[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availability of a draft guidance entitled ``Guidance for Industry: 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draft guidance, once finalized, will supersede the guidance entitled 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 This draft guidance is now being revised to reflect 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draft guidance is intended to assist manufacturers in the development 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