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 is listed under ICR 202410-0920-021.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
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 14 Capacity Test	Form
Form 0920-0109 Att 13 Data Collection Form (Man testing)	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 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 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
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

Historical document collections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

OMB Details

Att 4_Standard Application Form

Federal Enterprise Architecture: Workforce Management - Worker Safety

Information collection instruments
Form	Name	Electronic access	Type
Form 0920-0109	Standard Application Form	NA	Form

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.