[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Draft Guidance for Industry: Pilot Program for Electronic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availability of a draft guidance document entitled ``Guidance for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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Pilot Program for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 Submit written comments on the draft
guidance document to the Dockets Management Branch (HFA-305), Food and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]
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