Request for Nominations for a Human Studies Review Board, 116-118 [E5-8220]
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116
Federal Register / Vol. 71, No. 1 / Tuesday, January 3, 2006 / Notices
already filed their required Electric
Quarterly Reports in compliance with
the Commission’s requirements, its
inclusion herein is inadvertent. Any
such market-based rate seller is
directed, within 15 days of the date of
issuance of this order, to identify itself
and provide details about its prior
filings that establish that it complied
with the Commission’s Electric
Quarterly Report filing requirements.
10. If any of the above-captioned
market-based rate sellers does not wish
to continue having market-based rate
authority and does not foresee entering
into any contracts to sell power at
market-based rates, it may file a notice
of cancellation with the Commission
pursuant to section 205 of the FPA to
cancel its market-based rate tariff and
relieve it of its obligation to submit
further Electric Quarterly Reports.
rmajette on DSK29S0YB1PROD with NOTICES6
The Commission Orders
(A) Within 15 days of the date of
issuance of this order, each public
utility listed in the caption of this order
shall file all delinquent Electric
Quarterly Reports. If a public utility
fails to make this filing, the Commission
will revoke that public utility’s
authority to sell power at market-based
rates and terminate its electric marketbased rate tariff. Upon expiration of the
filing deadline in this order, the
Secretary shall promptly issue a notice,
effective on the date of issuance, listing
the public utilities whose tariffs have
been revoked.
(B) Pursuant to the authority
contained in and subject to the
jurisdiction conferred upon the Federal
Energy Regulatory Commission by
section 402(a) of the Department of
Energy Organization Act and by the
Federal Power Act, particularly section
206 thereof, and pursuant to the
Commission’s Rules of Practice and
Procedure and the regulations under the
Federal Power Act (18 CFR Chapter I),
the Commission hereby institutes a
proceeding to determine whether the
above-captioned companies may
continue to make wholesale power sales
at market-based rates and whether any
refunds would be appropriate, as
discussed in the body of this order.
(C) The Secretary is hereby directed to
publish this order in the Federal
Register.
By the Commission.
Magalie R. Salas,
Secretary.
[FR Doc. E5–8159 Filed 12–30–05; 8:45 am]
BILLING CODE 6717–01–P
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Letter is non-public material. The
Commission’s eFiling system is not
ready to accept non-public material at
this time and therefore, it is not
available for the filing of requests for
No-Action Letter.
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
[Docket No. PL06–4–000]
Informal Staff Advice on Regulatory
Requirements; Notice of New Docket
Prefix ‘‘NL’’ and Guidelines for Filing
Request for No-Action Letter
December 27, 2005.
On November 18, 2005, the
Commission issued an Interpretive
Order Regarding No-Action Letter
Process 1 in Docket PL06–4–000. Notice
is hereby given that the Commission has
established a new docket prefix ‘‘NL’’ to
identify issuances related to No-Action
Letters.
The prefix will have the format
NLFY–NNN–000, where ‘‘FY’’ stands for
the fiscal year in which the request for
No-Action Letter was received by the
Commission and ‘‘NNN’’ is a sequential
number.
The Commission is also issuing with
this notice guidelines for filing requests
for No-Action Letter. The guidelines are
available on https://www.ferc.gov under
the Documents and Filing tab.
Magalie R. Salas,
Secretary.
Filing Guidelines for Requests for NoAction Letter
What to Submit: Submit one original
and two paper copies of the request,
along with a text-searchable file (or
files) on a 31⁄4’’ diskette or CD–ROM.
Each page of the request and any
supporting information or documents
should include a header or footer stating
‘‘Request for No-Action Letter.’’
Contact Info: Each request must
include the name, address, telephone
number, and e-mail address of the
person to whom the response should be
directed.
Where to Submit: Send your request
to: Federal Energy Regulatory
Commission, Office of the General
Counsel, Room 10A–01, ATTN: Request
for No-Action Letter, 888 First Street,
NE., Washington, DC 20426.
Use express mail or courier services to
submit a Request for No-Action Letter to
FERC. Regular mail sent through the US
Postal Service to the Commission is
subject to a 7–10 day delay for scanning.
The scanning process also may destroy
any diskettes and CD–ROMs included in
the submittal.
The Commission determined that, at
least initially, a Request for No-Action
1 Interpretive Order Regarding No-Action Letter
Process, 113 FERC ¶ 61,174 (2005).
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[FR Doc. E5–8178 Filed 12–30–05; 8:45 am]
BILLING CODE 6717–01–P
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.
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.
E:\FR\FM\03JAN1.SGM
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Federal Register / Vol. 71, No. 1 / Tuesday, January 3, 2006 / Notices
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
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15:46 Nov 10, 2010
Jkt 223001
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,
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117
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
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Federal Register / Vol. 71, No. 1 / Tuesday, January 3, 2006 / Notices
rmajette on DSK29S0YB1PROD with NOTICES6
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
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15:46 Nov 10, 2010
Jkt 223001
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
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Fmt 4703
Sfmt 4703
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
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8014–1]
Tribal Solid Waste Management
Assistance Project: Request for
Proposals
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice of withdrawal of Notice
of Availability.
SUMMARY: This action withdraws the
Tribal Solid Waste Interagency
Workgroup announcement of the FY 06
Solicitation request for proposals of the
Tribal Solid Waste Management
Assistance Project (previously called the
Open Dump Cleanup Project), published
in the Federal Register Notice on
Wednesday, November 23, 2005 (70 FR
70828). EPA is withdrawing the
November 23, 2005 Notice of
Availability because it has determined
that it is necessary to make certain
changes and clarifications to the
funding solicitation contained therein.
EPA will issue a revised solicitation in
the near future. The revised solicitation
will be published on the Internet at
https://www.epa.gov/tribalmsw (click on
the ‘‘Grants/Funding’’ link) and will also
be available through https://
www.grants.gov.
FOR FURTHER INFORMATION CONTACT: For
general information contact, Christopher
Dege, at (703) 308–2392 or Tonya
Hawkins at (703) 308–8278.
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Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 6560-50-P