CONTENTS 
Page 
Introductory letter from the Director, NIH 1 
Preamble by the Secretary of Health, Education, and Welfare 3 
Decision of the Director, NIH, To Issue Revised Guidelines 5 
NIH Guidelines (as revised December 1978) 29 
FDA Notice of Intent to Propose Regulations 54 
Letter to the Administrator, Environmental Protection Agency .... 57 
Administrative Practices Supplement 59 
Memorandum on transition to revised Guidelines 87 
[The following documents are in chronological order] 
Transcript of HEW hearing, September 15, 1978 91 
Statements by witnesses at HEW hearing 279 
The 1978 Nobel Prize in Medicine 420 
Minutes, Interagency Advisory Committee, October 12, 1978 426 
Federal Register notices of meetings 440 
NIH workshop for chairmen of institutional biosafety committees. . . 442 
Press release on new members. Recombinant ONA Advisory Committee . . 446 
APPENDICES (under separate cover) 
A. Comments on NIH-proposed revised Guidelines A-l 
B. Friends of the Earth v. Califano et al B-l 
vi i 
