[Federal Register Volume 64, Number 78 (Friday, April 23, 1999)]
[Notices]
[Pages 20006-20007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0693]


``Guidance for Industry: On the Content and Format of Chemistry, 
Manufacturing and Controls Information and Establishment Description 
Information for an Allergenic Extract or Allergen Patch Test''; 
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 document entitled ``Guidance for Industry: On the 
Content and Format of Chemistry, Manufacturing and Controls Information 
and Establishment Description Information for an Allergenic Extract or 
Allergen Patch Test.'' 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 an allergenic extract 
or allergen patch test. 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: On the Content and Format of 
Chemistry, Manufacturing and Controls Information and Establishment 
Description Information for an Allergenic Extract or Allergen Patch 
Test'' 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

[[Page 20007]]

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:  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: On the Content and Format of Chemistry, 
Manufacturing and Controls Information and Establishment Description 
Information for an Allergenic Extract or Allergen Patch Test.'' 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 finalizes the draft guidance document entitled 
``Guidance for Industry: On the Content and Format of Chemistry, 
Manufacturing and Controls Information and Establishment Description 
Information for an Allergenic Extract or Allergen Patch Test'' 
published in the Federal Register of August 27, 1998 (63 FR 45826).
    In the Federal Register of July 8, 1997 (62 FR 36558), FDA 
announced the availability of a revised 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 an allergenic extract or allergen patch test. 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 an allergenic extract 
or allergen patch test. 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 guidance 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 should be identified with the 
docket number found in the brackets in the heading of this document. A 
copy of the 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 document using 
the World Wide Web (WWW). For WWW access, connect to CBER at ``http://
www.fda.gov/cber/guidelines.htm''.

    Dated: April 16, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10228 Filed 4-22-99; 8:45 am]
BILLING CODE 4160-01-F