[Federal Register Volume 64, Number 121 (Thursday, June 24, 1999)]
[Notices]
[Pages 33868-33869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-1718]


Draft Guidance for Industry on Monoclonal Antibodies Used as 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availability of a draft guidance for industry entitled ``Monoclonal 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 This draft 
guidance provides recommendations to sponsors and applicants on the 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

DATES: Written comments on the draft guidance document may be submitted 
by September 22, 1999. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single 
copies of the draft guidance for industry to the Drug Information 
Branch (HFD-210), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or 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 the office in processing your 
requests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Monoclonal Antibodies Used as 
Reagents in Drug Manufacturing.'' This draft guidance focuses on 
chemistry, manufacturing, and control issues relating to the use of 
monoclonal antibodies as reagents in drug substance and drug product 
manufacture that should be addressed in IND's, NDA's, ANDA's, BLA's, 
and supplements to these applications.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It represents 
the agency's current thinking on monoclonal antibodies used as 
reagents. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An

[[Page 33869]]

alternative approach may be used if such approach satisfies the 
requirement of the applicable statute, regulations, or both.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management 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 draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: June 16, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-16139 Filed 6-23-99; 8:45 am]
BILLING CODE 4160-01-F