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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 22, 2017 FBO #5598
SOURCES SOUGHT

40 -- Quality Improvement Initiative on Preventing the Diversion of Opioid Medications - Improvement Initiative on Preventing the Diversion of Opioid Medications

Notice Date
3/20/2017
 
Notice Type
Sources Sought
 
NAICS
325412 — Pharmaceutical Preparation Manufacturing
 
Contracting Office
Other Defense Agencies, Defense Health Agency, Contracting Office- Falls Church, 7700 Arlington Blvd., Suite 1M401, Falls Church, Virginia, 22042, United States
 
ZIP Code
22042
 
Solicitation Number
HT001117RFI0024
 
Point of Contact
Chrystal M Pierce, Phone: 7036815937, Jeannette Jordan, Phone: 7036817270
 
E-Mail Address
chrystal.m.pierce.ctr@mail.mil, jeannette.jordan.civ@mail.mil
(chrystal.m.pierce.ctr@mail.mil, jeannette.jordan.civ@mail.mil)
 
Small Business Set-Aside
N/A
 
Description
Department of Defense Quality Improvement Initiative on Preventing the Diversion of Opioid Medications Title: Department of Defense Quality Improvement Initiative on Preventing the Diversion of Opioid Medications RFI #: HT0011-17-RFI-0024 Introduction: 1. This announcement constitutes a Request for Information (RFI). This announcement does not constitute a commitment, implied or otherwise that a solicitation will be issued. This is not a request for proposal (RFP) or an invitation for bids (IFB). 2. Please note that the collection of this requested information does not obligate the U.S. Government to incorporate any solicited comments nor does it obligate the Government to procure the services. Proprietary information should not be included in the RFI response. Responses to this RFI will not be returned. The Government is not liable to pay any costs associated with companies responding to this RFI. 3. All information received resulting from this RFI will be used by the Defense Health Agency (DHA) for acquisition planning and market research purposes only. However, your response may be releasable to the public under the Freedom of Information Act (FOIA). If you wish the DHA to consider any portion of your response as "confidential commercial information", you should clearly mark the portion as "confidential commercial information". 4. The Defense Health Agency (DHA), at its discretion, may request respondents to this RFI to elaborate on information in their written response. Respondents to this RFI will not be notified of any results derived from a review of the information provided. 5. The DHA invites all interested parties to submit a written response to this Request for Information (RFI). This RFI is issued for the sole purpose of conducting market research in accordance with the Federal Acquisition Regulation (FAR) Part 10. Background The National Defense Authorization Act of 2017, under Section 746 directs a review to assess preventing diversion with affordable vial technologies. The review will focus on preventing diversion by using affordable vial technologies such as a vial with a locking-cap closure mechanism. Statement of Capability The Government is interested in gaining insight on vial technology products available and/or used in practice, evidence of feasibility and efficacy in preventing diversion, and methods for identification of the appropriate patient population for this type product. Interested parties are asked to submit information which includes but is not limited to the following: a. Type of product that can address dispensing opioid medications in vials using "affordable technologies" designed to prevent diversion or access to medications by anyone other than the intended patient. i. Describe the product ii. Describe how the product is used iii. Describe how the product prevents diversion iv. Include what setting(s) the product has been successfully used and/or studied in v. Provide evaluations from any third party studies or reviews from both academia and/or health systems identifying successful deployment of the product. vi. Provide any identified situations where the product has failed or has the potential to fail in preventing diversion vii. Describe the educational materials that are supplied with your product that addresses opioid diversion b. Provide evidence that supports the feasibility of using the product as part of a system wide approach to preventing diversion of opioid medications i. List and describe the types of health system(s) that the product has been deployed ii. Describe data collected on implementing the product within the pharmacy setting 1. Provide any pharmacy time studies with new process implementation using the product iii. Provide and explain situations when the product was declined or refused by the patient iv. Explain the federal and state laws pertaining to the usage of your product. Include whether the product can be used multiple times or whether the law dictates that this is a single use product. List the useful life of the product. c. Provide evidence that outlines the efficacy of the product in preventing diversion of opioid medications i. List approvals for the product from government agencies including the Food and Drug Administration ii. Provide evaluations from third party reviews pertaining to the effectiveness of the product iii. Describe any recalls on available (or deployed) products and the reasons for the recalls iv. List the limitations of your product in regards to different dosage forms. List the sizes and dimensions of tablets, capsules, liquids, patches, or other dosage forms that can be accommodated in your product. List the typical quantity of tablets or other available dosages that can be stored in your product. v. Explain measures taken to prevent the patient from not being able to access the medications because of product failure or user failure. vi. List the failure rate of your product including the types of calculations and measures used to come to this conclusion d. Provide supporting evidence that shows cost effectiveness of the product in preventing diversion. i. Provide the economic evaluations that have been performed on the product ii. Describe the patient population that implementation of the product will be most cost effective for the Military Health System iii. List the methods that can be used to identify the population identified above Information Submission Instructions: The Government encourages responses from interested parties who are capable of responding to the entire scope of the RFI, as well as interested parties who may have specific expertise in only limited areas of this RFI. 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 responding party's expense. Proprietary information may be submitted; however, interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. Proper restrictions shall be marked as such on each page. Only the Government will review this RFI. Interested qualified interested parties, small or large organization, should submit information for this request. The information should not to exceed fifteen (15) single side pages, using 12 point Arial font. An additional ten (10) pages of other materials (e.g., graphs, tables, figures) may be submitted. All responses should be submitted using PDF, HTML, MS Word or PowerPoint formats with subject "RFI MTM Pilot. Only electronic submissions will be accepted. Electronic files larger than 10 MB should be broken down into multiple files with no one (1) file exceeding 10 MB. Each electronic submission shall include: a) RFI number and "DoD Opioid Diversion Prevention Quality Improvement Initiative" in the subject line. b) If the submission includes more than one (1) electronic email, the file number and total files being submitted (e.g., File 1 of 4, File 2 of 4, etc.) in the subject line. c) A brief summary of the email's content, the vendor's name, and mailing address. ______________________________________________________________________________ Contractors will be required to be registered through the System for Award Management (SAM) at https://www.sam.gov/portal/SAM/#1 to be eligible for award of Government contracts. All responses to the RFI must be submitted electronically (via e-mail) to: Chrystal Pierce (chrystal.m.pierce.ctr@mail.mil), the Contracts Analyst and copy to Mr. Astley Davy (astley.b.davy.civ@mail.mil ), the Contracting Officer.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/notices/d7338b0366f5849c7840f31ad296274e)
 
Place of Performance
Address: 7700 Arlington Blvd, Falls Church, Virginia, 22551, United States
Zip Code: 22551
 
Record
SN04441203-W 20170322/170320234802-d7338b0366f5849c7840f31ad296274e (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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