AMENDMENT #3 - Elastomeric Half Mask Respirator - COVID-19

AMENDMENT #3 is published to include the following information. FOB Destination, the address(es) will be provided at time of award and will be to a Government designated location within the United States, not to exceed 8 locations CONUS. For planning and estimating purposes, the locations are within a 25 mile radius of the below cities. Atlanta, GA Baltimore, MD Indianapolis, IL Dallas, TX Salt Lake, UT Los Angeles, CA Sacramento, CA Memphis, TN **No other changes are made by way of Amendment #3. ------------------------------------------------------------------------- NOTE: Due to the length of this combined synopsis/solicitation, a pdf copy to help provide easier readability is attached to this posting. COMBINED SYNOPSIS SOLICITATION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation document will not be issued. The solicitation number is 75A50121Q00011 which is being issued as a Request for Quotes (RFQ). Contract Type will be Firm Fixed Price. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03, effective February 16, 2021. This acquisition is being posted as Full and Open, and is not set aside for small businesses. 339113 (Surgical Appliance and Supplies Manufacturing, Respiratory Protective Mask Manufacturing). The size standard is 750 (number of employees). 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), has a requirement for Elastomeric Half Mask Respirators. See below for line item numbers and product, quantities, and units of measure. The Government intends to evaluate offers and award a contract without discussions. However, the Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government. See below for description of requirements. The period of performance is anticipated to be 12 months. See below for place(s) of delivery and acceptance and FOB point(s). . The provision at FAR 52.212-1, Instructions to Offerors-Commercial Items, applies to this acquisition. The Government intends, but is not obligated, to award multiple contracts. The provision 52.212-2, Evaluation-Commercial Items, applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that affect in accordance with this clause). The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition and FAR clauses applicable are 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-5, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See below for details. There are no special contract requirements or terms and conditions related to contract financing arrangements. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System. Offers are due no later than March 10, 2021 on or before 3:00 PM Eastern Time , with the Subject Line RFQ 75A50121Q00011, by email to [email protected] . The offeror’s complete quote (including all information required to be submitted as part of the offeror’s Volume A -Technical Quote, and Volume B - Price/Business Quote) must be received by the date and time specified for receipt of offers. In accordance with FAR 52.212-1(f), quotes received after the deadline will not be accepted. See General Instructions for additional details. Electronics submissions only will be accepted and shall be submitted via email to [email protected]. All submissions should include the solicitation number and the word “SUBMISSION”. Email submissions are limited to 2MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) All questions regarding this RFQ of contractual or technical nature, must be submitted electronically by email to [email protected] later than 1:00 p.m., ET, March 02, 2021. For proper submission of questions, include the solicitation number and the word “QUESTION” in the subject of the email. The Government’s responses to questions will be posted as an attachment to the combined synopsis/solicitation posting. Please be advised that the Government reserves the right to transmit those questions and answers of a common interest to all prospective offerors. 16. The point of contact for information regarding this combined synopsis/solicitation is: Contracting Officer Sherica Teshome Office of Resource Management (ORM) Assistant Secretary of Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: [email protected] Section B - Supplies Or Services And Prices/Costs B.1 Contract Line Items *See Table In Attachment * NOTE: The Government anticipates making multiple awards under this solicitation, and different vendors will propose on and be awarded different quantities of Elastomeric Half Mask Respirators and particulate filters. The exact number of Elastomeric Half Mask Respirators and particulate filters ordered across all awards is unlikely to equal exactly 375,000, and that total (across all awards) may vary by up to 10%. Each individual vendor’s award will show only the quantity awarded to them. B.2. Delivery Schedule Milestone Desired delivery schedule. Vendor shall update this per their current capabilities. (See B.2 in PDF Attachment) B.3 Schedule of Supplies/Services SECTION 1- STATEMENT OF WORK Assistant Secretary for Preparedness and Response (ASPR)/Division of Strategic National Stockpile (DSNS) Elastomeric Half Face Masks B.3-1(a) 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 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, tribe and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicine and supplies get to those who need them most during emergency. The Strategic National Stockpile (SNS) is a national repository of large quantities of medicines, vaccines, medical supplies, and medical 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. Since America’s battle with COVID-19 began, supplies of N95 filtering facepiece respirators, which are the standard face