[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14099-14101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5484]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2007-0143; FRL-8291-5]


Request for Nominations to the EPA Human Studies Review Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 biostatistics 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 April 25, 
2007.

ADDRESSES: Submit your nominations (``comments''), identified by Docket 
ID No. EPA-HQ-ORD-2007-0143, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    E-mail: [email protected].
    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-2007-0143. Deliveries are only 
accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays.

[[Page 14100]]

Special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your nominations to Docket ID No. EPA-HQ-ORD-
2007-0143. 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: [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 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.
    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 biostatistics. 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 
biostatistics, specifically expertise in statistical design and 
analysis of research involving human subjects.
    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;

[[Page 14101]]

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 May. 
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 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 
ADDRESSEES.
    The Agency will consider all nominations for HSRB membership that 
are received on or before April 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: March 19, 2007.
George M. Gray,
Science Advisor.
 [FR Doc. E7-5484 Filed 3-23-07; 8:45 am]
BILLING CODE 6560-50-P