OMB control number

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

OMB 0920-0109 · HHS/CDC.

OMB 0920-0109

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.

The latest form for [NIOSH] Information Collection Provisions in 42 CFR Part 84 - Tests and Requirements for Certification and Approval of Respiratory Protective Devices expires 2027-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 0920-0109 Att 4_Standard Application Form Form
Form 0920-0109 Att 4_Standard Application Form Form
Form 0920-0109 Att 24 Test 118 Form
Form 0920-0109 Att 24 Test 118 Form
Form ETB 1211A Rev 1 FP Att 26 Wearability Test Form
Form ETB 1211A Rev 1 FP Att 26 Wearability Test Form
Form 0920-0109 Att 25 Test 147 Form
Form 0920-0109 Att 25 Test 147 Form
Form ETB-1214 Rev 1 FPW Att 23 Stressors Form
Form ETB-1214 Rev 1 FPW Att 23 Stressors Form
Form ETB-1014-APR -0030 Att 22 Sound Level STP-30_STP 111 Form
Form ETB-1014-APR -0030 Att 22 Sound Level STP-30_STP 111 Form
Form TEB-1214A Rev 0 Att 21 Performance Test Form
Form TEB-1214A Rev 0 Att 21 Performance Test Form
Form TEB-1107 Rev 0 Att 20 LRPL Bitrex Donning Form
Form TEB-1107 Rev 0 Att 20 LRPL Bitrex Donning Form
Form TEB-1107 Rev 0 Att 19 Fogging test Form
Form TEB-1107 Rev 0 Att 19 Fogging test Form
Form ETB-1028 Rev 5 Att 18 Fit Test STP -9 and 10 Form
Form ETB-1028 Rev 5 Att 18 Fit Test STP -9 and 10 Form
Form TEB-1023 Rev.1 Att 17 Fit Test STP 5_5.1_6 Form
Form TEB-1023 Rev.1 Att 17 Fit Test STP 5_5.1_6 Form
Form 0920-0109 Att 16 Donning Test Form
Form 0920-0109 Att 16 Donning Test Form
Form 0920-0109 Att 15 Communication Test Form
Form 0920-0109 Att 15 Communication Test Form
Form 0920-0109 Att 14 Capacity Test Form
Form 0920-0109 Att 13 Data Collection Form (Man testing) Form
Form Form ETB-1035 Rev Att 12 Health and Wellness Screent (each test, fit testing) Form
Form Form ETB-1035 Rev Att 12 Health and Wellness Screent (each test, fit testing) Form
Form 0920-0109 Att 11Pre-test Questionnaire for Respirator Fit Testing Form
Form 0920-0109 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form
Form 0920-0109 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form
Form 0920-0109 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form
Form 0920-0109 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form
Form 0920-0109 Att 8_Test Participant Information Sheet Form
Form 0920-0109 Att 8_Test Participant Information Sheet Form
Form 0920-0109 Att 7c_Site audits,Site audits (completed for each corrective action) Form
Form 0920-0109 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form
Form 0920-0109 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form
Form 0920-0109 Att 5_Request manufacturing code Form and Instruction
Form 0920-0109 Att 5_Request manufacturing code Form and Instruction
Form 0920-0109 Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form
Change request justification_0920-0109_09.23.2024.docx Justification for No Material/Nonsubstantive Change
Change request justification_0920-0109_09.23.2024.docx Justification for No Material/Nonsubstantive Change
Atch_6_IRB determination.pdf Supplementary Document
Atch_6_IRB determination.pdf Supplementary Document
Atch_3_60-day Federal Register Notice.pdf Supplementary Document
Atch_2_42 CFR part 84.docx Supplementary Document
Atch_2_42 CFR part 84.docx Supplementary Document
Atch_1_OSH Act.docx Supplementary Document
Atch_1_OSH Act.docx Supplementary Document
SupportingStatement_B_23November_1.docx Supporting Statement B
SupportingStatement_B_23November_1.docx Supporting Statement B
SupportingStatement_A_24September_17_Clean-2 (1).docx Supporting Statement A
SupportingStatement_A_24September_17_Clean-2 (1).docx Supporting Statement A
Att 4_Standard Application Form Form
Att 4_Standard Application Form Form
Att 24 Test 118 Form
Att 24 Test 118 Form
Att 26 Wearability Test Form
Att 26 Wearability Test Form
Att 25 Test 147 Form
Att 25 Test 147 Form
Att 23 Stressors Form
Att 23 Stressors Form
Att 22 Sound Level STP-30_STP 111 Form
Att 22 Sound Level STP-30_STP 111 Form
Att 21 Performance Test Form
Att 21 Performance Test Form
Att 20 LRPL Bitrex Donning Form
Att 20 LRPL Bitrex Donning Form
Att 19 Fogging test Form
Att 19 Fogging test Form
Att 18 Fit Test STP -9 and 10 Form
Att 18 Fit Test STP -9 and 10 Form
Att 17 Fit Test STP 5_5.1_6 Form
Att 17 Fit Test STP 5_5.1_6 Form
Att 16 Donning Test Form
Att 16 Donning Test Form
Att 15 Communication Test Form
Att 15 Communication Test Form
Att 14 Capacity Test Form
Att 14 Capacity Test Form
Att 13 Data Collection Form (Man testing) Form
Att 13 Data Collection Form (Man testing) Form
Att 12 Health and Wellness Screent (each test, fit testing) Form
Att 12 Health and Wellness Screent (each test, fit testing) Form
Att 11Pre-test Questionnaire for Respirator Fit Testing Form
Att 11Pre-test Questionnaire for Respirator Fit Testing Form
Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form
Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form
Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form
Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form
Att 8_Test Participant Information Sheet Form
Att 8_Test Participant Information Sheet Form
Att 7c_Site audits,Site audits (completed for each corrective action) Form
Att 7c_Site audits,Site audits (completed for each corrective action) Form
Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form
Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form
Att 5_Request manufacturing code Form and Instruction
Att 5_Request manufacturing code Form and Instruction
Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form
Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form

