[Federal Register: June 27, 2002 (Volume 67, Number 124)]
[Notices]
[Page 43331-43332]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn02-96]
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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: ESUB--
OGD@CDER.fda.gov.
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