[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Notices]
[Pages 45826-45827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0693]
Draft ``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availability of a draft guidance document entitled ``Guidance for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.'' The draft guidance
document, when finalized, is intended to provide guidance to applicants
who wish to market an allergenic product or allergen patch test for the
completion of the chemistry, manufacturing and controls (CMC) section
and the establishment description section of revised Form FDA 356h
entitled ``Application to Market a New Drug, Biologic, or an Antibiotic
for Human Use.'' This draft guidance document is part of FDA's
continuing effort to achieve the objectives of the President's
``Reinventing Government'' initiatives and the Food and Drug
Administration Modernization Act of 1997, and is intended to reduce
unnecessary burdens on industry without diminishing public health
protection.
DATES: Written comments may be provided at any time, however, comments
should be submitted by October 26, 1998, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: On the Content and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'' 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 The draft guidance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 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: Dano B. Murphy, 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 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.'' The draft guidance document, when finalized, is intended to
provide manufacturers of allergenic products and allergen patch tests
guidance on the kinds of information that should be gathered to
adequately describe steps of manufacturing, product validation, final
container filling, and other aspects of production. The draft also
provides guidance on how the information should be formatted and
organized when submitted with Form FDA 356h entitled ``Application to
Market a New Drug, Biologic, or an Antibiotic for Human Use.''
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 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 biologics license
application, instead of two separate license application submissions
(product license application and establishment license application).
This draft guidance document represents the agency's current
thinking with regard to the content and format of the CMC and
establishment description sections of an application to market an
[[Page 45827]]
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 document is intended to provide information and
does not set forth requirements.
II. Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit to the Dockets Management Branch (address
above) written comments regarding this draft guidance document. Written
comments may be submitted at any time, however, comments should be
submitted by October 26, 1998, to ensure adequate consideration in
preparation of the final 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 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: August 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23024 Filed 8-26-98; 8:45 am]
BILLING CODE 4160-01-F