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Federal Register / Vol. 53. No. 74 / Monday. April 18. 1988 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
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 3lC. Conference Room 6. 9000 
Rockville Pike. Bet'nesda. Maryland 
20892. on June 3. 1968 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. 
• Other matters to hr considered by 
the Committee 
Attendance by the public will l»- 
limited to space available. Members of 
the public wishing to speak at the 
meeting may be giver, such ar 
opportunity a! the discretion of th.- 
Chair. 
Dr Williiim ) Cartl.imi Executive 
Secretary. Recombinant DNA Advisory 
Committee. National Institutes oi 
Health. 12441 Parkluvvn Drive. Suite 58. 
Rockville. Maryland 20652 telephone 
(3011 770-0131. will p-ovide materials to 
be discussed at the meeting rosters of 
committee members, and substantivp 
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 Ccta/oy of Federc.' Domestic 
Assistance Normally NIH lists in its 
announcements the number and title of 
affected individual programs fer 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. NTH 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. NTH invites readers to 
direct questions to the information 
address above about whether individual 
programs listed in the Coinin'! of 
Federal Domestic Assistance are 
affected. 
Dated. April 5. 196H 
Belly J. Beveridge. 
ConmiHit Stcnciiement 0‘ v ir, .- A "snarni 
Institutes nf Health 
|FR Doc. 68-836* Filed 4— 15— B8 8 45 am] 
BILUNG COO£ 4140-01-M 
Recombinant DNA Research; 
Proposed Actions Under Gu'delines 
agency: National Institutes of Health. 
PHS DHHS. 
action: Notice of Proposed Actions 
Under NTH Guidelines for Research 
Involving Recombinant DNA Molecules. 
summary: This notice sets forth 
piop'ised actions to be taken under the 
National Institutes of Health (NTH ) 
Guidelines for Research Involving 
Recun binant DNA Molecules. 
Interested parties are invited to submit 
comments concerning these proposals. 
These proposals wili be considered bv 
the Recombinant DNA Advisory 
Committee (RAC) at its meeting on June 
3. 19&8 After consideration of the c e 
proposals and comments by the RAC. 
the Director of the National Institutes of 
Health will issue a decision on these 
proposals m accord with the NTH 
Guidelines. 
date: Comments received by May 24. 
1988. wili be reproduced and distributed 
to the RAC for consideration at its June 
3. 1988. meeting. 
address: Written comments and 
recommendations should be submitted 
to the Director. Office of Recombinant 
NDA Activities. 12441 Parklawr. Drive. 
Suite 58. Rockville. MO 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 Parklawr. Drive. Suite 
56. Rockville. Maryland 20852. (301) 770- 
0131. 
supplementary information: The NTH 
v. ill consider the following actions 
under the NTH Guidelines for Research 
Involving Recombinant DNA Molecules: 
l. Proposed Amendment of Section I-C 
Section. 1-C of the NTH Guidelines 
currently reads as follows: 
T-C General Applicability. 
"The Guidelines are applicable to all 
rerom.bir.ant DNA research within the 
United States or its territories which is 
conducted at or sponored by an 
institution that receiv es cry support for 
recombinant DNA research from the 
National Institutes of Health (NTH). This 
includes rcsr.r.rch performed by the NTH 
directly 
"An individual receiving suppjrt for 
research involving recombinant DNA 
must be associated with or sponsored 
by "an institution that car. and does 
assume the responsibilities assigned ir: 
these Guidelines 
"The Guidelines are also applicable to 
projects done abroad if they are 
supported by NTH funds. If the host 
country, however has established rules 
for the conduct of recombinant DNA 
projects, tren a certificate of complianLfi 
with those rules may be submitted to 
NIH ir. lieu of compliance with the NTH 
Guidelines. The NIH res.rves the righi 
to withhold funding if the safety 
practices to be employed abroad are not 
reasonably consist. r.» with the NTH 
Guiceiincs 
In a letter daicd January 1937. Mi. 
Edwdid Lte Rogft.v Counsel fur the 
Foundation or. Economlr Trends, and 
Mr. Jeremy Rifi.ir.. Foundation on 
Economic Tr r nds. Was!, ngton. D C.. 
proposed that the following !*-xt be 
inserted after the first sentence of thv 
third paragraph of Section 1-C: 
‘Tor purposes of the preceding 
sentence, the te-m project' includes any 
research or development of the 
recombinant organism or other product 
or process in question, including all such 
work that is reasonably forseeahle when 
the NTH support is received. NTH 
support includes both money grants and 
any type of ir.-kind support, including 
research conducted directly by NTH. 
supplies, equipment, the use of facilities, 
and biological research materials. NT! I 
support nos been giver wheie the source 
of funds or in-kind supper! is. directly or 
indirectly, the N’1H.“ 
This proposed amendment of Section 
I-C was initially published for comment 
in the Federal Register of March 11. 1987 
(52 FR 75 ^ 5 ). prior to a scheduled RAC 
meeting on Jure 15. 1567. The June 15. 
1987, meeting was postponed and 
rescheduled on September 21. 1967. 
Accordingly, this proposed amendment 
was published again for comment in tn<- 
Federal Register of August 11. 196* (52 
FR 29800). 
After extensive discussion at its 
meeting of Sepiember 21. 1987, the RAC. 
voted to establish a working group to 
make recommendations regarding 
international projects and to report buck 
to t'nc full RAC. 
A Working Group on International 
Projects me: a: the NTH on February i 
1988 After extensive discussion, the 
Recombinant DNA Research, Voiume 13 
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