[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Proposed Rules]
[Pages 18535-18547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06914]


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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.

[[Page 18536]]


ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Department of Health and Human Services (HHS) proposes to 
revise 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 proposed rule is designed to update the 
regulations.

DATES: HHS invites comments on this proposed rule from interested 
parties. Comments must be received by May 28, 2013.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For detailed instructions on submitting comments and 
additional information on the rulemaking process, see the ``Public 
Participation'' heading of the SUPPLEMENTARY INFORMATION section of 
this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov or http://www.cdc.gov/niosh/docket/review/docket216/default.html.

FOR FURTHER INFORMATION CONTACT: David Book, NIOSH National Personal 
Protective Technology Laboratory (NPPTL), 626 Cochrans Mill Road, 
Pittsburgh, PA 15236; (412) 386-6691 or (412) 386-5200 (these are not a 
toll-free number).

SUPPLEMENTARY INFORMATION: This proposed rule is designed to establish 
fees for the following: (1) Reviewing applications submitted to NIOSH; 
(2) issuing a certificate of approval; (3) modifying a certificate of 
approval; (4) maintaining a certificate of approval; (5) performing 
specific, standard laboratory tests which are requested by applicants; 
(6) developing and/or performing novel tests which are required to 
evaluate respirator performance; (7) qualifying applicant respirator 
product sites and quality systems; (8) verifying quality system 
performance through site quality audits; (9) verifying commercially 
available respirator performance through product quality audits; (10) 
replacing testing equipment; and (11) providing and maintaining 
laboratories and office space.
    The preamble is organized as follows:

I. Public Participation
II. Background
    A. Introduction
    B. Background and Significance
    C. Need for Rulemaking
    D. Public Meetings for Discussion and for Comment
III. Summary of Proposed Rule
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 are invited to participate in 
this rulemaking by submitting written views, recommendations, and data. 
In addition, HHS invites comments specifically on the following 
recommendations proposed in this notice of proposed rulemaking:
    (1) To delay the implementation of the approval maintenance fee 
specified in ``Respirator Certification Fee Schedule A --Administrative 
Fees'' \1\ 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 invites 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\ ``Respirator Certification Fee Schedule A--Administrative 
Fees'' and ``Respirator Certification Fee Schedule B--Testing Fees'' 
are available in the docket for this rulemaking. The proposed fee 
schedules will not take effect until after publication of the final 
rule.
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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.
    Comments submitted by mail should be addressed to the ``NIOSH 
Docket Officer,'' titled ``Amendments to Respirator Certification Fees, 
NIOSH Docket 216,'' and should identify the author(s), return 
address, and a phone number, in case clarification is needed. Comments 
can be submitted electronically to http://www.regulations.gov. Printed 
comments can be sent to the NIOSH Docket Office at the address above. 
All communications received on or before the closing date for comments 
will be fully considered by HHS.
    All comments submitted will be available for examination in the 
rule docket (a publicly available repository of the documents 
associated with the rulemaking) both before and after the closing date 
for comments. A complete electronic docket containing all comments 
submitted will be available on http://www.regulations.gov. Comments 
will be available in writing by request. NIOSH includes all relevant 
comments received without change in the docket, including any personal 
information provided.

II. Background

A. Introduction

    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 conducting the 
examination, inspection and testing of such respirators which is 
necessary to grant the required approval. This proposed rule is 
designed to assure that all approval activities are covered by 
appropriate fees, to update the fees charged, and to create a mechanism 
for routinely updating fees in the future.

B. Background and Significance

    The current fees and fee structure for certifying respirators were 
codified by HHS in 42 CFR part 84, which was published in June of 1995. 
The fees and

[[Page 18537]]

fee structure were carried over from 30 CFR Part 11 \2\ without any 
significant changes, and had not been amended since their initial 
publication in March 1972. Although the existing fees and fee structure 
have not been updated in 4 decades, since that time, the cost to NIOSH 
of respirator examination, inspection, and testing has risen 
significantly.
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    \2\ 30 CFR part 11, replaced by 42 CFR part 84 in 1995, formerly 
prescribed approval procedures, established fees, and consolidated 
and extended requirements for obtaining joint approval of 
respirators by the Bureau of Mines within the Department of the 
Interior, and NIOSH.
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C. Need for Rulemaking

