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

Forms and Documents

Document Name	Status
Form 0920-0109 Att 4_Standard Application Form Form	Unchanged
Form 0920-0109 Att 4_Standard Application Form Form	Unchanged
Form 0920-0109 Att 24 Test 118 Form	Unchanged
Form 0920-0109 Att 24 Test 118 Form	Unchanged
Form ETB 1211A Rev 1 FP Att 26 Wearability Test Form	Unchanged
Form ETB 1211A Rev 1 FP Att 26 Wearability Test Form	Unchanged
Form 0920-0109 Att 25 Test 147 Form	Unchanged
Form 0920-0109 Att 25 Test 147 Form	Unchanged
Form ETB-1214 Rev 1 FPW Att 23 Stressors Form	Unchanged
Form ETB-1214 Rev 1 FPW Att 23 Stressors Form	Unchanged
Form ETB-1014-APR -0030 Att 22 Sound Level STP-30_STP 111 Form	Unchanged
Form ETB-1014-APR -0030 Att 22 Sound Level STP-30_STP 111 Form	Unchanged
Form TEB-1214A Rev 0 Att 21 Performance Test Form	Unchanged
Form TEB-1214A Rev 0 Att 21 Performance Test Form	Unchanged
Form TEB-1107 Rev 0 Att 20 LRPL Bitrex Donning Form	Unchanged
Form TEB-1107 Rev 0 Att 20 LRPL Bitrex Donning Form	Unchanged
Form TEB-1107 Rev 0 Att 19 Fogging test Form	Unchanged
Form TEB-1107 Rev 0 Att 19 Fogging test Form	Unchanged
Form ETB-1028 Rev 5 Att 18 Fit Test STP -9 and 10 Form	Unchanged
Form ETB-1028 Rev 5 Att 18 Fit Test STP -9 and 10 Form	Unchanged
Form TEB-1023 Rev.1 Att 17 Fit Test STP 5_5.1_6 Form	Unchanged
Form TEB-1023 Rev.1 Att 17 Fit Test STP 5_5.1_6 Form	Unchanged
Form 0920-0109 Att 16 Donning Test Form	Unchanged
Form 0920-0109 Att 16 Donning Test Form	Unchanged
Form 0920-0109 Att 15 Communication Test Form	Unchanged
Form 0920-0109 Att 15 Communication Test Form	Unchanged
Form 0920-0109 Att 14 Capacity Test Form	Unchanged
Form 0920-0109 Att 14 Capacity Test Form	Unchanged
Form 0920-0109 Att 13 Data Collection Form (Man testing) Form	Unchanged
Form 0920-0109 Att 13 Data Collection Form (Man testing) Form	Unchanged
Form Form ETB-1035 Rev Att 12 Health and Wellness Screent (each test, fit testing) Form	Unchanged
Form Form ETB-1035 Rev Att 12 Health and Wellness Screent (each test, fit testing) