Number 95-02

Animal Welfare

The Animal Welfare Division of OPRR was renamed Office of Laboratory Animal Welfare (OLAW) in 2000.

March 8, 1995

Subject: Sources of Custom Antibody Production

This letter is being forwarded to Institutional Officials and Institutional Animal Care and Use Committee (IACUC) Chairs throughout the country. It is provided as guidance when determining sources for the production of antibodies in animals as part of activities supported by the Public Health Service (PHS), either directly or as a consequence of subgranting or subcontracting such production.

The Office for Protection from Research Risks (OPRR) is aware that some applicant organizations are uncertain about the PHS animal welfare requirements when animal use takes place outside the institution through subgrants or subcontracts. A common example of this is the production of antibodies using antigens provided by an investigator ("custom" antibodies) in animals. Institutions and investigators should be aware that if animals are utilized to produce such antibodies for use in PHS­supported research, the organization producing those antibodies must either have on file with OPRR an approved Animal Welfare Assurance (Assurance) or be included as a component of the applicant organization's Assurance. In addition, if species covered by the Animal Welfare Act are utilized, the producer must be registered as a "Research Facility" with the U.S. Department of Agriculture (USDA).

OPRR recognizes that many institutions have found it difficult to ensure that investigators procuring "custom" antibodies do so only from Assured sources. To facilitate and assist institutions in complying with PHS Policy requirements, OPRR urges PHS­supported investigators and institutions that utilize custom antibodies to follow the guidelines presented below.

When procuring custom antibody production services from non­institutional sources:

1) Contact the proposed producer to determine its Assured status, and if Assured, obtain the Assurance number. Alternatively, consult with OPRR for information on the Assured status of the preferred antibody producer. If the producer is Assured, the procurement action may proceed without additional actions. [NOTE: In cases where the intended producer is known at the time a grant proposal is being submitted to the National Institutes of Health, the producer's organization should be included as a performance site on the grant application.]

2) If the producer is not Assured, at least two options are available:

• (a) Antibodies may be procured from other producers that are Assured; or
  

• (b) The producer or the applicant organization may request that OPRR negotiate an Assurance with the producer's organization. [NOTE: If the producer was identified as a performance site on the grant application, the PHS funding component will notify OPRR of the need for an Assurance.] Upon successful completion of negotiations with the proposed producer and approval of an Assurance, which usually can be accomplished expeditiously, antibodies may be procured in accord with 1) above.
  

Adherence to the above guidelines will serve several worthwhile ends: (1) Animals involved in custom antibody production will be maintained and used in accord with federal humane standards; (2) antibody production will be conducted in a manner that is scientifically reliable; and (3) compliance burdens to investigators and institutions will be minimized.