[Federal Register Volume 66, Number 61 (Thursday, March 29, 2001)]
[Notices]
[Pages 17184-17185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7680]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-1718]


Guidance for Industry on Monoclonal Antibodies Used as Reagents 
in Drug Manufacturing; 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 guidance for industry entitled ``Monoclonal 
Antibodies Used as Reagents in Drug Manufacturing.'' This guidance is 
intended to provide recommendations for sponsors and applicants of new 
drug applications (NDA's), abbreviated new drug applications (ANDA's), 
biologics license applications (BLA's), their supplements, or 
investigational new drug applications (IND's) on information that 
should be included in applications when monoclonal antibodies (mAb's) 
are used as reagents in the manufacture of drug substances regulated by 
the Center for Drug Evaluation and Research (CDER) or the Center for 
Biologics Evaluation and Research (CBER).

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Drug Information Branch (HFD-210), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit written comments on the 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Eugenia M. Nashed, Center for Drug 
Evaluation and Research (HFD-570), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1050, or Kurt A. Brorson, 
Center for Biologics Evaluation and Research (HFM-561), 8800 Rockville 
Pike, Bethesda, MD 20892-0029, 301-827-0661.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Monoclonal Antibodies Used as Reagents in Drug 
Manufacturing.'' This guidance focuses on the chemistry, manufacturing, 
and control (CMC) issues that should be addressed in NDA's, ANDA's, 
BLA's, their supplements, or IND's. This document is not intended to 
cover mAb's used as diagnostics, radiolabeled imaging agents, or 
therapeutic products. In the Federal Register of June 24, 1999 (64 FR 
33868), FDA announced the availability of a draft version of this 
guidance. The June 1999 document gave interested persons an opportunity 
to submit comments through September 22, 1999. All comments received 
during the comment period have been carefully reviewed and incorporated 
in this revised guidance where appropriate. As a result of public input 
during the comment period, the final guidance is clearer and more 
concise than the draft version.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). The guidance represents the agency's current thinking on 
monoclonal antibodies used as reagents in drug manufacturing. 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 statutes 
and regulations.

II. Comments

    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management

[[Page 17185]]

Branch (address above). 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. The guidance 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 at 
http://www.fda.gov/cder/guidance/index.htm.

    Dated: March 22, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7680 Filed 3-28-01; 8:45 am]
BILLING CODE 4160-01-S