. JOHNSON of Ohio, Mr. MATHESON, Mr. ROSKAM, Mr. 
FLEISCHMANN, Mr. CHABOT, and Mr. RENACCI 
JULY 24, 2014 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on March 13, 2014] 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide an alternative process for review of safety and 
effectiveness of nonprescription sunscreen active ingredi-
ents and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Sunscreen Innovation 
Act’’. 
SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN 
ACTIVE INGREDIENTS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the 
end the following: 
‘‘Subchapter I—Nonprescription Sunscreen 
Active Ingredients 
‘‘SEC. 586. DEFINITIONS. 
‘‘In this subchapter: 
‘‘(1) The term ‘Advisory Committee’ means the 
Nonprescription Drug Advisory Committee or any 
successor to such Committee. 
‘‘(2) The terms ‘generally recognized as safe and 
effective’ and ‘GRASE’ mean generally recognized, 
among experts qualified by scientific training and ex-
perience to evaluate the safety and effectiveness of 
drugs, as safe and effective for use under the condi-
tions prescribed, recommended, or suggested in the 
product’s labeling, as described in section 201(p). 
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‘‘(3) The term ‘GRASE determination’ means, 
with respect to a nonprescription sunscreen active in-
gredient or a combination of nonprescription sun-
screen active ingredients, a determination of whether 
such ingredients or combination of ingredients is gen-
erally recognized as safe and effective and not mis-
branded for use under the conditions prescribed, rec-
ommended, or suggested in the product’s labeling, as 
described in section 201(p). 
‘‘(4) The term ‘nonprescription’ means not sub-
ject to section 503(b)(1). 
‘‘(5) The term ‘pending request’ means each re-
quest submitted to the Secretary— 
‘‘(A) for consideration for inclusion in the 
over-the-counter drug monograph system; 
‘‘(B) that was deemed eligible for such re-
view by publication of a notice of eligibility in 
the Federal Register prior to the date of enact-
ment of the Sunscreen Innovation Act; and 
‘‘(C) for which safety and effectiveness data 
has been submitted to the Secretary prior to such 
date of enactment. 
‘‘(6) The term ‘sponsor’ means the person sub-
mitting the request under section 586A(a), including 
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a time and extent application under section 586B, or 
the person that submitted the pending request. 
‘‘(7) The term ‘sunscreen active ingredient’ 
means an active ingredient that is intended for appli-
cation to the skin of humans for purposes of absorb-
ing, reflecting, or scattering radiation. 
‘‘(8) The term ‘sunscreen’ means a product con-
taining one or more sunscreen active ingredients. 
‘‘SEC. 586A. GENERAL PROVISIONS. 
‘‘(a) REQUESTS.—Any person may submit a request 
to the Secretary for a determination of whether a non-
prescription sunscreen active ingredient or a combination 
of nonprescription sunscreen active ingredients, for use 
under specified conditions, to be prescribed, recommended, 
or suggested in the labeling thereof (including dosage form, 
dosage strength, and route of administration) is generally 
recognized as safe and effective and not misbranded. 
‘‘(b) RULES OF CONSTRUCTION.— 
‘‘(1) CURRENTLY
MARKETED
SUNSCREENS.— 
Nothing in this subchapter shall be construed to affect 
the marketing of sunscreens that are lawfully mar-
keted in the United States on or before the date of en-
actment of this subchapter. 
‘‘(2) ENSURING SAFETY AND EFFECTIVENESS.— 
Nothing in this subchapter shall be construed to alter 
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the Secretary’s authority to prohibit the marketing of 
a sunscreen that is not safe and effective or to impose 
restrictions on the marketing of a sunscreen to ensure 
safety and effectiveness. 
‘‘(3) OTHER PRODUCTS.—Nothing in this sub-
chapter shall be construed to affect the Secretary’s 
regulation of products other than sunscreens. 
‘‘(c) SUNSET.—This subchapter shall cease to be effec-
tive at the end of the 5-year period beginning on the date 
of enactment of this subchapter. 
‘‘SEC. 586B. ELIGIBILITY DETERMINATION. 
