[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Rules and Regulations]
[Pages 35665-35668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 310

[Docket No. FDA-2010-D-0509]


Draft Guidance for Industry on Enforcement Policy for Over-the-
Counter Sunscreen Drug Products Marketed Without an Approved 
Application; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Enforcement 
Policy--OTC Sunscreen Drug Products Marketed Without an Approved 
Application.'' The draft guidance is intended to inform manufacturers 
of over-the-counter (OTC) sunscreen products about our enforcement 
policy for certain OTC sunscreen products marketed without an approved 
new drug application. The draft guidance describes our intended 
approach to enforcement for certain OTC sunscreen products prior to an 
effective final monograph.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers all comments on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 16, 2011. Submit written comments on the proposed 
collection of information by August 16, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New

[[Page 35666]]

Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Enforcement Policy--OTC Sunscreen Drug Products Marketed 
Without an Approved Application.'' Certain OTC sunscreen products 
without an approved new drug application \1\ have been marketed under 
our enforcement discretion while we work to establish a final monograph 
for OTC sunscreen products. These products are not yet the subject of 
an effective final monograph.
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    \1\ See section 505 of the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 355). Approved applications under section 505 include 
both new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs).
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    We continue to evaluate information to determine appropriate 
conditions for OTC sunscreen products to be generally recognized as 
safe and effective (GRASE) and not misbranded. In a final rule 
published elsewhere in this issue of the Federal Register, we establish 
in Sec.  201.327 (21 CFR 201.327) and Sec.  310.545 (21 CFR 310.545) 
labeling and testing requirements for OTC sunscreen products that 
contain certain active ingredients and are marketed without approved 
applications. We are also publishing a proposed rule elsewhere in this 
issue of the Federal Register that would, if finalized, limit the 
maximum labeled sun protection factor (SPF) value for OTC sunscreen 
products to ``50 +''or ``50 plus.'' In addition to both rules mentioned 
previously, we are publishing an ANPRM where we are asking sunscreen 
manufacturers and other interested parties to submit data on OTC 
sunscreen drug products marketed without approved applications that are 
formulated in certain dosage forms. For spray dosage forms, we are 
requesting data to resolve specific questions about both effectiveness 
and safety. We are also inviting comment on possible labeling and 
testing requirements for spray dosage forms.
    Because of this complex regulatory backdrop, we are developing a 
guidance to clarify our enforcement policy towards certain OTC 
sunscreen products before a final monograph becomes effective. The 
draft guidance applies only to OTC sunscreen products marketed without 
an approved application that contain only active ingredients or 
combinations of active ingredients identified as GRASE in a 1999 
sunscreen final rule published in the Federal Register of May 21, 1999 
(64 FR 27666) (the 1999 final rule) that was stayed before becoming 
effective (69 FR 53801, September 3, 2004);
    The draft guidance states our intention to continue to exercise 
enforcement discretion for these types of products under certain 
circumstances. The draft guidance addresses OTC sunscreen products 
subject to the final rule codified in Sec.  201.327 (i.e., products 
with Broad Spectrum SPF values of 15 or higher, products that do not 
provide broad spectrum protection, and products with Broad Spectrum SPF 
values between 2 and 14). The draft guidance also indicates the 
Agency's enforcement approach for sunscreen products labeled with 
specific SPF values higher than 50, sunscreens formulated in various 
dosage forms, and products that contain an insect repellent active 
ingredient registered with the Environmental Protection Agency. In 
addition, the draft guidance addresses enforcement policy with regard 
to the continued labeling of certain OTC sunscreens with SPF values 
determined using the SPF test methods contained in either the Agency's 
1999 final rule (64 FR 27666 at 27689 through 27693) or a proposed rule 
that published in the Federal Register of August 27, 2007 (the 2007 
proposed rule) (72 FR 49070 at 49114 through 49119).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on 
``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an 
Approved Application.'' It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance discusses our intended enforcement policy for 
OTC sunscreen products marketed without approved applications, 
including recommendations for labeling and testing of these products. 
Certain of these provisions are subject to review and approval by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (PRA) (44 U.S.C. 3501 et seq.). These provisions are discussed 
further in the following paragraphs.
    The draft guidance also references submissions under 21 CFR 330.14. 
The information collections provisions of that regulation have been 
submitted to OMB for approval, in accordance with the PRA (76 FR 6801, 
February 8, 2011).
    Under the PRA, Federal Agencies must obtain approval from OMB for 
each collection of information that they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA, (44 U.S.C. 
3506(c)(2)(A)), requires Federal Agencies to provide a 60-day notice in 
the Federal Register for each proposed collection of information before 
submitting the collection to OMB for approval.
    This draft guidance refers to labeling and testing requirements 
applicable to certain OTC sunscreen products under Sec.  201.327. 
Elsewhere in this issue of the Federal Register, in accordance with 
section 3506(c)(2)(A) of the PRA, we are publishing a 60-day notice 
soliciting public comment on the collections of information in that 
regulation and will then submit these information collection provisions 
to OMB for approval. These requirements will not be effective until we 
obtain OMB approval.
    This draft guidance also contains additional information collection 
provisions that are not addressed by the notice regarding the 
provisions of Sec.  201.327. To comply with the requirements of the 
PRA, we are publishing this notice of the additional proposed 
collection of information set forth in this guidance document and 
inviting comments on the following topics: (1) Whether the proposed 
information collected is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimated burden of the proposed 
information collected, including the validity of the methodology and 
assumptions used; (3) ways to enhance the quality, utility, and clarity 
of the information collected; and (4) ways to minimize the burden of 
information collected on the respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Information Collections Applicable to Sunscreens That Choose To Defer 
Retesting of SPF Values and Continue Labeling With a Previously-
Calculated SPF Value

