DOCUMENT
B -- IRB4 Services - Justification and Approval (J&A)
- Notice Date
- 7/23/2010
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- Contracting Office
- Department of Veterans Affairs;GLAC (69D);5000 W. National Ave;Milwaukee WI 53295-0005
- ZIP Code
- 53295-0005
- Solicitation Number
- VA69D09RP0094
- Archive Date
- 7/11/2010
- Point of Contact
- Patrice R Bond
- E-Mail Address
-
ct
- Small Business Set-Aside
- N/A
- Award Number
- VA69D-P-1487
- Award Date
- 7/1/2010
- Description
- JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION 1.Identification of the Agency and the Contracting Activity: Department of Veterans Affairs, Great Lakes Acquisition Center, 5000 W National Avenue, Bldg 5, Milwaukee WI 53295 2.Nature and/or description of the action being approved: Justification and approval for other than full and open competition of research expertise and services for University Institutional Review Board (IRB) No. 4 registered with the Office for Human Research Protection (OHRP) as IRB# 00006412(IRB4) whereby Jesse Brown VA Medical Center ™s Research & Development Service will utilize its Affiliate, University of Illinois at Chicago, IRB Services. 3.A description of supplies/services required: UIC ™s IRBs shall perform all of the functions required under 38 CFR 16 (Common Rule) for reviewing and approving human subject research conducted under the auspices of Jesse Brown VA Medical Center Federalwide Assurance (FWA00000290). This includes, but is not limited to, research supported by the VA or conducted at a VA facility, and research involving VA patients as research subjects (hereafter œVA research ). IRB review and approval of VA research shall be conducted in accordance with 38 CFR 16 and 17, 45 CFR 46 subparts A through D, 45 CFR 160, 164, 21 CFR 50 and 56, 312, 600 and 812 (where applicable), and other pertinent federal regulations and guidance; and VA rules and policies as set forth in writing in VA policy Manual 3 and Handbooks. 4.Statutory authority permitting other than full and open competition: FAR 6.302-1. Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements. The VA ™s minimum needs need not be provided through full and open competition when a statute expressly authorizes or requires that the acquisition be made from a specific source. (41 U.S.C. 253 (c)(1)). 5.Facilities Unique Qualifications: This contract is necessary for the continuation of the Research program at Jesse Brown VAMC, as federal regulations prohibit conducting human subject research without IRB approval. It is unlawful to conduct human subjects ™ research without the services of an IRB. VA policy states that if a VAMC does not convene its own IRB, it must contract with the academic affiliate. Use of commercial IRBs is prohibited. 6.Efforts made to ensure that offers are solicited from as many potential sources as is practicable: Services can only be obtained from Jesse Brown VA Medical Center ™s Academic Affiliate. 7.Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable: The Affiliate will provide a price breakdown and this data will be shared with VA ™s Research & Development Service. As experts in the field, they will assist the Contracting Officer in determining price reasonableness. Based upon prior year costs, the Contracting Officer anticipates awarding a Base plus two-year contract for $258,450. Therefore, the Contracting Officer anticipates the cost to the Government will be fair and reasonable. 8.Market survey conducted: None 9.Other facts: None 10.Other sources expressing an interest: None 11.Actions to remove or overcome any barriers to competition: None 12.Certification: I certify that this justification is accurate and complete to the best of my knowledge. PATRICE R. BOND Contracting Officer
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAGLHS/VAGLHCS/VA69D09RP0094/listing.html)
- Document(s)
- Justification and Approval (J&A)
- File Name: VA69D-P-1487 VA69D-P-1487 J A.doc (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=138627&FileName=VA69D-P-1487-000.doc)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=138627&FileName=VA69D-P-1487-000.doc
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA69D-P-1487 VA69D-P-1487 J A.doc (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=138627&FileName=VA69D-P-1487-000.doc)
- Record
- SN02216242-W 20100725/100723235426-e2a5b115fe4531946df9ea70b79e66aa (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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