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Amendments to Respirator Certification Fees

March 2013
NIOSH Docket Number 216, CDC-2013-0004

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:

  1. reviewing applications submitted to NIOSH;
  2. issuing a certificate of approval;
  3. modifying a certificate of approval;
  4. maintaining a certificate of approval;
  5. performing specific, standard laboratory tests which are requested by applicants;
  6. developing and/or performing novel tests which are required to evaluate respirator performance;
  7. qualifying applicant respirator product sites and quality systems;
  8. verifying quality system performance through site quality audits;
  9. verifying commercially available respirator performance through product quality audits;
  10. replacing testing equipment; and
  11. providing and maintaining laboratories and office space.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting. The purpose of this meeting is 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, 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 here.

View the submissions received in response to this docket

Reference Documents

Public Comment Period

Comments will be accepted until 5:00 p.m. EST on May, 28, 2013.

Written comments, identified by CDC-2013-0004 and docket number NIOSH-216, may be submitted by any of the following methods:

  • Federal rulemaking portal: Follow the instructions for submitting comments.

    Instructions: All submissions received must include the agency name and docket number. All relevant comments, including any personal information provided, will be posted without change to

  • Mail: NIOSH Docket Office
    Robert A. Taft Laboratories
    4676 Columbia Parkway
    Cincinnati, OH 45226
  • Page last reviewed: March 27, 2013
  • Page last updated: March 27, 2013
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