[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Rules and Regulations]
[Pages 3891-3913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01046]


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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.

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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 <a href="/cdn-cgi/l/email-protection#baf4f3f5e9f2c8dfddc9fad9ded994ddd5cc"><span class="__cf_email__" data-cfemail="753b3c3a263d07101206351611165b121a03">[email protected]</span></a>.

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
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    \1\ This 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.
    \2\ The 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.
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    (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

[[Page 3892]]

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 Sec.  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

[[Page 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 
well-defined 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 ``air-supplying'' 
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 ``air-
supplied'' 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

[[Page 3894]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 [Sec.  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 <plus-minus> 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.

[[Page 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 [Sec.  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 [Sec.  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 [Sec.  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

[[Page 3896]]

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 
paper-based 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) [Sec.  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) [Sec.  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 closed-circuit 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.''

[[Page 3897]]

    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 Sec. Sec.  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 Sec.  84.66 establishes procedures for the withdrawal of 
respirator certification applications. Paragraph (b) directs 
stakeholders to the fee calculation procedures in Sec.  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 Sec.  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 Sec.  
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 Sec.  84.21(e), no comments were 
received.

Section 84.76 Facepieces; Eyepieces; Minimum Requirements

    Existing Sec.  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 Sec.  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 Sec.  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 
Closed-Circuit Apparatus; Maximum Allowable Limits

    Existing Sec.  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.''

[[Page 3898]]

Section 84.110 Gas Masks; Description

    Existing Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  84.21 
apply to this group of respirators. No comments were received on this 
section.

Section 84.1102 Fees

    Existing Sec.  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 Sec.  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 Sec.  84.1136 establishes the minimum requirements for 
facepieces, hoods, and helmets for dust, fume, mist, pesticide, paint 
spray, and powered air-purifying 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 Sec.  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 air-purifying 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 Sec.  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 air-supplying 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 battery-powered 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,

[[Page 3899]]

the most recent data available.\3\ A summary of market segmentation, by 
respirator type, is offered in Table 1, below.
---------------------------------------------------------------------------

    \3\ Frost & Sullivan [2008]. North American Respiratory 
Protective Equipment Market. Report N2E7-39 at 1-1.

                       Table 1--Industry overview
------------------------------------------------------------------------
                                           Market share    Revenues 2007
             Respirator type                 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   23,480.
 approval activities.
Annual cost for certification and        $233,156.
 approval activities.
------------------------------------------------------------------------
                             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 approval-based fees 
(including application, approval, approval modification, and site 
qualification fees, as well as all

[[Page 3900]]

laboratory tests conducted on air-supplied 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.
---------------------------------------------------------------------------

    \4\ Note: One application may result in multiple approvals, so 
it is not unusual for the number of new approvals to exceed the 
number of applications.
---------------------------------------------------------------------------

    Approval Modification: An approval-holder 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.
---------------------------------------------------------------------------

    \5\ Note: 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.
---------------------------------------------------------------------------

    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,

[[Page 3901]]

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 x $50/hour). In 2009, NIOSH performed 12 paper reviews for 
existing approval holders (12 x 400 = 4,800), and 4 domestic (4 x 2,500 
= 10,000) and 2 foreign (2 x 7,500 = 15,000) site qualification audits, 
which would have resulted in payments in the amount of $30,000.
---------------------------------------------------------------------------

    \6\ NIOSH typically employs contractors to conduct site audits, 
at an average cost of $100 per hour.
---------------------------------------------------------------------------

    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      75%.
 billable fees.
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.

[[Page 3902]]

 
Percentage of activities related to      85%.
 billable fees.
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      100%.
 billable fees.
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-for-profit 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 self-
contained 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

[[Page 3903]]

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 
approval-holders 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of       Number of
                   Group ID                                Group type                employees       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\
---------------------------------------------------------------------------

    \7\ Fees 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.
---------------------------------------------------------------------------

    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                  0.6             0.8             1.8             3.5
 company........................................
Avg. number modification applications per year               0.4             0.9             2.6             6.6
 per company....................................
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
----------------------------------------------------------------------------------------------------------------



[[Page 3904]]



             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   \1/2\ (3 total)........  18/33 (51 total).......  92/159 (251 total).
 production employees.
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.
----------------------------------------------------------------------------------------------------------------


[[Page 3905]]

    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

[[Page 3906]]

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

0
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

0
2. In Sec.  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:


Sec.  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

0
3. In Sec.  84.10, revise paragraphs (b), (c), and (d) to read as 
follows:


Sec.  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 Sec.  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.
* * * * *

0
4. In Sec.  84.12, revise paragraph (b) to read as follows:


Sec.  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.
* * * * *
0
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


Sec.  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 Sec. Sec.  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

[[Page 3907]]

    (4) Regulatory review activities, including participation in the 
development of health and safety standards, regulations, and 
legislation.