‘‘(a) IN GENERAL.—Upon receipt of a request under 
section 586A(a), not later than 60 days after the date of 
receipt of such request, the Secretary shall— 
‘‘(1) determine whether the request is eligible for 
further review under sections 586C and 586D, as de-
scribed in subsection (b); 
‘‘(2) notify the sponsor of the Secretary’s deter-
mination; and 
‘‘(3) make such determination publicly available 
in accordance with subsection (c). 
‘‘(b) CRITERIA FOR ELIGIBILITY.— 
‘‘(1) IN
GENERAL.—To be eligible for review 
under sections 586C and 586D, a request shall be for 
a nonprescription sunscreen active ingredient or com-
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bination of nonprescription sunscreen active ingredi-
ents, for use under specified conditions, to be pre-
scribed, recommended, or suggested in the labeling 
thereof, that— 
‘‘(A) is not included in the stayed sunscreen 
monograph in part 352 of title 21, Code of Fed-
eral Regulations; and 
‘‘(B) has been used to a material extent and 
for a material time, as described in section 
201(p)(2). 
‘‘(2) TIME AND EXTENT APPLICATION.—A spon-
sor shall include in a request under section 586A(a) 
a time and extent application including all the infor-
mation required to meet the standard described in 
paragraph (1)(B). 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) REDACTIONS FOR CONFIDENTIAL INFORMA-
TION.—If a nonprescription sunscreen active ingre-
dient or combination of nonprescription sunscreen ac-
tive ingredients is determined to be eligible for further 
review under subsection (a)(1), the Secretary shall 
make the request publicly available, with redactions 
for information that is treated as confidential under 
section 552(b) of title 5, United States Code, section 
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1905 of title 18, United States Code, or section 301(j) 
of this Act. 
‘‘(2) IDENTIFICATION OF CONFIDENTIAL INFOR-
MATION BY SPONSOR.—Sponsors shall identify any 
information which the sponsor considers to be con-
fidential information described in paragraph (1). 
‘‘(3) CONFIDENTIALITY DURING ELIGIBILITY RE-
VIEW.—The information contained in a request under 
section 586A(a) shall remain confidential during the 
Secretary’s consideration under this section of wheth-
er the request is eligible for further review. 
‘‘SEC. 586C. DATA SUBMISSION; FILING DETERMINATION. 
‘‘(a) IN GENERAL.—In the case of a request under sec-
tion 586A(a) that is determined to be eligible under section 
586B for further review under this section and section 
586D— 
‘‘(1) the Secretary shall, in notifying the public 
under section 586B(a)(3) of such eligibility deter-
mination, invite the sponsor of the request and any 
other interested party to submit, in support of or oth-
erwise relating to a GRASE determination— 
‘‘(A) published and unpublished data and 
other information related to the safety and effec-
tiveness of the nonprescription sunscreen active 
ingredient or combination of nonprescription 
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‘‘(B) limit such public comment, and the 
comment period under paragraph (1), to the pe-
riod ending on the date that is 60 days after 
such filing; 
‘‘(4) if the Secretary refuses to file the request— 
‘‘(A) the sponsor may, within 30 days of re-
ceipt of written notification of such refusal, seek 
a meeting with the Secretary regarding whether 
the Secretary should file the request; and 
‘‘(B) the Secretary shall convene the meet-
ing; and 
‘‘(5) following any such meeting— 
‘‘(A) if the sponsor asks that the Secretary 
file the request (with or without amendments to 
correct any purported deficiencies to the request) 
the Secretary shall file the request over protest, 
issue a written notification of the filing to the 
sponsor, and make such notification publicly 
available; and 
‘‘(B) if the request is so filed over protest, 
the Secretary shall not require the sponsor to re-
submit a copy of the request for purposes of such 
filing. 
