[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