Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 3891 

1This fee was improperly referenced as the 

‘‘approval’’ maintenance fee when HHS was instead 

requesting input on the records maintenance fee. As 

discussed below, commenters did offer feedback on 

the timing of the records maintenance fee. 

2The final fee schedules have been renamed and 

slightly reorganized and will be added to 42 CFR 

part 84 as appendices A and B. The fee schedules 

appear in full at the end of this document, 

following the regulatory text. 

accordance with the ‘‘Attorney 

General’s Supplemental Guidelines for 

the Evaluation of Risk and Avoidance of 

Unanticipated Takings’’ issued under 

the executive order. This rule does not 

impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501 et seq. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this document and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication in the Federal Register. A 

major rule cannot take effect until 60 

days after it is published in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). This 

action will be effective March 27, 2015, 

unless objections to this authorization 

are received. 

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous waste, Hazardous waste 

transportation, Indian lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements. 

Authority: This action is issued under the 

authority of sections 2002(a), 3006, and 

7004(b) of the Solid Waste Disposal Act, as 

amended, 42 U.S.C. 6912(a), 6926, and 

6974(b). 

Dated: January 13, 2015. 

Heather McTeer Toney, 

Regional Administrator Region 4. 

[FR Doc. 2015–01040 Filed 1–23–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 84 

[Docket No. CDC–2013–0004; NIOSH–216] 

RIN 0920–AA42 

Respirator Certification Fees 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Final rule. 

SUMMARY: The Department of Health and 

Human Services (HHS) is revising the 

fee structure 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 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. This final rule is 

designed to update the regulations. 

DATES: This final rule is effective on 

May 26, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Weiss, Program Analyst; 1090 

Tusculum Ave., MS: C–46, Cincinnati, 

OH 45226; telephone (855) 818–1629 

(this is a toll-free number); email 

NIOSHregs@cdc.gov. 

SUPPLEMENTARY INFORMATION: This final 

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 production sites 

and quality systems; (8) verifying 

quality system performance through 

manufacturing 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 preamble is organized as follows: 

I. Public Participation 

II. Background 

III. Summary of Final Rule and Response to 

Public Comments 

IV. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act of 1995 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

I. Public Participation 

Interested persons or organizations 

were invited to participate in this 

rulemaking by submitting written views, 

recommendations, and data. In addition, 

HHS invited comments specifically on 

the following: 

(1) To delay the implementation of 

the approval 1 maintenance fee specified 

in ‘‘Respirator Certification Fee 

Schedule A—Administrative Fees’’ 2

until 4 months after the publication date 

of the final rule to allow current 

approval holders to adjust their 

inventory of old, obsolete, or marginally 

profitable certificates of approval. In 

particular, HHS invited comments on 

whether 4 months after publication of 

the final rule allows for a sufficient 

amount of time to make such 

adjustments; and 

(2) One year as the minimum amount 

of time for new fees to remain in effect 

to provide manufacturers sufficient time 

to plan for application submissions and 

to determine which approvals to 

maintain. 

Substantive comments were 

submitted by 11 interested parties, both 

to the rulemaking docket and during the 

public meeting held April 30, 2013. 

Commenters included respirator 

manufacturers, trade associations, and a 

private testing laboratory. 

II. Background 

Under 42 CFR part 84—Approval of 

Respiratory Protective Devices, NIOSH 

approves respirators used by workers in 

mines and other workplaces for 

protection against hazardous 

atmospheres. The Mine Safety and 

Health Administration (MSHA) and the 

Occupational Safety and Health 

Administration (OSHA) require U.S. 

employers to supply NIOSH-approved 

respirators to their employees whenever 

the employer requires the use of 

respirators. NIOSH currently charges 

fees for the examination, inspection, 

and testing of such respirators which is 

necessary to grant the required 

approval. This final rule is designed to 

ensure that all approval activities are 

covered by appropriate fees, to update 

the fees charged, and to create a 


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3892 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 

mechanism for routinely updating fees 

in the future. 

Accordingly, with this rule, and for 

the reasons discussed in the notice of 

proposed rulemaking published on 

March 27, 2013 (78 FR 18535), HHS 

updates the fee structure for the 

inspection, approval, and certification 

of manufacturers’ respirators to cover 

the costs of these processes, and 

establishes a process to periodically 

update these fees through rulemaking as 

necessary to remain current with 

changes to costs arising from factors 

such as inflation, new certification 

requirements, and technological 

changes. 

III. Summary of Final Rule and 

Response to Public Comments 

This final rule amends several 

sections in 42 CFR part 84 and replaces 

Subpart C—Fees in its entirety. The 

revisions establish a new fee structure 

designed to enable NIOSH to fully 

recover the costs associated with the 

examination, inspection, and testing of 

complete respirator assemblies. Unlike 

the existing fee structure, the new fee 

structure takes into account the 

complexity of the class of respirator and 

the amount of testing required, as well 

as the work and resources required to 

perform the testing. Also, the new fee 

structure charges applicants for the 

costs of issuing, modifying, and 

maintaining certificates of approval, 

production facility inspection (site 

qualification fee), and for verification of 

ongoing quality system compliance and 

commercial product performance. 

The fee schedule is divided into two 

parts—Fee Schedule A comprises 

annual (fixed) fees; Fee Schedule B 

comprises application-based fees, 

including fees for individual test 

procedures. The fee schedules are 

included in new Appendices A and B to 

the regulatory text in Part 84. The final 

rule and fee schedules will be effective 

on May 26, 2015. As described in 

Appendix A, annual fees, including 

records maintenance, quality assurance 

maintenance, maintenance of testing 

and approval facilities, and 

maintenance of test equipment, will not 

be invoiced until 2015. As described in 

the fee schedule, NIOSH will send 

invoice previews to manufacturers for 

maintenance fees in July 2015 and final 

invoices in September 2015, with 

payment expected no later than October 

30, 2015; all other services will be billed 

upon completion of the project for 

which they were conducted. Subsequent 

fee schedules will be updated 

periodically by notice and comment 

rulemaking in the Federal Register, 

according to the provisions in § 84.23, 

discussed below. 

The following summary of public 

comments and NIOSH responses to the 

comments is organized by topic and by 

section, and describes and explains the 

provisions of the final rule. 

Overall Response 

Comment: Six commenters express 

unequivocal support for the fee 

increases. Of the six, some state that 

they understand NIOSH’s need to raise 

testing and certification fees, after not 

having done so in over 40 years. Two 

suggest that it is reasonable for 

manufacturers to expect NIOSH to 

provide improved services as a result of 

the higher fees. 

Two commenters express concern that 

increased fees would reduce worker 

safety. Specifically, one commenter is 

concerned that the fee increase may 

cause ‘‘manufacturers [to] scale back 

their research and development.’’ 

Another suggests that higher fees would 

be ‘‘passed on to the user in the form of 

higher prices.’’ 

Response: NIOSH recognizes the 

concerns expressed by the commenters. 

However, NIOSH does not believe that 

the fee increases, being relatively minor 

(as discussed in Section IV.A. of this 

preamble) could have a negative effect 

on research and development activities 

or the appropriate use of respirators. 

Furthermore, in accordance with OMB 

Circular No. A–25 Revised (OMB 

Circular), it is NIOSH’s obligation to 

‘‘ensure that each service, sale, or use of 

Government goods or resources 

provided by an agency to specific 

recipients be self-sustaining.’’ 

Use of Fee Increases 

Comment: Three commenters state 

that it is imperative that NIOSH does 

not transfer resources resulting in a 

reduction in service or an increase in 

certification processing time. The 

commenters encourage NIOSH to use 

the increased fees to add equipment or 

otherwise improve the certification 

process. Some commenters further 

assert that NIOSH should use the 

revised fees to establish firm 

certification time requirements or to 

maintain its current goal of completing 

respirator approvals within 90 days. 

Finally, one commenter indicates that 

some certification agencies offer 

expedited service for a higher fee and 

encourages NIOSH to pursue this 

possibility. 

Response: NIOSH has historically 

used retained fees within the 

certification program to maintain and 

improve current operations (e.g., to 

replace equipment and supplies), and 

intends to continue using the collected 

fees to augment certification activities. 

NIOSH is committed to working with 

manufacturers to maintain efficient 

turnaround times and expeditiously 

process the certification applications. 

NIOSH is also committed to equitable 

treatment of applicants without regard 

to ability or willingness to pay and 

accordingly will not establish expedited 

testing services on a supplemental fee 

basis. 

Comment: One commenter suggests 

that the revised fees should support a 

higher priority for correlation testing. 

Response: The revised fee schedules 

are not intended to support a higher 

priority for correlation testing, although 

NIOSH will continue to provide this 

service to applicants. NIOSH prioritizes 

activities that most directly increase, 

monitor, and ensure the quality of the 

national inventory of respiratory 

protective devices. 

Number of Approvals 

Comment: Several of the annual 

administrative and maintenance fees in 

Fee Schedule A are applicable ‘‘per 

every active approval on file with 

NIOSH.’’ Two commenters request 

clarification of the meaning of the 

phrase ‘‘every active approval on file,’’ 

and ask whether ‘‘every active 

approval’’ is intended to indicate every 

respirator model or every NIOSH testing 

and certification (TC) number. 

Response: ‘‘Every active approval’’ 

means every TC number on file with 

NIOSH; TC numbers are issued to 

identify specific respirator approvals. 

NIOSH recognizes three kinds of 

approvals: active, obsolete, and 

revoked/rescinded; the NIOSH Certified 

Equipment List (CEL) contains all active 

and obsolete approvals and does not 

contain revoked/rescinded (delisted) TC 

numbers. Together, active and obsolete 

approvals are referred to as ‘‘listed’’ 

approvals. 

Active approvals are those under 

which a manufacturer is currently 

authorized by NIOSH to produce and 

offer for sale respirator configurations 

represented as NIOSH-approved 

devices. 

Obsolete approvals are also 

considered to be active approvals 

because the respirator model is still 

being used in the workplace and the 

manufacturer can continue to sell spare 

parts for the fielded units even though 

the device is no longer being 

manufactured and there is no plan to 

resume production. NIOSH retains and 

actively maintains the records of 

obsolete approvals. 

Delisted approvals have been 

removed from the CEL product listings 


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Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 3893 

through either NIOSH revocation for 

cause or the approval holder’s request 

for voluntary rescission of approval. 

NIOSH archives the records of revoked 

or rescinded approvals. 

Where applicable to both active and 

obsolete approvals in the fee schedule, 

NIOSH has replaced the term ‘‘active’’ 

with ‘‘listed.’’ 

Comment: One commenter suggests 

that NIOSH should determine how a 

manufacturer can obsolete an approval. 

Response: To obsolete an approval, 

manufacturers should submit a 

Standard Application for the Approval 

of Respirators to NIOSH and specify in 

the ‘‘application type’’ section of the 

application that they desire to obsolete 

the existing approval. The Standard 

Application Procedure for the 

Certification of Respirators under 42 

CFR 84 (Standard Application 

Procedure) will be updated to inform 

manufacturers of the procedures to 

follow to obsolete an approval. 

Comment: Three commenters express 

concern that the NIOSH Certified 

Equipment List (CEL) and the 

manufacturers’ internal records of 

approvals may not agree. They would 

also like a method for resolving 

discrepancies and ask that NIOSH 

provide a list of current active, obsolete, 

and inactive approvals. 

Response: NIOSH considers the 

information in the Certified Equipment 

List to be correct and that the CEL is the 

official location of these records. If an 

approval holder has a discrepancy they 

should contact NIOSH for resolution 

and clarification. As requested, NIOSH 

will send each manufacturer a list of 

current approvals. 

Assignment of Testing and Certification 

(TC) Numbers 

Comment: Two manufacturers express 

concerns that the procedures for 

assigning approval (TC) numbers to 

respirator configurations are not welldefined or consistent. Commenters 

argue that NIOSH practice is to issue 

‘‘separate approval numbers for 

variations of a device rather than 

allowing variations to be included in the 

umbrella of a single approval,’’ and that 

more approval numbers will result in 

more fees. 

Response: NIOSH determines whether 

a requested configuration can be 

evaluated as a modification to an 

existing approval or requires a new TC 

number during the application review 

process. If a change is made to an 

approved respirator configuration that 

allows the end-user to be able to build 

more than one unique configuration that 

does not visually appear the same or 

does not provide the same protections 

as the approved configuration, a new TC 

number is issued for the modified 

configuration. If the modification does 

not substantially change the appearance 

or performance of the respirator, the 

modification will be incorporated into 

the existing TC number. The original 

configuration will retain the existing TC 

number. 

Revision of Standard Application Form 

Comment: One commenter suggests 

that the Standard Application for the 

Approval of Respirators should be 

revised to include the standard test 

procedure (STP) identification numbers 

to assist in aligning certification 

activities and expected fees. 

Response: NIOSH concurs with the 

need for improved tools and 

information for manufacturers to align 

activities with fees, and accepts the 

recommendation to link the STPs to 

certification activities and fees in the 

Standard Application Procedure, which 

will be revised for this purpose. 

Testing by Private Sector Laboratories 

Comment: One commenter suggests 

that NIOSH pursue the use of private 

sector laboratories to do certification 

testing rather than establishing fees to 

cover the current costs of testing by the 

government. 

Response: NIOSH has, at times, used 

third parties to perform certain specific 

parts of respirator testing activities. For 

example, chemical warfare agent tests 

(conducted to evaluate chemical, 

biological, radiological, and nuclear 

protections) are presently performed by 

the U.S. Army Edgewood Chemical and 

Biological Center with oversight 

provided by NIOSH. NIOSH is 

continuing to assess options for third 

party testing. However, the matter is 

outside the scope of this rulemaking. No 

changes to the final rule are made in 

response to this comment. 

Air-Supplying Respirator Clarification 

Comment: One commenter is 

concerned about the use of the terms 

‘‘air-supplying’’ and ‘‘air-supplied’’ 

rather than ‘‘atmosphere-supplying’’ to 

specify one of the broad groupings of 

respirators referenced in the proposed 

rule preamble and in Fee Schedule B. 

The commenter’s specific concern is 

whether respirators that supply oxygen 

by means of chemical oxygen generation 

or using compressed oxygen will no 

longer be approved by NIOSH. 

Response: Respirators approved by 

NIOSH fall into two broad categories: 

‘‘Air- or atmosphere-supplying’’ and 

‘‘air- or atmosphere-purifying.’’ NIOSH 

has consistently used the phrases ‘‘airsupplying’’ and ‘‘air-supplied’’ 

throughout 42 CFR part 84 and other 

official NIOSH documents to refer to 

respirators which supply air to the 

respirator user from remote air supplies, 

chemical generation of oxygen, 

controlled release of compressed 

oxygen, or other means of supplying air/ 

oxygen. The Occupational Safety and 

Health Administration uses the term 

‘‘atmosphere-supplying respirator’’ in 

29 CFR 1910.134 to refer to a respirator 

that supplies the respirator user with 

breathing air from a source independent 

of the ambient atmosphere, and 

includes supplied-air respirators (SARs) 

and self-contained breathing apparatus 

(SCBA) units. NIOSH considers the 

terms ‘‘air-supplying,’’ ‘‘air-supplied,’’ 

and ‘‘atmosphere-supplying’’ to be 

equivalent. 

NIOSH will continue to use the 

phrases ‘‘air-supplying’’ or ‘‘airsupplied’’ to describe this type of 

respirator. Use of these terms does not 

reflect any change in policy or 

regulation about the types of respirators 

which are referenced or will be 

approved. 

Balance of Fees Between Small and 

Large Companies 

Comment: One commenter expresses 

concern that NIOSH’s plan to base fees 

on the number of existing approvals will 

minimize fees to small companies that 

hold a limited number of approvals but 

also may give them an unfair advantage 

by conveying benefits and services 

which are not fully covered by the fees 

that they are charged. For example, the 

commenter points out that because the 

new fees will be assessed per every 

active approval on file with NIOSH, 

manufacturers with few approvals will 

not be charged for ‘‘services and benefits 

that they alone receive,’’ such as the 

quality site audit. 

Response: NIOSH is committed to 

ensuring that the fees charged to small 

and large companies are commensurate 

with their costs. NIOSH finds that a fee 

based on the number of approvals held 

is appropriate for recovering fixed costs. 

