[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