

[Federal Register: January 3, 2006 (Volume 71, Number 1)]
[Notices]
[Page 116-118]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja06-78]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2005-0553; FRL-8016-5]


Request for Nominations for a 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 to serve on a proposed Human Studies Review Board
(HSRB). The Agency anticipates establishment of such a board to provide
advice and recommendations on issues related to the scientific and
ethical review of human subjects research. EPA was directed to
establish such a Board pursuant to the 2006 EPA Appropriations Act and
included such a Board in a proposed rule for protection of subjects in
human research. See: ``Department of Interior, Environment, and Related
Agencies Appropriations Act, 2006'', Public Law No. 109-54 and
``Protections for Subjects in Human Research: Proposed Rule,'' 70 FR
53,838; September 12, 2005.

DATES: Nominations should be submitted to EPA no later than February 2,
2006.

ADDRESSES: Submit your nominations (``comments''), identified by Docket
ID No. EPA-HQ-ORD-2005-0553, by one of the following methods:
     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 B102, EPA
West Building, 1301 Constitution Avenue, NW., Washington, DC 20460,
Attention Docket ID No. EPA-HQ-ORD-2005-0553. 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.

[[Page 117]]

    Instructions: Direct your nominations to Docket ID No. EPA-HQ-ORD-
2005-0553. 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, EPA West, Room B102, 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, or
William Sette, Office of the Science Advisor, Mail Code 8105R,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number: (202) 564-0693, fax number:
(202) 564-2070, e-mail: sette.william@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 research
on substances regulated by EPA or to persons who are or may be required
to conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and the Food Quality Protection Act of 1996
(FQPA). 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,
Public Law 109-54 (Appropriations Act), which provides appropriated
funds for the Environmental Protection Agency and other Federal
departments and agencies. Section 201 of the Appropriations Act
includes the following provision:

    None of the funds made available by this Act may be used by the
Administrator of the Environmental Protection Agency to accept,
consider or rely on third-party intentional dosing human toxicity
studies for pesticides, or to conduct intentional dosing human
toxicity studies for pesticides until the Administrator issues a
final rulemaking on this subject. The Administrator shall allow for
a period of not less than 90 days for public comment on the Agency's
proposed rule before issuing a final rule. Such rule shall not
permit the use of pregnant women, infants or children as subjects;
shall be consistent with the principles proposed in the 2004 report
of the National Academy of Sciences on intentional human dosing and
the principles of the Nuremberg Code with respect to human
experimentation; and shall establish an independent Human Subjects
Review Board. The final rule shall be issued no later than 180 days
after enactment of this Act.

    Consistent with the express Congressional directive, on September
12, 2005 (70 FR 53838), EPA published a Notice of Proposed Rulemaking
(NPRM) regarding protections for subjects in human research and the
establishment of the Human Studies Review Board (HSRB or Board).
    Concurrent with this rulemaking process, EPA is reevaluating older
registered pesticides with a goal of meeting the August 2006 deadline
for completing the reregistration of pesticide active ingredients with
food uses and the reassessment of tolerances mandated by section 408(q)
of the FFDCA, as amended by the 1996 Food Quality Protection Act (FQPA)
[Pub. L. 104-70]. In addition, EPA has received applications for
registration or amended registration of pesticide products. Under the
provisions of the Pesticide Registration Improvement Act (PRIA), EPA
has deadlines by which it must make a decision whether to approve new
applications for pesticide registrations or amendments to
registrations.
    EPA expects to issue the final rule in early 2006 after considering
all public comments provided to the Agency. However, once the rule is
finalized, there will be limited time between the establishment of the
HSRB and the mandatory completion dates for tolerance reassessment and
PRIA deadlines. Therefore, the Agency is initiating the actions
necessary to enable a HSRB to begin reviewing completed

[[Page 118]]

human research that would be relevant to pending reregistration,
tolerance reassessment and new registration decisions, and in
accordance with the provisions of the final rule. The first step toward
establishing a HSRB is to solicit nominations for qualified individuals
to serve on the HSRB for a review of intentional dosing human studies.

Process and Deadline for Submitting Nominations

    Any interested person or organization may nominate qualified
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. Nominees are requested who are nationally recognized experts in
one or more of the following areas:
    Biostatistics: expertise in statistical design and analysis of
human subjects research studies.
    Human toxicology: Expertise in pharmacokinetic and toxicokinetic
studies, clinical trials, toxicology of cholinesterase inhibitors, and
other classes of environmental substances.
    Bioethics: Expertise in the ethics of research on human subjects;
research ethics.
    Human health risk assessment
    To be considered, all nominations should include: a current
curriculum vitae (C.V.) which provides the nominee's background,
qualifications, relevant research experience and publications; and a
brief biographical sketch (``biosketch''). The biosketch should be no
longer than one page and should contain the following information for
the nominee:
    (a) Current professional affiliations and positions held;
    (b) Area(s) of expertise, and research activities and publications
relevant to the HSRB;
    (c) Leadership positions in national associations or professional
publications or other significant distinctions;
    (d) Educational background, especially advanced degrees, including
when and from which institutions these were granted.

The credentials of nominees received in reply to this notice will be
compared to the specific expertise sought for the HSRB. Qualified
nominees who agree to be further considered will be included in a
smaller subset (known as the ``Short List''). This subset will be
posted on the OSA Web site http://www.epa.gov/osa/index.htm and will

include, for each candidate, the nominee's name and their biosketch.
Public comments will be accepted for 14 calendar days on the Short
List. During this comment period, the public will be requested to
provide relevant information or other documentation on nominees that
OSA should consider in evaluating the candidates. Board members will be
selected from the Short List.
    The selection of experts to serve on the HSRB will be based on the
function of the Board and the expertise needed. No interested
candidates shall be ineligible to serve by reason of their membership
on any other advisory committee to a Federal department or agency or
their employment by a Federal department or agency (except the EPA).
Other factors that will be considered during the selection process
include availability of the potential Board member to fully participate
in the Board's reviews, absence of any conflicts of interest,
impartiality, independence with respect to the matters under review,
and public comments to the Short List. Though financial conflicts of
interest, the appearance of lack of impartiality, lack of independence,
and bias may result in disqualification, the absence of such concerns
does not assure that a candidate will be selected to serve on the HSRB.
Numerous qualified candidates may be identified. Therefore, selection
decisions involve carefully 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.
    If a prospective candidate for service on the HSRB is considered,
the candidate is subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by the EPA in 5
CFR part 6401. As such, the HSRB candidate is required 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]) which shall fully disclose,
among other financial interests, the candidate's employment, stocks,
and bonds, and where applicable, sources of research support. The EPA
will evaluate the candidate's financial disclosure form to assess that
there are no financial conflicts of interest, no appearance of lack of
impartiality, and no 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.
    Those who are selected from the pool of prospective candidates will
be asked to attend public meetings and to participate in the discussion
of key issues and assumptions at these meetings. In addition, they will
be asked to review and to help finalize the meeting minutes. The Agency
will consider all nominations of prospective candidates for this
meeting that are received on or before February 2, 2006. However, final
selection of members is a discretionary function of the Agency.
Nominations should be submitted by one of the methods listed under
ADDRESSES.

    Dated: December 22, 2005.
William H. Farland,
Chief Scientist, Office of the Science Advisor.
 [FR Doc. E5-8220 Filed 12-30-05; 8:45 am]

BILLING CODE 6560-50-P
