Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices 78045 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

General Public—Adults ................................... Patient Quarterly Assessment ....................... 134 3 45/60 

General Public—Adults ................................... CleverCap App Setup .................................... 134 1 10/60 

General Public—Adults ................................... Patient Interview Guide .................................. 10 1 90/60 

Health Practitioners ......................................... Provider Screener .......................................... 14 1 10/90 

Health Practitioners ......................................... Provider Locator Form ................................... 7 1 10/90 

Health Practitioners ......................................... Provider Pre-Training Assessment ................ 7 1 30/60 

Health Practitioners ......................................... Provider Post-Training Assessment ............... 7 1 30/60 

Health Practitioners ......................................... Provider Interview Guide ................................ 7 1 60/60 

Health Practitioners ......................................... Clinic Assessment Baseline and Final ........... 4 1 120/60 

Health Practitioners ......................................... Clinic Assessment Every Six Months ............ 4 2 90/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–25081 Filed 11–13–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–24–0109] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Respiratory 

Protective Devices—42 CFR part 84’’ to 

the Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on November 28, 2022 to obtain 

comments from the public and affected 

agencies. CDC did not receive comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Respiratory Protective Devices—42 

CFR part 84 (OMB Control No. 0920– 

0109, Exp. 03/31/2024)—Revision— 

National Institute for Occupational 

Safety and Health (NIOSH), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The regulatory authority for the 

National Institute for Occupational 

Safety and Health (NIOSH) certification 

program for respiratory protective 

devices is found in the Mine Safety and 

Health Amendments Act of 1977 (30 

U.S.C. 577a, 651 et seq., and 657(g)) and 

the Occupational Safety and Health Act 

of 1970 (30 U.S.C. 3, 5, 7, 811, 842(h), 

844). These regulations have, as their 

basis, the performance tests and criteria 

for approval of respirators used by 

millions of American construction 

workers, miners, painters, asbestos 

removal workers, fabric mill workers, 

and fire fighters. 

Regulations of the Environmental 

Protection Agency (EPA) and the 

Nuclear Regulatory Commission (NRC) 

also require the use of NIOSH Approved 

respirators. These regulations also 

establish methods for respirator 

manufacturers to submit respirators for 

testing under the regulation and have 

them certified as NIOSH Approved if 

they meet the criteria given in the above 

regulation. This data collection was 

formerly named Respiratory Protective 

Devices 30 CFR part 11 but in 1995, the 

respirator standard was moved to 42 

CFR part 84. 

NIOSH, in accordance with 42 CFR 

part 84: (1) issues certificates of 

approval for respirators which have met 

specified construction, performance, 

and protection requirements; (2) 

establishes procedures and 

requirements to be met in filing 

applications for approval; (3) specifies 

minimum requirements and methods to 

be employed by NIOSH and by 

applicants in conducting inspections, 

examinations, and tests to determine 

effectiveness of respirators; (4) 

establishes a schedule of fees to be 

charged for testing and certification; and 

(5) establishes approval labeling 

requirements. Information is collected 

from those who request services under 

42 CFR part 84 in order to properly 

establish the scope and intent of 

request. 

Information collected from requests 

for respirator approval functions 

includes contact information and 

information about factors likely to affect 

respirator performance and use. Such 


khammond on DSKJM1Z7X2PROD with NOTICES
78046 Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices 

information includes, but is not 

necessarily limited to, respirator design, 

manufacturing methods and materials, 

quality assurance plans and procedures, 

and user instruction and draft labels, as 

specified in the regulation. 

The main instrument for data 

collection for respirator approval 

functions is the Standard Application 

Form for the Approval of Respirators 

(SAF), currently Version 9. Respirator 

manufacturers are the respondents 

(estimated to average 140 each year) and 

upon completion of the SAF, their 

requests for approval are evaluated. A 

total of 375 applications were submitted 

in CY2019, which preceded the surge in 

application received in conjunction 

with the COVID–19 pandemic. The 

applications are submitted, at will, and 

taking into account both historical 

conditions as well as the current 

situation, our prediction of the number 

of respondents each year for the next 

three years is 140. A $200 fee is required 

for each application. Respondents 

requesting respirator approval or certain 

extensions of approval are required to 

submit additional fees for necessary 

testing and evaluation as specified in 42 

CFR parts 84.20–22, 84.66, 84.258 and 

84.1102. Applicants are required to 

provide test data that shows that the 

manufacturer is able to ensure that the 

respirator is capable of meeting the 

specified requirements in 42 CFR part 

84. The requirement for submitted test 

data is likely to be satisfied by standard 

testing performed by the manufacturer 

and is not required to follow the 

relevant NIOSH Standard Test 

Procedures. As additional testing is not 

required, providing proof that an 

adequate test has been performed is 

limited to providing existing paperwork. 

The secondary instruments for data 

collection for respirator approval 

functions are instruments used to 

collect data from human participants 

who are serving as test fixture surrogates 

to perform tests while wearing the 

respirator being evaluated. Such 

instruments are completed by the 

human participant or test operator and 

are limited to specific information 

required for the test. 

Approvals under 42 CFR part 84 offer 

corroboration that approved respirators 

are produced to certain quality 

standards. Although 42 CFR part 84 

Subpart E prescribes certain quality 

standards, it is not expected that 

requiring approved quality standards 

will impose an additional cost burden 

over similarly effective quality 

standards that are not approved under 

42 CFR part 84. Manufacturers with 

current approvals are subject to site 

audits by the Institute or its agents. 

Audits may occur periodically (typically 

every second year), or because of a 

reported issue. Approximately, 50% of 

the sites are audited each year, each 

having a primary point of contact. It is 

estimated that the average number of 

site audits over the next three years will 

be 85. 

CDC requests OMB approval for an 

additional three years of data collection. 

The estimated annual burden hours are 

131,059. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Business or other for-profit ............................ Standard application form ................................................................ 140 4 229 

Request manufacturing code ........................................................... 10 1 30/60 

Site audits, Part 1 ............................................................................. 85 1 30/60 

Site audits, Part 2 ............................................................................. 85 1 9/60 

Site audits (completed for each corrective action) ........................... 70 2 16 

Member of general public .............................. Information sheet (initial participant visit only—contact info) ........... 10 1 9/60 

Informed consent (annually, all test participants) ............................ 40 1 15/60 

Health and wellness screening (annually, all test participants) ....... 40 1 15/60 

Health and wellness screening (each test, fit testing) ..................... 40 20 6/60 

Health and wellness screening (each test, man testing) ................. 10 10 15/60 

Data collection form (man testing) ................................................... 10 10 45/60 

Capacity test ..................................................................................... 10 1 6/60 

Communication Tests ....................................................................... 10 1 2 

Donning test ..................................................................................... 10 1 1 

Fit test STP 5_5.1_6 ......................................................................... 14 20 9/60 

Fit tests STP–9 and 10 .................................................................... 14 20 9/60 

Fogging test ...................................................................................... 10 1 30/60 

LRPL_Bitrex_Donning ...................................................................... 38 1 1 

Performance Test ............................................................................. 10 1 1 

Sound level STP–30_STP–111 ........................................................ 25 2 6/60 

Stressors ........................................................................................... 10 1 1 

Test 118 ............................................................................................ 10 25 30/60 

Test 147 ............................................................................................ 10 4 9/60 

Wearability test ................................................................................. 10 1 18/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–25083 Filed 11–13–23; 8:45 am] 

BILLING CODE 4163–18–P 


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