[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Notices]
[Pages 39684-39685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-0315]


Guidance for Industry on Providing Regulatory Submissions to the 
Center for Biologics Evaluation and Research in Electronic Format--Lot 
Release Protocols; 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 Evaluation and 
Research (CBER) in Electronic Format--Lot Release Protocols'' dated 
July 2006. The guidance is intended to provide manufacturers of 
biological products regulated by CBER with recommendations for 
submitting lot release protocols in electronic format to CBER Product 
Release Branch. This guidance document finalizes the draft guidance 
entitled ``Guidance for Industry: Instructions for Submitting 
Electronic Lot Release Protocols to the Center for Biologics Evaluation 
and Research'' dated May 1998.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 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, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist the office 
in processing your requests. The guidance may also be obtained by mail 
by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Astrid Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N,Rockville, MD 20852-1448, 301-827-6210.

[[Page 39685]]


SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Providing Regulatory Submissions to the Center 
for Biologics Evaluation and Research (CBER) in Electronic Format--Lot 
Release Protocols'' dated July 2006. This guidance document finalizes 
the draft guidance entitled ``Guidance for Industry: Instructions for 
Submitting Electronic Lot Release Protocols to the Center for Biologics 
Evaluation and Research'' dated May 1998 (63 FR 29742, June 1, 1998). 
The guidance announced in this notice was revised based on public 
comments submitted to the Division of Dockets Management on the draft 
guidance. The guidance is intended to provide manufacturers of 
biological products regulated by CBER with recommendations for 
submitting to CBER Product Release Branch lot release protocols in 
electronic format.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. 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 statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 610.2(a) have been approved under 
OMB control number 0910-0206.

III. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Division of Dockets Management (see ADDRESSES) 
regarding this guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number found in the brackets in the heading of this document. A copy of 
the guidance and received comments are available for public examination 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11040 Filed 7-12-06; 8:45 am]
BILLING CODE 4160-01-S