    As already noted, the information collection provisions resulting 
from

[[Page 35667]]

Sec.  201.327 addressed in this draft guidance are the subject of a 60-
day PRA notice published elsewhere in this issue of the Federal 
Register. This draft guidance proposes to temporarily modify that 
information collection by stating that we do not intend to initiate 
enforcement action before June 17, 2013, if an OTC sunscreen subject to 
Sec.  201.327 that was initially marketed prior to June 17, 2011, the 
date of publication of the 2011 final rule, continues to include an SPF 
value in its labeling that was determined prior to that date according 
to either the SPF test method described in the 1999 final rule (64 FR 
27666 at 27689 through 27693) or the SPF test method described in the 
2007 proposed rule (72 FR 49070 at 49114 through 49119). We believe 
that the majority of currently-marketed sunscreen formulations will 
meet this standard and, therefore, may defer their conduct of new SPF 
testing. However, this one-time testing will need to be conducted 
within 2 years after publication of the 2011 final rule (Sec.  
201.327), which is within the period addressed in the PRA notice for 
that regulation. We, therefore, do not expect this draft guidance will 
alter the burden calculated for SPF testing under 201.327(i) or 
calculated for developing the PDP (principal display panel) label in 
compliance with 201.327(a)(1), as indicated in that document.
    Under the draft guidance, manufacturers who do choose to delay SPF 
testing in accordance with 201.327(i) would nonetheless be expected to 
include on their product's PDP the effectiveness statement required by 
201.327(a)(1)--either ``Broad Spectrum SPF'' or ``SPF'', as 
applicable--followed by the numerical SPF value resulting from prior 
testing. This creates a burden for third-party disclosure. With respect 
to the 2011 final rule, we estimated that there are approximately 100 
manufacturers of sunscreens (respondents) and we anticipated that it 
would require no more than 0.5 hours per stock keeping units (SKU) for 
these manufacturers to prepare and review labeling that inserts the SPF 
value into the effectiveness statement provided by 201.327(a)(1).\2\ We 
anticipate that manufacturers will choose to avail themselves of the 
delay of SPF testing provided for under the guidance for as many as 
half (1,175) of the 2,350 formulations estimated in the 2011 final 
rule. Based on the estimate that there are about 1.53 SKUs for every 
formulation, we estimate that as many as 1,798 SKUs may have to be re-
labeled. For these 1,798 SKUs, we estimate that it will take no more 
than 0.5 hours per SKU to prepare and review labeling that inserts a 
previously derived SPF value into the effectiveness (SPF) statement 
required under 201.327(a)(1). Therefore, the total burden is estimated 
be 899 hours (1,798 SKUs times 0.5 hours per SKU).
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    \2\ By the terms of our enforcement policy, such manufacturers 
would be employing an existing test value, and thus would not incur 
any additional burden of testing associated with this information 
collection provision.
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    The final rule becomes effective 1 year after its date of 
publication, so that firms that seek to fall within the enforcement 
policy described in the guidance will need to begin labeling products 
with their previously-derived SPF value within the first year after 
publication of the rule. (Under the enforcement policy guidance, 
labeling bearing a previously derived SPF value will have to be 
discontinued and replaced by the labeling required by 201.327(a)(1) no 
later than 2 years after the date of publication of the final rule.) We 
therefore assume that the entire burden of labeling products with 
previously derived SPF values will be incurred in the first year, with 
no recurrence. This burden estimate is presented in table 1 of this 
document.

[[Page 35668]]



                           Table 1--Estimated Annual Third-Party Disclosure Burden\1\
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                                                      Annual
            Activity                 Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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Create PDP labeling statement                100           17.98           1,798             0.5             899
 ``Broad Spectrum SPF [fill in
 value]'' based on existing SPF
 test results \2\...............
                                                                                                 ---------------
    Total first-year burden.....  ..............  ..............  ..............  ..............             899
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ First-year burden.

    We conclude that other labeling recommendations of the draft 
guidance are not subject to review by OMB under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.). The labeling statements for 
additional directions and warnings recommended in the guidance for 
sunscreens formulated as sprays are a ``public disclosure of 
information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)) and, therefore, are not collections of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14767 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P