Request for Nominations to the EPA Human Studies Review Board
[Federal Register: May 24, 2007 (Volume 72, Number 100)]
[Notices]
[Page 29164-29166]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my07-74]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2007-0430; FRL-8318-2]
Request for Nominations to the EPA Human Studies Review Board
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency)
Office of the Science Advisor (OSA) is soliciting nominations of
qualified individuals in the area of human health risk assessment to
serve on the Human Studies Review Board (HSRB). The HSRB is a Federal
advisory committee, operating in accordance with the Federal Advisory
Committee Act (FACA) 5 U.S.C. App. 2 Section 9, providing advice,
information, and recommendations to EPA on issues related to scientific
and ethical aspects of human subjects research.
DATES: Nominations should be submitted to EPA no later than June 25, 2007.
ADDRESSES: Submit your nominations (``comments''), identified by Docket
ID No. EPA-HQ-ORD-2007-0430, by one of the following methods:
Internet: http://www.regulations.gov Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov.
Mail: ORD Docket, Environmental Protection Agency, Mailcode:
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery: EPA Docket Center (EPA/DC), Room 3304, EPA West
Building, 1301 Constitution Avenue, NW., Washington, DC 20460,
Attention Docket ID No. EPA-HQ-ORD-2007-0430. Deliveries are only
accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. Special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your nominations to Docket ID No. EPA-HQ-ORD-
2007-0430. EPA's policy is that all nominations received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the nomination includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise protected through
http://www.regulations.gov or e-mail. The http://www.regulations.gov
Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your nomination. If you send an e-mail nomination directly to
EPA, without going through http://www.regulations.gov, your e-mail
address will be automatically captured and included as part of the
nomination that is placed in the public docket and made available on
the Internet. If you submit a nomination electronically, EPA recommends
that you include your name and other contact information in the body of
your nomination and with any disk or CD-ROM you submit. If EPA cannot
read your nomination due to technical difficulties and cannot contact
you for clarification, EPA may not be able to consider it. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Room 3334, EPA West, 1301 Constitution Ave., NW., Washington, DC.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the telephone number for the
ORD Docket is (202) 566-1752.
FOR FURTHER INFORMATION CONTACT: Paul I. Lewis, Office of the Science
Advisor, Mail Code 8105R, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202)
564-8381, fax number: (202) 564-2070, e-mail: lewis.paul@epa.gov.
I. General Information
A. Does This Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies,
especially studies on substances regulated by EPA or to persons who are
or may be required to conduct testing of substances under the Federal
Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Since other entities may also
be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of This Document and Other
Related Information?
In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
C. What Should I Consider as I Prepare My Nomination for EPA?
You may find the following suggestions helpful for preparing your
nomination:
1. Providing as much supporting information as possible about the
nominee, including contact information.
2. Make sure to submit your nomination by the deadline in this
document.
[[Page 29165]]
3. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date and Federal
Register citation.
SUPPLEMENTARY INFORMATION:
Background
On August 2, 2005, the President signed into law the Department of
Interior, Environment, and Related Agencies Appropriations Act, 2006,
Pub. L. 109-54 (Appropriations Act), which provided appropriated funds
for the Environmental Protection Agency and other Federal departments
and agencies. The Appropriations Act, among other points, addressed
intentional dosing human toxicity studies for pesticides and directed
the Agency to establish an independent Human Subjects Review Board to
review such studies. On February 6, 2006 the Agency published a final
rule for protections for subjects in human research (71 FR 6138) that
called for creating a new, independent Human Studies Review Board and
described its responsibilities in the following language:
The Human Studies Review Board shall comment on the scientific
and ethical aspects of research proposals and reports of completed
research with human subjects submitted by EPA for its review and on
request, advise EPA on ways to strengthen its programs for
protection of human subjects of research. 40 CFR 26.1603(b)
A charter for the Human Studies Review Board dated February 21,
2006 was issued in accordance with the provisions of the Federal
Advisory Committee Act (FACA), 5 U.S.C. App. 2 Section 9(c) stating
that the HSRB will:
Provide advice, information and recommendations on issues related to
scientific and ethical aspects of human subjects research. The major
objectives are to provide advice and recommendations on: (a)
Research proposals and protocols; (b) reports of completed research
with human subjects; and (c) how to strengthen EPA's programs for
protection of human subjects.
This notice requests nominations of candidates to serve as a member
of the HSRB in the area of Human Health Risk Assessment. General
information concerning the HSRB can be found on the EPA Web site at
http://www.epa.gov/osa/hsrb/.
