[Federal Register Volume 74, Number 91 (Wednesday, May 13, 2009)]
[Notices]
[Pages 22560-22561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0122] (formerly Docket No. 2004D-0327)


Compliance Guidance for Small Business Entities on Labeling Over-
the-Counter Human Drug Products; 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 OTC Human Drug Products; Small Entity Compliance 
Guide.'' FDA has prepared this guidance in accordance with the Small 
Business Regulatory Enforcement Fairness Act. It is intended to help 
small businesses better understand and comply with the agency's over-
the-counter (OTC) labeling requirements and to prepare new labeling. 
This compliance guidance finalizes the draft compliance guidance 
published on December 9, 2004.

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

ADDRESSES: Submit written requests for single copies of this compliance 
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 compliance 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 
compliance guidance document.

FOR FURTHER INFORMATION CONTACT: Marina Y. Chang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5418, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a compliance guidance for 
small business entities entitled ``Labeling OTC Human Drug Products; 
Small Entity Compliance Guide.'' FDA has prepared this guidance in 
accordance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act. This is one of several guidances the agency 
has developed to help manufacturers, packers, and distributors 
implement the final rule establishing standardized content and format 
requirements for the labeling of all OTC drug products. Once finalized, 
these guidances supersede all other statements, feedback, and 
correspondence provided by the agency on these matters since the 
issuance of the final rule.
    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final rule establishing standardized content and format 
requirements for the labeling of OTC drug products (21 CFR 201.66). 
This regulation is intended to standardize labeling for all OTC drug 
products so consumers can easily read and understand OTC drug product 
labeling and use these products safely and effectively. The regulation 
requires manufacturers to present OTC drug labeling information in a 
prescribed order and format. The standardized format requires revision 
of all existing labeling and covers all OTC drug and drug-cosmetic 
products, whether marketed under a new drug application, abbreviated 
new drug application, or OTC drug monograph (or drug product not yet 
the subject of a final OTC drug monograph).
    Following issuance of the final rule, the agency received a number 
of inquiries from manufacturers seeking guidance on how to present the 
labeling information for their OTC drug products using the standardized 
content and format requirements. To address these inquiries, FDA 
published a notice in the Federal Register of December 9, 2004 (69 FR 
71420), announcing the availability of a draft compliance guidance for 
small business entities entitled ``Labeling OTC Human Drug Products; 
Small Entity Compliance Guide.'' The draft compliance guidance 
summarizes the new Drug Facts labeling requirements set forth in Sec.  
201.66. The

[[Page 22561]]

draft compliance guidance also describes how to list those inactive 
ingredients that are different when a finished OTC drug product is 
obtained from multiple suppliers.
    The notice invited interested persons to submit comments on the 
draft compliance guidance by February 7, 2005. FDA did not receive any 
comments in response to the notice, and is announcing the availability 
of this final compliance guidance with only editorial revisions to the 
draft guidance.
    This compliance guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The compliance guidance 
represents the agency's current thinking on how OTC drug product 
labeling can be converted to the new OTC Drug Facts format labeling. 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 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.

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.

    May 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11089 Filed 5-12-09; 8:45 am]
BILLING CODE 4160-01-S