However, because NIOSH does 

acknowledge this approach may not 

always recover the full cost of services 

to companies with a very limited 

number of approvals, NIOSH is 

expanding the use of the concept of 

fixed costs and variable costs to the 

quality assurance maintenance (site 

audit), maintenance of product 

performance (product audit), and site 

qualification fees (discussed below). 

Where possible, fixed costs will be 

broken out and based on the broadest 

possible base (such as number of 

approval holders or number of listed 

approvals held). Likewise, variable costs 


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3894 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 

will be calculated and fees will be based 

on one or more measures associated 

with the work performed. NIOSH has 

determined that these modifications 

will more equitably support the actual 

usage of the various NIOSH services as 

well as contributing to the costs for 

maintaining their continued availability. 

Section 84.2 Definitions 

This existing section establishes 

definitions of terms found in the Part 84 

regulations. 

Comment: One commenter indicates 

that NIOSH must add a definition for 

NIOSH National Personal Protective 

Technology Laboratory (NPPTL). 

Another commenter indicates that the 

definition of Certification and Quality 

Assurance Branch (CQAB) should be 

stricken from 42 CFR 84.2. 

Response: The definition of NPPTL 

was proposed in the notice of proposed 

rulemaking and is included in 42 CFR 

84.2. Further, NIOSH agrees that the 

definition of ‘‘Certification and Quality 

Assurance Branch’’ is outdated, and is 

stricken from § 84.2. The term 

‘‘Certification and Quality Assurance 

Branch’’ is replaced with ‘‘National 

Personal Protective Technology 

Laboratory (NPPTL).’’ As discussed 

below, all references to the 

‘‘Certification and Quality Assurance 

Branch’’ are stricken from all of Part 84. 

Finally, the definition of ‘‘Institute’’ is 

also slightly amended to include the 

acronym ‘‘NIOSH.’’ 

Section 84.10 Application Procedures 

This existing section establishes 

procedures for submitting applications 

to NIOSH for respirator approval. 

Although no comments were received 

on this section, changes have been made 

to this section to clarify that 

applications must be submitted in 

accordance with the Standard 

Application Procedure. The text has 

also been changed to acknowledge that 

the NIOSH National Personal Protective 

Technology Laboratory may use an 

independent laboratory to conduct 

certification testing, at its discretion. 

Section 84.12 Delivery of Respirators 

and Components by Applicant; 

Requirements 

Section 84.12 specifies the 

requirements for submitting respirators 

to NIOSH for certification testing. 

Paragraph (b) of this existing section is 

revised to identify NPPTL as the entity 

to which applicants must deliver 

respirator units for certification testing. 

Although no comments were received 

on this section, the text has been 

changed slightly to clarify our intent. 

Section 84.19 Applicability 

Proposed § 84.19 was intended to 

specify the effective dates of various 

parts of the rule. However, because this 

section was confusing and NIOSH’s 

intent better communicated by 

extending the effective date of the rule 

and clarifying the dates in the fee 

schedule, this section has been stricken. 

Comment: Two commenters suggest 

alternate phase-in schedules for the new 

fees, citing a concern that manufacturers 

will find the 4-month implementation 

plan to be a hardship. One suggests that 

NIOSH should phase in the new fee 

schedule over the course of 3 years; the 

other was to delay implementation for 

18 months for current approval holders. 

Response: After consideration of 

public comments as well as 

programmatic administrative concerns, 

NIOSH has found it appropriate to 

extend the effective date of this final 

rule to 120 days after publication. 

Accordingly, the application-based fees 

in Appendix B, as well as the product 

audit fee in Appendix A will be 

effective and applicable beginning on 

[INSERT DATE 120 DAYS AFTER 

PUBLICATION IN THE Federal 

Register]. The fixed fees in Appendix A 

will be determined on a typical annual 

period. Manufacturers will be sent an 

invoice preview showing initial fixed 

(annual) fee assessments for records 

maintenance, quality assurance 

maintenance, and maintenance of 

testing and approval facilities and test 

equipment in July 2015 and a final 

invoice in September (with payment 

expected by the end of October 2015). 

If an approved respiratory protective 

product has been selected for evaluation 

in a product audit as part of the planned 

quality assurance maintenance activities 

for the upcoming year, the invoice will 

include a fee to cover NIOSH purchase 

of audit product samples. The assessed 

fee for purchase of audit samples can be 

reduced or eliminated if test samples are 

made available to NIOSH without 

charge. 

Section 84.20 Establishment of Fees 

Section 84.20 replaces existing § 84.20 

in its entirety. Paragraph (a) establishes 

the fee structure for the examination, 

inspection, and testing required to issue, 

maintain, and modify certificates of 

approval. Paragraph (b) specifies the 

activities for which NIOSH will charge 

fees, including (1) application and 

approval processing; (2) approval 

maintenance, including records 

management, product audits, and site 

audits; and (3) the qualification of new 

respirator production sites. Finally, 

paragraph (c) specifies the activities for 

which NIOSH does not intend to charge 

fees. HHS received many comments on 

the specific fees within § 84.20; those 

comments and the corresponding 

responses are identified by paragraph, 

below. Changes have been made to the 

rule text to better clarify our intent, and 

changes to the fee schedule have been 

made in response to public comment. 

The specific changes are discussed 

below. 

Application Processing [§ 84.20(b)(1)] 

Comment: One commenter believes 

that applications vary in complexity 

and, therefore, more NIOSH resources 

will be required for issuing, modifying, 

and maintaining certificates of approval 

for more complicated devices as 

compared to simpler ones. According to 

the commenter, applications requiring 

more resources should result in higher 

fees than ones requiring less 

information and material. 

Response: The commenter correctly 

points out that the time to process 

different applications is variable. 

NIOSH concurs that this variability is 

not reflected anywhere in the current or 

updated fees process. The proposed fee 

was calculated to cover an application 

time of 4 ± 2 hours, which is the average 

amount of time it takes NIOSH to 

complete a review of the application. In 

NIOSH’s experience, very few 

applications require more than 6 hours 

to complete. To address variation 

between application processing times, 

NIOSH will retain a single basic 

application fee of $200 per application 

to be submitted with each application. 

Because NIOSH has not historically 

tracked application processing times, 

we will monitor the application 

processing times to obtain current 

information during implementation of 

the new fee structure. As discussed 

below, the fee schedules will be 

reviewed every two years to assure that 

the fees are being assessed as intended. 

Comment: Two commenters observed 

that modifications of approvals vary in 

complexity and, therefore, the resources 

required for processing them vary as 

well. Applications requiring more 

resources should cost more than ones 

requiring less information and material. 

Another commenter suggests that fees 

for modification of approvals (e.g., 

‘‘adding new cleaning and disinfection 

procedures to the Instructions for Use, 

document format changes and any other 

type of modification to the records that 

may be currently on file at NIOSH 

where testing is not required’’) should 

incur lower fees or include only the 

application fee and not the product 

modification fee. 


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Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 3895 

Response: The modification of 

approval fee covers the cost of issuing 

the modification, which is basically a 

fee for generating a written letter to 

approval holders acknowledging the 

modification of certification. The costs 

associated with processing approval 

modifications do not vary significantly. 

Differences in the complexity of a 

modification of approval are captured in 

the same way as applications for new 

approval with the variable application 

and testing fees. The application fee is 

set at $100 for each new approval 

granted; the approval modification fee is 

set at $50 for each modification of an 

existing approval. No changes to the fee 

schedule have been made in response to 

this comment. 

Records Maintenance [§ 84.20(b)(1)] 

Comment: One commenter does not 

concur with NIOSH’s assertion that 

records maintenance fees are predicated 

on an analysis of the OMB Circular, 

which requires agencies to establish 

charges for special benefits provided to 

specific recipients. One example of a 

special benefit is a license to carry on 

a specific activity. The commenter 

‘‘contends that the special recipient is 

actually the respirator user,’’ and not the 

manufacturer. 

Response: As discussed in the notice 

of proposed rulemaking (78 FR 18535, 

18537), NIOSH finds that because 

manufacturers derive economic benefit 

from the sale of respirators which would 

not be possible without NIOSH 

approval, the approval is a license, and 

the manufacturer is the special 

beneficiary. Although the current fee 

structure and rates have not been 

adjusted in recent years to cover the 

actual program costs for the 

examination, inspection, and testing of 

complete respirator assemblies, the 

principle of the government recovering 

fees from the applicant are traceable to 

the origins of the standards. 

Comment: Eight stakeholders 

comment on the records maintenance 

fee. One questions whether the fee 

implies that NIOSH will review all 

approvals annually, and recommends 

that we base the records maintenance 

fee on the complexity of the device and 

the number of records associated with 

the approval. Another asserts that since 

NIOSH does not maintain samples of 

approved products, approvals should 

require very little maintenance, and that 

there should be no costs to 

manufacturers. The commenter further 

states that the records maintenance fee 

‘‘appears to be more of a NIOSH 

imposed manufacturer tax.’’ The 

remaining commenters feel either that 

records maintenance fees should be the 

same for all approvals regardless of 

status, or alternatively that they should 

not be the same and should instead be 

based on the approval status (active, 

obsolete, or revoked/rescinded). 

Response: The records maintenance 

fee pays for the computer database used 

to hold and access all of the records of 

listed (active and obsolete) approvals. 

The fee also pays for NIOSH staff to 

maintain and modify the database. All 

active and obsolete approval records 

must be retained, retrievable, and 

maintained, even though they may not 

be routinely used, reviewed, or 

inspected. 

NIOSH has considered basing the fee 

on the number of approval holders 

(manufacturers) or, alternatively, on the 

number of records in the files. Neither 

of these options would improve the 

proposed fee structure in terms of 

equitably distributing costs among 

approval holders. Therefore, HHS finds 

it appropriate to establish a flat fee for 

records maintenance for all listed 

approvals, based on the number of 

active and obsolete approvals contained 

in the NIOSH Certified Equipment List, 

as presented in the proposed rule. 

Maintenance of NIOSH Facilities and 

Test Equipment [§ 84.20(b)(2)] 

Comment: One commenter agrees that 

the facilities maintenance fee is fixed 

and independent of certification activity 

or approval status in any given year. 

Two commenters suggest that 

maintenance fees should be based on 

the activity status of respirator 

approvals. Two commenters state that 

any maintenance fee is an economic 

hardship that could ‘‘ultimately lead to 

diminished availability of variations 

and choices to the users.’’ 

Response: Maintenance of facilities is 

a fixed cost. NIOSH has determined that 

it is equitable to spread this cost over all 

approvals. For these purposes, the 

activity status of an application is not an 

important cost factor. NIOSH has 

retained the proposed maintenance of 

facilities fees. 

Comment: One commenter suggests 

that testing equipment depreciation be 

spread out over the life of the 

equipment. One manufacturer 

comments that the testing fees should be 

modified to capture the depreciation 

cost associated with maintaining testing 

capacity. 

Response: Maintenance of test 

equipment is a fixed cost. NIOSH can 

neither predict which applications will 

be submitted by manufacturers, nor 

which pieces of equipment will be 

required to support these applications. 

Therefore, we cannot estimate the use of 

each piece of equipment and 

incorporate that into the testing fees 

schedule. However, NIOSH recognizes 

that listed approvals identified as 

obsolete are not expected to require the 

use of test equipment. Accordingly, 

NIOSH has determined that it is 

equitable to spread this cost over all 

listed active approvals and to exempt 

facilities maintenance fees for listed 

obsolete approvals, and has so amended 

Fee Schedule A. 

Site Qualification [§ 84.20(b)(3)] 

Comment: One commenter asks if the 

site qualification fee is intended for new 

manufacturers who do not yet have 

NIOSH approvals or if it is intended for 

the routine ongoing factory quality 

system audits. Four commenters state 

that the $5000 fixed cost for a new site 

qualification should be reconsidered in 

favor of charging direct and true costs. 

Response: The site qualification fee is 

different from the quality assurance 

maintenance (site audit) fee: The former 

provides for a one-time inspection of 

new production facilities; the latter for 

the ongoing manufacturing quality 

system audits NIOSH requires of 

approval holders. As discussed in the 

notice of proposed rulemaking (78 FR 

18535, 18544), the site qualification 

program is designed to cover three 

groups of manufacturers. The first group 

consists of manufacturers with no 

approvals who want to receive a 3-letter 

manufacturer’s code. This is the first 

step in submitting a respirator for 

NIOSH approval. The code is issued 

after receipt of an application if NIOSH 

is satisfied that the potential approval 

holder has the capabilities and 

documented system required to 

manufacture a quality product; the site 

qualification inspection is a tool to 

provide that assurance. The 

manufacturers in this group are 

basically unknown to NIOSH, and will 

have a site visit to determine their 

manufacturing abilities and credibility 

to become an approved respirator 

manufacturer. 

The second group consists of 

manufacturers that have one or more 

listed NIOSH-approved respirators and 

that are in the process of opening a new 

manufacturing site for the production of 

respirators. These manufacturers will 

require a document review to determine 

their manufacturing capabilities to 

produce approved respirators at the new 

site. 

The third group consists of NIOSH 

approval holders that have been 

acquired by another entity and the 

manufacturing site for the production of 

approved respirators is relocated to a 

new site. These manufacturers will also 

require a document review to determine 


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3896 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 

their manufacturing capabilities to 

produce approved respirators at the new 

site. 

In response to public comments, 

NIOSH has reconsidered the site 

qualification fee, which will now 

distinguish between the cost of a paperbased review for the new manufacturing 

site of an existing approval holder and 

the actual cost of a one-time site visit for 

manufacturers with no existing 

approvals. Flat fees will be established 

for the inspection of domestic and 

foreign manufacturing sites, 

respectively. Fee Schedule B has been 

amended accordingly. 

Quality Assurance Maintenance (Site 

Audits) [§ 84.20(b)(4)] 

Comment: Six commenters express 

concern about using the number of 

approvals as the basis for calculating the 

quality site audit fee. All six 

commenters suggest that the fees should 

be tied to the actual (or average) cost to 

perform each site audit. One commenter 

asks for clarification of the intent of this 

fee, and claims that the quality 

assurance maintenance fee and the 

maintenance of product performance fee 

(discussed below) will result in 

economic hardship to manufacturers, 

which in turn will impact the U.S. 

workforce and the ‘‘overall safety of the 

working public.’’ 

Response: The fees for the site audit 

program are divided between 

management of the site audit program 

(largely fixed costs) and individual 

quality audits and associated expenses 

(variable costs). NIOSH has modified 

the site audit fee in response to the 

commenters’ request that the fee be 

more equitably allocated. Accordingly, 

the quality assurance maintenance (site 

audit) fee will be a combination of fixed 

and variable costs. Beginning in 2015, 

manufacturers will be charged annually 

a flat fee per every manufacturing site 

registered with NIOSH (those sites that 

exclusively conduct design activities are 

exempt from this annual fixed fee). 

Variable fees will be billed within the 

fiscal year during which the site audit 

is conducted, and are established based 

on the duration of the audit (either 1 or 

2 days) and whether the site is domestic 

or outside the United States. Any site 

that is not scheduled to be audited 

within a fiscal year will not be billed the 

variable fee for that year. The variable 

cost fee also applies to sites that only do 

design. Fee Schedule A has been 

amended accordingly. 

Maintenance of Product Performance 

(Product Audits) [§ 84.20(b)(5)] 

Comment: One commenter stated that 

NIOSH should not be billing 

manufacturers for product audits 

because manufacturers have no input in 

determining which products NIOSH 

will select for audit. One commenter 

feels that, ‘‘[s]ince NIOSH does not 

typically maintain samples of approved 

products there should be no reason to 

charge the Manufacturers a fee for the 

maintenance.’’ If a change of the 

product or design of any type is 

requested by the manufacturer, it will be 

submitted to NIOSH as an Extension of 

Approval at which time the submittal 

fee is charged.’’ Another commenter 

states that NIOSH should charge each 

approval holder directly for the cost of 

product audits, rather than add the fee 

to a modification request. One 

commenter further supports the use of 

a respirator selection audit logic to 

establish an audit schedule for the 

upcoming year, allowing NIOSH time to 

notify manufacturers that a charge is 

forthcoming. 

