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
37650 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

B. Regulatory Flexibility Act 

This rule will not have a significant 

cost or administrative impact on 

contractors or offerors, or a significant 

effect beyond the internal operating 

procedures of DoD. Therefore, 

publication for public comment under 

41 U.S.C. 418b is not required. 

However, DoD will consider comments 

from small entities concerning the 

affected DFARS subparts in accordance 

with 5 U.S.C. 610. Such comments 

should cite DFARS Case 2008–D029. 

C. Paperwork Reduction Act 

The Paperwork Reduction Act does 

not apply, because the rule does not 

impose any 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 217 and 

252 

Government procurement. 

Michele P. Peterson, 

Editor, Defense Acquisition Regulations 

System. 

■ Therefore, 48 CFR parts 217 and 252 

are amended as follows: 

■ 1. The authority citation for 48 CFR 

Parts 217 and 252 continues to read as 

follows: 

Authority: 41 U.S.C. 421 and 48 CFR 

Chapter 1. 

PART 217—SPECIAL CONTRACTING 

METHODS 

■ 2. Section 217.7404–4 is amended by 

designating the existing text as 

paragraph (a) and adding paragraph (b) 

to read as follows: 

217.7404–4 Limitations on obligations. 

* * * * * 

(b) In determining the appropriate 

amount to obligate, the contracting 

officer shall assess the contractor’s 

proposal for the undefinitized period 

and shall obligate funds only in an 

amount consistent with the contractor’s 

requirements for the undefinitized 

period. 

■ 3. Section 217.7404–6 is revised to 

read as follows: 

217.7404–6 Allowable profit. 

When the final price of a UCA is 

negotiated after a substantial portion of 

the required performance has been 

completed, the head of the contracting 

activity shall ensure the profit allowed 

reflects— 

(a) Any reduced cost risk to the 

contractor for costs incurred during 

contract performance before negotiation 

of the final price; 

(b) The contractor’s reduced cost risk 

for costs incurred during performance of 

the remainder of the contract; and 

(c) The requirements at 215.404–71– 

3(d)(2). The risk assessment shall be 

documented in the contract file. 

217.7405 [Redesignated as 217.7406] 

■ 4. Section 217.7405 is redesignated as 

section 217.7406. 

■ 5. A new section 217.7405 is added to 

read as follows: 

217.7405 Plans and reports. 

(a) To provide for enhanced 

management and oversight of UCAs, 

departments and agencies shall— 

(1) Prepare and maintain a 

Consolidated UCA Management Plan; 

and 

(2) Prepare semi-annual Consolidated 

UCA Management Reports addressing 

each UCA with an estimated value 

exceeding $5 million. 

(b) Consolidated UCA Management 

Reports and Consolidated UCA 

Management Plan updates shall be 

submitted to the Office of the Director, 

Defense Procurement and Acquisition 

Policy, by October 31 and April 30 of 

each year in accordance with the 

procedures at PGI 217.7405. 

PART 252—SOLICITATION 

PROVISIONS AND CONTRACT 

CLAUSES 

252.217–7027 [Amended] 

■ 6. Section 252.217–7027 is amended 

in the introductory text by removing 

‘‘217.7405’’ and adding in its place 

‘‘217.7406’’. 

[FR Doc. E9–17947 Filed 7–28–09; 8:45 am] 

BILLING CODE 5001–08–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Parts 225 and 252 

RIN 0750–AG31 

Defense Federal Acquisition 

Regulation Supplement; Trade 

Agreements—Costa Rica and Peru 

(DFARS Case 2008–D046) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Interim rule with request for 

comments. 

SUMMARY: DoD has issued an interim 

rule amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement the Dominican 

Republic-Central America-United States 

Free Trade Agreement with respect to 

Costa Rica, and the United States-Peru 

Trade Promotion Agreement. The trade 

agreements waive the applicability of 

the Buy American Act for some foreign 

supplies and construction materials and 

specify procurement procedures 

designed to ensure fairness. 

DATES: Effective date: July 29, 2009. 

Comment date: Comments on the 

interim rule should be submitted in 

writing to the address shown below on 

or before September 28, 2009, to be 

considered in the formation of the final 

rule. 

ADDRESSES: You may submit comments, 

identified by DFARS Case 2008–D046, 

using any of the following methods: 

Æ Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

Æ E-mail: dfars@osd.mil. Include 

DFARS Case 2008–D046 in the subject 

line of the message. 

Æ Fax: 703–602–7887. 

Æ Mail: Defense Acquisition 

Regulations System, Attn: Ms. Amy 

Williams, OUSD (AT&L) DPAP (DARS), 

IMD 3C132, 3062 Defense Pentagon, 

Washington, DC 20301–3062. 

Æ Hand Delivery/Courier: Defense 

Acquisition Regulations System, Crystal 

Square 4, Suite 200A, 241 18th Street, 

Arlington, VA 22202–3402. 

Comments received generally will be 

posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Amy Williams, 703–602–0328. 

SUPPLEMENTARY INFORMATION

A. Background 

This interim rule amends trade 

agreement provisions and clauses in 

DFARS Part 252 to implement the 

Dominican Republic-Central AmericaUnited States Free Trade Agreement 

with respect to Costa Rica, and the 

United States-Peru Trade Promotion 

Agreement. Congress approved these 

trade agreements in the Dominican 

Republic-Central America-United States 

Free Trade Agreement Implementation 

Act (Pub. L. 109–53) and the United 

States-Peru Trade Promotion Agreement 

Implementation Act (Pub. L. 110–138) 

(19 U.S.C. 3805 note). Presidential 

proclamations were published in the 

Federal Register on December 30, 2008, 

with regard to Costa Rica (73 FR 79585) 

and on January 22, 2009, with regard to 

Peru (74 FR 4105). The corresponding 

determinations by the Office of the 

United States Trade Representative were 

published in the Federal Register on 

January 6, 2009 (74 FR 472), and 


sroberts on DSKD5P82C1PROD with RULES