[Federal Register: March 29, 2002 (Volume 67, Number 61)]
[Notices]
[Page 15212-15213]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr02-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0314]
``Guidance for Industry: Providing Regulatory Submissions to CBER
in Electronic Format--Investigational New Drug Applications (INDs);''
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 document entitled ``Guidance for Industry: Providing
Regulatory Submissions to CBER in Electronic Format--Investigational
New Drug Applications (INDs)'' dated March 2002. The document is
intended to provide guidance to sponsors on the design, development,
organization, and submission in electronic format of an IND to the
Center for Biologics Evaluation and Research (CBER). This guidance
finalizes the draft guidance that was announced in the Federal Register
on June 1, 1998 (63 FR 29741).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.
Send one self-addressed adhesive label to assist the office in
processing your requests. The document may also be obtained by mail by
calling the CBER Voice Information System at 1-800-835-4709 or 301-827-
1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX
or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
Submit written comments on the guidance document 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.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Providing Regulatory Submissions to CBER in
Electronic Format--Investigational New Drug Applications (INDs)'' dated
March 2002. The agency has developed this guidance to assist sponsors
on the design, development, organization, and submission in electronic
format of INDs to CBER. The guidance announced in this notice finalizes
the draft ``Guidance for Industry: Pilot Program for Electronic
Investigational New Drug (eIND) Applications for Biological Products''
dated May 1998 (63 FR 29741, June 1, 1998).
This document reflects CBER's experience with the electronic IND
pilot program and incorporates knowledge gained from development of the
electronic marketing applications guidance document entitled ``Guidance
for Industry: Providing Regulatory Submissions to the Center for
Biologics Evaluation and Research (CBER) in Electronic Format--
Biologics Marketing Applications [Biologics License Application (BLA),
Product License Application (PLA)/Establishment License Application
(ELA) and New Drug Applications (NDA)]'' November 12, 1999 (64 FR
61647), revised. The agency also incorporated suggestions and
recommendations from sponsors in developing a table of contents driven
navigational system. However, this guidance does not address the
scientific, clinical, and regulatory requirements for preparing an IND
submission. These requirements can be found in title 21 of the Code of
Federal Regulations, part 312 (21 CFR part 312). Part 312 must be
followed in the preparation of any IND.
FDA currently is working on electronic submissions in the Common
Technical Document (CTD) format developed by the International
Conference on Harmonization (ICH). As FDA develops guidance on
electronic CTD submissions, CBER intends to harmonize this guidance
with the CTD guidance. This guidance describes how sponsors may submit
electronic INDs to CBER. Sponsors may continue to submit INDs in paper
form.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance document represents
the agency's current thinking on this topic. 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 requirement
[[Page 15213]]
of the applicable statutes and regulations.
II. Comments
Interested persons may, at any time, submit written or electronic
comments to the Dockets Management Branch (see ADDRESSES) regarding
this guidance document. Two copies of any comments are to be submitted,
except individuals may submit one copy. Comments should be identified
with the docket number found in brackets in the heading of this
document. A copy of the 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/cber/guidelines.htm or http://www.fda.gov/
ohrms/dockets/default.htm.
Dated: March 13, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7581 Filed 3-28-02; 8:45 am]
BILLING CODE 4160-01-S