[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Draft Guidance for Industry on Monoclonal Antibodies Used as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availability of a draft guidance for industry entitled ``Monoclonal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 This draft
guidance provides recommendations to sponsors and applicants on the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DATES: Written comments on the draft guidance document may be submitted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ADDRESSES: Copies of this draft guidance are available on the Internet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copies of the draft guidance for industry to the Drug Information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 Submit written comments on the draft guidance to the Dockets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]
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