Sec.  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 Sec.  
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 previously-authorized 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 Sec.  
84.10.


Sec.  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.


Sec.  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.


Sec.  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


Sec.  84.36  [Amended]

0
6. In Sec.  84.36, remove ``Certification and Quality Assurance 
Branch'' and add in its place ``National Personal Protective Technology 
Laboratory''.

Subpart E--Quality Control


Sec. Sec.  84.41 and 84.43  [Amended]

0
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:
0
a. Sec.  84.41(b); and
0
b. Sec.  84.43(a)

Subpart G--General Construction and Performance Requirements

0
8. In Sec.  84.66, revise the section heading and paragraph (b) to read 
as follows:


Sec.  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 Sec.  84.21(e).

Subpart H--Self-Contained Breathing Apparatus


Sec. Sec.  84.76, 84.79, 84.81, and 84.97  [Amended]

0
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:
0
a. Sec.  84.76(b)
0
b. Sec.  84.79(c) and (d)
0
c. Sec.  84.81(d)
0
d. Sec.  84.97(a)

Subpart I--Gas Masks


Sec.  84.110  [Amended]

0
10. In Sec.  84.110(c), remove ``Certification and Quality Assurance 
Branch'' and add in its place ``National Personal Protective Technology 
Laboratory''.


Sec. Sec.  84.113 and 84.119  [Amended]

0
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:
0
a. Sec.  84.113
0
b. Sec.  84.119(b)

Subpart J--Supplied-Air Respirators


Sec. Sec.  84.136 and 84.141  [Amended]

0
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:
0
a. Sec.  84.136(b)
0
b. Sec.  84.141(b) and (c)

[[Page 3908]]

Subpart L--Chemical Cartridge Respirators


Sec.  84.193  [Amended]

0
13. In Sec.  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


Sec.  84.258  [Removed]

0
14. Remove Sec.  84.258.

Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray; Powered 
Air-Purifying High Efficiency Respirators and Combination Gas Masks


Sec.  84.1102  [Removed]

0
15. Remove Sec.  84.1102.


Sec. Sec.  84.1136, 84.1154 and 84.1157  [Amended]

0
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:
0
a. Sec.  84.1136(b)
0
b. Sec.  84.1154(b)
0
c. Sec.  84.1157(d)(5) and (e)(5)

0
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  42 CFR 84.20(b)(5)...  <bullet> Annual fee: $761   <bullet> Upon billing
 (product audit).                                           per each approval holder.   from NIOSH.\1\
                                                           <bullet> Variable fee: As   <bullet> October.
                                                            billed by NIOSH based on
                                                            the respirators chosen to
                                                            be tested each year.
Records Maintenance...............  42 CFR 84.20(b)(1)...  $50 for all listed \2\      <bullet> Upon billing
                                                            approvals on file with      from NIOSH.\1\
                                                            NIOSH on July 1st of each  <bullet> October
                                                            year.                       (beginning in 2015).
Quality Assurance Maintenance       42 CFR 84.20(b)(4)...  <bullet> Annual fee:        <bullet> Upon billing
 (site audit).                                              $3,000 per every            from NIOSH.\1\
                                                            manufacturing site         <bullet> October
                                                            registered with NIOSH.      (beginning in 2015).
                                                           <bullet> Variable fee: \3\
                                                           [ssquf] 1 day domestic
                                                            audit--$2,500 per site.
                                                           [ssquf] 2 day domestic
                                                            audit--$5,000 per site.
                                                           [ssquf] 1 day
                                                            international audit--
                                                            $7,500 per site.
                                                           [ssquf] 2 day
                                                            international audit--
                                                            $10,000 per site.
Maintenance of Testing and          42 CFR 84.20(b)(2)...  $34 per every listed \2\    <bullet> Upon billing
 Approval Facilities.                                       approval on file with       from NIOSH.\1\
                                                            NIOSH on July 1st of each  <bullet> October
                                                            applicable year.            (beginning in 2015).
Maintenance of Test Equipment.....  42 CFR 84.20(b)(2)...  $36 per every active \4\    <bullet> Upon billing
                                                            approval on file with       from NIOSH.\1\
                                                            NIOSH on July 1st of each  <bullet> October
                                                            applicable year.            (beginning in 2015).
----------------------------------------------------------------------------------------------------------------
\1\ For 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.
\3\ Applies to design as well as manufacturing sites.
\4\ Does not include obsolete approvals.


