[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]


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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.

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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availability of the draft guidance document entitled ``Guidance for 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 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 The draft guidance 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In addition, the draft guidance document provides assistance for the 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