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Federal forms, ICRs, and supporting documents

Information Collection Request

[NIOSH] Information Collection Provisions in 42 CFR Part 84 - Tests and Requirements for Certification and Approval of Respiratory Protective Devices

ICR 202410-0920-021 · OMB 0920-0109 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-0109 Att 4_Standard Application Form Form Unchanged Available
Form 0920-0109 Att 4_Standard Application Form Form Unchanged Repair queued
Form 0920-0109 Att 24 Test 118 Form Unchanged Available
Form 0920-0109 Att 24 Test 118 Form Unchanged Missing upstream
Form ETB 1211A Rev 1 FP Att 26 Wearability Test Form Unchanged Repair queued
Form ETB 1211A Rev 1 FP Att 26 Wearability Test Form Unchanged Repair queued
Form 0920-0109 Att 25 Test 147 Form Unchanged Available
Form 0920-0109 Att 25 Test 147 Form Unchanged Repair queued
Form ETB-1214 Rev 1 FPW Att 23 Stressors Form Unchanged Available
Form ETB-1214 Rev 1 FPW Att 23 Stressors Form Unchanged Repair queued
Form ETB-1014-APR -0030 Att 22 Sound Level STP-30_STP 111 Form Unchanged Repair queued
Form ETB-1014-APR -0030 Att 22 Sound Level STP-30_STP 111 Form Unchanged Repair queued
Form TEB-1214A Rev 0 Att 21 Performance Test Form Unchanged Available
Form TEB-1214A Rev 0 Att 21 Performance Test Form Unchanged Missing upstream
Form TEB-1107 Rev 0 Att 20 LRPL Bitrex Donning Form Unchanged Available
Form TEB-1107 Rev 0 Att 20 LRPL Bitrex Donning Form Unchanged Missing upstream
Form TEB-1107 Rev 0 Att 19 Fogging test Form Unchanged Available
Form TEB-1107 Rev 0 Att 19 Fogging test Form Unchanged Repair queued
Form ETB-1028 Rev 5 Att 18 Fit Test STP -9 and 10 Form Unchanged Available
Form ETB-1028 Rev 5 Att 18 Fit Test STP -9 and 10 Form Unchanged Repair queued
Form TEB-1023 Rev.1 Att 17 Fit Test STP 5_5.1_6 Form Unchanged Repair queued
Form TEB-1023 Rev.1 Att 17 Fit Test STP 5_5.1_6 Form Unchanged Repair queued
Form 0920-0109 Att 16 Donning Test Form Unchanged Available
Form 0920-0109 Att 16 Donning Test Form Unchanged Repair queued
Form 0920-0109 Att 15 Communication Test Form Unchanged Available
Form 0920-0109 Att 15 Communication Test Form Unchanged Repair queued
Form 0920-0109 Att 14 Capacity Test Form Unchanged Repair queued
Form 0920-0109 Att 14 Capacity Test Form Unchanged Repair queued
Form 0920-0109 Att 13 Data Collection Form (Man testing) Form Unchanged Available
Form 0920-0109 Att 13 Data Collection Form (Man testing) Form Unchanged Repair queued
Form Form ETB-1035 Rev Att 12 Health and Wellness Screent (each test, fit testing) Form Unchanged Repair queued
Form Form ETB-1035 Rev Att 12 Health and Wellness Screent (each test, fit testing) Form Unchanged Repair queued
Form 0920-0109 Att 11Pre-test Questionnaire for Respirator Fit Testing Form Unchanged Available
Form 0920-0109 Att 11Pre-test Questionnaire for Respirator Fit Testing Form Unchanged Repair queued
Form 0920-0109 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form Unchanged Available
Form 0920-0109 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form Unchanged Repair queued
Form 0920-0109 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form Modified Available
Form 0920-0109 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form Modified Repair queued
Form 0920-0109 Att 8_Test Participant Information Sheet Form Modified Available
Form 0920-0109 Att 8_Test Participant Information Sheet Form Modified Missing upstream
Form 0920-0109 Att 7c_Site audits,Site audits (completed for each corrective action) Form Unchanged Available
Form 0920-0109 Att 7c_Site audits,Site audits (completed for each corrective action) Form Unchanged Repair queued
Form 0920-0109 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged Repair queued
Form 0920-0109 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged Repair queued
Form 0920-0109 Att 5_Request manufacturing code Form and Instruction Unchanged Repair queued
Form 0920-0109 Att 5_Request manufacturing code Form and Instruction Unchanged Repair queued
Form 0920-0109 Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged Available
Form 0920-0109 Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged Repair queued
Change request justification_0920-0109_09.23.2024.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-10-18 Available
Change request justification_0920-0109_09.23.2024.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-10-18 Repair queued
Atch_6_IRB determination.pdf Supplementary Document Uploaded 2020-10-07 Available
Atch_6_IRB determination.pdf Supplementary Document Uploaded 2020-10-07 Repair queued
Atch_3_60-day Federal Register Notice.pdf Supplementary Document Uploaded 2023-11-06 Available
Atch_3_60-day Federal Register Notice.pdf Supplementary Document Uploaded 2023-11-06 Repair queued
Atch_2_42 CFR part 84.docx Supplementary Document Uploaded 2020-10-07 Available
Atch_2_42 CFR part 84.docx Supplementary Document Uploaded 2020-10-07 Repair queued
Atch_1_OSH Act.docx Supplementary Document Uploaded 2020-10-07 Repair queued
Atch_1_OSH Act.docx Supplementary Document Uploaded 2020-10-07 Repair queued
