[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availability of a draft guidance document entitled ``Guidance for 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 The draft guidance 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 This draft guidance document is part of FDA's 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: On the Content and 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