    Office of Management and Budget (OMB) Circular A-25 Revised 
(Circular) and the Independent Offices Appropriations Act of 1952 (31 
U.S.C. 9701) establish Federal policy regarding fees assessed for 
Government services, and provide guidance to agencies on the 
implementation of charges. Among other things, a government agency 
will: (1) Collect fees for services provided to specific recipients in 
order for such services to remain self-sustaining; and (2) establish 
charges for special benefits provided to specific recipients that are 
at least as great as costs to the agency of providing such benefits. An 
example of a special benefit from a government agency is a license to 
carry on a specific activity or business.
    Currently, NIOSH spends approximately $2,500,000 annually for 
creating and modifying certificates of approval, verifying conformance 
to 42 CFR Part 84, and conducting certification testing. Because the 
fee structure reflects the 1972 economy, NIOSH currently charges 
applicants only $240,000 to $500,000 annually. This annual disparity of 
between $2,000,000 and $2,500,000 does not allow the respirator 
certification program to be self-sustaining, as required by OMB. Under 
the Consolidated Appropriations Act of 2012 (Pub. L. 112-74), NIOSH is 
authorized to retain collected user fees. Therefore, it is vital that 
NIOSH update the fees it charges to applicants to fully recover the 
actual costs of respirator certification.
    Under 42 CFR Part 84, a NIOSH certificate of approval is equivalent 
to a license providing a specific recipient, a respirator manufacturer, 
the ability to sell its NIOSH-approved respirators to U.S. businesses 
or industries that require the use of respirators by their employees. 
In accordance with the Circular, NIOSH will charge the recipient for 
the special benefit of examination, inspection, and testing that 
comprise the approval. Additionally, NIOSH is required to recover the 
costs of maintaining approvals, which include maintenance of 
certification records, verification of continued applicant compliance 
with approved quality systems and procedures, and verification of 
actual commercial product performance.
    Accordingly, HHS proposes to update the fee schedule for the 
inspection, approval, and certification of manufacturers' (specific 
recipients) respirators to cover NIOSH's costs in conducting these 
processes. HHS proposes to establish a process of periodically updating 
these fees as necessary to maintain current with changes to costs 
arising from inflation, new certification requirements, and/or 
technological changes.

D. Public Meetings for Discussion and for Comment

    NIOSH will convene a public meeting to provide stakeholders an 
opportunity to comment orally on this rulemaking during the comment 
period. The meeting will be held in the Pittsburgh, Pennsylvania, metro 
area, and will be announced in a separate notice in the Federal 
Register. This meeting will also be available through remote access 
capabilities.

III. Summary of Proposed Rule

    This proposed rule would amend several sections in 42 CFR Part 84 
and replace Subpart C--Fees in its entirety. The proposed provisions 
would establish a new fee structure designed to enable NIOSH to fully 
recover the cost to the agency of certification examination, testing, 
and inspection. Unlike the existing fee structure, the proposed fee 
structure would take 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 proposed fee 
structure would charge applicants for the costs of issuing, modifying, 
and maintaining certificates of approval, production facility 
inspection (site qualification fee), and for verification of on-going 
quality system compliance and commercial product performance.
    The first proposed fee schedules are not included in the proposed 
regulatory text but are offered as supporting material in NIOSH Docket 
216 and on www.regulations.gov Docket CDC-2013-0004 for this 
rulemaking. After the public comment period, the new fee schedules will 
be published in a Federal Register notice after publication of the 
final rule. The fees will be effective at that time or as otherwise 
specified in the final rule. Subsequent fee schedules will be updated 
periodically through notices in the Federal Register, according to the 
proposed provisions in Sec.  84.23, discussed below.
    The following is a section-by-section summary which describes and 
explains the provisions of the proposed rule. The public is invited to 
provide comment on any aspect of this rule.

84.2 Definitions

    This existing section, under subpart A, establishes definitions of 
terms found in the Part 84 regulations. The proposed amendment to this 
section would simply add a definition for the NIOSH National Personal 
Protective Technology Laboratory (NPPTL), which is the NIOSH unit that 
conducts respirator certification testing.

84.10 Application Procedures

    This existing section, under subpart B, establishes procedures for 
submitting applications to NIOSH for respirator approval. Under this 
section, paragraphs (a) and (e) will remain unchanged. Respectively, 
these paragraphs require that applicants submit to NIOSH a written 
application and that respirators with electrical or electronic 
components will be tested in accordance with 30 CFR Part 18.
    The proposed amendment to paragraph Sec.  84.10(b) would remove all 
references to checks or money orders being submitted as part of the 
application. Instead, NIOSH would bill the applicant under the 
provisions of proposed Sec.  84.22. The mailing address would be 
updated to reflect the current address in Pittsburgh, Pennsylvania. 
Changes to paragraphs (c) and (d) would identify NPPTL as the entity 
that will conduct the respirator testing.

84.12 Delivery of Respirators and Components by Applicant; Requirements

    Paragraph (b) of this existing section would be revised to identify 
NPPTL as the entity to which applicants must deliver respirator units 
for certification testing.

84.19 Applicability

    HHS proposes that the final rule will take effect 30 days after 
publication in the Federal Register. HHS understands that fees for 
maintaining existing approvals may cause some approval holders to 
modify their current business practices (e.g., some manufacturers 
maintain approvals for products that are not commercially available). 
Therefore, HHS proposes to delay the implementation of the approval

[[Page 18538]]

maintenance fee specified in ``Respirator Certification Fee Schedule 
A--Administrative Fees'' (included in the docket for this rulemaking) 
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. HHS believes that 4 
months is sufficient time for manufacturers to request rescission of 
approvals for items not in production. However, public comments on this 
timeframe are welcomed.
    Paragraph (c) would specify that fees for site audits would be 
assessed beginning in the October that falls more than 4 months after 
publication of the final rule.

