Defense Federal Acquisition Regulation Supplement; Protection of Human Subjects in Research Projects (DFARS Case 2007-D008), 37648-37649 [E9-17949]
Download as PDF
<![CDATA[
37648
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
Subparts 245.4 and 245.5 [Removed]
8. Subparts 245.4 and 245.5 are
removed.
■
PART 252—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
252.217–7005
[Amended]
9. Section 252.217–7005 is amended
as follows:
■ a. By revising the clause date to read
‘‘(JUL 2009)’’; and
■ b. In paragraph (e)(7) by removing
‘‘(Fixed-Price Contracts)’’.
■
252.217–7010
[Amended]
10. Section 252.217–7010 is amended
as follows:
■ a. By revising the clause date to read
‘‘(JUL 2009)’’; and
■ b. In paragraph (c)(3) by removing
‘‘(Fixed Price Contracts)’’.
■
252.242–7004
[Amended]
11. Section 252.242–7004 is amended
as follows:
■ a. By revising the clause date to read
‘‘(JUL 2009)’’; and
■ b. In paragraph (e)(9) introductory
text, in the first sentence, by removing
‘‘Regardless of the provisions of FAR
45.505–3(f)(1)(ii), have’’ and adding in
its place ‘‘Have’’.
■
252.245–7000
[Amended]
12. Section 252.245–7000 is amended
in the introductory text by removing
‘‘245.310–70’’ and adding in its place
‘‘245.107–70’’.
■
clause for use in contracts that include
or may include research involving
human subjects.
DATES: Effective Date: July 29, 2009.
FOR FURTHER INFORMATION CONTACT: Mr.
Mark Gomersall, Defense Acquisition
Regulations System, OUSD (AT&L)
DPAP (DARS), IMD 3D139, 3062
Defense Pentagon, Washington, DC
20301–3062. Telephone 703–602–0302;
facsimile 703–602–7887. Please cite
DFARS Case 2007–D008.
SUPPLEMENTARY INFORMATION:
A. Background
This final rule adds DFARS policy
addressing statutory and regulatory
requirements for the ethical treatment of
human subjects involved in research
projects. The rule contains a clause for
use in contracts involving human
subjects in research, to inform
contractors of their responsibilities for
compliance with 32 CFR Part 219; DoD
Directive 3216.02; applicable DoD
component policies; 10 U.S.C. 980; and,
when applicable, Food and Drug
Administration policies and regulations.
DoD published a proposed rule at 73
FR 63666 on October 27, 2008. DoD
received no comments on the proposed
rule. Therefore, DoD has adopted the
proposed rule as a final rule without
change.
This rule was subject to Office of
Management and Budget review under
Executive Order 12866, dated
September 30, 1993.
B. Regulatory Flexibility Act
48 CFR Parts 207, 235, and 252
DoD certifies that this final rule will
not have a significant economic impact
on a substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.,
because the rule is a reinforcement of
existing requirements and obligations
that apply with regard to the protection
of human subjects involved in research
projects.
RIN 0750–AF96
C. Paperwork Reduction Act
Defense Federal Acquisition
Regulation Supplement; Protection of
Human Subjects in Research Projects
(DFARS Case 2007–D008)
The Paperwork Reduction Act does
not apply, because the rule does not
contain any new information collection
requirements that require the approval
of the Office of Management and Budget
under 44 U.S.C. 3501, et seq.
[FR Doc. E9–17954 Filed 7–28–09; 8:45 am]
BILLING CODE 5001–08–P
DEPARTMENT OF DEFENSE
sroberts on DSKD5P82C1PROD with RULES
Defense Acquisition Regulations
System
AGENCY: Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
List of Subjects in 48 CFR Parts 207,
235, and 252
DoD has issued a final rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to address requirements for the
protection of human subjects involved
in research projects. The rule contains a
SUMMARY:
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
1. The authority citation for 48 CFR
parts 207, 235, and 252 continues to
read as follows:
■
Authority: 41 U.S.C. 421 and 48 CFR
Chapter 1.
PART 207—ACQUISITION PLANNING
2. Section 207.172 is added to read as
follows:
■
207.172
Human research.
Any DoD component sponsoring
research involving human subjects—
(a) Is responsible for oversight of
compliance with 32 CFR Part 219,
Protection of Human Subjects; and
(b) Must have a Human Research
Protection Official, as defined in the
clause at 252.235–7004, 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 252.235–7004 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 252.235–7004,
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 252.235–7004 is added to
read as follows:
■
Government procurement.
Michele P. Peterson,
Editor, Defense Acquisition Regulations
System.
252.235–7004
Subjects.
Therefore, 48 CFR parts 207, 235, and
252 are amended as follows:
As prescribed in 235.072(e), use the
following clause:
■
PO 00000
Frm 00154
Fmt 4700
Sfmt 4700
E:\FR\FM\29JYR1.SGM
29JYR1
Protection of Human
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations
sroberts on DSKD5P82C1PROD with RULES
PROTECTION OF HUMAN SUBJECTS
(JUL 2009)
(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.
