SOLICITATION NOTICE
65 -- JUSTIFICATION & APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION: Four (4) Brand Name only GAMBRO Trima Blood Collection System apheresis machines and seal systems including year of on-site maintenance at a total value of $314,432.00.
- Notice Date
- 5/2/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH14T0191
- Response Due
- 5/19/2014
- Archive Date
- 7/1/2014
- Point of Contact
- Hugo Robinson, 301-619-7811
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(hugo.m.robinson.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. JUSTIFICATION AND APPROVAL FOR OTHER, THAN FULL AND OPEN COMPETITION 1.Contracting Activity: The contracting activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), in support of the Pharmaceutical Systems Project Management Office (PSPMO), of the U.S. Army Medical Materiel Development Activity (USAMMDA). 2.Description of Action: Approval is being sought for a new Firm-Fixed Price contract utilizing FY 2014 US Army Research, Development, Test and Evaluation (RDT&E) funds. 3.Description of supplies/services: Four (4) Brand Name only GAMBRO Trima Blood Collection System apheresis machines and seal systems including one additional year of on-site maintenance at a total value of $314,432.00. 4.Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1). The FAR citation is 6.302-1 (FAR 6.302-1(a)(iii)(A)) and the FAR citation title is quote mark Only one responsible source and no other supplies or services will satisfy agency requirements quote mark. 5.Reason for Authority Cited: The Food and Drug Administration has approved a supplement to the Army Blood Program biologics license application for Whole Blood and blood components to include the manufacture of single Fresh Frozen Plasma collected by automated plasmapheresis using the GAMBRO Trima Automated Blood Collection System under U.S. License Number 611. The Food and Drug Administration approves not only the process for the manufacture of single Fresh Frozen Plasma but also the equipment that is used in the process. This ensures the safety and efficacy of the product when it is used. Any deviation of the biologics license could result in revocation (21 CFR 601.5) or suspension (21 CFR 601.6) of the existing license. The proposed contractor for this requirement is Terumobct and is the only known source to distribute the GAMBRO Trima Automated Blood Collection System. 6.Efforts to Obtain Competition: No efforts will be made to obtain competition for this action as competition offers no expected financial savings or other benefits to the government. Based on the Food and Drug Administration's approval of the required equipment there is only one source capable of providing the required equipment and services. 7.Actions to Increase Competition: This is a one-time requirement and no future similar acquisitions are anticipated at this time. If a similar requirement should arise in the future, every effort will be made to compete it to the maximum extent practicable. 8.Market Research: Market analysis was conducted based on the Food and Drug Administration approval and only one distributor for the requirement was located. 9.Interested Sources: To date, no other sources have written to express an interest. The notice required by FAR 5.201 shall be published. 10.Other Facts: a. Procurement History. Reasonable efforts to retrieve the following items from the computer records, contract files, competition advocate files or other sources are expected: i.Contract numbers and dates of the last several awards. Not applicable. ii.Competitive status of these actions. Not applicable. iii.Authority previously used for less than full and open competition. Not applicable. iv.If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not applicable. v.If any prior award was accomplished by full and open competition, a detailed explanation of the changed circumstance. Not applicable. vi.An explanation of any unusual patterns, which may be revealed by the history, e.g. several consecutive urgent buys. Not applicable. vii.If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes. Not applicable. b.Acquisition data availability. A statement of need and the minimum essential characteristics for the required equipment and services exists for this procurement. c.Unusual and compelling urgency. Not applicable. d.Subcontracting Competition. Not applicable. 11.Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief. 12.Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief. 13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The price established for the required services will be determined to be fair and reasonable based upon the price analysis technique of comparing the proposed prices received with previous prices paid for the same service. Certified cost or pricing data will not be required in accordance with the exception at FAR 14.403-1 (b)(3).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH14T0191/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03355590-W 20140504/140502234337-01a3626d88e17fd2d3d8865a547c6ed8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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