SPECIAL NOTICE
A -- REQUEST FOR INFORMATION (RFI) ONLY to identify an effective pharmacotherapeutic agent(s) as a viable treatment option for service members with Combat Related PTSD
- Notice Date
- 10/6/2016
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- RFI-HK-DTPTSD-FY17
- Archive Date
- 12/21/2016
- Point of Contact
- Herbert Caj Keen, Phone: 3016191011
- E-Mail Address
-
herbert.e.keen.civ@mail.mil
(herbert.e.keen.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes. This RFI does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This RFI does not commit the Government to contract for any supply or service. The Government will not accept unsolicited proposals. Federal Acquisition Regulations (FAR) clause 52.215-3, Request for Information or Solicitation for Planning Purposes (Oct 1997), is included by reference. Not responding to this RFI does not preclude participation in any future RFP. If a RFP is issued, it will be publicized on the Federal Business Opportunities (FedBizOpps) website, https://www.fbo.gov. It is the responsibility of the interested party to monitor this site for additional information pertaining to this requirement. US Army Medical Research and Materiel Command The US Army Medical Materiel Development Activity Neurotrauma and Psychological Health Project Management Office Request for Information Regarding Pharmacotherapeutics for the Treatment of Post Traumatic Stress Disorder 1.0 Description The US Army Medical Research and Materiel Command (USAMRMC), the Neurotrauma and Psychological Health Program Management Office (NPH PMO) of the US Army Medical Materiel Development Activity (USAMMDA), in collaboration with the Military Operational Medicine Research Program (MOMRP), is seeking information on pharmacotherapeutic(s) that will subsequently lead to the U.S. Food and Drug Administration (FDA) approval for the treatment of Post Traumatic Stress Disorder (PTSD). Due to the urgent need in identifying an effective pharmacotherapeutic agent(s) as a viable treatment option for service members with Combat Related PTSD, responses to this RFI should focus on pharmacotherapeutic(s) that have reached, at a minimum, a Technology Readiness Level (TRL) of 6 (Phase 1 and/or Phase 2 trials) as described online in Appendix E at: www.dtic.mil/cgi-bin/GetTRDoc?AD=ADA524200&Location=U2&doc...pdf. 2.0 Background The mission of USAMMDA is to develop and deliver quality medical solutions to protect, treat, and sustain the health of Our Service Members. The NPH PMO specifically develops medical products for Service Members and Veterans suffering from psychological health illnesses, e.g. PTSD. USAMMDA works with science and technology partners, such as MOMRP, to achieve these goals. DESCRIPTION: USAMMDA is requesting information from companies capable of developing safe and efficacious FDA approved pharmacotherapeutic(s) to treat service members/veterans with combat related PTSD. The pharmacotherapeutic(s) should reduce/eliminate the symptoms associated with PTSD and improve global functioning. More specifically, academic investigators and companies should provide information on applicable pharmacotherapeutic(s) that result in a significant decrease in one or more of the symptoms from the following criteria as described in the DSM-5: a) Criterion B – presence of one or more intrusion symptoms associated with the traumatic event; b) Criterion C – persistent avoidance of stimuli associated with the traumatic event; c) Criterion D – negative alterations in cognition and mood associated with the traumatic event; d) Criterion E – marked alterations in arousal and reactivity associated with the traumatic event; e) Criterion F – duration of disturbance is more than 1 month; and f) Criterion G – clinically significant distress or impairment in social, occupational, or other important areas of functioning (i.e., global functioning). 2.1 Delivery Period: 60 days. Early submissions are authorized. 2.2 Limitations: 2.3 Security Requirements: Not applicable Respondents are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. 3.0 Requested Information Regarding possible pharmacotherapeutic(s) in the treatment of PTSD, USAMMDA specifically requests information answering the following questions: a. What is the mechanism of action for the pharmacotherapeutic agent? b. What is the scientific rationale behind the development of this agent for the treatment of PTSD? c. What is the intended population for this pharmacotherapeutic agent? How has the effectiveness and safety been tested in this population and with what results? d. What is the maturity of the technology (e.g. stage of development)? e. What is/are the next step(s) in the development of this agent? What is the estimated timeframe and cost to move this agent to the next phase of development and/or to FDA approval? f. Identify any risks and liabilities for the development of this agent. How will risk(s) and liability(ies) be addressed? g. What interaction, if any, has there been with the FDA concerning this pharmacotherapeutic agent? h. How can the pharmacotherapeutic agent be used in conjunction with a clinician-based Standard of Care (SOC)? i. What is the estimated cost, per pill, associated with manufacturing the phamacotherapeutic agent? What is the expected dosing schedule? 4.0 Responses 4.1 Interested parties are requested to respond to this RFI with a cover letter and white paper. 4.2 Cover letters and white papers shall be provided in a Microsoft Word for Office 2000 compatible format are due no later than 06 December 2016 by 2:00 PM Eastern Time. Responses shall be limited to three pages, answer the questions posed in Section 3 and submitted via e-mail only to Mr. Herbert Caj Keen, Contract Specialist, herbert.e.keen.civ@mail.mil. The font shall be Times New Roman, size 10, single space. Electronic files shall not exceed 3 MB. All submissions become Government property and will not be returned. 4.3 Proprietary information, if any, MUST BE CLEARLY MARKED. 4.4. The cover letter shall be on organization letterhead and is limited to no more than two pages. The cover letter shall include the organization name, and the following: 4.4.1. Mailing address, overnight delivery address (if different from mailing address), phone number, fax number, e-mail of designated point(s) of contact, DUNS number (if available) and CAGE code (if available). 4.4.2. North American Industry Classification System (NAICS) code within which the organization operates and the organization’s associated business size (e.g., large business, small business, small disadvantaged business, 8(a)-certified small disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business). Respondents should refer to Federal Acquisition Regulation FAR 19 for additional detailed information on Small Business Size Standards. The Federal Acquisition Regulation (FAR) is available at https://www.acquisition.gov/?q=browsefar. 4.5. The white paper shall answer the technical questions and issues addressed in Section 3 of this RFI. The total number of pages of the white paper shall be limited to three pages. Relevant data points should be referenced. 5.0 Summary THIS IS A REQUEST FOR INFORMATION (RFI) ONLY to identify existing or emerging pharmacotherapeutics for the treatment of combat related PTSD. The information provided in the RFI is subject to change and is not binding on the Government. The Government has not made a commitment to procure any of the items discussed, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/RFI-HK-DTPTSD-FY17/listing.html)
- Record
- SN04300167-W 20161008/161006234709-95d33f5a996766b565c48359523a4425 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |