[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73940-73941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de08-44]
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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guidance announced in this notice finalizes the draft guidance of the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