[Federal Register: February 22, 2001 (Volume 66, Number 36)]
[Notices]
[Page 11174-11175]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22fe01-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0005]
Draft Guidance for Industry on Labeling Over-the-Counter Human
Drug Products; Updating Labeling in ANDA's; 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availability of a draft guidance for industry entitled ``Labeling Over-
the-Counter Human Drug Products; Updating Labeling in ANDA's.'' This
draft guidance is intended to assist manufacturers, packers, and
distributors of over-the-counter (OTC) drug products marketed under
abbreviated new drug applications (ANDA's) and manufacturers of
reference listed drugs (RLD's) to implement the agency's regulation on
standardized content and format requirements for the labeling of OTC
drug products.
DATES: Submit written comments on the draft guidance for industry by
April 23, 2001.
ADDRESSES: Copies of the draft guidance for industry are available on
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit
written requests for single copies of the draft guidance to the Drug
Information Branch (HFD-210), 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 request. Submit written comments on the draft guidance
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: 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draft guidance for industry entitled ``Labeling OTC Human Drug
Products; Updating
[[Page 11175]]
Labeling in ANDA's.'' This is one of several guidances the agency is
developing to help manufacturers, packers, and distributors implement
the recently issued 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
requirements for the labeling of OTC drug products. This rule 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. This new format will require revision of all existing
labeling.
Following issuance of the final rule, the agency received several
inquiries from manufacturers of generic OTC drug products seeking
guidance on whether they may convert products to the new labeling
format before the applicable innovator (or RLD) product revises its
labeling. This guidance addresses those inquiries.
Generally, the agency believes manufacturers of generic OTC drug
products (i.e., products marketed under ANDA's) need not wait to
implement the new labeling format until after the RLD holder has
submitted its labeling. This guidance is intended to facilitate the
updating of labeling in ANDA's to meet the new OTC drug products format
requirement. Accordingly, the agency has developed labeling examples as
guidance for manufacturers to follow. Two such labeling examples are
attached to the draft guidance. The additional labeling examples that
the agency proposes to develop will be made available for review in
this docket and at the Internet site referenced in this draft guidance
before the close of the comment period.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September
19, 2000). The draft guidance represents the agency's current thinking
on updating labeling in ANDA's consistent with the new OTC drug
products standardized labeling content and format. 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 an
approach satisfies the requirements of the applicable statutes and
regulations.
Interested persons may, on or before April 23, 2001, submit written
comments on the draft guidance to the Dockets Management Branch
(address above). Two copies of any 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 guidance and received comments are available for
public examination in the Dockets Management Branch between 9 a.m. and
4 p.m., Monday through Friday.
Dated: February 8, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-4312 Filed 2-21-01; 8:45 am]
BILLING CODE 4160-01-F