316 Federal Register / Vol. 57, No. 2 / Friday, January 3. 1992 / 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 February 10-11, 1992. The meeting 
will be held at the National Institutes of 
Health (N1H). Building 31C, Conference 
Room 10. 9000 Rockville Pike, Bethesda. 
Maryland 20892, starting at 
approximately 9 a.m. on February 10, 
1992, to adjournment at approximately 5 
p.m. on February 11. 1992. The meeting 
will be open to the public to discuss the 
following proposed actions under the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules (51 FR 
16958): 
Proposed Major Actions to the NIH 
Guidelines; 
Five additions to appendix D of the 
NIH Guidelines Regarding Human Gene 
Therapy/Gene Transfer Protocols: 
An amendment to appendix D-XV of 
the NIH Guidelines Regarding a Human 
Gene Therapy Protocol; 
Amend section IV-B and add sections 
IV-C and IV-D to the Points to Consider 
in the Design and Submission of 
Protocols for the Transfer of 
Recombinant DNA Into the Genome of 
Human Subjects Regarding Reporting 
Requirements for Human Gene 
Transfer/Gene Therapy Protocols: 
Amend sections IU-A and IV-C of the 
NIH Guidelines regarding publishing 
notice of meetings and proposed actions 
in the Federal Register 
Amend introduction, section IV-B and 
V of the Points to Consider regarding 
review by the Human Gene Therapy 
Subcommittee; 
Amend appendices B-I-B-l and B-I- 
B-2 of the NIH Guidelines to include 
only pathogenic genera and species of 
the bacterial order, Actinomycetales, in 
the current list of microorganisms; 
Amend Appendices B-I-C-l and B-I- 
B-l in the NIH Guidelines regarding 
Mycobacterium avium; 
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, Phone 
(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 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: December 24, 1991. 
Susan K. Feldman, 
Committee Management Officer, NIH. 
[FR Doc. 92-107 Filed 1-2-92; 8:45 am] 
BILUNQ COOE 4 140-01 -M 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Recombinant DNA Research: 
Proposed Actions Under the 
Guidelines 
AGENCY: National Institutes of Health, 
PHS, 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 under the 
National Institutes of Health (NIH) 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit 
comments concerning these proposals. 
These proposals will be considered by 
the Recombinant DNA Advisory 
Committee (RAC) at its meeting on 
February 10-11, 1992. After 
consideration of these proposals and 
comments by the RAC, the Director of 
the National Institutes of Health will 
issue decisions in accordance with the 
NIH Guidelines. 
OATES: Comments received by January 
28, 1992, will be reproduced and 
distributed to the RAC for consideration 
at its February 10-11, 1992, meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
to Dr. Nelson A. Wivel. Director, Office 
of Recombinant DNA Activities, 
Building 231, 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 will be available for 
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 4B11, 
' National Institutes of Health, Bethesda, 
Maryland 20892, (301) 496-9838. 
SUPPLEMENTARY INFORMATION: The NIH 
will consider the following actions 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules: 
I. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Nabel 
In a letter dated October 18, 1991, Dr. 
Gary J. Nabel of the University of 
Michigan Medical School. Ann Arbor, 
Michigan, indicated his intention to 
submit a human gene therapy protocol 
to the Human Gene Therapy 
Subcommittee and the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: 
“Immunotherapy of Malignancy by In 
Vivo Gene Transfer into Tumors." 
This request was published for 
comment in the Federal Register on 
November 4, 1991 (56 FR 56415). 
The protocol was reviewed during the 
Human Gene Therapy Subcommittee 
meeting on November 21-22, 1991. 
Provisional approval was given with the 
following conditions: (i) Amend consent 
form regarding possibility of 
sensitization to the human antigen; (ii) 
expand the clinical protocol regarding 
the number of biopsies; (iii) make 
available the nucleotide sequence |L 
analysis of the total construct of the 
vector; and (iv) provide clarification 
concerning the status of DNA 
integration in tumor cells. 
The Human Gene Therapy 
Subcommittee forwarded the protocol to 
the Recombinant DNA Advisory 
f 
B 
[302] 
Recombinant DNA Research, Volume 15 