‘‘(b) REASONS FOR REFUSAL TO FILE REQUEST.—The 
Secretary may refuse to file a request submitted under sec-
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tion 586A(a) if the Secretary determines the data or other 
information submitted by the sponsor under this section are 
not sufficiently complete to conduct a substantive review 
with respect to such request. 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) REDACTIONS FOR CONFIDENTIAL INFORMA-
TION.—The Secretary shall make data and other in-
formation submitted in connection with a request 
under section 586A(a) publicly available, with 
redactions for information that is treated as confiden-
tial under section 552(b) of title 5, United States 
Code, section 1905 of title 18, United States Code, or 
section 301(j) of this Act. 
‘‘(2) IDENTIFICATION OF CONFIDENTIAL INFOR-
MATION BY SPONSOR.—Sponsors or any other indi-
vidual submitting data or other information under 
this section shall identify any information which the 
sponsor or individual considers to be confidential in-
formation described in paragraph (1). 
‘‘SEC. 586D. GRASE DETERMINATION. 
‘‘(a) REVIEW OF NEW REQUEST.— 
‘‘(1) PROPOSED ORDER BY CDER.—In the case of 
a request under section 586A(a), the Director of the 
Center for Drug Evaluation and Research shall— 
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‘‘(A) not later than 300 days after the date 
on which the request is filed under section 
586C(a), complete the review of the request and 
issue a proposed order determining that— 
‘‘(i) the nonprescription sunscreen ac-
tive ingredient or combination of non-
prescription sunscreen active ingredients 
that is the subject of the request— 
‘‘(I) is GRASE; and 
‘‘(II) is not misbranded; 
‘‘(ii) the nonprescription sunscreen ac-
tive ingredient or combination of non-
prescription sunscreen active ingredients 
that is the subject of the request— 
‘‘(I) is not GRASE; or 
‘‘(II) is misbranded; or 
‘‘(iii) additional information is nec-
essary to allow the Director of the Center 
for Drug Evaluation and Research to com-
plete the review of such request; 
‘‘(B) within such 300-day period, convene a 
meeting of the Advisory Committee to review the 
request under section 586A(a): and 
‘‘(C) if the Director fails to issue such pro-
posed order within the 300-day period referred to 
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in subparagraph (A), transmit the request to the 
Commissioner of Food and Drugs for review. 
‘‘(2) PROPOSED
ORDER
BY
COMMISSIONER.— 
With respect to a request transmitted to the Commis-
sioner of Food and Drugs under paragraph (1)(C), 
the Commissioner shall, not later than 60 days after 
the date of such transmission, issue— 
‘‘(A) a proposed order described in para-
graph (1)(A)(i); 
‘‘(B) a proposed order described in para-
graph (1)(A)(ii); or 
‘‘(C) a proposed order described in para-
graph (1)(A)(iii). 
‘‘(3) PUBLICATION IN FEDERAL REGISTER; PUB-
LIC
COMMENT
PERIOD.—A proposed order issued 
under paragraph (1) or (2) with respect to a request 
shall— 
‘‘(A) be published in the Federal Register; 
and 
‘‘(B) solicit public comments for a period of 
not more than 45 days. 
‘‘(4) FINAL ORDER BY CDER.—In the case of a 
proposed order under paragraph (1)(A) or (2) with 
respect to a request, the Director of the Center for 
Drug Evaluation and Research shall— 
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‘‘(A) issue a final order with respect to the 
request— 
‘‘(i) in the case of a proposed order 
under clause (i) or (ii) of paragraph (1)(A) 
or subparagraph (A) or (B) of paragraph 
(2), not later than 90 days after the end of 
the public comment period under paragraph 
(3)(B); or 
‘‘(ii) in the case of a proposed order 
under paragraph (1)(A)(iii) or paragraph 
(2)(C), not later than 210 days after the 
date on which the sponsor submits the addi-
tional information requested pursuant to 
such proposed order; or 
‘‘(B) if the Director fails to issue such final 
order within such 90- or 210-day period, as ap-
plicable, transmit such proposed order to the 
Commissioner of Food and Drugs for review. 
‘‘(5) FINAL ORDER BY COMMISSIONER.—With re-
spect to a proposed order transmitted to the Commis-
sioner of Food and Drugs under paragraph (4)(B), 
the Commissioner shall issue a final order with re-
spect to such proposed order not later than 60 days 
after the date of such transmission. 
