[Federal Register: December 9, 2004 (Volume 69, Number 236)]
[Notices]
[Page 71420-71421]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de04-63]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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