II 
113TH CONGRESS 
2D SESSION 
H. R. 4250 
IN THE SENATE OF THE UNITED STATES 
JULY 29, 2014 
Received 
AN ACT 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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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 recog-
nized, among experts qualified by scientific training 
and experience to evaluate the safety and effective-
ness of drugs, as safe and effective for use under the 
conditions prescribed, recommended, or suggested in 
the product’s labeling, as described in section 
201(p). 
‘‘(3) The term ‘GRASE determination’ means, 
with respect to a nonprescription sunscreen active 
ingredient or a combination of nonprescription sun-
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screen active ingredients, a determination of whether 
such ingredients or combination of ingredients is 
generally recognized as safe and effective and not 
misbranded for use under the conditions prescribed, 
recommended, 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 
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 ap-
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plication to the skin of humans for purposes of ab-
sorbing, reflecting, or scattering radiation. 
‘‘(8) The term ‘sunscreen’ means a product 
containing 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 mis-
branded. 
‘‘(b) RULES OF CONSTRUCTION.— 
‘‘(1) CURRENTLY
MARKETED
SUNSCREENS.— 
Nothing in this subchapter shall be construed to af-
fect the marketing of sunscreens that are lawfully 
marketed in the United States on or before the date 
of enactment of this subchapter. 
‘‘(2) ENSURING
SAFETY
AND
EFFECTIVE-
NESS.—Nothing in this subchapter shall be con-
strued to alter the Secretary’s authority to prohibit 
the marketing of a sunscreen that is not safe and ef-
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fective 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 ef-
fective 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 described 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 
combination of nonprescription sunscreen active in-
gredients, for use under specified conditions, to be 
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prescribed, recommended, or suggested in the label-
ing thereof, that— 
‘‘(A) is not included in the stayed sun-
screen monograph in part 352 of title 21, Code 
of Federal 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 
sponsor shall include in a request under section 
586A(a) a time and extent application including all 
the information required to meet the standard de-
scribed in paragraph (1)(B). 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) REDACTIONS FOR CONFIDENTIAL INFOR-
MATION.—If a nonprescription sunscreen active in-
gredient or combination of nonprescription sun-
screen active ingredients is determined to be eligible 
for further review under subsection (a)(1), the Sec-
retary shall make the request publicly available, with 
redactions for information that is treated as con-
fidential 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. 
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‘‘(2) IDENTIFICATION
OF
CONFIDENTIAL
IN-
FORMATION BY SPONSOR.—Sponsors shall identify 
any information which the sponsor considers to be 
confidential information described in paragraph (1). 
‘‘(3) CONFIDENTIALITY
DURING
ELIGIBILITY 
REVIEW.—The information contained in a request 
under section 586A(a) shall remain confidential dur-
ing the Secretary’s consideration under this section 
of whether the request is eligible for further review. 
‘‘SEC. 586C. DATA SUBMISSION; FILING DETERMINATION. 
‘‘(a) IN GENERAL.—In the case of a request under 
section 586A(a) that is determined to be eligible under 
section 586B for further review under this section and sec-
tion 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 
otherwise relating to a GRASE determination— 
‘‘(A) published and unpublished data and 
other information related to the safety and ef-
fectiveness of the nonprescription sunscreen ac-
tive ingredient or combination of nonprescrip-
tion sunscreen active ingredients for its in-
tended nonprescription uses; or 
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under section 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 sub-
stantive review with respect to such request. 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) REDACTIONS FOR CONFIDENTIAL INFOR-
MATION.—The Secretary shall make data and other 
information submitted in connection with a request 
under section 586A(a) publicly available, with 
redactions for information that is treated as con-
fidential 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
IN-
FORMATION BY SPONSOR.—Sponsors or any other 
individual submitting data or other information 
under this section shall identify any information 
which the sponsor or individual considers to be con-
fidential information 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 
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to in subparagraph (A), transmit the request to 
the Commissioner of Food and Drugs for re-
view. 
‘‘(2) PROPOSED ORDER BY COMMISSIONER.— 
With respect to a request transmitted to the Com-
missioner 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; 
PUBLIC
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 
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respect to a request, the Director of the Center for 
Drug Evaluation and Research shall— 
‘‘(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 para-
graph (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 ad-
ditional 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 applicable, transmit such proposed order to 
the Commissioner of Food and Drugs for re-
view. 
‘‘(5) FINAL ORDER BY COMMISSIONER.—With 
respect to a proposed order transmitted to the Com-
missioner of Food and Drugs under paragraph 
(4)(B), the Commissioner shall issue a final order 
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with respect to such proposed order not later than 
60 days after the date of such transmission. 
‘‘(b) REVIEW OF PENDING REQUESTS.— 
‘‘(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 accord-
ance 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 Direc-
tor of the Center for Drug Evaluation and Research 
shall— 
‘‘(A) within the timeframe applicable under 
paragraph (4), complete the review of the re-
quest 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 re-
quest— 
‘‘(I) is GRASE; and 
‘‘(II) is not misbranded; 
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‘‘(ii) the nonprescription sunscreen ac-
tive ingredient or combination of non-
prescription sunscreen active ingredients 
that is the subject of the pending re-
quest— 
‘‘(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 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 pro-
posed 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 en-
actment of the Sunscreen Innovation Act, not 
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later than 45 days after such date of enact-
ment; 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 
enactment of the Sunscreen Innovation Act, not 
later than 90 days after such date of enact-
ment. 
‘‘(5) PROPOSED ORDER BY COMMISSIONER.— 
With respect to a pending request transmitted to the 
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; 
PUBLIC
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 
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‘‘(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 
‘‘(B) shall not be required to submit more 
than 3 submissions to the Advisory Committee 
per meeting. 
‘‘(2) MEMBERSHIP.—In appointing the mem-
bers of the Advisory Committee, the Secretary may 
select to serve temporarily as voting members on the 
Advisory Committee— 
‘‘(A) members of other Federal advisory 
committees; or 
‘‘(B) consultants from outside of the De-
partment 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.— 
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‘‘(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 
active ingredient or combination of nonprescription 
sunscreen active ingredients that is the subject of 
the request— 
‘‘(A) is GRASE and is not misbranded; or 
‘‘(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 
subject to the final order, in accordance with all re-
quirements applicable to drugs not subject to section 
503(b)(1). 
‘‘(3) ACTIVE INGREDIENTS DETERMINED NOT 
TO BE GRASE.—Upon issuance of a final order de-
termining that the nonprescription sunscreen active 
ingredient or combination of nonprescription sun-
screen active ingredients is not GRASE or is mis-
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branded, the active ingredient or combination of ac-
tive ingredients shall not be introduced or delivered 
into interstate commerce, for use under the condi-
tions subject to the final order, unless an application 
submitted pursuant to section 505(b) with respect to 
such active ingredient or combination of active in-
gredients is approved. 
‘‘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 Com-
mittee on Energy and Commerce of the House of 
Representatives; 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, includ-
ing the number of requests transferred to the 
Office of the Commissioner under section 586D. 
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‘‘(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 section. Each report under this subsection shall 
be posted on the Internet site of the Food and Drug 
Administration. 
‘‘(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 de-
termination submitted by the sponsor; 
‘‘(ii) resulting in a determination that 
the nonprescription sunscreen active ingre-
dient or combination of nonprescription 
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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 
‘‘(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 
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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 
‘‘(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 
meeting the deadlines with respect to processing 
requests under this subchapter; 
‘‘(E) to the extent the Secretary deter-
mines appropriate, recommendations for process 
improvements in the handling of pending and 
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