84.20 Establishment of Fees

    Proposed Sec.  84.20 would replace existing Sec.  84.20 in its 
entirety. Proposed paragraph (a) would establish the fee structure for 
the examination, testing and inspection required to issue, maintain, 
and modify certificates of approval.
    Proposed paragraph (b) would specify the activities for which NIOSH 
would charge fees. Such activities would include: (1) Application and 
approval processing, including the review of documents, analysis of 
drawings, technical evaluation and testing of respirators; (2) approval 
maintenance, including records management, product audits, and site 
audits to verify the maintenance of approved quality systems; and (3) 
the qualification of new respirator production sites. Direct and 
indirect costs associated with those activities would include: (1) 
Clerical services, computer tracking, status reporting, control of 
records and document preparation; (2) management and overhead costs 
(for further discussion, see Section IV.A., below); and (3) the 
purchase, maintenance, and replacement of the facilities and equipment 
required to test and evaluate respirators. As discussed below in the 
Executive Order 12866 economic analysis, the fee structure proposed in 
this notice is intended to recover the full cost of providing 
respirator certification services to manufacturers.
    Finally, proposed paragraph (c) would specify the activities for 
which NIOSH does not intend to charge fees. Such activities would 
include: (1) Technical assistance not associated with applications for 
approval; (2) research and surveillance activities conducted by other 
NIOSH branches; (3) respirator research; and (4) regulatory review 
activities, and the development of standards and regulations.

84.21 Fees Calculation

    Proposed Sec.  84.21 would specify how fees would be calculated and 
administered. Paragraph (a) would specify that the fees charged would 
reflect the actual costs incurred by the government for the requested 
services.
    Paragraph (b) would specify the procedure by which NIOSH would 
estimate the fee for an applicant, including deriving the estimate 
using a published fee schedule. The paragraph would require that NIOSH 
provide the estimate to the applicant and receive authorization before 
beginning the technical evaluation. The testing requirements for the 
various classes of respirators that NIOSH evaluates under 42 CFR Part 
84 are well defined. NIOSH has extensive experience with processing 
applications for respirator approval, and therefore expects that most 
applications will be of a routine nature and the final charges within 
the original fee estimate. Application and certification fees are 
generally standard for each type of respirator, although some charges, 
such as quality assurance audits, will be dependent on the number of 
approvals and manufacturing sites maintained by the manufacturer 
seeking approval. As described in Sec.  84.24, occasionally, unusual or 
undisclosed features or characteristics of the design under 
investigation require more evaluation time or additional tests that 
were not anticipated in the initial fee estimate. Accordingly, NIOSH 
will notify applicants what the maximum additional cost would be for 
such tests. NIOSH will require advance authorization from applicants 
for the additional costs associated with this testing.
    Proposed paragraph (c) would establish that, in the event that 
NIOSH determines that actual costs exceed the estimate provided to 
applicants, NIOSH would revise the fee estimate. The applicant will 
have the option of either withdrawing the application and paying for 
NIOSH services already performed or authorizing payment of the revised 
estimate, in which case NIOSH will continue the application review and 
related testing.
    Proposed paragraph (d) would require that NIOSH charge no more than 
the actual costs of respirator application processing, including the 
review of documents, analysis of drawings, technical evaluation, and 
testing of respirators. (See section IV.A., below, for a thorough 
discussion of these costs.)
    Proposed paragraph (e) would describe how the applicant may 
withdraw an application before NIOSH has completed its review, and the 
costs for which the applicant would remain liable. Such costs would 
include any work that NIOSH has already performed when the request to 
withdraw an application is received by NIOSH. Examples include any 
administrative work, any technical evaluations of drawings and designs, 
and any testing which has been set up or performed.

84.22 Fee Administration

    Section 84.22 would establish the procedure NIOSH would use to bill 
applicants. Proposed paragraph (a) would explain that applicants will 
be billed for all fees assessed upon completion of NIOSH testing, 
rather than be asked to submit an estimated fee with the application, 
as is currently done. Payment instructions will be provided in the 
invoice. Applicants will be advised of payment options, including 
procedures for submitting payments electronically through the Federal 
Web site https://pay.gov.
    Proposed paragraph (b) would address billing for maintenance fees, 
which have not previously been charged by NIOSH.
    Proposed (c) would establish that NIOSH may impose sanctions in the 
event that a manufacturer fails to remit payment for a service 
performed by the agency. Such sanctions may include, but would not be 
limited to, NIOSH taking the following actions: (1) Refusing to accept 
future applications for approval, except for applications for 
extensions of approval needed to address respirator recall and retrofit 
matters that are associated with health and safety issues for workers; 
(2) imposing a stop-sale order for all approved products; or (3) 
engaging appropriate Federal government authorities to initiate debt 
collection procedures for the unpaid fees. Sanctions will be determined 
on a case-by-case basis; considerations will include an assessment of 
the manufacturer's particular circumstances and other stakeholders' 
needs. Flexibility in meeting these needs cannot be achieved without 
the ability to choose and impose appropriate sanctions on manufacturers 
who may miss one or several payments.

