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Federal Register / Vol. 44, No. 151 / Friday, August 3, 1979 / Notices 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
National Institutes of Health 
Proposed Supplement to the NIH 
Guidelines for Recombinant DNA 
Research 
On December 22, 1978, the Director, 
National Institutes of Health, with the 
approval of the Assistant Secretary for 
Health and the Secretary of Health, 
Education, and Welfare, issued revised 
Guidelines for Research Involving 
Recombinant DNA Molecules (43 FR 
60108). These Guidelines were 
accompanied in the Federal Register by 
a Notice of Intent to Propose 
Regulations issued by the Food and 
Drug Administration. In addition, the 
Secretary sent letters to Administrator 
Douglas Costle, Environmental 
Protection Agency, and to Secretary of 
Agriculture Bob Bergland, requesting 
comparable actions to ensure a 
commonality of standards throughout 
the private sector. In July the Secretary 
sent a similar request to Secretary of 
Labor Ray Marshall. 
Several responses to the FDA notice 
questioned that agency’s legal authority 
to regulate private research in this field. 
In view of these comments, NIH Director 
Donald S. Fredrickson and the 
Commissioner of Food and Drugs, 
Donald Kennedy, developed a draft 
supplement to the NIH Guidelines that 
would extend them on a voluntary basis 
to industry. This draft was reviewed by 
Peter Libassi, then General Counsel for 
the Department, who also consulted 
with representatives from the 
pharmaceutical industry and from public 
interest and environmental 
organizations. The representatives from 
the pharmaceutical industry considered 
the supplement to provide a feasible 
basis for voluntary compliance; the 
representatives from the other groups 
considered a voluntary system 
insufficient and urged that mandatory 
compliance be achieved through 
legislation or regulation. 
In light of those discussions it was 
agreed that the draft supplement 
prepared by NIH and FDA should also 
be reviewed by the Federal Interagency 
Advisory Committee on Recombinant 
DNA Research which includes all 
relevant Federal research and regulatory 
agencies. This Committee, created in 
October 1976 to consider extension of 
the Guidelines nationally, had 
recommended in March 1977 that 
legislation be developed. On July 16, 
1979, the Committee met to consider the 
draft supplement and alternative 
approaches to extend the revised NIH 
guidelines to the private sector. It was 
the Committee's unanimous opinion that 
NIH should proceed to publish for public 
comment the draft supplement to the 
NIH Guidelines. The conclusion was not 
unanimous that the voluntary approach 
would achieve complete compliance 
within the private sector. 
On the basis of the recommendations 
by the Interagency Committee, the 
Director, NIH, invites public comment 
on the proposed supplement to the NIH 
Guidelines, which is set forth below. 
Written comments and inquiries 
concerning this draft supplement and 
the questions above should be 
addressed to the Director, National 
Institutes of Health, Bethesda, Maryland 
20205. All comments received will be 
available for public inspection at the 
Director's office on weekdays (Federal 
holidays excepted) between the hours of 
8:30 a.m. and 5:00 p.m. All comments 
will be considered at the next meeting of 
the Recombinant DNA Advisory 
Committee scheduled for September 6-7, 
when this item will be placed on the 
agenda for action. 
Dated: July 27, 1979. 
Donald S. Fredrickson, 
Director, National Institutes of Health. 
Guidelines for Research Involving 
Recombinant DNA Molecules 
New Sections to Be Added 
IV-G-5. Voluntary Compliance. Any 
individual, corporation, or institution 
that is not otherwise covered by the 
Guidelines is encouraged to conduct 
recombinant DNA research activities in 
accordance with the Guidelines, through 
the procedures set forth in Part VI. 
VI. Voluntary Compliance 
VI-A. Basic Policy. Individuals, 
corporations, and institutions not 
otherwise covered by the Guidelines are 
encouraged to do so by following the 
standards and procedures set forth in 
Parts I-IV of the Guidelines. In order to 
simplify discussion, references hereafter 
to “institutions” are intended to 
encompass corporations, and 
individuals who have no organizational 
affiliation. For purposes of complying 
with the Guidelines, an individual 
intending to carry out research involving 
recombinant DNA is encouraged to 
affiliate with an institution that has an 
Institutional Biosafety Committee 
approved under the Guidelines. 
Since commercial organizations have 
special concerns, such as protection of 
proprietary data, some modifications 
and explanations of the procedures in 
Parts I-IV are provided below, in order 
to address these concerns. 
VI-B. IBC Approval. The NIH Office 
of Recombinant DNA Activities (ORDA) 
will review the membership of an 
institution's Institutional Biosafety 
Committee (IBC) and, where it finds the 
IBC meets the requirements set forth 
Section IV-D-2, will give its approval to 
the IBC membership. 
It should be emphasized that 
employment of an IBC member solely 
for purposes of membership on the IBC 
does not itself make the member an 
institutionally affiliated member for 
purposes of Section IV-D-2-a. 
Except for the unaffiliated members, a 
member of an IBC for an institution not 
otherwise covered by the Guidelines 
may participate in the review and 
approval of a project in which the 
member has a direct financial interest, 
so long as the member has not been and 
does not expect to be engaged in the 
project. Section IV-D-2-d is modified 10 
that extent for purposes of these 
institutions. 
VI-C. Registration. Upon approval of 
a recombinant DNA research project by 
the IBC, an institution may register the 
project by submitting to ORDA the 
information required in the 
Administrative Practices Supplement. 
VI-D. Certification of Host-Vector 
Systems. A host-vector system may be 
proposed for certification by the 
Director, NIH, in accordance with the 
procedures set forth in Section II-D-2-a. 
Institutions not otherwise covered by 
the Guidelines will not be subject to 
Section II-D-3 by complying with these 
procedures. 
In order to ensure protection for 
proprietary data, any public notice 
regarding a host-vector system which is 
designated by the institution as 
proprietary under Section VI-F-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
VI-E Requests for Exceptions, 
Exemptions, Approvals. Requests for 
exceptions from prohibitions, 
exemptions, or other approvals required 
by the Guidelines should be requested 
by following the procedures set forth in 
the appropriate sections in Parts I-IV of 
the Guidelines. 
In order to ensure protection for 
proprietary data, any public notice 
regarding a request for an exception, 
exemption, or other approval which is 
designated by the institution as 
proprietary under Section VI-F-1 will be 
issued only after consultation with the 
institution as to the content of the 
notice. 
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