[Federal Register Volume 64, Number 218 (Friday, November 12, 1999)]
[Notices]
[Pages 61647-61648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29549]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 98D-0316 and 98D-0317]
``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 Application (NDA)]''; 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 the Center for Biologics and Research (CBER)
in Electronic Format-Biologics Marketing Applications [Biologics
License Application (BLA), Product License Application (PLA)/
Establishment License Application (ELA) and New Drug Application
(NDA)].'' The guidance document provides information regarding the
electronic submission of license applications, i.e., BLA, PLA/ELA, NDA,
and supplements and amendments to those applications intended for
submission to Center for Biologics Evaluation and Research (CBER). This
guidance document is part of CBER's 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.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry: Providing Regulatory Submissions to
the Center for Biologics and Research (CBER) in Electronic Format-
Biologics Marketing Applications [Biologics License Application (BLA),
Product License Application (PLA)/Establishment License Application
(ELA) and New Drug Application (NDA)]'' 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.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 400N, 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 the Center
for Biologics and Research (CBER) in Electronic Format-Biologics
Marketing Applications [Biologics License Application (BLA), Product
License Application (PLA)/Establishment License Application (ELA) and
New Drug Application (NDA)].'' This guidance document is intended to
provide a degree of uniformity for electronically submitted biologics
marketing 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 purposes. The guidance announced in this notice finalizes
the two draft guidances entitled ``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,'' and
``Draft `Guidance for Industry: Electronic Submissions of Case Report
Forms (CRF's), Case Report Tabulations (CRT's) and Data to the Center
for Biologics Evaluation and Research,''' which were announced in the
Federal Register of June 1, 1998 (63 FR 29741 and 29739, respectively).
In the Federal Register of January 28, 1999 (64 FR 4433), FDA announced
the availability of a document entitled ``Guidance for Industry on
General Considerations for Providing Regulatory Submissions in
Electronic Format'' which provided a list of guidance documents that
are under development regarding electronic submissions, and guidance on
general issues relevant to all electronic submissions.
In the Federal Register of March 20, 1997 (62 FR 13430), FDA
published the electronic records; electronic signatures final rule,
which provided for the voluntary submission of parts or all of an
application, as defined in the relevant regulations, in electronic
format without an accompanying paper copy (21 CFR part 11). FDA also
established public docket number 92S-0251 to provide a permanent
location for a list of the agency units that are prepared to receive
electronic submissions and the specific types of regulatory records
that can be accepted in electronic format (62 FR 13467, March 20,
1997). CBER will identify in this public docket any submission type
that can be reviewed and archived in an electronic format as they
become available. This public docket can be accessed on the Internet at
http://www.fda.gov/ohrms/dockets/dockets/92s0251/92s0251.htm.
This guidance document represents the agency's current thinking
with regard to regulatory submissions in electronic format. 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 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. Comments
Interested persons, may at any time, submit written comments to
the Dockets Management Branch (address above) 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 the 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.
[[Page 61648]]
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cber/guidelines.htm.
Dated: November 5, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-29549 Filed 11-10-99; 8:45 am]
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