[Federal Register Volume 67, Number 124 (Thursday, June 27, 2002)]
[Notices]
[Pages 43331-43332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0475]


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 guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--ANDAs.'' This guidance provides 
information for applicants on how to submit abbreviated new drug 
applications (ANDAs) in electronic format.

DATES:  Submit written or electronic comments on agency guidances 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 20857. 
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: Ruth A. 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 guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
ANDAs.'' Traditionally, FDA has required that regulatory submissions, 
such as ANDAs and new drug applications, be submitted as paper 
documents. In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published the electronic records and electronic signatures regulation, 
which provided for the voluntary submission of parts or all of an 
application, as defined in the relevant regulations, in electronic 
format without an accompanying paper copy (21 CFR part 11). The agency 
also established public Docket No. 92S-0251 to provide a list of the 
agency units that are prepared to receive electronic submissions and 
the specific types of records and submissions that can be accepted in 
electronic format (62 FR 13430 at 13467). 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. This guidance 
should be used in conjunction with ``Providing Regulatory Submissions 
in Electronic Format--NDAs'' and ``Providing Regulatory Submissions in 
Electronic Format--General Considerations.''
    The Center for Drug Evaluation and Research (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. In the Federal Register of November 16, 2001 (66 FR 57721), 
CDER announced the availability of a draft guidance entitled 
``Providing Regulatory Submissions in Electronic Format--ANDAs.'' This 
guidance provided new information on submitting a complete archival 
copy of the ANDA in electronic format. The comment period closed on 
January 15, 2002, and the agency considered the received comments as it 
finalized this guidance. As in the past, applicants planning to make 
submissions in electronic format should consult public Docket No. 92S-
0251 to determine which agency units are prepared to receive electronic 
submissions and the specific types of documents that can be submitted 
in electronic format.
    This guidance is being issued consistent with FDA's good guidance 
practices (GGPs) regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on providing

[[Page 43332]]

regulatory submissions in electronic format for 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 statutes or 
regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (see 
ADDRESSES). 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: June 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16163 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S