[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