REQUEST FOR INFORMATION (RFI) NOTICE Subject: Elastomeric Half Face Mask Respirators (EHMR) Classification Code: NAICS 423450 - Medical, Dental and Hospital Equipment and Supplies Merchant Wholesalers Product Service Code: 6515 Medical, Dental, and Hospital Equipment and Supplies Contracting Office: Assistant Secretary for Preparedness and Response (ASPR) Strategic National Stockpile (SNS) Office of Resource Management (ORM) SNS Contracts Branch 2945 Flowers Road Atlanta, GA 30341 Point of Contact: Sherica Teshome Solicitation Number: TBD Place of Performance: TBD, variable Recovery Act Funds: N/A Set-Aside: No Instructions: Each response must include; Company Name Company Address Company point of contact; phone, email address, and DUNS Complete Attached MS Excel Spreadsheet (It is encouraged to submit completed spreadsheet to
[email protected]) Please limit responses to five (5) pages. Not responding to this request does not preclude participation in future solicitations. General questions regarding this may be submitted via email to
[email protected] no later than June 7, 2022. Please note, that during this time the government is unable to provide direct responses to any questions received. However, consideration will be given to all feedback, and any feedback received may be used to revise anticipated requirements. Information from this Request for Information (RFI) may lead to one-on-one market research discussions and other recommended approaches toward industry engagement. Partial responses are acceptable. Disclaimer: This RFI is issued for information and planning purposes only and does not constitute a solicitation. All information received in response to the RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. This is a Request for Information synopsis only. It is not a request for proposal and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. After review of the responses to this RFI, one or more solicitations are likely to be published. All information submitted in response to the RFI shall remain with the Government and will not be returned. Request for Information Description: The purpose of this RFI is to: Gain knowledge relative to current/future production capabilities of Elastomeric Half Face Mask Respirators (EHMR) manufactured domestically and internationally Identify location of manufacturing of the components Identify products that meet the below product technical requirements Determine if the EHMR and its ancillaries can be manufactured in the U.S. with 100% of the components also manufactured in the U.S. Please provide responses in the attached Excel Spreadsheet . You are limited to 5 pages of additional information when responding to this RFI. Responses to this RFI will be used by the Government to make appropriate acquisition decisions. Please provide any additional information that you feel may be of interest to the Government when reviewing responses to this request. Product Technical Requirements: Mandatory criteria: General Mandatory Criteria Comment NIOSH-approved EHMR Product must have a current NIOSH approval P100/ or N95 Particulate Filters Filters shall fit the facepiece as part of the NIOSH-approved configuration. Filters must be housed in a filter holder/cover or cartridge body where the particulate filter—or the cartridge housing the particulate filter— can be removed from the facepiece and replaced. Filter must be able to be reused multiple times. Cartridge Availability Cartridges to fit this model must be commercially available and manufacturing supported through the end of 2027. Safety and Effectiveness Mandatory Criteria Comment Cartridge/Filter Cover/Filter Holder Cartridge/filter covers/filter holders intended to increase infection control measures (i.e., prevent patients from contaminating the filters). Cartridge/filter covers/filter holders must be able to be wiped clean. Low profile cartridges Cartridges shall have a low profile to allow for increased visibility for the wearer. Filtered or no Exhalation Channel/valve The direction of the exhalation channel/valve has an impact on both worker and patient safety, as it could direct airflow towards an unprotected individual. In a pandemic situation, this could increase the rate of hospital-associated transmission. The exhalation valve directs exhaled breath and moisture downward to reduce face shield fogging. Comfort and Tolerability Mandatory Criteria Comment 1. Latex-free, non-allergenic materials (e.g., silicone) Preferred Criteria: Safety and Effectiveness Preferred Criteria Comment Distortion-resistant materials EHMRs made of distortion-resistant materials likely to help maintain the integrity of these devices during high-usage, limited storage situations. Comfort and Tolerability Preferred Criteria Comment Softer, lighter, and less rigid materials i.e., softer, flexible, silicone Minimal dead space Reduced weight, enhanced visibility, less bulk Fully adjustable head cradle The straps should have a full range of adjustment to ensure a sealed fit Non-Interference with Work Duties Preferred Criteria Comment High Speech Intelligibility (e.g., speaking membrane) Procured EHMRs should have similar speech intelligibility comparable to N95 filtering facepiece respirators (FFR). May include speaking membranes (i.e., voice augmentation device) which have been shown to improve word intelligibility. Wide Visual Field (e.g., smaller cartridges, ability to wear prescription glasses/goggles simultaneously) Smaller sized cartridges as recommended in safety and effectiveness section would aid in increasing the visual field. Other Characteristics Preferred Characteristic Comment Facepiece must have multiple available model sizes to meet needs of total population (estimated sizes for acquisition include 25% small, 60% medium, 15% large) Per OSHA’s Respiratory Protection Standard, employers are responsible for providing workers with a variety of different sized respirators. This ensures that workers are able to select a Respiratory Protective Device (RPD) that fits properly. Use with other PPE Adjustment points located on face piece to ensure compatibility with other PPE such as hoods, face shields, etc. Particulate Filters The USG prefers P100 particulate filters enclosed in a cartridge body/filter holder/filter cover, however, impermeable material-encased cartridges/filter holders/filter covers with minimum N95 particulate filter protection may be acceptable. The Government is planning solicitation for immediate response needs, as well as making assessments for longer-term needs, potentially up to five (5) years for these Elastomeric Half Face Mask Respirators (EHMR) and/or their ancillaries. The Government is interested in assessing overall availability as well as encouraging domestic production and availability. As stated above, no solicitation(s) is/are yet available.