[Federal Register Volume 64, Number 31 (Wednesday, February 17, 1999)]
[Notices]
[Pages 7896-7897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0007]


``Guidance for Industry: For the Submission of Chemistry, 
Manufacturing and Controls and Establishment Description Information 
for Human Plasma-Derived Biological Products, Animal Plasma or Serum-
Derived Products;'' 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 guidance document entitled ``Guidance for Industry: 
For the Submission of Chemistry, Manufacturing and Controls and 
Establishment Description Information for Human Plasma-Derived 
Biological Products, Animal Plasma or Serum-Derived Products.'' The 
guidance document is intended to assist applicants in the preparation 
of the content and format of the chemistry, manufacturing, and controls 
(CMC) section and the establishment description section of a biologics 
license application (BLA), revised Form FDA 356h, which is currently 
being implemented for human plasma-derived biological products, animal 
plasma or serum-derived products. This action 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 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: For the Submission of 
Chemistry, Manufacturing and Controls and Establishment Description 
Information for Human Plasma-Derived Biological Products, Animal Plasma 
or Serum-Derived Products'' 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 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: Valerie A. Butler, 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: For the Submission of Chemistry, Manufacturing 
and Controls and Establishment Description Information for Human 
Plasma-Derived Biological

[[Page 7897]]

Products, Animal Plasma or Serum-Derived Products.'' This guidance 
document provides general information for the preparation of CMC and 
establishment description sections of the BLA, revised Form FDA 356h, 
which is currently being implemented for human plasma-derived 
biological products, animal plasma or serum-derived products. This 
guidance document supersedes the draft guidance entitled ``Guidance for 
Industry: For the Submission of Chemistry, Manufacturing and Controls 
and Establishment Description Information for Human Plasma-Derived 
Biological Products or Animal Plasma or Serum-Derived Products'' that 
was announced in the Federal Register of January 21, 1998 (63 FR 3145).
    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 drugs and licensed 
biological products. Manufacturers may voluntarily begin using this 
form for human plasma-derived biological products, animal plasma or 
serum-derived products. 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 BLA instead of two separate license 
applications (product license application and establishment license 
application).
    This guidance document represents the agency's current thinking on 
the content and format of the CMC and establishment description 
information section of a BLA for human plasma-derived biological 
products, animal plasma or serum-derived 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 
guidance 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 to the Dockets 
Management Branch (address above) written comments 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 guidance 
document using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''.

    Dated: February 5, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-3715 Filed 2-16-99; 8:45 am]
BILLING CODE 4160-01-F