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Federal Register / Vol. 51. No. 244 / Friday. December 19, 1986 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes Of Health 
Recombinant DNA Advisory 
Committee; Meeting 
Pursuant to Pub. L 92—163. notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
at the National Institutes of Health. 
Building 1. Wilson Hall. 9000 Rockville 
Pike. Bethesda. Maryland 20892. on 
February 2. 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; 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. Building 31. Room 3B10, 
Bethesda. Maryland, telephone (301) 
496-0051, will provide materials to be 
discussed at the meeting, rosters of 
committee members, and substantive 
program informa ton. 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 
essenttally 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: December 10. 1986. 
Betty |. Beveridge. 
Committee Management Officer. NIH. 
(FR Doc. 86-26441 Filed 12-8-86: 8:45 ami 
BtUJNO COO€ 414O-01-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 
February 2. 1987. 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 accord with the 
Guidelines. 
date Comments received by January 
22. 1987. will be reproduced and 
distributed to the RAC for consideration 
at its February 2. 1987. meeting. 
aooress: Written comments and 
recommendations should be submitted 
to the Director. Office of Recombinant 
DNA Activities. Building 31. Room 3B10, 
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: 
Background documentation and 
additional information can be obtained 
from the Office of Recombinant DNA 
Activities. National Institutes of Health. 
Bethesda. Maryland 20892 (301) 498- 
eosi. 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
I. Proposed Amendments of Sections I- 
A and III— A of the NIH Guidelines 
Dr. Bernard Talbot. Deputy Director. 
National Institute of Allergy and 
Infectious Diseases, has requested that 
the following proposed amendments of 
the NIH Guidelines and rationale be 
published for comment and considered 
by the RAC: 
The current NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules (Guidelines) contain the 
following text in section III— A of the 
Guidelines. 
If the experiments in this category are 
submitted for review to another Federal 
agency, the submitter shall notify ORDA: 
ORDA may then determine that such review 
serves the same purpose, and based on that 
determination, notify the submitter that no 
RAC review will take place, no NIH approval 
is necessary, and the experiment may 
proceed upon approval from the other 
Federal agency. 
This text appears in section III— A of 
the Guidelines and is applicable only to 
experiments covered by Section UI-A. 
It requires that: (1) An investigator 
who has submitted a proposal to 
another Federal agency notify the NIH 
Office of Recombinant DNA Activities 
(ORDA); (2) ORDA determine if the 
review serves the same purpose (as NIH 
review); (3) and. if so. ORDA notify the 
aubmitter that the experiment may 
proceed upon approval from the other 
Federal agency. 
On June 26. 1988. the Office of Science 
and Technology Policy published in the 
Federal Register (51 FR 23302) a 
“Coordinated Framework for Regulation 
of Biotechnology." it contains a 
Preamble, followed by Statements of 
Policy from the Food and Drug 
Administration. Environmental 
Protection Agency, U.S. Department of 
Agriculture. Occupational Safety and 
Health Administration, and the National 
Institutes of Health. The Preamble states 
that. 
... for coniained federally funded 
research for biomedical and agricultural 
purposes, research approval will be granted 
by the funding agency. . . . Jurisdiction for 
release may be under SAE. NSF, APHIS, or 
EPA. 
There is no mention in the June 26 
Federal Register document of any 
requirement, once approval for a 
recombinant DNA experiment is 
obtained from a Federal agency other 
than NIH. for communication with the 
NIH Office of Recombinant DNA 
Activities. And indeed, I believe that the 
absence of such a requirement should be 
the case: not only for experiments 
covered by Section III— A of the 
Guidelines, but for all recombinant DNA 
experiments. 
Therefore. I propose the following 
changes in the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. 
1. Delete from section III— A of the 
Guidelines the following paragraph: 
If the experiments in this category are 
submitted for review to another Federal 
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Recombinant DNA Research, Volume 1 1 
