[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Notices]
[Pages 29741-29742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14314]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0316]
Draft ``Guidance for Industry: Electronic Submissions of a
Biologics License Application (BLA) or Product License Application
(PLA)/Establishment License Application (ELA) to the Center for
Biologics Evaluation and Research;'' 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availability of a draft guidance document entitled ``Guidance for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: Electronic Submissions of a Biologics License Application
(BLA) or Product License Application (PLA)/Establishment License
Application (ELA) to the Center for Biologics for Evaluation and
Research.'' The draft guidance document, when finalized, is intended to
provide information regarding the electronic submission of a Biologic
License Application (BLA), or a Product License Application/
Establishment License Application (PLA/ELA) to the Center for Biologics
Evaluation and Research (CBER). This draft guidance document is part of
CBER's continuing effort to develop 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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Electronic
Submissions of a Biologics License Application (BLA) or Product License
Application (PLA)/Establishment License Application (ELA) to the Center
for Biologics Evaluation and Research'' to the Office of Communication,
Training, and Manufacturers Assistance (HFM-40), Center for Biologics
Evaluation and Research, 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 The draft guidance
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
document.
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: Electronic Submissions of a Biologics
License Application (BLA) or Product License Application (PLA)/
Establishment License Application (ELA) to the Center for Biologics
Evaluation and Research.'' This draft guidance document, when
finalized, is intended to provide a degree of uniformity to future
electronically submitted license applications to assure timely review,
archiving, and retrieval processes for agency reviewers and to describe
those electronic formats that CBER is currently able to support for
review and archive. This draft guidance document, when finalized, is
intended to supersede the guidance manual entitled ``Computer Assisted
Product License Application (CAPLA) Guidance Manual'' as announced in
the Federal Register of March 21, 1996 (61 FR 11644).
This draft guidance document represents the agency's current
thinking with regard to the electronic submissions of a Biologics
License Application (BLA) or Product License Application (PLA)/
Establishment License Application (ELA) to the Center for Biologics
Evaluation and Research. 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 draft guidance
document to be all-inclusive and cautions that not all information may
be applicable to all situations. The draft guidance document
[[Page 29742]]
is intended to provide information and does not set forth requirements.
II. Request for Comments
This draft guidance 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 guidance document. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Comments and requests should be identified with the docket number found
in 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. 98-14314 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F