[Code of Federal Regulations]

[Title 48, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 48CFR370.303]



[Page 89]

 

            TITLE 48--FEDERAL ACQUISITION REGULATIONS SYSTEM

 

                  CHAPTER 3--HEALTH AND HUMAN SERVICES

 

PART 370_SPECIAL PROGRAMS AFFECTING ACQUISITION--Table of Contents

 

           Subpart 370.3_Acquisitions Involving Human Subjects

 

Sec. 370.303  Notice to offerors.



    (a) Solicitations shall contain the notice to offerors in 352.270-

8(a) whenever contract performance is expected to involve human 

subjects.

    (b) IRB approval of proposals submitted by institutions having an 

OPRR-approved MPA should be certified in the manner required by 

instructions for completion of the contract proposal; or by completion 

of a DHHS Form 310, Protection of Human Subjects Assurance 

Identification/Certification/Declaration; or by letter indicating the 

institution's OPRR-assigned MPA number, the date of IRB review and 

approval, and the type of review (convened or expedited). The date of 

IRB approval must not be more than 12 months prior to the deadline for 

proposal submission.

    (c) SPAs for contractors, subcontractors, or cooperating 

institutions generally will not be requested prior to determination that 

a contract proposal has been selected for negotiation. When an SPA is 

submitted, it provides certification for the initial contract period. No 

additional documentation is required. If the contract provides for 

additional years to complete the project, the noncompetitive renewal 

proposal shall be certified in the manner described in the preceding 

paragraph.