Interagency Cooperation Under the Endangered Species Act, 63667-63668 [E8-25678]
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Federal Register / Vol. 73, No. 208 / Monday, October 27, 2008 / Proposed Rules
(b) Must have a Human Research
Protection Official, as defined in the
clause at 252.235–70XX, Protection of
Human Subjects, and identified in the
DoD component’s Human Research
Protection Management Plan. This
official is responsible for the oversight
and execution of the requirements of the
clause at 252.235–70XX and shall be
identified in acquisition planning.
PART 235—RESEARCH AND
DEVELOPMENT CONTRACTING
3. Section 235.072 is amended by
adding paragraph (e) to read as follows:
235.072
Additional contract clauses.
*
*
*
*
*
(e) Use the clause at 252.235–70XX,
Protection of Human Subjects, in
solicitations and contracts that include
or may include research involving
human subjects in accordance with 32
CFR Part 219, DoD Directive 3216.02,
and 10 U.S.C. 980, including research
that meets exemption criteria under 32
CFR 219.101(b).
The clause—
(1) Applies to solicitations and
contracts awarded by any DoD
component, regardless of mission or
funding Program Element Code; and
(2) Does not apply to use of cadaver
materials alone, which are not directly
regulated by 32 CFR Part 219 or DoD
Directive 3216.02, and which are
governed by other DoD policies and
applicable State and local laws.
PART 252—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
4. Section 252.235–70XX is added to
read as follows:
252.235–70XX
Subjects.
Protection of Human
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As prescribed in 235.072(e), use the
following clause:
PROTECTION OF HUMAN SUBJECTS (XXX
2008)
(a) Definitions. As used in this clause—
(1) Assurance of compliance means a
written assurance that an institution will
comply with requirements of 32 CFR Part
219, as well as the terms of the assurance,
which the Human Research Protection
Official determines to be appropriate for the
research supported by the Department of
Defense (DoD) component (32 CFR 219.103).
(2) Human Research Protection Official
(HRPO) means the individual designated by
the head of the applicable DoD component
and identified in the component’s Human
Research Protection Management Plan as the
official who is responsible for the oversight
and execution of the requirements of this
clause, although some DoD components may
use a different title for this position.
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(3) Human subject means a living
individual about whom an investigator
(whether professional or student) conducting
research obtains data through intervention or
interaction with the individual, or
identifiable private information (32 CFR
219.102(f)). For example, this could include
the use of human organs, tissue, and body
fluids from individually identifiable living
human subjects as well as graphic, written,
or recorded information derived from
individually identifiable living human
subjects.
(4) Institution means any public or private
entity or agency (32 CFR 219.102(b)).
(5) Institutional Review Board (IRB) means
a board established for the purposes
expressed in 32 CFR Part 219 (32 CFR
219.102(g)).
(6) IRB approval means the determination
of the IRB that the research has been
reviewed and may be conducted at an
institution within the constraints set forth by
the IRB and by other institutional and
Federal requirements (32 CFR 219.102(h)).
(7) Research means a systematic
investigation, including research,
development, testing, and evaluation,
designed to develop or contribute to
generalizable knowledge. Activities that meet
this definition constitute research for
purposes of 32 CFR Part 219, whether or not
they are conducted or supported under a
program that is considered research for other
purposes. For example, some demonstration
and service programs may include research
activities (32 CFR 219.102(d)).
(b) The Contractor shall oversee the
execution of the research to ensure
compliance with this clause. The Contractor
shall comply fully with 32 CFR Part 219 and
DoD Directive 3216.02, applicable DoD
component policies, 10 U.S.C. 980 and, when
applicable, Food and Drug Administration
policies and regulations.
(c) The Contractor shall not commence
performance of research involving human
subjects that is covered under 32 CFR Part
219 or that meets exemption criteria under 32
CFR 219.101(b), or expend funding on such
effort, until and unless the conditions of
either the following paragraph (c)(1) or (c)(2)
have been met:
(1) The Contractor furnishes to the HRPO,
with a copy to the Contracting Officer, an
assurance of compliance and IRB approval
and receives notification from the
Contracting Officer that the HRPO has
approved the assurance as appropriate for the
research under the Statement of Work and
also that the HRPO has reviewed the protocol
and accepted the IRB approval for
compliance with the DoD component
policies. The Contractor may furnish
evidence of an existing assurance of
compliance for acceptance by the HRPO, if
an appropriate assurance has been approved
in connection with previous research. The
Contractor shall notify the Contracting
Officer immediately of any suspensions or
terminations of the assurance.
