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SAMDAILY.US - ISSUE OF APRIL 03, 2020 SAM #6700
SPECIAL NOTICE

65 -- Priority ICU Medicines COVID-19

Notice Date
4/1/2020 12:16:39 PM
 
Notice Type
Special Notice
 
NAICS
325412 — Pharmaceutical Preparation Manufacturing
 
Contracting Office
PROGRAM SUPPORT CENTER ACQ MGMT SVC ROCKVILLE MD 20857 USA
 
ZIP Code
20857
 
Solicitation Number
HHS-2020-RFI-COVID-19-2
 
Response Due
4/3/2020 3:00:00 PM
 
Archive Date
04/18/2020
 
Point of Contact
ASPRNext@hhs.gov
 
E-Mail Address
ASPRNext@hhs.gov
(ASPRNext@hhs.gov)
 
Description
Request for Information (RFI) � Priority ICU Medicines COVID-19 This is NOT a solicitation announcement. This is a Request for Information only. RFI #: HHS-2020-RFI-COVID-19-2 NAICS: 325412, Pharmaceutical Preparation Manufacturing PSC Code: 6505, Drugs and Biologicals Title: Priority ICU Medicines COVID-19 Synopsis: This is a request for information (RFI). It is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to: Identify manufacturers who have current capability to produce priority ICU medicines in the quantity requested below; Identify manufacturers who are able to quickly modify their current capabilities to produce priority ICU medicines in the quantity requested below; and Make use of this information to inform acquisition strategies that may be used to support COVID-19 emergency response efforts. Background: On Friday, March 13, 2020, the President declared a national emergency concerning the novel coronavirus disease (COVID-19) under section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the �Stafford Act). Within the Federal government, the Department of Health and Human Services (HHS) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional and unintentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemic influenza and emerging infectious diseases. Ventilators are a critical life-saving medical countermeasure for patients experiencing respiratory failure. The United States has a critical need to procure priority medicines for ventilated ICU patients in response to COVID-19. Requirement: HHS is seeking information from the manufacturing community on their ability to rapidly produce the maximum number of priority ICU medicines their facilities can support. Please provide multiple scenarios of price and quantity. Additional purchases may be necessary. Purchase may also be made for associated consumables. HHS is interested in both finished drug and API manufacturing capabilities for this RFI. HHS is seeking information regarding peak production potential and associated price per requested priority ICU medication on a weekly basis from April 6th through the end of the calendar year. Consideration will be given to vendors with the ability to domestically produce, the price per unit, as well as additional future manufacturing capabilities. HHS is interested in both finished drug and API manufacturing capabilities for this RFI. The Vendor shall not be identified on the U.S. Government�s Excluded Party List System, or successor listing, as being suspended, debarred, or excluded from receiving Federal awards or assistance.� Given that the production of prescription drugs is governed by various federal statutes, i.e. the Food Drug & Cosmetic Act and the Controlled Substances Act, each manufacturer must demonstrate their ability to comply with federal laws governing production. Minimum requirements for priority ICU medicines are detailed in �Tab 2 � Min. Requirements� of Attachment 1. Submission Instructions: Respondents (manufacturers) are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability in line with this notice. Respondents (manufacturers) are asked to provide a cover page that contains the following information: All Point of Contact information (email addresses, phone numbers, and mailing address) DUNS number All relevant NAICS Codes Identification as a large or small business. If small, indicate the classification. Identification of products on Federal Supply Schedules, if any, and the relevant schedule numbers. Additionally, respondents (manufacturers) must include a completed Attachment 1: Complete all fields provided in �Tab 1 �Priority Medicines� Name and location of all plants. Please note if the vendor manufactures different types of priority ICU medicines that meet the required specifications at different unit prices, vendors must denote the different prices/models in their quotations, being sure to include the information requested above (1 - 5) for each medicine with a different price. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid HHS, please segregate and clearly mark proprietary information. Please be advised that all submissions become the property of the Government and will not be returned. This REQUEST FOR INFORMATION is in accordance with FAR 52.215-3 Request for Information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only. Submit responses electronically, with subject �[Company Name], HHS-2020-RFI-COVID-19-1, Priority ICU Medicines COVID-19� to ASPRNext@hhs.gov. All responses must be received in writing by no later than Friday, April 3, 2020, 6:00 PM, Eastern Time. Attachments Attachment 1, Priority ICU Medicines COVID-19 Response Sheet
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/56a5816e698e46bda590239132350db9/view)
 
Place of Performance
Address: USA
Country: USA
 
Record
SN05606871-F 20200403/200401230142 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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