[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