HHS Proposes Revision to Respirator Certification Fees


The Department of Health and Human Services (HHS) proposes to revise the fee structure established in 42 CFR Part 84 (Part 84), currently used by the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC) to charge respirator manufacturers for the examination, inspection and testing of respirators which are submitted to NIOSH for the purpose of creating or modifying a certificate of approval.

Existing regulations in Part 84, Subpart C--Fees reflect prices for respirator testing and approval that were promulgated in 1972, and have not kept pace with the actual costs of providing these services that benefit respirator manufacturers. The proposed rule is designed to establish fees for the following:

- reviewing applications submitted to NIOSH

- issuing a certificate of approval

- modifying a certificate of approval

- maintaining a certificate of approval

- performing specific, standard laboratory tests which are requested by applicants

- developing and/or performing novel tests which are required to evaluate respirator performance

- qualifying applicant respirator product sites and quality systems

- verifying quality system performance through site quality audits

- verifying commercially available respirator performance through product quality audits

- replacing testing equipment

- providing and maintaining laboratories and office space.

NIOSH will hold a public meeting to allow stakeholders to present information the impact of an increase on respirator fees on individual respirator manufacturers, the respirator market, or on those industries that rely on NIOSH-approved respiratory equipment. The meeting will be held on April 30, 2013, from 10 a.m. to 4 p.m. EDT, or after the last public commenter has spoken, whichever occurs first. Additional meeting information can be found at: www.cdc.gov/niosh/npptl

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