Process and Deadline for Submitting Nominations
Any interested person or organization may nominate individuals to
be considered as prospective candidates for the HSRB. Additional
avenues and resources may be utilized in the solicitation of nominees
to encourage a broad pool of expertise. Nominees should be experts who
have sufficient professional qualifications, including training and
experience, to be capable of providing expert comments on the ethical
and/or scientific issues that may be considered by the HSRB. EPA is
seeking nominees who are nationally recognized experts in human health
risk assessment, specifically expertise in epidemiology, exposure
analysis, public health and/or human subject research regulations. All
nominations should include: (1) A current curriculum vitae (C.V.) which
provides the nominee's educational background, qualifications,
leadership positions in national associations or professional
publications, relevant research experience and publications; and (2) a
summary of the above in a biographical sketch (``biosketch'') of no
more than one page.
The qualifications of nominees received in reply to this notice
will be assessed in terms of the specific expertise sought for the
HSRB. Qualified nominees who agree to be considered further will be
included in a smaller subset (known as the ``Short List''). This Short
List consisting of nominee's name and biosketch will be posted for
public comment on the OSA Web site http://www.epa.gov/osa/index.htm.
The public will be requested to provide relevant information or other
documentation on nominees that OSA should consider in evaluating the
candidates. Public comments will be accepted for 14 calendar days on
the Short List. Board members will be selected from the Short List.
Short List candidates not selected for HSRB membership may be
considered for future HSRB membership as vacancies become available or
as HSRB consultants for future HSRB meetings. The Agency estimates
posting the names of Short List candidates sometime in late July.
However, please be advised that this is an approximate time frame and
the date could change. Thus, if you have any questions concerning
posting of Short List candidates on the OSA Web site, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
For the HSRB, a balanced panel is characterized by inclusion of
members who possess the necessary domains of knowledge, the relevant
technical perspectives, and the collective breadth of experience to
adequately address the Agency's charge. Interested candidates who are
employees of a federal department or agency (other than EPA) or are
members of another federal advisory committee are eligible to serve on
the HSRB, and their nominations are welcome. Other factors that will be
considered include: Availability to participate in the Board's
scheduled meetings, absence of any conflicts of interest and absence of
an appearance of a lack of impartiality, independence with respect to
the matters under review, and public comments in response to the Short
List. Though financial conflicts of interest or the appearance of a
lack of impartiality, lack of independence, or bias may lead to
nonselection, the absence of such concerns does not ensure that a
candidate will be selected to serve on the HSRB. Numerous qualified
candidates are likely to be identified. Selection decisions will
involve careful weighing of a number of factors including, but not
limited to, the candidates' areas of expertise and professional
qualifications, and responses to the Short List in achieving an overall
balance of different perspectives on the Board.
People who are hired to serve on the Board are subject to the
provisions of 5 CFR part 2634, Executive Branch Financial Disclosure,
as supplemented by the EPA in 5 CFR part 6401. In anticipation of this
requirement, each nominee will be asked to submit a Confidential
Financial Disclosure Form for Special Government Employees Serving on
Federal Advisory Committees at the U.S. Environmental Protection Agency
(EPA Form 3110-48 [5-02]). This form seeks information regarding the
candidate's financial interests, the candidate's employment, stocks,
and bonds, and where applicable, sources of research support. However,
this form is confidential and will not be disclosed to the public. The
EPA will evaluate the candidate's financial disclosure form to assess
whether there are financial conflicts of interest, appearance of a lack
of impartiality, or any prior involvement with the development of the
documents under consideration, including previous scientific peer
review, before the candidate is considered further for service on the HSRB.
Candidates selected from the Short List will be appointed to the
HSRB. HSRB members are to perform several activities including
reviewing extensive background materials between meetings of the Board,
preparing draft responses to Agency charge questions, attending Board
meetings, participating in the discussion and deliberations at these
meetings, drafting assigned sections of meeting reports, and reviewing
and helping to finalize Board reports.
Nominations should be submitted by one of the methods listed under
ADDRESSES.
[[Page 29166]]
The Agency will consider all nominations for HSRB membership that
are received on or before June 25, 2007. However, final selection of
members is a discretionary function of the Agency and will be announced
on the OSA Web site http://www.epa.gov/osa/index.htm soon after
comments are received on the Short List.
Dated: May 18, 2007.
George M. Gray,
Science Advisor.
[FR Doc. E7-10066 Filed 5-23-07; 8:45 am]
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