Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 18535 

1Public Law 107–295, 116 Stat. 2064 (Nov. 2, 

2002). 

2Transportation Worker Identification Credential 

(TWIC) Implementation in the Maritime Sector; 

Hazardous Materials Endorsement for a Commercial 

Driver’s License, 72 FR 3492 (Jan. 25, 2007). 

3A transportation security incident is a security 

incident resulting in a significant loss of life, 

environmental damage, transportation system 

disruption, or economic disruption in a particular 

area, as defined in 46 U.S.C. 70101 (49 CFR 

1572.103). 

4Public Law 109–347, 120 Stat. 1884 (Oct. 13, 

2006). 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

On March 22, 2013, the Coast Guard 

published a notice of proposed 

rulemaking (NPRM) in the Federal 

Register (78 FR 17781), in which we 

proposed to require owners and 

operators of certain vessels and facilities 

regulated by the Coast Guard to use 

electronic readers designed to work 

with the Transportation Worker 

Identification Credential (TWIC) as an 

access control measure. The NPRM also 

proposed additional requirements 

associated with electronic TWIC 

readers, including recordkeeping 

requirements for those owners and 

operators required to use an electronic 

TWIC reader, and security plan 

amendments to incorporate TWIC 

reader requirements. The TWIC 

program, including the TWIC reader 

requirements proposed in the NPRM, is 

an important component of the Coast 

Guard’s multi-layered system of access 

control requirements and other 

measures designed to enhance maritime 

security. 

As authorized by the Maritime 

Transportation Security Act of 2002 1

(MTSA), the Transportation Security 

Administration (TSA) established the 

TWIC program to address identity 

management shortcomings and 

vulnerabilities identified in the nation’s 

transportation system and to comply 

with the MTSA statutory requirements. 

On January 25, 2007, the Department of 

Homeland Security (DHS), through the 

Coast Guard and TSA, promulgated 

regulations that require mariners and 

other individuals granted unescorted 

access to secure areas of MTSAregulated vessels or facilities to undergo 

a security threat assessment by TSA and 

obtain a TWIC.2

This NPRM that is the subject of this 

public meeting, which would require 

owners and operators of certain types of 

vessels and facilities to use electronic 

TWIC readers, would advance the goals 

of the TWIC program. In crafting the 

proposals in the NPRM, the Coast Guard 

conducted a risk-based analysis of 

MTSA-regulated vessels and facilities to 

categorize them into one of three risk 

groups, labeled A, B, and C. Risk Group 

A is comprised of vessels and facilities 

that present the highest risk of being 

involved in a transportation security 

incident (TSI).3 The NPRM proposes 

TWIC reader requirements for vessels 

and facilities in Risk Group A. Under 

the NPRM, vessels and facilities in Risk 

Groups B and C present progressively 

lower risks, and would continue to 

follow existing regulatory requirements 

for visual TWIC inspection. 

The Coast Guard believes that in 

addition to receiving written comments 

on the NPRM, a public meeting would 

benefit the impacted community by 

providing another forum to raise 

relevant issues. Also, the Security and 

Accountability For Every (SAFE) Port 

Act of 2006 4 requires the Coast Guard 

to hold at least one public hearing 

before promulgating final TWIC reader 

regulations (see 46 U.S.C. 70105(k)(3)). 

This public meeting will further enable 

the Coast Guard to craft policy informed 

by the public. 

We may hold one or more additional 

public meetings regarding the proposals 

in the NPRM on TWIC reader 

requirements. We will notify the public 

of the date(s), time(s), location(s), and 

other details of any such meeting(s) by 

publishing a separate notice in the 

Federal Register as soon as we have 

information available. 

You may view the NPRM, written 

comments, and supporting documents 

in the online docket by going to 

http://www.regulations.gov and using 

‘‘USCG–2007–28915’’ as your search 

term. Locate the NPRM among the 

search results and use the filters on the 

left side of the page to search for 

specific types of documents. If you do 

not have access to the Internet, you may 

view the docket online by visiting the 

Docket Management Facility in Room 

W12–140 on the ground floor of the 

Department of Transportation West 

Building, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9:00 

a.m. and 5:00 p.m., Monday through 

Friday, except Federal holidays. The 

Coast Guard has an agreement with the 

Department of Transportation to use its 

Docket Management Facility. 

We encourage you to participate by 

submitting comments either orally at the 

meeting or in writing. If you bring 

written comments to the meeting, you 

may submit them to Coast Guard 

personnel specified at the meeting to 

receive written comments. These 

comments will be submitted to our 

online public docket. All comments 

received will be posted without change 

to http://www.regulations.gov and will 

include any personal information you 

have provided. 

