Description
The mission of the Division of Strategic National Stockpile (DSNS), of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological pathogens, and chemical agents. When state, local, tribal, and territorial responders request federal assistance to support their response efforts, the stockpile ensures that the right medicines and supplies get to those who need them most during an emergency. Strategic National Stockpile (SNS) is a national repository of large quantities of medicines, vaccines, and other medical supplies stored in strategic locations around the nation. These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out. At all times, the SNS maintains specific minimum capabilities for responding to a variety of situations including deployable teams with all required personnel and equipment, contracted aircraft with surge capability, properly configured and ready materiel, appropriate warehouse staff to conduct contingency operations. Large scale medical emergencies present multiple challenges to the health care environment and the ability of the state and local medical providers to have enough medical equipment for all persons in need, to include emergency response personnel. ASPR and DSNS maintain a large repository of medical and laboratory equipment strategically located that would be used to supplement the supply currently in use by the nation’s acute care facilities and to be utilized by emergency medical response personnel. The equipment can be requested and allocated to areas of need. Protection of healthcare workers and first responders from respiratory transmission is essential to maintaining resilience of the U.S. healthcare system. Facemasks and N95 respirators are one part of an infection control strategy and are examples of PPE that are used to protect the wearer from liquid and airborne particles contaminating the face. The appropriate use of PPE is an important component of the overall strategy of certain infection prevention controls. Description: This is a Presolicitation Notice only and Not a solicitation or Request For Proposal (RFP). Proposals are not being solicited or accepted at this time. The solicitation will include information on how to obtain the plans and specifications. ASPR/DSNS intends to issue a solicitation to obtain Personal Protective Equipment (PPEs) via firm-fixed price contracts. A split award resulting in multiple contracts is anticipated. The solicitation is expected to be posted on or about March 11, 2020 this is a target date which may slip or change. Once the solicitation is released, all responsible sources may submit a proposal which shall be considered by the agency. Sources must have a valid DUNS Number or have the ability to obtain one, and also must be registered in beta.sam.gov. The anticipated requirement is for 50 million N95 or other facemasks (see below) to be delivered over the course of 12 months. A delay in commencement of deliveries may occur; the Government’s requirement is for domestically produced and Buy American Act & Trade Agreements Act compliant product. Options for increased quantity are contemplated, for up to 500 million additional masks over the 3 year period of performance. The following is a summary to provide clarification about different types of PPE for facial protection: Surgical Mask (Facemask) : A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878.4040 and are not to be shared nor are they intended to be used more than once. They may be labeled as surgical, isolation, dental or medical procedure masks and may come with or without a face shield. These are often referred to as face masks, although not all face masks are regulated as surgical masks. While a surgical mask may be effective in blocking splashes and large-particle droplets, a surgical mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the surgical mask and an individual’s face. Respiratory Protective Device (RPD): Any device designed to protect the user’s respiratory tract against the inhalation of a hazardous atmosphere. RPDs should not be referred to as “masks.” Approval of respiratory protective devices falls under CDC’s National Institute for Occupational Safety and Health (NIOSH) and a subset of these devices, N95 filtering facepiece respirators used in healthcare, also fall under the regulatory purview of the FDA. FDA and CDC have an MOU which provides a framework for coordination and collaboration between the Agencies relating to N95 respirators used in healthcare settings. N95 filtering facepiece respirator (FFR): Single-use, disposable half-mask RPD that covers the user’s airway (nose and mouth) and offers protection from particulate materials [1] at an N95 filtration efficiency level. N95 FFRs are approved by NIOSH under 42 CFR Part 84 and are referred to as N95 respirators in this document. N95 respirators used in healthcare settings : Includes N95 filtering facepiece respirators (FFR) used in healthcare settings and surgical N95 respirators. Such an N95 FFR used in a healthcare setting is a class II device and is also regulated by FDA under 21 CFR 878.4040 (FDA product code MSH). Surgical N95 respirator: Single-use, disposable respiratory protective device (RPD) used in a healthcare setting that is worn by HCP during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level. [2] , [3] The offeors shall furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to manufacture and deliver the following PPE items: NIOSH approved (and/or FDA cleared) N95 Respirators, Face Masks,