‘‘(b) REVIEW OF PENDING REQUESTS.— 
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‘‘(1) IN GENERAL.—The review of a pending re-
quest shall be carried out by the Director of the Center 
for Drug Evaluation and Research in accordance 
with paragraph (3). 
‘‘(2) 
INAPPLICABILITY
OF
CERTAIN
PROVI-
SIONS.—Sections 586B and 586C shall not apply 
with respect to any pending request. 
‘‘(3) PROPOSED ORDER BY CDER.—The Director 
of the Center for Drug Evaluation and Research 
shall— 
‘‘(A) within the timeframe applicable under 
paragraph (4), complete the review of the request 
and issue a proposed order determining that— 
‘‘(i) the nonprescription sunscreen ac-
tive ingredient or combination of non-
prescription sunscreen active ingredients 
that is the subject of the pending request— 
‘‘(I) is GRASE; and 
‘‘(II) is not misbranded; 
‘‘(ii) the nonprescription sunscreen ac-
tive ingredient or combination of non-
prescription sunscreen active ingredients 
that is the subject of the pending request— 
‘‘(I) is not GRASE; or 
‘‘(II) is misbranded; or 
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‘‘(iii) additional information is nec-
essary to allow the Director of the Center 
for Drug Evaluation and Research to com-
plete the review of the pending request; and 
‘‘(B) if the Director fails to issue such pro-
posed order within the timeframe applicable 
under paragraph (4), transmit the pending re-
quest to the Commissioner of Food and Drugs for 
review. 
‘‘(4) TIMEFRAME FOR ISSUANCE OF PROPOSED 
ORDER
BY
CDER.—The Director of the Center for 
Drug Evaluation and Research shall issue a proposed 
order, as required by paragraph (3)(A)— 
‘‘(A) in the case of a pending request for 
which the Food and Drug Administration has 
issued a feedback letter before the date of enact-
ment of the Sunscreen Innovation Act, not later 
than 45 days after such date of enactment; and 
‘‘(B) in the case of a pending request for 
which the Food and Drug Administration has 
not issued a feedback letter before the date of en-
actment of the Sunscreen Innovation Act, not 
later than 90 days after such date of enactment. 
‘‘(5) PROPOSED
ORDER
BY
COMMISSIONER.— 
With respect to a pending request transmitted to the 
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Commissioner of Food and Drugs under paragraph 
(3)(B), the Commissioner shall, not later than 60 
days after the date of such transmission, issue— 
‘‘(A) a proposed order described in para-
graph (3)(A)(i); 
‘‘(B) a proposed order described in para-
graph (3)(A)(ii); or 
‘‘(C) a proposed order described in para-
graph (3)(A)(iii). 
‘‘(6) PUBLICATION IN FEDERAL REGISTER; PUB-
LIC
COMMENT
PERIOD.—A proposed order issued 
under paragraph (3) or (5) with respect to a pending 
request shall— 
‘‘(A) be published in the Federal Register; 
and 
‘‘(B) solicit public comments for a period of 
not more than 45 days. 
‘‘(7) ADVISORY
COMMITTEE.—For a proposed 
order issued under paragraph (3)(A)(iii) or (5)(C) re-
questing additional information, an Advisory Com-
mittee meeting shall be convened if the sponsor re-
quests, or the Director of the Center for Drug Evalua-
tion and Research or the Commissioner of Food and 
Drugs decides, to convene such a meeting for the pur-
pose of reviewing the pending request. 
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which the sponsor submits such addi-
tional information; or 
‘‘(B) if the Director fails to issue such final 
order within such 90-, 210-, and 270-day period, 
as applicable, transmit such proposed order to 
the Commissioner of Food and Drugs for review. 
‘‘(9) FINAL ORDER BY COMMISSIONER.—With re-
spect to a proposed order transmitted to the Commis-
sioner of Food and Drugs under paragraph (8)(B), 
the Commissioner shall issue a final order with re-
spect to such proposed order not later than 60 days 
after the date of such transmission. 
