PREFACE 
This report is the second in a series documenting the activities 
of the National Institutes of Health in respect to research involving 
recombinant DNA molecules. Volume 1 of the series, prepared in 
August 1976, covered events from February 1975--the Asilomar 
conference --through June 1976--the issuance of N1H Guidelines. 
Volume 2 covers subsequent events culminating with those surrounding 
(but not including) the publication of proposed revisions to the Guide- 
lines on September 27, 1977. 
During the period covered here, NIH undertook an evaluation of 
HEW's patent policy, with a view to deciding whether a change was 
in order for recombinant DNA inventions made under Departmental 
support. The present volume includes an analysis of current policy 
by the Director, NIH, and the comments on this analysis by members 
of the Recombinant Advisory Committee, the Director's Advisory 
Committee, and pharmaceutical companies. 
In July 1976 a letter from Senators Javits and Kennedy to President 
Ford recommended that the NIH Guidelines be extended to the entire 
Nation's research community by appropriate executive or legislative 
action. In response, the Secretary of HEW, with the approval of the 
President, convened an interagency committee to review and coordinate 
the activities of Federal agencies and to conduct other related inquiries. 
The Federal Interagency Committee has held eight meetings, and two 
subcommittees met to review patent policy and international safety 
measures. Included in the present volume are the minutes of the 
Committee's meetings and various Committee documents relating to 
the above subjects and to recombinant DNA activities in other govern- 
ment agencies, the private sector, and abroad. The Committee's 
recommendations on the matter of legislation are also reported. 
A staff review of congressional action, documented by the major 
bills of 1977, is included. Up to February 1978, no law regulating 
recombinant DNA activities has been enacted. Compliance with the 
NIH Guidelines, however, extends throughout private industry on a 
voluntary basis and is compulsory under the far-ranging NIH awards 
system . 
A bibliography of popular literature on recombinant DNA and a 
selection of typical news articles have been included to illustrate the 
diverse interests and points of view that have attended this con- 
troversial subject. 
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