Request for Nominations to the EPA Human Studies Review Board, 10261-10263 [2010-4703]
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erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
Road, Suite 175, Columbia, MD 21046.
Active Ingredient: Paecilomyces
fumosoroseus var. Apopka strain 97.
Proposed Uses: All food commodities.
Contact: Shanaz Bacchus, (703) 308–
8097, bacchus.shanaz@epa.gov.
2. Registration Number: 70051–44.
Docket Number: EPA–HQ–OPP–2010–
0059. Company Name and Address:
Certis USA LLC, 9145 Guilford Road,
Suite 175, Columbia, MD 21046. Active
Ingredient: Cydia pomonella
granulovirus. Proposed Uses:
Residential uses. Contact: Jeannine
Kausch, (703) 347–8920,
kausch.jeannine@epa.gov.
3. Registration Numbers: 70127–7,
70127–8, 70127–10. Docket Number:
EPA–HQ–OPP–2010–0081. Company
Name and Address: Novozymes
Biologicals Incorporated, 5400
Corporate Circle, Salem, VA 24153.
Active Ingredient: Metarhizium
anisopliae F52. Proposed Uses: All food
commodities. Contact: Shanaz Bacchus,
(703) 308–8097,
bacchus.shanaz@epa.gov.
4. File Symbol: 73049–UTR. Docket
Number: EPA–HQ–OPP–2010–0091.
Company Name and Address: Valent
BioSciences Corporation, 870
Technology Way, Suite 100,
Libertyville, IL 60048–6316. Active
Ingredient: Bacillus thuringiensis subsp.
kurstaki strain ABTS–351. Proposed
Uses: Ornamental fruit, nut, and citrus
trees; forests, shade trees, and sugar
maple. Contact: Kathleen Martin, (703)
308–2857, martin.kathleen@epa.gov.
5. File Symbol: 84418–E. Docket
Number: EPA–HQ–OPP–2010–0105.
Company Name and Address: New
Century Channel Group, d/b/a Pignx
Incorporated, 1150 Connecticut Avenue
NW., Suite 1100, Washington, DC
20036. Active Ingredient: Capsaicin.
Proposed Uses: Rodenticide. Contact:
Cheryl Greene, (703) 308–0352,
greene.cheryl@epa.gov.
6. File Symbol: 85004–G. Docket
Number: EPA–HQ–OPP–2010–0060.
Company Name and Address:
MacIntosh and Associates Incorporated,
1203 Hartford Avenue, Saint Paul, MN
55116–1622 (on behalf of Pasteuria
Bioscience Incorporated, 12085
Research Drive, Suite 185, Alachua, FL
32615). Active Ingredient: Pasteuria
usgae. Proposed Uses: Strawberries.
Contact: Jeannine Kausch, (703) 347–
8920, kausch.jeannine@epa.gov.
List of Subjects
Environmental protection, Pesticides
and pests.
VerDate Nov<24>2008
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Dated: February 24, 2010.
Keith A. Matthews,
Acting Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
[FR Doc. 2010–4718 Filed 3–4–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2010–0195; FRL–9123–5]
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 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
§ 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 March 22, 2010.
ADDRESSES: Submit your nominations,
identified by Docket ID No. EPA–HQ–
ORD–2010–0195, by any of the
following methods:
Internet: https://www.regulations.gov:
Follow the on-line instructions for
submitting comments.
E-mail: ORD.Docket@epa.gov.
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–2010–
0195. 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–2010–
0195. 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
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10261
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 https://
www.regulations.gov or e-mail that you
consider to be CBI or otherwise
protected from disclosure.
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. By contrast, 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 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 https://
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: Jim
Downing, Office of the Science Advisor,
Mail Code 8105R, Environmental
Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460;
telephone number: (202) 564–2468, fax
number: (202) 564–2070, e-mail:
downing.jim@epa.gov.
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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
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
https://www.regulations.gov or through
the EPA Web site 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. 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.
erowe on DSK5CLS3C1PROD with NOTICES
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
§ 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
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14:45 Mar 04, 2010
Jkt 220001
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
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 https://
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
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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 https://
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 March 2010. 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
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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Notices
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
ADDRESSES. The Agency will consider
all nominations received on or before
March 22, 2010. Final selection of
members is a discretionary function of
the Agency and will be announced on
the EPA Web site at https://
www.epa.gov/osa/hsrb as soon as they
are made.
Dated: March 2, 2010.
Paul T. Anastas,
Science Advisor.
[FR Doc. 2010–4703 Filed 3–4–10; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information
Collections Being Reviewed by the
Federal Communications Commission,
Comments Requested
erowe on DSK5CLS3C1PROD with NOTICES
02/26/2010.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
Federal agencies to take this
opportunity to comment on the
following information collections, as
required by the Paperwork Reduction
Act of 1995, 44 U.S.C. 3501–3520. An
agency may not conduct or sponsor a
collection of information unless it
displays a currently valid control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act (PRA) that
does not display a valid control number.
Comments are requested concerning (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
(b) the accuracy of the Commission’s
burden estimate; (c) ways to enhance
the quality, utility, and clarity of the
information collected; (d) ways to
VerDate Nov<24>2008
14:45 Mar 04, 2010
Jkt 220001
minimize the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology and (e) ways to
further reduce the information burden
for small business concerns with fewer
than 25 employees.
