[Federal Register Volume 64, Number 17 (Wednesday, January 27, 1999)]
[Notices]
[Pages 4117-4118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1850]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-1268]
Guidance for Industry on Variations in Drug Products That May Be
Included in a Single Abbreviated New Drug Application; 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 guidance for industry entitled ``Variations in Drug
Products That May Be Included in a Single ANDA.'' This guidance was
developed by the Office of Generic Drugs (OGD) in the Center for Drug
Evaluation and Research to provide information to applicants on certain
specific variations of a drug product that should be included in a
single abbreviated new drug application (ANDA) and describe the general
factors to be considered when determining whether single or multiple
ANDA's should be submitted. It is intended to reduce the burden on
industry for submitting and maintaining separate applications for
certain variations of the same drug product.
DATES: Written comments may be submitted on the guidance by April 27,
1999. General comments on agency guidances are welcome at any time.
ADDRESSES: Copies of this guidance for industry are available on the
Internet at ``http://www.fda.gov/cder/guidance/index.htm''. Submit
written requests for single copies of ``Variations in Drug Products
That May Be Included in a Single ANDA'' 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
requests. Submit written comments on the guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Robert L. West, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5846.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Variation in Drug Products That May Be
Included in a Single ANDA.'' Prior
[[Page 4118]]
to October 1, 1990, applicants were to submit separate ANDA's for each
dosage form of a drug product and also for each variation (e.g.,
strength, color, shape) within a dosage form. Separate applications
were requested for ease of review since having information on a number
of variations within one application could make review more difficult.
On October 1, 1990, the OGD Interim Policy and Procedure Guide (PPG)
20-90 was issued. This guide permitted certain variations of solid oral
dosage forms and injectables to be submitted within a single
abbreviated application. On June 7, 1995, PPG 20-90 was amended to
allow certain variations to be filed as supplements.
This guidance incorporates the policies and procedures in PPG 20-90
and clarifies the practice of permitting variations of products in a
single application.
This guidance is being issued as a level 1 guidance consistent with
FDA's good guidance practices (62 FR 8961, February 27, 1997). It is
being implemented immediately without prior public comment because it
is intended to reduce the burden on industry. However, the agency
wishes to solicit comments from the public and is providing a 90-day
comment period and establishing a docket for the receipt of comments.
This guidance represents the agency's current thinking on
variations in drug products that may be included in a single
abbreviated application. 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 statute, regulations, or both.
Interested persons may, at any time, submit written comments on the
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 guidance and received
comments may be seen in the office above between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: January 20, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1850 Filed 1-26-99; 8:45 am]
BILLING CODE 4160-01-F