covering when healthcare providers require high-level respiratory protection, have been in short supply in healthcare facilities. A cost-effective strategy for healthcare systems to offset N95 respirator shortages due to COVID-19 is to utilize reusable elastomeric respirators. Elastomeric Half Mask Respirators (EHMRs) are made of a tight-fitting, flexible, silicone or rubber-like material that can adjust to nearly all individuals’ faces and can withstand multiple cleanings and maintenance. These devices use a replaceable filter or cartridge and offer healthcare workers equal or better protection from airborne infectious substances compared with N95 respirators. EHMRs cover the nose and mouth and provide protection against gases, vapors, or particles when equipped with the appropriate cartridge or filter. B.3-1(b) Purpose & Scope The Coronavirus Disease 2019 (COVID-19) is a respiratory disease caused by infection with a new form of coronavirus (SARS-COV-2) has been detected in multiple locations around the world, including the U.S. COVID-19 has been declared a public health emergency both within the United States and worldwide. Healthcare workers are on the front lines and therefore at an increased risk of being exposed to and contracting the disease. The Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) require health care workers caring for patients with suspected or confirmed infections disease to wear respiratory protection. In response to the COVID-19 pandemic, the U.S. Government has a requirement to purchase National Institute for Occupational Safety and Health (NIOSH)-approved, EHMRs intended for use in healthcare settings. A single Offeror or multiple Offerors may be awarded contracts to supply the required number of EHMRs. The Government intends to purchase a complete EHMR (an EHMR includes the half mask respirator and one pair of P100 particulate filters OR a pair of impermeable material-encased cartridges with minimum N-95 particulate filter protection). The Government also intends to purchase an additional pair of filter cartridges per EHMR kit during the period of this contract. The requested size distribution of EHMRs is: 25% small, 60% medium, 15% large. B.3-1(c) Technical Requirements Mandatory criteria: General Mandatory Criteria Comment 1. NIOSH Approved EHMR Product shall have a current NIOSH approval 2. P-100/ or N-95 Particulate Filters Filters shall fit the facepiece Filters housed in cartridge bodies where the particulate filter can be replaced Filter must be able to be reused multiple times. 3. Cartridge Availability Cartridges to fit this model must be commercially available and manufacturing supported through the end of 2023. Safety and Effectiveness Mandatory Criteria Comment 1. Cartridge/Filter Cover Filter covers intended to increase infection control measures (i.e., prevent patients from contaminating the filters). Covers must be able to be wiped clean. 2. Low profile cartridges Cartridges shall have a low profile to allow for increased visibility for the wearer. 3. Filtered or no Exhalation Channel The direction of the exhalation channel 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. No exhalation valve is optimal or a filtered exhalation valve. 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 1. 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 1. Softer, lighter, and less rigid materials I.E. softer, flexible, silicone 2. Minimal dead space Reduced weight, enhanced visibility, less bulk 3. 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 1. 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 2. 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 1. 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. 2. Use with other PPE Adjustment points located on face piece to ensure compatibility with other PPE such as hoods, face shields, etc. 3. Particulate Filters The USG prefers P100 particulate filters however, impermeable material-encased cartridges with minimum N-95 particulate filter protection may be acceptable. B.3-1(d) Contract Period of Performance The contract period of performance will be twelve (12) months from date of award. Shipping and packaging requirements, found in section B.3(f) below, are included in the price of the units. B.3-1(e) Deliverables Deliverable Format/Deliver to Date Delivery Documents Scan and email to COR/POC 2 Business Days Prior to Delivery Packing Slips Scan and email to COR/POC 48 hours after delivery Final Report Summary of all deliveries under performance of this contract. Within 5 business days from final delivery or end of contract, whichever comes first. B.3-1(f) Shipping Instructions: • All shipments will include packing slips and contract number. • Storage Requirements shall be on all packing lists. • Shelf-life shall be included on all packing lists. • No Partial Case or Packages quantities will be accepted unless approved by SNS in advance. • No Mixed Lot #'s per Case, Packages, or Pallets will be accepted unless approved by SNS in advance. • Item description, Part number, Lot numbers and quantities shall be included on the packing list. • All pallets are to have the identical TyHi stack pattern except for the final pallet. • All product to be packaged on standard 48" by 40" pallet, not to exceed 60” in height, stretch wrapped and secured to pallet for safe transport. • Full case quantities only unless approved by SNS in advance. • Contractor shall contact the designated POC to schedule delivery appointments. • Must adhere to applicable FDA labeling regulations • No deliveries accepted on weekends without prior approval of the COR/Project Officer. B.3-1(g) Inspection and acceptance under this contract will be in accordance with