[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Notices]
[Pages 29740-29741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0314]


Draft Guidance for Industry: Pilot Program for Electronic 
Investigational New Drug (eIND) Applications for Biological Products; 
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availability of a draft guidance document entitled ``Guidance for 
Industry: Pilot Program for electronic Investigational New Drug (eIND) 
Applications for Biological Products.'' This draft document, when 
finalized, is intended to provide guidance to sponsors on the design, 
development, organization, and submission of an eIND application to the 
Center for Biologics Evaluation and Research (CBER) as part of a pilot 
eIND program. This draft document is part of CBER's effort to develop, 
in cooperation with sponsors, an efficient process for electronic 
submissions of regulatory information relating to the development and 
marketing of biological products. Submissions in electronic format are 
voluntary.

DATES: Written comments may be submitted at any time, however, comments 
should be submitted by July 31, 1998, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Pilot Program for 
electronic Investigational New Drug (eIND) Applications for Biological 
Products'' 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. Submit written comments on the draft 
guidance document to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, 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 draft guidance document 
entitled ``Guidance for Industry: Pilot Program for electronic 
Investigational New Drug (eIND) Applications for Biological Products.'' 
This draft guidance document, when finalized, is intended to provide 
sponsors guidance on the design, development, organization, and 
submission of eIND applications. This draft guidance document does not 
address the scientific, clinical, and regulatory requirements of 
preparing an IND submission. These requirements can be found in Title 
21 of the Code of Federal Regulations, part 312 (21 CFR

[[Page 29741]]

part 312). Part 312 must be followed in the preparation of any IND or 
eIND application.
    This draft guidance document represents the agency's current 
thinking with regard to the eIND applications for biological products. 
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 
statute, regulations, or both. As with other guidance documents, FDA 
does not intend this document to be all-inclusive and cautions that not 
all information may be applicable to all situations. The document is 
intended to provide information and does not set forth requirements.

II. Request for Comments

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Written comments may 
be submitted at any time, however, comments should be submitted by July 
31, 1998, to ensure adequate consideration in preparation of the final 
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 the brackets in the heading of this document. A 
copy of 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 draft guidance 
document by using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''.

    Dated: May 22, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14313 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F