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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-0109
ICR Reference No:
202311-0920-004
Status:
Active
Previous ICR Reference No:
202009-0920-023
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-0109
Title:
[NIOSH] Information Collection Provisions in 42 CFR Part 84 - Tests and Requirements for Certification and Approval of Respiratory Protective Devices
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
01/02/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/21/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2027
36 Months From Approved
03/31/2024
Responses
2,978
0
630
Time Burden (Hours)
131,060
0
129,920
Cost Burden (Dollars)
0
0
0
Abstract:
This collection enables the submission of respirators for NIOSH evaluation under 42 C.F.R. 84 “Approval of Respiratory Devices” requirements. The updated ICR accounts for an increase of 6,218 estimated total annual burden hours (from 123,702 total annual burden hours per year in 2017 to 129,920 total annual burden hours in 2020). This occurred because NIOSH issued an interim final rulemaking entitled “Approval Tests and Standards for Air-Purifying Particulate Respirators” to allow for the approval of respirators in a new class, PAPR100, better suited to the needs of workers in the healthcare and public safety sectors currently experiencing a shortage of air-purifying particulate respirators, due to Coronavirus Disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).• The resulting data allows NIOSH to certify that qualifying respirators meet published criteria, allowing proper selection of respiratory protection
Authorizing Statute(s):
US Code:
30 USC 811
Name of Law: Mandatory Safety and Health Standards
US Code:
30 USC 5
Name of Law: Reports of Investigations
US Code:
30 USC 842(h)
Name of Law: Dust Concentration and Respiratory Equipment
US Code:
30 USC 7
Name of Law: Fees for Tests or Investigations
US Code:
30 USC 3
Name of Law: Duties of the United States Bureau of Mines
US Code:
29 USC 657
Name of Law: Inspections and Recordkeeping
US Code:
42 USC 84
Name of Law: Approval of Respiratory Protective Devices
US Code:
30 USC 844
Name of Law: Rock, Dust, and Gas Hazards, Controls
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
87 FR 73000
11/28/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 78045
11/14/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
24
IC Title
Form No.
Form Name
Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023)
0920-0109, 0920-0109
OSHA/NPPTL Medical Evaluation: Annually for all Test ParticipantsRev 1 (10.25.2023)
,
Test Subject Information Sheet
Att 11Pre-test Questionnaire for Respirator Fit Testing
0920-0109, W-9
Pre-test Questionnaire for Respirator Fit Testing
,
Request for Identification Number and Certification
Att 12 Health and Wellness Screent (each test, fit testing)
Form ETB-1035 Rev 2, ETB-1254 Rev 0
Health and Wellness Screening (each test, man testing)
,
ETB Anthropometric Datasheet
Att 13 Data Collection Form (Man testing)
0920-0109
Man Test 1, SCBA -Operating and Breathing (30 min)
Att 14 Capacity Test
0920-0109
Determination of Capacity (CCER)
Att 15 Communication Test
0920-0109
CBRN APR Communication Performance Test Data Analysis Sheets
Att 16 Donning Test
0920-0109
Donning
Att 17 Fit Test STP 5_5.1_6
TEB-1023 Rev.1
Subject Template (Fit test STP 5_5.1_6)
Att 18 Fit Test STP -9 and 10
ETB-1028 Rev 5
Fit Testing Report
Att 19 Fogging test
TEB-1107 Rev 0
CBRN APR Lens FOgging Test Data Collection Sheet
Att 20 LRPL Bitrex Donning
TEB-1107 Rev 0
Fit Test Data (PortaCount, PortaCount Plus, Corn Oil, Bitrex
Att 21 Performance Test
TEB-1214A Rev 0
Determination of Performance Form
Att 22 Sound Level STP-30_STP 111
ETB-1014-APR -0030 Rev 3
Determination of Noise Level Test Data Sheet
Att 23 Stressors
ETB-1214 Rev 1 FPW
Determination of Performance Form
Att 24 Test 118
0920-0109
Cold Temperature Test, Open Circuit, SCBA STP #: 118
Att 25 Test 147
0920-0109
Special Test - Model Transfer- Combination, Open-Circuit, SCBA and Supplied Air Respirators, SCBA/SAR STP#: 147
Att 26 Wearability Test
ETB 1211A Rev 1 FPW
Determination of Wearability (CCER)
Att 4_Standard Application Form
0920-0109
Standard Application Form
Att 5_Request manufacturing code
0920-0109
NIOSH RESPIRATOR APPROVAL PROGRAM QUESTIONNAIRE FOR POTENTIAL APPLICANTS
Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit)
0920-0109
Audit Form
Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit)
0920-0109
Audit Form
Att 7c_Site audits,Site audits (completed for each corrective action)
0920-0109
NIOSH CORRECTIVE ACTION REQUEST (CAR) Form
Att 8_Test Participant Information Sheet
0920-0109
Test Participant Information Sheet
Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination
0920-0109
Pre- and Post-Test Session Participant Questionnaire and Examination
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
2,978
630
0
1,943
405
0
Annual Time Burden (Hours)
131,060
129,920
0
1,105
35
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
NIOSH submits this revision to improve its description of information collected to ensure that information collected from human participants while testing respirators to the required performance standards is sufficiently described. Previously, NIOSH included its non-research determination, clearly indicating the involvement of human participants. However, past information collection packages did not describe the data being collected from these human participants or the burden to them as individuals.
Annual Cost to Federal Government:
$6,363,646
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Yes
Agency Contact:
Thelma Sims 4046394771
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
11/21/2023