Federal Rb^dter / Vol. 57, No. 88 / Wednesday, May 6, 1992 / Notices 19513 
and approval. The title of this protocol 
is: ‘Treatment of HIV Infection with 
Transplantation of Genetically Altered 
Syngeneic Peripheral Blood 
Lymphocytes." 
V. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Smith 
In a letter dated April 9, 1992, Dr. Clay 
Smith of Memorial Sloan Kettering 
Cancer Center, New York, New York, 
submitted a human gene therapy 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: "Treatment of HIV Infection with 
Reinfusion of Genetically Altered 
Peripheral Blood Lymphocytes." 
VL Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Dunbar 
In a letter dated April 14, 1992, Dr. 
Cynthia E. Dunbar of the National 
Institutes of Health, Bethesda, 
Maryland, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: "Retroviral-Mediated Gene 
Transfer of Bone Marrow and Peripheral 
Blood Stem Cells During Autologous 
Bone Marrow Transplantation for 
Multiple Myeloma." 
VII. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Dunbar 
In a letter dated April 14, 1992, Dr. 
Cynthia E. Dunbar of the National 
Institutes of Health, Bethesda, 
Maryland, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: "Retroviral-Mediated Gene 
Transfer of Bone Marrow and Peripheral 
Blood Stem Cells DuringlAutologous 
Bone Marrow Transplantation for 
Metastatic Breast Cancer." 
VIII. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Dunbar 
In a letter dated April 14, 1992, Dr. 
Cynthia E. Dunbar of the National 
Institutes of Health, Bethesda, 
Maryland, submitted a human gene 
transfer protocol to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The title of this 
protocol is: "Retroviral-Mediated Gene 
Transfer of Bone Marrow and Peripheral 
Blood Stem Cells During Autologous 
Bone Marrow Transplantation for 
Chronic Myelogenous Leukemia." 
[ 662 ] 
IX. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Transfer Protocol/Dr. Deisseroth 
In a letter dated February 28, 1992, Dr. 
Albert B. Deisseroth of MD Anderson 
Cancer Center, Houston, Texas, 
indicated his intention to submit a 
human gene transfer protocol to the 
Recombinant Advisory Committee for 
formal review and approval. The title of 
this protocol is: "Use of Two Retroviral 
Markers to Test Relative Contribution of 
Marrow and Peripheral Blood 
Autologous Cells to Recovery After 
Preparative Therapy." 
X. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Gansbacher 
In a letter dated January 16, 1992, Dr. 
Bemd Gansbacher of the Memorial 
Sloan Kettering Cancer Center, New 
York, New York, indicated his intention 
to submit a human gene therapy 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: "Immunization with HLA-A2 
Matched Allogeneic Melanoma Cells 
that Secrete Interleukin-2 Patients with 
Metastatic Melanoma.". 
XI. Addition to Appendix D of the NIH 
Guidelines Regarding a Human Gene 
Therapy Protocol/Dr. Gansbacher 
In a letter dated January 16, 1992, Dr. 
Bemd Gansbacher of the Memorial 
Sloan Kettering Cancer Center, New 
York, New York, indicated his intention 
to submit a human gene therapy 
protocol to the Recombinant DNA 
Advisory Committee for formal review 
and approval. The title of this protocol 
is: “Immunization with Interleukin-2 
Secreting Allogeneic HLA-A2 Matched 
Renal Cell Carcinoma Cells in Patients 
with Advanced Renal Cell Carcinoma." 
XII. Addition to Section IV-C-2 of the 
NIH Guidelines Regarding Conflicts of 
Interest/Mr. Rifkin 
In a letter dated April 24. 1992, Mr. 
Jeremy Rifkin of the Foundation of 
Economic Trends, Washington, DC 
submitted a petition to the Recombinant 
DNA Advisory Committee for formal 
review and approval. The addition 
would read: 
Section IV-C-2-a. Avoidance of Conflicts 
of Interest. Members of the RAC shall avoid 
actual conflicts of interest and the 
appearance of conflicts of interest. 
Section IV-C-2-b. Members of the RAC 
shall be held responsible for knowledge of 
the statutory and regulatory requirements of 
special Government employees (SGEs) 
regarding conflicts of interest, including but 
not limited to the HHS Standards of Conduct 
(45 C.F.R. Section 73.735), the Federal 
Personnel Manual, the Federal Criminal Codfe 
concerning conflicts of interest (18 U.S.C. 
Section 201 et seq.). the HHS regulations 
concerning committee management (45 C.F.R. 
Subtitle A. Part 11), and any further 
requirements that may be promulgated by 
HHS. the Congress, or the President. 
Section IV-C-2-c. Full disclosure of all 
relevant affiliations and financial interests, 
as defined in Section IV-C-2-d, shall be 
made by prospective members of the RAC. 
This shall include the relevant financial 
interests of their spouses, dependent children 
and other dependents. Disclosures made by 
members of the RAC shall be updated 
promptly in the event of changes in 
information previously reported or when new 
information arises that is relevant to the 
question of conflict of interest. At a minimum, 
these disclosures shall be updated semi- 
annually. 
Section IV-C-2-d. Individuals who are 
required to file a financial disclosure report 
under the Ethics in Government Act (5 U.S.C. 
Appx Section 101) shall follow the 
requirements of that section. Individuals who 
are net required to file a public financial 
disclosure report under Section 101 of the 
Ethics in Government Act shall disclose: 
Section IV-C-2-<i-(l). The identity of their 
principal employment; 
Section IV-C-2-d-{2). A list of positions 
held (whether paid or unpaid) and any 
contractual relationships for the performance 
of services with any corporation, company, 
firm, partnership or other business enterprise, 
any non-profit organization, any labor 
organization, or any educational or other 
institution whose activities or purposes may 
be (or may foreseeable become) relevant to 
the purposes and functions of the RAC as 
determined by the NIH, and any such 
relevant relationships held by their spouses, 
dependent children or other dependents; 
Section IV-C-2-d-{3). The identity, but not 
value or amount, of any other sources of 
income or any other interests In a trade or 
business, real estate, or other asset held for 
investment or production of income, 
exceeding $1000 in value which are relevant 
to the purposes and functions of the RAC as 
determined by the NIH, and any such 
relevant income or interests of their spouse, 
dependent children, or other dependents. 
Section IV-C-2-e. The information 
required under Section IV-C-2-d-{l). (2). and 
(3) shall be made available to the public upon 
request. 
Section IV-C-2-f. For the purposes of 
Section IV-C-2-c and IV-C-2-d, the word 
"relevant" means those relationships, 
affiliations, holdings or interests of an 
individual, his/her spouse, dependent 
children, or other dependents, which could be 
substantially affected by review, policy 
recommendations or the giving of advice by 
the RAC. A "substantial effect" is where 
there is a significant possibility that RAC 
action will have an direct or indirect 
economic impact on the individual, on others 
with whom the individual is closely 
associated, or on any person with whom the 
Individual has a family or marital 
relationship or similar close personal 
relationship. 
Recombinant DNA Research, Volume 15 
