Replacement Attachment E - Face Masks.docx

70FA2020R00000011 Attachment E Face Masks C.1 Background

The mission of the Division of Strategic National Stockpile (DSNS), of the United States (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 biological, chemical, radiological, natural disasters or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

The Strategic National Stockpile (SNS) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment 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.

Protection of healthcare workers and first responders from respiratory transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. Surgical masks or Face masks are one part of an infection control strategy and are examples of personal protective equipment (PPE) that are devices used to help protect the patient by limiting the spread of potentially hazardous particles that are expelled by the wearer and to protect the wearer from splashes, sprays, and splatters of fluids and large particles in the air. They are designed to cover the mouth and nose loosely, not sized for individual fit. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines.

C.2 Purpose

The U.S. Government is interested in establishing multiple awards for immediate purchases of Face Masks used in healthcare settings as described below. This will enable the United States to ensure sufficient availability of such items during national emergencies and/or pandemic events. The Government is concerned about the risks of disruption of any manufacturing facilities or supply chains located outside of the United States. Thus, offerors are advised to pay special attention to the instructions regarding manufacturing capability and/or supply chains located outside of the United States as well as the evaluation criteria related to manufacturing capability and foreign supply chains. The Government is concerned about the risks related to excessive pricing of critical PPE and intends only to acquire PPE at prices that it can determine are fair and reasonable. Thus, offerors are advised to pay special attention to the instructions regarding pricing.

The following is a summary to provide clarification about the different types of acceptable Face Masks for facial protection that may be proposed as part of the requirement:

a. Surgical masks are fluid-resistant, disposable, and loose-fitting protection devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment. FDA reviews and clears surgical masks under 21 CFR 878.4040 as Class II medical devices, which may be labeled as surgical, isolation, dental, or medical procedure masks. They 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.

Surgical masks that are not cleared or approved by FDA preferably should demonstrate conformance to the following performance requirements through either a 1) Manufacturers declaration of conformity or through verification of testing by a 2) ISO 17025 accredited laboratory declaration of conformity to the following performance requirements:

Under the current FDA enforcement discretion (guidance), prior submission of a premarket notification under section 510(k), Registration and Listing requirements, Quality System Regulation requirements, reports of corrections and removals, and Unique Device Identification requirements are not required under COVID-19 emergency response declarations. FDA currently believes such devices would not create such an undue risk where the product is labeled as follows:

1. Fluid resistance: Fluid resistance is met if the mask passes the test method below, or comparable test method, at any specific velocity as identified in the labeling. The mask shall be tested on a pass/fail basis at velocities specified in the standard.

ASTM F 1862: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood

1. Viral or bacterial filtration performance (e.g., filters 95% of bacteria)

· Filtration testing (e.g., ASTM F2101–01 (Bacterial Filtration Efficiency) and ASTM F2299 (Particulate Filtration Efficiency)

2. Biocompatibility: Appropriate analysis and testing (such as that outlined in the ISO-10993-1 standard, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.”) must demonstrate the biocompatibility of the mask. Tests selected must be appropriate for expected duration and level of contact with the device (e.g., limited contact devices including skin). Masks should be tested on a pass/fail basis with respect to cytotoxicity, sensitization, and irritation.

4. The product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas);

5. The product includes labeling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which does not include any drugs or biologics); and

6. The product is not intended for any use that would create an undue risk in light of the public health emergency, for example the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses and does not include particulate filtration claims.

b. Face masks are disposable loose-fitting protection devices that create a physical barrier between the mouth and the nose of the wearer and the immediate environment. They may or may not meet fluid barrier or filtration efficiency levels. FDA has not cleared or approved any non-surgical face masks, although non-surgical face masks are authorized for emergency use.

C.3. Scope of Work

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all labor, materials, supplies, facilities, equipment, transportation and travel necessary to deliver one or more of the following acceptable Face Masks. Preference will be given in order by:

· Surgical masks cleared by FDA under 21 CFR 878.4040 as Class II medical devices; 510K number shall be provided by offeror if applicable.

· Equivalent or similar to Medline NON27402

· Surgical masks that are not cleared or approved by FDA but meet the above performance requirements through 1) manufacturer’s declaration of conformity or 2) ISO 17025 accredited laboratory declaration of conformity (please indicate which requirements are met and by which method 1) or 2)

· Equivalent or similar to Medline NON27122

A combination of the Face Masks described above may be acceptable to meet the Government’s requirement.

Offerors shall disclose and identify the following the following information

1. FDA Registration and date registered (if applicable)

2. FDA Listings and date listed for respective gown FDA product codes (if applicable)

3. FDA Premarket Document Number (e.g. 510k clearance) for respective product codes proposed (if applicable

Product manufacturer and part number, description, and literature must be included in the proposal for consideration and mapped to appropriate FDA Product Codes.