[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Notices]
[Pages 518-519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


``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.


[[Page 519]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a 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 guidance document provides 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'' (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.

ADDRESSES: Submit written requests for single copies of the 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 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, 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 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 guidance document is intended to 
provide guidance to applicants in completing the CMC section and the 
establishment description information of revised Form FDA 356h. The 
guidance announced in this notice supersedes the draft guidance 
entitled ``Guidance for Industry: Content and Format of Chemistry, 
Manufacturing and Controls Information and Establishment Description 
Information for a Vaccine or Related Product'' announced in the Federal 
Register of June 19, 1998 (63 FR 33686). In the Federal Register of 
July 8, 1997 (62 FR 36558), FDA announced the availability of Form FDA 
356h that will be used as a single harmonized application form for all 
drug and licensed biological products. Manufacturers may voluntarily 
begin using this form for vaccines or related products. FDA will 
announce in the future when manufacturers are required to use this form 
for all products. Use of the new harmonized Form FDA 356h 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 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 guidance document to be all-inclusive and cautions that not 
all information may be applicable to all situations. The guidance 
document is intended to provide information and does not set forth 
requirements.

II. Comments

     Interested persons, may at any time, submit to the Dockets 
Management Branch (address above) written comments regarding this 
guidance 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 by 
using the World Wide Web (WWW). For WWW access, connect to CBER at 
``http://www.fda.gov/cber/guidelines.htm''.

    Dated: December 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-30 Filed 1-4-99; 8:45 am]
BILLING CODE 4160-01-F