Response: The maintenance of 

product performance fee allows NIOSH 

to purchase and test commercially 

available respirators for audit. The 

purpose of the NIOSH product audit 

program is to select respirators for sale 

in the marketplace and test them in the 

laboratory to verify that approved 

manufacturing systems are meeting 

NIOSH quality standards. Participating 

in the product audit program is an 

obligation of all approval holders, and 

all listed approvals are subject to audit. 

NIOSH has a process in place to 

identify and help prioritize the 

identification of respirator 

configurations for audit activities. 

NIOSH introduced the ‘‘Default to Test’’ 

procedures in 2009 to support the 

product audit program. These 

procedures were implemented to help 

locate and procure samples of product 

for testing, and were developed to work 

within funding limitations that 

constrained the number and types of 

respirator configurations as well as how 

many products NIOSH could 

accommodate for testing and evaluation. 

NIOSH is exploring approaches to be 

able to efficiently, effectively, and 

economically obtain candidate 

respirators for product audit without 

placing undue burden on the 

manufacturers of those products. The 

increased fees recovered for product 

audits will enable NIOSH to redesign 

the product audit program, to make its 

scope and content more consistent with 

the wide variety of products being 

marketed under the NIOSH approval 

label. 

Manufacturers can defray the audit 

costs by providing sample units rather 

than providing funds to NIOSH to 

purchase the samples. Respirators 

selected for audit may be obtained from 

distributors and other typically 

available market outlets, or directly 

from the manufacturer during 

production runs. 

In response to comments, NIOSH 

agrees to de-couple the maintenance of 

product performance (product audit) fee 

from the fee for approval modification. 

The product audit fee is segmented into 

an annual fixed cost fee and a variable 

cost fee that is assessed based on the 

respirators chosen to be tested each 

year. The fixed cost portion of the fee 

is designed to cover the cost of staff 

associated with product audit program 

management. The variable fee is 

designed to cover the cost to NIOSH of 

obtaining sample respirators and 

performing the audit tests. This variable 

fee will be collected for the same fiscal 

year in which the product audit is 

scheduled to occur. The fee schedules 

have been changed accordingly. 

Comment: One commenter inquires 

whether the closed-circuit escape 

respirators sampled in the Long-Term 

Field Evaluation (LTFE) program will be 

billed to the approval holder as a 

component of the product audit 

sampling program. 

Response: Although the LTFE 

program is a component of the product 

audit program, respirators used in the 

LTFE program are currently not billed to 

the approval holder. Approval holders 

will, however, be billed for closedcircuit escape respirators chosen for 

routine audit sampling. 

Section 84.21 Fees Calculation 

Section 84.21 specifies how fees will 

be calculated and administered. 

Although no comments were received 

on this section, the rule text is changed 

to better clarify our intent. 

Section 84.22 Fee Administration 

Section 84.22 establishes the 

procedure NIOSH will use to invoice 

applicants. Although there are no 

changes made to this section as a result 

of public comment, HHS is making 

slight adjustments to the rule text in 

paragraphs (a) and (b) to clarify our 

intent. 

Comment: Four commenters ask that 

the fee system be as simple as possible 

and that manufacturers receive a single, 

consolidated maintenance invoice at the 

same time each year. One commenter 

asks whether manufacturers will be 

invoiced on a calendar year or on the 

U.S. Government fiscal year basis. They 

also requested that online billing be 

available so that manufacturers can 

‘‘view and update their records without 

an overabundance of paperwork.’’ 


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Response: NIOSH intends to send a 

single consolidated invoice for annual 

maintenance fee assessments in the 

month of September, with payment 

expected in October. Pay.gov will be 

available for online fee collection, and 

we expect it to become the preferred 

means for the collection of fees in the 

future. 

Comment: One manufacturer concurs 

that NIOSH should have the ability to 

impose sanctions on manufacturers who 

may miss one or several payments, but 

requests clarification regarding what 

constitutes a missed payment. The 

commenter proposes that a minimum 

period of 120 days from the date of the 

invoice be allowed before the payment 

is considered to be ‘‘missed.’’ 

Response: Standard government 

contracts are written in terms of ‘‘net 60 

days.’’ This implies a standard payment 

period of 60 days. Late payment notices 

are typically sent at 60 and 90 days. 

Missed payment activity would 

typically start at 120 days. Accordingly, 

NIOSH will send late payment notices 

at 60 and 90 days and missed payment 

activity will start at 120 days. 

Section 84.23 Fee Revision 

Section 84.23 establishes the fee 

schedules for NIOSH’s respirator 

certification activities. 

Comment: Three commenters ask that 

NIOSH provide a formal mechanism for 

public comment prior to any future 

revisions to the fee schedules. 

Response: NIOSH agrees to propose 

future fee schedule revisions in the 

Federal Register, subject to public 

comment. Accordingly, the fee 

schedules are added to 42 CFR part 84 

in a new Appendix A (annual fees) and 

a new Appendix B (application-based 

fees). 

Comment: One commenter suggests 

that a 1-year period between revisions of 

fees schedules will not allow sufficient 

time for companies to plan. The 

commenter proposes a fixed 5-year 

interval for fee revisions with no 

revisions outside of the 5-year cycle. 

Response: HHS agrees that the 

proposed 1-year interval between 

revisions of the fee schedules may not 

provide sufficient time for planning; 

however the 5-year minimum suggested 

by the commenter will be inadequate to 

keep fees reasonably updated. Variables 

such as inflation and other factors that 

might affect the cost of testing supplies 

will be taken into account as NIOSH 

updates the fee schedules. Accordingly, 

in response to public comment and in 

accordance with the OMB Circular, the 

rule text is changed to establish a 2-year 

minimum interval for fee schedule 

revisions. The text is further changed to 

indicate that the fee schedules will not 

be revised at least once every 5 years, 

as proposed, and instead will be revised 

as needed based on the biennial 

reviews. 

Section 84.24 Authorization for 

Additional Tests and Fees 

Section 84.24 allows NIOSH the 

discretion to conduct special or 

additional examinations, inspections, or 

tests, apart from those specified for a 

particular respirator class under this 

Part, as might be necessary due to 

unusual characteristics of the respirator 

design, manufacturing information, or 

product samples. The text has been 

changed to acknowledge that the NIOSH 

National Personal Protective 

Technology Laboratory may use an 

independent laboratory to conduct 

certification testing, at its discretion. No 

comments were received on this section. 

Section 84.36 Delivery of Changed or 

Modified Approved Respirator 

Section 84.36 informs manufacturers 

that respirators for which a formal 

certificate of modification has been 

issued should be delivered to the 

National Personal Protective 

Technology Laboratory, rather than the 

Certification and Quality Assurance 

Branch. 

Section 84.41 Quality Control Plans; 

Contents and 84.43 Quality Control 

Records; Review by the Institute; 

Revocation of Approval 

Existing §§ 84.41 and 84.43 establish 

requirements for quality control plans 

and records. These sections are 

amended to replace reference to the 

‘‘Certification and Quality Assurance 

Branch’’ with ‘‘National Personal 

Protective Technology Laboratory.’’ 

Section 84.66 Withdrawal of 

Applications 

Existing § 84.66 establishes 

procedures for the withdrawal of 

respirator certification applications. 

Paragraph (b) directs stakeholders to the 

fee calculation procedures in § 84.21(e) 

for the withdrawal of applications, 

where NIOSH has already performed 

some administrative and/or testing 

services. There are no changes made to 

this section as a result of public 

comment. 

Comment: In response to NIOSH’s 

statement in the preamble to the 

proposed rule that more information 

about billing will be available in the 

guidance document Standard 

Application Procedure, one commenter 

says that the current edition of the 

Standard Application Procedure does 

not address billing under the new rule 

and that the new billing procedures 

were not made available for public 

comment. 

Response: NIOSH respirator 

certification fee estimates will be 

calculated according to the procedures 

established in § 84.21. Paragraph (e) of 

that section concerns those applications 

for which a manufacturer opts to 

withdraw an application but NIOSH has 

already begun application review and 

testing. In that case, according to 

§ 84.21(e), the applicant will be 

invoiced for services already performed 

by NIOSH. 

Although HHS provided an 

opportunity to comment on the 

proposed withdrawal billing procedures 

in § 84.21(e), no comments were 

received. 

Section 84.76 Facepieces; Eyepieces; 

Minimum Requirements 

Existing § 84.76 establishes minimum 

requirements for facepieces and 

eyepieces for self-contained breathing 

apparatus. The text in paragraph (b) is 

amended to replace ‘‘Certification and 

Quality Assurance Branch’’ with 

‘‘National Personal Protective 

Technology Laboratory.’’ 

Section 84.79 Breathing Gas; 

Minimum Requirements 

Existing § 84.79 establishes minimum 

requirements for breathing gas. The text 

in paragraphs (c) and (d) is amended to 

replace ‘‘Certification and Quality 

Assurance Branch’’ with ‘‘National 

Personal Protective Technology 

Laboratory.’’ 

Section 84.81 Compressed Breathing 

Gas and Liquefied Breathing Gas 

Containers; Minimum Requirements 

Existing § 84.81 establishes minimum 

requirements for compressed breathing 

gas and liquefied breathing gas. The text 

in paragraph (d) is amended to replace 

‘‘Certification and Quality Assurance 

Branch’’ with ‘‘National Personal 

Protective Technology Laboratory.’’ 

Section 84.97 Test for Carbon Dioxide 

in Inspired Gas; Open- and ClosedCircuit Apparatus; Maximum Allowable 

Limits 

Existing § 84.97 establishes the 

method NIOSH uses to measure the 

concentration of carbon dioxide in 

inspired gas in open- and closed-circuit 

respirators. The text in paragraph (a) is 

amended to replace ‘‘Certification and 

Quality Assurance Branch’’ with 

‘‘National Personal Protective 

Technology Laboratory.’’ 


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Section 84.110 Gas Masks; Description 

Existing § 84.110 includes 

descriptions of different types of gas 

masks. The text in paragraph (c) is 

amended to replace ‘‘Certification and 

Quality Assurance Branch’’ with 

‘‘National Personal Protective 

Technology Laboratory.’’ 

Section 84.113 Canisters and 

Cartridges; Color and Markings; 

Requirements 

Existing § 84.113 establishes 

requirements for the color and markings 

of canisters and cartridges or labels. The 

text is amended to replace ‘‘Certification 

and Quality Assurance Branch’’ with 

‘‘National Personal Protective 

Technology Laboratory.’’ 

Section 84.119 Facepieces, Eyepieces; 

Minimum Requirements 

Existing § 84.119 establishes the 

minimum requirements for facepieces 

and eyepieces for gas masks. The text in 

paragraph (b) is amended to replace 

‘‘Certification and Quality Assurance 

Branch’’ with ‘‘National Personal 

Protective Technology Laboratory.’’ 

Section 84.136 Facepieces, Hoods, and 

Helmets; Eyepieces; Minimum 

Requirements 

Existing § 84.136 establishes the 

minimum requirements for facepieces, 

hoods, and helmets for gas masks. The 

text in paragraph (b) is amended to 

replace ‘‘Certification and Quality 

Assurance Branch’’ with ‘‘National 

Personal Protective Technology 

Laboratory.’’ 

Section 84.141 Breathing Gas; 

Minimum Requirements 

Existing § 84.141 establishes the 

minimum requirements for breathing 

gas for supplied-air respirators. The text 

in paragraphs (b) and (c) is amended to 

replace ‘‘Certification and Quality 

Assurance Branch’’ with ‘‘National 

Personal Protective Technology 

Laboratory.’’ 

Section 84.193 Cartridges; Color and 

Markings; Requirements 

Existing § 84.193 establishes 

requirements for the color and markings 

of all cartridges or labels. The text is 

amended to replace ‘‘Certification and 

Quality Assurance Branch’’ with 

‘‘National Personal Protective 

Technology Laboratory.’’ 

Section 84.258 Fees 

Existing § 84.258 is removed from 

subpart N. This section contains a 

special respirator fee schedule for vinyl 

chloride respirators. The fees 

established by this final rule under 

§ 84.21 apply to this group of 

respirators. No comments were received 

on this section. 

Section 84.1102 Fees 

Existing § 84.1102 is removed from 

subpart KK. This section contains a 

special respirator fee schedule for a 

series of respirators, including powered 

air purifying respirators. The fees that 

are established by this final rule under 

§ 84.21 apply to this group of 

respirators. No comments were received 

on this section. 

Section 84.1136 Facepieces, Hoods, 

and Helmets; Eyepieces; Minimum 

Requirements 

Existing § 84.1136 establishes the 

minimum requirements for facepieces, 

hoods, and helmets for dust, fume, mist, 

pesticide, paint spray, and powered airpurifying high efficiency respirators and 

combination gas masks. The text in 

paragraph (b) is amended to replace 

‘‘Certification and Quality Assurance 

Branch’’ with ‘‘National Personal 

Protective Technology Laboratory.’’ 

Section 84.1154 Canister and 

Cartridge Requirements 

Existing § 84.1154 establishes 

requirements for two or more canisters 

and for color and markings of canisters 

or cartridges and labels for facepieces, 

hoods, and helmets for dust, fume, mist, 

pesticide, paint spray, and powered airpurifying high efficiency respirators and 

combination gas masks. The text in 

paragraph (b) is amended to replace 

‘‘Certification and Quality Assurance 

Branch’’ with ‘‘National Personal 

Protective Technology Laboratory.’’ 

Section 84.1157 Chemical Cartridge 

Respirators With Particulate Filters; 

Performance Requirements; General. 

Existing § 84.1157 establishes 

minimum requirements for the 

performance and protection of chemical 

cartridge respirators with particulate 

filters. The text in paragraphs (d)(5) and 

(e)(5) is amended to replace 

‘‘Certification and Quality Assurance 

Branch’’ with ‘‘National Personal 

Protective Technology Laboratory.’’ 

Appendix A and Appendix B 

Appendix A is added to Part 84 to 

establish the fee schedule for annual 

(fixed) respirator certification fees. 

Appendix B is added to Part 84 to 

establish the fee schedule for 

application-based respirator 

certification fees. 

IV. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Order 12866 and Executive 

Order 13563 direct agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). 

This final rule is not being treated as 

a ‘‘significant regulatory action’’ within 

the meaning of E.O. 12866. The final 

rule is not considered economically 

significant, as defined in section 3(f)(1) 

of the executive order, and does not 

raise novel policy issues or have any of 

the other effects specified in section 

3(f)(2)–(4). Thus, this rule has not been 

reviewed by the Office of Management 

and Budget (OMB). 

NIOSH approves two categories of 

respirators: air-purifying respirators 

(APR), which filter contaminants in the 

environment (ambient air); and airsupplying respirators (ASR), which 

provide the user with clean breathing 

air (from a supply separate from the 

ambient air). APR includes particulate 

respirators, like the disposable N95 

commonly used in healthcare settings; 

the elastomeric respirator with 

replaceable filters (i.e., ‘‘gas mask’’); and 

the powered air-purifying respirator 

(PAPR), which employs a batterypowered blower to move breathing air 

through the filters. 

ASR includes respirators that deliver 

breathing air to the wearer, using either 

compressed or chemical breathing air or 

a remote source. The respirator types in 

this category include the self-contained 

breathing apparatus (SCBA) commonly 

worn by members of the fire service; the 

closed-circuit escape respirator (CCER) 

used for emergency escape in 

underground coal mining and on-board 

ships; and the airline (air hose) 

respirator used for industrial chemical 

and paint applications and hazardous 

materials management. 

Of the U.S. respirator market of 

products approved by NIOSH, 

approximately 35 percent of approval 

holders are U.S. companies and 65 

percent are foreign. The foreign 

component of this distribution has 

nearly doubled since 2000, and is 

largely represented by manufacturers 

producing low-cost filtering facepiece 

respirators. The North American 

respiratory protection market generated 

revenues around $1,830 million in 2007, 


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3Frost & Sullivan [2008]. North American 

Respiratory Protective Equipment Market. Report 

N2E7–39 at 1–1. 

the most recent data available.3 A 

summary of market segmentation, by 

respirator type, is offered in Table 1, 

below. 

