Federal Register / Vol. 53. No. 146 / Friday. July 29. 1988 / Notices 
28819 
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: July 28, 1988 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland. Office of 
Recombinant DNA Activities, National 
Institutes of Health. 12441 Parklawn 
Drive, Suite 58, Rockville. Maryland 
20852. (301) 770-0131. 
SUPPLEMENTARY INFORMATION: Today 
an action is being promulgated under 
the NTH Guidelines for Research 
Involving Recombinant DNA Molecules. 
This proposed action was published for 
comment in the Federal Register of 
August 11. 1987 (52 FR 29800), and 
reviewed and recommended for 
approval by the NTH Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on September 21. 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 NTH Guidelines, this action has 
been found to comply with the NTH 
Guidelines and to present no significant 
risk to health or the environment. 
Part I of this announcement provides 
background information on the action. 
Part II provides a summary of the action 
of the Director. NIH. 
I. Decision on Action Under NIH 
Guidelines 
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. requested 
that Bacillus stearothermophilis be 
added to Appendix C-V, 
Extrachromosomal Elements of Gram 
Positive Organisms. Information on 
genetic exchange involving this 
organism was provided in the 
submission. 
This proposal was published in the 
August 11, 1987, Federal Register (52 FR 
29800) for public comment. No 
comments on the proposal were 
received. 
The RAC considered this proposal at 
the September 21. 1987 meeting. By a 
vote of eighteen in favor, none opposed, 
and no abstentions, the RAC 
recommended approval of the proposal. 
I accept this recommendation and 
Appendix C-V has been modified 
accordingly. 
II. Summary of Action 
Revision of Appendix C-V 
Appendix C-V. Extrachromosomal 
Elements of Gram Positive Organisms. 
is modified by the addition of Bacillus 
stearothermophilis 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 NTH 
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 Catalog of Federal 
Domestic Assistance are affected. 
Dated: July 22. 1988. 
James B. Wyngaarden. 
Director. National Institutes o f Health. 
(FR Doc. 88-17030 Filed 7-27-68: 8:45 arr.| 
BILLING COO€ 4140-01-H 
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Recombinant DNA Research, Volume 13 
