Document ID: FDA-2012-D-1086-0001
Agency: fda
Document Type: Notice
Title: Compliance Guidancesfor Small Business Entities; Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Availability
Posted Date: 2012-12-06T05:00Z

[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Notices]
[Pages 72868-72869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29462]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1086]

Compliance Guidance for Small Business Entities on Labeling and 
Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter 
Human Use; Notice of Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a compliance guidance for small business entities 
entitled ``Labeling and Effectiveness Testing: Sunscreen Drug Products 
for Over-the-Counter Human Use; Small Entity Compliance Guide.'' This 
guidance is intended to help small businesses understand and comply 
with the requirements of the final rule addressing labeling and 
effectiveness testing requirements for over-the counter (OTC) sunscreen 
drug products. The guidance describes the requirements of the final 
rule in plain language and provides answers to common questions on how 
to comply with the rule. This guidance was prepared in accordance with 
the Small Business Regulatory Enforcement Fairness Act.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 
guidance document.
    Submit electronic comments on the 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 
Hampshire Ave., Bldg. 22, Rm. 5493, Silver Spring, MD 20993-0002, 301-
796-1009.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a compliance guidance for 
small business entities entitled ``Labeling and Effectiveness Testing: 
Sunscreen Drug Products for Over-the-Counter Human Use; Small Entity 
Compliance Guide.'' This guidance summarizes the June 17, 2011, final 
rule (76 FR 35620) regarding labeling and testing requirements for OTC 
sunscreen drug products. Under the 2011 sunscreen final rule, required 
and permitted labeling is based upon the results of effectiveness 
testing. The effectiveness testing consists of a sun protection factor 
(SPF) Test and a Broad Spectrum (ultraviolet A (UVA) and ultraviolet B 
(UVB) protection) Test. In addition, a test demonstrating water 
resistance that accompanies the SPF Test to ensure retention of SPF

[[Page 72869]]

protection while swimming or sweating is described. The 2011 sunscreen 
final rule makes the following changes to OTC sunscreen drug product 
regulations:
     Requires that OTC sunscreen drug products follow Drug 
Facts labeling content and format requirements in Sec.  201.66 (21 CFR 
201.66).
     Establishes new labeling requirements for marketed OTC 
sunscreen drug products set forth in Sec.  201.327 (21 CFR 201.327).
     Revises SPF, broad spectrum, and water-resistant testing 
requirements and the indications and claims allowed based upon the 
results of these tests in Sec.  201.327(i) and (j).
    FDA is issuing this compliance guidance for small business entities 
as a level 2 guidance consistent with FDA's good guidance practices 
regulation (21 CFR 10.115). The guidance represents the Agency's 
current thinking on the testing requirements for OTC sunscreen drug 
products and revision of labeling requirements for OTC sunscreen drug 
products. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec.  201.327 have been approved under 
OMB control number 0910-0717.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: November 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29462 Filed 12-5-12; 8:45 am]
BILLING CODE 4160-01-P