84.23 Fee Revision

    Proposed Sec.  84.23 would establish the fee schedules for NIOSH's 
respirator certification activities. Proposed paragraph (a) would 
require fee schedules to remain in effect for at least 1 year and to be 
revised at least every 5 years. NIOSH chose 1 year as the minimum 
amount of time for the fees to remain in effect to give manufacturers 
an opportunity to plan for application submissions. Five years was 
chosen as

[[Page 18539]]

a maximum amount of time for the fees to remain in effect to ensure 
that NIOSH is reimbursed for the actual costs of respirator approval, 
in the event that costs to the program increase. HHS welcomes public 
comment on whether a 1-year minimum is adequate for manufacturers to 
plan their submissions.
    Proposed paragraph (b) would specify that notification of changes 
in schedules would be published in the Federal Register.
    Proposed paragraph (c) would establish that the current fee 
schedules would remain in effect until new schedules are published.

84.24 Authorization for Additional Tests and Fees

    Proposed Sec.  84.24 would allow NIOSH the discretion to conduct 
special or additional examinations 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. This authority would be 
retained without substantive change, as currently specified under 
existing Sec.  84.22(b).

84.66 Withdrawal of Applications

    Existing Sec.  84.66 of subpart G establishes procedures for the 
withdrawal of respirator certification applications. Existing paragraph 
Sec.  84.66(a), which establishes an applicant's right to withdraw an 
application, will be retained in its entirety.
    Paragraph (b) would be amended to specify that NIOSH would bill the 
applicant for costs incurred during the incomplete processing of the 
application until and including its withdrawal, as provided under Sec.  
84.21(e). NIOSH would bill the applicant upon receipt of the written 
withdrawal notice. More information about billing procedures will be 
available in the guidance document, ``Standard Application Procedure 
for the Certification of Respirators Under 42 CFR 84.'' \3\
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    \3\ The 2005 version of the Standard Application Procedure is 
available at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/pdfs/SAPJul2005.pdf. This document does not reflect the changes 
proposed in this rulemaking and will be updated prior to publication 
of this final rule.
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84.258 Fees

    HHS proposes to remove existing Sec.  84.258 from subpart N, which 
contains a special respirator fee schedule for vinyl chloride 
respirators. The fees that would be established by this proposed rule 
under Sec.  84.21 would apply to this group of respirators.

84.1102 Fees

    HHS proposes to remove existing Sec.  84.1102 from subpart KK, 
which contains a special respirator fee schedule for a series of 
respirators, including powered air purifying respirators. The fees that 
would be established by this proposed rule under Sec.  84.21 would 
apply to this group of respirators.

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 proposed rule is not being treated as a ``significant 
regulatory action'' within the meaning of E.O. 12866. The proposed 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 (ie., ``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, the most recent data available.\4\ A summary of market 
segmentation, by respirator type, is offered in Table 1, below.
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    \4\ Frost & Sullivan [2008]. North American Respiratory 
Protective Equipment Market. Report N2E7-39 at 1-1.

                       Table 1--Industry Overview
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                                        Market share      Revenues 2007
           Respirator type                2007  (%)       (millions $)
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                             Air-Purifying
------------------------------------------------------------------------
Elastomeric.........................              28.1             514.2
Particulate.........................              21.1             386.1
Powered air purifying...............               7.0             115.3
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                             Air-Supplying
------------------------------------------------------------------------
SCBA (open- and closed-circuit).....              35.2             677.1
CCER................................               2.8              31.1

[[Page 18540]]

 
Airline.............................               5.8            106.1
------------------------------------------------------------------------
Source: Frost & Sullivan [2008]. North American Respiratory Protective
  Equipment Market. Report N2E7-39.

    As discussed above, 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. HHS proposes to set 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 proposed rule, and NIOSH believes there has been 
minimal inflation affecting the NIOSH costs in the past 2 years. NIOSH 
will update the fee schedules and related analyses using the most 
current available data in the final rule.
    All of the proposed 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 proposed 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)........................................            3.96            1.12            5.08
                                                                 -----------------------------------------------
    Prorated Total..............................................           40.62           10.67           51.29
----------------------------------------------------------------------------------------------------------------

    Fixed costs are approximately $500,000 per year. These are the 
costs required to ensure the continued availability of a testing 
laboratory and are reasonably independent of the number of respirators 
tested or reviewed at any given time. These costs are broken down in 
Table 3, below.

