[Federal Register Volume 73, Number 234 (Thursday, December 4, 2008)]
[Notices]
[Pages 73940-73941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0128] (formerly Docket No. 1999D-2013)


Guidance for Industry: Cooperative Manufacturing Arrangements for 
Licensed Biologics; 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: 
Cooperative Manufacturing Arrangements for Licensed Biologics,'' dated 
November 2008. The guidance document provides information concerning 
cooperative manufacturing arrangements applicable to biological 
products subject to licensure under the U.S. Public Health Service Act 
(PHS Act). The guidance describes the licensing strategies for meeting 
the increased need for flexible manufacturing arrangements. The 
guidance announced in this notice finalizes the draft guidance of the 
same title.

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

[[Page 73941]]

Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, or the Division of Drug 
Information, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver 
Spring, MD 20993-0002. 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210; or
    David Cummings, Center for Drug Evaluation and Research (HFD-354), 
Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 21, rm. 
3525, Silver Spring, MD 20993, 301-796-2400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Cooperative Manufacturing Arrangements for 
Licensed Biologics'' dated November 2008. The guidance document 
provides information concerning the various cooperative manufacturing 
arrangements used in the production of biological products subject to 
licensure under section 351 of the PHS Act (42 U.S.C. 262). The 
guidance describes FDA's current thinking on licensing strategies for 
meeting the increased need for planning flexible manufacturing 
arrangements. Because cooperative manufacturing arrangements can take a 
considerable amount of time to develop, the guidance may also be useful 
for planning purposes in the early phases of product development. 
Several types of manufacturing arrangements discussed in the guidance 
include short supply arrangements, divided manufacturing arrangements, 
shared manufacturing arrangements, and contract manufacturing 
arrangements. The guidance supersedes ``FDA's Policy Statement 
Concerning Cooperative Manufacturing Arrangements for Licensed 
Biologics'' published in the Federal Register of November 25, 1992 (57 
FR 55544).
    In the Federal Register of August 3, 1999 (64 FR 42136), FDA 
announced the availability of the draft guidance of the same title 
dated August 1999. FDA received several comments on the draft guidance; 
those comments were considered as the guidance was finalized. In 
response to public comments, we clarified the document and reformatted 
it into plain language. In the Federal Register of July 23, 2007 (72 FR 
40157), FDA published a 60-day notice requesting public comment on the 
information collections in the draft guidance of the same title dated 
July 2007, which revised the draft guidance dated August 1999. The 
guidance announced in this notice finalizes the draft guidance dated 
July 2007.
    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 contains information collection provisions that are 
subject to review by the Office of Management (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in this guidance were approved under OMB control number 
0910-0629.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

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.regulations.gov.

    Dated: November 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28693 Filed 12-3-08; 8:45 am]
BILLING CODE 4160-01-S