[Federal Register Volume 67, Number 61 (Friday, March 29, 2002)]
[Notices]
[Pages 15212-15213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7581]


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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finalizes the draft guidance that was announced in the Federal Register 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