Request for Nominations for a Human Studies Review Board, 116-118 [E5-8220]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 1 (Tuesday, January 3, 2006)]
[Notices]
[Pages 116-118]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8220]


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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:
     https://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 https://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 
https://www.regulations.gov or e-mail. The https://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 https://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 https://
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 https://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 https://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 https://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]
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