                          Table 3--Fixed Costs
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                               Facilities
------------------------------------------------------------------------
Total cost..............................................      $5,161,860
Total square feet used by NIOSH.........................         474,000
Cost per square foot....................................           $9.93
Square feet used for certification and approval                   23,480
 activities.............................................
Annual cost for certification and approval activities...        $233,156
------------------------------------------------------------------------
                             Test Equipment
------------------------------------------------------------------------
Total cost..............................................      $2,510,000
Amortization period.....................................        10 years
Annual cost of test equipment...........................        $251,000
------------------------------------------------------------------------

    The fee schedules that are the basis for the analysis below are 
broken down into administrative fees (including site qualification, new 
applications, new approvals, modification, records maintenance, quality 
assurance maintenance [site audits], product performance maintenance 
[product audits], facility maintenance, and testing capacity 
maintenance [test equipment depreciation]), and testing fees (including 
all laboratory tests conducted on air-supplied and air-purifying 
respirators, and respirators certified for use against chemical, 
biological, radiological, and nuclear agents). To view the full 
proposed fee schedules, see ``Respirator Certification Fee Schedule A--
Administrative Fees'' and ``Respirator Certification Fee Schedule B--
Testing Fees,'' which are available in the docket for this rulemaking. 
HHS offers the following explanation for the fee structure proposed 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 proposed 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 new approvals are estimated to require 2 hours each 
above the base application fee, the proposed fee is set at $100. In 
2009, NIOSH granted 700 approvals \5\ and would have received payments 
in the amount of $70,000.
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    \5\ 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.
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    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 approvals are estimated to require 1 hour 
each above the base application fee. Thus, the proposed modification 
fee is set at $50. In 2009, NIOSH granted 820 modifications of approval 
\6\ and would have received payments in the amount of $41,000.
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    \6\ 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.
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    Records Maintenance: Each existing approval is estimated to require 
1 hour of records maintenance time per year. The proposed maintenance 
fee is set at $50. Manufacturers held a total of 6,800 current 
approvals in 2009 and would have remitted maintenance payments in the 
amount of $340,000.
    Quality Assurance Maintenance: The quality assurance maintenance 
fee will cover the costs of the quality auditing program. The cost to 
NIOSH for conducting facility audits depends on many variables, 
including the number of

[[Page 18541]]

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. NIOSH finds it appropriate 
to divide the overall cost to the agency among all existing approvals, 
as the quality systems for all approvals need to be verified. 
Therefore, quality audits will be charged annually per approval. The 
proposed quality assurance maintenance fee is set at $85 per existing 
approval. Manufacturers held a total of 6,800 current approvals in 2009 
and would have made payments in the amount of $578,000 to cover in full 
the costs of quality audits at the sites.
    Product Performance Maintenance: The product performance 
maintenance fee will cover the costs of the product audit program. 
Product audits are conducted on approved respirators and these 
respirators are, typically, obtained through normal commercial 
purchases. A decision logic is used to determine which respirators to 
purchase and test; one of the central factors in this decision is 
whether significant modifications have been made from the original, 
approved design. Accordingly, a fee for product performance audits will 
be added to each modification of approval requested. The proposed 
product performance maintenance fee is set at $150. A manufacturer that 
does not modify an approval will not be subject to a product 
performance maintenance fee. In 2009, NIOSH granted 820 modifications 
of approval and would have received payments in the amount of $123,000 
to cover in full the costs of product audits.
    Site qualification: The site qualification fee provides for a one-
time inspection of new production facilities. The fee would include 
travel expenses for personnel (including travel to sites outside the 
United States) as well as hourly charges.\7\ 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); travel expenses are 
estimated at $3000 for each site qualification inspection ($3000 is the 
average cost of travel for staff conducting site audits). Thus, the 
proposed site qualification fee is set at $5,000. In 2009, NIOSH 
performed six site qualifications and would have received payments in 
the amount of $30,000.
---------------------------------------------------------------------------

    \7\ 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. 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 approval. In 2009, 
the facility operating costs specific to respirator certification were 
$233,156 and manufacturers held 6,800 current approvals. A fee of 
$34.00 per approval would have returned $231,200 to the program.
    Testing Capacity Maintenance: 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. The testing capacity 
maintenance fee will be assessed annually per 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 approval would have returned $244,800 to 
the program.
    Testing: The proposed fees for each individual test are specified 
in ``Respirator Certification Fee Schedule B--Testing Fees,'' posted in 
NIOSH Docket 216 and on www.regulations.gov in Docket CDC-
2013-0004. 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. 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 proposed fees 
have also been grouped into three categories--administrative/
evaluation, testing, and audit activities--as summarized in Table 4, 
below.

