[Federal Register Volume 67, Number 231 (Monday, December 2, 2002)]
[Notices]
[Pages 71575-71576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0451]


Withdrawal of 20 Guidances on Individual Product Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of 20 individual product labeling guidances. The guidances 
are being withdrawn because they are out of date and of little use to 
the generic drug industry. The agency has developed other guidance and 
resources to assist the industry in obtaining up-to-date labeling for 
reference listed drugs.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(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

[[Page 71576]]

the SUPPLEMENTARY INFORMATION section for electronic access to agency 
guidance documents.

FOR FURTHER INFORMATION CONTACT: Rita Hassall, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5845.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the withdrawal of 20 individual product labeling 
guidances. A list of FDA's Center for Drug Evaluation and Research 
(CDER) guidances (the Comprehensive List) can be found on the Internet 
on the CDER guidance page at http://www.fda.gov/cder/guidance/index.htm, and many of the guidances on the Comprehensive List are 
posted on the CDER guidance page (old draft guidances have not been 
posted). This withdrawal of labeling guidances is in addition to the 
withdrawal of 53 individual product labeling guidances announced in the 
Federal Register of July 5, 2002 (67 FR 44857).
    The labeling guidances being withdrawn were intended to provide 
sponsors of abbreviated new drug applications (ANDAs) with product 
specific templates for package insert labeling that could be submitted 
to the Office of Generic Drugs (OGD). Because package insert labeling 
for innovator products changes frequently, it is difficult to keep the 
guidances updated; and because these labeling guidances are out of 
date, they are being withdrawn.
    In May 2000, the agency issued a guidance for industry entitled 
``Revising ANDA Labeling Following Revision of the RLD Labeling.'' This 
guidance provides information on how to access current package insert 
labeling on OGD's Labeling Review Branch Internet site at http://www.fda.gov/cder/ogd/rld/labeling_review_branch.htm.
    The withdrawal of product-specific labeling guidances is part of a 
long-term effort in OGD to review guidance documents on the development 
of generic drug products with the goal of identifying documents that 
need to be revised, reformatted, or withdrawn because they are no 
longer current.
    CDER is withdrawing the following labeling guidances:
Chlordiazepoxide Hydrochloride Capsules--January 1, 1988
Clorazepate Dipotassium Capsules/Tablets--March 1, 1993
Cyproheptadine Hydrochloride Tablets/Syrup--December 1, 1986
Dipivefrin Hydrochloride Ophthalmic Solution, 0.1%--November 2, 1998
Ergoloid Mesylate Tablets--January 1, 1988
Hydroxyzine Hydrochloride Injection--December 1, 1989
Isoetharine Inhalation Solution--March 1, 1989
Meclofenamate Sodium Capsules--July 1, 1992
Naphazoline Hydrochloride Ophthalmic Solution--March 1, 1989
Niacin Tablets--July 1, 1992
Phendimetrazine Tartrate Capsules/Tablets, and Extended-Release 
Capsules--February 1, 1991
Phentermine Hydrochloride Capsules/Tablets--August 1, 1988
Promethazine Hydrochloride Tablets--March 1, 1990
Propantheline Bromide Tablets--August 1, 1988
Pyridoxine Hydrochloride Injection--June 1, 1984
Quinidine Sulfate Capsules USP--October 1, 1995
Sulfamethoxazole and Phenazopyridine Hydrochloride Tablets--February 1, 
1992
Theophylline Immediate Release Oral Dosage Forms--February 1, 1995
Thiamine Hydrochloride Injection--February 1, 1988
Vitamin A Capsules--February 1, 1992

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments. Two copies of any 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. Received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain guidance documents 
at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: November 25, 2002.
Margaret M. Dotzel
Assistant Commissioner for Policy.
[FR Doc. 02-30481 Filed 11-29-02; 8:45 am]
BILLING CODE 4160-01-S