ANIMAL HEALTH INSTITUTE 
January 21 , 1987 
Director, Office of Recombinant DMA Activities 
National Institutes of Health 
Building 31, Room 3B10 
9000 Rockville Pike 
Bethesda , HD 20892 
RE: Notice of proposed actions under NIH guidelines for research 
involving recombinant DNA molecules, 51 Fed. Reg. 45650 (December 19, 
1986) 
Dear Director: 
The Animal Health Institute is composed of the major U.S. 
manufacturers of animal health products. We are pleased to have the 
opportunity to comment on the changes proposed in the NIH Guidelines, 
which will have direct or indirect effects on our members engaged in 
research and development involving recombinant DNA molecules. 
We are in full agreement with the changes proposed in Section I, 
■Proposed Amendments of Sections I-A and III -A of the NIH Guidelines," 
and Section IV," Proposed Revisions of Appendices C-II, C-III, and C-IV." 
The changes are justified for the reasons stated in the notice, and we 
recommend their prompt adoption. 
Section II, "Proposed Revision of Section III-A-2 of the NIH 
Guidelines," offers us a choice. We recommend adoption of the approach 
of the RAC Working Group on Definitions. We particularly support this 
approach because of the planned development of Appendix 0, which would 
apparently provide more specific guidance on "deliberate release" of 
recombinant DNA-containing organisms in connection with use of a vaccine. 
With regard to Section III of the notice, "Proposed Revision of 
Section I-B or Section III-A-2 of the NIH Guidelines," we have no 
preference between the options, bearing in mind our recommendation 
regarding vaccines described above. 
We thank you for the opportunity to provide these comments, and we 
congratulate you on the good effort. 
FHH:dbk 
Office Address: 119 Oronoco Street • Alexandria, Virginia 22314 • Telephone: 703/684-0011 
Mailing Address: PO. Box I4I7-D50 • Alexandria. Virginia 22313 • Telecopier: 703/684-0125 
Si ncerel y yours , 
Fred H. Holt 
President 
Recombinant DNA Research, Volume 1 1 
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