0
18. Add Appendix B to Part 84 to read as follows:

Appendix B to Part 84--Application-Based 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        Upon receipt of any
                                                            submitted.                  application request.
Approval..........................  42 CFR 84.20(b)(1)...  $100 per each certificate   Upon completion of the
                                                            of approval issued.         application and granting
                                                                                        of an approval number.
Approval Modification.............  42 CFR 84.20(b)(1)...  $50 per each certificate    Upon completion of the
                                                            of approval modified.       application and issuing
                                                                                        a modified approval.
Site Qualification................  42 CFR 84.20(b)(3)...  <bullet> Existing approval  Upon agreement on the
                                                            holder, paper review:       date of the site
                                                            $400 per each request to    qualification
                                                            inspect new production      examination.
                                                            facility.
                                                           <bullet> Non-approval
                                                            holders:.
                                                           [ssquf] Domestic site
                                                            visit--$2,500.
                                                           [ssquf] International site
                                                            visit--$7,500.
----------------------------------------------------------------------------------------------------------------


[[Page 3909]]


------------------------------------------------------------------------
            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    150
 filter penetration (PAPR).
RCT-APR-STP-0003--Determination of exhalation    150
 resistance.
TEB-APR-STP-0004--Determination of exhalation    300
 valve leakage.
TEB-APR-STP-0005--Determination of qualitative   1,800
 isoamyl acetate (IAA) facepiece fit test.
TEB-APR-STP-0005A--Determination of qualitative  1,800
 isoamyl acetate (IAA) facepiece fit test.
TEB-APR-STP-0006--Determination of qualitative   1,800
 isoamyl acetate (IAA) facepiece fit test.
TEB-APR-STP-0007--Determination of inhalation    150
 resistance.
RCT-APR-STP-0012--Determination of air flow for  150
 powered air-purifying respirators.
RCT-APR-STP-0014--Determination of leakage of    300
 drinking tube and accessories for respirator
 facepieces.
RCT-APR-STP-0025--Determination of silica dust   1,200
 loading test for powered air-purifying
 respirator filters.
RCT-APR-STP-0030--Determination of noise level   450
 test, powered air-purifying respirator with
 hoods or helmets.
TEB-APR-STP-0033A--Determination of ammonia      750
 service-life test, air-purifying respirators
 with cartridges.
TEB-APR-STP-0033B--Determination of ammonia      750
 service-life test, air-purifying respirators
 with canisters.
TEB-APR-STP-0033C--Determination of ammonia      750
 service-life test, powered air-purifying
 respirators with cartridges.
TEB-APR-STP-0033D--Determination of ammonia      750
 service-life test, tight-fitting powered air-
 purifying respirators with gas mask
 canister(s).
RCT-APR-STP-0034--Carbon monoxide service life.  750
RCT-APR-STP-0035--Determination of chlorine      750
