[Federal Register Volume 64, Number 148 (Tuesday, August 3, 1999)]
[Notices]
[Pages 42136-42137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D092013]
Draft ``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availability of a draft guidance entitled ``Guidance for Industry:
Cooperative Manufacturing Arrangements for Licensed Biologics.'' This
draft guidance, once finalized, will supersede the guidance entitled
``FDA's Policy Statement Concerning Cooperative Manufacturing
Arrangements for Licensed Biologics,'' previously made available in the
Federal Register, that describes innovative arrangements among
applicants who wish to cooperate in the manufacture of a licensed
biological product. This draft guidance is now being revised to reflect
recent changes in the biologics regulations and to provide for
additional flexibility in cooperative manufacturing arrangements. The
draft guidance is intended to assist manufacturers in the development
and production of both conventional and biotechnology-derived
biological products, and to increase flexibility in the licensing
options for biological products without diminishing the protection of
public health.
[[Page 42137]]
DATES: Written comments may be submitted at any time, however, comments
should be submitted by October 4, 1999, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of the draft
``Guidance for Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics'' to the Office of Communication, Training, and
Manufacturers Assistance (HFM0940), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852091448. Send one self-addressed adhesive label to
assist the office in processing your request. The document may also be
obtained by mail by calling the CBER Voice Information System at
10980009835094709 or 30109827091800, or by fax by calling the FAX
Information System at 10988809CBER09FAX or 30109827093844. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance.
Submit written comments on the document to the Dockets Management
Branch (HFA09305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Gloria J. Hicks, Center for Biologics
Evaluation and Research (HFM0917), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852091448, 30109827096210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Cooperative Manufacturing Arrangements for
Licensed Biologics.'' Once finalized, this document will supersede
``FDA's Policy Statement Concerning Cooperative Manufacturing
Arrangements for Licensed Biologics,'' published in the Federal
Register of November 25, 1992 (57 FR 55544). This revised guidance
document is intended to advise current and potential manufacturers of
biological and biotechnology products subject to licensure under
section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262)
of available cooperative manufacturing arrangements. These arrangements
include short supply, divided manufacturing, shared manufacturing, and
contract manufacturing.
CBER recognizes that because development of important new
biological products is both expensive and time consuming, increasing
flexibility in manufacturing arrangements is desirable. In the Federal
Register of May 14, 1996 (61 FR 24227), FDA published a final rule
amending the biologics regulations at 21 CFR 601.2 to eliminate the
establishment license application requirements for certain
biotechnology and synthetic biological products subject to licensing
under the PHS Act. This final rule also amended 21 CFR 600.3(t) to
redefine the term ``manufacturer'' as it is used in 21 CFR 600 through
680. The definition was amended to include ``any legal person or entity
who is an applicant for a license where the applicant assumes
responsibility for compliance with the applicable product and
establishment standards.'' This document is intended to provide
guidance to those interested in the manufacture of new biological
products, to those already engaged in cooperative manufacturing
arrangements, and to those considering changing their present
manufacturing arrangements. The guidance document may be useful to
applicants submitting product, establishment, and biologics license
applications and supplements.
This draft guidance represents the agency's current thinking on
cooperative manufacturing arrangements for licensed biologics. 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 requirement of the applicable statute,
regulations, or both. As with other guidance documents, FDA does not
intend this document to be all-inclusive and cautions that not all
information may be applicable to all situations. The document is
intended to provide information and does not set forth requirements.
II. Comments
This draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Dockets Management Branch (address above) written
comments regarding this draft guidance. Written comments may be
submitted at any time, however, comments should be submitted by October
4, 1999, to ensure adequate consideration in preparation of the final
document. Two copies of any comments are to be submitted, except
individuals may submit one copy. Comments should be identified with the
docket number found in brackets in the heading of this document. A copy
of the document and received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document using
the World Wide Web (WWW). For WWW access, connect to CBER at ``http://
www.fda.gov/cber/guidelines.htm''.
Dated: July 27, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19796 Filed 8-2-99; 8:45 am]
BILLING CODE 4160-01-F
