[Federal Register: April 23, 1999 (Volume 64, Number 78)]
[Notices]
[Page 20006-20007]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap99-83]

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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