 service life.
RCT-APR-STP-0036--Determination of chlorine      750
 dioxide service life.
RCT-APR-STP-0037--Determination of a-            2,400
 chloroacetophenone (CN) service life.
RCT-APR-STP-0038--Determination of ethylene      450
 oxide service life.
TEB-APR-STP-0039A--Determination of              750
 formaldehyde service-life test, air-purifying
 respirators with cartridges.
TEB-APR-STP-0039B--Determination of              750
 formaldehyde service-life test, air-purifying
 respirators with canisters.
TEB-APR-STP-0039C--Determination of              750
 formaldehyde service-life test, powered air-
 purifying respirators with cartridges.
RCT-APR-STP-0040--Determination of hydrogen      500
 chloride service life.
RCT-APR-STP-0041--Determination of hydrogen      1,800
 cyanide service life.
RCT-APR-STP-0042--Determination of hydrogen      750
 fluoride service life.
TEB-APR-STP-0043A--Determination of hydrogen     750
 sulfide service-life test, air-purifying
 respirators with cartridges.
TEB-APR-STP-0043B--Determination of hydrogen     750
 sulfide service-life test, air-purifying
 respirators with canisters.
TEB-APR-STP-0043C--Determination of hydrogen     750
 sulfide service-life test, powered air-
 purifying respirators with cartridges.
RCT-APR-STP-0044--Determination of mercury       2,400
 vapor service life.
TEB-APR-STP-0045A--Determination of methylamine  450
 service-life test, air-purifying respirators
 with cartridges.
TEB-APR-STP-0045B--Determination of methylamine  450
 service-life test, air-purifying respirators
 with canisters.
TEB-APR-STP-0045C--Determination of methylamine  450
 service-life test, powered air-purifying
 respirators with cartridges.
TEB-APR-STP-0045D--Determination of methylamine  450
 service-life test, tight-fitting powered air-
 purifying respirators with gas mask
 canister(s).
TEB-APR-STP-0046A--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, air-purifying respirators with
 cartridges.
TEB-APR-STP-0046B--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, air-purifying respirators with
 cartridges.
TEB-APR-STP-0046C--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, powered air-purifying respirators with
 cartridges.
TEB-APR-STP-0046D--Determination of organic      450
 vapor (carbon tetrachloride) service-life
 test, tight-fitting powered air-purifying
 respirators with gas mask canister(s).
RCT-APR-STP-0047--Determination of phosphine     750
 service life.
TEB-APR-STP-0048A--Determination of sulfur       450
 dioxide service-life test, air-purifying
 respirators with cartridges.
TEB-APR-STP-0048B--Determination of sulfur       450
 dioxide service-life test, air-purifying
 respirators with canisters.
TEB-APR-STP-0048C--Determination of sulfur       450
 dioxide service-life test, powered air-
 purifying respirators with cartridges.
TEB-APR-STP-0048D--Determination of sulfur       450
 dioxide service-life test, tight-fitting
 powered air-purifying respirators with gas
 mask canisters.
RCT-APR-STP-0050--Determination of O-            2,400
 chlorobenzylidene malononitrile (CS) service
 life.
TEB-APR-STP-0051--Determination of particulate   1,200
 filter efficiency level for P100 series
 filters against liquid particulates for non-
 powered, air-purifying respirators.
TEB-APR-STP-0052--Determination of particulate   1,200
 filter efficiency level for P99 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0053--Determination of particulate   1,200
 filter efficiency level for P95 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0054--Determination of particulate   1,200
 filter efficiency level for R100 series
 filters against liquid particulates for non-
 powered, air-purifying respirators.

