John Jennings. MD. 
V)CE PRESIDENT 
sc;enc= and Technology 
Pharmaceutical 
]VIanufacturers 
Association 
January 21, 1987 
Dr. William T. Gartland 
Director, Office of Recombinant 
DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda, Maryland 20892 
Dear Dr. Gartland: 
Re: Recombinant DNA Research: Proposed Actions under 
Guidelines . 
Federal Register Notice (Vol. 51, pp. 45650-45652, 
Doc. 66-28442, December 19, 1986) 
The Pharmaceutical Manufacturers Association ( PMA) is a 
voluntary non-profit trade association representing over 100 
companies engaged in research on, and the development, 
manufacturing and marketing of, prescription and ethically 
promoted drugs, biologicals and in vivo diagnostic products. 
Increasingly, these therapeutic and diagnostic products are 
created through biotechnological processes. We are, therefore, 
vitally interested in how biotechnology is addressed under 
national science policy and in regulatory decisions that affect 
research and development of biotechnology-derived products. 
Accordingly, we welcome this opportunity to comment on proposed 
changes in NIH recombinant DNA ( rDNA ) research guidelines. 
Overall, the PMA recommends adoption of each of the 
amendments proposed in Sections I, II, III and IV of the Federal 
Register notice. Detailed comments concerning individual 
sections are given below. 
Section I 
The modifications suggested in this section are appropriate 
and important clarifications of the regulatory processes for 
review of proposed experiments and reduce the possibility of 
unnecessary, duplicative review and/or notification. 
Section II 
The proposed changes, while relatively minor, are important 
steps toward defining "deliberate release" and allow exemptions 
for cases where experience provides adequate evidence of 
biological and/or physical control of the rDNA containing 
[280] 
1100 Fifteenth Street NW. Washinorton. DC 20005 • Tel: 202-835-3540 • TWX: 7108229494-PMAWSH 
Recombinant DNA Research, Volume 1 1 
