[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37401-37402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18404]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0512]
Draft ``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 FDA Form 356h,
Application to Market a New Drug, Biologic or an Antibiotic Drug for
Human Use;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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availability of the draft guidance document entitled ``Guidance for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 Blood and Blood
Components Intended for Transfusion or for Further Manufacture and For
the Completion of the FDA Form 356h, Application to Market a New Drug,
Biologic or an Antibiotic Drug for Human Use.'' The draft guidance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 blood and
blood components intended for transfusion or for further manufacture.
In addition, the draft guidance document provides assistance for the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
[[Page 37402]]
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, however, comments
should be submitted by September 8, 1998, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of ``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 FDA Form 356h, 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, 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. 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 draft 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 draft guidance 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 FDA Form 356h,
Application to Market a New Drug, Biologic or an Antibiotic Drug for
Human Use.'' The draft document, when finalized, 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. 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. 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 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 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. Requests for 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 to the Dockets Management Branch (address
above) written comments regarding the draft guidance document. Written
comments may be submitted at any time, however, comments should be
submitted by September 8, 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 and
requests 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 using the World Wide Web (WWW). For WWW access, connect to
CBER at ``http://www.fda.gov/cber/guidelines.htm''.
Dated: June 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18404 Filed 7-9-98; 8:45 am]
BILLING CODE 4160-01-F