(2) The Contractor furnishes to the HRPO,
with a copy to the Contracting Officer, a
determination that the human research
proposed meets exemption criteria in 32 CFR
219.101(b) and receives written notification
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63667
from the Contracting Officer that the
exemption is determined acceptable. The
determination shall include citation of the
exemption category under 32 CFR 219.101(b)
and a rationale statement. In the event of a
disagreement regarding the Contractor’s
furnished exemption determination, the
HRPO retains final judgment on what
research activities or classes of research are
covered or are exempt under the contract.
(d) DoD staff, consultants, and advisory
groups may independently review and
inspect the Contractor’s research and
research procedures involving human
subjects and, based on such findings, DoD
may prohibit research that presents
unacceptable hazards or otherwise fails to
comply with DoD procedures.
(e) Failure of the Contractor to comply with
the requirements of this clause will result in
the issuance of a stop-work order under
Federal Acquisition Regulation clause
52.242–15 to immediately suspend, in whole
or in part, work and further payment under
this contract, or will result in other issuance
of suspension of work and further payment
for as long as determined necessary at the
discretion of the Contracting Officer.
(f) The Contractor shall include the
substance of this clause, including this
paragraph (f), in all subcontracts that may
include research involving human subjects in
accordance with 32 CFR Part 219, DoD
Directive 3216.02, and 10 U.S.C. 980,
including research that meets exemption
criteria under 32 CFR 219.101(b). This clause
does not apply to subcontracts that involve
only the use of cadaver materials.
(End of clause.)
[FR Doc. E8–25562 Filed 10–24–08; 8:45 am]
BILLING CODE 5001–08–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 402
[FWS–R9–ES–2008–0093]
RIN 1018–AT50
DEPARTMENT OF COMMERE
National Marine Fisheries Service
50 CFR Part 402
[0808011023–81048–01]
RIN 0618–AX15
Interagency Cooperation Under the
Endangered Species Act
U.S. Fish and Wildlife
Service, Interior; National Marine
Fisheries Service, Commerce.
ACTION: Proposed rule; availability of
Draft Environmental Assessment on
proposed rule revising regulations
implementing section 7 of the
Endangered Species Act (ESA).
AGENCIES:
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63668
Federal Register / Vol. 73, No. 208 / Monday, October 27, 2008 / Proposed Rules
SUMMARY: The United States Fish and
Wildlife Service (FWS) and the National
Marine Fisheries Service (NMFS)
(collectively, ‘‘Services’’ or ‘‘we’’)
previously proposed to amend
regulations governing interagency
cooperation under the Endangered
Species Act of 1973 (Act) (73 FR 47868–
47875; August 15, 2008).
The Services proposed these
regulatory changes to improve the
effectiveness and efficiency of the
section 7(a)(2) consultation process.
This Federal Register notice advises the
public that we (FWS and NOAA) have
prepared a Draft Environmental
Assessment (Draft EA) under the
National Environmental Policy Act
(NEPA) that assesses the potential
environmental effects of the proposed
regulatory changes currently under
consideration. The Draft EA is available
for public review at the following Web
site: https://www.doi.gov/issues/
esa.html.
To ensure consideration, we
must receive written comments by
November 6, 2008.
ADDRESSES: Comments may be
submitted in two ways: (1) Through the
Federal eRulemaking Portal at https://
www.regulations.gov. Follow the
instructions on the Web site for
submitting comments; or (2) by U.S.
mail or hand-delivery to Public
Comment Processing, Attention: 1018AT50, Division of Policy and Directives
Management, U.S. Fish and Wildlife
Service, 4401 North Fairfax Drive, Suite
222, Arlington, VA 22203. We will not
accept e-mail or faxes.
Our practice is to make comments,
including names and home addresses of
respondents, available for public
review. Individual respondents may
request that we withhold their home
address from public disclosure, which
we will honor to the extent allowable by
law. If you wish us to withhold your
name and/or address, you must state
this prominently at the beginning of
your comment. We will make all
submissions from organizations or
businesses, and from individuals
identifying themselves as
representatives or officials of
organizations or businesses, available
for public disclosure in their entirety.