‘‘(c) ADVISORY COMMITTEE.— 
‘‘(1) LIMITATIONS.—The Food and Drug Admin-
istration— 
‘‘(A) shall not be required to convene the 
Advisory Committee— 
‘‘(i) more than once with respect to 
any request under section 586A(a) or any 
pending request; or 
‘‘(ii) more than twice in any twelve 
month period with respect to the review of 
submissions under this section; and 
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‘‘(B) shall not be required to submit more 
than 3 submissions to the Advisory Committee 
per meeting. 
‘‘(2) MEMBERSHIP.—In appointing the members 
of the Advisory Committee, the Secretary may select 
to serve temporarily as voting members on the Advi-
sory Committee— 
‘‘(A) members of other Federal advisory 
committees; or 
‘‘(B) consultants from outside of the Depart-
ment of Health and Human Services who have 
substantive expertise regarding sunscreen active 
ingredients. 
‘‘(d) NO DELEGATION.—Any responsibility vested by 
this section in the Commissioner of Food and Drugs is not 
delegable. 
‘‘(e) EFFECT OF FINAL ORDER.— 
‘‘(1) CONTENT.—A final order under subsection 
(a)(4), (a)(5), (b)(8), or (b)(9) with respect to a re-
quest under section 586A(a) or a pending request 
shall determine that the nonprescription sunscreen ac-
tive ingredient or combination of nonprescription 
sunscreen active ingredients that is the subject of the 
request— 
‘‘(A) is GRASE and is not misbranded; or 
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‘‘(B) is not GRASE or is misbranded. 
‘‘(2) ACTIVE INGREDIENTS DETERMINED TO BE 
GRASE.—Upon issuance of a final order determining 
that a nonprescription sunscreen active ingredient or 
combination of nonprescription sunscreen active in-
gredients is GRASE and is not misbranded, the ac-
tive ingredient or combination of active ingredients 
shall be permitted to be introduced or delivered into 
interstate commerce, for use under the conditions sub-
ject to the final order, in accordance with all require-
ments applicable to drugs not subject to section 
503(b)(1). 
‘‘(3) ACTIVE INGREDIENTS DETERMINED NOT TO 
BE GRASE.—Upon issuance of a final order deter-
mining that the nonprescription sunscreen active in-
gredient or combination of nonprescription sunscreen 
active ingredients is not GRASE or is misbranded, 
the active ingredient or combination of active ingredi-
ents shall not be introduced or delivered into inter-
state commerce, for use under the conditions subject 
to the final order, unless an application submitted 
pursuant to section 505(b) with respect to such active 
ingredient or combination of active ingredients is ap-
proved. 
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‘‘SEC. 586E. REPORTS. 
‘‘(a) GAO REPORT.—Not later than 1 year after the 
date of enactment of the Sunscreen Innovation Act, the 
Comptroller General of the United States shall— 
‘‘(1) submit a report reviewing the overall 
progress of the Secretary in carrying out this sub-
chapter to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representa-
tives; and 
‘‘(2) include findings on— 
‘‘(A) the progress made in completing the 
review of pending requests; and 
‘‘(B) the role of the Office of the Commis-
sioner of Food and Drugs in issuing determina-
tions with respect to pending requests, including 
the number of requests transferred to the Office 
of the Commissioner under section 586D. 
‘‘(b) SECRETARY’S REPORT.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the Sunscreen Innovation 
Act, and every 2 years thereafter, the Secretary shall 
issue a report to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives describing actions taken under this 
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section. Each report under this subsection shall be 
posted on the Internet site of the Food and Drug Ad-
ministration. 
