SOURCES SOUGHT
A -- SERVICES FOR PHARMACOKINETIC STUDY
- Notice Date
- 6/16/2017
- Notice Type
- Sources Sought
- 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
- W81XWH17T0282
- Archive Date
- 7/13/2017
- Point of Contact
- Sharon R. Smith, Phone: 3016191352
- E-Mail Address
-
sharon.r.smith.civ@mail.mil
(sharon.r.smith.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- TITLE: PHARMACOKINETIC STUDY SUBJECT: NON-PERSONAL SCIENTIFIC SUPPORT SERVICES FOR STATISTICAL ANALYSIS OF NON-HUMAN PRIMATE DATA FOR PHARMACOKINETIC/ PHARMACODYNAMICS STUDIES. DESCRIPTION: THIS IS A REQUEST FOR INFORMATION (RFI) TO DETERMINE IF THERE ARE SMALL BUSINESSES AVAILABLE AND CAPABLE OF PROVIDING NON-PERSONAL SCIENTIFIC SUPPORT SERVICES FOR STATISTICAL ANALYSIS OF NON-HUMAN PRIMATE DATA FOR PHARMACOKINETIC/ PHARMACODYNAMICS STUDIES. THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY AN RFI FOR THE PURPOSES OF MARKET RESEARCH. NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS SOURCE SOUGHT. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. The United States Army Medical Research Acquisition Activity (USAMRAA) is conducting market research on behalf of the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), located at Fort Detrick, Maryland. The research is to determine the availability of small business sources capable of providing non-personal scientific support services for statistical Analysis of nonhuman primate data for pharmacokinetic/pharmacodynamic studies. Information gathered from this notice will assist with determining the procurement strategy prior to issuance of a solicitation. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Information and representative samples as responses to the RFI will not be returned. At this time, USAMRIID will not entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future RFP. BACKGROUND: USAMRIID's mission is to protect the war-fighter from biological threats and to be prepared to investigate disease outbreaks or threats to public health. The Institute's core competencies are enhanced by the Bacteriology Division's immunological and therapeutic countermeasure development and its expert capabilities in the characterization of bacterial pathogenesis. Division members are active in training efforts within the DoD and overseas. The Bacteriology Division strives to be a team-oriented and dynamic scientific body that accomplishes mission-related milestones within the Nation's preeminent research laboratory and in collaboration with external agencies. The division is the DoD resource for subject matter expertise in bacterial pathogens and the countermeasures to those threats. The division has several mission areas: bacterial pathogenesis, immunology, vaccines, and therapeutics. This requirement is a follow on requirement and familiarity with the study will reduce the amount of time required to inform the vendor of study and USAMRIID parameters that might influence the data. Since the data provided to the FDA would potentially include the original pharmaceutical pharmacokinetic data, consistency would assure that there are no irregularities between methods that could compromise the data and by default, the study. 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. Respondents shall provide their capabilities for statistical analysis of nonhuman primate data from pharmacokinetic/pharmacodynamic studies. The services provided will allow for statistical analysis of data acquired during nonhuman primate studies involving antibiotic effectiveness against select agents. The results of the statistical analysis will be included in the final package provided to the FDA for indication that various antibiotics can be used as an antibiotic against select agents. The Government anticipates release of a solicitation to industry for a single Firm Fixed Priced Purchase Order with a Period of Performance consisting of one (1) twelve-month base period plus four (4) optional periods that total forty eight (48) months. Upon review of industry response to this RFI, the Government will determine whether the requirement will be solicited on a small business set aside or sole source basis. It is requested that all interested parties submit to the contracting office a brief capabilities statement package (no more than 10 pages in length) demonstrating its ability to perform the requested services. RESPONSE SUBMISSION: Responses are due on Friday, 28 June 2017 by 3:00 p.m. Eastern Time to the attention of Ms. Sharon Smith, email: sharon.r.smith.civ@mail.mil. Responses in reference to this RFI shall be submitted via e-mail. Please include point of contact, phone number, email address, and web site information. Respondents shall certify whether the company they represent is a U.S. business. The response should describe the company's capability to offer, field, and sustain a solution as characterized by the requirements addressed in this RFI. If unable to provide a solution capable of meeting all requirements, the respondent should offer tradeoff considerations for unmet requirements. Respondents should mark all proprietary data as appropriate. USAMRAA and USAMRIID will protect proprietary information from unauthorized use and disclosure. Unless clearly marked otherwise, submission of a response to this RFI signifies agreement to allow USAMRIID personnel to use the information to aid in developing an acquisition approach. OWNERSHIP OF RESPONSE TO RFI: All material submitted in response to this RFI shall become the property of Government. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall the Government be responsible for any contractor expenses in preparation of this RFI, such as: submission costs, any other expenses, costs, damages, or whatever nature incurred. Respondent understands and agrees that respond submission is at their own risk and expense, and the Government is released from any claim for damages or other liability arising out of the RFI process. The Government is not obligated to and will not pay for any information received from potential sources as a result of this notice.
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