FAR 52.212-4 Contract Terms and Conditions - Commercial Items (Oct 2018). SECTION 2 - PACKAGING, MARKING AND SHIPPING B.3-2(a) Payment of Postage Fees All postage and fees related to submission of information, including forms, and reports, etc., to the Contracting Officer or Contracting Officer’s Representative (COR) or other persons designated to receive, shall be paid by the Contractor. B.3-2(b) MARKINGS All deliverables required and submitted to the CO or the COR or other DSNS personnel designated to receive deliverables under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name and clearly indicate the following information: Agency/Requiring LOC Service Unit and MAIL STOP/Room Number Description of information/data being submitted Contract Number Contract Name and Address The Contractor shall guarantee and comply with the following: Shelf life will be included on packaging. Lot # will be included on packaging. NIOSH TC# printed both on the box as well as the product itself. NIOSH name in block letters or a NIOSH logo. NIOSH filter series Alpha-numerical rating followed by filter efficiency level. Must adhere to applicable FDA labeling regulations SECTION 3 – CONTRACT ADMINSTRATION DATA B.3-3(a) ADMINISTRATION This contract will be administered by the following ASPR/DSNS personnel: Contracting Officer Sherica Teshome Office of Resource Management (ORM) Assistant Secretary of Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: [email protected]| 202-870-8536 office Contracting Officer Annette Wright, Team Lead Office of Resource Management (ORM) Assistant Secretary for Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: [email protected]| 404-498-0949 office Contracting Officer’s Representative (COR)/Technical Point of Contact (POC) David Kelley Division of Strategic National Stockpile (DSNS) Assistant U.S. Department of Health and Human Services (HHS) Email: [email protected] | 770-488-2662 office B.3-3(b) – CONTRACTING OFFICER The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract. No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract. B.3-3(c) – CONTRACTING OFFICER’S REPRESENTATIVE Performance of work under this contract is subject to the technical direction of the COR identified in Section B.3-3, or a representative designated by the contracting officer in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily. Technical direction must be within the scope of the contract specification(s)/work statement. The COR does not have authority to issue technical direction that: 1. Constitutes additional work outside the contract specification(s)/work statement; 2. Constitutes a change as defined in the “Changes” clause of this contract; 3. Causes an increase or decrease in the contract price, or the time required for contract performance 4. Interferes with the contractor’s right to perform under the terms and conditions of the contract; or 5. Directs, supervises or otherwise controls the actions of the contractor’s employees. Technical direction may be oral or in writing. The COR must confirm oral direction in writing within five workdays, with a copy to the contracting officer. The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR, if the opinion of the contractor, any direction of the COR or the designated representative falls within the limitations above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government workday. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subjected the terms of the “Disputes” clause of this contract. B.3-3(d) – CONTRACTOR PUBLICITY The Contractor, or any entity or representative acting on behalf of the Contractor, may not refer to the equipment or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the Contracting Officer. Should any reference to such equipment or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government will consider institution of all remedies available under applicable law. B.3-3(e) – PAYMENT TERMS INVOICES (a) Invoice Submission. The Contractor shall submit invoices within five (5) business days after each delivery. A proper invoice, with all required back-up documentation shall be sent electronically, via email, to the COR mailbox: Contracting Officer’s Representative(COR): David Kelley; [email protected] A proper invoice, not including non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent electronically, via email, to: Contract Officer via mailbox: [email protected] Financial Management Service (FMS) viamailbox:[email protected] The subject line of your email invoice submission shall contain the contract number, order number (if applicable), and the number of invoices. The email may have multiple invoices for the contract. Invoices must be in the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF or TIFF or Word). Invoices shall be submitted in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc. All calls concerning contract payment shall be directed to the COR. Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315. Invoice Elements. In accordance with FAR 52.212-4, Contract Terms and Conditions-Commercial Items, the Contractor shall submit an electronic invoice to the email addresses designated in the contract to receive invoices. A proper invoice must include the following items: Name and address of the Contractor;Invoice date and number; Contract number, contract line item number and, if applicable, the order number; Description, quantity, unit of measure, unit price and extended price of the items delivered; Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading; Terms of any discount for prompt payment offered; Name and address of official to whom payment is to be sent; Name, title, and phone number of persons to notify in event of defective invoice; and Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract. Electronic funds transfer (EFT) banking information. The Contractor shall include EFT banking information on the invoice. In accordance with the requirements of the Debt Collection Improvement Act of 1996, all payments under this order will be made by electronic funds transfer (EFT). The Contractor shall provide financial institution information to the Finance Office designated above in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer - System for Award Management. Additionally, the Program Support Center (PSC) requires: The invoice to break-out price/cost by contract line item number (CLIN) as specified in the pricing section of the contract The invoice to include the Dun & Bradstreet Number (DUNS) of the Contractor. ) SECTION C – CONTRACT CLAUSES C.1 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of Clause) FAR SOURCE TITLE AND DATE 52.204-7 System for Award Management (Oct 2018) 52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18 Commercial and Government Entity Code (Aug 2020) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (June 2016) 52.209-7 Information Regarding Responsibility Matters (Oct 2018) 52.209-12 Certification Regarding Tax Matters (Oct 2020) 52.211-17 Delivery of Excess of Quantities (Sep 1989) 52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2018) 52.222-56 Certification Regarding Trafficking in Person Compliance Plan (Oct 2020) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.242-15 Stop-Work Order (Aug 1989) 52.246-16 Responsibility for Supplies (April 1984) 52.247-34 F.O.B. Destination (Nov 1991) HHSAR SOURCE 352.203-70 Anti-Lobbying (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.223-70 Safety and Health (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015) 352.224-70 Privacy Act (Dec 2015) 352.233-71 Litigation and Claims (Dec 2015 ) 352.239-74 Electronic and Information Technology (EIT) Acquisitions (Dec 2015) C.2 Clauses Incorporated in Full Text C.2-1. 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. (Jan 2021) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)). (2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91). (3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232). (4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015). (5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553). (6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). _X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509)). __ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) _X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note). __ (5) [Reserved]. __ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C). __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C). _X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note). __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313). __ (10) [Reserved]. __ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C. 657a). __ (ii) Alternate I (Mar 2020) of 52.219-3. __ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (ii) Alternate I (Mar 2020) of 52.219-4. __ (13) [Reserved] __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644). __ (ii) Alternate I (Mar 2020) of 52.219-6. __ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644). __ (ii) Alternate I (Mar 2020) of 52.219-7. __ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)). _X_ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)). __ (ii) Alternate I (Nov 2016) of 52.219-9. _X_ (iii) Alternate II (Nov 2016) of 52.219-9. __ (iv) Alternate III (Jun 2020) of 52.219-9. __ (v) Alternate IV (Jun 2020) of 52.219-9 __ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)). __ (ii) Alternate I (Mar 2020) of 52.219-13. __ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)). _X_ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657f). __ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Nov 2020) (15 U.S.C. 632(a)(2)). __ (ii) Alternate I (MAR 2020) of 52.219-28. __ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)). __ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020) (15 U.S.C. 637(m)). __ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)). _X_ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)). __ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755). _X_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan2020) (E.O.13126). _X_ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). X__ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246). __ (ii) Alternate I (Feb 1999) of 52.222-26. _X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212). __ (ii) Alternate I (Jul 2014) of 52.222-35. _X_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793). __ (ii) Alternate I (Jul 2014) of 52.222-36. _X_ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212). _X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X_ (35) (i) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O. 13627). __ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). __ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693). __ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693). __ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514). __ (ii) Alternate I (Oct 2015) of 52.223-13. __ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514). __ (ii) Alternate I (Jun2014) of 52.223-14. _X_ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b). __ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-16. __ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513). __ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693). _X_ (46) 52.223-21, Foams (Jun2016) (E.O. 13693). __ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a). __ (ii) Alternate I (Jan 2017) of 52.224-3. _X_ (48) 52.225-1, Buy American-Supplies (Jan2021) (41 U.S.C. chapter 83). __ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Jan 2021)(41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43. __ (ii) Alternate I (Jan 2021) of 52.225-3. __ (iii) Alternate II (Jan 2021) of 52.225-3. __ (iv) Alternate III (Jan 2021) of 52.225-3. _X_ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). __ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302Note). __ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150). __ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150). _X_ (55) 52.229-12, Tax on Certain Foreign Procurements (Jun 2020). __ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). __ (57) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332). __ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). __ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). _X_ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)). __ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). __ (ii) Alternate I (Apr 2003) of 52.247-64. __ (iii) Alternate II (Feb 2006) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67). __ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67). __ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67). __ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020). __ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706). __ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509). (ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)). (iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91). (iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232). (v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246). (viii) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212). (ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793). (x) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212). (xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (xii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67). (xiii) (A) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O 13627). (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). (xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May2014) (41 U.S.C. chapter 67). (xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67). (xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989). (xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020). (xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706). (xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a). (B) Alternate I (Jan 2017) of 52.224-3. (xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause) C.2-2 FAR 52.217-6 Option for Increased Quantity (Mar 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of the date the Government intends to exercise the option. The preliminary written notice shall not commit the Government to exercise the option. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. (End of Clause) SECTION D - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS This Section is Left Blank SECTION E - SOLICITATION PROVISIONS E.1. SOLICITATION COPIES AND ENCLOSURES An electronic copy of the solicitation and related documents will be available via the internet at: beta.SAM.gov 24 hours a day. E.2. QUOTE PREPARATION COSTS This RFQ does not commit the Government to pay any cost for the preparation and submission of a quote in response to this RFQ. The Contracting Officer is the only individual who can legally commit the Government to the expenditures of public funds in connection with this proposed procurement. E.3. GENERAL INSTRUCTIONS Offerors shall examine and follow all instructions. Failure to do so will be at the offeror’s own risk. Quotes shall conform to solicitation provision FAR 52.215-1 – INSTRUCTIONS TO OFFERORS – COMPETITIVE ACQUISITION and be prepared in accordance with this Section E. To aid in the evaluations, quotes shall be clearly and concisely written, as well as neat, indexed (cross-indexed as appropriate) and logically assembled. Prospective offerors are asked to bear in mind that all material submitted should be directly pertinent to the requirements of this RFQ. Extraneous narratives, elaborate brochures, uninformative “PR” material and so forth, shall not be submitted. All pages of each part shall be appropriately numbered and identified with the name of the offeror, the date, and the solicitation number to the extent practicable. The Government intends to award multiple contracts. The Government reserves the right to award fewer contracts. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer. The Government intends to award one or more Firm Fixed Price (FFP) contracts to the eligible, responsible offeror(s) that represent the Best Value offer. In order to be determined technically acceptable: (1) the offeror must propose on all of the items specified, meeting the minimum specifications; (2) the offeror must meet the required delivery dates; and (3) the Government will consider past performance information in accordance with FAR 15.305 where negative information within CPARS may render a quote being deemed technically unacceptable. E.3-1. PACKAGING OF QUOTE: In order for the technical quote to be evaluated strictly on the merit of the material, NO PRICE INFORMATION IS TO BE INCLUDED in Volume I, TECHNICAL QUOTE. To expedite the quote evaluation, all documents required for responding to the RFQ should be placed in the following order COVER PAGE See instructions below. All quote parts (Technical Quote and Business Quote) must begin with a Cover Page. TECHNICAL QUOTE It is recommended that the technical quote consist of a cover page, a table of contents, responses to the technical