CDC Reviews Mask Maker Data Collection Plan
Published Date: 10/5/2026
Notice
Summary
The CDC wants your thoughts on a plan to keep tracking and approving respirators, the masks that help protect us from breathing in harmful stuff. This affects companies making these masks and anyone who uses them, making sure the masks stay safe and reliable. You’ve got until December 4, 2026, to share your ideas—no money changes now, just a chance to help shape the rules!
Analyzed Economic Effects
5 provisions identified: 2 benefits, 3 costs, 0 mixed.
Respirator approval applications: time and fees
If you make respirators, you must complete the Standard Application Form (SAF) for approval. Each SAF response averages about 229 hours, there are an estimated 120 respondents per year, and a $200 fee is required for each application, with additional testing/evaluation fees required as specified in 42 CFR parts 84.20-22, 84.66, 84.258 and 84.1102.
Large overall annual paperwork burden
CDC estimates the total annualized burden for this data collection at 113,708 hours and requests OMB approval for an additional three years of collection. This total includes SAF responses, audits, and human participant forms.
Periodic site audits for approved manufacturers
Manufacturers with current approvals are subject to site audits, typically every second year; about 50% of sites are audited each year and CDC estimates an average of 89 site audits annually. Each audit response averages 16 hours, and audits may occur periodically or in response to reported issues.
Existing manufacturer test paperwork acceptable
Applicants must provide test data that shows their respirator meets 42 CFR part 84, but they are not required to follow NIOSH Standard Test Procedures and additional testing is not required; providing proof can be limited to existing manufacturer paperwork. This means manufacturers can rely on standard tests they already perform rather than performing new NIOSH-specific tests.
Human test participants must complete forms
Members of the general public who serve as human test surrogates will complete consent, payment information, questionnaires, and information sheets as part of respirator testing. CDC estimates 425 participants for the consent/payment/questionnaire forms and 150 participants for the information sheet, with per-form time burdens such as 12/60 hour for consent and 24/60 hour for payment information.
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