TABLE 1—INDUSTRY OVERVIEW

Respirator type 

Market share 

2007 

(%) 

Revenues 

2007 

(millions $) 

Air-Purifying: 

Elastomeric ....................................................................................................................................................... 28.1 514.2 

Particulate ......................................................................................................................................................... 21.1 386.1 

Powered air purifying ........................................................................................................................................ 7.0 115.3 

Air-Supplying: 

SCBA (open- and closed-circuit) ...................................................................................................................... 35.2 677.1 

CCER ................................................................................................................................................................ 2.8 31.1 

airline ................................................................................................................................................................ 5.8 106.1 

Source: Frost & Sullivan [2008]. North American Respiratory Protective Equipment Market. Report N2E7–39. 

As discussed in the notice of 

proposed rulemaking, OMB Circular A– 

25 Revised requires that the NIOSH 

respirator program be self-sustaining, 

and that the Agency recover the full cost 

of certification and testing services 

offered to respirator manufacturers. 

With this final rule, HHS sets fees for 

these services based upon costs 

generated in a typical calendar year, 

2009. The data and analyses discussed 

here were generated at the outset of the 

drafting of this final rule, and NIOSH 

believes there has been minimal 

inflation affecting the NIOSH costs in 

the years since. All of the fees 

incorporate direct and indirect costs of 

providing testing and approval services, 

including personnel costs, physical 

overhead, and management and 

supervisory costs. For the purposes of 

this final rule, an average hourly cost of 

$50 per hour (rounded figure from Table 

2) was used as a reasonable estimate; in 

cases where there were special or 

unique costs (e.g. chemicals for testing, 

travel for site audits), those costs were 

accounted for over and above the hourly 

cost. 

TABLE 2—HOURLY COSTS

Salary/hour 

($) 

Benefits/hour 

($) 

Total 

($) 

Certification Staff ................................................................................................................... 36.66 9.55 46.21 

Management Overhead (OD) Prorated ................................................................................. 3.96 1.12 5.08 

Total ................................................................................................................................ 40.62 10.67 51.29 

Fixed costs are approximately 

$500,000 per year. These are the costs 

required to ensure the continued 

availability of a testing laboratory and 

are reasonably independent of the 

number of respirators tested or reviewed 

at any given time. These costs are 

broken down in Table 3, below. 

TABLE 3—FIXED COSTS

Facilities 

Total cost .......................................................................................................................................................................................... $5,161,860. 

Total square feet used by NIOSH .................................................................................................................................................... 474,000. 

Cost per square foot ......................................................................................................................................................................... $9.93. 

Square feet used for certification and approval activities ................................................................................................................ 23,480. 

Annual cost for certification and approval activities ......................................................................................................................... $233,156. 

Test Equipment 

Total cost .......................................................................................................................................................................................... $2,510,000. 

Amortization period ........................................................................................................................................................................... 10 years. 

Annual cost of test equipment .......................................................................................................................................................... $251,000. 

The fee schedules that are the basis 

for the analysis below are broken down 

into annual (fixed) fees (including 

product performance maintenance 

[product audits], records maintenance, 

quality assurance maintenance [site 

audits], facility maintenance, and 

testing capacity maintenance [test 

equipment depreciation]), and approvalbased fees (including application, 

approval, approval modification, and 

site qualification fees, as well as all 


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4Note: One application may result in multiple 

approvals, so it is not unusual for the number of 

new approvals to exceed the number of 

applications. 

5Note: One application may result in multiple 

modifications of approval, so it is not unusual for 

the number of modifications of approval to exceed 

the number of applications. 

laboratory tests conducted on airsupplied and air-purifying respirators, 

and respirators certified for use against 

chemical, biological, radiological, and 

nuclear agents). HHS offers the 

following explanation for the fee 

structure established in this rulemaking: Application: The application fee 

allows NIOSH to process the paperwork 

associated with a new application 

request. New applications were 

estimated at 4 hours of processing time 

with no other expenses. Thus, the new 

application processing fee is set at $200. 

In 2009, NIOSH processed 435 

applications and would have received 

payments in the amount of $87,000. Approval: A fee is charged for each 

new approval granted an applicant. 

Because the issuance of new approvals 

is estimated to require 2 hours each 

above the base application fee, the fee 

is set at $100. In 2009, NIOSH granted 

700 approvals 4 and would have 

received payments in the amount of 

$70,000. 

Approval Modification: An approvalholder may apply to NIOSH for the 

modification of an existing approval. 

Requests to obsolete a certificate of 

approval are considered to be 

modifications of an existing approval. 

Modified approval activities are 

estimated to require 1 hour each above 

the base application fee. Thus, the 

modification fee is set at $50. In 2009, 

NIOSH granted 820 modifications of 

approval 5 and would have received 

payments in the amount of $41,000. Records Maintenance: The proposed 

fee schedule is changed to clarify that 

this fee applies to all active and 

obsolete, or listed, approvals. Each 

listed approval is estimated to require 1 

hour of records maintenance time per 

year. The maintenance fee is set at $50. 

Manufacturers held a total of 6,800 

current approvals (active and obsolete) 

in 2009 and would have remitted 

maintenance payments in the amount of 

$340,000. 

Quality Assurance Maintenance (site 

audit): The quality assurance 

maintenance fee will cover the costs of 

the quality auditing program. As 

discussed above, the proposed fee 

schedule is amended in response to 

commenters who suggested that the site 

audit fee reflect the actual cost to 

perform each audit. Accordingly, the fee 

is changed from the proposal to base the 

fee on each active approval on file with 

NIOSH. The cost to NIOSH for 

conducting facility audits depends on 

many variables, including the number of 

manufacturing sites, the size of the 

manufacturing sites, the quality 

performance of the manufacturing sites, 

the location of the sites, and whether 

the respirators are used for mining. 

Therefore, a fixed fee for quality audits 

will be charged annually per every 

manufacturing site registered with 

NIOSH, which is set at $3,000 per every 

manufacturing site registered with 

NIOSH. Sites which do only design, but 

not production, are excluded from this 

fixed fee. In addition to the fixed annual 

fee, NIOSH will also bill for the average 

cost of a site audit based on audit 

duration and geographic location 

(domestic or foreign), during the same 

fiscal year in which the audit occurs. 

Sites which do only design, but not 

production, will be charged the variable 

fee during the same fiscal year in which 

the audit occurs. 

The initial schedule for these variable 

fees is: 

VARIABLE SITE AUDIT FEES

U.S. site .................................................................... 1-day audit ........................................................................................................ $ 2,500 

U.S. site .................................................................... 2-day or longer audit ........................................................................................ 5,000 

International site ....................................................... 1-day audit ........................................................................................................ 7,500 

International site ....................................................... 2-day or longer audit ........................................................................................ 10,000 

In the draft ‘‘Respirator Certification Fee 

Schedule A—Administrative Fees,’’ 

included in the docket for the notice of 

proposed rulemaking published in 

March 2013, NIOSH proposed a site 

audit fee of $85 per approval, which 

would have generated $578,000 during 

the 2009 evaluation period. The billing 

structure established in this final rule 

results in the same recovery to NIOSH, 

for the 2009 basis period, as the original 

proposal. 

REVISED BILLING STRUCTURE

Fee Total 

Fixed site audit fee production sites 

101 ............................................................................................................................................................................ $3,000 $303,000 

Variable site audit fee audit sites 

7 U.S. sites ............................................................................................................................................................... 2,500 17,500 

11 U.S. sites ............................................................................................................................................................. 5,000 55,000 

15 non-U.S. .............................................................................................................................................................. 7,500 112,500 

9 non-U.S. ................................................................................................................................................................ 10,000 90,000 

Total recovery .................................................................................................................................................... .................... 578,000 

Maintenance of Product Performance 

(product audit): The product 

performance maintenance fee will cover 

the costs of the product audit program. 

As discussed above, the proposed fee 

schedule is changed in response to 

public comments to charge each 

approval holder directly for the cost of 

product audits, rather than link the fee 

to modification requests. Product audits 

are conducted on approved respirators 

and these respirators are, typically, 

obtained through normal commercial 

purchases. One of the central factors in 

determining which respirators to 

purchase and test is whether significant 

modifications have been made from the 

original, approved design. Accordingly, 


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6NIOSH typically employs contractors to conduct 

site audits, at an average cost of $100 per hour. 

a fee for product performance audits 

will be added to each modification of 

approval requested. The product 

performance maintenance fee is set at 

$761 per approval holder ($53,300 

staffing/70 approval holders). The 

variable cost portion of the fee is 

designed to cover the cost of obtaining 

respirators and performing the testing. 

This cost will be billed directly to the 

approval holder in the October billing 

for testing to be performed within the 

next 12 months. In 2009, NIOSH 

conducted 42 product audits; the 

variable portion of the fee would have 

been $70,000. 

Site qualification: The site 

qualification fee provides for a one-time 

inspection of new production facilities. 

As discussed above, the proposed fee 

schedule is changed in response to 

public comments to charge each 

approval holder directly for the cost of 

site qualification inspections. A flat fee 

is established for existing approval 

holders, who will undergo a paper 

review only: $400 per each request. 

Non-approval holders will be charged 

$2,500 for inspection of a domestic 

facility, and $7,500 for an international 

site visit. The fee for non-approval 

holders includes travel expenses for 

personnel (including travel to sites 

outside the United States) as well as 

hourly charges.6 Each site qualification 

is estimated to take 4 hours of 

preparation time, 16 hours in travel 

time, 16 hours on-site, and 4 hours of 

document/report time for a total of 

$2000 in staff costs (40 hours × $50/

hour). In 2009, NIOSH performed 12 

paper reviews for existing approval 

holders (12 × 400 = 4,800), and 4 

domestic (4 × 2,500 = 10,000) and 2 

foreign (2 × 7,500 = 15,000) site 

qualification audits, which would have 

resulted in payments in the amount of 

$30,000. 

Maintenance of Testing and Approval 

Facilities: The facility maintenance fee 

will cover the costs of the respirator 

certification facilities located at the 

HHS-owned site in Pittsburgh, 

Pennsylvania. The costs for utilities, 

security, maintenance, maintenance 

equipment, maintenance staff and 

facilities management staff are included 

in this fee. The proposed fee schedule 

is changed to clarify that this fee applies 

to all active and obsolete, or listed, 

approvals. Facility maintenance is 

considered to be a fixed cost and 

independent of the certification activity 

in any given year. Accordingly, this fee 

will be assessed annually per listed 

approval. In 2009, the facility operating 

costs specific to respirator certification 

were $233,156 and manufacturers held 

6,800 current approvals (active and 

obsolete). A fee of $34.00 per approval 

would have returned $231,200 to the 

program. 

Maintenance of Test Equipment: The 

testing capacity maintenance fee is 

designed to recover the depreciation of 

testing equipment used for respirator 

certification. Equipment depreciation is 

typically considered to be a fixed cost 

and, therefore, NIOSH has classified it 

as an administrative (maintenance) fee. 

In accordance with the comments 

discussed above, the proposed fee 

schedule is changed to clarify that this 

fee applies to all active, and not 

obsolete, approvals. The fee itself is 

unchanged because the number of 

obsolete approvals included in the 

calculation of the proposed fee was 

insignificant. The testing capacity 

maintenance fee will be assessed 

annually per active approval. In 2009, 

the total cost of all certification 

equipment was $2,510,000. A 10 year 

amortization schedule is consistent with 

the life expectancy used in the 

purchasing of this equipment; therefore 

the annual depreciation of testing 

equipment is $251,000. In 2009, 

manufacturers held 6,800 approvals. A 

fee of $36.00 per each active approval 

would have returned $244,800 to the 

program. 

Testing: The fees for each individual 

test are specified in Fee Schedule B. The 

testing fees include the cost of materials 

and equipment as well as hourly wages. 

Testing fees are established by analyzing 

the time, equipment, chemicals and 

supplies required for each individual 

test. The actual tests performed by 

NIOSH in 2009 generated estimated fees 

of $717,000 for that year. Unlike other 

fees charged by NIOSH, fees for testing 

respirators against chemical, biological, 

radiological, and nuclear (CBRN) agents 

have been recently generated and are 

currently billed according to the actual 

cost of testing performed by either U.S. 

military laboratories or by the NIOSH 

National Personal Protective 

Technology Laboratory. Accordingly, 

manufacturers should refer to the U.S. 

Army Research, Development and 

Engineering Command Edgewood 

Chemical Biological Center (ECBC) Web 

site at http://www.ecbc.army.mil/ for a 

list of current testing costs. Costs for 

tests listed in Fee Schedule B and 

identified by the symbol ‘‘#’’ may not be 

reflective of current prices charged by 

ECBC. In 2009, NIOSH performed three 

CBRN tests and received payments in 

the amount of $150,000. These CBRN 

fees have been excluded from Table 4. 

In order to use the existing accounting 

system, the fees have also been grouped 

into three categories—administrative/

evaluation, testing, and audit 

activities—as summarized in Table 4, 

below. 

TABLE 4—VARIABLE FEE RECOVERY ESTIMATES

Administrative/Evaluation Activities 

2009 Budget ..................................................................................................................................................................................... $775,000. 

Percentage of activities related to billable fees ................................................................................................................................ 75%. 

Fees target ........................................................................................................................................................................................ $581,000. 

Estimated recovery under revised regulation: 

Applications ............................................................................................................................................................................... $87,000. 

New approvals ........................................................................................................................................................................... $70,000. 

Modifications .............................................................................................................................................................................. $41,000. 

Maintenance fee, records .......................................................................................................................................................... $340,000. 

Site qualification ........................................................................................................................................................................ $30,000. 

Total fees ................................................................................................................................................................................... $568,000. 

Percent recovery ....................................................................................................................................................................... 97.1%* 

Testing Activities ** 

2009 Budget ..................................................................................................................................................................................... $840,000. 


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TABLE 4—VARIABLE FEE RECOVERY ESTIMATES—Continued 

Percentage of activities related to billable fees ................................................................................................................................ 85%. 

Fees target ........................................................................................................................................................................................ $714,000. 

Estimated recovery under revised regulation: 

Testing fees ............................................................................................................................................................................... $717,000. 

Total fees ................................................................................................................................................................................... $717,000. 

Percent recovery ....................................................................................................................................................................... 100%. 

Audit Activities 

2009 Budget ..................................................................................................................................................................................... $708,000. 

Percentage of activities related to billable fees ................................................................................................................................ 100%. 

Fees target ........................................................................................................................................................................................ $708,000. 

Estimated recovery under revised regulation: 

Product audit fees ..................................................................................................................................................................... $123,000. 

Site audit fees ............................................................................................................................................................................ $578,000. 

Total audit fees .......................................................................................................................................................................... $701,000. 

Percent Recovery ...................................................................................................................................................................... 99.0%. 

* Given the level of variation in submissions from year to year, projections of 90–100% are considered to be full recovery. 

** CBRN fees have been excluded. 

In Table 4, above, the administrative/ 

evaluation category includes most of the 

NPPTL Technology Evaluation Branch 

overhead in addition to the certification 

activities. HHS estimates that 75 percent 

of this category provided services that 

were directly related to billable 

certification activities. The testing 

category targets maintenance of 

certification equipment, laboratory 

supplies, and testing. HHS estimates 

that 85 percent of this category provides 

services directly related to billable 

certification testing activities. The audit 

category includes both the site audit and 

product audit activities. HHS estimates 

that 100 percent of this category 

provides services directly related to 

billable audit activities. 

TABLE 5—FIXED FEE RECOVERY ESTIMATES

Facility maintenance Test equipment depreciation 

2009 Actual Cost ....................................................... $233,156 .......... 2009 Depreciation ..................................................... $251,000. 

New Fee .................................................................... $231,200 .......... New Fee .................................................................... $249,600. 

Percent Recovery ...................................................... 99.2% ............... Percent Recovery ...................................................... 99.4%. 

The fixed fee categories are 

recoverable operating expenses of the 

respirator certification activity. 

However, they have not historically 

been part of the NIOSH National 

Personal Protective Technology 

Laboratory budget process and, 

therefore, they are broken out here 

separately. The facilities maintenance 

costs have been appropriated through 

NIOSH appropriation requests. 