[[Page 3910]]

 
TEB-APR-STP-0055--Determination of particulate   1,200
 filter efficiency level for R99 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0056--Determination of particulate   1,200
 filter efficiency level for R95 series filters
 against liquid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0057--Determination of particulate   1,200
 filter efficiency level for N100 series
 filters against solid particulates for non-
 powered, air-purifying respirators.
TEB-APR-STP-0058--Determination of particulate   1,200
 filter efficiency level for N99 series filters
 against solid particulates for non-powered,
 air-purifying respirators.
TEB-APR-STP-0059--Determination of particulate   1,200
 filter efficiency level for N95 series filters
 against solid particulates for non-powered,
 air-purifying respirators.
RCT-APR-STP-0060--Determination of end-of-       300
 service-life indicator drop.
RCT-APR-STP-0061--Determination of end-of-       300
 service-life indicator visibility.
RCT-APR-STP-0062--Determination of nitrogen      750
 dioxide service life.
RCT-APR-STP-0063--Determination of facepiece     300
 carbon dioxide and oxygen concentration
 levels--tight fitting, powered air-purifying
 respirators, with the blower unit running.
RCT-APR-STP-0064--Determination of facepiece     300
 carbon dioxide and oxygen concentration
 levels, tight fitting, powered air-purifying
 respirators, with the blower unit off.
RCT-APR-STP-0065--Determination of air flow      300
 resistance, breath responsive, powered air-
 purifying respirators.
RCT-APR-STP-0066--Determination of end-of-       300
 service-life indicator (ESLI).
RCT-APR-STP-0067--Particulate respirator         1800
 qualitative fit test utilizing saccharin or
 bitrex solutions.
------------------------------------------------------------------------
                        Air-Supplied Respirators
------------------------------------------------------------------------
RCT-ASR-STP-0100--Determination of strength of   150
 hoses and couplings, type C and CE supplied-
 air respirators.
RCT-ASR-STP-0101--Determination of tightness of  150
 hoses and couplings, type C and CE supplied-
 air respirators.
RCT-ASR-STP-0102--Determination of               150
 nonkinkability of hoses, type C and CE
 supplied-air respirators.
RCT-ASR-STP-0103--Determination of gasoline      450
 permeation of hoses and couplings, type C and
 CE supplied-air respirators.
RCT-ASR-STP-0104--Determination of air-          3,000
 regulating valve 100,000 cycles performance,
 demand and pressure-demand type C and CE
 supplied-air respirators.
RCT-ASR-STP-0105--Determination of airflow,      300
 continuous flow type C and CE supplied-air
 respirators.
RCT-ASR-STP-0105A--Determination of airflow,     300
 demand and pressure-demand type C and CE
 supplied-air respirators.
RCT-ASR-STP-0106--Determination of inhalation    150
 airflow resistance, pressure-demand type C and
 CE supplied-air respirators.
RCT-ASR-STP-0107--Determination of exhalation    150
 airflow resistance, pressure-demand type C and
 CE supplied-air respirators.
RCT-ASR-STP-0108--Determination of inhalation    150
 airflow resistance, demand type C and CE
 supplied-air respirators.
RCT-ASR-STP-0109--Determination of exhalation    150
 airflow resistance, demand type C and CE
 supplied-air respirators.
RCT-ASR-STP-0110--Determination of gas-          450
 tightness test, isoamyl acetate (IAA), type C
 and CE supplied-air respirators.
RCT-ASR-STP-0111--Determination of air velocity  450
 and noise levels--sound level, type C and CE
 supplied-air respirators.
RCT-ASR-STP-0112--Determination of the level of  450
 protection provided by abrasive blast, type CE
 supplied-air respirators using a challenge
 aerosol of NaCl (sodium chloride) or corn oil.
RCT-ASR-STP-0113--Determination of airflow       150
 resistance--continuous-flow, type C and CE
 supplied-air respirators.
RCT-ASR-STP-0114--Determination of sound-level   450
 measurement--escape, open-circuit self-
 contained breathing apparatus using hoods or
 helmets.
RCT-ASR-STP-0115--Determination of rated         150
 service time--constant-flow, escape, open-
 circuit self-contained breathing apparatus.
RCT-ASR-STP-0116--Determination of airflow       150
 resistance--continuous-flow, escape, open-
 circuit self-contained breathing apparatus
 with hoods.
RCT-ASR-STP-0117--Determination of positive      150
 pressure--closed-circuit, pressure-demand,
 self-contained breathing apparatus.
RCT-ASR-STP-0118--Determination of low           1,200
 temperature operation--minimum temperature per
 applicant, open-circuit self-contained
 breathing apparatus.
RCT-ASR-STP-0119--Determination of low-          1,200
 temperature operation--minimum temperature per
 applicant, combination open-circuit self-
 contained breathing apparatus and type C and
 CE supplied-air respirators.
RCT-ASR-STP-0120--Determination of positive      75
 pressure--open-circuit, pressure-demand self-
 contained breathing apparatus.
RCT-ASR-STP-0121--Determination of rated         75
 service time--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0121A--Determination of rated        75
 service time--closed-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0122--Determination of exhalation    150
 breathing resistance--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0123--Determination of gas flow      150
 measurements--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0124--Determination of remaining     150
 service-life indicator--open-circuit, demand
 and pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0124A--Determination of alarm        150
 pressure--closed-circuit, demand and pressure-
 demand, self-contained breathing apparatus.
RCT-ASR-STP-0125--Determination of gas           750
 tightness--isoamyl acetate (IAA)--self-
 contained breathing apparatus with facepieces
 and mouthpieces.
RCT-ASR-STP-0125A--Determination of gas          750
 tightness--isoamyl acetate (IAA)--self-
 contained breathing apparatus with hoods or
 helmets.
RCT-ASR-STP-0126--Determination of by-pass       150
 valve flow--open-circuit, demand and pressure-
 demand, self-contained breathing apparatus.
RCT-ASR-STP-0127--Determination of by-pass       150
 valve flow--closed-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0128--Determination of accuracy of   150
 gauge--self-contained breathing apparatus.

