49584 
Federal Register / Vol. 57. No. 212 / Monday, November 2. 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 December 3-4, 1992. The meeting will 
be held at the National Institutes of 
Health (NIH), Building 1, Third Floor. 
Wilson Hall. 9GG0 Rockville Pike, 
Bethesda. Maryland 20892, starting at 
approximately 9 a.m. on December 3, 
1992, to adjournment at approximately 5 
p.m. on December 4, 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; Four additions to Appendix 
D of the NIH Guidelines Regarding 
Human Gene Therapy/Gene Transfer 
Protocols; Amendments 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 (1) Reporting 
Requirements for Human Gene 
Transfer/Gene Therapy Protocols, and 
(2) the separation of Gene Marking 
Information Consent Document from the 
Therapeutic Informed Consent - 
Documents; Discussion regarding Costs 
Associated with Treatment for 
Research-Related Injuries; Report on 
Murine Replication-Competent 
Retrovirus (RCR) Assays; 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 tide 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: October 23, 1992. 
Susan K, Feldman. 
Committee Management Officer. NIH. 
(FR Doc. 92-25484 Filed 10-30-92: 8:45 am| 
BILLING COO£ 4140-01-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 
December 3-4, 1992. After consideration 
of these proposals and comments by the 
RAG, the Director of the National - 
Institutes of Health will issue decisions 
in accordance with the NIH Guidelines. 
DATES: Comments received by - 
November 19, 1992. will be reproduced 
and distributed to the RAC for 
consideration at its December 3-4. 1992. 
meeting. 
ADDRESSES: Written comments and 
recommendations should be submitted 
-to Dr. Nelson A. Wivel, Director. Office 
■ of Recombinant DNA Activities 
(ORDA). 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 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 cf 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. O’Shaughnessy 
In a letter dated September 9. 1992, a 
letter was received indicating the 
intention of Dr. Joyce A. O'Shaughnessy. 
National Institutes of Health, Bethesda. 
Maryland, to submit a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approvaL The title of this 
protocol is: Retroviral Mediated 
Transfer of the Human Multi-Drug 
Resistance Gene (MDR-1) into 
Hematopoietic Stem Cells During 
Autologous Transplantation after 
Intensive Chemotherapy for Breast 
Cancer. 
IL Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Crystal 
In a letter dated October 7, 1992, Dr. 
Ronald G. Crystal, National Institutes of 
Health, Bethesda, Maryland, submitted 
a human gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
of this protocol is: Gene Therapy of the 
Respiratory Manifestations of Cystic 
Fibrosis using a Replication Deficient. 
Recombinant Adenovirus to Transfer 
the Normal Human Cystic Fibrosis 
Transmembrane Conductance Regulator 
cDNA to the Airway Epithelium. 
. III. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Welsh 
In a letter dated October 5. 1992, Dr. 
Michael J. Welsh, Howard Hughes 
Medical Institute Research Laboratories. 
Iowa City, Iowa, submitted a human 
gene therapy protocol to the 
Recombinant DNA Advisory Committee 
for formal review and approval. The title 
- of this protocol is: Cystic Fibrosis Gene 
Therapy Using an Adenovirus Vector In 
Recombinant DNA Research, Volume 16 
[525] 
