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Federal Register / Vol. 58, No. 84 / Tuesday, May 4, 1993 / 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 June 7-8, 1993. The 
meeting will be held at the National 
Institutes of Health, Building 31C, 
Conference Room 6, 9000 Rockville 
Pike, Bethesda, Maryland 20892, 
starting at approximately 9 a.m. on June 
7, 1993, to adjournment at 
approximately 5 p.m. on June 8. 1993. 
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 
Additions to Appendix D of the NIH 
Guidelines regarding thirteen (13) 
Human Gene Therapy/Gene Transfer 
Protocols; 
Additions to Appendix D of the NIH 
Guidelines Regarding Semliki Forest 
Virus; Poxvirus Vectors-NYVAC, 
ALVAC, TROVAC, and Reickettsia 
prowazeki; 
Amendment to Section IV-G-3-c of 
the NIHGuidelines Regarding the 
Recombinant DNA Technical Bulletin 
and the Data Management of the NIH- 
Approved Human 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 Repeating 
Requirements for Human Gene Transfer/ 
Gene Therapy Protocols; the term 
"Subject(s);’' Satellite Institutions; 
Categorization of Protocols; and 
Protocol Format. 
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) 496-8838, FAX 
(301) 496-9839, will provide materials 
to be discussed at this meeting, roster of 
committee members, and substantive 
program information. Individuals who 
plan to attend and need special 
assistance, such as sign language 
interpretation or other reasonable 
accommodations, should contact Dr. 
Wivel in advance of the meeting. 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: April 28, 1993. 
Susan K. Feldman, 
Committee Management Officer, NIH. 
(FR Doc. 93-10487 Filed 5-3-93; 8:45 ami 
MLUNQ COO€ 4140-X-M 
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 Recombinan* 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 (51 FR 
16958). 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 June 7-8, 1993. 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. 
DATES: Comments received by May 25, 
1993, will be reproduced and 
distributed to the RAC for consideration 
at its June 7-8, 1993, 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 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/Drs. Deisseroth, 
Kavanagh, Champlin 
In a letter dated March 4, 1993, Drs. 
Albert B. Deisseroth, John Kavanagh, 
and Richard Champlin of the University 
of Texas MD Anderson Cancer Center, 
Houston, Texas, indicated their 
intention to resubmit a human gene 
therapy protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: Use of Safety-Modified 
Retroviruses to Introduce Chemotherapy 
Resistance Sequences into Normal 
Hematopoietic Stem Cells for 
Chemoprotection During the Therapy of 
Ovarian Cancer: A Pilot Trial. 
II. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Drs. Das Gupta, 
Cohen, Richards 
In a letter dated February 26, 1993, 
Drs. Tapas K. Das Gupta and Edward P. 
Cohen of the University of Illinois 
College of Medicine, Chicago, Illinois, 
and Dr. Jon M. Richards of the 
University of Chicago, Chicago, Illinois, 
submitted a human gene therapy 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: Immunization of Malignant 
Melanoma Patients with Interleukin-2- 
Recombinant DNA Research, Volume 17 
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