SPECIAL NOTICE
B -- Continuation of Mini-Pig Stent Implantation and Husbandry Services - J & A
- Notice Date
- 7/25/2013
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SS-1119730
- Point of Contact
- James Chestnut, , William T. Lee, Phone: 3014435863
- E-Mail Address
-
james.chestnut@fda.hhs.gov, william.lee@fda.hhs.gov
(james.chestnut@fda.hhs.gov, william.lee@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Justification for Other than Full and Open Competition. Notice of Intent to Sole Source - MedStar Health Research Institute The Food and Drug Administration intends to award a Sole Source contract to MedStar Health Research Institute, 6525 Belcrest Road, Suite 700, Hyattesville, MD 20782-2031. The NAICS code is 541711 Research and Development in Biotechnology. The purpose and objective of this acquisition is for continuation of existing Mini-Pig Implantation and Husbandry Services. To date, Medstar Health Research Institute (MHRI) has performed 12 minipig implantations for FDA/CDRH/OSEL/DSFM and plans to implant a total of 18 animals by the end of this FY. We recently were awarded the Critical Path Initiative grant to add another cohort (6 animals) to continue this important study on correlating in-vivo to in-vitro corrosion. During the original contract, MHRI developed extensive experience and knowledge of our custom stents, delivery systems, and experimental procedures; therefore, only MHRI has the technical expertise to properly implant custom made nitinol stents and provide on-site husbandry for 6 months. Consistency of personnel (surgeons, technicians, etc.), surgical techniques/methods, and animals are critical to preventing artifacts in scientific data which will negatively affect statistical analyses and overall conclusions of this study. For this FDA study MHRI has developed unique protocols and procedures to acquire blood, urine, and tissue samples in order to prevent contamination of metal and maintain consistency across animals. If MHRI is not selected to continue this service, substantial variability in the animals, implantations, protocols, and procedures may prevent adequate statistical comparison of results between the original 18 animal implantations and the requested 6 minipig implantations. This notice is not a request for competitive proposals. The Government intends to solicit and negotiate with only one source under the authority of 41 U.S.C. 253(c)(1), in accordance with FAR part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Part 13. All inquiries shall be submitted to William.Lee@fda.hhs.gov before 4:30 PM (1630) Eastern Time on 30 July 2013.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1119730/listing.html)
- Record
- SN03127165-W 20130727/130725235447-4b11e2f97137a4710e087d1e7e1a4d7c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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