[Federal Register Volume 64, Number 89 (Monday, May 10, 1999)]
[Notices]
[Pages 25049-25050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11735]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0512]
``Guidance for Industry: For the Submission of Chemistry,
Manufacturing and Controls and Establishment Description Information
for Human Blood and Blood Components Intended for Transfusion or for
Further Manufacture and for the Completion of the Form FDA 356h,
`Application to Market a New Drug, Biologic or an Antibiotic Drug for
Human Use;''' 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 document entitled ``Guidance for Industry: For the
Submission of Chemistry, Manufacturing and Controls and Establishment
Description Information for Human Blood and Blood Components Intended
for Transfusion or for Further Manufacture and For the Completion of
the Form FDA 356h, `Application to Market a New Drug, Biologic or an
Antibiotic Drug for Human Use.''' This 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 blood and blood components
intended for transfusion or for further manufacture. In addition, this
guidance document provides assistance for the completion of the BLA.
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
(Modernization Act), 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
entitled ``Guidance for Industry: For the Submission of Chemistry,
Manufacturing and Controls and Establishment Description Information
for Human Blood and Blood Components Intended for Transfusion or for
Further Manufacture and For the Completion of the Form FDA 356h,
[[Page 25050]]
`Application to Market a New Drug, Biologic or an Antibiotic Drug for
Human Use''' 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 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: Astrid L. Szeto, 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 document entitled
``Guidance for Industry: For the Submission of Chemistry, Manufacturing
and Controls and Establishment Description Information for Human Blood
and Blood Components Intended for Transfusion or for Further
Manufacture and For the Completion of the Form FDA 356h, `Application
to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.'''
This guidance document is intended to provide instructions on the
completion of the revised Form FDA 356h, including CMC and
establishment description sections for human blood and blood components
intended for transfusion or for further manufacture. The guidance
announced in this notice has been revised based on comments received on
the draft guidance entitled ``Guidance for Industry: For the Submission
of Chemistry, Manufacturing and Controls and Establishment Description
Information for Human Blood and Blood Components Intended for
Transfusion or for Further Manufacture and For the Completion of the
Form FDA 356h, `Application to Market a New Drug, Biologic or an
Antibiotic Drug for Human Use''' announced in the Federal Register of
July 10, 1998 (63 FR 37401) and finalizes that draft document.
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, to include blood and
blood components. Manufacturers may voluntarily begin using the form
for human blood and blood components. FDA will announce in the future
when manufacturers are required to use this form for all products. Use
of the new harmonized form 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).
This guidance document represents the agency's current thinking on
content and format of the CMC and establishment description information
sections of a license application for human blood and blood components
intended for transfusion or for further manufacture. 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
Interested persons, may at any time, submit written comments to
the Dockets Management Branch (address above) 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 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: April 30, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-11735 Filed 5-7-99; 8:45 am]
BILLING CODE 4160-01-F