[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