SupportingStatement_B_23November_1.docx Supporting Statement B Uploaded 2023-11-15 Available
SupportingStatement_B_23November_1.docx Supporting Statement B Uploaded 2023-11-15 Repair queued
SupportingStatement_A_24September_17_Clean-2 (1).docx Supporting Statement A Uploaded 2024-10-18 Available
SupportingStatement_A_24September_17_Clean-2 (1).docx Supporting Statement A Uploaded 2024-10-18 Missing upstream
IC Document Collections
IC IDCollectionTypeStatusForm
6639 Att 4_Standard Application Form Form Unchanged
6639 Att 4_Standard Application Form Form Unchanged
263434 Att 24 Test 118 Form Unchanged
263434 Att 24 Test 118 Form Unchanged
263433 Att 26 Wearability Test Form Unchanged
263433 Att 26 Wearability Test Form Unchanged
263430 Att 25 Test 147 Form Unchanged
263430 Att 25 Test 147 Form Unchanged
263429 Att 23 Stressors Form Unchanged
263429 Att 23 Stressors Form Unchanged
263426 Att 22 Sound Level STP-30_STP 111 Form Unchanged
263426 Att 22 Sound Level STP-30_STP 111 Form Unchanged
263425 Att 21 Performance Test Form Unchanged
263425 Att 21 Performance Test Form Unchanged
263424 Att 20 LRPL Bitrex Donning Form Unchanged
263424 Att 20 LRPL Bitrex Donning Form Unchanged
263423 Att 19 Fogging test Form Unchanged
263423 Att 19 Fogging test Form Unchanged
263422 Att 18 Fit Test STP -9 and 10 Form Unchanged
263422 Att 18 Fit Test STP -9 and 10 Form Unchanged
263421 Att 17 Fit Test STP 5_5.1_6 Form Unchanged
263421 Att 17 Fit Test STP 5_5.1_6 Form Unchanged
263417 Att 16 Donning Test Form Unchanged
263417 Att 16 Donning Test Form Unchanged
263416 Att 15 Communication Test Form Unchanged
263416 Att 15 Communication Test Form Unchanged
263413 Att 14 Capacity Test Form Unchanged
263413 Att 14 Capacity Test Form Unchanged
263412 Att 13 Data Collection Form (Man testing) Form Unchanged
263412 Att 13 Data Collection Form (Man testing) Form Unchanged
263411 Att 12 Health and Wellness Screent (each test, fit testing) Form Unchanged
263411 Att 12 Health and Wellness Screent (each test, fit testing) Form Unchanged
263410 Att 11Pre-test Questionnaire for Respirator Fit Testing Form Unchanged
263410 Att 11Pre-test Questionnaire for Respirator Fit Testing Form Unchanged
263408 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form Unchanged
263408 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form Unchanged
263389 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form Modified
263389 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form Modified
263388 Att 8_Test Participant Information Sheet Form Modified
263388 Att 8_Test Participant Information Sheet Form Modified
263230 Att 7c_Site audits,Site audits (completed for each corrective action) Form Unchanged
263230 Att 7c_Site audits,Site audits (completed for each corrective action) Form Unchanged
263229 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged
263229 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged
263228 Att 5_Request manufacturing code Form and Instruction Unchanged
263228 Att 5_Request manufacturing code Form and Instruction Unchanged
197842 Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged
197842 Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form Unchanged
ICR Details
0920-0109 202410-0920-021
Active 202311-0920-004
HHS/CDC 0920-0109
[NIOSH] Information Collection Provisions in 42 CFR Part 84 - Tests and Requirements for Certification and Approval of Respiratory Protective Devices
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/21/2024
Retrieve Notice of Action (NOA) 10/18/2024
  Inventory as of this Action Requested Previously Approved
01/31/2027 01/31/2027 01/31/2027
2,978 0 2,978
131,060 0 131,060
0 0 0
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 This Non-Substantive Change Request is submitted to revise the incentive structure based on activities of the contractor. Consent Forms and the Supporting Statement A will also be slightly modified. There is no anticipated change associated with currently approved burden.
US Code: 29 USC 657 Name of Law: Inspections and Recordkeeping
   US Code: 30 USC 844 Name of Law: Rock, Dust, and Gas Hazards, Controls
   US Code: 30 USC 3 Name of Law: Duties of the United States Bureau of Mines
   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: 42 USC 84 Name of Law: Approval of Respiratory Protective Devices
   US Code: 30 USC 7 Name of Law: Fees for Tests or Investigations
  
None
Not associated with rulemaking
  87 FR 73000 11/28/2022
88 FR 78045 11/14/2023
No
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, 0920-0109 Test Participant Information Sheet ,   Test Participant Information Sheet_18OCT2024
Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination 0920-0109 Pre- and Post-Test Session Participant Questionnaire and Examination
  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 2,978 0 0 0 0
Annual Time Burden (Hours) 131,060 131,060 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$6,363,646
No
    No
    No
No
No
No
Yes
Jeffrey Zirger 404 639-7118 [email protected]
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/18/2024