Equipment replacement has been 

handled as either (a) a special one-time 

request related to special circumstances 

or special needs; or (b) as a distribution 

from retained user fees provided by 

manufacturers for certification 

activities. 

This final rule is designed to recover 

the costs associated with providing 

services for the examination, inspection, 

and testing of respirators for the 

purposes of issuing, modifying, and 

maintaining certificates of approval. The 

current annual cost for this program is 

$2,500,000. NIOSH currently recovers 

approximately 10 to 20 percent of these 

costs under an outdated fee schedule 

that has remained in effect since 1972. 

NIOSH estimates that the total 

additional cost of this rulemaking to the 

70 manufacturers of NIOSH-approved 

respirators would be between 

$2,000,000 and $2,500,000 annually, 

approximately 0.125 percent of the 

almost $2 billion industry, and less than 

2.5 percent of the $100 million 

significance threshold. 

The final rule will not interfere with 

state, local, and tribal governments in 

the exercise of their governmental 

functions. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities, 

including small businesses, small 

governmental units, and small not-forprofit organizations. HHS certifies this 

rule under the RFA, but prepared an 

Initial Regulatory Flexibility Analysis in 

order to solicit feedback regarding the 

impact of this rulemaking on revenues 

of small entities. 

This rule updates the user fee 

structure for the certification of 

respiratory protective devices. The 

current fee structure, in place since 

1972, has limited the Agency’s ability to 

recover the majority of costs for 

respirator testing and certification. The 

current fee structure charges a set fee for 

the examination, inspection, and testing 

of eight broad groups of respirators. A 

single fixed fee is specified for each type 

of respirator without regard to the 

complexity of the respirator or the 

number of specific tests which are 

required. For example, the examination, 

inspection, and testing of a selfcontained breathing apparatus for entry 

and escape, 1 hour or more costs $3,500; 

for a single hazard gas mask, the cost is 

$1,100; a supplied-air respirator will 

cost $750 for examination, inspection, 

and testing (42 CFR 84.20). As a result, 

NIOSH currently recovers only about 10 

to 20 percent of the costs to provide 

initial certification and testing activities. 

The OMB Circular requires that the 

NIOSH respirator certification program 

be self-sustaining, and that the Agency 

recover the full cost of certification, 

maintenance and testing (see Section 

II.C. in the notice of proposed 

rulemaking published on March 27, 

2013 (78 FR 18535)). NIOSH’s objective 

is to recover all of these costs. The fee 


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7Fees for the certification of respirators that 

provide protection from chemical, biological, 

radiological, and nuclear (CBRN) agents processed 

during the 2005–2009 time period were not 

included in the comparison for the following 

reasons: Only one small company holds any current 

CBRN approvals; CBRN approvals tend to be very 

expensive (∼$100,000) and would skew all of the 

statistics; CBRN fees were set fairly recently (2002) 

and are based on actual testing costs; and CBRN 

fees will not change significantly as a result of this 

rulemaking. 

schedules include fees for each 

individual test required to grant a new 

approval or modification of an approval; 

processing the paperwork associated 

with any application request; granting a 

new approval or modifying an existing 

approval; maintaining each approval 

held during the year; and inspecting 

new production facilities. 

This final rule applies only to those 

companies that hold NIOSH approvals 

for certified respirators, or wish to apply 

for such approvals. It does not 

duplicate, overlap, or conflict with other 

rules. 

There are 70 respirator manufacturers 

that hold NIOSH approvals. Of this 

group, 10 manufacturers are considered 

large companies; 35 are approvalholders based outside of the United 

States; and 25 are classified as small 

businesses as defined under the Small 

Business Act for this industry sector 

(NAICS 339113—Surgical Appliance 

and Supplies Manufacturing), 

employing fewer than 500 employees. 

Accordingly, HHS has given 

consideration to the potential impact of 

this rule on these 25 companies. 

HHS must establish whether the final 

rule has a significant economic impact 

on a substantial number of small 

businesses. According to HHS guidance, 

5 percent or more of affected small 

businesses within an industry is 

considered a substantial number of 

businesses; an average annual impact on 

small businesses of 3–5 percent or more 

is considered a significant economic 

impact. Given that 25 of 70 regulated 

companies that comprise the respirator 

industry are small businesses, HHS 

considers a significant number to be 

affected by this final regulation. Many of 

these small companies are privately 

owned and, therefore, do not release 

public financial statements. However, as 

discussed below, the final rule does not 

exceed the HHS threshold for economic 

significance. For the purposes of this 

analysis, HHS has further categorized 

the small companies into three groups, 

as presented in Table 6 below. 

TABLE 6—COMPANIES GROUPED BASED ON SIZE

Group ID Group type Number of 

employees 

Number of 

companies 

Group 1 ......................................................................... Small ............................................................................. <50 10 

Group 2 ......................................................................... Small ............................................................................. 51–250 8 

Group 3 ......................................................................... Small ............................................................................. 251–500 7 

Group 4 ......................................................................... Large ............................................................................. >500 10 

In order to predict the effects of the 

new fee structure, the existing fees 

submitted to NIOSH for approval 

activities were examined for the years 

2005 through 2009 inclusive. This 

5-year period was considered to be 

representative of typical approval 

activities. The recent past is the best 

model that NIOSH has to predict likely 

application behavior in the near future.7

The current fee structure specifies a 

single fee for each type of respirator 

approval. This type of fee structure 

tends to favor those companies that 

demand extensive services and 

disadvantage companies that have fairly 

simple, easily executed requests. In 

order to better balance actual fees 

charged with actual services requested, 

the fees have been reallocated to be 

proportionate to the extent of services 

required. 

HHS is committed to ensuring that the 

regulatory burden does not 

disproportionately impact small 

businesses. Accordingly, the fee 

structure takes into account the 

complexity of the testing required to 

approve a respirator model. Typically, 

small companies have simple approval 

requests with few testing requirements. 

By designing a fee structure which 

would charge for the actual testing 

performed and individual fees which 

would be based on the number of active 

and obsolete approvals held, small 

companies would not pay for potential 

services that they do not use. Likewise, 

small companies typically have a 

limited number of listed approvals, so 

maintenance fees based on the number 

of listed approvals would minimize the 

fees charged to small companies versus 

large companies. Simply increasing the 

fees under the existing fee structure 

would impose a competitive 

disadvantage on small companies, 

because any fixed increase in fees 

would represent a greater percentage of 

revenue for small companies than for 

large companies. This is particularly 

relevant for the respirator manufacturers 

since the smallest companies have 1–10 

employees while the largest 

significantly exceed 1,000 employees. 

Tables 7, 8, and 9, below, address the 

costs for existing approval holders. The 

site qualification fee has not been 

incorporated into those figures. 

TABLE 7—CURRENT STATISTICS FOR APPROVAL HOLDERS

Group 1 Group 2 Group 3 Group 4 

Avg. number listed approvals held per company ............................................ 3 30 31 566 

Avg. new approval applications per year per company .................................. 0.6 0.8 1.8 3.5 

Avg. number modification applications per year per company ....................... 0.4 0.9 2.6 6.6 

Avg. fees paid per year per company ($) ........................................................ 850 2,050 4,150 8,100 

Total fees for 2005–2009 ($) .................................................................... 42,200 81,820 145,450 403,965 


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TABLE 8—STATISTICS FOR APPROVAL HOLDERS IF NEW FEES HAD BEEN IN PLACE DURING 2005–2009 

[$] 

Average cost per company per year Group 1 Group 2 Group 3 Group 4 

Testing fees ..................................................................................................... 1,400 2,730 10,600 15,680 

New approvals ................................................................................................. 185 255 575 2,490

Modified approvals ........................................................................................... 95 225 525 1,740 

Records maintenance ...................................................................................... 150 1,500 1,570 28,310

Product audits .................................................................................................. 60 135 390 990 

Site audits ........................................................................................................ 255 2,550 2,640 48,100 

Facilities maintenance fee ............................................................................... 100 990 1,020 18,680 

Test equipment depreciation ........................................................................... 95 960 990 18,110 

Total fees .................................................................................................. 2,340 9,345 18,310 134,100 

TABLE 9—COMPARISON OF CURRENT AND NEW FEES

Group 1 Group 2 Group 3 Group 4 

Avg. current fees per year per company ($) ................................................... 850 2,050 4,150 8,100 

Avg. new fees per year per company ($) ........................................................ 2,340 9,345 18,310 134,100 

Avg. increase in cost per company ($) ............................................................ 1,490 7,295 14,160 126,000 

Avg. percentage increase per company (%) ................................................... 175 356 341 1,556 

Percentage of current fees paid per group (%) ............................................... 6 12 22 60 

Percentage of new fees paid per group (%) ................................................... 1.5 5 8 85.5 

A site qualification fee will likely be 

triggered very infrequently. The types of 

events that will trigger a site audit 

include: The company becomes an 

approval holder for the first time (Event 

1); the approval holder moves to or adds 

a new production site (Event 2); or the 

approval holder is sold and production 

moves to a new site (Event 3). The site 

qualification fee (covering costs for 

inspection of either a domestic or 

foreign manufacturing site) will apply to 

all new approval holders, since their 

facilities will not have been previously 

qualified. NIOSH does not believe that 

this fee represents a significant entry 

cost, in relation to the costs required to 

newly manufacture NIOSH-certified 

respirators. In any event, these do not 

represent new costs imposed on existing 

small businesses in respirator 

manufacturing impacted by this 

rulemaking. 

For both small and large companies, 

the most common reason that a site 

qualification fee will be required is 

Event 2. That is, a company either adds 

a new production site or moves the 

existing production site to a new 

facility. The cost of qualifying a new 

production site will be very small ($400) 

compared to the costs of acquiring, 

designing, staffing, and beginning 

production at a new site. 

Small companies often experience 

type 3 events. They are often sold and 

then relocated by the acquiring 

company. Again, the cost of qualifying 

a production site will be very small 

compared to the cost of buying a 

company and relocating it. 

As discussed above, financial 

information from the small respirator 

manufacturers is difficult to discover, as 

many of these companies are privately 

held and are not required to file public 

financial statements. The only 

component of total revenues that is 

publically available is salary data. 

Attempts to determine the other 

production costs and/or the levels of 

profits for these companies did not 

generate reliable or consistent data. In 

order to estimate the revenues of these 

companies, statistics from the 2007 

Economic Census for NAICS code 

339113 were used. As a base for the 

revenues, it was assumed that the 

company needed, at a minimum, to 

cover the cost of its staff. Staffing levels 

were placed at the smallest likely levels 

for each size group. 

As can be seen in Table 10, below, 

even using the limited estimator of 

salaries as a surrogate for total revenues, 

the cost of the final rule does not, on 

average, reach the HHS threshold of 

more than 3 percent of revenues for the 

final rule to be considered significant 

for any of the groups of companies. 

TABLE 10—ECONOMIC IMPACT: FEES AS PERCENTAGE OF REVENUE

Group 1 Group 2 Group 3 

Number of employees ..................................................... 1–50 ................................... 51–250 ............................... 251–500. 

Econ. Census Table ........................................................ 5–9 employees .................. 50–99 employees .............. 250–499 employees. 

Management salary/year ................................................. $70,000 .............................. $64,200 .............................. $72,800. 

Production wages/year .................................................... $31,000 .............................. $30,400 .............................. $41,900. 

Management percent of employees ................................ 35.7% ................................ 35.2% ................................ 36.5%. 

Number of management staff/number of production employees.

1⁄2 (3 total) ......................... 18/33 (51 total) .................. 92/159 (251 total). 

Total salaries/company .................................................... $132,000 ............................ $2,160,000 ......................... $13,400,000. 

Total new fees (ref. Tables 7 and 9) ............................... $2,940 ................................ $9,595 ................................ $18,740. 

Fees as percentage of revenues .................................... 2.2 ...................................... 0.44 .................................... 0.14. 


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However, because the usage of NIOSH 

services varies markedly from company 

to company, and even from year to year 

for any specific company, it is difficult 

to determine whether or not the final 

rule could, sporadically, have a 

significant impact on individual 

companies. Although we requested 

input from the regulated manufacturers 

on the accuracy of our estimates and 

asked that they provide data regarding 

the economic impact of this rule, HHS 

did not receive any public comments on 

this matter. 

The RFA requires that the initial 

regulatory flexibility analysis describe 

significant alternatives to this final rule. 

HHS has identified two alternatives in 

addition to the final rule, which 

increases respirator fees on a test-by-test 

basis: (1) Retain the current fee and fee 

structure; or (2) increase the fees 

themselves. 

Alternative 1: Retain the Current Fees 

and Fee Structure 

HHS could have continued to use the 

current fees and fee structure. However, 

those fees have been in effect since 1972 

and return only 10 to 20 percent of the 

annual costs associated with providing 

initial certification and testing activities. 

This does not meet the cost needs of the 

NIOSH certification and testing 

programs, and does not meet the 

specifications of the OMB Circular 

which requires NIOSH to recover all of 

these costs. Hence, HHS chose not to 

pursue this alternative. 

Alternative 2: Retain the Current Fee 

Structure and Increase the Fees 

HHS could have maintained the 

current fee structure but increased the 

fees to cover current NIOSH costs. 

Typically, small companies have simple 

approval requests with few testing 

requirements. Likewise, small 

companies typically have a limited 

number of existing approvals requiring 

certification maintenance activities by 

NIOSH (see Table 6, above). The current 

fee structure distributes the cost burden 

equally across applicants despite the 

higher level of service provided to large 

companies with higher numbers of 

applications and approvals. The effect 

of the current fee structure is that small 

companies receive fewer tests and 

maintain fewer approvals for the same 

fixed application fee than do the large 

companies. This puts small companies 

at a disadvantage. HHS chose not to 

pursue this alternative. 

Final Rule: Modify Both the Fees and 

the Fee Structure To Reflect Actual 

Usage of NIOSH Services 

As established in this final rule, HHS 

chose to break up the fees into 

assignable services which reflect actual 

testing, certification and maintenance 

costs for respirator approvals. These fees 

are discussed in detail above and 

include fees for: (1) Testing; (2) 

application requests; (3) approvals; (4) 

modifications; (5) maintenance; and (6) 

site qualification. This alternative 

increases fees to all business groups, but 

does so in a graduated way which 

minimizes the burden on the small 

companies. Projected fees increase by 

175 percent, 355 percent and 340 

percent, respectively, for the smallest to 

largest groups of small companies. 

Projected fees increase by 1560 percent 

for the group of large companies. The 

final rule also allows NIOSH to fully 

recover its costs associated with 

respirator testing and certification, as 

required by the OMB Circular. 

Therefore, HHS has chosen to pursue 

this alternative. 

Based on the analysis provided above, 

HHS believes that this final rule will not 

have a significant economic impact on 

a substantial number of small 

businesses. 

C. Paperwork Reduction Act of 1995 

The Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on and 

to obtain OMB approval of any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. 

NIOSH has obtained approval from 

OMB to collect information from 

respirator manufacturers under 

‘‘Information Collection Provisions in 

42 CFR part 84—Tests and 

Requirements for Certification and 

Approval of Respiratory Protective 

Devices’’ (OMB Control No. 0920–0109, 

exp. November 30, 2017), which covers 

all information collected under 42 CFR 

part 84. The information NIOSH will 

collect under this rule does not differ 

substantially from the information 

presently collected from respirator 

manufacturers who obtain NIOSH 

certification of their products; nor will 

there be an increase in the reporting 

burden on respirator manufacturers. 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), HHS will report to Congress the 

promulgation of a final rule, prior to its 

taking effect. The report will state that 

HHS has concluded that the rule is not 

a ‘‘major rule’’ because it is not likely 

to result in an annual effect on the 

economy of $100 million or more. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1531 et 

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and tribal governments, and 

the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this final rule 

does not include any Federal mandate 

that may result in increased annual 

expenditures in excess of $100 million 

by state, local or tribal governments in 

the aggregate, or by the private sector, 

adjusted annually for inflation. For 

2014, the inflation-adjusted threshold is 

$152 million. 

F. Executive Order 12988 (Civil Justice) 

This final rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, Civil Justice Reform and 

will not unduly burden the federal court 

system. NIOSH has provided a fee 

structure that will apply uniformly to all 

applicants. This final rule has been 

reviewed carefully to eliminate drafting 

errors and ambiguities. 

