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Federal Register / Vol. 53. No. 251 / Friday, December 30. 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 
(NIH), Building 31 C. Conference Room 8. 
9000 Rockville Pike. Bethesda. Maryland 
20892. on (anuary 30. 1989. from 
approximately 9 a m. to adjournment at 
approximately 5 p.m. This meeting will 
be open to the public to discuss: 
Proposed amendment to the 
Recombinant DNA Advisory Committee 
Charter. 
Proposed revision of NIH Guidelines 
to refer specifically to research with 
plants and animals: 
Request for permission to perform 
certain experiments: 
Public information brochure on human 
gene therapy: 
Amendment of NIH Guidelines: 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 opportunity 
at the discretion of the Chair. 
Ms. Rachel E. Levinson. Office of 
Recombinant DNA Activities, National 
Institutes of Health. Building 31. Room 
B1C34. Bethesda. Maryland 20892. 
telephone (301) 496-9838, 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 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 ninny 
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: December 27. 1988. 
Betty J. Beveridge. 
Committee Management Officer. StH. 
|FR Doc. 88-30075 Filed 12-29-88; 845 am| 
•1UJMC COOt 4140-01-M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health. 
PHS, DHHS. 
action: Notice of piuposed action under 
NTH 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 
January 30. 1989. After consideration of 
these proposals and comments by the 
RAC. the Director of the National 
Institutes of Health will issue decisions 
on these proposals in accordance and 
with the Guidelines. 
OATES: Comments receded by (anuary 
20. 1989. will be reproduced and 
distributed to the RAC for consideration 
at its (anuary 30. 1989. meeting. 
address: Written comments and 
recommendations should be submitted 
to Rachel E. Levinson. Office of 
Recombinant DNA Activities. Building 
31. Room B1C34. National Institutes of 
Health. Bethesda. Maryland 20892. 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. Building 31. Room B1C34. 
National Institutes of Health. Bethesda. 
Maryland 20892. (301) 496-9838. 
sufpuemfntary information: The NTH 
will consider the following actions 
under the NUI Guidelines for Research 
Involving Recombinant DNA Molecules: 
I. Proposal To Recommend Amending 
the Recombinant DNA Advisory 
Committee Charter 
The Recombinant DNA Advisory 
Committee (RAC) is governed by the 
provisions of Pub. L 92—163. the Federal 
Advisory Committee Act. as amended (5 
U.S.C. Appendix 2). which sets forth 
standards for the formation and use of 
advisory committees. The RAC operates 
under terms described in a charter that 
is approved by the Secretary'. 
Department of Health and Human 
Services. The Director. National 
Institutes of Health, has asked the 
Recombinant DNA Advisory Committee 
(RAC) to discuss and comment on a 
proposed amendment to the RAC 
charter prior to asking the Secretary to 
consider such an amendment. 
The pertinent section of the Charter is 
as follows: 
There shall be four s!aiid;ng 
subscommittoes and ad hoc subcommittees 
as needed * * * Subcommittees shall be 
composed of committee members and. as 
required, of ad hoc consultants tvith expertise 
in (he particular areas addressed by each 
subcommittee. All subcommittees shall report 
to the pa>ent committee. 
The proposed amendment would be 
inserted aflcr the paragraph above, as 
follows: 
All proposals referred to a subcommittee 
for formal review most be approved by a 
majority of subcommittee members before 
being submitted to the parent committee. If a 
proposal is rejected by a subcommittee, the 
investigator may appeal this derision by 
application to the Director. NTH. 
II. Proposed Changes in Appendices P 
and Q of the NTH Guidelines 
On August 11. 1987. a Proposal to 
Modify and Amend the Guidelines for 
Research Involving Recombinant DNA 
Molecules' to Refer Specifically to 
Research with Plants and Animals." was 
published in the Federal Register (52 FR 
29800). These amendments would 
provide containment levels for plants in 
Appendix P and for animals in 
Appendix Q. On September 21. 1967, the 
Recombinant DNA Advisory Committee 
approved the amendments with certain 
changes. These changes arc summarized 
here. Paragraph numbers refer to the 
August 11. 1987. Federal Register 
announcement (52 FR 29000). 
4. The second sentence is revised to 
read as follows: 
"Biosafety Level 1 for plants (El.l-P) 
is designed to provide a moderate level 
of containment for specific recombinant 
DNA research involving plants aod is 
Recombinant DNA Research, Volume 13 
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