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Federal Register / Vol. 53, No. 171 / Friday, September 2, 1988 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisor/ 
Committee; Meeting 
Pursuant to Pub. L. 92-463, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health, 
Building 31C, Conference Room 6, 9000 
Rockville Pike, Bethesda, Maryland 
20892, on October 3, 1988, from 
approximately 9 a.m. to adjournment at 
approximately 5 p.m. This meeting will 
be open to the public to discuss: 
Amendment of Guidelines; 
Proposed major actions; 
Human gene therapy protocol; 
Other matters to be considered by the 
Committee. 
Attendance by the public will be 
limited to space available. Members of 
the public wishing to speak at the 
meeting may be given such an 
opportunity at the discretion of the 
Chair. 
Dr. William J. Gartland, Executive 
Secretary, Recombinant DNA Advisory 
Committee, National Institutes of 
Health, 12441 Parklawn Drive, Suite 58, 
Rockville, Maryland 20852, telephone 
(301) 770-0131, will provide materials to 
be discussed at the meeting, rosters of 
committee members, and substantive 
program information. A summary of die 
meeting will be available at a later date. 
OMB'a “Mandatory Information 
Requirements for Federal Aegistanoa 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 alao 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: August 23, 1988. 
Betty J. Beveridge, 
Committee Management Officer, NIH. 
(FR Doc. 88-19869 Filed 9-1-88; 8:45 amj 
BILLING CODE 4140-01-M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
AGENCY: National Institutes cf Health, 
PHS, DHHS. 
action: Notice of proposed actions 
under NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
SUMMARY: This notice sets forth 
proposed actions to be taken under the 
National Institutes of Health (NTH) 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit 
comments concerning these proposals. 
These proposals will be considered by 
the Recombinant DNA Advisory 
Committee (RAC) at its meeting on 
October 3, 1988. After consideration of 
these proposals and comments by the 
RAC, the Director of the National 
Institutes of Health will issue a decision 
on these proposals in accord with the 
NIH Guidelines. 
DATE: Comments received by September 
23, 1988, will be reproduced and 
distributed to the RAC for consideration 
at its October 3, 1988, meeting. 
ADDRESS: Written comments and 
recommendations. should be submitted 
to tBe Director, Office of Recombinant 
DNA Activities, 12441 Parklawn Drive, 
Suite 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 &30 a Jn. and 5:00 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from the Office of Recombinant DNA 
Activities, 12441 Parklawn Drive, Suite 
58, RockviSe, Maryland 20852, (301) 770- 
0131. 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules: 
I. 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 
estabiished 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, Counsel for the 
Foundation on Economic Trends, and 
Mr. Jeremy Rifkin, Foundation on 
Economic Trends, Washington, DC, 
proposed that the following text be 
inserted after the first sentence of the 
third paragraph of Section I-C: 
For purposes of the preceding sentence, the 
term ‘'project" includes any research or 
development of the recombinat organism or 
other product or process in question, 
including all such work that is reasonably 
forseeable 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. 
This proposed amendment of Section 
I-C was initially published for comment 
in the Federal Register of March 11, 1987 
(52 FR 7525), prior to a scheduled RAC 
meeting on June 15, 1987. The June 15, 
1987, meeting was postponed and 
rescheduled on September 21, 1987. 
Accordingly, this proposed amendment 
was published again for comment in the 
Federal Register of August 11, 1987 (52 
FR 29800). 
After extensive discussion at its 
meeting on September 21, 1987, the RAC 
voted to establish a working group to 
make recommendations regarding 
international projects and to report back 
to the full RAC. 
A Working Group on International 
Projects met at the NIH on February 1, 
1988. After extensive discussion, the 
working group voted seven in favor, 
none opposed, and no abstentions that 
the following proposed revision of the 
last paragraph of Section I-C be 
published for comment: 
The NIH Guidelines are also applicable: (1) 
to projects done abroad if they are supported 
by NIH funds or (2) to research done abroad 
if it involves deliberate release into the 
environment or testing in humans of 
materials containing recombinant DNA 
developed with NIH funds and the research 
is a direct extension of the development 
process. If the host country, however, has 
established rules for the conduct of 
recombinant DNA projects then a written 
assurance of compliance with those rules 
Recombinant DNA Research, Volume 13 
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