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Federal Register / Vol. 58, No. 84 / Tuesday, May 4, 1993 / Notices 
XV. Addition to Appendix D of the NIH 
Guidelines Regarding Poxvirus Vectore- 
NYVAC, ALVAC, TROV AC/Dr. Trag 
In a letter dated January 8, 1993, Dr. 
Arvilla L. Trag of Virogenetics 
Corporation, Troy, New York, submitted 
a request for reduction in physical 
containment from Biosafety Level 2 to 
Biosafety Level 1 for three poxvirus 
vectors: NYVAC, ALVAC. TROVAC. 
XVI. Addition to Appendix D of the 
NIH Guidelines Regarding Rickettsia 
prowazeki/Dr. Policastro 
In a letter dated March 23, 1993, Dr. 
Paql Policastro of the National Institutes 
of Health, Bethesda, Maryland, 
submitted a request to transfer a 
chloramphenicol resistance marker to 
an avirulent strain of Rickettsia 
prowazeki. 
XVII. Amendment to Section IV-C-3-c 
of the NIH Guidelines Regarding the 
Recombinant DNA Technical Bulletin 
and the Data Management of the NIH- 
Approved Human Gene Transfer 
Protocols/Ms. Wilson 
In a letter dated April 5, 1993, Debra 
Wilson of the National Institutes of 
Health submitted a request that Section 
IV-C-3-c be amended to delete the 
requirement that the Office of 
Recombinant DNA Activities (ORDA) 
publish the Recombinant DNA 
Technical Bulletin, and to add the 
requirement that ORDA will serve as the 
food point for data management of the 
NIH-approved human gene transfer 
protocols. 
XVIII. Amendment 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 Reporting 
Requirements for Human Gene 
Transfer/Gene Therapy Protocols 
The Points to Consider (March 1, 
1990, 55 FR 7447) under Part IV— 
Reporting Requirements states that: 
”B. Reports regarding the general progress 
of patients should be filed with both your 
local IRB and ORDA within six-months of the 
commencement of the experiments and at 
six-month intervals thereafter. These twice- 
yearly reports should continue for a 
sufficient period of time to allow observation 
of all major effects. In the event of a patient’s 
death, a summary of the special port-mortem 
studies and statements of the cause of death 
should be submitted to the IRB and ORDA, 
if available.” 
Dr. Brigid Leventhal, Chair of 
Working Group on Data Management, 
will provide a summary of the reports 
submitted to'ORDA by the principal 
investigators of NIH-approved protocols, 
and make recommendations regarding 
actions to be taken in the event of non- 
reporting. 
XIX. Amendment to Section I II- A -4 of 
the NIH Guidelines and the Points to 
Consider in the Design and Submission 
of Protocols for the Transfer of 
Recombinant DNA Into the Genome of 
Human Subjects Regarding the Term 
Subject(s) 
During the March 1-2, 1993, 
Recombinant DNA Advisory Committee 
meeting, Dr. Robertson Par km an 
requested that the terms subject and 
subjects be amended to read subject(s). 
Section EQ-A-4 currently reads: 
'TII-A-4. Deliberate transfer of 
recombinant DNA or DNA or RNA derived 
from recombinant DNA into human subjects 
[ 21 ] * * * 
Throughout the Points to Consider 
document the terras subject and subjects 
are used. 
This amendment will clarify Section 
III-A-4 and the Points to Consider. 
XX. Amendment 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 Satellite 
Institutions 
On April 19, 1993, Dr. Nelson A. 
Wivel made a request that NIH- 
approved human gene therapy/gene 
transfer protocols may be conducted at 
satellite institutions with approval from 
the Chair of the Recombinant DNA 
Advisory Committee. The amendment 
would read: 
"Protocols can be conducted at satellite 
institutions with approval from the Chair of 
the Recombinant DNA Advisory Committee. 
The Chair may consult others as necessary. 
The principal investigators must submit to 
the Office of the Recombinant DNA Activities 
the following: (1) Curricula vitae of new 
principal investigators. (2) Institutional 
Biosafety Committee approval, (3) 
Institutional Review Board approval, and (4) 
new Informed Consent document.” 
XXI. Amendment 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 
Categorization of Protocols 
The Working Group on Categorization 
of Protocols will make a report on 
decentralizing review for gene marking 
protocols utilizing vectors that have 
been previously approved by the 
Recombinant DNA Advisory Committee. 
XXII. Amendment 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 Protocol 
Format 
The Working Group on Protocol 
Format will present its report on 
condensing materials required for the 
submission of human gene therapy/gene 
transfer protocols for review and 
approval by the Recombinant DNA 
Advisory Committee. 
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 26, 1993. 
Jay Moskowitz, 
Deputy Director jor Science Policy and 
Technology Transfer, NIH. 
[FR Doc. 93-10486 Filed 5-3-93; 8:45 ami 
8ILUN0 CODE 41 40-01 -M 
Recombinant DNA Research, Volume 17 [537] 