G. Executive Order 13132 (Federalism) 

HHS has reviewed this final rule in 

accordance with Executive Order 13132 

regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The final 

rule does not ‘‘have substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, HHS has evaluated the 

environmental health and safety effects 

of this final rule on children. HHS has 

determined that the final rule will have 

no effect on children. 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, HHS has evaluated the effects of 

this final rule on energy supply, 

distribution, or use because it applies to 


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3906 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 

the underground coal mining sector 

since coal mine operators are consumers 

of respirators. The final rule is unlikely 

to affect the cost of respirators used in 

coal mines and hence is not likely to 

have ‘‘a significant adverse effect on the 

supply, distribution, or use of energy.’’ 

Accordingly, this final rule does not 

constitute a ’’significant energy action’’ 

under E.O. 13211 and requires no 

further Agency action or analysis. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS has 

attempted to use plain language in 

promulgating the final rule consistent 

with the Federal Plain Writing Act 

guidelines. 

Final Rule 

List of Subjects in 42 CFR Part 84 

Fees, Mine safety and health, 

Occupational safety and health, 

Personal protective equipment, 

Respirators. 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services amends 42 CFR part 84 

as follows: 

PART 84—APPROVAL OF 

RESPIRATORY PROTECTIVE DEVICES 

■ 1. The authority citation for part 84 is 

revised to read as follows: 

Authority: 29 U.S.C. 651 et seq.; 30 U.S.C. 

3, 5, 7, 811, 842(h), 844; 31 U.S.C. 9701. 

Subpart A—General Provisions 

■ 2. In § 84.2, remove the alphabetical 

paragraph designations, arrange 

definitions in alphabetical order, 

remove the definitions of ‘‘Certification 

and Quality Assurance Branch’’ and 

‘‘Institute’’, and add in alphabetical 

order definitions for ‘‘Institute or 

NIOSH’’ and ‘‘National Personal 

Protective Technology Laboratory’’ to 

read as follows: 

§ 84.2 Definitions. 

* * * * * 

Institute or NIOSH means the 

National Institute for Occupational 

Safety and Health, Department of Health 

and Human Services. 

* * * * * 

National Personal Protective 

Technology Laboratory (NPPTL) means 

the National Personal Protective 

Technology Laboratory, National 

Institute for Occupational Safety and 

Health (NIOSH), Centers for Disease 

Control and Prevention, Department of 

Health and Human Services, P.O. Box 

18070, 626 Cochrans Mill Road, 

Pittsburgh, PA 15236. NPPTL 

administers the NIOSH conformity 

assessment program for respiratory 

protective devices, replacing the former 

Certification and Quality Assurance 

Branch within the Division of Safety 

Research, Appalachian Laboratory for 

Occupational Safety and Health, 

NIOSH. 

* * * * * 

Subpart B—Application for Approval 

■ 3. In § 84.10, revise paragraphs (b), (c), 

and (d) to read as follows: 

§ 84.10 Application procedures. 

* * * * * 

(b) Applications must be submitted in 

accordance with the Standard 

Application Procedure for the 

Certification of Respirators under 42 

CFR 84, (Standard Application 

Procedure) available on the NPPTL Web 

site, to Records Room, National Personal 

Protective Technology Laboratory, P.O. 

Box 18070, 626 Cochrans Mill Road, 

Pittsburgh, PA 15236. 

(c) Except as provided in § 84.64, the 

examination, inspection, and testing of 

all respirators will be conducted or 

caused to be conducted by the National 

Personal Protective Technology 

Laboratory. 

(d) Applicants, manufacturers, or 

their representatives may visit or 

communicate with the National 

Personal Protective Technology 

Laboratory in order to discuss the 

requirements for approval of any 

respirator or the proposed designs 

thereof. No charge will be made for such 

consultation and no written report will 

be issued to applicants, manufacturers, 

or their representatives by the Institute 

as a result of such consultation. 

* * * * * 

■ 4. In § 84.12, revise paragraph (b) to 

read as follows: 

§ 84.12 Delivery of respirators and 

components by applicant; requirements. 

* * * * * 

(b) The applicant will deliver, at his 

or her own expense, the number of 

completely assembled respirators and 

component parts required for their 

examination, inspection, and testing, to 

the National Personal Protective 

Technology Laboratory. 

* * * * * 

■ 5. Revise subpart C to read as follows: 

Subpart C—Fees 

Sec. 

84.20 Establishment of fees. 

84.21 Fee calculation. 

84.22 Fee administration. 

84.23 Fee revision. 

84.24 Authorization for additional 

examinations, inspections, tests, and 

fees. 

Subpart C—Fees 

§ 84.20 Establishment of fees. 

(a) This section establishes a system 

under which NIOSH charges a fee for 

services provided to applicants for 

conformity assessment activities 

conducted by NIOSH for respiratory 

protective devices under 42 CFR part 

84. This section specifies the purposes 

for which fees will be assessed and the 

cost factors for such assessments. 

(b) Fees will be charged for: 

(1) Respirator certification 

application, approval, approval 

modification, records maintenance, and 

testing. Application processing under 

this Part by engineers, technicians and 

other specialists, including 

administrative review of applications, 

analysis of drawings, technical 

evaluation, testing, test set up and tear 

down, and consultation on applications, 

clerical services, computer tracking and 

status reporting, records control and 

security, and document preparation 

directly supporting application 

processing. This fee also contributes to 

a proportionate share of management, 

administration and operation of the 

NIOSH National Personal Protective 

Technology Laboratory; 

(2) Maintenance of testing and 

approval facilities and test equipment. 

Amortization of facility improvements 

and depreciation of buildings and 

equipment used for testing and 

evaluation or otherwise directly 

associated with application processing; 

(3) Site qualification. Initial review 

and approval, as specified under 42 CFR 

part 84 subpart E—Quality Control, of 

manufacturing facilities that may be 

used to manufacture respirators, 

principal components, and/or 

subassemblies; 

(4) Quality assurance maintenance. 

Quality site audits to verify 

conformance to the requirements of 

§§ 84.33, 84.40, 84.41, 84.42, 84.43; and 

(5) Maintenance of product 

performance. Product audits to verify 

the performance of commercially 

available respirators which have been 

granted a NIOSH certificate of approval. 

(c) Fees will not be charged for: 

(1) Technical assistance not related to 

application processing; 

(2) Technical programs including 

development of new technology 

programs; 

(3) Participation in research; and 


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(4) Regulatory review activities, 

including participation in the 

development of health and safety 

standards, regulations, and legislation. 

§ 84.21 Fee calculation. 

(a) This section explains the process 

NIOSH uses to calculate estimates of the 

direct and indirect costs of services 

provided in the course of application 

processing. 

(b) Upon completion of an initial 

administrative review of the 

application, NIOSH will calculate a fee 

estimate for each application, including 

the maximum cost of conducting 

additional tests under § 84.24, and will 

provide that estimate, with payment 

details, to the applicant. The fee 

estimate will be derived using the 

current schedules of fees published by 

NIOSH in Part 84. NIOSH will begin the 

technical evaluation once the applicant 

accepts the terms of the fee estimate and 

authorizes payment. 

(c) If NIOSH determines that actual 

costs for application processing and 

related testing will exceed the fee 

estimate provided to the applicant, 

NIOSH will provide a revised fee 

estimate for completing the application 

review before exceeding the previouslyauthorized fees. The applicant will have 

the option of either withdrawing the 

application and paying for services 

already performed or authorizing 

payment of the revised estimate, in 

which case NIOSH will continue the 

application review and testing. 

(d) If the actual cost of processing the 

application is less than the fee estimate 

NIOSH provided to the applicant, 

NIOSH will charge the actual cost. 

(e) If the applicant withdraws an 

application, the applicant will be 

invoiced for services already performed 

by NIOSH. Withdrawal of an 

application will be effective on the first 

business day following the date NIOSH 

receives a withdrawal notice from the 

applicant in writing. Withdrawal 

notices will be submitted to NIOSH in 

accordance with the Standard 

Application Procedure using the 

address specified in § 84.10. 

§ 84.22 Fee administration. 

(a) Applicants will be invoiced for all 

fees incurred in the processing of an 

application when all required reviews, 

analyses, evaluations, and tests are 

completed or the application is 

withdrawn. Invoices will contain 

specific payment instructions and 

identify authorized methods of 

payment. 

(b) Applicants who hold active and/ 

or obsolete certificates of approval will 

be invoiced by NIOSH annually for 

applicable maintenance fees, in 

accordance with the fee schedule 

published in Appendix A of this part. 

(c) NIOSH reserves the right to impose 

sanctions for any missed payment, and 

will administer such penalties after 

assessing the circumstances of the 

manufacturer and the needs of other 

stakeholders. Sanctions may include but 

are not limited to: 

(1) Refusal to accept future 

applications for approval; 

(2) Stop-sale of all approved product; 

and 

(3) Engaging appropriate government 

authorities to initiate debt collection 

procedures for the unpaid fees. 

§ 84.23 Fee revision. 

(a) Each fee schedule will remain in 

effect for at least 2 years and will be 

revised as needed to reflect cost 

increases identified in biennial reviews. 

(b) Fee schedule updates will be 

proposed in a notice of proposed 

rulemaking published in the Federal 

Register. 

(c) The current fee schedules will be 

published in Appendix A and Appendix 

B of this part and will remain in effect 

until the effective date of the new fee 

schedules published in the Federal 

Register. 

§ 84.24 Authorization for additional 

examinations, inspections, tests, and fees. 

NIOSH will conduct or cause to be 

conducted any additional examinations, 

inspections, or tests it deems necessary 

to determine the quality and 

effectiveness of any respirator submitted 

to NIOSH for the purposes of seeking a 

certificate of approval. The costs of such 

examinations, inspections, or tests will 

be paid by the applicant prior to 

issuance of a certificate of approval for 

the subject respirator. 

Subpart D—Approval and Disapproval 

§ 84.36 [Amended] 

■ 6. In § 84.36, remove ‘‘Certification 

and Quality Assurance Branch’’ and add 

in its place ‘‘National Personal 

Protective Technology Laboratory’’. 

Subpart E—Quality Control 

§§ 84.41 and 84.43 [Amended] 

■ 7. In Subpart E, remove ‘‘Certification 

and Quality Assurance Branch, 1095 

Willowdale Road, Morgantown, WV 

26505–2888’’ and add in its place 

‘‘National Personal Protective 

Technology Laboratory, P.O. Box 18070, 

626 Cochrans Mill Road, Pittsburgh, PA 

15236’’ wherever it appears in the 

following places: 

■ a. § 84.41(b); and 

■ b. § 84.43(a) 

Subpart G—General Construction and 

Performance Requirements 

■ 8. In § 84.66, revise the section 

heading and paragraph (b) to read as 

follows: 

§ 84.66 Withdrawal of applications. 

* * * * * 

(b) Upon the receipt of a written 

request from the applicant for the 

withdrawal of an application, NIOSH 

will invoice the applicant based on the 

fee calculated, as specified under 

§ 84.21(e). 

Subpart H—Self-Contained Breathing 

Apparatus 

§§ 84.76, 84.79, 84.81, and 84.97 

[Amended] 

■ 9. In Subpart H, remove ‘‘Certification 

and Quality Assurance Branch, 1095 

Willowdale Road, Morgantown, WV 

26505–2888’’ and add in its place 

‘‘National Personal Protective 

Technology Laboratory, P.O. Box 18070, 

626 Cochrans Mill Road, Pittsburgh, PA 

15236’’ in the following places: 

■ a. § 84.76(b) 

■ b. § 84.79(c) and (d) 

■ c. § 84.81(d) 

■ d. § 84.97(a) 

Subpart I—Gas Masks 

§ 84.110 [Amended] 

■ 10. In § 84.110(c), remove 

‘‘Certification and Quality Assurance 

Branch’’ and add in its place ‘‘National 

Personal Protective Technology 

Laboratory’’. 

§§ 84.113 and 84.119 [Amended] 

■ 11. Remove ‘‘Certification and Quality 

Assurance Branch, 1095 Willowdale 

Road, Morgantown, WV 26505–2888’’ 

and add in its place ‘‘National Personal 

Protective Technology Laboratory, P.O. 

Box 18070, 626 Cochrans Mill Road, 

Pittsburgh, PA 15236’’ in the following 

places: 

■ a. § 84.113 

■ b. § 84.119(b) 

Subpart J—Supplied-Air Respirators 

§§ 84.136 and 84.141 [Amended] 

■ 12. In Subpart J, remove ‘‘Certification 

and Quality Assurance Branch, 1095 

Willowdale Road, Morgantown, WV 

26505–2888’’ and add in its place 

‘‘National Personal Protective 

Technology Laboratory, P.O. Box 18070, 

626 Cochrans Mill Road, Pittsburgh, PA 

15236’’ in the following places: 

■ a. § 84.136(b) 

■ b. § 84.141(b) and (c) 


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Subpart L—Chemical Cartridge 

Respirators 

§ 84.193 [Amended] 

■ 13. In § 84.193, remove ‘‘Certification 

and Quality Assurance Branch, 1095 

Willowdale Road, Morgantown, WV 

26505–2888’’ and add in its place 

‘‘National Personal Protective 

Technology Laboratory, P.O. Box 18070, 

626 Cochrans Mill Road, Pittsburgh, PA 

15236’’. 

Subpart N—Special Use Respirators 

§ 84.258 [Removed] 

■ 14. Remove § 84.258. 

Subpart KK—Dust, Fume, and Mist; 

Pesticide; Paint Spray; Powered AirPurifying High Efficiency Respirators 

and Combination Gas Masks 

§ 84.1102 [Removed] 

■ 15. Remove § 84.1102. 

§§ 84.1136, 84.1154 and 84.1157 

[Amended] 

■ 16. Remove ‘‘Certification and Quality 

Assurance Branch, 1095 Willowdale 

Road, Morgantown, WV 26505–2888’’ 

and add in its place ‘‘National Personal 

Protective Technology Laboratory, P.O. 

Box 18070, 626 Cochrans Mill Road, 

Pittsburgh, PA 15236’’ in the following 

places: 

■ a. § 84.1136(b) 

■ b. § 84.1154(b) 

■ c. § 84.1157(d)(5) and (e)(5) 

■ 17. Add Appendix A to Part 84 to read 

as follows: 

Appendix A to Part 84—Annual (Fixed) 

Respirator Certification Fees 

RESPIRATOR CERTIFICATION FEE SCHEDULE A—ANNUAL (FIXED) FEES

[Implemented on May 26, 2015] 

Fee type Legal citation Amount Due date 

Maintenance of Product Performance 

(product audit).

42 CFR 84.20(b)(5) .... • Annual fee: $761 per each approval holder 

• Variable fee: As billed by NIOSH based on 

the respirators chosen to be tested each 

year.

• Upon billing from NIOSH.1

• October. 

Records Maintenance 42 CFR 84.20(b)(1) .... $50 for all listed 2 approvals on file with 

NIOSH on July 1st of each year.

• Upon billing from NIOSH.1

• October (beginning in 2015). 

Quality Assurance 

Maintenance (site 

audit).

42 CFR 84.20(b)(4) .... • Annual fee: $3,000 per every manufacturing site registered with NIOSH.

• Variable fee: 3 ..............................................

D 1 day domestic audit—$2,500 per site 

D 2 day domestic audit—$5,000 per site 

D 1 day international audit—$7,500 per 

site.

D 2 day international audit—$10,000 per 

site.

• Upon billing from NIOSH.1

• October (beginning in 2015). 

Maintenance of Testing 

and Approval Facilities.

42 CFR 84.20(b)(2) .... $34 per every listed 2 approval on file with 

NIOSH on July 1st of each applicable year.

• Upon billing from NIOSH.1

• October (beginning in 2015). 

Maintenance of Test 

Equipment.

42 CFR 84.20(b)(2) .... $36 per every active 4 approval on file with 

NIOSH on July 1st of each applicable year.

• Upon billing from NIOSH.1

• October (beginning in 2015). 

