Public Consultation on a Proposed Framework for Oversight of Dual Use Life Sciences Research, 36341-36343 [E8-14438]

Download as PDF rfrederick on PROD1PC67 with NOTICES Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference Call). Contact Person: Carol J. Goter-Robinson, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 748, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7791, goterrobinsonc@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Multi-Center Clinical Studies Planning Grants in Hepatology. Date: July 25, 2008. Time: 4 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Maria E. Davila-Bloom, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 758, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7637, davilabloomm@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Endoscopic Research in Pancreatic and Billiary Disease. Date: July 28, 2008. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Thomas A. Tatham, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 760, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–3993, tathamt@mail.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Polycystic Kidney Disease Program Projects. Date: August 8, 2008. Time: 9 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Carol J. Goter-Robinson, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 748, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7791, goterrobinsonc@extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) VerDate Aug<31>2005 15:05 Jun 25, 2008 Jkt 214001 Dated: June 20, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–14546 Filed 6–25–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Regulation of Placental Signaling and Function by Maternal Nutrient Availability. Date: July 24, 2008. Time: 2 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Gopal M. Bhatnagar, PhD, Scientific Review Administrator, National Institute of Child Health and Human Development, National Institutes of Health, 6100 Bldg Rm 5B01, Rockville, MD 20852, (301) 435–6889, bhatnagg@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: June 20, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–14548 Filed 6–25–08; 8:45 am] PO 00000 Frm 00047 Fmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Training SEP. Date: July 18, 2008. Time: 2 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Shanta Rajaram, PhD, Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Blvd., Suite 3208, Msc9529, Bethesda, MD 20852, (301) 435– 6033, rajarams@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) Dated: June 20, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–14553 Filed 6–25–08; 8:45 am] BILLING CODE 4140–01–P 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. BILLING CODE 4140–01–P Sfmt 4703 36341 E:\FR\FM\26JNN1.SGM 26JNN1 36342 Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices Notice of Public Consultation Meeting. ACTION: 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. 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 hillro@od.nih.gov or by telephone at 301–435–2137. Faxes may be sent to the NIH Office of Biotechnology Activities at 301–496–9839. SUPPLEMENTARY INFORMATION: rfrederick on PROD1PC67 with NOTICES DATE AND TIME: 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, VerDate Aug<31>2005 15:05 Jun 25, 2008 Jkt 214001 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) awarenessraising 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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? I If so, how should that determination be made? Æ Should the determination routinely include input from others? If so, who E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices else should participate in the initial evaluation? Æ To whom should the investigator report this determination? I 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? I Should institutions be required to establish their own review committees? Æ Can existing institutional review committees fulfill these characteristics (e.g., the Institutional Biosafety Committee) as is or with some modification? Æ If the IBC, what additional expertise would be needed to facilitate the review of dual use research of concern? Æ Would most institutions likely have the necessary in-house expertise for this review? Æ Would it be helpful to have the option of utilizing a commercial review entity or the review entity at another institution? I Should regional committees or a national committee be established Æ As optional review mechanisms? Æ In lieu of a requirement to establish committees at the institutional level? Æ In an advisory capacity (e.g., the NIH RAC) to give recommendations on specific protocols, leaving final approval authority with the institutions? Æ How much of a burden would this proposed oversight system pose to your institution? rfrederick on PROD1PC67 with NOTICES 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: VerDate Aug<31>2005 15:05 Jun 25, 2008 Jkt 214001 • 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: I Criterion and associated guidance. I Guidance on responsible communication of dual use research of concern. I 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. Preregistration 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 shippa@od.nih.gov 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 DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS–2008–0067] The National Infrastructure Advisory Council Directorate for National Protection and Programs, Department of Homeland Security. ACTION: Committee Management; Notice of Federal Advisory Council Meeting. AGENCY: SUMMARY: The National Infrastructure Advisory Council will meet on Tuesday July 8, 2008 in Washington, DC. The meeting will be open to the public. Notice of this meeting was previously published in the Federal Register to permit timely solicitation of public comment. This notice provides the meeting location. This notice is being published less than 15 days before the date of the meeting because the meeting location has just been finalized. DATES: The National Infrastructure Advisory Council will meet Tuesday, PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 36343 July 8, 2008 from 1:30 p.m. to 4:30 p.m. Please note that the meeting may close early if the committee has completed its business. For additional information, please consult the NIAC Web site, http://www.dhs.gov/niac, or contact Timothy McCabe by phone at 703–235– 2888 or by e-mail at timothy.mccabe@associates.dhs.gov. ADDRESSES: The meeting will be held at the Ritz-Carlton Hotel’s Salon I, 1150 22nd Street, NW., Washington, DC 20037. While we will be unable to accommodate oral comments from the public, written comments may be sent to Carlos Kizzee, Department of Homeland Security, Directorate for National Protection and Programs, Washington, DC 20528. Written comments should reach the contact person listed no later than July 1, 2008. Comments must be identified by DHS– 2008–0067 and may be submitted by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • E-mail: timothy.mccabe@associates.dhs.gov. Include the docket number in the subject line of the message. • Fax: 703–235–3055. • Mail: Carlos Kizzee, Department of Homeland Security, Directorate for National Protection and Programs, Washington, DC 20528. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the docket number for this action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received by the National Infrastructure Advisory Council, go to http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Carlos Kizzee, NIAC Designated Federal Officer, Department of Homeland Security, Washington, DC 20528; telephone 703–235–2888. SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92–463). The National Infrastructure Advisory Council shall provide the President through the Secretary of Homeland Security with advice on the security of the critical infrastructure sectors and their information systems. The National Infrastructure Advisory Council will meet to address issues relevant to the protection of critical infrastructure as directed by the E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 73, Number 124 (Thursday, June 26, 2008)]
[Notices]
[Pages 36341-36343]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 hillro@od.nih.gov 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

[[Page 36343]]

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 
shippa@od.nih.gov 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