be made publicly available, within 45 days of 
receiving such recommendation, and indicate 
whether such sunscreen condition determined to 
be not generally recognized as safe and effective 
to be marketed and sold unless an application 
with respect to such condition is approved 
under section 505(b), or whether additional 
data must be submitted to the advisory com-
mittee. 
‘‘(2) SUPERVISORY
REVIEW
OF
DETERMINA-
TION.— 
‘‘(A) IN GENERAL.—Any person may re-
quest a supervisory review of a determination of 
the Center for Drug Evaluation and Research 
to not accept a recommendation of an advisory 
committee. Such review may be conducted at 
the next supervisory or higher level above the 
individual who made the determination. 
‘‘(B) REQUEST
FOR
SUPERVISORY
RE-
VIEW.—A request described in subparagraph 
(A) shall be made to the Secretary not later 
than 30 days after such decision and shall indi-
cate in the request whether such person seeks 
an in-person meeting or a teleconference. The 
Secretary shall schedule an in-person or tele-
VerDate Mar 15 2010 
04:11 Mar 21, 2014
Jkt 039200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H4250.IH
H4250
jbell on DSK7SPTVN1PROD with BILLS
conference review, if so requested, not later 
than 30 days after such request is made. The 
Secretary shall issue a decision to the person 
requesting a review under this paragraph not 
later than 45 days after the meeting. 
‘‘(C) STANDARD
OF
SUPERVISORY
RE-
VIEW.—The Secretary shall be authorized to 
overturn a determination of the Center for 
Drug Evaluation and Research not to accept a 
recommendation of the advisory committee if 
the supervisory review results in a decision by 
the reviewer that the individual who made the 
determination did not provide reasonable and 
sufficient substantive support for the decision 
to disregard the advisory committee’s rec-
ommendation. 
‘‘(D) SUPERVISORY REVIEW DECISION.—If 
the Secretary overturns a determination by the 
Center for Drug Evaluation and Research not 
to accept a favorable recommendation of an ad-
visory committee, the nonprescription sunscreen 
condition shall be generally recognized as safe 
and effective, not misbranded, and permitted to 
be marketed and sold in accordance with all ap-
VerDate Mar 15 2010 
04:11 Mar 21, 2014
Jkt 039200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H4250.IH
H4250
jbell on DSK7SPTVN1PROD with BILLS
plicable rules and regulations for over-the- 
counter drugs. 
‘‘(E) FINAL AGENCY ACTION.—A decision 
made through supervisory review shall con-
stitute final agency action subject to judicial re-
view. 
‘‘(j) REPORTS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the Sunscreen Innovation 
Act, on March 1, 2015, and every 2 years thereafter, 
the Secretary shall issue a report to Congress de-
scribing actions taken under this section. 
‘‘(2) CONTENTS.—The reports under paragraph 
(1) shall include— 
‘‘(A) a review of the progress made in 
issuing in a timely manner decisions on the 
safety and effectiveness for sunscreen condi-
tions for applications pending as of the date of 
enactment of the Sunscreen Innovation Act, in-
cluding the number of pending applications— 
‘‘(i) reviewed and the decision times 
for each application, measured from the 
date of original eligibility application sub-
mission by the sponsor; 
VerDate Mar 15 2010 
04:11 Mar 21, 2014
Jkt 039200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H4250.IH
H4250
jbell on DSK7SPTVN1PROD with BILLS
‘‘(ii) resulting in a determination of 
generally recognized as safe and effective 
and not misbranded; 
‘‘(iii) resulting in a determination of 
not generally recognized as safe and effec-
tive and not 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 application, and the length of 
time such applications have been pending, 
measured from the date of original eligi-
bility application submission by the spon-
sor; 
‘‘(B) a review of the progress made in 
issuing in a timely manner a decision on safety 
and effectiveness for sunscreen condition appli-
cations submitted after the date of enactment 
of the Sunscreen Innovation Act, including the 
number of such applications— 
‘‘(i) reviewed and the decision times 
for each application; 
VerDate Mar 15 2010 
04:11 Mar 21, 2014
Jkt 039200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H4250.IH
H4250
jbell on DSK7SPTVN1PROD with BILLS
‘‘(ii) resulting in a determination of 
generally recognized as safe and effective 
and not misbranded; and 
‘‘(iii) resulting in a determination of 
not generally recognized as safe and effec-
tive and not misbranded and the reasons 
for such determinations; 
‘‘(C) a description of the staffing and re-
sources relating to the costs associated with the 
review and decisionmaking pertaining to appli-
cations; 
‘‘(D) a review of the progress in meeting 
the deadlines with respect to processing applica-
tions under this section; 
‘‘(E) to the extent the Secretary deter-
mines appropriate, recommendations for process 
improvements in the handling of pending and 
new applications; and 
‘‘(F) recommendations for expanding the 
applicability of this section to nonprescription 
active ingredients or conditions that are not re-
lated to the sunscreen category of over-the- 
counter drugs. 
‘‘(3) METHOD.—The Secretary shall publish the 
reports required under this subsection in the manner 
VerDate Mar 15 2010 
04:11 Mar 21, 2014
Jkt 039200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H4250.IH
H4250
jbell on DSK7SPTVN1PROD with BILLS
the Secretary determines to be the most effective for 
efficiently disseminating the report, including publi-
cation of the report on the Internet website of the 
Food and Drug Administration. 
‘‘(k) RULES OF CONSTRUCTION.— 
‘‘(1) AUTHORITY
TO
WITHDRAW
OR
SUS-
PEND.—Nothing in this section shall be construed to 
alter the Secretary’s authority to withdraw or sus-
pend from the market a drug that the Secretary de-
termines to be unsafe or ineffective. 
‘‘(2) OTHER CONDITIONS.—Nothing in the sec-
tion shall affect the Secretary’s authority to review 
nonprescription conditions other than sunscreen con-
ditions.’’. 
SEC. 3. SUNSCREEN TESTING AND LABELING. 
Not later than 180 days after the date of enactment 
of this Act, the Secretary shall issue determinations with 
respect to— 
(1) the appropriate testing and labeling require-
ments for sunscreens sold as an aerosol; and 
(2) whether sunscreen may contain a label indi-
cating a sun protection factor greater than 50. 
Æ 
VerDate Mar 15 2010 
04:11 Mar 21, 2014
Jkt 039200
PO 00000
Frm 00025
Fmt 6652
Sfmt 6301
E:\BILLS\H4250.IH
H4250
jbell on DSK7SPTVN1PROD with BILLS