[Federal Register Volume 63, Number 104 (Monday, June 1, 1998)]
[Notices]
[Page 29742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0315]


Draft ``Guidance for Industry: Instructions for Submitting 
Electronic Lot Release Protocols 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availability of a draft guidance document entitled ``Guidance for 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: Instructions for Submitting Electronic Lot Release Protocols 
to the Center for Biologics Evaluation and Research.'' The draft 
guidance document, when finalized, is intended to provide instructions 
to manufacturers regarding the submission of the electronic protocols 
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 This draft 
guidance document is part of CBER's continuing effort to develop an 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 guidance document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Instructions for 
Submitting Electronic Lot Release Protocols 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 The draft guidance document may 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comments on the draft guidance document to the Dockets Management 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: Instructions for Submitting 
Electronic Lot Release Protocols to the Center for Biologics Evaluation 
and Research.'' Under 21 CFR 610.2(a), samples of any lot of licensed 
product, together with the protocols showing results of applicable 
tests, may at any time be required to be submitted to CBER for review 
and confirmatory testing. This draft guidance document, when finalized, 
is intended to assist those manufacturers who choose to submit the 
required protocols electronically.
    This draft guidance document represents the agency's current 
thinking with regard to the submission of electronic lot release 
protocols. 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 draft guidance document to be all-
inclusive and cautions that not all information may be applicable to 
all situations. The draft guidance document 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 for copies 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. 98-14312 Filed 5-29-98; 8:45 am]
BILLING CODE 4160-01-F