(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
VerDate Nov<24>2008
22:13 Jul 28, 2009
Jkt 217001
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
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. E9–17949 Filed 7–28–09; 8:45 am]
BILLING CODE 5001–08–P
PO 00000
Frm 00155
Fmt 4700
Sfmt 4700
37649
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Parts 217 and 252
RIN 0750–AG29
Defense Federal Acquisition
Regulation Supplement; Requirements
Applicable to Undefinitized Contract
Actions (DFARS Case 2008–D029)
AGENCY: Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
SUMMARY: DoD has issued a final rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to address requirements for
DoD management and oversight of
undefinitized contract actions,
consistent with the provisions of
Section 809 of the National Defense
Authorization Act for Fiscal Year 2008.
DATES: Effective Date: July 29, 2009.
FOR FURTHER INFORMATION CONTACT: Ms.
Cassandra Freeman, Defense
Acquisition Regulations System, OUSD
(AT&L) DPAP (DARS), IMD 3D139, 3062
Defense Pentagon, Washington, DC
20301–3062. Telephone 703–602–8383;
facsimile 703–602–7887. Please cite
DFARS Case 2008–D029.
SUPPLEMENTARY INFORMATION:
A. Background
Section 809 of the National Defense
Authorization Act for Fiscal Year 2008
(Pub. L. 110–181) required DoD to issue
guidance to ensure the implementation
and enforcement of requirements
applicable to undefinitized contract
actions. On August 29, 2008, the
Director, Defense Procurement and
Acquisition Policy, issued a
memorandum to DoD departments and
agencies as required by Section 809 of
Public Law 110–181. This final rule
amends the DFARS to address the
requirements of the August 29, 2008
memorandum, specifically,
requirements for DoD departments and
agencies to submit semi-annual reports
regarding undefinitized contract actions
exceeding $5 million; for obligation of
funds for the undefinitized period
consistent with the contractor’s
proposal for that period; and for
compliance with existing DFARS policy
relating to profit computation for
undefinitized contract actions.
This rule was not subject to Office of
Management and Budget review under
Executive Order 12866, dated
September 30, 1993.
E:\FR\FM\29JYR1.SGM
29JYR1
]]>Agencies
[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37648-37649]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17949]
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations System
48 CFR Parts 207, 235, and 252
RIN 0750-AF96
Defense Federal Acquisition Regulation Supplement; Protection of
Human Subjects in Research Projects (DFARS Case 2007-D008)
AGENCY: Defense Acquisition Regulations System, Department of Defense
(DoD).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: DoD has issued a final rule amending the Defense Federal
Acquisition Regulation Supplement (DFARS) to address requirements for
the protection of human subjects involved in research projects. The
rule contains a clause for use in contracts that include or may include
research involving human subjects.
DATES: Effective Date: July 29, 2009.
FOR FURTHER INFORMATION CONTACT: Mr. Mark Gomersall, Defense
Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), IMD 3D139,
3062 Defense Pentagon, Washington, DC 20301-3062. Telephone 703-602-
0302; facsimile 703-602-7887. Please cite DFARS Case 2007-D008.
SUPPLEMENTARY INFORMATION:
A. Background
This final rule adds DFARS policy addressing statutory and
regulatory requirements for the ethical treatment of human subjects
involved in research projects. The rule contains a clause for use in
contracts involving human subjects in research, to inform contractors
of their responsibilities for compliance with 32 CFR Part 219; DoD
Directive 3216.02; applicable DoD component policies; 10 U.S.C. 980;
and, when applicable, Food and Drug Administration policies and
regulations.
DoD published a proposed rule at 73 FR 63666 on October 27, 2008.
DoD received no comments on the proposed rule. Therefore, DoD has
adopted the proposed rule as a final rule without change.
This rule was subject to Office of Management and Budget review
under Executive Order 12866, dated September 30, 1993.
B. Regulatory Flexibility Act
DoD certifies that this final rule will not have a significant
economic impact on a substantial number of small entities within the
meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq.,
because the rule is a reinforcement of existing requirements and
obligations that apply with regard to the protection of human subjects
involved in research projects.
C. Paperwork Reduction Act
The Paperwork Reduction Act does not apply, because the rule does
not contain any new information collection requirements that require
the approval of the Office of Management and Budget under 44 U.S.C.
3501, et seq.
List of Subjects in 48 CFR Parts 207, 235, and 252
Government procurement.
Michele P. Peterson,
Editor, Defense Acquisition Regulations System.
0
Therefore, 48 CFR parts 207, 235, and 252 are amended as follows:
0
1. The authority citation for 48 CFR parts 207, 235, and 252 continues
to read as follows:
Authority: 41 U.S.C. 421 and 48 CFR Chapter 1.
PART 207--ACQUISITION PLANNING
0
2. Section 207.172 is added to read as follows:
207.172 Human research.
Any DoD component sponsoring research involving human subjects--
(a) Is responsible for oversight of compliance with 32 CFR Part
219, Protection of Human Subjects; and
(b) Must have a Human Research Protection Official, as defined in
the clause at 252.235-7004, 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 252.235-7004 and shall be identified
in acquisition planning.
PART 235--RESEARCH AND DEVELOPMENT CONTRACTING
0
3. Section 235.072 is amended by adding paragraph (e) to read as
follows:
235.072 Additional contract clauses.
* * * * *
(e) Use the clause at 252.235-7004, 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
0
4. Section 252.235-7004 is added to read as follows:
252.235-7004 Protection of Human Subjects.
As prescribed in 235.072(e), use the following clause:
[[Page 37649]]
PROTECTION OF HUMAN SUBJECTS (JUL 2009)
(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.
(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 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. E9-17949 Filed 7-28-09; 8:45 am]
BILLING CODE 5001-08-P
