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Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
AGENCY: National Institutes of Health, 
PHS, HEW. 
ACTION: Notice of actions under NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
SUMMARY: This notice sets forth actions 
taken by the Director, NIH, under the 
1978 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(43 FR 60108). Revised NIH Guidelines 
are printed following this notice. 
EFFECTIVE DATE: January 29, 1980. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health, Bethesda, 
Maryland 20205. (301) 496-6051. 
SUPPLEMENTARY INFORMATION: I am 
promulgating today revised NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. This 
announcement is a “Decision 
Document" explaining the background 
and reasons for my decision. 
Immediately following this 
announcement there appears a copy of 
the revised NIH Guidelines. 
The structure of this Decision 
Document is as follows: 
I. History of the NIH Guidelines Through 
1978. 
II. Revision of the December 1978 
Guidelines. 
III. Analysis of Comments on Decision 
Document/Environmental Impact 
Assessment/Proposed Revised Guidelines as 
Published For Comment in the Federal 
Register on November 30, 1979 (44 FR 69210). 
I. History of the NIH Guidelines Through 
1978 
The history leading to the issuance of 
the original 1976 NIH Guidelines for 
Recombinant DNA Research is 
described in detail in the Environmental 
Impact Statement on the 1976 
Guidelines, and in the "Decision 
Document” accompanying the 
Guidelines in the Federal Register of 
July 7, 1976. Key points in the history 
included: 
• The Maxine Singer-Dieter Soil letter 
[Science 181, 1114, 1973) arising from the 
Gordon Research Conference on Nucleic 
Acids of July 1973. 
• The Paul Berg et al. letter to Science 
(185, 303, 1974) calling for the NIH to 
establish an advisory committee to write 
guidelines. 
» The Asilomar conference of 
February 1975. 
• The work of the NIH Recombinant 
DNA Advisory Committee (RAC) 
through 1975, resulting in the proposed 
guidelines of December 1975. 
• The special meeting of the Advisory 
Committee to the Director, NIH, on 
February 9-10, 1976, to review the 
proposed guidelines. 
• Final issuance of the NIH 
Guidelines on June 23, 1976 (published in 
the Federal Register on July 7, 1976). 
The history from the period July 1976 
to December 1978 included the following 
key points: 
• Deliberations on revisions by the 
RAC during 1977, resulting in proposed 
revisions published for comment in the 
Federal Register on September 27, 1977 
(42 FR 49596). 
• A public hearing on the revisions, at 
the meeting of the Advisory Committee 
to the Director, NIH, December 15-16, 
1977. 
• Publication for public comment in 
the Federal Register on July 28, 1978 (43 
FR 33042), of new proposed revised 
guidelines accompanied by a detailed 
Decision Document and a detailed 
Environmental Impact Assessment. 
• A public hearing on the proposed 
revisions, chaired by the General 
Counsel of HEW, on September 15, 1978. 
• Publication of revised guidelines on 
December 22, 1978 (43 FR 60080), 
accompanied by a detailed Decision 
Document and Environmental Impact 
Assessment. 
The entire history is extensively 
documented in Volumes 1-4 of 
“Recombinant DNA Research” — a series 
constituting a readily available public 
record of activities in regard to the NIH 
Guidelines. 
II. Revision of the December 1978 
Guidelines 
The December 1978 NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules (43 FR 60108) include 
procedures for changing the Guidelines. 
As detailed in Section IV-E-l-b-(l) of 
the Guidelines, this involves: (1) 
publication in the Federal Register for 
public comment, at least 30 days prior to 
a RAC meeting, of the proposed 
changes: (2) consideration of the 
proposed changes by the RAC; and (3) 
publication in the Federal Register of the 
final decision by the Director, NIH. 
In accordance with these procedures, 
proposed changes in the Guidelines 
appeared in the Federal Register on 
January 15, 1979 (44 FR 3226), were 
considered by the RAC at its February 
16-17, 1979, meeting, and were 
promulgated by the NIH Director in the 
Federal Register on April 11, 1979 (44 FR 
21730). 
Proposed changes in the Guidelines 
appeared in the Federal Register on 
April 13, 1979 (44 FR 22314), were 
considered by the RAC at its May 21-23, 
1979, meeting, and were promulgated by 
the NIH Director in the Federal Register 
on July 20, 1979 (44 FR 42914). 
Proposed changes in the Guidelines 
appeared in the Federal Register on July 
31, 1979 (44 FR 45088) and were 
considered by the RAC at its September 
6-7, 1979, meeting. Rather than 
promulgating the recommended changes, 
the Director, NIH, instead issued them 
for 30 days of additional public 
comment in the Federal Register on 
November 30, 1979 (44 FR 69210). 
This was in accordance with Section 
IV-E-l-b-(l) of the NIH Guidelines (43 
FR 60126) which says, "The Director’s 
proposed decision, at his discretion, may 
be published in the Federal Register for 
30 days of comment before final action 
is taken." What appeared in the Federal 
Register on November 30 was a detailed 
"Decision Document” explaining the 
background and reasons for the 
proposed decision, an Environmental 
Impact Assessment, and proposed 
revised NIH Guidelines. Included was 
an analysis of many letters received 
prior to November 30. Part III of the 
present document contains an analysis 
by the Director, NIH, of all comments 
received during the period November 30, 
1979 to January 18, 1980 on the Decision 
Document/Environmental Impact 
Assessment/Proposed Revised 
Guidelines as published in the Federal 
Register on November 30, 1979. All of 
the changes in the Guidelines accepted 
by the Director, NIH, and promulgated 
today have been found by the Director, 
NIH, in accordance with Section IV-E- 
1-b of the NIH Guidelines, to comply 
with the Guidelines and to present no 
significant risk to health or the 
environment. 
Proposed changes in the Guidelines 
appeared in the Federal Register on 
November 1, 1979 (44 FR 63074), were 
considered by the RAC at its December 
6-7, 1979, meeting, and were 
promulgated by the NIH Director in the 
Federal Register on January 17, 1980 (45 
FR 3552). 
Immediately following this “Decision 
Document,” there appears a copy of the 
revised NIH Guidelines which are 
effective today. These were obtained by 
incorporating into the December 1978 
Guidelines all the changes made 
following the February 16-17, 1979, May 
21-23, 1979, September 6-7, 1979, and 
December 6-7, 1979, RAC meetings. 
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