Document Number: Revision Level/Date: Page 1 of 3 

POL-NPPTL-2016-XX Rev. 0 October 3, 2016 

Preparer: 

10/5/2016

Reviewer:

10/5/2016

 Approver: 

1/13/2017

X David Chirdon

David Chirdon

Chief, CVSDB

Signed by: David C. Chirdon ­S

X Christopher Coffey

Chris Coffey

Associate Director for Science, NPPTL

Signed by: Christopher C. Coffey ­A

X Maryann M. D'Alessandro

Maryann D'Alessandro

Director, NPPTL

Signed by: PIV

Policy supporting the collections of NIOSH Approval Fees
 

1.	 PURPOSE 

This policy document is intended to provide specific implementation guidance and interpretation 

to support fee collections in accordance with the requirements of Title 42 Code of Federal 

Regulations (42 C.F.R.), Part 84, Subpart C--Fees. 

2.	 SCOPE 

This policy applies to all fees collected by the National Institute for Occupational Safety and 

Health (NIOSH) in carrying out the provisions for approval of respiratory protective devices in 

accordance with the provisions of 42 C.F.R. Part 84. 

3.	 REFERENCES 

3.1	 Title 42, Code of Federal Regulations, Part 84. 

3.1.1	 § 84.20 Establishment of Fees 

3.1.2	 § 84.34, titled “Revocation of certificates of approval” states, “The Institute 

reserves the right to revoke, for cause, any certificate of approval issued pursuant 

to the provisions of this part. Such causes include, but are not limited to, misuse 

of approval labels and markings, misleading advertising, and failure to maintain 

or cause to be maintained the quality control requirements of the certificate of 

approval.” 

4.	 BACKGROUND 

A final rule was published in the Federal Register on January 26, 2015 that provided a revised 

fee structure used by NIOSH to charge respirator manufacturers for the examination, inspection, 

and testing of respirators which are submitted to NIOSH for the purpose of creating or modifying 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Document Number: 

POL-NPPTL-2016-XX 

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a certificate of approval. This fee revision established a new fee structure designed to enable 

NIOSH to fully recover the costs associated with the examination, inspection, and testing of 

complete respirator assemblies. 

The fee schedule is divided into two parts: (1) Fee Schedule A comprises annual (fixed) fees; 

and (2) Fee Schedule B comprises application-based fees, including fees for individual test 

procedures. This final rule and fee schedules became effective May 26, 2015. 

5.	 POLICY 

5.1.	 In accordance with the collection of Annual (Fixed) Fees as established at Part 84, 

Appendix A, the following apply: 

5.1.1.	 NIOSH will issue a single consolidated annual fee invoice for annual maintenance 

fee assessments in the month of September of each year. 

5.1.1.1.	 With regard to the fee for annual product audit, the annual invoice will 

assess the approval-holder only for the annual product audit fixed fee. In 

roughly the same time frame, the approval-holder will be given the option 

to provide the approved product identified for audit or to reimburse 

NIOSH for the cost (annual variable fee) to purchase the product. If 

chosen, the annual variable fee will be assessed at the close of the product 

audit along with the assessment of testing fees pursuant to Appendix B, 

Application-Based Fees (see 5.2). 

5.1.1.2.	 Payments not received by October 31 will be considered late. Late notices 

will be provided at 60 and 90 days. 

5.1.1.3.	 NIOSH will initiate sanctions when payment is past due by 120 days. In 

addition to the non-payment remedies specified at § 84.22(c)(1), (2), and 

(3), the following specific actions will be considered as suggested by the 

specific circumstances related to outstanding, overdue payment(s): 

5.1.1.3.1. Suspension of processing for in-house applications. 

5.1.1.3.2. Revocation of approvals. (See 3.1.2) 

5.2.	 In accordance with the collection of Application-Based Fees as established at Part 84, 

Appendix B, the following apply: 

5.2.1.	 NIOSH will not process any application unless it is accompanied by the required 

application fee. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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5.2.2.	 Upon receipt of a complete application, the initial reviewer will prepare a fee 

estimate covering the total fee expected to be necessary to complete the request for 

approval. This estimate will include testing costs and the cost of issuance for 

approval(s) or extension of approval(s). 

5.2.2.1.	 The applicant must respond to this request with either acceptance of the 

fee estimate and authorization of payment or a request to withdraw the 

application within two weeks or the application will be denied. 

5.2.2.2.	 If during the course of evaluation, NIOSH determines that the original fee 

estimate is not sufficient to cover the cost of processing the application, a 

revised fee estimate will be issued. As with the original estimate, the 

applicant must respond to this request with either acceptance of the reestimated fee and authorization of payment or a request to withdraw the 

application. 

5.2.2.3.	 NIOSH will send the final fee invoice will be sent with the certificate of 

approval letter. Payment is due from the approval holder within 30 days. 

5.2.2.4.	 Late notices will be provided when payment is past due by 60 and 90 

days. 

5.2.2.5.	 Should payment pass the due date by more than 120 days, NIOSH will 

initiate sanctions. In addition to the non-payment remedies specified at § 

84.22(c)(1), (2), and (3), the following specific actions will be considered 

as suggested by the specific circumstances related to outstanding, overdue 

payment(s): 

5.2.2.5.1. Suspension of processing for in-house applications. 

5.2.2.5.2. Revocation of approvals. (See 3.1.2)