[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availability of a draft guidance document entitled ``Guidance for 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 The draft guidance document, when finalized, is intended to 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 This draft guidance document is part of 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Electronic 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 The draft guidance 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]
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