Federal Register / Vol. 52. No. 47 / Wednesday, March 11. 1987 / Notices 
7525 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research: 
Proposed Action Under Guidelines 
agency: National Institutes of Health. 
PHS, DHHS. 
ACTION: Notice of proposed action 
under NIH guidelines for research 
involving recombinant DNA molecules. 
SUMMARY: This notice sets forth a 
proposed action to be taken under the 
National Institutes of Health (NIH) 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit 
comments concerning this proposal. This 
proposal will be considered by the 
Recombinant DNA Advisory Committee 
(RAC) at its meeting on June 15, 1987. 
After consideration of this proposal and 
comments by the RAC, the Director of 
the National Institutes of Health will 
issue a decision on this proposal in 
accord with the NIH Guidelines. 
DATES: Comments received by May 29, 
1987, will be reproduced and distributed 
to the RAC for consideration at its June 
15, 1987, meeting. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
DNA Activities, 12441 Parklawn Drive, 
Room 58, Rockville, MD 20852. All 
comments received in timely response to 
this notice will be considered and will 
be available for public inspection in the 
above office on weekdays between the 
hours of 8:30 a.m. and 5:00 p.m. 
FOR FURTHER INFORMATION: Background 
documentation and additional 
information can be obtained from the 
Office of Recombinant DNA Activities, 
12441 Parklawn Drive, Room 58, 
Rockville. Maryland 20852, (301) 770- 
0131. 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following action under 
the NIH Guidelines for Research 
Involving Recombinant DNA Molecules: 
Proposed Amendment of Section I-C 
Section I-C of the NIH Guidelines 
currently reads as follows: 
I-C General Applicability 
The Guidelines are applicable to all 
recombinant DNA research within the United 
States or its territories which is conducted at 
or sponsored by an institution that receives 
any support for recombinant DNA research 
from the National Institutes of Health (NIH). 
This includes research performed by the NIH 
directly. 
An individual receiving support for 
research involving recombinant DNA must be 
associated with or sponsored by an 
institution that can and does assume the 
responsibilities assigned in these Guidelines. 
The Guidelines are also applicable to 
projects done abroad if they are supported by 
NIH funds. If the host country, however, has 
established rules for the conduct of 
recombinant DNA projects, then a certificate 
of compliance with those rules may be 
submitted to NIH in lieu of compliance with 
the NIH Guidelines. The NIH reserves the 
right to withhold funding if the safety 
practices to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines. 
In a letter dated January 9, 1987, Mr. 
Edward Lee Rogers of Washington, DC, 
Counsel for the Foundation on Economic 
Trends and Jeremy Rifkin, has proposed 
that the following text be inserted after 
the first sentence of the third paragraph 
of Section I-C: 
For the purposes of the preceding sentence, 
the term 'project' includes any research or 
development of the recombinant organism or 
other product or process in question. 
Including all such work that is reasonably 
foreseeable when the NIH support is 
received. NIH support includes both money 
grants and any type of in-kind support, 
including research conducted directly by 
NIH. supplies, equipment the use of facilities, 
and biological research materials. NIH 
support has been given where the source of 
funds or in-kind support is, directly or 
Indirectly, the NIH. 
OMB'8 "Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in the Catalog of Federal Domestic 
Assistance. Normally NIH lists in its 
announcements the number and title of 
affected individual programs for the 
guidance of the public. Because the 
guidance in this notice covers not only 
virtually every NIH program but also 
essentially every Federal research 
program in which DNA recombinant 
molecule techniques could be used, it 
has been determined to be not cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition, NIH could 
not be certain that every Federal 
program would be included as many 
Federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NIH Guidelines. In lieu of the individual 
program listing, NIH invites readers to 
direct questions to the information 
address above about whether individual 
Programs listed in the Catalog of 
Federal Domestic Assistance are 
affected. 
Dated: March 3, 1987. 
Bernard Talbot, 
Acting Director. National Institute of Allergy 
and Infectious Diseases. 
[FR Doc. 87-4904 Filed 3-10-87; 8:45 am] 
BIL1JNQ CODE 4140-01-M 
[198] 
Recombinant DNA Research, Volume 1 1 