FOR FURTHER INFORMATION CONTACT:
Office of the Assistant Secretary for Fish
and Wildlife and Parks, 1849 C Street,
NW., Washington, DC 20240, telephone:
202–208–4416; or James H. Lecky,
Director, Office of Protected Resources,
National Marine Fisheries Service, 1315
East-West Highway, Silver Spring, MD
20910; telephone: 301–713–2332.
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DATES:
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The
Endangered Species Act of 1973, as
amended (‘‘Act’’; 16 U.S.C. 1531 et seq.)
provides that the Secretaries of the
Interior and Commerce (the
‘‘Secretaries’’) share responsibilities for
implementing most of the provisions of
the Act. Generally, marine species are
under the jurisdiction of the Secretary of
Commerce and all other species are
under the jurisdiction of the Secretary of
the Interior. With respect to agency
consultation pursuant to Section 7 of
the Act, authority to administer the Act
has been delegated by the Secretary of
the Interior to the Director of the FWS
and by the Secretary of Commerce
through the Administrator of the
National Oceanic and Atmospheric
Administration to the Assistant
Administrator for NMFS.
On May 15, 2008, Secretary
Kempthorne announced that he would
propose common sense modifications to
the existing regulations that implement
this section of the ESA in order to
provide greater clarity and certainty to
the inter-agency consultation process. In
the Federal Register notice proposing
the regulatory modifications analyzed in
this EA, the Services noted the
importance of refining the ESA section
7(a)(2) consultation process to better set
forth certain regulatory definitions and
the applicability of this important
interagency process.
While neither NEPA nor its
implementing regulations require that
EAs be made available for public
comment, the Services’ have concluded
that it is appropriate in this instance to
provide an opportunity for public
review and comment on the draft EA, as
set forth above.
SUPPLEMENTARY INFORMATION:
Dated: October 23, 2008.
David M. Verhey,
Acting Assistant Secretary, Fish and Wildlife
and Parks, Department of the Interior.
Samuel D. Rauch,
Deputy Assistant Administrator for
Regulatory Programs, National Marine
Fisheries Service, National Oceanic and
Atmospheric Administration.
[FR Doc. E8–25678 Filed 10–23–08; 4:15 pm]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 635
[Docket No. 080723890–81314–01]
RIN 0648–AX03
Atlantic Highly Migratory Species;
Atlantic Commercial Shark
Management Measures
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
SUMMARY: This proposed rule would
adjust quotas for the 2009 fishing season
for sandbar sharks, non–sandbar large
coastal sharks (LCS), small coastal
sharks (SCS), and pelagic sharks
managed under Amendment 2 to the
2006 Consolidated Atlantic Highly
Migratory Species (HMS) Fishery
Management Plan (FMP) based on any
over– and/or underharvests experienced
during the 2008 Atlantic commercial
shark fishing season. The purpose of
this proposed action is to provide
advance notice of quotas for the Atlantic
commercial shark fishery and address
any over– and/or underharvests that
may have occurred in the Atlantic shark
fishery during the 2008 fishing season.
DATES: Written comments will be
accepted until November 26, 2008.
ADDRESSES: You may submit comments,
identified by 0648–AX03, by any one of
the following methods:
• Electronic Submissions: Submit all
electronic public comments via the
Federal eRulemaking Portal https://
www.regulations.gov
• Fax: 301–713–1917, Attn: Karyl
Brewster–Geisz
• Mail: 1315 East–West Highway,
Silver Spring, MD 20910. Please mark
the outside of the envelope ‘‘Comments
on Proposed Rule for 2009 Atlantic
Commercial Shark Fishing Season. ’’
Instructions: All comments received
are a part of the public record and will
generally be posted to https://
www.regulations.gov without change.
All Personal Identifying Information (for
example, name, address, etc.)
voluntarily submitted by the commenter
may be publicly accessible. Do not
submit Confidential Business
Information or otherwise sensitive or
protected information.
NMFS will accept anonymous
comments (enter N/A in the required
fields, if you wish to remain
E:\FR\FM\27OCP1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 208 (Monday, October 27, 2008)]
[Proposed Rules]
[Pages 63667-63668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25678]
=======================================================================
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 402
[FWS-R9-ES-2008-0093]
RIN 1018-AT50
DEPARTMENT OF COMMERE
National Marine Fisheries Service
50 CFR Part 402
[0808011023-81048-01]
RIN 0618-AX15
Interagency Cooperation Under the Endangered Species Act
AGENCIES: U.S. Fish and Wildlife Service, Interior; National Marine
Fisheries Service, Commerce.