[[Page 3911]]

 
RCT-ASR-STP-0132--Determination of inhalation    150
 breathing resistance--open-circuit, demand,
 self-contained breathing apparatus.
RCT-ASR-STP-0133--Determination of exhalation    150
 breathing resistance--open-circuit, pressure-
 demand, self-contained breathing apparatus
 using two second stage regulators.
RCT-ASR-STP-0134--Determination of gasoline      750
 permeation test on breathing bags--closed-
 circuit, self-contained breathing apparatus.
RCT-ASR-STP-0135--Determination of inhalation    150
 and exhalation breathing resistance--closed-
 circuit, demand and pressure-demand, self-
 contained breathing apparatus.
RCT-ASR-STP-0136--Determination of demand gas    150
 flow--closed-circuit, demand and pressure-
 demand, self-contained breathing apparatus.
RCT-ASR-STP-0137--Determination of continuous    450
 gas flow on constant flow with demand flow--
 closed-circuit, self-contained breathing
 apparatus.
RCT-ASR-STP-0138--Determination of safety        150
 relief valve operation--closed-circuit, demand
 and pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0139--Determination of facepiece     450
 carbon dioxide concentrations--self-contained
 breathing apparatus.
RCT-ASR-STP-0140--Man tests--self-contained      3,000
 breathing apparatus.
RCT-ASR-STP-0141--Man test number 5--closed-     150
 circuit, self-contained breathing apparatus.
RCT-ASR-STP-0142--Determination of vibration     750
 (Ro-Tap test) for man test number 1--escape,
 closed-circuit, demand, self-contained
 breathing apparatus.
RCT-ASR-STP-0143--Determination of low-          1,200
 temperature operation--minimum per
 manufacturer--closed-circuit, self-contained
 breathing apparatus.
RCT-ASR-STP-0144--Determination of continuous    300
 gas flow on constant flow--closed-circuit,
 self-contained breathing apparatus.
RCT-ASR-STP-0145--Determination of sound level   750
 measurements for remaining service-life
 indicators--self-contained breathing apparatus.
RCT-ASR-STP-0146--Determination of diaphragm     300
 over-pressurization--open-circuit, self-
 contained breathing apparatus with belt
 mounted regulators and breathing tubes.
RCT-ASR-STP-0147--Determination of mode          150
 transfer test--combination, open-circuit self-
 contained breathing apparatus and supplied-air
 respirators (SCBA/SAR).
RCT-ASR-STP-0148--Determination of remote gauge  150
 leak-flow test--open-circuit, demand and
 pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0148A--Determination of remote       150
 gauge leak-flow test--closed-circuit, demand
 and pressure-demand, self-contained breathing
 apparatus.
RCT-ASR-STP-0155--Man test number 6--self-       2,400
 contained breathing apparatus using liquefied
 gas.
------------------------------------------------------------------------
 Chemical, Biological, Radiologic, Nuclear (CBRN) Air-Purifying and Air-
                          Supplied Respirators
------------------------------------------------------------------------
NIOSH/NPPTL administrative support for all CBRN  1,300
 projects.
# RCT-CBRN-STP-0200, 0201--Determination of      6,000
 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.
# RCT-CBRN-STP-0200, 0201--Determination of      6,000
 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.
# RCT-CBRN-STP-0200, 0201--aerosol process TDA-  600
 99M only.
CET-APRS-STP-CBRN-0301--Determination of CBRN    1,000
 organic vapor (cyclohexane) service-life test.
CET-APRS-STP-CBRN-0302--Determination of CBRN    2,400
 acid gases (cyanogen chloride) service-life
 test.
CET-APRS-STP-CBRN-0303--Determination of CBRN    2,400
 acid gases (hydrogen cyanide) service-life
 test.
CET-APRS-STP-CBRN-0304--Determination of CBRN    1,400
 acid gases (phosgene) service-life test.
CET-APS-STP-CBRN-0305--Determination of CBRN     800
 acid gases (hydrogen sulfide) service-life
 test.
CET-APRS-STP-CBRN-0306--Determination of CBRN    800
 acid gases (sulfur dioxide) service-life test.
CET-APRS-STP-CBRN-0307--Determination of CBRN    1,000
 acid gases (ammonia) service-life test.
CET-APRS-STP-CBRN-0308--Determination of CBRN    1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test.
CET-APRS-STP-CBRN-0309--Determination of CBRN    1,000
 hydride gases (phosphine) service-life test.
CET-APRS-STP-CBRN-0310--Determination of CBRN    1,000
 formaldehyde service-life test, air-purifying
 respirators.
CET-APRS-STP-CBRN-0311--Laboratory durability    20,000
 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.
CET-APRS-STP-CBRN-0311--NPPTL environmental      16,000
 conditioning.
CET-APRS-STP-CBRN-0311--RDECOM modified          16,000
 environmental conditioning--minus 125
 canisters.
CET-APRS-STP-CBRN-0311--NPPTL modified           8,000
 environmental conditioning--minus 125
 canisters.
CET-APRS-STP-CBRN-0312--Determination of field   1,000
 of view for full facepiece chemical biological
 radiological nuclear (CBRN) respiratory
 protective devices (RPD).
TEB-CBRN-APR-STP-0313--Determination of          5,000
 communication performance test for speech
 conveyance and intelligibility of chemical
 biological radiological and nuclear (CBRN)
 full-facepiece air-purifying respirator.
CET-APRS-STP-CBRN-0314--Determination of lens    3,000
 fogging on full facepiece chemical biological
 radiological nuclear (CBRN) air-purifying
 respirator.
CET-APRS-STP-CBRN-0316--Determination of haze,   2,000
 luminous-transmittance, and abrasion-
 resistance properties of the primary lens
 system material for full-facepiece respiratory
 protective devices (RPD).
# RCT-CBRN-APR-STP-0350--Determination of full   7,000
 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.
# RCT-CBRN-APR-STP-0350--remainder live agent    6,000
 testing (RLAT).