evaluation criteria and the information requested in the Statement of Work- maximum 20 pages total. (The cover page and table of contents do not count toward this total.) BUSINESS QUOTE It is recommended that the business quote consist of a cover page, a table of contents, and the information requested in the SOW associating cost with each item identified for a prospective contract- maximum 20 pages total. (The cover page and table of contents do not count toward this total.) E.3-2. VOLUME I – TECHNICAL QUOTE E.3-2(a). Technical Quote Instructions Offerors shall prepare their technical quote submissions to address the evaluation factors listed in SECTION E Technical Evaluation Criteria while responding to the requirements listed in SECTION B. The technical quote should reflect a clear understanding of the work being undertaken. The technical quote must include information on the capabilities of the Offeror and a response to the Government’s requirements as defined in the Statement of Work in SECTION B. At minimum, Offerors should address the technical requirements/tasks (detailed in SECTION B) and the deliverables found in Section B. Quotes will be evaluated by a technical review panel in accordance with the evaluation criteria rating as described in SECTION E below. This evaluation produces adjectival ratings which are based upon the information contained in the Offeror's quote. E.3-3. VOLUME II CONTRACT BUSINESS QUOTE AND COST/PRICE E.3-3 (a) Business Quote Instructions The business quote shall not exceed 20 pages. The quote must be signed by an official authorized to bind the Offeror(s) organization and must stipulate that it is predicated upon all the terms and conditions of this RFQ. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt by the Government E.3-3 (b). Business Quote – Components Section 1: Cover Page Quote Title Page including RFQ title, number, name of organization and DUNs number. Government notice for handling of quotes Table of Contents / Cross reference to RFQ Section 2: All Pricing Information The Offeror shall provide all cost and pricing information for each CLIN in this RFQ. Offeror should discuss its proposed rate as compared to historical experience and include when and how escalation will be calculated/implemented. Section 3: Representations and Certifications The Offeror shall include the Representations and Certifications in accordance with Section K. E.4. AWARD WITHOUT DISCUSSIONS The Government intends to evaluate quotes and may award a contract without discussions with offerors. Therefore, the offeror’s initial quote should contain the offeror’s best terms from a cost or price standpoint. However, the Government reserves the right to conduct discussion if the Contracting Officer later determines them to be necessary. If the Contracting Officer determines that the number of quotes that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of quotes in the competitive range to the greatest number that will permit an efficient competition among the most highly rated quotes. E.5 52.212-2 Evaluation-Commercial Items (Oct 2014) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Mandatory Criteria Offerors must be a(n): Authorized reseller of NIOSH-approved, Elastomeric Half Mask Respirators (EHMRs) that are manufactured by domestic manufacturers or manufactured in countries eligible for consideration under the Trade Agreements Act (TAA); or a domestic manufacturer of NIOSH-approved, Elastomeric Half Mask Respirators (EHMRs); or a manufacturer eligible for consideration under the TAA. Offerors representing Non-domestic manufacturers must certify that the NIOSH-approved, Elastomeric Half Mask Respirators (EHMRs) intended for use in healthcare settings proposed are compliant with TAA in accordance with Federal Acquisition Regulation (FAR) provision 52.225- 6. Offerors shall provide the following detailed information for the NIOSH-approved, Elastomeric Half Mask Respirators (EHMRs) intended for use in healthcare settings. This must include: Manufacturer name, part number for EHMR and filter manufacturer name Product specifications and product literature NIOSH approval certification (NIOSH approval TC number) Filter disposal and replacement recommendations for healthcare settings during COVID-19 Cleaning and decontamination instructions Shelf life and supporting data used to assign shelf life Offerors shall provide evidence that supports the below specifications. General Mandatory Criteria Comment 1. NIOSH Approved EHMR Product shall have a current NIOSH approval 2. P-100/ or N-95 Particulate Filters Filters shall fit the facepiece Filters housed in cartridge bodies where the particulate filter can be replaced Filter must be able to be reused multiple times. 3. Cartridge Availability Cartridges to fit this model must be commercially available and manufacturing supported through the end of 2023. Safety and Effectiveness Mandatory Criteria Comment 1. Cartridge/Filter Cover Filter covers intended to increase infection control measures (i.e., prevent patients from contaminating the filters). Covers must be able to be wiped clean. 2. Low profile cartridges Cartridges shall have a low profile to allow for increased visibility for the wearer. 3. Filtered or no Exhalation Channel The direction of the exhalation channel 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. No exhalation valve is optimal or a filtered exhalation valve. 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 1. 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 1. Softer, lighter, and less rigid materials I.E. softer, flexible, silicone 2. Minimal dead space Reduced weight, enhanced visibility, less bulk 3. 