23210 
Federal Register / Vol. 51. No. 122 / Wednesday, June 25, 1936 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Advisory 
Committee; Meeting 
Pursuant io Pub. L. 92^4G3, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
et the National Institutes of Health, 
Building 31C, Conference Room 6. 9000 
Rockville Pike, Bethesda. Maryland 
20892. on September 29. 1906, from 
approximately 9:C0 a.m. to adjournment 
at approximately 5:00 p.m. This meeting 
will be open to the public to discuss: 
Scientific issues in human gene therapy: 
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 opportunity 
at the discretion of the Chair. 
Dr. William J. Gartland. Executive 
Secretary, Recombinant DNA Advisory 
Committee. National Institutes of 
Health, Building 31, Room 3B10, 
Esthssda, Maryland 20602, 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: June 18. 1986. 
Betty J. Beveridge, 
Committee Mcr.agement Officer. NIH. 
OMB's “Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in the Cctc.'og 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 baen 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, NIH invites readers to 
direct Questions to the information 
address above 3bout whether individual 
programs listed in the Catalog of 
Federal Domestic Assistance are 
affected. 
[FR Doc. 86-14378 Filed 6-24-86: S:43 am] 
BILLING CODS 4MO-01-M 
Recombinant DNA Research: 
Proposed Action Under Guidelines 
agency: National Institutes of Health, 
PHS. DHHS. 
action: Notice of Proposed Action 
under NTH Guidelines for Research 
Involving Recombinant DNA Molecules. 
summary: This notice sets forth a 
proposed action to be taker, under the 
National Institutes of Health (NTH) 
Guideiir.es for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited !o submit 
comments concerning th : s proposal. This 
proposal will be considered by the 
Recombinant DNA Advisory Committee 
(RAC) Working Group on Human Gene 
Therapy ei its meeting cn August 8, 
1983. and by the full RAC at its meeting 
or, September 29. 1936. After 
consideration of this proposal ard 
comments by the RAC. the Director of 
the National Institutes of Health will 
issue a decision or. this proposal in 
accord with the Guidelines. 
DATE: Comments received bv July 31, 
1936, will be reproduced and distributed 
to the Working Group on Human Gene 
Therapy for consideration at its August 
8, 19S6, meeting. Those comments and 
comments received after July 31, 1986, 
but prioi to September 19, 1986. will be 
reproduced and distribuled to the full 
RAC for consideration at its September 
29, 1986, meeting. 
address: 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. 
FCR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Bethesda, Maryland 20892, (301) 496- 
6051. 
SUPPLEMENTARY INFORMATION: The 
National Institutes of Health will 
consider the following action under the 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
I. Proposal lo Modify Section IIJ-A-4 of 
the NIH Guidelines 
The Committee foi Responsible 
Genetics. Boston. Massachusetts, has 
submitted the following proposal and 
ralionule to modify Section HI— A— 4 of 
the Guidelines: 
"Proposed Addition to the end of 
section III-A— 4 of the NIH Guidelines on 
Redombinant DNA Molecules. 
"The RAC will net review and the 
NIH will not approve any human genetic 
therapy: 
"1. That is not aimed solely at the 
relief of a life-thrsalenir.g or severely 
disabling condition: or 
“2. That could alter germ line cells. 
"Furthermore, the RAC will not 
review and the NIH will not approve 
any in vitro recombinant DNA 
experiments that alter human germ lira 
cells or early human embryos. 
"Rationale 
"This addition to the NIK Guidelines 
is proposed in order to place a clear 
statement in the public record 
describing NIH's policy or experiment 
in human genetic engineering. The 
published “Points to Consider in the 
Design and Submission of Human 
Somatic-Cel! Therapy Protocols" (sic) 
define a process fc: reviewing protocols 
but set no limitations and place no 
boundaries on human gene therapy 
experiments and on research or. human 
germ line cells. This proposal is 
designed to give assurance to the public 
that, by opening up possibilities of 
human genetic engineering in areas 
where there is wide social consensus or. 
at least, no strong public opposition, the 
technolog}' will not be applied to other 
situations where adequate public deba’.t 
has not taken place. 
“1. Somatic Cell Therapy for the 
Treatment of Disease. 
Medical technologies that have 
initially been developed with 
governmental approval for specific 
purposes are easily adapted to other 
circumstances without commensurate 
accountability, once public attention 
and debate have waned. In our present 
socioeconomic environment, there are 
strong professional and business 
motivations for increasing the 
application of medical technologies. 
"Human somatic cell gene therapy 
(HSCT) is currently being considered for 
use in life-threatening diseases. An 
American scientist already has carried 
out such experiments outside the United 
States. But the potential range of 
applications of HSCT is very broad. 
Genes regulate numerous biochemical 
processes including the production of 
[ 32 ] 
Recombinant DNA Research, Volume 1 1 