Anyone can search the electronic 

form of comments received into any of 

our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, or other entity). You may review 

a Privacy Act notice regarding our 

public dockets in the January 17, 2008, 

issue of the Federal Register (73 FR 

3316). 

Information on Services for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with disabilities 

or to request special assistance at the 

public meeting, contact LCDR Gregory 

Callaghan at the telephone number or 

email address indicated under the FOR

FURTHER INFORMATION CONTACT section of 

this notice of public meeting. 

Public Meeting 

The Coast Guard will hold a public 

meeting regarding the ‘‘Transportation 

Worker Identification Credential 

(TWIC)—Reader Requirements’’ NPRM 

(78 FR 17781) on Thursday, April 18, 

2013 from 1:00 p.m. to 5:00 p.m., at the 

Crystal City Marriott at Reagan National 

Airport, 1999 Jefferson Davis Highway, 

Arlington, Virginia 22202. The building 

is accessible by taxi, public transit, and 

privately-owned conveyance. Please 

note that the session may adjourn early 

if all business, concerns, and questions 

are addressed. We will post a written 

summary of the meeting and oral 

comments in the docket. 

Authority 

This notice of public meeting is 

issued under the authority of 46 U.S.C. 

70105(k)(3) and 5 U.S.C. 552(a). 

Dated: March 21, 2013. 

A.E. Tucci, 

Captain, U.S. Coast Guard, Chief, Office of 

Port and Facility Compliance (CG–FAC). 

[FR Doc. 2013–07173 Filed 3–25–13; 4:15 pm] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 84 

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

RIN 0920–AA42 

Respirator Certification Fees 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 


srobinson on DSK4SPTVN1PROD with PROPOSALS
18536 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 

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. 

ACTION: Notice of Proposed Rulemaking. 

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 

(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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 18537 

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. 

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. 

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 § 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 § 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 § 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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
18538 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 

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 § 84.20 would replace 

existing § 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 § 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 

§ 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 caseby-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 § 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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 18539 

3The 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. 

4Frost & Sullivan [2008]. North American 

Respiratory Protective Equipment Market. Report 

N2E7–39 at 1–1. 

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 § 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 

§ 84.22(b). 

84.66 Withdrawal of Applications 

Existing § 84.66 of subpart G 

establishes procedures for the 

withdrawal of respirator certification 

applications. Existing paragraph 

§ 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 

§ 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

84.258 Fees 

HHS proposes to remove existing 

§ 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 § 84.21 would apply to this 

group of respirators. 

84.1102 Fees 

HHS proposes to remove existing 

§ 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 

§ 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 airsupplying respirators (ASR), which 

provide the user with clean breathing 

air (from a supply separate from the 

ambient air). APR includes particulate 

respirators, like the disposable N95 

commonly used in healthcare settings; 

the elastomeric respirator with 

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

the powered air-purifying respirator 

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

through the filters. 

ASR includes respirators that deliver 

breathing air to the wearer, using either 

compressed or chemical breathing air or 

a remote source. The respirator types in 

this category include the self-contained 

breathing apparatus (SCBA) commonly 

worn by members of the fire service; the 

closed-circuit escape respirator (CCER) 

used for emergency escape in 

underground coal mining and on-board 

ships; and the airline (air hose) 

respirator used for industrial chemical 

and paint applications and hazardous 

materials management. 

Of the U.S. respirator market of 

products approved by NIOSH, 

approximately 35 percent of approval 

holders are U.S. companies and 65 

percent are foreign. The foreign 

component of this distribution has 

nearly doubled since 2000, and is 

largely represented by manufacturers 

producing low-cost filtering facepiece 

respirators. The North American 

respiratory protection market generated 

revenues around $1,830 million in 2007, 

the most recent data available.4 A 

summary of market segmentation, by 

respirator type, is offered in Table 1, 

below. 

TABLE 1—INDUSTRY OVERVIEW

Respirator type 

Market share 

2007 

(%) 

Revenues 2007 

(millions $) 

Air-Purifying 

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

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

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

Air-Supplying 

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

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


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5Note: one application may result in multiple 

approvals, so it is not unusual for the number of 

new approvals to exceed the number of 

applications. 

6Note: 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. 

TABLE 1—INDUSTRY OVERVIEW—Continued 

Respirator type 

Market share 

2007 

(%) 

Revenues 2007 

(millions $) 

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 activities ..................................... 23,480 

Annual cost for certification 

and approval activities ...... $233,156 

Test Equipment 

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

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

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

The fee schedules that are the basis 

for the analysis below are broken down 

into 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 airpurifying 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. 

