Reports and guidance documents; availability, etc.: Center for Biologics Evaluation and Research; electronic regulatory submissions,

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Federal Register: July 13, 2006 (Volume 71, Number 134)NoticesPage 39684-39685From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr13jy06-82

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 1998D-0315Guidance 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.

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 This guidance document finalizes the draft guidance entitled ``Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research'' dated May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 amBILLING CODE 4160-01-S

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