[Federal Register Volume 73, Number 124 (Thursday, June 26, 2008)]
[Notices]
[Pages 36341-36343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14438]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Public Consultation on a Proposed Framework for Oversight of Dual 
Use Life Sciences Research

AGENCY: National Institutes of Health, HHS.

[[Page 36342]]


ACTION: Notice of Public Consultation Meeting.

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SUMMARY: The Federal Government is sponsoring a public consultation to 
engage the scientific community and research organizations in a 
discussion of a framework for the oversight of dual use life sciences 
research proposed by the National Science Advisory Board for 
Biosecurity (NSABB), which is an advisory committee to the Federal 
Government. In its report, the NSABB posed a series of questions on 
which the Board encouraged the Federal Government to solicit public 
comment. These questions concerned such matters as the clarity of the 
criteria proposed by the Board for identifying dual use research of 
concern, institutional oversight responsibilities, who should make 
determinations regarding dual use research of concern, and how to 
balance appropriate controls with academic freedom and scientific 
exchange. This public consultation is an opportunity for members of the 
scientific community and general public to provide input on these 
important issues.


DATE AND TIME: The one day public consultation will be held on July 15, 
2008, from 8:30 a.m. to 5 p.m.

ADDRESSES: The public meeting will be held on the National Institutes 
of Health (NIH) campus. The meeting will be in the Natcher Conference 
Center, Building 45, Balcony B. The NIH is located at 9000 Rockville 
Pike, Bethesda, Maryland. There is a metro stop on the NIH campus--
Medical Center Station on the Red Line. The Natcher Center is a very 
short walk from the Metro station and a campus shuttle is also 
available.

FOR FURTHER INFORMATION CONTACT: Ms. Ronna Hill, NIH Office of 
Biotechnology Activities, by e-mail at [email protected] or by 
telephone at 301-435-2137. Faxes may be sent to the NIH Office of 
Biotechnology Activities at 301-496-9839.

SUPPLEMENTARY INFORMATION: 

Background

    The Federal Government is sponsoring a public consultation to 
engage the scientific community and research organizations in a 
discussion of a framework for the oversight of dual use life sciences 
research proposed by the NSABB. The proposed framework (accessible at 
http://www.biosecurityboard.gov/news.asp), which has been formally 
submitted by the Board to the Federal Government for its consideration, 
outlines key features of oversight of dual use research, including 
criterion for identifying dual use research of concern, local 
oversight, evaluation and risk assessment of research with dual use 
potential, responsible communication of research with dual use 
potential, considerations in developing codes of conduct, and the need 
for outreach and education. The proposed framework also outlines the 
roles and responsibilities of key individuals and institutions in 
managing dual use research, including researchers, research 
institutions, institutional review entities, the NSABB, and the Federal 
Government.
    The public consultation meeting will focus on a set of questions, 
included in Appendix 2 of the proposed framework, on which the USG and 
the NSABB would specifically like to solicit comment. These questions 
concern such matters as the clarity of the criterion proposed by the 
Board for identifying dual use research of concern; institutional 
oversight responsibilities, including how to balance appropriate 
controls with academic freedom and scientific exchange; and approaches 
to education to enhance awareness of the issue.
    The meeting will be conducted as a series of panels where invited 
speakers and meeting attendees will be asked to discuss particular 
topics of interest to the Government. Each panel will include ample 
time for in-depth discussion of the issues surrounding each topic. The 
three panels will focus on: (1) The criterion for identifying dual use 
research of concern and associated guidance, (2) the process for 
identification and oversight of dual use research of concern, and (3) 
awareness-raising and educational resources. Explanation of and 
discussion questions for each panel follow:

Panel I: ``Criterion for Identifying Dual Use Research of Concern''

    The NSABB proposed a criterion for identifying ``dual use research 
of concern,'' i.e., that research with the highest potential for 
yielding knowledge, products, or technology that could be misapplied to 
threaten public health or other aspects of national security. The 
proposed criterion is: ``Research that, based on current understanding, 
can be reasonably anticipated to provide knowledge, products, or 
technologies that could be directly misapplied by others to pose a 
threat to public health and safety, agriculture, plants, animals, the 
environment, or materiel.''
    In the NSABB report, the criterion is accompanied by guidance that 
provides examples of research that deserves especially careful 
consideration with regard to the applicability of the criterion. The 
guidance is not meant to be definitive in identifying dual use research 
of concern, but rather to serve as a tool for focusing attention and 
evaluation. The U.S. Government is seeking input on the utility of the 
criterion and the accompanying guidance and on how they could be 
implemented. The following questions will be discussed in Panel I:
     Is the criterion sufficiently specific and understandable 
so that it can be applied consistently? If not, how could it be 
improved?
     Is the criterion too broad? Will the criterion capture 
research that is not appropriately considered dual use of concern? If 
so, what are some examples of research that would be inappropriately 
captured?
     Is the criterion too narrow? Might it fail to include 
research that should be considered dual use of concern? How might it be 
modified to be more appropriately encompassing?
     Is the guidance that follows the criterion for identifying 
dual use research of concern helpful and sufficient? Is it clear and 
understandable? Should additional categories of research that may yield 
dual use findings of concern be included in the guidance?
     What share of research at your institution would likely be 
captured with the proposed criterion for dual use research of concern?

