[Federal Register Volume 66, Number 36 (Thursday, February 22, 2001)]
[Notices]
[Pages 11174-11175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4312]


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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Draft Guidance for Industry on Labeling Over-the-Counter Human 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availability of a draft guidance for industry entitled ``Labeling Over-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draft guidance is intended to assist manufacturers, packers, and 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DATES: Submit written comments on the draft guidance for industry by 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ADDRESSES: Copies of the draft guidance for industry are available on 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written requests for single copies of the draft guidance to the Drug 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 Submit written comments on the draft guidance 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draft guidance for industry entitled ``Labeling OTC Human Drug 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