1For the first year that annual fees are in effect, NIOSH will provide manufacturers with a pre-invoice/advanced billing/invoice preview no later 

than July 1, 2015. The actual invoice will be sent in September 2015. 2 ‘‘Listed’’ approvals include all active and obsolete approvals. The Certified Equipment List (CEL) reflects the current listed approvals maintained by NIOSH. See http://www.cdc.gov/niosh/npptl/topics/respirators/CEL/default.html. 3Applies to design as well as manufacturing sites. 

4 Does not include obsolete approvals. 

■ 18. Add Appendix B to Part 84 to read 

as follows: 

Appendix B to Part 84—ApplicationBased Respirator Certification Fees 

RESPIRATOR CERTIFICATION FEE SCHEDULE B—APPLICATION-BASED FEES

[Implemented on May 26, 2015] 

Fee type Legal citation Amount Due date 

Application ................... 42 CFR 84.20(b)(1) .... $200 per application submitted ....................... Upon receipt of any application request. 

Approval ...................... 42 CFR 84.20(b)(1) .... $100 per each certificate of approval issued Upon completion of the application and granting of an approval number. 

Approval Modification .. 42 CFR 84.20(b)(1) .... $50 per each certificate of approval modified Upon completion of the application and 

issuing a modified approval. 

Site Qualification ......... 42 CFR 84.20(b)(3) .... • Existing approval holder, paper review: 

$400 per each request to inspect new production facility.

• Non-approval holders: .................................

D Domestic site visit—$2,500 ..................

D International site visit—$7,500 .............

Upon agreement on the date of the site qualification examination. 


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Standard Test Procedure Fee 

($) 

Testing Fees 

Descriptor: ............................................................................................................................................................................................. For testing 

respirators. 

Amount: ................................................................................................................................................................................................. See below. 

Basis: ..................................................................................................................................................................................................... Per each test. 

Due date: ............................................................................................................................................................................................... Upon initiation of 

testing. 

Air-Purifying Respirators 

TEB–APR–STP–0001 Determination of particulate filter penetration (PAPR) ..................................................................................... 150 

RCT–APR–STP–0003—Determination of exhalation resistance ......................................................................................................... 150 

TEB–APR–STP–0004—Determination of exhalation valve leakage .................................................................................................... 300 

TEB–APR–STP–0005—Determination of qualitative isoamyl acetate (IAA) facepiece fit test ............................................................ 1,800 

TEB–APR–STP–0005A—Determination of qualitative isoamyl acetate (IAA) facepiece fit test .......................................................... 1,800 

TEB–APR–STP–0006—Determination of qualitative isoamyl acetate (IAA) facepiece fit test ............................................................ 1,800 

TEB–APR–STP–0007—Determination of inhalation resistance ........................................................................................................... 150 

RCT–APR–STP–0012—Determination of air flow for powered air-purifying respirators ..................................................................... 150 

RCT–APR–STP–0014—Determination of leakage of drinking tube and accessories for respirator facepieces ................................. 300 

RCT–APR–STP–0025—Determination of silica dust loading test for powered air-purifying respirator filters ..................................... 1,200 

RCT–APR–STP–0030—Determination of noise level test, powered air-purifying respirator with hoods or helmets .......................... 450 

TEB–APR–STP–0033A—Determination of ammonia service-life test, air-purifying respirators with cartridges ................................. 750 

TEB–APR–STP–0033B—Determination of ammonia service-life test, air-purifying respirators with canisters ................................... 750 

TEB–APR–STP–0033C—Determination of ammonia service-life test, powered air-purifying respirators with cartridges .................. 750 

TEB–APR–STP–0033D—Determination of ammonia service-life test, tight-fitting powered air-purifying respirators with gas mask 

canister(s).

750 

RCT–APR–STP–0034—Carbon monoxide service life ........................................................................................................................ 750 

RCT–APR–STP–0035—Determination of chlorine service life ............................................................................................................ 750 

RCT–APR–STP–0036—Determination of chlorine dioxide service life ................................................................................................ 750 

RCT–APR–STP–0037—Determination of a-chloroacetophenone (CN) service life ............................................................................ 2,400 

RCT–APR–STP–0038—Determination of ethylene oxide service life ................................................................................................. 450 

TEB–APR–STP–0039A—Determination of formaldehyde service-life test, air-purifying respirators with cartridges .......................... 750 

TEB–APR–STP–0039B—Determination of formaldehyde service-life test, air-purifying respirators with canisters ............................ 750 

TEB–APR–STP–0039C—Determination of formaldehyde service-life test, powered air-purifying respirators with cartridges ........... 750 

RCT–APR–STP–0040—Determination of hydrogen chloride service life ............................................................................................ 500 

RCT–APR–STP–0041—Determination of hydrogen cyanide service life ............................................................................................ 1,800 

RCT–APR–STP–0042—Determination of hydrogen fluoride service life ............................................................................................. 750 

TEB–APR–STP–0043A—Determination of hydrogen sulfide service-life test, air-purifying respirators with cartridges ...................... 750 

TEB–APR–STP–0043B—Determination of hydrogen sulfide service-life test, air-purifying respirators with canisters ....................... 750 

TEB–APR–STP–0043C—Determination of hydrogen sulfide service-life test, powered air-purifying respirators with cartridges ...... 750 

RCT–APR–STP–0044—Determination of mercury vapor service life .................................................................................................. 2,400 

TEB–APR–STP–0045A—Determination of methylamine service-life test, air-purifying respirators with cartridges ............................ 450 

TEB–APR–STP–0045B—Determination of methylamine service-life test, air-purifying respirators with canisters ............................. 450 

TEB–APR–STP–0045C—Determination of methylamine service-life test, powered air-purifying respirators with cartridges ............. 450 

TEB–APR–STP–0045D—Determination of methylamine service-life test, tight-fitting powered air-purifying respirators with gas 

mask canister(s).

450 

TEB–APR–STP–0046A—Determination of organic vapor (carbon tetrachloride) service-life test, air-purifying respirators with cartridges.450 

TEB–APR–STP–0046B—Determination of organic vapor (carbon tetrachloride) service-life test, air-purifying respirators with cartridges.450 

TEB–APR–STP–0046C—Determination of organic vapor (carbon tetrachloride) service-life test, powered air-purifying respirators 

with cartridges.

450 

TEB–APR–STP–0046D—Determination of organic vapor (carbon tetrachloride) service-life test, tight-fitting powered air-purifying 

respirators with gas mask canister(s).

450 

RCT–APR–STP–0047—Determination of phosphine service life ........................................................................................................ 750 

TEB–APR–STP–0048A—Determination of sulfur dioxide service-life test, air-purifying respirators with cartridges ........................... 450 

TEB–APR–STP–0048B—Determination of sulfur dioxide service-life test, air-purifying respirators with canisters ............................ 450 

TEB–APR–STP–0048C—Determination of sulfur dioxide service-life test, powered air-purifying respirators with cartridges ............ 450 

TEB–APR–STP–0048D—Determination of sulfur dioxide service-life test, tight-fitting powered air-purifying respirators with gas 

mask canisters.

450 

RCT–APR–STP–0050—Determination of O-chlorobenzylidene malononitrile (CS) service life .......................................................... 2,400 

TEB–APR–STP–0051—Determination of particulate filter efficiency level for P100 series filters against liquid particulates for nonpowered, air-purifying respirators.1,200 

TEB–APR–STP–0052—Determination of particulate filter efficiency level for P99 series filters against liquid particulates for nonpowered, air-purifying respirators.1,200 

TEB–APR–STP–0053—Determination of particulate filter efficiency level for P95 series filters against liquid particulates for nonpowered, air-purifying respirators.1,200 

TEB–APR–STP–0054—Determination of particulate filter efficiency level for R100 series filters against liquid particulates for nonpowered, air-purifying respirators.1,200 


tkelley on DSK3SPTVN1PROD with RULES
3910 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 

Standard Test Procedure Fee 

($) 

TEB–APR–STP–0055—Determination of particulate filter efficiency level for R99 series filters against liquid particulates for nonpowered, air-purifying respirators.1,200 

TEB–APR–STP–0056—Determination of particulate filter efficiency level for R95 series filters against liquid particulates for nonpowered, air-purifying respirators.1,200 

TEB–APR–STP–0057—Determination of particulate filter efficiency level for N100 series filters against solid particulates for nonpowered, air-purifying respirators.1,200 

TEB–APR–STP–0058—Determination of particulate filter efficiency level for N99 series filters against solid particulates for nonpowered, air-purifying respirators.1,200 

TEB–APR–STP–0059—Determination of particulate filter efficiency level for N95 series filters against solid particulates for nonpowered, air-purifying respirators.1,200 

RCT–APR–STP–0060—Determination of end-of-service-life indicator drop ....................................................................................... 300 

RCT–APR–STP–0061—Determination of end-of-service-life indicator visibility .................................................................................. 300 

RCT–APR–STP–0062—Determination of nitrogen dioxide service life ............................................................................................... 750 

RCT–APR–STP–0063—Determination of facepiece carbon dioxide and oxygen concentration levels—tight fitting, powered airpurifying respirators, with the blower unit running.300 

RCT–APR–STP–0064—Determination of facepiece carbon dioxide and oxygen concentration levels, tight fitting, powered air-purifying respirators, with the blower unit off.300 

RCT–APR–STP–0065—Determination of air flow resistance, breath responsive, powered air-purifying respirators ......................... 300 

RCT–APR–STP–0066—Determination of end-of-service-life indicator (ESLI) ..................................................................................... 300 

RCT–APR–STP–0067—Particulate respirator qualitative fit test utilizing saccharin or bitrex solutions .............................................. 1800 

Air-Supplied Respirators 

RCT–ASR–STP–0100—Determination of strength of hoses and couplings, type C and CE supplied-air respirators ........................ 150 

RCT–ASR–STP–0101—Determination of tightness of hoses and couplings, type C and CE supplied-air respirators ...................... 150 

RCT–ASR–STP–0102—Determination of nonkinkability of hoses, type C and CE supplied-air respirators ....................................... 150 

RCT–ASR–STP–0103—Determination of gasoline permeation of hoses and couplings, type C and CE supplied-air respirators .... 450 

RCT–ASR–STP–0104—Determination of air-regulating valve 100,000 cycles performance, demand and pressure-demand type C 

and CE supplied-air respirators.

3,000 

RCT–ASR–STP–0105—Determination of airflow, continuous flow type C and CE supplied-air respirators ....................................... 300 

RCT–ASR–STP–0105A—Determination of airflow, demand and pressure-demand type C and CE supplied-air respirators ............ 300 

RCT–ASR–STP–0106—Determination of inhalation airflow resistance, pressure-demand type C and CE supplied-air respirators 150 

RCT–ASR–STP–0107—Determination of exhalation airflow resistance, pressure-demand type C and CE supplied-air respirators 150 

RCT–ASR–STP–0108—Determination of inhalation airflow resistance, demand type C and CE supplied-air respirators ................ 150 

RCT–ASR–STP–0109—Determination of exhalation airflow resistance, demand type C and CE supplied-air respirators ............... 150 

RCT–ASR–STP–0110—Determination of gas-tightness test, isoamyl acetate (IAA), type C and CE supplied-air respirators .......... 450 

RCT–ASR–STP–0111—Determination of air velocity and noise levels—sound level, type C and CE supplied-air respirators ......... 450 

RCT–ASR–STP–0112—Determination of the level of protection provided by abrasive blast, type CE supplied-air respirators 

using a challenge aerosol of NaCl (sodium chloride) or corn oil.

450 

RCT–ASR–STP–0113—Determination of airflow resistance—continuous-flow, type C and CE supplied-air respirators ................... 150 

RCT–ASR–STP–0114—Determination of sound-level measurement—escape, open-circuit self-contained breathing apparatus 

using hoods or helmets.

450 

RCT–ASR–STP–0115—Determination of rated service time—constant-flow, escape, open-circuit self-contained breathing apparatus.150 

RCT–ASR–STP–0116—Determination of airflow resistance—continuous-flow, escape, open-circuit self-contained breathing apparatus with hoods.150 

RCT–ASR–STP–0117—Determination of positive pressure—closed-circuit, pressure-demand, self-contained breathing apparatus 150 

RCT–ASR–STP–0118—Determination of low temperature operation—minimum temperature per applicant, open-circuit self-contained breathing apparatus.1,200 

RCT–ASR–STP–0119—Determination of low-temperature operation—minimum temperature per applicant, combination open-circuit self-contained breathing apparatus and type C and CE supplied-air respirators.1,200 

RCT–ASR–STP–0120—Determination of positive pressure—open-circuit, pressure-demand self-contained breathing apparatus .. 75 

RCT–ASR–STP–0121—Determination of rated service time—open-circuit, demand and pressure-demand, self-contained breathing apparatus.75 

RCT–ASR–STP–0121A—Determination of rated service time—closed-circuit, demand and pressure-demand, self-contained 

breathing apparatus.

75 

RCT–ASR–STP–0122—Determination of exhalation breathing resistance—open-circuit, demand and pressure-demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0123—Determination of gas flow measurements—open-circuit, demand and pressure-demand, self-contained 

breathing apparatus.

150 

RCT–ASR–STP–0124—Determination of remaining service-life indicator—open-circuit, demand and pressure-demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0124A—Determination of alarm pressure—closed-circuit, demand and pressure-demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0125—Determination of gas tightness—isoamyl acetate (IAA)—self-contained breathing apparatus with 

facepieces and mouthpieces.

750 

RCT–ASR–STP–0125A—Determination of gas tightness—isoamyl acetate (IAA)—self-contained breathing apparatus with hoods 

or helmets.

750 

RCT–ASR–STP–0126—Determination of by-pass valve flow—open-circuit, demand and pressure-demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0127—Determination of by-pass valve flow—closed-circuit, demand and pressure-demand, self-contained 

breathing apparatus.

150 

RCT–ASR–STP–0128—Determination of accuracy of gauge—self-contained breathing apparatus .................................................. 150 


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Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 3911 

Standard Test Procedure Fee 

($) 

RCT–ASR–STP–0132—Determination of inhalation breathing resistance—open-circuit, demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0133—Determination of exhalation breathing resistance—open-circuit, pressure-demand, self-contained breathing apparatus using two second stage regulators.150 

RCT–ASR–STP–0134—Determination of gasoline permeation test on breathing bags—closed-circuit, self-contained breathing 

apparatus.

750 

RCT–ASR–STP–0135—Determination of inhalation and exhalation breathing resistance—closed-circuit, demand and pressuredemand, self-contained breathing apparatus.150 

RCT–ASR–STP–0136—Determination of demand gas flow—closed-circuit, demand and pressure-demand, self-contained 

breathing apparatus.

150 

RCT–ASR–STP–0137—Determination of continuous gas flow on constant flow with demand flow—closed-circuit, self-contained 

breathing apparatus.

450 

RCT–ASR–STP–0138—Determination of safety relief valve operation—closed-circuit, demand and pressure-demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0139—Determination of facepiece carbon dioxide concentrations—self-contained breathing apparatus ............... 450 

RCT–ASR–STP–0140—Man tests—self-contained breathing apparatus ............................................................................................ 3,000 

RCT–ASR–STP–0141—Man test number 5—closed-circuit, self-contained breathing apparatus ...................................................... 150 

RCT–ASR–STP–0142—Determination of vibration (Ro-Tap test) for man test number 1—escape, closed-circuit, demand, selfcontained breathing apparatus.750 

RCT–ASR–STP–0143—Determination of low-temperature operation—minimum per manufacturer—closed-circuit, self-contained 

breathing apparatus.

1,200 

RCT–ASR–STP–0144—Determination of continuous gas flow on constant flow—closed-circuit, self-contained breathing apparatus.300 

RCT–ASR–STP–0145—Determination of sound level measurements for remaining service-life indicators—self-contained breathing apparatus.750 

RCT–ASR–STP–0146—Determination of diaphragm over-pressurization—open-circuit, self-contained breathing apparatus with 

belt mounted regulators and breathing tubes.

300 

RCT–ASR–STP–0147—Determination of mode transfer test—combination, open-circuit self-contained breathing apparatus and 

supplied-air respirators (SCBA/SAR).

