NOT-OD-00-019: OFFICE OF EXTRAMURAL RESEARCH GUIDANCE CONCERNING THE PRODUCTION OF MONOCLONAL ANTIBODIES IN ANIMALS

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®


OFFICE OF EXTRAMURAL RESEARCH GUIDANCE CONCERNING THE PRODUCTION OF 
MONOCLONAL ANTIBODIES IN ANIMALS

Release Date:  February 3, 2000

NOTICE:  OD-00-019

National Institutes of Health

This Notice provides guidance to Public Health Service (PHS) awardee 
institutions and Institutional Animal Care and Use Committees (IACUCs) on 
avoiding or minimizing discomfort, distress, and pain to animals in the 
production of monoclonal antibodies (mAbs), in accordance with the PHS Policy 
on Humane Care and Use of Laboratory Animals.

BACKGROUND

On December 10, 1999, the NIH Director responded to a petition by the American 
Anti-Vivisection Society to prohibit the routine use of animals in the 
production of mAbs.  That response endorses the conclusions and 
recommendations of the National Research Council (NRC) report "Monoclonal 
Antibody Production.  It reiterates the applicable federal animal welfare 
standards, affirms existing guidance from the Office for Protection from 
Research Risks on policy implementation at the institutional level, and lists 
important information resources and NIH-supported core facilities with tissue 
culture capabilities.

GUIDANCE TO AWARDEE INSTITUTIONS

Institutions should examine their current IACUC practices regarding the review 
and approval of proposals to produce mAbs in animals.  The IACUC semiannual 
evaluation of the institutional program of animal care and use is an 
appropriate mechanism for accomplishing this self-evaluation.  Institutions 
should use the guidance in the following documents as the basis for 
evaluation:

o  November 17, 1997 OPRR "Dear Colleague" letter at:  
http://grants.nih.gov/grants/olaw/references/dc98-01.htm

o  the NRC Monoclonal Antibody Production Report at:  
http://grants.nih.gov/grants/policy/antibodies.pdf

o  the NIH Director"s December 10, 1999 letter at:
http://grants.nih.gov/grants/olaw/references/resp121099.pdf

Institutions currently following the November 1997 OPRR guidance need not make 
additional changes in order to be in compliance with the Public Health Service 
Policy on Humane Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/phspol.htm).  The NRC Report and the NIH 
Director"s response should be used as additional resources to assist IACUCs in 
making scientifically and ethically informed assessments of all future 
proposals to use the mouse ascites method of mAb production.

INQUIRIES

For questions or further information, contact:

Office of the Director
Office of Extramural Research
Office for Protection from Research Risks

Division of Animal Welfare
6100 Executive Blvd., Suite 3B01
Rockville, Maryland 20892-7507
Telephone: (301) 496-7163
FAX: (301) 402-2803
[email protected]
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