63074 
Federal Register / Vol. 44, No. 213 / Thursday, November 1, 1979 / Notices 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
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, 
Conference Room 10. Building 31 C, 
Bethesda. Maryland 20205, on December 
6-7. 1979, from 9:00 a.m. to 5:00 p.m. This 
meeting will be open to the public on 
December 6 from 9:00 a.m. to 5:00 p.m., 
and December 7. from 9:00 a.m. to 3:00 
p.m., to discuss: 
Amendment of Guidelines 
Containment practices appropriate for large- 
scale production 
Exception to a prohibition 
Procedures for lowering characterized clones 
Large-scale experiments 
Prokaryote host-vectors other than £ coli K- 
12 
N1H risk-assessment plan 
Review of protocols for required containment 
levels 
Other matters requiring necessary action by 
the Committee. 
Attendance by the public will be 
limited to space available. 
In accordance with the provisions set 
forth in section 552b(c)(4). Title 5. U.S. 
Code and section 10(d) of Pub. L 92-463, 
the meeting will be closed to the public 
on December 7 from 3:00 p.m. to 5:00 
p.m. for the review, discussion and 
evaluation of a proposal from a 
commercial concern for scale-up of 
recombinant DNA experiments. This 
proposals and the discussions could 
reveal confidential trade secrets or 
commercial property such as patentable 
material. 
Dr. William ). Cartland, Jr. Executive 
Secretary. Recombinant DNA Advisory 
Committee. National Institutes of 
Health. Building 31. Room 4A52. 
telephone 301-496-6051. 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. 
Dated: October 26. 1979. 
Suzanne L Fremeau. 
Committee Management Officer. NIH. 
FR Doc F.l*d 10-J1-7W a 45 .m| 
MU-INO coot 411 O- 0 S-M 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health. 
PHS. DHEW. 
ACTION: Notice of proposed actions 
under NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
summary: This notice sets forth 
proposals for actions to be taken under 
the 1978 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(Federal Register of December 22. 1978 
(43 FR 60108)). Interested parties are 
invited to submit comments concerning 
these proposals. After consideration of 
these proposals and comments by the 
NIH Recombinant DNA Advisory 
Committee (RAC) at its December 6-7, 
1979, meeting, the Director of the 
National Institutes of Health will issue 
decisions on these proposals in accord 
with the Guidelines. 
DATE: Comments must be received by 
December 3, 1979. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director. Office of Recombinant 
DNA Activities. Building 31. Room 4A52, 
National Institutes of Health, Bethesda. 
Maryland 20205. 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: 
Additional information can be obtained 
from Drs. Stanley Barban or Elizabeth 
Milewski. Office of Recombinant DNA 
Activities. National Institutes of Health, 
Bethesda. Maryland 20205. (301) 496- 
6051. 
SUPPLEMENTARY INFORMATION: The 
National Institutes of Health will 
consider the following changes and 
amendments under the Guidelines for 
Research Involving Recombinant DNA 
Molecules (43 FR 60108). as well as 
actions under these Guidelines. 
1. Revision of Requirements for 
Exempt Experiments. As a result of 
discussions by the RAC at its September 
6-7. 1979 meeting, a working group has 
proposed an amendment of the 
requirements for conducting 
experiments exempted under Section 
I-E of the Guidelines. The proposal 
would amend Section I-E of the 
Guidelines to read as follows (new 
wording is in italics:) 
I-E. Exemptions. It must be emphasized 
that the following exemptions[4) are not 
meant to apply to experiments described in 
the Sections I-D-l to I-D-5 as being 
prohibited. 
The following recombinant DNA molecules 
are exempt from these Guidelines, and no 
registration with NIH is necessary provided, 
however, that where exempted experiments 
are conducted at. or sponsored by an 
institution receiving financial support or 
verba! sanction (i.e.. industry) from NIH for 
research involving recombinant DNA 
molecules, notice of such experiments shall 
be given to the local 1 BC. which will upon 
request provide ORDA with a summary 
report of the number and nature of such 
exempt experiments conducted at or by such 
institutions: 
2. Expiration Date for Section VI of 
the Guidelines. A proposed Section VI 
to be added to Guidelines entitled 
"Voluntary Compliance" was 
recommended by the RAC at its 
September 6-7, 1979 meeting by a vote 
of 11 to 0 with 4 abstentions. Final 
action on this recommendation by the 
Director. NIH, has not yet been taken. 
Dr. Richard Novick has proposed the 
following resolution with regard to 
compliance with the Guidelines by non- 
federally funded institutions: 
Whereas it is desirable to establish a 
uniform standard of conduct for the 
performance of experiments involving 
recombinant DNA techniques. 
And whereas the RAC has recommended 
mandatory compliance with the NIH 
Guidelines for non-federally funded 
institutions. 
And whereas there is currently no extent 
legal framework within which this can be 
effected. 
The RAC congratulates the Pharmaceutical 
Manufacturers Association and its member 
companies for the cooperative spirit that they 
have shown in agreeing to comply with the 
NIH Guidelines voluntarily under provisions 
of the supplement to the Guidelines adopted 
by the RAC at its meeting of September 6-7, 
1979. 
At the same time, the Committee regards 
the concept of voluntary compliance as 
experimental: in order to ensure further 
consideration after a trial period, it sets 
hereby an expiration date of June 1, 1980. 
subject to renewal, on these supplementary 
provisions (Section VI of the Guidelines). 
3. Amendment of Sections I-A and II- 
D of the Guidelines. Dr. Richard Novick 
has recommended that Sections I-A and 
II— D of the Guidelines be amended to 
include additional text (new text is in 
italics): 
I- A. Purpose. The purpose of these 
Guidelines is to specify practices for 
constructing and handling (i) recombinant 
DNA molecules and (ii) organisms and 
viruses containing recombinant DNA 
molecules in cases where there is a clearly 
perceived hazard to plants or aninials. 
II— D. Biological Containment. Whenever a 
molecular done poses a clearly definable 
hazard, a level of biological containment 
appropriate to the severity of the hazard will 
be used. 
Dr. Novick has proposed that the 
following new sections be inserted in 
the Guidelines as Sections II-D-l-a, II- 
D-l-a-(l), and II-D-l-a-(2). The current 
text on HV1 with these numbers would 
be retained and renumbered. The 
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