[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]
BILLING CODE 4160-01-F