                Table 4--Variable Fee Recovery Estimates
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                  Administrative/Evaluation Activities
------------------------------------------------------------------------
2009 Budget.............................................        $775,000
Percentage of activities related to billable fees.......             75%
Fees target.............................................        $581,000
------------------------------------------------------------------------
               Estimated recovery under revised regulation
------------------------------------------------------------------------
Applications............................................         $87,000
New approvals...........................................         $70,000
Modifications...........................................         $41,000
Maintenance fee, records................................        $340,000
Site qualification......................................         $30,000
Total fees..............................................        $568,000
Percent recovery........................................         97.1% *
------------------------------------------------------------------------
                          Testing Activities **
------------------------------------------------------------------------
2009 Budget.............................................        $840,000
Percentage of activities related to billable fees.......             85%
Fees target.............................................        $714,000
------------------------------------------------------------------------
               Estimated recovery under revised regulation
------------------------------------------------------------------------
Testing fees............................................        $717,000
Total fees..............................................        $717,000
Percent recovery........................................            100%
------------------------------------------------------------------------
                            Audit Activities
------------------------------------------------------------------------
2009 Budget.............................................        $708,000
Percentage of activities related to billable fees.......            100%
Fees target.............................................        $708,000
------------------------------------------------------------------------
               Estimated recovery under revised regulation
------------------------------------------------------------------------
Product audit fees......................................        $123,000
Site audit fees.........................................        $578,000
Total audit fees........................................        $701,000
Percent Recovery........................................           99.0%
------------------------------------------------------------------------
* Given the level of variation in submissions from year to year,
  projections of 90-100% are considered to be full recovery.
** CBRN fees have been excluded.

    In Table 4, above, the administrative/evaluation category includes 
most of the NPPTL Technology Evaluation Branch overhead in addition to 
the certification activities. HHS estimates that 75 percent of this 
category provided services that were directly related to billable 
certification activities. The testing category targets maintenance of 
certification equipment, laboratory supplies and testing. HHS estimates 
that 85 percent of this category provides services directly related to 
billable certification testing activities. The audit category includes 
both the site audit and

[[Page 18542]]

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                $251,000
                                             Depreciation.
Proposed Fee.................      231,200  Proposed Fee...      249,600
Percent Recovery.............        99.2%  Percent                99.4%
                                             Recovery.
------------------------------------------------------------------------

    The fixed fee categories are recoverable operating expenses of the 
respirator certification activity. However, they have not historically 
been part of the NPPTL 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 proposed 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 proposed rule would 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 
believes that it can certify this rule under the RFA, but has prepared 
an Initial Regulatory Flexibility Analysis because it lacks information 
about the revenues of small entities that would be impacted. Therefore, 
HHS requests comments from manufacturers on this matter as the 
financial operations of these small entities are not publicly available 
to be directly analyzed.
    This rule would update 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 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. above). 
NIOSH's objective is to recover all of these costs. The proposed 
schedules (included in NIOSH Docket 216 and 
www.regulations.gov Docket CDC-2013-0004 for this rulemaking) will 
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 proposed 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 proposed rule would have 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 proposed regulation. Many of these small companies are privately 
owned and, therefore, do not release public financial statements. 
However, as discussed below, we believe it is unlikely that the 
proposed regulation will 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

[[Page 18543]]

 
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.\8\
---------------------------------------------------------------------------

    \8\ 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 the proposed revision to fees.
---------------------------------------------------------------------------

    The current fee structure specifies a single fee for each type of 
respirator approval (See 42 CFR 84.20-84.22). This type of fee 
structure tends to favor those companies who demand extensive services 
and disadvantage companies who have fairly simple, easily executed 
requests. In order to better balance actual fees charged with actual 
services requested, the proposed 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 proposed 
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 approvals 
granted/modified, small companies would not pay for potential services 
that they do not use. Likewise, small companies typically have a 
limited number of existing approvals, so maintenance fees based on the 
number of 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 manufactures 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 ($5000) has not been incorporated 
into those figures.

                                Table 7--Current Statistics for Approval Holders
----------------------------------------------------------------------------------------------------------------
                                                                Group 1      Group 2      Group 3      Group 4
----------------------------------------------------------------------------------------------------------------
Avg. number approvals held per company......................            3           30           31          566
Avg. new approval applications per year per company.........          0.6          0.8          1.8          3.5
Avg. number modification applications per year per company..          0.4          0.9          2.6          6.6
Avg. fees paid per year per company ($).....................          850        2,050        4,150        8,100
                                                             ---------------------------------------------------
Total fees for 2005-2009 ($)................................       42,200       81,820      145,450      403,965
----------------------------------------------------------------------------------------------------------------


        Table 8--Statistics for Approval Holders if Proposed 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 Proposed Fees
----------------------------------------------------------------------------------------------------------------
                                                      Group 1         Group 2         Group 3         Group 4
----------------------------------------------------------------------------------------------------------------
Avg. current fees per year per company ($)......             850           2,050           4,150           8,100
Avg. proposed fees per year per company ($).....           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

[[Page 18544]]

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

    According to Table 10, below, a site qualification fee would be 
triggered very infrequently. The types of events that would trigger a 
site audit include: The company becomes an approval holder for the 
first time (Event 1); the company moves to or adds a new production 
site (Event 2); or the company is sold and production moves to a new 
site (Event 3). Based on the 2005-2009 NIOSH data, an existing small 
approval holder would require a site qualification about once every 14 
years [(5 years) x (25 companies) / (9 events) = 13.9 years between 
events]. Existing large approval holders would require a site 
qualification about once every 5 years [(5 years) x (10 companies) / 
(11 events) = 4.5 years between events]. While NIOSH cannot predict the 
type or number of events that might trigger a site audit in the future, 
the number of events that triggered such audits in the past is used 
here to provide a realistic estimate of future site qualification fees.
    The site qualification fee would 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 would 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 would 
be very small 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 would be very small compared to the cost 
of buying a company and relocating it.

