[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availability of a draft guidance document entitled ``Guidance for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 The draft guidance document would provide guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Content and Format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 The draft guidance document may also be obtained by mail by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
