SOURCES SOUGHT
A -- CONDUCT OF NON-CLINICAL STUDIES IN SUPPORT OF MEDICAL COUNTERMEASURE DEVELOPMENT
- Notice Date
- 1/30/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-15-S-NON-CLINICAL
- Response Due
- 3/5/2015
- Archive Date
- 4/4/2015
- Point of Contact
- Jessica Ely, 301-619-8457
- E-Mail Address
-
ACC-APG - Natick (SPS)
(jessica.l.ely.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. BACKGROUND: Medical Countermeasures Systems (MCS) is the DoD organization responsible for developing, producing and stockpiling medical solutions to counter Chemical, Biological, Radiological and Nuclear threats. The current MCS portfolio includes products in support of the following mission areas: -Develop, produce and stockpile Food and Drug Administration (FDA) licensed biological defense vaccines -Develop and field FDA-cleared diagnostic medical devices -Develop and produce FDA-approved therapeutic & prophylactic solutions to counter chemical, radiological, and nuclear threats -Develop and produce FDA-approved therapeutic solutions to counter biological threats -Provide DoD focused manufacturing facility -Serve as the principal resource of high quality, validated, and standardized biological detection assays and reagents Many of the target threat agents for the MCS mission require development under the FDA's Animal Rule as human efficacy testing is not possible, either due to low incidence of occurrence and/or efficacy could never be verified using clinical studies. REQUIREMENT: MCS has a requirement for non-clinical safety and efficacy studies to support product development through FDA approval (licensure) as well as the development, qualification, validation of supporting assays to characterize MCM responses and support animal model efforts. The MCS mission also includes comprehensive assessment and developmental testing of detection and diagnostic systems. PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to gather information that will assist in determining a suitable contract solution that efficiently, effectively, and economically provides and maintains a high standard for CBRN medical countermeasure advanced development, manufacture, and production to meet DoD's objectives. MCS is seeking companies with capability to conduct Non-clinical studies in support of medical countermeasure development (drugs and biologics), diagnostic medical devices and biological detection assays and reagents. Specifically, please describe your company's current in-house capabilities/facilities and experience in the areas listed below. If the current capability does not exist for one or more of the areas, please note if and when it will be available. Using the attached tables, indicate the types of studies performed and, whether it was GLP compliant and facility capacity. Include information concerning experience on both small and large animals. A.Describe the animal species and capacity that your facility can support B.Describe your experience in animal model development, specifically highlighting studies conducted under Good Laboratory Practice (GLP) compliance, challenge route of agent exposure, and animal species. C.Describe experience in assay development, qualification, and validation of both safety and efficacy endpoint assays in support of nonclinical and clinical studies. Provide specific examples of such assays. D.Describe experience conducting assessments of in vitro diagnostic assays with human clinical samples E.Describe experience decontaminating devices without harm to the technology F.Indicate if the facility has a Chemical Personnel Reliability Program (CPRP) in compliance with AR50-6 and/or Biological Personnel Reliability Program in compliance with AR50-1. G.Describe your experience interacting with the FDA, ie preparing regulatory submissions and/or FDA inspections. H.Address ability to test using chemical, biological, radiological and nuclear agents/exposures. Provide information concerning ability to meet Biological and Chemical Safety Level compliance. Radiation testing sources and radiation safety program. I.Provide an overview of quality systems, technical expertise, large and small scale molecule therapy/diagnostics experience and statistical capability. J.Indicate company business size (based on the NAICS size standard), business status (i.e., large business, small business, disadvantaged, service-disabled veteran-owned small business, etc.), and date of incorporation. Respondents should indicate if their level of interest is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the e-mail address listed below within 5 days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received within thirty (30) days of issuance of this RFI. Submissions should: (1) Include the completed mandatory form (2) use Microsoft Word or Adobe Portable Document Format (PDF); (3) be sent to Jessica Ely via email; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone number, and e-mail address(es); and (6) not exceed 10 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to US the Contracting Office Address and Point of Contact identified below. Material that is advertisement only in nature is not desired. Contracting Office Address: US Army Contracting Command, Aberdeen Proving Grounds Natick Division ATTN: Jessica Ely, 110 Thomas Johnson Drive, Ste 210 Frederick, MD 21702 Point of Contact(s): jessica.l.ely.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/05042ae4dd77658cb4438f2dd4d68605)
- Place of Performance
- Address: ACC-APG - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Record
- SN03629443-W 20150201/150130234757-05042ae4dd77658cb4438f2dd4d68605 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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