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Federal Register / Vol. 52, No. 154 / Tuesday. August 11. 1907 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant lo Pub. L 92-163. notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health. 
Building 31 C, Conference Room 6. 9000 
Rockville Pike. Bcthesda. Maryland 
20892. on September 21. 1987, 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 revision of Guidelines to refer 
specifically to research with plants 
and animals; and 
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 ). 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 the 
meeting will be available at a later date. 
OMB's "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 cover* 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 lo 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 question* to the information 
address above about whether individual 
Programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
Dated: August 3. 1987. 
Betty J. Beveridge. 
CommiUec Management Officer. NIH. 
|FR Doc. 87-18200 Filed 8-10-87; 8 45 am) 
BILLING COOt 4 140-0 1 -M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
aqency: National Institutes of 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 (NIH) 
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 
September 21. 1987. 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. 
DATES: Comments received by 
September 4. 1987, will be reproduced 
and distributed to the RAC for 
consideration at its September 21. 1987. 
meeting. 
AOORESS: Written comments and 
recommendations should be submitted 
to the 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 8:30 a.m. and 5:00 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from the Office of Recombinant DNA 
Activities (ORDA). 12441 Parklawn 
Drive. Suite 58, Rockville. Maryland 
20852. (301) 770-0131. 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules: 
1. Proposed Amendment of Section I-C 
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 
of Section I-C is being published again 
for comment. 
Section I-C of the NIH Guidelines 
currently reads 06 follows: "l-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 Nil I 
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 
lo withhold funding if the safety 
practices to be employed abroad are not 
reasonably consistent with the NTH 
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 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 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. NTH 
support has been given where the source 
of funds or in-kind support is. directly or 
indirectly, the NTH. 
II. Proposal to Add Bacillus 
Stearothermophilis to Appendix C-V 
Drs. Richard Novick and June Polak of 
the Public Health Research Institute of 
the City of New York, Inc., have 
requested that Bacillus 
stearothermophilis be added to 
Appendix C-V. Extrachromosomal 
Elements of Gram Positive Organisms. 
Information on genetic exchange 
involving this organism is provided in 
the submission to ORDA. 
Recombinant DNA Research, Volume 13 
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