[Federal Register Volume 73, Number 150 (Monday, August 4, 2008)]
[Notices]
[Pages 45227-45228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17835]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0387]
Draft Guidance for Industry on Labeling OTC Skin Protectant Drug
Products; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 45228]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Labeling OTC
Skin Protectant Drug Products.'' This guidance provides recommendations
on how to label over-the-counter (OTC) skin protectant drug products.
An OTC skin protectant active ingredient can be combined with another
OTC skin protectant active ingredient or OTC external analgesic, first
aid antiseptic, or sunscreen active ingredients. Each of these
combinations has specific labeling requirements, and therefore labeling
of OTC skin protectant drug products is complex. This guidance is
designed to clarify the permitted combinations of active ingredients
along with the corresponding required labeling.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 3, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5424, Silver Spring, MD 20993-0002, 301-
796-2090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Labeling OTC Skin Protectant Drug Products.'' In the Federal
Register of June 4, 2003 (68 FR 33362), FDA published a final rule
establishing conditions under which OTC skin protectant drug products
are generally recognized as safe and effective and not misbranded. In
developing this final rule, FDA acknowledged the complex task that
manufacturers of these products would face in meeting all the pertinent
labeling requirements. This draft guidance provides recommendations on
how to meet current labeling requirements according to OTC skin
protectant active ingredient.
Because OTC skin protectant active ingredients can be combined with
active ingredients from other OTC drug product categories, this draft
guidance is based upon the following rulemakings: (1) Final rule for
OTC skin protectant drug products (68 FR 33362, June 4, 2003); (2)
final rule for format and content of labeling of OTC drugs (64 FR
13254, March 17, 1999); (3) proposed rule for OTC sunscreen drug
products (72 FR 49070, August 27, 2007); (4) proposed rule for OTC
external analgesic drug products (48 FR 5852, February 8, 1983); and
(5) proposed rule for OTC first aid antiseptic drug products (56 FR
33644, July 22, 1991).
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 labeling OTC
skin protectant 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket numbers 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17835 Filed 8-1-08; 8:45 am]
BILLING CODE 4160-01-S