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 1. 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. 2. 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 1. 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. 2. Use with other PPE Adjustment points located on face piece to ensure compatibility with other PPE such as hoods, face shields, etc. 3. Particulate Filters The USG prefers P100 particulate filters however, impermeable material-encased cartridges with minimum N-95 particulate filter protection may be acceptable. Only Offerors meeting the mandatory criteria will be considered for award. Technical Evaluation Criteria The following criteria are in descending order of importance. Manufacturing Capability Offeror’s will be evaluated on their manufacturing capability, output, and ability to meet the Offeror’s proposed quantities. Non-manufacturing resellers will be evaluated on the capability of their proposed manufacturers. The agency will also evaluate any risks of potential disruptions to the manufacturing capability based upon the location of proposed manufacturing facilities for the end product NIOSH-approved, Elastomeric Half Mask Respirators (EHMRs), the location of proposed manufacturing facilities for critical components and the location of all supply chains and capability such as raw materials sourced, or manufacturing performed outside of the United States and the potential ramifications a pandemic may have on the supply chains or on non-domestic manufacturing sources. Risk is a major consideration of this factor, and Offerors are advised to pay special attention to the instructions related to manufacturing capability. Production Schedule Offerors will be evaluated on their ability to provide a detailed delivery schedule and/or production timeline and how quickly the Offeror can deliver the quantity proposed over the 12-Month Period of Performance. Shelf-life The agency will evaluate the remaining shelf-life of NIOSH-approved, Elastomeric Half Mask Respirators (EHMRs) that will be delivered during the period of performance. The Government’s overall best value determination will consider the cost of the product as it relates to the shelf-life at time of delivery and the best value determination will also consider the time, effort, and cost to sustain product with lesser shelf-life. Preferred Criteria The below criteria are preferred and will be evaluated based upon the products ability to meet these criteria. There are 9 preferred criteria listed below. EMHR’s will be rated on their ability to meet the preferred criteria. The more preferred criteria that are met the more desirable the EMHR will be to the Government. 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 1. Softer, lighter, and less rigid materials I.E. softer, flexible, silicone 2. Minimal dead space Reduced weight, enhanced visibility, less bulk 3. 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 1. 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. 2. 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 Criteria Comment 1. 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. 2. Use with other PPE Adjustment points located on face piece to ensure compatibility with other PPE such as hoods, face shields, etc. 3. Particulate Filters The USG prefers P100 particulate filters however, impermeable material-encased cartridges with minimum N-95 particulate filter protection may be acceptable. 4. Past Performance The government will evaluate the Offeror’s experience in performing manufacturing projects of similar scope, size and complexity to the requirements described in the statement of work (SOW) and/or the Offerors past performance in providing the NIOSH-approved, Elastomeric Half Mask Respirators (EHMRs). Price Evaluation The government will evaluate each Offeror’s prices to determine that those prices are fair and reasonable and to determine which Offerors’ overall quotes offer the best value to the agency. Risk of excessive pricing is a major concern and Offerors are advised to pay special attention to the instructions related to pricing. The government reserves the right to reject any quotes that, in its opinion, does not offer fair and reasonable prices. Evaluations against other Performance Test Methods or Standards Specific to Healthcare Consideration will be given to those Offerors that provide satisfactory data for elastomeric facepiece and/or the filter cartridges when evaluated against the following standards/test methods. Providing this information is optional. It is preferred if the relevant testing is done by a laboratory meeting FDA’s Good Laboratory Practices requirement (21 CFR Part 58). Fluid resistance: ASTM F1862: “Standard Test Method for Resistance of Surgical Masks to Penetration by Synthetic Blood”, or equivalent. Flammability: Evaluations against either of the following standards by NFPA Class: 1) CPSC-191-53 Flammability Test Method (16 CFR Part 1610) or 2) Standard for Flammability of Clothing Textiles NFPA Standard 7021980 (“Standard for Classification of Flammability of Wearing Apparel UL 2154”). The NFPA Class should be identified. Biocompatibility: Evaluations against tests outlined in the ISO-10993-1 standard, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process”, including cytotoxicity, sensitization, and irritation. Technical and past performance, when combined, are more important than price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of provision) E.6. Subcontracting Plan If applicable, a Subcontracting Plan shall be submitted only by offerors who are large business concerns. Offerors must comply with FAR 52.219-9 Small Business Subcontracting Plan (Jun 2020). ATTACHMENT - EHMR RFQ 75A50121Q00011.final2