150 

RCT–ASR–STP–0148—Determination of remote gauge leak-flow test—open-circuit, demand and pressure-demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0148A—Determination of remote gauge leak-flow test—closed-circuit, demand and pressure-demand, self-contained breathing apparatus.150 

RCT–ASR–STP–0155—Man test number 6—self-contained breathing apparatus using liquefied gas .............................................. 2,400 

Chemical, Biological, Radiologic, Nuclear (CBRN) Air-Purifying and Air-Supplied Respirators 

NIOSH/NPPTL administrative support for all CBRN projects .............................................................................................................. 1,300 

# RCT–CBRN–STP–0200, 0201—Determination of open-circuit self-contained breathing apparatus (SCBA) performance during 

dynamic testing against chemical agents of sarin (GB) vapor and distilled sulfur mustard (HD) vapor and liquid—GB live agent 

testing.

6,000 

# RCT–CBRN–STP–0200, 0201—Determination of open-circuit self-contained breathing apparatus (SCBA) performance during 

dynamic testing against chemical agents sarin (GB) vapor and of distilled sulfur mustard (HD) vapor and liquid—HD live agent 

testing.

6,000 

# RCT–CBRN–STP–0200, 0201—aerosol process TDA–99M only ..................................................................................................... 600 

CET–APRS–STP–CBRN–0301—Determination of CBRN organic vapor (cyclohexane) service-life test ........................................... 1,000 

CET–APRS–STP–CBRN–0302—Determination of CBRN acid gases (cyanogen chloride) service-life test ...................................... 2,400 

CET–APRS–STP–CBRN–0303—Determination of CBRN acid gases (hydrogen cyanide) service-life test ....................................... 2,400 

CET–APRS–STP–CBRN–0304—Determination of CBRN acid gases (phosgene) service-life test ................................................... 1,400 

CET–APS–STP–CBRN–0305—Determination of CBRN acid gases (hydrogen sulfide) service-life test ........................................... 800 

CET–APRS–STP–CBRN–0306—Determination of CBRN acid gases (sulfur dioxide) service-life test .............................................. 800 

CET–APRS–STP–CBRN–0307—Determination of CBRN acid gases (ammonia) service-life test .................................................... 1,000 

CET–APRS–STP–CBRN–0308—Determination of CBRN nitrogen oxide gases (nitrogen dioxide) service-life test ......................... 1,200 

CET–APRS–STP–CBRN–0309—Determination of CBRN hydride gases (phosphine) service-life test ............................................. 1,000 

CET–APRS–STP–CBRN–0310—Determination of CBRN formaldehyde service-life test, air-purifying respirators ........................... 1,000 

CET–APRS–STP–CBRN–0311—Laboratory durability conditioning process for environmental, transportation and rough handling 

use conditions on chemical, biological, radiological, and nuclear (CBRN) respiratory protective devices (RPD) standard conditioning procedure (SCP)—US Army Research Development and Engineering Command (RDECOM) environmental conditioning.

20,000 

CET–APRS–STP–CBRN–0311—NPPTL environmental conditioning ................................................................................................. 16,000 

CET–APRS–STP–CBRN–0311—RDECOM modified environmental conditioning—minus 125 canisters .......................................... 16,000 

CET–APRS–STP–CBRN–0311—NPPTL modified environmental conditioning—minus 125 canisters .............................................. 8,000 

CET–APRS–STP–CBRN–0312—Determination of field of view for full facepiece chemical biological radiological nuclear (CBRN) 

respiratory protective devices (RPD).

1,000 

TEB–CBRN–APR–STP–0313—Determination of communication performance test for speech conveyance and intelligibility of 

chemical biological radiological and nuclear (CBRN) full-facepiece air-purifying respirator.

5,000 

CET–APRS–STP–CBRN–0314—Determination of lens fogging on full facepiece chemical biological radiological nuclear (CBRN) 

air-purifying respirator.

3,000 

CET–APRS–STP–CBRN–0316—Determination of haze, luminous-transmittance, and abrasion-resistance properties of the primary lens system material for full-facepiece respiratory protective devices (RPD).2,000 

# RCT–CBRN–APR–STP–0350—Determination of full facepiece, tight-fitting, negative-pressure, air-purifying respirator (APR) 

performance during dynamic testing against the chemical agent vapor sarin (GB)—qualifier live agent testing (QLAT) only.

7,000 

# RCT–CBRN–APR–STP–0350—remainder live agent testing (RLAT) ............................................................................................... 6,000 


tkelley on DSK3SPTVN1PROD with RULES
3912 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 

Standard Test Procedure Fee 

($) 

# RCT–CBRN–APR–STP–0351—Determination of full-facepiece, tight-fitting, negative-pressure, air-purifying respirator (APR) 

performance during dynamic testing against chemical agent distilled sulfur mustard (HD) vapor and liquid CBRN—qualifier live 

agent testing (QLAT) only.

7,000 

# RCT–CBRN–APR–STP–0351—remainder live agent testing (RLAT) ............................................................................................... 6,000 

# RCT–CBRN–APR–STP–0350 and RCT–CBRN–APR–STP–0351—aerosol process TDA–99M ..................................................... 600 

TEB–CBRN–APR–STP–0352—Determination of laboratory respirator protection level (LRPL) values for CBRN self-contained 

breathing apparatus (SCBA) facepieces or CBRN air-purifying respirator (APR)—LRPL.

20,000 

TEB–CBRN–APR–STP–0352—partial laboratory respirator protection level (LRPL) (in cases where failure occurs with less than 

50% of subjects tested).

16,000 

* TEB–CBRN–APR–STP–0353—Weight and diameter ........................................................................................................................ 200 

CET–APRS–STP–CBRN–0401—Determination of CBRN organic vapor (cyclohexane) service-life test, air-purifying escape respirators.1,000 

CET–APRS–STP–CBRN–0402—Determination of CBRN acid gases (cyanogen chloride) service-life test, air-purifying escape 

respirators.

2,400 

CET–APRS–STP–CBRN–0403—Determination of CBRN acid gases (hydrogen cyanide) service-life test, air-purifying escape 

respirators.

2,400 

CET–APRS–STP–CBRN–0404—Determination of CBRN acid gases (phosgene) service-life test, air-purifying escape respirators 1,400 

CET–APRS–STP–CBRN–0405—Determination of CBRN acid gases (hydrogen sulfide) service-life test, air-purifying escape respirators.800 

CET–APRS–STP–CBRN–0406—Determination of CBRN acid gases (sulfur dioxide) service-life test, air-purifying escape respirators.800 

CET–APRS–STP–CBRN–0407—Determination of CBRN base gases (ammonia) service-life test, air-purifying escape respirators 1,000 

CET–APRS–STP–CBRN–0408—Determination of CBRN nitrogen oxide gases (nitrogen dioxide) service-life test, air-purifying 

escape respirators.

1,200 

CET–APRS–STP–CBRN–0409—Determination of CBRN hydride gases (phosphine) service-life test, air-purifying escape respirators.1,000 

CET–APRS–STP–CBRN–0410—Determination of CBRN formaldehyde service-life test, air-purifying escape respirators .............. 1,000 

CET–APRS–STP–CBRN–0411—Laboratory durability conditioning process for environmental, transportation and rough handling 

use conditions on chemical, biological, radiological and nuclear (CBRN) (air-purifying or self-contained) escape respirator— 

RDECOM environmental conditioning.

22,000 

CET–APRS–STP–CBRN–0411—NPPTL environmental conditioning ................................................................................................. 20,000 

* CET–APRS–STP–CBRN–0414—Fogging ......................................................................................................................................... 4,000 

* CET–APRS–STP–CBRN–0417—Flammability, heat resistance ....................................................................................................... 14,000 

# CET–APRS–STP–CBRN–0450—Determination of chemical agent permeation and penetration resistance performance against 

sarin (GB) vapor of chemical, biological, radiological, and nuclear (CBRN) air-purifying escape respirator—qualifier live agent 

testing (QLAT) only.

7,000 

# CET–APRS–STP–CBRN–0450—remainder live agent testing (RLAT) ............................................................................................ 6,000 

# CET–APRS–STP–CBRN–0451—Determination of chemical agent permeation and penetration resistance performance against 

sulfur mustard (HD) liquid and vapor of the chemical, biological, radiological, and nuclear (CBRN) air-purifying escape respirator—qualifier live agent testing (QLAT) only.

7,000 

# CET–APRS–STP–CBRN–0451—remainder live agent testing (RLAT) ............................................................................................ 6,000 

# CET–APRS–STP–CBRN–0450 and CET–APRS–STP–CBRN–0451—aerosol process TDA–99M ................................................. 600 

TEB–CBRN–APR–STP–0452—Determination of laboratory respirator protection level (LRPL) values for CBRN air-purifying escape respirator—LRPL.20,000 

TEB–CBRN–APR–STP–0452—partial LRPL ....................................................................................................................................... 16,000 

CET–APRS–STP–CBRN–0454—Determination of human subject breathing gas (HSBG) concentrations (carbon dioxide and oxygen) for chemical, biological, radiological and nuclear (CBRN) air-purifying escape respirator.3,500 

* CET–APRS–STP–CBRN–0455—Human subject breathing gas test ................................................................................................ 6,000 

CET–APRS–STP–CBRN–0456—Determination of practical performance level for chemical, biological, radiological and nuclear 

(CBRN) (air-purifying or self-contained) escape respirator.

(1) 

CET–APRS–STP–CBRN–0499—Determination of donning effectiveness of chemical, biological, radiological and nuclear (CBRN) 

(air-purifying or self-contained) escape respirator.

( 1) 

TEB–CBRN–STP–0501—Determination of CBRN organic vapor (cyclohexane) service-life test, tight-fitting powered air-purifying 

respirators (PAPR).

1,000 

TEB–CBRN–STP–0502—Determination of CBRN acid gases (cyanogen chloride) service-life test, tight-fitting powered air-purifying respirators (PAPR).2,400 

TEB–CBRN–STP–0503—Determination of CBRN acid gases (hydrogen cyanide) service-life test, tight-fitting powered air-purifying respirators (PAPR).2,400 

TEB–CBRN–STP–0504—Determination of CBRN acid gases (phosgene) service-life test, tight-fitting powered air-purifying respirators (PAPR).1,400 

TEB–CBRN–STP–0505—Determination of CBRN acid gases (hydrogen sulfide) service-life test, tight-fitting powered air-purifying 

respirators (PAPR).

800 

TEB–CBRN–STP–0506—Determination of CBRN acid gases (sulfur dioxide) service-life test, tight-fitting powered air-purifying 

respirators (PAPR).

800 

TEB–CBRN–STP–0507—Determination of CBRN base gases (ammonia) service-life test, tight-fitting powered air-purifying respirators (PAPR).1,000 

TEB–CBRN–STP–0508—Determination of CBRN nitrogen oxide gases (nitrogen dioxide) service-life test, tight-fitting powered 

air-purifying respirators (PAPR).

1,200 

TEB–CBRN–STP–0509—Determination of CBRN hydride gases (phosphine) service-life test, tight-fitting powered air-purifying 

respirators (PAPR).

1,000 

TEB–CBRN–STP–0510—Determination of CBRN formaldehyde service-life test, tight-fitting powered air-purifying respirators 

(PAPR).

1,000 


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Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations 3913 

Standard Test Procedure Fee 

($) 

TEB–APR–STP–0511–CBRN—Determination of CBRN organic vapor (cyclohexane) service-life test, loose-fitting powered airpurifying respirators (PAPR).1,000 

TEB–APR–STP–0512–CBRN—Determination of CBRN acid gases (cyanogen chloride) service-life test, loose-fitting powered airpurifying respirators (PAPR).2,400 

TEB–APR–STP–0513–CBRN—Determination of CBRN acid gases (hydrogen cyanide) service-life test, loose-fitting powered airpurifying respirators (PAPR).2,400 

TEB–APR–STP–0514–CBRN—Determination of CBRN acid gases (phosgene) service-life test, loose-fitting powered air-purifying 

respirators (PAPR).

1,400 

TEB–APR–0515–CBRN—Determination of CBRN acid gases (hydrogen sulfide) service-life test, loose-fitting powered air-purifying respirators (PAPR).800 

TEB–APR–STP–0516–CBRN—Determination of CBRN acid gases (sulfur dioxide) service-life test, loose-fitting powered air-purifying respirators (PAPR).800 

TEB–APR–STP–0517–CBRN—Determination of CBRN base gases (ammonia) service-life test, loose-fitting powered air-purifying respirators (PAPR).1,000 

TEB–APR–STP–0518–CBRN—Determination of CBRN nitrogen oxide gases (nitrogen dioxide) service-life test, loose-fitting powered air-purifying respirators (PAPR).1,200 

TEB–APR–STP–0519–CBRN—Determination of CBRN hydride gases (phosphine) service-life test, loose-fitting powered air-purifying respirators (PAPR).1,000 

TEB–APR–STP–0520–CBRN—Determination of CBRN formaldehyde service-life test, loose-fitting powered air-purifying respirators (PAPR).1,000 

NPPTL–STP–CBRN–PAPR–0550—Determination of CBRN powered air-purifying respirator (PAPR) performance during dynamic 

testing against the chemical agent vapor sarin (GB) chemical, biological, radiological and nuclear (CBRN) standard testing 

procedure (STP).

7,000 

NPPTL–STP–CBRN–PAPR–0551—Determination of CBRN, powered air-purifying respirator (PAPR) performance during dynamic testing against chemical agent distilled sulfur mustard (HD) vapor and distilled sulfur mustard (HD) liquid chemical, biological, radiological, and nuclear (CBRN) standard testing procedure (STP).7,000 

TEB–CBRN–APR–STP–0552—Determination of laboratory respirator protection level (LRPL) values for CBRN tight-fitting powered air-purifying respirator (PAPR).20,000 

TEB–CBRN–APR–STP–0553—Determination of laboratory respiratory protection level (LRPL) values for CBRN loose-fitting 

powered air-purifying respirator (PAPR).

20,000 

New and Unspecified Tests 

This category is to be used for new, on-going, tests which are developed between revisions of the test fee schedule or for special, one-time tests which are required for respirators with unique features (per 42 CFR 84.63).(2) 

* Draft test procedure in place, but final STP has not been published. 

# Test is conducted by U.S. Army Research, Development and Engineering Command Edgewood Chemical Biological Center (ECBC). 

1 No Fee, done as part of LRPL (TEB–CBRN–APR–STP–0452). 

2 $500/day + the actual cost of non-NPPTL staff (typically medical staff and test subjects). 

Dated: January 14, 2015. 

Sylvia M. Burwell, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2015–01046 Filed 1–23–15; 8:45 am] 

BILLING CODE 4163–18–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 79 

[MB Docket Nos. 12–108, 12–107; FCC 13– 

138] 

Accessibility of User Interfaces, and 

Video Programming Guides and Menus 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection associated with 

the Commission’s Report and Order 

implementing provisions of the TwentyFirst Century Communications and 

Video Accessibility Act of 2010 (CVAA) 

related to accessible user interfaces and 

video programming guides and menus. 

This document is consistent with the 

Report and Order, which stated that the 

Commission would publish a document 

in the Federal Register announcing 

OMB approval and the effective date of 

the requirements. 

DATES: 47 CFR 79.107(c), 79.108(a)(5), 

79.108(c) through (e), and 79.110 

published at 78 FR 77210, December 20, 

2013 are effective on January 26, 2015. 

FOR FURTHER INFORMATION CONTACT: For 

additional information contact Cathy 

Williams, Cathy.Williams@fcc.gov, (202) 

418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on October 1, 

2014, OMB approved the information 

collection requirements contained in the 

Commission’s Report and Order, FCC 

13–138, published at 78 FR 77210, 

December 20, 2013. The OMB Control 

Number is 3060–1203. The Commission 

publishes this document as an 

announcement of the effective date of 

the requirements. If you have any 

comments on the burden estimates 

listed below, or how the Commission 

can improve the collections and reduce 

any burdens caused thereby, please 

contact Cathy Williams, Federal 

Communications Commission, Room 1– 

C823, 445 12th Street SW., Washington, 

DC 20554. Please include the OMB 

Control Number, 3060–1203, in your 

correspondence. The Commission will 

also accept your comments via email at 

PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 


tkelley on DSK3SPTVN1PROD with RULES