ACTION: Proposed rule; availability of Draft Environmental Assessment
on proposed rule revising regulations implementing section 7 of the
Endangered Species Act (ESA).
-----------------------------------------------------------------------
[[Page 63668]]
SUMMARY: The United States Fish and Wildlife Service (FWS) and the
National Marine Fisheries Service (NMFS) (collectively, ``Services'' or
``we'') previously proposed to amend regulations governing interagency
cooperation under the Endangered Species Act of 1973 (Act) (73 FR
47868-47875; August 15, 2008).
The Services proposed these regulatory changes to improve the
effectiveness and efficiency of the section 7(a)(2) consultation
process. This Federal Register notice advises the public that we (FWS
and NOAA) have prepared a Draft Environmental Assessment (Draft EA)
under the National Environmental Policy Act (NEPA) that assesses the
potential environmental effects of the proposed regulatory changes
currently under consideration. The Draft EA is available for public
review at the following Web site: https://www.doi.gov/issues/esa.html.
DATES: To ensure consideration, we must receive written comments by
November 6, 2008.
ADDRESSES: Comments may be submitted in two ways: (1) Through the
Federal eRulemaking Portal at https://www.regulations.gov. Follow the
instructions on the Web site for submitting comments; or (2) by U.S.
mail or hand-delivery to Public Comment Processing, Attention: 1018-
AT50, Division of Policy and Directives Management, U.S. Fish and
Wildlife Service, 4401 North Fairfax Drive, Suite 222, Arlington, VA
22203. We will not accept e-mail or faxes.
Our practice is to make comments, including names and home
addresses of respondents, available for public review. Individual
respondents may request that we withhold their home address from public
disclosure, which we will honor to the extent allowable by law. If you
wish us to withhold your name and/or address, you must state this
prominently at the beginning of your comment. We will make all
submissions from organizations or businesses, and from individuals
identifying themselves as representatives or officials of organizations
or businesses, available for public disclosure in their entirety.
FOR FURTHER INFORMATION CONTACT: Office of the Assistant Secretary for
Fish and Wildlife and Parks, 1849 C Street, NW., Washington, DC 20240,
telephone: 202-208-4416; or James H. Lecky, Director, Office of
Protected Resources, National Marine Fisheries Service, 1315 East-West
Highway, Silver Spring, MD 20910; telephone: 301-713-2332.
SUPPLEMENTARY INFORMATION: The Endangered Species Act of 1973, as
amended (``Act''; 16 U.S.C. 1531 et seq.) provides that the Secretaries
of the Interior and Commerce (the ``Secretaries'') share
responsibilities for implementing most of the provisions of the Act.
Generally, marine species are under the jurisdiction of the Secretary
of Commerce and all other species are under the jurisdiction of the
Secretary of the Interior. With respect to agency consultation pursuant
to Section 7 of the Act, authority to administer the Act has been
delegated by the Secretary of the Interior to the Director of the FWS
and by the Secretary of Commerce through the Administrator of the
National Oceanic and Atmospheric Administration to the Assistant
Administrator for NMFS.
On May 15, 2008, Secretary Kempthorne announced that he would
propose common sense modifications to the existing regulations that
implement this section of the ESA in order to provide greater clarity
and certainty to the inter-agency consultation process. In the Federal
Register notice proposing the regulatory modifications analyzed in this
EA, the Services noted the importance of refining the ESA section
7(a)(2) consultation process to better set forth certain regulatory
definitions and the applicability of this important interagency
process.
While neither NEPA nor its implementing regulations require that
EAs be made available for public comment, the Services' have concluded
that it is appropriate in this instance to provide an opportunity for
public review and comment on the draft EA, as set forth above.
Dated: October 23, 2008.
David M. Verhey,
Acting Assistant Secretary, Fish and Wildlife and Parks, Department of
the Interior.
Samuel D. Rauch,
Deputy Assistant Administrator for Regulatory Programs, National Marine
Fisheries Service, National Oceanic and Atmospheric Administration.
[FR Doc. E8-25678 Filed 10-23-08; 4:15 pm]
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