[Federal Register Volume 64, Number 44 (Monday, March 8, 1999)]
[Notices]
[Pages 11023-11024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5521]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0964]
``Guidance for Industry: Content and Format of Chemistry,
Manufacturing and Controls Information and Establishment Description
Information for a Biological In Vitro Diagnostic 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 guidance document entitled ``Guidance for Industry:
Content and Format of Chemistry, Manufacturing and Controls Information
and Establishment Description Information for a Biological In Vitro
Diagnostic Product.'' The guidance document is intended to 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'' (revised Form FDA 356h) for a biological in vitro
diagnostic product. 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
entitled ``Guidance for Industry: Content and Format of Chemistry,
Manufacturing and Controls Information and Establishment Description
Information for a Biological In Vitro Diagnostic 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 the 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.
Submit written comments on the guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, 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 Biological In Vitro Diagnostic Product.'' The 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 document announced in this notice supersedes the
draft guidance entitled ``Guidance for Industry: Content and Format of
Chemistry, Manufacturing and Controls Information and Establishment
[[Page 11024]]
Description Information for a Biological In Vitro Diagnostic Product''
published in the Federal Register of November 10, 1998 (63 FR 63067).
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 a
biological in vitro diagnostic product. 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 the agency's current thinking
with regard to the content and format of the CMC and establishment
description sections of a license application for a biological in vitro
diagnostic 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 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
Interested persons may, at any time, submit written comments to
the Dockets Management Branch (address above) regarding this guidance
document. Two copies of any comments are to be submitted, except
individuals may submit one copy. Comments are to 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: March 1, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-5521 Filed 3-5-99; 8:45 am]
BILLING CODE 4160-01-F