[[Page 3912]]

 
# RCT-CBRN-APR-STP-0351--Determination of full-  7,000
 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.
# RCT-CBRN-APR-STP-0351--remainder live agent    6,000
 testing (RLAT).
# RCT-CBRN-APR-STP-0350 and RCT-CBRN-APR-STP-    600
 0351--aerosol process TDA-99M.
TEB-CBRN-APR-STP-0352--Determination of          20,000
 laboratory respirator protection level (LRPL)
 values for CBRN self-contained breathing
 apparatus (SCBA) facepieces or CBRN air-
 purifying respirator (APR)--LRPL.
TEB-CBRN-APR-STP-0352--partial laboratory        16,000
 respirator protection level (LRPL) (in cases
 where failure occurs with less than 50% of
 subjects tested).
* TEB-CBRN-APR-STP-0353--Weight and diameter...  200
CET-APRS-STP-CBRN-0401--Determination of CBRN    1,000
 organic vapor (cyclohexane) service-life test,
 air-purifying escape respirators.
CET-APRS-STP-CBRN-0402--Determination of CBRN    2,400
 acid gases (cyanogen chloride) service-life
 test, air-purifying escape respirators.
CET-APRS-STP-CBRN-0403--Determination of CBRN    2,400
 acid gases (hydrogen cyanide) service-life
 test, air-purifying escape respirators.
CET-APRS-STP-CBRN-0404--Determination of CBRN    1,400
 acid gases (phosgene) service-life test, air-
 purifying escape respirators.
CET-APRS-STP-CBRN-0405--Determination of CBRN    800
 acid gases (hydrogen sulfide) service-life
 test, air-purifying escape respirators.
CET-APRS-STP-CBRN-0406--Determination of CBRN    800
 acid gases (sulfur dioxide) service-life test,
 air-purifying escape respirators.
CET-APRS-STP-CBRN-0407--Determination of CBRN    1,000
 base gases (ammonia) service-life test, air-
 purifying escape respirators.
CET-APRS-STP-CBRN-0408--Determination of CBRN    1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test, air-purifying escape
 respirators.
CET-APRS-STP-CBRN-0409--Determination of CBRN    1,000
 hydride gases (phosphine) service-life test,
 air-purifying escape respirators.
CET-APRS-STP-CBRN-0410--Determination of CBRN    1,000
 formaldehyde service-life test, air-purifying
 escape respirators.
CET-APRS-STP-CBRN-0411--Laboratory durability    22,000
 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.
CET-APRS-STP-CBRN-0411--NPPTL environmental      20,000
 conditioning.
*  CET-APRS-STP-CBRN-0414--Fogging.............  4,000
*  CET-APRS-STP-CBRN-0417--Flammability, heat    14,000
 resistance.
# CET-APRS-STP-CBRN-0450--Determination of       7,000
 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.
# CET-APRS-STP-CBRN-0450--remainder live agent   6,000
 testing (RLAT).
# CET-APRS-STP-CBRN-0451--Determination of       7,000
 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.
# CET-APRS-STP-CBRN-0451--remainder live agent   6,000
 testing (RLAT).
# CET-APRS-STP-CBRN-0450 and CET-APRS-STP-CBRN-  600
 0451--aerosol process TDA-99M.
TEB-CBRN-APR-STP-0452--Determination of          20,000
 laboratory respirator protection level (LRPL)
 values for CBRN air-purifying escape
 respirator--LRPL.
TEB-CBRN-APR-STP-0452--partial LRPL............  16,000
CET-APRS-STP-CBRN-0454--Determination of human   3,500
 subject breathing gas (HSBG) concentrations
 (carbon dioxide and oxygen) for chemical,
 biological, radiological and nuclear (CBRN)
 air-purifying escape respirator.
* CET-APRS-STP-CBRN-0455--Human subject          6,000
 breathing gas test.
CET-APRS-STP-CBRN-0456--Determination of         (\1\)
 practical performance level for chemical,
 biological, radiological and nuclear (CBRN)
 (air-purifying or self-contained) escape
 respirator.
CET-APRS-STP-CBRN-0499--Determination of         ( \1\)
 donning effectiveness of chemical, biological,
 radiological and nuclear (CBRN) (air-purifying
 or self-contained) escape respirator.
TEB-CBRN-STP-0501--Determination of CBRN         1,000
 organic vapor (cyclohexane) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0502--Determination of CBRN acid    2,400
 gases (cyanogen chloride) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0503--Determination of CBRN acid    2,400
 gases (hydrogen cyanide) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0504--Determination of CBRN acid    1,400
 gases (phosgene) service-life test, tight-
 fitting powered air-purifying respirators
 (PAPR).
TEB-CBRN-STP-0505--Determination of CBRN acid    800
 gases (hydrogen sulfide) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0506--Determination of CBRN acid    800
 gases (sulfur dioxide) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0507--Determination of CBRN base    1,000
 gases (ammonia) service-life test, tight-
 fitting powered air-purifying respirators
 (PAPR).
TEB-CBRN-STP-0508--Determination of CBRN         1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test, tight-fitting powered air-
 purifying respirators (PAPR).
TEB-CBRN-STP-0509--Determination of CBRN         1,000
 hydride gases (phosphine) service-life test,
 tight-fitting powered air-purifying
 respirators (PAPR).
TEB-CBRN-STP-0510--Determination of CBRN         1,000
 formaldehyde service-life test, tight-fitting
 powered air-purifying respirators (PAPR).

