SSN-BARDA-2018 Hypodermic Needle and Syringe Products

Synopsis:
This is a Sources Sought Notice. The purpose of this notice is to obtain information from all qualified U.S. manufacturing sources to fulfill a potential requirement for hypodermic needle and syringe products. It is NOT a solicitation for proposals, proposal abstracts, or quotations. The NAICS code for this notice is 339112, Surgical and Medical Instrument Manufacturing, specifically Hypodermic needles and syringes manufacturing. The government will evaluate information to:
(1) Obtain product listings of FDA approved, safety engineered needle and syringe products,
(2) Obtain information on current manufacturing processes, capabilities, capacities, constraints and limitations in the manufacturing and availability of these products,
(3) Utilize this information to inform acquisition strategies that may be used to support preparedness and response to public health emergencies, and
(4) Conduct Site Visits.
Background:
Within the Federal Government, the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) 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 exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemic influenza and emerging infectious diseases.
To accurately estimate the capability and limitations to deploy medical countermeasures, HHS requires information on the manufacturability and availability of hypodermic needle and syringe products, which would be critical to the administration of medical countermeasures during a public health emergency.
Purpose and Objectives:
HHS intends to issue a Request for Proposal (RFP) for the manufacture and acquisition of hypodermic needles, syringes and ancillary medical supplies from medical/surgical device manufacturers to meet the vaccine and other therapeutic administration needs of the American public during a public health emergency.
To accurately assess the capability to deploy medical countermeasures in a timely manner, HHS requires information on product availability, current manufacturing processes, resource contraints, and other limitations which may impact the administration of medical countermeasures during a public health emergency.
Submission Instructions:
To respond to this sources sought notice, manufacturers must:
Hold a current manufacturing site registration with the FDA, and
Manufacture one or more FDA licensed, safety engineered needle and syringe products.
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:
1. All Point of Contact information (email addresses, phone numbers, and mailing address).
2. Identification as a large or small business. If small, indicate the classification.
3. Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers.
Respondents (Manufacturers) are asked to provide the following information:
1. Product literature and specifications sheets for safety engineered needle and syring products.
2. Sufficient information on the topics below for discussion during a site visit:
a) U.S based manufacturing capabilities and plant locations (city, state)
b) Non U.S. based manufacturing capabilities and plant locations (country, city)
c) Manufacturing processes
d) Manufacturing surge capacities that can be achieved in 30, 60 and 90 day timeframes
e) Raw/starting materials that may impact production
f) Supply and manufacturing constraints, limitations or other pertinent information
Small Business Manufacturers who meet the requirements are encouraged to respond.
Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. 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 Sources Sought Notice 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.
Responses to this Sources Sought Notice, along with a firm's capability statement referencing "Sources Sought Notice - Hypodermic Needle and Syringe Products" may be submitted electronically via email to the points of contact listed below NO LATER THAN 5PM EST, December 14, 2017).

ASPR Contracting Officer: Tasha.McMillian@hhs.gov AND Kyle.Roberts@hhs.gov
ASPR Project Officer: Patrick.Byrne@hhs.gov

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

RESPONSES TO THIS NOTICE WILL NOT BE CONSIDERED ADEQUATE RESPONSES TO A SOLICITATION.