[Federal Register Volume 63, Number 118 (Friday, June 19, 1998)]
[Notices]
[Pages 33686-33687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0401]


Draft ``Guidance for Industry: Content and Format of Chemistry, 
Manufacturing and Controls Information and Establishment Description 
Information for a Vaccine or Related Product''; 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availability of a draft guidance document entitled ``Guidance for 
Industry: Content and Format of Chemistry, Manufacturing and Controls 
Information and Establishment Description Information for a Vaccine or 
Related Product.'' The draft guidance document would provide guidance 
to applicants on the content and format of the Chemistry, Manufacturing 
and Controls (CMC) and Establishment Description sections of the 
``Application to Market a New Drug, Biologic, or an Antibiotic Drug for 
Human Use''

[[Page 33687]]

(revised Form FDA 356h) for vaccines or related products. This action 
is part of FDA's continuing effort to achieve the objectives of the 
President's ``Reinventing Government'' initiatives and the FDA 
Modernization Act of 1997, and is intended to reduce unnecessary 
burdens for industry without diminishing public health protection.

DATES: Written comments may be submitted at any time, however, comments 
should be submitted by August 18, 1998, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Content and Format 
of Chemistry, Manufacturing and Controls Information and Establishment 
Description Information for a Vaccine or Related Product'' 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, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. The draft guidance document may also be obtained by mail by 
calling the CBER Voice Information System at 1-800-835-4709 or 301-827-
1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX 
or 301-827-3844. Submit written comments on the draft guidance document 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance document 
entitled ``Guidance for Industry: Content and Format of Chemistry, 
Manufacturing and Controls Information and Establishment Description 
Information for a Vaccine or Related Product.'' This draft guidance 
document, when finalized, is intended to provide guidance to applicants 
in completing the CMC section and the establishment description 
information of revised Form FDA 356h. As announced in the Federal 
Register of July 8, 1997 (62 FR 36558), this form will be used as a 
single harmonized application form for all drug and licensed biological 
products. Use of the new harmonized Form FDA 356h, when fully 
implemented, will allow a biologic product manufacturer to submit one 
biologics license application instead of two separate applications 
(product license application and establishment license application).
    This draft guidance document represents FDA's current thinking on 
the content and format of the CMC and Establishment Description 
sections of a license application for a vaccine or related product. 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 draft guidance document to be all-inclusive and cautions 
that not all information may be applicable to all situations. The draft 
guidance document is intended to provide information and does not set 
forth requirements.

II. Request for Comments

    This draft guidance document 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 the draft guidance document. Written 
comments may be submitted at any time, however, comments should be 
submitted by August 18, 1998, 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 draft guidance 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 draft guidance 
document by using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''.

    Dated: June 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-16291 Filed 6-18-98; 8:45 am]
BILLING CODE 4160-01-F