[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Notices]
[Pages 59623-59624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24032]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2008-0720; FRL-8728-2]


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 people 
qualified in the areas of bioethics, biostatistics, human health risk 
assessment and human toxicology 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 Sec.  9, providing advice and recommendations to EPA on scientific 
and ethical aspects of research with human subjects.

DATES: Nominations (``comments'') should be submitted to EPA no later 
than November 10, 2008.

ADDRESSES: Submit your nominations, identified by Docket ID No. EPA-HQ-
ORD-2008-0720, by any of the following methods:
    Internet: http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: [email protected].
    USPS Mail: ORD Docket, Environmental Protection Agency, Mailcode: 
28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
    Hand or Courier 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-2008-0720. Deliveries are 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-
2008-0720. 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 through http://www.regulations.gov or e-mail that you 
consider to be CBI or otherwise protected from disclosure.
    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. By 
contrast, 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 under the docket number. Even though it will 
be listed by title in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Copyright material will be publicly available 
only in hard copy. Publicly available docket materials are available 
either electronically through 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: [email protected].

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 particular interest to persons who conduct or assess 
human studies, especially studies on substances regulated by EPA, and 
to persons who may sponsor or conduct research with human subjects with 
the intention to submit it to EPA for consideration under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) or section 408 of 
the Federal Food, Drug, and Cosmetic Act (FFDCA). 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?

    You may access this Federal Register document electronically either 
through http://www.regulations.gov or through the EPA Web site 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. Provide 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.
    3. To ensure proper receipt by EPA, be sure to include 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 February 6, 2006 the Agency published a final rule for 
protection of human subjects of research (71 FR 24 6138) that called 
for creating a new, independent human studies review board (i.e. HSRB). 
The HSRB is a Federal advisory committee operating in accordance with 
the Federal Advisory Committee Act (FACA) 5 U.S.C. App. 2 Sec.  9. The 
HSRB provides advice, information, and recommendations to EPA on issues 
related to scientific and ethical aspects of human subjects research. 
The major objectives of the HSRB are to provide advice and 
recommendations on: (1) Research proposals and protocols; (2) reports 
of completed research with human subjects; and (3) how to strengthen

[[Page 59624]]

EPA's programs for protection of human subjects of research. The HSRB 
reports to the EPA Administrator through EPA's Science Advisor.
    This notice solicits nominations of individuals with expertise in 
bioethics, biostatistics, human health risk assessment and/or human 
toxicology to fill anticipated vacancies on the Board. General 
information concerning the HSRB, including its charter, current 
membership, and activities 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 someone to be 
considered as prospective nominees 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, by training and experience, to 
provide expert comment on the ethical and scientific issues that may 
come before the HSRB. Responsibilities of HSRB members include 
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.
    EPA seeks nominees who are nationally recognized experts in one or 
more of the following areas:
     Bioethics: Expertise in the ethics of research with human 
subjects.
     Biostatistics: Expertise in statistical design and 
analysis of research with human subjects, especially research with 
small sample sizes.
     Human health risk assessment: Expertise in epidemiology, 
exposure analysis, public health or human research regulations.
     Human toxicology: Expertise in toxicity of environmental 
substances, mechanisms of toxicity and/or clinical studies.
    All nominations should include: (1) A current curriculum vitae 
(C.V.) providing the nominee's educational background, qualifications, 
leadership positions in national associations or professional 
societies, relevant research experience and publications; and (2) a 
summary of the above in a one-page biographical sketch.
    The qualifications of nominees for membership on the HSRB 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 ``Short List''. The Short List of nominees' names and 
biographical sketches will be posted for 14 calendar days for public 
comment on the EPA Web site at http://www.epa.gov/osa/index.htm. The 
public will be encouraged to provide additional information about the 
nominees that EPA should consider. At the completion of this comment 
period, EPA will select new Board members from the Short List. 
Candidates not selected for HSRB membership at this time may be 
considered for HSRB membership as vacancies arise in the future, or for 
service as consultants to the HSRB. The Agency estimates that the names 
of Short List candidates will be posted in February, 2009. 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.
    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, and 
independence with respect to the matters likely to come under HSRB 
review. 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 many factors, including, but not limited 
to, the candidates' areas of expertise and professional qualifications, 
and responses to the Short List in achieving the overall balance of 
different perspectives and areas of expertise on the Board.
    Members of the HSRB 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 confidential financial information which shall 
fully disclose, among other financial interests, the candidate's 
employment, stocks and bonds, and where applicable, sources of research 
support. The information provided is confidential and will not be 
disclosed to the public. Before a candidate is considered further for 
service on the HSRB, EPA will evaluate each candidate to assess whether 
there is any conflict of financial interest, appearance of a lack of 
impartiality, or prior involvement with matters likely to be reviewed 
by the Board.
    Nominations should be submitted by one of the methods listed under 
ADDRESSEES. The Agency will consider all nominations received on or 
before November 10, 2008. Final selection of members is a discretionary 
function of the Agency and will be announced on the EPA Web site at 
http://www.epa.gov/osa/hsrb as soon as they are made.

    Dated: September 26, 2008.
George M. Gray,
Science Advisor.
 [FR Doc. E8-24032 Filed 10-8-08; 8:45 am]
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