[Federal Register Volume 69, Number 236 (Thursday, December 9, 2004)]
[Notices]
[Pages 71420-71421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0327]


Draft 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 draft 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 the new over-the-counter (OTC) 
labeling requirements and to prepare new labeling within the prescribed 
implementation compliance dates.

DATES: Submit written or electronic comments on the draft compliance 
guidance by February 7, 2005. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
compliance guidance to the Division of Drug Information (HFD-240), 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft 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.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft compliance 
guidance document.

FOR FURTHER INFORMATION CONTACT: Cazemiro R. Martin or Gerald M. 
Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2222.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft 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 is developing 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 will 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 
regulations for the labeling of OTC drug products. 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 for this new standardized labeling requires 
manufacturers to present OTC drug labeling information in a prescribed 
order and format. The new format will require revision of all existing 
labeling and covers all OTC drug and drug-cosmetic products, whether 
marketed under a new drug marketing application (NDA), abbreviated new 
drug application (ANDA), or OTC drug monograph (or product not yet the 
subject of a final OTC drug monograph). To reduce the economic impact 
on small business entities, the new regulations provide an additional 
1-year period to comply with Sec.  201.66 (21 CFR 201.66) for OTC drug 
products with sales of less than $25,000 per year. You can find a copy 
of Sec.  201.66 at the Division of Dockets Management Web site at 
http://www.fda.gov/cder/otc/label/label-fr-reg.htm.
    Following issuance of the final rule, the agency received a number 
of inquires from manufacturers seeking guidance on how to present the 
labeling information for their OTC drug products using the new 
standardized content and format requirements. This draft guidance 
summarizes the new Drug Facts labeling requirements as set forth in 
Sec.  201.66. The draft guidance also describes how to list those 
inactive ingredients that are different when a finished OTC drug 
product is obtained from multiple suppliers.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (21 CFR 10.115). The draft compliance guidance, when 
finalized, will represent the agency's current thinking on how OTC drug 
monograph labeling finalized prior to or after the new requirements 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.

I. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft compliance 
guidance. Two copies of mailed comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The draft compliance guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 71421]]

II. 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.fda.gov/ohrms/dockets/default.htm.

    Dated: December 1, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26993 Filed 12-8-04; 8:45 am]
BILLING CODE 4160-01-S