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’’. 

[FR Doc. E9–17954 Filed 7–28–09; 8:45 am] 

BILLING CODE 5001–08–P 

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. 

■ Therefore, 48 CFR parts 207, 235, and 

252 are amended as follows: 

■ 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: 

252.235–7004 Protection of Human 

Subjects. 

As prescribed in 235.072(e), use the 

following clause: 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 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 

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. 


sroberts on DSKD5P82C1PROD with RULES