RFI_Atropine and Pralidoxime Chloride Injection _ 4-2024 1.docx

REQUEST FOR INFORMATION (RFI)

For

U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response (ASPR) Strategic National Stockpile (SNS)

1.0 DESCRIPTION

The mission of the Strategic National Stockpile (SNS), of the United States (U.S.) Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-savings pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological pathogens, chemical agents, radiological, natural disasters, or other emerging infectious disease agents. When state, local, tribe and territorial public health and medical systems request federal assistance to support their response efforts, SNS ensures that the right pharmaceuticals, supplies, and equipment get to those most in need during a public health emergency or pandemic event.

SNS is a national repository of pharmaceuticals, vaccines, medical supplies, and equipment stored in strategic locations around the nation. The assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that depletes local supplies during an emergency operation. Pharmaceuticals and Medical Supplies are stored for rapid deployment to protect the U.S. population against 21st century health security threats, such as anthrax, botulism, smallpox, plague, tularemia, and viral hemorrhagic fevers, as well as emerging infectious diseases, pandemic influenza, natural disasters, and other chemical, biological, radiological, and nuclear incidents.

Strategic National Stockpile (SNS) is seeking information from interested vendors that can provide Food and Drug Administration (FDA) approved Atropine and Pralidoxime Chloride Injection, single dose auto-injectors that delivers 2.1mg/0.7ml atropine and 600mg/2mg(300mg/ml) pralidoxime chloride.

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes to support market research efforts. It does not constitute a Request for Proposal (RFP), Request for Quotation (RFQ), Invitation for Bids (IFB) or a promise to issue an RFP, RFQ, IFB in the future. The request does not obligate or commit the Government to contract for any supply or service nor does it intend to award a contract on the basis of this RFI. There shall be no basis for claims against the Government as a result of information submitted in response to this RFI. Further, HHS is not seeking an RFP and will not accept any related unsolicited proposals.

Responders are advised that the Government will not pay for any information, or any administrative costs incurred in response to the RFI. All associated costs will be solely at the responding party’s expense. Information and materials provided in response to this RFI will not be returned. Based on the response to this RFI, a determination to compete or not to compete a future procurement is solely within the discretion of the U.S. Government.

If a solicitation or invitation is released, it will be via a Government Wide Point of Entry

(GPE).

2.0 REQUESTED INFORMATION

SNS is seeking information on vendor’s availability to provide acceptable pharmaceuticals of Atropine and Pralidoxime Chloride Injection, single dose auto-injectors that delivers 2.1mg/0.7ml atropine and 600mg/2mg(300mg/ml) pralidoxime chloride. SNS requires that all pharmaceuticals are FDA approved.

CAUTION

The Government is conducting market research to identify potential sources that possess the capability, expertise, and experience to provide Atropine and Pralidoxime Chloride Injection, single dose auto-injectors that delivers 2.1mg/0.7ml atropine and 600mg/2mg(300mg/ml) pralidoxime chloride.

The Contractor shall furnish all labor, materials, supplies, facilities, equipment, and transportation to meet the requirements.

INSTRUCTIONS

1. The information below details more about the Atropine and Pralidoxime Chloride, Single Dose Auto-Injectors, and a Contractor Capability Submission. The submission allows vendors to provide their company’s capability to provide the product.

2. After reviewing the information, if you desire to participate in the market research, provide documentation that supports your company’s capability in meeting the requirement. Failure to provide documentation may result in the Government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience/capabilities in order to perform that portion of the requirement (teaming, subcontracting, etc.). If not a small business, identify any areas of work that your organization believes should be broken out exclusively for a small business.

3. Both large and small businesses are encouraged to participate in this RFI.

4. Questions relative to this RFI should be addressed to Contract Specialist at the email listed below. Verbal questions will NOT be accepted.

5. All information received will be treated as public knowledge; therefore, vendors should NOT submit proprietary information in response to this RFI. Please be advised that all submissions become Government property and will not be returned.

CONTRACTOR CAPABILITY SUBMISSION

Part I. Business Information Please provide the following business information for your company/institution.

· Company/Institute Name:

· Address:

· Point of Contact:

· CAGE Code:

· SAM UEI Number:

· Phone Number:

· E-mail Address:

· Web Page URL:

· Size of business pursuant to North American Industry Classification System (NAICS) Code: 325412 Pharmaceutical Preparation Manufacturing

· Specify whether your company is domestically owned or foreign owned. If foreign owned, indicate the country of ownership.

· Total package should not exceed fifteen (15) pages (to include Attachment A) Based on the above NAICS Code, state whether your company is:

Part II. Capability Submission Questions and General Capability Questions In our commitment to fostering a competitive marketplace and cultivating an environment that embraces diverse vendor participation, we recognize the importance of soliciting input from all stakeholders. Your valuable comments, feedback, or recommendations aimed at refining this requirement are welcomed and encouraged. Your insights play a pivotal role in enhancing our procurement processes and advancing our shared goals of promoting fairness, transparency, and innovation within our vendor community.

Please review capability questions 1 through 22 in Attachment (A) and provide your responses within the Excel spreadsheet.

Part III. Capability Statement and Other Pertinent Information Please provide any additional information you deem relevant in order to respond to the specific inquiries of this RFI. To support budget and planning purposes, please also include a rough cost estimate based upon the objective outlined in this RFI. Information provided will be used solely by SNS as market research and will not be released outside of the SNS requirement team (May use separate attachment to provide additional information).

ASPR will not accept telephone, facsimile, courier, mail, or hand delivered responses. Further, access by ASPR to information in any files attached to a response is the responsibility of the submitting party. ASPR is not responsible for any failure to access information. Therefore, please ensure that files are easily accessible by ASPR – Microsoft Word or .pdf files are strongly preferred.

ASPR will not notify respondents of the results of this market research. Information submitted will not be returned and will not be accepted after the due date for responses. Responses must be received electronically no later than 2:00 PM ET, Tuesday, 23 April 2024. Written responses shall be provided electronically. The subject line of the e-mail message shall read: “Atropine and Pralidoxime Chloride RFI Response”. Please email your response to the following ASPR/SNS individual:

Contract Specialist:

LaMonica Norwood Email: lamonica.norwood@hhs.gov

END OF DOCUMENT