Approval Modification: An approvalholder may apply to NIOSH for the 

modification of an existing approval. 

Requests to obsolete a certificate of 

approval are considered to be 

modifications of an existing approval. 

Modified 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. 

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 


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7NIOSH typically employs contractors to conduct 

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

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. 

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 


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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 

Proposed Fee ................................................................... 231,200 Proposed 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 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-forprofit 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 selfcontained breathing apparatus for entry 

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

for a single hazard gas mask, the cost is 

$1,100; a supplied-air respirator will 

cost $750 for examination, inspection, 

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

NIOSH currently recovers only about 10 

to 20 percent of the costs to provide 

initial certification and testing activities. 

The Circular requires that the NIOSH 

respirator certification program be selfsustaining, 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 approvalholders based outside of the United 

States; and 25 are classified as small 

businesses as defined under the Small 

Business Act for this industry sector 

(NAICS 339113–-Surgical Appliance 

and Supplies Manufacturing), 

employing fewer than 500 employees. 

Accordingly, HHS has given 

consideration to the potential impact of 

this rule on these 25 companies. 

HHS must establish whether the 

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

Group ID Group type Number of 

employees 

Number of 

companies 

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


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8Fees 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. 

TABLE 6—COMPANIES GROUPED BASED ON SIZE—Continued 

Group ID Group type Number of 

employees 

Number of 

companies 

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

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 


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TABLE 9—COMPARISON OF CURRENT AND PROPOSED FEES—Continued 

Group 1 Group 2 Group 3 Group 4 

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) × (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) × (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 year 5 ($) .............................................................................................. 600 250 430 1,100 

1Example Group 1 has 10 companies and total cost is calculated over 5 years. Avg cost/company/year = $30000/(10 co)(5 yr). 

2Event 1—Company becomes an approval holder for the first time. 

3Event 2—Company moves to or adds a new production site. 

4Event 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 

employees 

50–99 

employees 

250–499 

employees 

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

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

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

Number of management staff/number of production employees ................................................................ 1/2 

(3 total) 

18/33 

(51 total) 

92/159 

(251 total) 

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

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


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Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 18545 

TABLE 11—ECONOMIC IMPACT: FEES AS PERCENTAGE OF REVENUE—Continued 

Group 1 Group 2 Group 3 

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.’’ 


srobinson on DSK4SPTVN1PROD with PROPOSALS
18546 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 

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 

■ 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 

■ 2. In § 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: 

§ 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 

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

and (d) to read as follows: 

§ 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 § 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. 

* * * * * 

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

read as follows: 

§ 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. 

* * * * * 

■ 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 

§ 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.] 

§ 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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Proposed Rules 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. 

§ 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 § 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 § 84.10 of this part. 

§ 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. 

§ 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. 

§ 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 

■ 7. In § 84.66, revise paragraph (b) to 

read as follows: 

§ 84.66 Withdrawal of applications. 

* * * * * 

(b) Upon the receipt of a written 

request from the applicant for the 

withdrawal of an application, NIOSH 

shall bill the applicant based on the fee 

calculated, as specified under § 84.21(e) 

of this part. 

Subpart N—Special Use Respirators 

§ 84.258 [Removed] 

■ 8. Remove § 84.258. 

Subpart KK—Dust, Fume, and Mist; 

Pesticide; Paint Spray; Powered AirPurifying High Efficiency Respirators 

and Combination Gas Masks 

§ 84.1102 [Removed] 

■ 9. Remove § 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 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

43 CFR Parts 3900, 3920, and 3930 

[LLWO–3200000 L13100000.PP0000 

L.X.EMOSHL000.241A] 

RIN 1004–AE28 

Oil Shale Management—General 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Proposed rule. 

SUMMARY: The Bureau of Land 

Management (BLM) is proposing to 

amend the BLM’s commercial oil shale 

regulations by revising these regulations 

in order to address concerns about the 

royalty system in the existing 

regulations and to provide more detail 

to the environmental protection 

requirements. 

DATES: Send your comments to reach 

the BLM on or before May 28, 2013. The 

BLM will not necessarily consider any 

comments received after the above date 

in making its decision on the final rule. 

ADDRESSES: Mail: Director (630) Bureau 

of Land Management, U.S. Department 

of the Interior, Mail Stop 2143LM, 1849 

C St. NW., Washington, DC 20240, 

Attention: 1004–AE28. Personal or 

messenger delivery: U.S. Department of 

the Interior, Bureau of Land 

Management, 20 M Street SE., Room 

2134 LM, Attention: Regulatory Affairs, 

Washington, DC 20003. Federal 

eRulemaking Portal: http:// 


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