19514 Federal Reg^ste. Vol. 57, No. 88 / Wednesday, May 6» . L / Notices 
Section IV-C-2-g. Prohibited Situations. No 
j RAC member, or his/her spouse, dependent 
children, or other dependents, shaft be 
ellowed to have personal equity holdings or 
options in any company that would be 
fleeted by the outcome of research or that 
produces a product or equipment being 
evaluated in a research project subject to 
approval by the RAC. This does not apply to 
equipment or products that are commonly 
found in research laboratories, such as 
commercialfy-ava liable centrifuges. pH 
meters, and common reagents. This 
prohibition does not include blind trusts, 
diversified mutual funds, or other financial 
interests over which the Individual has no 
: discretionary control. 
Section IV-C-2-h. Waivers. The N1H may 
grant a waiver to the requirement of Section 
lV-O-2-g if it determines that such holdings 
hre so insignificant that they do not have the 
potential of influencing the independent 
decision-making of the RAC. Such waiver 
shall take effect upon its publication in the 
Federal Register and shall Identify. 
Section rV-C-2-h-fIJ. The RAC member 
covered by the waiver by name, and 
Section fV-C-2-h-{2}. The reasons for 
i granting the waiver. 
This particular petition contains a 
background text that is not included in 
the meeting announcement It is 
available on request end can be 
! obtained from the Office of 
I Recombinant DNA Activities, National 
I Institutes of Health, building 31. room 
4B11, Bethesda, Maryland, (301} 496- 
9838. 
The following comments pertain to the 
; above request Members of the RAC are 
currently required t« 
(1) Meet the statutory and regulatory 
i conflict of interest requirements 
applicable to Special Government 
I Employees, and (2J file financial 
disdosure statements (Form HHS 474, 
Confidential Statement of Employment 
and Financial Interests]. These 
statements are evaluated by NIH to 
determine if a prospective or current 
member has a financial conflict of 
interest that would necessitate 
restrictions on his/her service on the 
RAC. Under the Ethics in Government 
Act (5 U.&CA. appx 4 section 207), the 
disclosures required on form HHS 474, 
Confidential Statement of Employment 
and Financial Interests, cannot be 
disclosed to the public without the 
consent of the m dividual Because 
members and prospective members of 
the RAC are already subject to statutory 
and regulatory requirements regarding 
financial conflicts of interest, it would 
appear that any addition to the NIH 
Guidelines on this issue would have to 
be limited to referencing the existing 
requirements in order to avoid any 
conflict with-those requirements. 
XIII. Addition 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 Submission 
Requirements for Human Gene 
Transfer/Gene Therapy Protocols 
Dr. Donald Krogstad. member of the 
RAC, suggested an outline for 
submission requirements fc« human 
gene transfer/gene therapy protocols 
during the RAC meeting of February 11. 
1992. This outline reads as follows: 
Suggestions for Focusing Discussion at the 
RAC. 
I. Investigator- Submitted Material. 
Format. Consider having both written and 
oral material presented in similar formats — 
eg- following the Point to Consider— with a 
150-250 word Abstract at the begi nni ng of 
written material. When a proposal has been 
presented previously, there should be a short 
section (<150 words) detailing the major 
revisions since the previous submission. 
Length of Written Material and Tune for 
Oral Presentation. Only on rare occasion is 
there significant new information after 20 
pages of written material or 20 minutes of 
oral presentation. To expedite both written 
and ora! review, written material could be 
limited to approximately 20 pages per 
proposal (not counting references, tables and 
figures), and oral presentations to 25 minutes. 
LL Reviewers' Responses 
Format. Reviewers' comments should state 
explicitly whether the Points to Consider 
have been addressed satisfactorily, and 
whether questions of Safety and Efficacy 
have been resolved. They should state also 
whether a pioposal is: (a) Acceptable as 
written, (b) Acceptable with specific 
revisions, or (c) Unacceptable In Us present 
form. 
Discussion of Written Reviews. Discussion 
among the various reviewers and with the 
Principal Investigator should help to clarify 
substantive questions about the protocols, 
which currently occupies a substantial 
amount of time at the RAC. 
Length of Time for Oral Presentation of 
Reviews. After discussion with other 
reviewers and the Principal Investigator, it 
should be possible to present most reviews 
orally in <5 minutes. 
OMFs "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: May 1. 1992. 
Jay Mmkowttz, 
Assoc tote Director for Science Policy and 
Legislation. NIH. 
(FR Doc. 92-10064 Filed 5-5-02: 8:45 am) 
BILLING coot 
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