.37846 it - fjederal Regii / 'Vol/ 55, No.‘ 178, / Thursday, Septen. .*'13, 1990 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Advisory 
Committee; Meeting ’ , 
Pursuant to Public Law 92-463, notice 
is hereby given of a meeting Of the 
Recombinant DNA Advisory Committee 
on October 16, 1990. The meeting will be 
held at the National Institutes of Health 
(NIH), Building :3lC, Conference Room 6, 
9000 Rockville Pike, Bethesda, Maryland 
20892, starting at approximately 9 a.m. 
to adjournment at approximately 5 p.m. 
The meeting will be open to the public to 
discuss the folloW'ing proposed actions 
under the “NIH Guidelines for Research 
Involving Recombinant DNA Molecules” 
(51 FR 16958): 
Proposed Major Actions to the “NIH 
Guidelines”; 
Revision of Appendix K'of the “NIH 
Guidelines” Regarding Establishment of 
Guidelines for Level of Containment 
Appropriate to Good Industrial Large 
Scale Practices (GILSP); 
Preliminary Review of the Regional 
Hearings Conducted by the 
Recombinant DNA Advisory Committee 
Concerning Future Role of this . 
Committee: 
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 this 
meeting may be given such opportunity 
at the discretion of the Chair. . : 
Dr. Nelson A. Wivel, Director. Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31. room 4B11, Bethesda, Maryland 
20892, telephone (301) 496-9838, fax 
(301) 496-9839, will provide materials to 
be discussed at this meeting, roster 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, 
June 11, 1980) 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 not to 
be cost effective or in the public interest 
to attempt to list those programs. Such a 
list w'ould 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 fpllow the 
“NIN Guidelines.” In lieu of the 
individual program listing, NIH invites 
readers to direct questions to the . 
information address above whether ; 
individual programs listed in the 
“Catalog of Federal Domestic , : 
Assistance” are affected, :;r - 
Dated: September 10, 1990. ' : 
Betty J. Beveridge, 
Committee Management Officer, NIH. 
(FR Doc. 90-21708 Filed 9-12-90; 8:45 am] 
BtLUNG CODE 414EH)1-M 
DEPARTMENT OP HEALTH AND 
HUMAN SERVICES 
Recombinant DNA Research; 
Proposed Actions Under the 
Guidelines 
agency: National Institutes of Health^ 
PKS.DHHS. 
action: Notice of Proposed Actions 
Under the “NIH Guidelines for Research . 
Involving Recombinant DNA Molecules” 
(51 FR 16958). 
SUMMARY: This notice sets forth 
proposed actions to be taken imder the 
National Institutes of Health (NIH) 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit, 
comments concerning these proposals. 
These propiosals will be considered by 
the Recombinant DNA Advisory 
Committee (RAC) at its meeting on 
October 16, 1990. After consideration of 
these proposals and comments by the 
RAC, the Director of the National 
Institutes of Health will issue decisions 
in accordance with “NIH Guidelines”. ; 
dates: Comments received by October 
8, 1990, will be reproduced and 
distributed to the RAC for consideration 
at its October 16, 1990, meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel, Director, Office 
of Recombinant DNA Activities, 
Building 31, room 4B11, National 
Institutes of Health, Bethesda, Maryland 
20892, or sent by fax to 301-496-9839. 
All comments received in timely 
response to this notice will be , 
considered and w’ill be available for ' i 
public inspection in the above office on 
weekdays between the hours of 8:30 
a.m. and 5 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from the Office of Recombinant DNA 
Activities, Building 31, Room 4Bll, 
National Institutes of Health, Bethesda, 
Maryland 20892, (301) 496-9838. 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following actions 
:■ undei- the “NIH Guidelines for Research 
Involving Recombinant DNA 
Molecules”: 
1. Revision of Appendix X of the “NIH 
Guidelines” Regarding Establisbinent of 
Guidelines for Level of Containment 
Appropriate to Good Industrial Large 
Scale ^actices (GILSP) 
In a letter dated June 28, 1990, the 
Industrial Biotechnology Association 
(IBA) and the Pharmaceutical 
Manufacturers Association (PMA) 
requested that the Recombinant DNA 
Advisory Committee revise appendix K 
of the '"NIH Guidelines for Research 
Involving Recombinant DNA 
Molecules" to reflect a formalization of 
suitable containment practices and 
facilitied for the conduct of large-scale 
experiments involving recombinant 
DNA-derived industrial microorganisms. 
In attachments to this request, there are 
(proposed definitions and requirements 
pertaining to the requested changes. The 
Revision of the NiH Guidelines 
Subcommittee will meet on October 15 
to review this request and report with a 
recommendation to the Recombinant 
DNA Advisory Committee. 
Proposed revision of appendix K 
reads as follows: 
"Appendix K-r-Physical Contaiment for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules 
“This part of the Guidelines specifies 
physical containment guidelines for 
large-scale (greater than 10 liters of 
culture) research or production involving 
viable organisms containing 
recombinant DNA molecules. It shall 
apply to large-scale research or 
production activities as specified in 
section III-B-5 of the Guidelines. It is 
important to note that this appendix 
addresses only the biological hazard 
associated with organisms containing 
recombinant DNA. Other hazards 
accompanying the large scale cultivation 
of such organisms (e.g., toxic properties 
of products; physical, mechanical and 
chemical aspects of downstream 
processing) are not addressed and must 
be considered separately, albeit in 
conjunction with this appendix.” 
(Remainder of Introduction remains 
unchanged I 
Recombinant DNA Research, Volume 14 
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