
[Federal Register: August 4, 2008 (Volume 73, Number 150)]
[Notices]               
[Page 45227-45228]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au08-46]                         

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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Draft Guidance for Industry on Labeling OTC Skin Protectant Drug 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availability of a draft guidance for industry entitled ``Labeling OTC 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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INFORMATION section for electronic access to the draft guidance 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
