[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 This guidance document finalizes the draft guidance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