The FCC may not conduct or sponsor
a collection of information unless it
displays a currently valid control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act (PRA) that
does not display a valid control number.
DATES: Persons wishing to comment on
this information collection(s) should
submit comments by May 4, 2010. If you
anticipate that you will be submitting
comments, but find it difficult to do so
within the period of time allowed by
this notice, you should advise the
contact listed below as soon as possible.
ADDRESSES: Direct all PRA comments to
Nicholas A. Fraser, Office of
Management and Budget (OMB), via fax
at (202) 395–5167, or via e–mail to
Nicholas_A._Fraser@omb.eop.gov and
to Cathy Williams, Federal
Communications Commission (FCC), via
e–mail to Cathy.Williams@fcc.gov and
to PRA@fcc.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information about the
information collections send an e–mail
to PRA@fcc.gov or contact Cathy
Williams on (202) 418–2918.
SUPPLEMENTARY INFORMATION:
OMB Control Number: 3060–0888.
Title: Section 76.7, Petition
Procedures; Section 76.9,
Confidentiality of Proprietary
Information; Section 76.61, Dispute
Concerning Carriage; Section 76.914,
Revocation of Certification; Section
76.1001, Unfair Practices; Section
76.1003, Program Access Proceedings;
Section 76.1302, Carriage Agreement
Proceedings; Section 76.1513, Open
Video Dispute Resolution.
Form Number: Not applicable.
Type of Review: Revision of a
currently approved collection.
Respondents: Businesses or other for–
profit.
Number of Respondents and
Responses: 640 respondents; 640
responses.
Estimated Time per Response: 4.1 to
61.4 hours.
Frequency of Response: On occasion
reporting requirement; Third party
disclosure requirement.
Obligation to Respond: Required to
obtain or retain benefits. The statutory
authority for this information is
contained in Sections 4(i), 303(r) and
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10263
628 of the Communications Act of 1934,
as amended.
Total Annual Burden: 20,960 hours
Total Annual Cost: $393,600.
Privacy Act Impact Assessment: No
impact(s).
Nature and Extent of Confidentiality:
A party that wishes to have
confidentiality for proprietary
information with respect to a
submission it is making to the
Commission must file a petition
pursuant to the pleading requirements
in Section 76.7 and use the method
described in Sections 0.459 and 76.9 to
demonstrate that confidentiality is
warranted.
On January 20, 2010, the Commission
adopted a First Report and Order In the
Matter of Review of the Commission’s
Program Access Rules and Examination
of Programming Tying Arrangements,
MB Docket No. 07–198, FCC 10–17. In
the First Report and Order, the
Commission establishes rules, policies,
and procedures for the consideration of
complaints alleging unfair acts
involving terrestrially delivered, cable–
affiliated programming in violation of
Section 628(b) of the Communications
Act. The Commission also establishes
procedures for the consideration of
requests for a temporary standstill of the
price, terms, and other conditions of an
existing programming contract by a
program access complainant seeking
renewal of such a contract.
The following rule sections contain
revised information collection
requirements that the Commission is
seeking approval for from the Office of
Management and Budget (OMB):
47 CFR Section 76.1001(b)(2) permits
any multichannel video programming
distributor to commence an
adjudicatory proceeding by filing a
complaint with the Commission alleging
that a cable operator, a satellite cable
programming vendor in which a cable
operator has an attributable interest, or
a satellite broadcast programming
vendor, has engaged in an unfair act
involving terrestrially delivered, cable–
affiliated programming (which, as
defined in this R&O, includes exclusive
contracts, discrimination, and undue or
improper influence), which must be
filed and responded to in accordance
with the procedures specified in Section
76.7, except to the extent such
procedures are modified by Sections
76.1001(b)(2) and 76.1003. In program
access cases involving terrestrially
delivered, cable–affiliated programming,
the defendant has 45 days from the date
of service of the complaint to file an
answer, unless otherwise directed by
the Commission. A complainant shall
have the burden of proof that the
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Agencies
[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Notices]
[Pages 10261-10263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4703]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2010-0195; FRL-9123-5]
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 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 March 22, 2010.
ADDRESSES: Submit your nominations, identified by Docket ID No. EPA-HQ-
ORD-2010-0195, by any of the following methods:
Internet: https://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov.
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-2010-0195. 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-
2010-0195. 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 through https://www.regulations.gov or e-mail that you
consider to be CBI or otherwise protected from disclosure.
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. By
contrast, 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 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 https://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: Jim Downing, Office of the Science
Advisor, Mail Code 8105R, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202)
564-2468, fax number: (202) 564-2070, e-mail: downing.jim@epa.gov.
[[Page 10262]]
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 https://www.regulations.gov or through the EPA Web site 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. 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
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 https://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 https://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 March 2010. 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
[[Page 10263]]
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
Addresses. The Agency will consider all nominations received on or
before March 22, 2010. Final selection of members is a discretionary
function of the Agency and will be announced on the EPA Web site at
https://www.epa.gov/osa/hsrb as soon as they are made.
Dated: March 2, 2010.
Paul T. Anastas,
Science Advisor.
[FR Doc. 2010-4703 Filed 3-4-10; 8:45 am]
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