All Historical Document Collections

202410-0920-021 Approved without change	No material or nonsubstantive change to a currently approved collection	2024-10-18
202311-0920-004 Approved with change	Revision of a currently approved collection	2023-11-21
202009-0920-023	Revision of a currently approved collection	2020-10-14
202004-0920-013 Approved with change	Revision of a currently approved collection	2020-04-21
201801-0920-002 Approved without change	Reinstatement with change of a previously approved collection	2018-02-22
201407-0920-016 Approved without change	Revision of a currently approved collection	2014-08-11
201105-0920-012 Approved without change	Extension without change of a currently approved collection	2011-05-25
200804-0920-003 Approved without change	Reinstatement with change of a previously approved collection	2008-04-23
200408-0920-003 Approved with change	Extension without change of a currently approved collection	2004-08-23
200106-0920-002 Approved without change	Extension without change of a currently approved collection	2001-06-11
199806-0920-001 Approved without change	Extension without change of a currently approved collection	1998-06-11
199506-0920-009 Approved without change	Revision of a currently approved collection	1995-06-23
199305-0920-004 Approved without change	Reinstatement with change of a previously approved collection	1993-05-21
199105-0920-006 Approved with change	No material or nonsubstantive change to a currently approved collection	1991-05-07
199101-0920-002 Approved without change	Revision of a currently approved collection	1991-01-30
198910-0920-001 Approved without change	Revision of a currently approved collection	1989-10-30
198906-0920-002 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-06-16
198811-0920-001 Approved without change	Revision of a currently approved collection	1988-11-01
198710-0920-004 Approved without change	Revision of a currently approved collection	1987-10-08
198410-0920-003 Approved without change	Revision of a currently approved collection	1984-10-31
198403-0920-002 Approved with change	No material or nonsubstantive change to a currently approved collection	1984-03-22
198209-0920-001 Approved without change	Revision of a currently approved collection	1982-09-09
198112-0920-006 Approved without change	Revision of a currently approved collection	1981-12-22
198112-0920-001 Approved without change	New collection (Request for a new OMB Control Number)	1981-12-04

OMB Details

Att 4_Standard Application Form

Federal Enterprise Architecture: Workforce Management - Worker Safety

Form 0920-0109

Standard Application Form

Form

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