‘‘(2) CONTENTS.—The reports under this sub-
section shall include— 
‘‘(A) a review of the progress made in 
issuing GRASE determinations for pending re-
quests, including the number of pending re-
quests— 
‘‘(i) reviewed and the decision times 
for each request, measured from the date of 
the original request for an eligibility deter-
mination submitted by the sponsor; 
‘‘(ii) resulting in a determination that 
the nonprescription sunscreen active ingre-
dient or combination of nonprescription 
sunscreen active ingredients is GRASE and 
not misbranded; 
‘‘(iii) resulting in a determination that 
the nonprescription sunscreen active ingre-
dient or combination of nonprescription 
sunscreen active ingredients is not GRASE 
and is misbranded and the reasons for such 
determinations; and 
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‘‘(iv) for which a determination has 
not been made, an explanation for the 
delay, a description of the current status of 
each such request, and the length of time 
each such request has been pending, meas-
ured from the date of original request for an 
eligibility determination by the sponsor; 
‘‘(B) a review of the progress made in 
issuing in a timely manner GRASE determina-
tions for requests submitted under section 
586A(a), including the number of such re-
quests— 
‘‘(i) reviewed and the decision times 
for each request; 
‘‘(ii) resulting in a determination that 
the nonprescription sunscreen active ingre-
dient or combination of nonprescription 
sunscreen active ingredients is GRASE and 
not misbranded; 
‘‘(iii) resulting in a determination that 
the nonprescription sunscreen active ingre-
dient or combination of nonprescription 
sunscreen active ingredients is not GRASE 
and is misbranded and the reasons for such 
determinations; and 
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‘‘(iv) for which a determination has 
not been made, an explanation for the 
delay, a description of the current status of 
each such request, and the length of time 
each such request has been pending, meas-
ured from the date of original request for an 
eligibility determination by the sponsor; 
‘‘(C) a description of the staffing and re-
sources relating to the costs associated with the 
review and decisionmaking pertaining to re-
quests under this subchapter; 
‘‘(D) a review of the progress made in meet-
ing the deadlines with respect to processing re-
quests under this subchapter; 
‘‘(E) to the extent the Secretary determines 
appropriate, recommendations for process im-
provements in the handling of pending and new 
requests, including the advisory committee re-
view process; and 
‘‘(F) recommendations for expanding the 
applicability of this subchapter to nonprescrip-
tion active ingredients that are not related to the 
sunscreen category of over-the-counter drugs. 
‘‘(c) METHOD.—The Secretary shall publish the re-
ports required under subsection (b) in the manner the Sec-
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retary determines to be the most effective for efficiently dis-
seminating the report, including publication of the report 
on the Internet website of the Food and Drug Administra-
tion.’’. 
SEC. 3. GUIDANCE. 
(a) IN GENERAL.— 
(1) ISSUANCE.—Not later than one year after the 
date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commis-
sioner of Food and Drugs, shall issue guidance, in ac-
cordance with good guidance practices, on the imple-
mentation of, and compliance with, subchapter I of 
chapter V of the Federal Food, Drug, and Cosmetic 
Act, as added by section 2, including guidance on— 
(A) the criteria for determining whether a 
nonprescription sunscreen active ingredient or 
combination of nonprescription sunscreen active 
ingredients has been used to a material extent 
and for a material time, as described in section 
201(p)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(p)(2)); 
(B) the format and content of a safety and 
effectiveness data submission; and 
(C) the safety and efficacy standards for de-
termining whether a nonprescription sunscreen 
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active ingredients or combination of non-
prescription sunscreen active ingredients is gen-
erally recognized as safe and effective, as defined 
in section 586 of such subchapter I. 
(2) INAPPLICABILITY OF PAPERWORK REDUCTION 
ACT.—Chapter 35 of title 44, United States Code, 
shall not apply to collections of information made for 
purposes of guidance under this subsection. 
(b) SUBMISSIONS PENDING ISSUANCE OF FINAL GUID-
ANCE.—Irrespective of whether final guidance under sub-
section (a) has been issued— 
(1) persons may, beginning on the date of enact-
ment of this Act, make submissions under subchapter 
I of chapter V of the Federal Food, Drug, and Cos-
metic Act, as added by section 2; and 
(2) the Secretary of Health and Human Serv-
ices, acting through the Commissioner of Food and 
Drugs, shall review and act upon such submissions in 
accordance with such subchapter. 
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Union Calendar No. 418 
113TH CONGRESS 
2D SESSION 
H. R. 4250 
[Report No. 113–558] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to provide an alternative process for review 
of safety and effectiveness of nonprescription 
sunscreen active ingredients and for other pur-
poses. 
JULY 24, 2014 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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