[Federal Register Volume 62, Number 40 (Friday, February 28, 1997)]
[Notices]
[Pages 9196-9197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5006]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0259]


``Points to Consider in the Manufacture and Testing of Monoclonal 
Antibody Products for Human Use (1997);'' 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 points to consider (PTC) document entitled ``Points 
to Consider in the Manufacture and Testing of Monoclonal Antibody 
Products for Human Use (1997).'' This PTC document is intended to 
assist sponsors and investigators engaged in monoclonal antibody 
product development and it includes information to submit when filing 
investigational new drug applications and product license applications. 
The document revises a 1994 document entitled ``Draft Points to 
Consider in the Manufacture and Testing of Monoclonal Antibody Products 
for Human Use.''

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the document 
entitled ``Points to Consider in the Manufacture and Testing of 
Monoclonal Antibody Products for Human Use (1997)'' to the 
Manufacturers Assistance and Communication Staff (HFM-42), 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 that office in processing your requests. The 
document may also be obtained by mail or fax by calling the CBER Fax 
Information System at 1-888-CBER-FAX or 301-827-3844.

    Persons with access to the Internet may obtain the document using 
the World Wide Web (WWW) or bounce-back e-mail. For WWW access, connect 
to CBER at ``http://www.fda.gov/cber/cberftp.html.'' For bounce back e-
mail send a message to ``[email protected].''
    Submit written comments on the PTC document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of the PTC 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.
FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a PTC 
document entitled ``Points to Consider in the Manufacture and Testing 
of Monoclonal Antibody Products for Human Use (1997).'' This PTC 
document supersedes the document entitled ``Draft Points to Consider in 
the Manufacture and Testing of Monoclonal Antibody Products for Human 
Use'' announced in the Federal Register of August 3, 1994 (59 FR 
39571), and is designed to assist sponsors and investigators engaged in 
monoclonal antibody product development.
    The PTC revision was undertaken for reasons that include but are 
not limited to: (1) Facilitating initial development of monoclonal 
antibodies for serious and immediately life-threatening indications; 
(2) updating and streamlining information from the 1994 PTC document; 
and (3) assuring consistency with current CBER policy and International 
Conference on Harmonisation documents dealing with this category of 
products. In the revision of this document, CBER reviewed and 
considered all comments submitted to the docket.
    The PTC document details an approach for sponsors and investigators 
to follow in product manufacturing and testing, preclinical and 
clinical studies, and the information to be provided for

[[Page 9197]]

review and evaluation of clinical testing and licensing. This document 
applies to monoclonal antibodies made by traditional hybridoma 
technology as well as by recombinant technologies. Some of the major 
changes in the revised PTC document include: (1) An updated definition 
of a monoclonal antibody; (2) modification of the quality control, 
product testing, and product comparability sections; and (3) 
clarification of the techniques for and necessity of retrovirus 
testing. The section of the draft 1994 PTC document dealing with 
changes to be reported after product approval is not included in the 
1997 PTC document because this subject is addressed in a separate 
rulemaking (61 FR 2739, January 29, 1996).
    A new section of the document discusses abbreviated product testing 
for feasibility trials in serious and immediately life-threatening 
conditions. Other important new concepts contained in the revised PTC 
document are those of generic and modular virus clearance studies and 
the acceptability of demonstrating the removal of some contaminants by 
means of clearance studies, as opposed to routine testing. The concepts 
of generic and modular virus clearance studies and of clearance studies 
for some contaminants apply not only to monoclonal antibodies but also 
to recombinant products, as appropriate. CBER intends to update other 
guidance documents to reflect these studies. New concepts on 
abbreviated product testing for feasibility trials in serious and 
immediately life-threatening conditions and on generic and modular 
virus clearance studies do not apply to products of entirely human 
origin or to products that have the potential to be contaminated by 
human pathogens.
    As with other guidance documents, FDA does not intend the PTC 
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. Manufacturers may 
follow the document or may choose to use alternative procedures that 
are not provided in this document. If a manufacturer chooses to use 
alternative procedures, that manufacturer may wish to discuss the 
matter further with FDA to prevent expenditure of resources to generate 
data on activities that FDA may later determine to be unacceptable. 
Although this document does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public, it does 
represent the agency's current thinking on the manufacture and testing 
of monoclonal antibody products for human use.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the PTC document. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.
    Received comments will be considered in determining whether further 
revision of the PTC document in warranted. Any revised version of the 
PTC document will be announced in the Federal Register.

    Dated: February 20, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-5006 Filed 2-27-97; 8:45 am]
BILLING CODE 4160-01-F