[Federal Register Volume 66, Number 222 (Friday, November 16, 2001)]
[Notices]
[Pages 57721-57722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0475]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--ANDAs; 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availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--ANDAs.'' This draft 
guidance provides information for applicants on how to submit 
abbreviated new drug applications (ANDAs) in electronic format.

DATES: Submit written or electronic comments on the draft guidance by 
January 15, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), 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comments on the draft guidance to the Dockets Management Branch (HFA-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electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ruth Warzala, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5845, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
ANDAs.'' In the Prescription Drug User Fee Act as amended by the Food 
and Drug Administration Modernization Act of 1997 (Public Law 105-115), 
the agency stated its plans to develop and update its information 
management capabilities to allow electronic submissions by 2002. In the 
Federal Register of January 28, 1999, the agency announced the 
availability of two guidances for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--NDAs'' (64 FR 4432) and 
``Providing Regulatory Submissions in Electronic Format--General 
Considerations'' (64 FR 4433). These guidances were the first two of a 
series of guidances for industry on making regulatory submissions in 
electronic format. In the 1999 guidance on general considerations, the 
agency stated that guidance would be forthcoming on other submission 
types and structured formats, including ANDAs, investigational new drug 
applications, and product licensing applications. When finalized, this 
draft guidance should be used in conjunction with the two previously 
issued guidances (64 FR 4432 and 4433, respectively).
    CDER has encouraged the electronic submission of some types of data 
on a voluntary basis since 1997. However, these electronic submissions 
could not previously be archived and could only be made in addition to 
a complete paper submission. The electronic data submission program is 
now being expanded to include all parts of ANDA so that the electronic 
submission can replace the paper submission as the archival copy of 
ANDA.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115).

[[Page 57722]]

 This draft guidance, when finalized, will represent the agency's 
current thinking on providing ANDAs in electronic 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 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the draft guidance. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments and requests are to be identified with 
the docket number found in brackets in the heading of this document. 
The draft guidance document 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: November 7, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-28681 Filed 11-15-01; 8:45 am]
BILLING CODE 4160-01-S