[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availability of the draft guidance document entitled ``Guidance for 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draft guidance document is intended to assist applicants in the 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: For the Submission of 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