[[Page 3913]]

 
TEB-APR-STP-0511-CBRN--Determination of CBRN     1,000
 organic vapor (cyclohexane) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0512-CBRN--Determination of CBRN     2,400
 acid gases (cyanogen chloride) service-life
 test, loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0513-CBRN--Determination of CBRN     2,400
 acid gases (hydrogen cyanide) service-life
 test, loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0514-CBRN--Determination of CBRN     1,400
 acid gases (phosgene) service-life test, loose-
 fitting powered air-purifying respirators
 (PAPR).
TEB-APR-0515-CBRN--Determination of CBRN acid    800
 gases (hydrogen sulfide) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0516-CBRN--Determination of CBRN     800
 acid gases (sulfur dioxide) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0517-CBRN--Determination of CBRN     1,000
 base gases (ammonia) service-life test, loose-
 fitting powered air-purifying respirators
 (PAPR).
TEB-APR-STP-0518-CBRN--Determination of CBRN     1,200
 nitrogen oxide gases (nitrogen dioxide)
 service-life test, loose-fitting powered air-
 purifying respirators (PAPR).
TEB-APR-STP-0519-CBRN--Determination of CBRN     1,000
 hydride gases (phosphine) service-life test,
 loose-fitting powered air-purifying
 respirators (PAPR).
TEB-APR-STP-0520-CBRN--Determination of CBRN     1,000
 formaldehyde service-life test, loose-fitting
 powered air-purifying respirators (PAPR).
NPPTL-STP-CBRN-PAPR-0550--Determination of CBRN  7,000
 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).
NPPTL-STP-CBRN-PAPR-0551--Determination of       7,000
 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).
TEB-CBRN-APR-STP-0552--Determination of          20,000
 laboratory respirator protection level (LRPL)
 values for CBRN tight-fitting powered air-
 purifying respirator (PAPR).
TEB-CBRN-APR-STP-0553--Determination of          20,000
 laboratory respiratory protection level (LRPL)
 values for CBRN loose-fitting powered air-
 purifying respirator (PAPR).
------------------------------------------------------------------------
                        New and Unspecified Tests
------------------------------------------------------------------------
This category is to be used for new, on-going,   (\2\)
 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).
------------------------------------------------------------------------
* 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


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