SOURCES SOUGHT
R -- This Request for Information (RFI) is seeking entities interested in providing support and services assisting in the development of the malaria drug, Tafenoquine (TQ).
- Notice Date
- 6/23/2014
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-14-RFI-00TQ
- Response Due
- 7/8/2014
- Archive Date
- 8/22/2014
- Point of Contact
- Shannyn Scassero, 301-619-2640
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shannyn.scassero.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- 1.0 SUBJECT: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission is the development and management of medical materiel to protect and sustain the Warfighter. This Request for Information (RFI) is seeking entities interested in providing support and services assisting in the development of the malaria drug, Tafenoquine (TQ). TQ is a product seeking approval for use as a prophylactic drug in the prevention of malaria, first in Australia and then in the U.S. 2.0 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 RFI 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 RFI. All information received in response to this RFI that is marked quote mark Proprietary quote mark will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for future Request for Proposals (RFPs) will not be entertained. 3.0 DESCRIPTION: This RFI is seeking entities interested in providing support and services assisting in the development of Tafenoquine (TQ) as a malaria prophylactic drug for FDA-TGA (Food and Drug Administration-Therapeutic Goods Administration)approval in Australia. Specifically, the Government is seeking a company interested in collaborating with international partners from industry, non-profit organizations, and academia. Such collaboration will require substantial coordination and support in a variety of administrative and technical disciplines and the provisions of various services by direct contract or via subcontracts, as appropriate. Subsequent to a regulatory approval there may also be the need to plan for 'Phase IV' studies if requested by regulatory authority. Specific support and services may include organization of meetings and provision of Regulatory support and strategy, development of clinical protocols, statistical or data management services, medical writing and electronic publishing, program management, provision of tropical medicine and clinical pharmacology expertise to an Integrated Product Team (IPT), and the preparation of required Regulatory documents to support the filing application. 4.0 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 assist in the licensure of a TQ product. Companies responding to this RFI 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 and favorable experience working with the FDA. 5.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Ms. Shannyn Scassero at shannyn.scassero.civ@mail.mil no later than the close of business 8 JUL 14. 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-14-RFI-00TQ/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03403295-W 20140625/140623234843-eb21175bb75e1764dc76d01892ceac0c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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