[Federal Register Volume 60, Number 154 (Thursday, August 10, 1995)]
[Notices]
[Pages 40984-40985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19872]
[[Page 40983]]
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Part IV
Department of Health and Human Services
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National Institutes of Health
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Recombinant DNA Research; Proposed Actions Under the Guidelines; Notice
Federal Register / Vol. 60, No. 154 / Thursday, August 10, 1995 /
Notices
[[Page 40984]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Recombinant DNA Research: Proposed Actions Under the Guidelines
Agency: National Institutes of Health (NIH), PHS, DHHS.
Action: Notice of Proposed Actions Under the NIH Guidelines for
Research Involving Recombinant DNA Molecules (59 FR 34496, amended 59
FR 40170, amended 60 FR 20726).
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Summary: This notice sets forth proposed actions to be taken under the
NIH Guidelines for Research Involving Recombinant DNA Molecules (59 FR
34496, amended 59 FR 40170, amended 60 FR 20726). Interested parties
are invited to submit comments concerning these proposals. These
proposals will be considered by the Recombinant DNA Advisory Committee
at its meeting on September 11-12, 1995. After consideration of these
proposals and comments by the Recombinant DNA Advisory Committee, the
Director of the National Institutes of Health will issue decisions in
accordance with the NIH Guidelines.
Dates: Comments received by September 4, 1995, will be reproduced and
distributed to the Recombinant DNA Advisory Committee for consideration
at its September 11-12, 1995, meeting.
Addresses: Written comments and recommendations should be submitted to
Dr. Nelson A. Wivel, Director, Office of Recombinant DNA Activities,
National Institutes of Health, MSC 7010, 6000 Executive Boulevard,
Suite 302, Bethesda, Maryland 20892-7010, 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, National Institutes of Health, MSC 7010, 6000 Executive
Boulevard, Suite 302, Bethesda, Maryland 20892-7010, Phone 301-496-
9838, FAX to 301-496-9839.
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
Transfer Protocol/Drs. Steiner and Holt
On April 13, 1995, Drs. Mitchell Steiner and Jeffrey Holt of
Vanderbilt University School of Medicine, Nashville, Tennessee,
submitted a human gene transfer protocol entitled: Gene Therapy for the
Treatment of Advanced Prostate Cancer by In Vivo Transduction with
Prostate-Targeted Retroviral Vectors Expressing Antisense c-myc RNA to
the Recombinant DNA Advisory Committee for formal review and approval
during the June 8-9, 1995, meeting. Due to reviewers' comments before
the June 1995 meeting, the protocol was deferred and not forwarded to
the committee.
On July 7, 1995, Drs. Steiner and Holt submitted a revised protocol
to the Recombinant DNA Advisory Committee for formal review and
approval during the September 11-12, 1995, meeting.
II. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene
Transfer Protocol/Dr. Crystal
In a letter dated July 17, 1995, Dr. Ronald Crystal of the New York
Hospital--Cornell Medical Center, New York, New York, submitted a human
gene transfer protocol entitled: A Phase I Study of Direct
Administration of a Replication Deficient Adenovirus Vector Containing
the E. coli Cytosine Deaminase Gene to Metastatic Colon Carcinoma of
the Liver in Association with the Oral Administration of the Pro-Drug
5-Fluorocytosine to the Recombinant DNA Advisory Committee for formal
review and approval.
III. Addition to Appendix D of the NIH Guidelines Regarding a Human
Gene Transfer Protocol/Drs. Hortobagyi, Lopez-Berestein, Hung
In a letter dated July 11, 1995, Drs. Gabriel Hortobagyi, Gabriel
Lopez-Berestein, and Mien-Chie Hung of the University of Texas, MD
Anderson Cancer Center, Houston, Texas, submitted a human gene transfer
protocol entitled: Phase I Study of E1A Gene Therapy for Patients with
Metastatic Breast or Ovarian Cancer that Overexpress HER-2/neu to the
Recombinant DNA Advisory Committee for formal review and approval.
IV. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene
Transfer Protocol/Drs. Curiel and Alvarez
In a letter dated January 5, 1995, Drs. David Curiel and Ronald
Alvarez of the University of Alabama, Birmingham, Alabama, submitted a
human gene transfer protocol entitled: A Phase I Study of Recombinant
Adenovirus Vector-Mediated Delivery of an Anti-erbB-2 Single-Chain
(sFv) Antibody Gene for Previously Treated Ovarian and Extraovarian
Cancer Patients to the Recombinant DNA Advisory Committee for formal
review and approval at its March 6-7, 1995, meeting. Due to reviewers'
comments before the March 1995 meeting, the protocol was not forwarded
to the committee.
In a letter dated April 12, 1995, Drs. Curiel and Alvarez submitted
a revised protocol to the Recombinant DNA Advisory Committee for formal
review and approval at its June 8-9, 1995, meeting. Due to reviewers'
comments before the June 1995 meeting, the protocol was deferred and
not forwarded to the committee.
On July 14, 1995, Drs. Curiel and Alvarez submitted a revised
protocol to the Recombinant DNA Advisory Committee for formal review
and approval during the September 11-12, 1995, meeting.
V. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene
Transfer Protocol/Dr. Isner
In a letter dated July 14, 1995, Dr. Jeffrey Isner of St.
Elizabeth's Medical Center, Tufts University School of Medicine,
Boston, Massachusetts, submitted a human gene transfer protocol
entitled: Arterial Gene Transfer for Restenosis to the Recombinant DNA
Advisory Committee for formal review and approval.
VI. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene
Transfer Protocol/Drs. Bozik, Gilbert, Lotze
In a letter dated July 13, 1995, Drs. Michael Bozik, Mark Gilbert,
and Michael Lotze of the University of Pittsburgh Cancer Institute,
Pittsburgh, Pennsylvania, submitted a human gene transfer protocol
entitled: Gene Therapy of Malignant Gliomas: A Phase I Study of IL-4
Gene-Modified Autologous Tumor to Elicit an Immune Response to the
Recombinant DNA Advisory Committee for formal review and approval.
VII. Addition to Appendix D of the NIH Guidelines Regarding a Human
Gene Transfer Protocol/Dr. Riddell
In a letter dated July 11, 1995, Dr. Stanley Riddell of the Fred
Hutchinson Cancer Research Center, Seattle, Washington, submitted a
human gene transfer protocol entitled: Phase I Study to Evaluate the
Safety of Cellular Adoptive Immunotherapy using Autologous Unmodified
and Genetically Modified CD8+ HIV-Specific T Cells in
[[Page 40985]]
HIV Seropositive Individuals to the Recombinant DNA Advisory Committee
for formal review and approval.
VIII. Addition to Appendix D of the NIH Guidelines Regarding a Human
Gene Transfer Protocol/Dr. Rosenblatt
In a letter dated July 13, 1995, Dr. Joseph Rosenblatt of the
University of California, Los Angeles, California, submitted a human
gene transfer protocol entitled: A Phase I Trial of Autologous CD34+
Hematopoietic Progenitor Cells Transduced with an Anti-HIV-1 Ribozyme
to the Recombinant DNA Advisory Committee for formal review and
approval.
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.
Effective Date: July 31, 1995.
Suzanne Medgyesi-Mitschang,
Acting Deputy Director for Science Policy and Technology Transfer.
[FR Doc. 95-19872 Filed 8-9-95; 8:45 am]
BILLING CODE 4140-01-P
