31848 
Federal Register / Vol. 52, No. 163 / Monday, August 24, 1987 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Action 
Under Guidelines 
AGENCY: National Institutes of Health, 
PHS, DHHS. 
action: Notice of Action under NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets forth an 
action to be taken by the Director, 
National Institutes of Health (NIH], 
under the May 7, 1986, NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules (51 FR 16958). 
EFFECTIVE DATE: August 24. 1987. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities, 12441 
Parklawn Drive, Suite 58, Rockville, 
Maryland 20852, (301) 770-0131. 
SUPPLEMENTARY INFORMATION: Today 
an action is being promulgated under 
the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
This proposed action was published 
for comment in the Federal Register of 
August 15, 1986 (51 FR 29423), and 
reviewed and recommended for 
approval by the NIH Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on September 29, 1986. Minutes 
of that meeting are available from the 
Office of Recombinant DNA Activities 
at the address given above. 
In accordance with Section IV-C-l-b 
of the NIH Guidelines this action has 
been found to comply with the NIH 
Guidelines, and to present no significant 
risk to health or the environment. 
I. Decision on Action Under NIH 
Guidelines 
Proposal to Add Bacillus Sphaericus to 
Appendix C-V of the NIH Guidelines 
Dr. William F. Burke, Jr., of Arizona 
State University, Tempe, Arizona, in a 
letter dated July 28, 1986, requested that 
Bacillus sphaericus be added to the list 
of Gram positive bacteria in Appendix 
C-V of the NIH Guidelines. References 
to published articles providing relevant 
data were included in his submission. 
This proposal was published in the 
August 15, 1986, Federal Register (51 FR 
29423) for public comment. No 
comments on the proposal were 
received. 
The RAC considered this proposal at 
the September 29, 1986, meeting. By a 
vote of nineteen in favor, none opposed, 
and no abstentions, RAC recommended 
approval of the proposal. 
I accept this recommendation and 
Appendix C-V has been modified 
accordingly. 
IL Summary of Actions 
Revision of Appendix C-V 
Appendix C-V, Exlrachromosomal 
Elements of Gram Positive Organisms, 
is modified by the addition of Bacillus 
sphaericus to the list of organisms. 
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 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 12, 1987. 
James B. Wyngaarden, 
Director, National Institutes of Health. 
(FR Doc. 87-19118 Filed 8-21-87: 8:45 am] 
BILLING CODE 4140-01-M 
Recombinant DNA Research; Actions 
Under Guidelines 
agency: National Institutes of Health, 
PHS. DHHS. 
action: Notice oT Actions under NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets forth two 
actions to be taken by the Director, 
National Institutes of Health (NIH), 
under the May 7, 1986, NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules (51 FR 16958). 
EFFECTIVE DATE: August 24, 1987. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities, 12441 
Parklawn Drive, Suite 58, Rockville, 
Maryland 20852, (301) 770-0131. 
SUPPLEMENTARY INFORMATION: Today 
two actions are being promulgated 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
These two proposed actions were 
published for comment in the Federal 
Register of December 19, 1988 (51 FR 
45650), and reviewed and recommended 
for approval by the NIH Recombinant 
DNA Advisory Committee (RAC) at its 
meeting on February 2, 1987. A 
transcript of that meeting is available 
from the Office of Recombinant DNA 
Activities at the address given above. 
In accordance with Section IV-C-l-b 
of the NIH Guidelines, these actions 
have been found to comply with the NIH 
Guidelines and to present no significant 
risk to health or the environment 
I. Decisions on Actions Under NIH 
Guidelines 
A. Proposed Amendments of Sections I- 
A and I1I-A of the NIH Guidelines 
Dr. Bernard Talbot then Deputy 
Director, National Institute of Allergy 
and Infectious Diseases, requested in a 
memorandum dated December 1, 1988, 
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 HI-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 III-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 
submitter that the experiment may proceed 
upon approval from the other Federal agency. 
On June 28, 1986, 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 
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Recombinant DNA Research, Volume 13 