Table 10--Statistics for Approval Holders if Proposed Site Qualification
                 Fee Were in Place During 2005-2009 \1\
------------------------------------------------------------------------
                               Group 1    Group 2    Group 3    Group 4
------------------------------------------------------------------------
Event 1 (New) \2\...........          1          1  .........          1
Event 2 (Adds) \3\..........          2          1          2         10
Event 3 (Sold) \4\..........          3  .........          1  .........
Total Events................          6          2          3         11
Total cost ($)..............     30,000     10,000     15,000     55,000
Avg. cost per company per           600        250        430      1,100
 year \5\ ($)...............
------------------------------------------------------------------------
\1\ Example Group 1 has 10 companies and total cost is calculated over 5
  years. Avg cost/company/year = $30000/(10 co)(5 yr).
\2\ Event 1--Company becomes an approval holder for the first time.
\3\ Event 2--Company moves to or adds a new production site.
\4\ Event 3--Company is sold and production moves to a new site.
\5\ Reflects occurrence of events within each group in NIOSH's internal
  certification data.

    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 their staff. 
Staffing levels were placed at the smallest likely levels for each size 
group.
    As can be seen in Table 11, below, even using the limited estimator 
of salaries as a surrogate for total revenues, the cost of the proposed 
rule does not, on average, reach the HHS threshold of more than 3 
percent of revenues for the proposed rule to be considered significant 
for any of the groups of companies.

                            Table 11--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                      50-99                   250-499
                                        employees                employees               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                      18/33                   92/159
 production employees.                  (3 total)                (51 total)              (251 total)
Total salaries/company................  $132,000                 $2,160,000              $13,400,000
Total proposed fees (ref. Tables 7 and  $2,940                   $9,595                  $18,740
 9).

[[Page 18545]]

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

    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 proposed rule 
could, sporadically, have a significant impact on individual companies. 
We request input from the regulated manufacturers on the accuracy of 
our estimates and ask that they provide data regarding the economic 
impact of this proposed rule.
    The RFA requires that the initial regulatory flexibility analysis 
describe significant alternatives to the rule proposed in this 
document. HHS has identified two alternatives in addition to the 
proposed increase in 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 continue 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 has chosen not to pursue this alternative.
Alternative 2: Retain the Current Fee Structure and Increase the Fees
    HHS could maintain the current fee structure but increase 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 has chosen not to pursue this alternative.
Proposed Rule: Modify Both the Fees and the Fee Structure To Reflect 
Actual Usage of NIOSH Services
    As proposed here, HHS could 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 proposed rule would also allow NIOSH to fully 
recover its costs associated with respirator testing and certification, 
as required by the Circular. Therefore, HHS has chosen to pursue this 
alternative.
    Based on the analysis provided above, HHS believes that the 
proposed rule would 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, 
expiration date August 31, 2014), which covers all information 
collected under 42 CFR Part 84. The information NIOSH would collect 
under this rule does not differ substantially from the information 
presently collected from respirator manufacturers who obtain NIOSH 
certification of their products; nor would 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 would 
report to Congress the promulgation of a final rule, once it is 
developed, prior to its taking effect. The report would 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 proposed 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 2011, the inflation adjusted threshold is $136 million.

F. Executive Order 12988 (Civil Justice)

    This proposed 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 would 
apply uniformly to all applicants. This proposed rule has been reviewed 
carefully to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    HHS has reviewed this proposed rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The proposed 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.''

[[Page 18546]]

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 proposed rule on 
children. HHS has determined that the proposed rule would 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 proposed rule on energy supply, distribution, or use 
because it applies to the underground coal mining sector since coal 
mine operators are consumers of respirators. The proposed 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 proposed 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 proposed rule consistent with the Federal 
Plain Writing Act guidelines.

Proposed 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 proposes to amend 42 CFR Part 84 as follows:

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

0
1. The authority citation for part 84 is amended 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, and add in alphabetical 
order a definition for ``National Personal Protective Technology 
Laboratory'' to read as follows:


Sec.  84.2  Definitions.

* * * * *
    National Personal Protective Technology Laboratory means the 
National Personal Protective Technology Laboratory, National Institute 
for Occupational Safety and Health, Centers for Disease Control and 
Prevention, Department of Health and Human Services, P.O. Box 18070, 
626 Cochrans Mill Road, Pittsburgh, PA 15236.
* * * * *

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 shall be submitted 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 shall 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 shall be made for 
such consultation and no written report shall 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 shall deliver, at his or her own expense, the 
number of completely assembled respirators and component parts required 
for testing, to the National Personal Protective Technology Laboratory.
* * * * *
0
5. Revise subpart C as follows:
Subpart C--Fees
Sec.
84.19 Applicability
84.20 Establishment of fees.
84.21 Fee calculation.
84.22 Fee administration.
84.23 Fee revision.
84.24 Authorization for additional tests and fees.

