[Federal Register Volume 63, Number 217 (Tuesday, November 10, 1998)]
[Notices]
[Pages 63067-63068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30094]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0964]


Draft ``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availability of the draft guidance document entitled ``Guidance for 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 The draft guidance document, when 
finalized, is intended to assist applicants in the preparation of the 
chemistry, manufacturing, and controls (CMC) section and the 
establishment description section of a biologics license application 
(BLA), revised Form FDA 356h, for biological in vitro diagnostic 
products. This action is part of FDA's continuing effort to achieve the 
objectives of the President's ``Reinventing Government'' initiatives 
and FDA Modernization Act of 1997, and it 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 January 11, 1998, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of ``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, 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 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 SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert A. Yetter, Center for Biologics 
Evaluation and Research (HFM-10), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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.'' This draft document, when 
finalized, is intended to provide general information for the content 
and format of the CMC section and establishment description section of 
the BLA for biological in vitro diagnostic products. This draft 
document is intended for use by those firms which manufacture any 
licensed in vitro diagnostic product used to screen donor blood, 
determine donor suitability, test for retroviral infection, or 
determine transfusion compatibility (e.g., blood grouping and typing 
reagents). This draft document is not intended to cover those in vitro 
diagnostic products used to test for endotoxins, such as limulus 
amebocyte lysate (LAL), or those products for which a premarket 
application (PMA) or a 510(k) must be submitted.
    In the Federal Register of July 8, 1997 (62 FR 36558), FDA 
announced the availability of a new harmonized Form FDA 356h entitled 
``Application to

[[Page 63068]]

Market a New Drug, Biologic, or an Antibiotic for Human Use.'' The new 
harmonized form is intended to be used by applicants for all drug and 
biological products. The new harmonized form, when fully implemented, 
will allow biological product manufacturers to submit a single 
application, the BLA, instead of two separate license application 
submissions, a product license application (PLA), and an establishment 
license application (ELA).
    This draft guidance document represents the agency's current 
thinking on content and format of the CMC information and establishment 
description information for biological in vitro diagnostic products. 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 requirements 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

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit written comments to the Dockets Management Branch (address 
above) regarding the draft guidance document. Written comments may be 
submitted at any time, however, comments should be submitted January 
11, 1998, to ensure their adequate consideration in preparation of the 
final document. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments and requests for copies 
should be identified with the docket number found in the 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 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: November 2, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-30094 Filed 11-9-98; 8:45 am]
BILLING CODE 4160-01-F