SPECIAL NOTICE
A -- Dengue Clinical Study Support - Philippines
- Notice Date
- 6/30/2016
- Notice Type
- Special Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- W81XWH-16-JD0001
- Archive Date
- 7/30/2016
- Point of Contact
- Jamie Diggs, Phone: 3016192663
- E-Mail Address
-
jamie.l.diggs.civ@mail.mil
(jamie.l.diggs.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought/ Intent to Award Sole Source Dengue Clinical Study Support - Philippines The United States Army Medical Research Acquisitions Activity (USAMRAA), on behalf of the U.S. Army Medical Material Development Activity (USAMMDA), is issuing a Notice of Intent to Award a Sole Source contract. This is not a request for proposals. This notice does not represent a commitment by the government to pay for cost incurred in preparation and submission of data in response to this announcement. This is a Sources Sought Notice with the intent to award a sole source contract to BioPath Clinical Diagnostics, Inc. Jones Avenue, Cebu City, Debu Phillipines, 60000 (DUNS 722926912), in accordance with FAR 6.302-1(a)(2), only one responsible source and no other supplies or services will satisfy agency requirements. This requirement is for the Dengue Clinical Study Support. This notice is provided as information to the marketplace, market research and is an invitation for any other qualified companies to express their interest in and demonstrate their capabilities to provide the required work. 1.0 SUBJECT: The US Army Medical Research and Materiel Command (USAMRMC) is poised to assist our co-development partner; Takeda Vaccines Limited, in the development of their tetravalent dengue vaccine (TDV). Specifically, the USAMRMC's Armed Forces Research Institute of Medical Science (AFRIMS) will utilize its infrastructure at the Philippines AFRIMS Virology Research Unit (PAVRU) to conduct a phase 3 dengue vaccine study (hereafter referred to as DEN 301). Throughout this effort, Takeda will serve as the regulatory sponsor of DEN 301m which is being conducted under US Investigational New Drug Application (IND). 1.1 DISCLAIMER: This sought synopsis/ notice to award sole source is issued solely for information and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this notice. All information received in response to this notice shall be marked Proprietary will be handled accordingly. Responses to the notice will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 2.0 DESCRIPTION: 2.1 The work items are associated with the technical and administrative support necessary for the maintenance of established clinical study site(s) and execution of clinical study-related activities for the conduct of DEN 301, and related sub-studies, to take place within (or near) Cebu, Philippines. The contractor shall complete work items including (but not limited to): hiring, maintaining, and managing a qualified and experienced study Principal Investigator(s) (PI) and study support personnel, at adequate levels, for execution of DEN 301(and related sub studies), procurement of clinical research support services, supplies and equipment, laboratory testing, transportation and communications services, and quality control for activities related to the preparation and execution of DEN 301. The contractor shall provide monthly technical reports to the Contracting Officer's representative (COR), work/coordinate with designated quality control and quality assurance personnel from Takeda, AFRIMS, USAMMDA, and the USAMRMC (in general). 3.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to provide the described product, including any necessary lead time. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts. 4.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Mrs. Jamie Diggs at jamie.l.diggs.civ@mail.mil no later than the close of business 15 July 2016. Telephonic communication will not be considered as submission or receive response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-16-JD0001/listing.html)
- Place of Performance
- Address: Phillipines, Philippines
- Record
- SN04169361-W 20160702/160701000914-36b5cc301f4d5b1766b27ee4120e6e61 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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