Subpart C--Fees


Sec.  84.19  Applicability.

    (a) For respirator manufacturers that intend to apply for a 
respirator certificate of approval under part 84, the provisions of 
Part 84 subpart C are applicable on [DATE 30 DAYS AFTER FINAL RULE 
PUBLICATION IN THE Federal Register.]
    (b) For current approval holders, the records maintenance fee 
specified in ``Respirator Certification Fee Schedule A--Administrative 
Fees'' is applicable on [DATE 4 MONTHS AFTER FINAL RULE PUBLICATION IN 
THE Federal Register.]
    (c) Fees for site audits are effective [DATE OF FIRST OCTOBER 1 
THAT OCCURS MORE THAN 4 MONTHS AFTER FINAL RULE PUBLICATION IN THE 
Federal Register.]


Sec.  84.20  Establishment of fees.

    (a) This section establishes a system under which NIOSH charges a 
fee for services provided to applicants under 42 CFR part 84. This 
section specifies the purposes for which fees shall be assessed and the 
cost factors for such assessments.
    (b) Fees will be charged for:
    (1) 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;
    (2) A proportionate share of management, administration and 
operation of the NIOSH organizational unit that conducts application 
processing;
    (3) Amortization of facility improvements and depreciation of 
buildings and equipment used for testing and evaluation or otherwise 
directly associated with application processing;
    (4) Initial review and approval, as specified under 42 CFR part 84 
subpart E--Quality Control of this Part, of manufacturing facilities 
that may be used to manufacturer respirators;
    (5) Quality site audits to verify conformance to the requirements 
of 42 CFR 84.33, 84.40, 84.41, 84.42, 84.43.; and
    (6) Product audits to verify the performance of commercially 
available

[[Page 18547]]

respirators which have been granted a NIOSH certificate of approval.
    (c) Fees will not be charged for:
    (1) Technical assistance not related to processing an approval 
application;
    (2) Technical programs including development of new technology 
programs;
    (3) Participation in research; and
    (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 provides the direct and indirect costs of NIOSH's 
services.
    (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 of this part, and will provide that estimate, with payment 
details, to the applicant. NIOSH will begin the technical evaluation 
once the applicant accepts the terms of the fee estimate and authorizes 
payment. The fee estimate will be derived using the current schedules 
of fees published by NIOSH in the Federal Register and on the NIOSH Web 
site at http://www.cdc.gov/niosh/npptl/default.html.
    (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 to the applicant a revised fee 
estimate for completing the application review. The applicant will have 
the option of either withdrawing the application and paying for NIOSH 
services already performed or authorizing payment of the revised 
estimate, in which case NIOSH will continue the application review and 
related 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 shall 
pay for services already performed by NIOSH for the application review. 
Such services shall include any administrative work (including any 
administrative work to process the withdrawal), and any examinations, 
inspections, or tests performed pursuant to such application. 
Withdrawal of an application shall be effective on the first business 
day following the date NIOSH receives a withdrawal notice from the 
applicant in writing. Withdrawal notices shall be submitted to NIOSH 
only at the application address specified under Sec.  84.10 of this 
part.


Sec.  84.22  Fee administration.

    (a) Applicants will be billed for all application fees when 
processing of the application is completed or the application is 
withdrawn. Invoices will contain specific payment instructions, 
including the address to mail payments and authorized methods of 
payment.
    (b) Applicants who hold active certificates of approval will be 
billed by NIOSH annually or as appropriate for any applicable 
maintenance fees. Such maintenance fees, where applicable, are 
specified in the current schedule of fees published by NIOSH in the 
Federal Register and on the NIOSH Web site at http://www.cdc.gov/niosh/npptl/default.html.
    (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 shall remain in effect for at least 1 year 
and shall be revised at least once every 5 years.
    (b) Updated fee schedules shall be published in the Federal 
Register and posted on the NIOSH Web site at http://www.cdc.gov/niosh/npptl/default.html.
    (c) The current fee schedules shall remain in effect until NIOSH 
publishes new fee schedules in the Federal Register as specified under 
paragraph (b) of this section.


Sec.  84.24  Authorization for additional tests and fees.

    NIOSH shall conduct any examination, inspection, or test 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 shall 
be paid by the applicant prior to issuance of a certificate of approval 
for the subject respirator.

Subpart G--General Construction and Performance Requirements

0
7. In Sec.  84.66, revise 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 shall bill the applicant based 
on the fee calculated, as specified under Sec.  84.21(e) of this part.

Subpart N--Special Use Respirators


Sec.  84.258  [Removed]

0
8. 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
9. Remove Sec.  84.1102.

    Dated: March 20, 2013.
Kathleen Sebelius
Secretary, Department of Health and Human Services.
[FR Doc. 2013-06914 Filed 3-26-13; 8:45 am]
BILLING CODE 4163-18-P