[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
