SOLICITATION NOTICE
A -- Statistical analysis of pharmacokinetic nonhuman primate study data involving antibiotic effectiveness against various select agents
- Notice Date
- 8/27/2016
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- 0010861555
- Archive Date
- 9/26/2016
- Point of Contact
- Samantha L. Connors,
- E-Mail Address
-
samantha.l.connors.civ@mail.mil
(samantha.l.connors.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Army Medical Research Acquisition Activity, 820 Chandler St., Fort Detrick, Maryland, 21702, intends to award a sole source contract to the University of Florida for statistical analysis of pharmacokinetic nonhuman primate study data involving antibiotic effectiveness against various select agents for the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID). The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority at FAR 13.106-1(b)(1)(i). USAMRIID has a requirement for statistical analysis of pharmacokinetic nonhuman primate study data involving antibiotic effectiveness against various select agents. The anticipated period of performance is one 12-month base period and one 12-month option period. The University of Florida is uniquely qualified to provide the required services. Because of its previous involvement with similar work undertaken by USAMRIID, the University of Florida has a familiarity with pertinent USAMRIID processes and procedures not possessed by any other source. This familiarity will reduce the risk of unacceptable delays caused by a need to inform another source of study and USAMRIID parameters that might influence the data. Furthermore, the University of Florida has previously worked with the pharmaceutical companies that develop the drugs being tested and are approved by these companies to be used for future pharmacokinetic study sample analysis. Using the same source for analysis that these companies are using will ensure consistency in reporting of information from benchtop to animal rule study data submitted to the FDA as use against select agents in humans. Since the data provided to the FDA would potentially include the original pharmaceutical pharmacokinetic data, consistency would ensure that there are no irregularities between methods that could compromise the data and by default, the study. If a source other than the University of Florida were to provide these services, USAMRIID would risk mission failure. If a contractor without the qualifications possessed by the University of Florida performed these complex simulations already used by pharmaceutical companies, the results could be proved incorrect. This would lead to repeating costly nonhuman primate studies and the possibility of USAMRIID losing its ability to perform animal rule studies. No other contractor has the combination of experience and defined processes that are required to perform the statistical analysis of the nonhuman primate pharmacokinetic study sample data to indicate human equivalent dosing for potential submission to the FDA for human use against select agents. An RFQ will be issued to the University of Florida on a sole source basis. The North American Industry Classification System (NAICS) code for this requirement is 541712 and the small business size standard is 1,000 employees. Any sources that believe they are eligible to provide these services must respond to this notice in writing. Responses must be supported with clear and convincing evidence which articulates the ability to perform the services outlined above. A request for documentation will not be considered an affirmative response. Information received will be considered solely for the purposes of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects fifteen (15) days after the publication of this notice, the contract will be awarded without further remark. All questions and responses concerning this notice shall be emailed to Ms. Samantha L. Connors at samantha.l.connors.civ@mail.mil. Interested concerns must identify their capability to the above email address no later than 11:59 PM Eastern Time, 11 September 2016.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/0010861555/listing.html)
- Record
- SN04244419-W 20160829/160827233148-1d76a10dc3d8ba64b7449ca4c5d8ed76 (fbodaily.com)
- Source
-
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