[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3145-3146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1293]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0007]
Draft ``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;'' 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availability of the draft guidance document entitled ``Guidance for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.'' The
draft guidance document is intended to assist applicants in the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 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 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, however, comments
should be submitted by April 21, 1998, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: For the Submission of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'' to the Office of Communication,
Training, and Manufacturers Assistance (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label
to assist that office in processing your requests.
[[Page 3146]]
The 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.
Submit written comments on the document to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857.
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 draft guidance document
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.'' The draft guidance provides general information for
the CMC and establishment description section of the BLA, Form FDA 356h
for human plasma-derived biological products, animal plasma, or serum-
derived products.
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 BLA, instead of two separate
license application submissions, a product license application (PLA)
and an establishment license application (ELA).
The draft guidance document represents the agency's current
thinking on content and format of the CMC, and establishment
description information section of a license application 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 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
The draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit written comments to the Dockets
Management Branch (address above) regarding the draft guidance
document. Written comments may be submitted at any time, however,
comments should be submitted by April 21, 1998, to ensure their
adequate consideration in preparation of the final document. Two copies
of any comments are to be submitted, except that individuals may submit
one copy. Comments and requests for copies should be identified with
the docket number found in the brackets in the heading of this
document. A copy of the draft 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 draft guidance
document by using the World Wide Web (WWW). For WWW access connect to
CBER at ``http://www.fda.gov/cber/guidelines.htm.''
Received comments will be considered in determining whether further
revision of the draft guidance document is warranted.
Dated: January 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-1293 Filed 1-20-98; 8:45 am]
BILLING CODE 4160-01-F
