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