CLASS RECERTIFICATION FOR AN EXCEPTION TOTHE MAKE PPE IN AMERICA ACT BASED UPON NONAVAILABILITY OF DOMESTIC COMPONENTS FOR DOMESTICALLY MANUFACTURED POWERED AIR PURIFYING RESPIRATOR (PAPR) SYSTEMS – Waiver Renewal 1

Waiver Details

Multi-procurement Waiver

NIH anticipates awarding multiple procurement actions over the 120-day period covered by the requested exception that would provide PAPR hoods to be ordered to support forecasted and emerging staff needs throughout HHS. The exact quantity of PAPR systems to be ordered is unable to be specified in advance; however, NIH estimates that 2,300 PAPR systems will be ordered annually on behalf of HHS, for an estimated total value of $5M, with estimated annual maintenance or components costs of up to $1M/year. This amount is required for NIH & CDC operations. For a period of 120 days, the NIH anticipates purchasing 235 units of specific 3M PAPR parts and 140 units of specific MaxAir CAPR products. To avoid ambiguity, the procurement actions covered by this exception include complete PAPR systems, configuration-specific head tops, hoods, helmets or face pieces, blowers, filters, cartridges, canisters, batteries, chargers, breathing tubes, belts, covers, and other required accessories or replacement components necessary to operate, maintain, and replace PAPR systems used by HHS personnel. The NIH has established the specifications required to meet its PAPR systems needs by reviewing standards developed or followed by technical, scientific, clinical health, and safety experts across CDC, FDA and NIH who perform critical research and essential services on behalf of HHS. These standards include: Occupational Safety and Health Standard 1910.134 “Respiratory protection,” National Institute for Occupational Safety and Health “Approval of Respiratory Protective Devices” under 42 CFR 84, National Fire and Protection Association 1710 “Standard for the Organization and Deployment of Fire Suppression Operations, Emergency Medical Operations, and Special Operations to the Public by Career Fire Departments,” 42 CFR 73 and 9 CFR 121 covering Select Agents and Toxins, the current edition of “Biosafety in Microbiological and Biomedical Laboratories, and “Occupational Health and Safety in the Care and Use of Research Animals” as referenced in “Guide for the Care and Use of Laboratory Animals” by the National Research Council. At a minimum, PAPR systems procured under this exception must meet the following salient characteristics: (i) NIOSH certification for the intended use and contaminants; (ii) filter, cartridge, or canister capability matched to the biological, particulate, gas, vapor, chemical, or mixed hazard identified through the applicable risk assessment; (iii) an assigned protection factor sufficient for the hazard and exposure scenario; (iv) approved and compatible batteries, chargers, breathing tubes, head-tops, hoods, helmets, face pieces, and other components required to maintain the certification and safe function of the system; (v) sizes, headgear options, or loose-fitting configurations sufficient to accommodate the user population; and (vi) cleanability, disinfection compatibility, and replacement-part availability needed for repeated laboratory, clinical, field, and emergency use. These characteristics are tied to OSHA respiratory-protection requirements and the NIOSH approval framework for respirator construction, performance, and component parts. See 29 CFR 1910.134(d); 42 CFR 84.60- 84.63; 42 CFR 84.171.

Yes

10/27/2026

Pending

Dates

01/01/2027

04/30/2027