Panel II: ``Responsibilities and Process for the Identification and 
Oversight of Dual Use Research of Concern''

    Everyone involved in life sciences research has a responsibility 
for identifying and responding appropriately to dual use research of 
concern. The NSABB has put forth recommendations regarding the general 
framework within which these responsibilities for oversight would be 
carried out. The Federal Government must determine how to translate 
those recommendations into policies and requirements that would apply 
to investigators, other laboratory staff, senior research 
administrators, institutional review committees, and other parties. 
Toward that end, the government is seeking input on the following 
matters:
Investigator Responsibilities
     Should the principal investigator bear primary 
responsibility for making the initial determination as to whether his 
or her research might be considered dual use of concern?
    [squf] If so, how should that determination be made?
    [cir] Should the determination routinely include input from others? 
If so, who

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else should participate in the initial evaluation?
    [cir] To whom should the investigator report this determination?
    [squf] If not, who should make this determination?
Institutional Review Responsibilities
     What are the characteristics of a dual use research review 
committee? What expertise will be needed?
     How should institutional review responsibilities be 
fulfilled?
    [squf] Should institutions be required to establish their own 
review committees?
    [cir] Can existing institutional review committees fulfill these 
characteristics (e.g., the Institutional Biosafety Committee) as is or 
with some modification?
    [cir] If the IBC, what additional expertise would be needed to 
facilitate the review of dual use research of concern?
    [cir] Would most institutions likely have the necessary in-house 
expertise for this review?
    [cir] Would it be helpful to have the option of utilizing a 
commercial review entity or the review entity at another institution?
    [squf] Should regional committees or a national committee be 
established
    [cir] As optional review mechanisms?
    [cir] In lieu of a requirement to establish committees at the 
institutional level?
    [cir] In an advisory capacity (e.g., the NIH RAC) to give 
recommendations on specific protocols, leaving final approval authority 
with the institutions?
    [cir] How much of a burden would this proposed oversight system 
pose to your institution?

Panel III: ``Guidance and Educational Resources Needed To Assist the 
Research Community in its Fulfillment of Oversight Responsibilities for 
Dual Use Research''

    Since the outset of its deliberations, the NSABB has noted the 
importance of awareness in dealing effectively with dual use research 
and the need for more outreach and education on this issue, 
particularly to the investigator community, where various studies 
document a low level of awareness. In its report, the NSABB makes a 
number of observations and recommendations for promoting awareness, as 
well as receiving stakeholder input on evolving policies. The NSABB 
also views several elements of the oversight framework--the code of 
conduct, communications guidance, and the guidance on identifying dual 
use research--as key educational tools. The U.S. Government is seeking 
input on the following matters:
     Has the NSABB identified the major educational and 
outreach priorities in its report (pages 29-31)? If not, what other 
priorities should there be?
     How might the following elements of the Oversight 
Framework be used as educational tools:
    [squf] Criterion and associated guidance.
    [squf] Guidance on responsible communication of dual use research 
of concern.
    [squf] Code of conduct.
     What other kinds of educational resources, tools, and 
strategies would be helpful or particularly effective in educating 
various audiences, such as investigators, research administration, 
biosafety staff, and others?
    This public consultation is open to the public and is free of 
charge. Pre-registration is encouraged, however, due to limited space. 
To pre-register, please access the pre-registration link at http://www.biosecurityboard.gov/meetings.asp.
    Any groups or individuals who cannot attend the meeting are 
encouraged to submit written comments in advance of the meeting to Mr. 
Allan Shipp, NIH Office of Biotechnology Activities by e-mail at 
[email protected] or by Fax at 301-496-9839.

    Dated: June 19, 2008.
Amy P. Patterson,
Director, Office of Biotechnology Activities, National Institutes of 
Health.
[FR Doc. E8-14438 Filed 6-25-08; 8:45 am]
BILLING CODE 4140-01-P