[Federal Register Volume 66, Number 246 (Friday, December 21, 2001)]
[Notices]
[Pages 65977-65978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0465]


Guidance for Industry on Major, Minor, and Telephone Amendments 
to Abbreviated New Drug Applications; 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 ``Major, Minor, and 
Telephone Amendments to Abbreviated New Drug Applications.'' This 
guidance is a second revision of the guidance entitled ``Major, Minor, 
FAX, and Telephone Amendments to Original Abbreviated New Drug 
Applications.'' FDA's Office of Generic Drugs (OGD) determined that 
further revision of the policy regarding determination of major, minor, 
and telephone amendments was necessary to help streamline the review of 
abbreviated new drug applications (ANDAs).

DATES: Submit written or electronic comments on the guidance by March 
21, 2002. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Rita R. 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 availability of a guidance for industry 
entitled ``Major, Minor, and Telephone Amendments to Abbreviated New 
Drug Applications.'' The guidance is intended to document OGDs policy 
regarding the determination of major, minor, and telephone amendments 
to original and supplemental ANDAs. This guidance first published in 
August 1999 and was originally entitled ``Major, Minor, FAX, and 
Telephone Amendments to Original Abbreviated New Drug Applications.'' 
It was revised in May 2000 to explain that the issuance of a major, 
minor, or FAX amendment would stop the review clock.
    The second revision of this guidance (1) deletes the FAX amendment 
designation, which was found to be unnecessary, (2) now applies to 
supplemental applications as well, and (3) changes the criteria for 
determining the type of amendment. The changes in criteria should 
result in more amendments being categorized as ``minor'' and fewer as 
``major.'' A minor amendment request (generally reviewed within 30 to 
60 days) has a higher priority than a major amendment. Since the review 
of a minor amendment takes place sooner than a major amendment after 
the original review, there is not a long break in the review process 
for a minor amendment. The response to a major amendment request, 
however, goes into the 180-day queue. This process causes a greater 
time lapse from when the original review was done and results in 
reviewers having to refamiliarize themselves with the application. It 
is expected that the new policy will help in moving applications 
through the approval process more quickly than under the previous 
policy. Thus the total time for approval of ANDAs will be reduced.
    Because it lessens the burden on industry, this guidance is being 
issued as a Level 1 guidance for immediate implementation, consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). As with 
other Level 1 guidances for immediate

[[Page 65978]]

implementation, the agency is soliciting comments from the public. This 
guidance represents the agency's current thinking on major, minor, and 
telephone amendments to ANDAs. 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 and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the guidance. 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 are available for public examination 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 the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: December 3, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-31454 Filed 12-20-01; 8:45 am]
BILLING CODE 4160-01-S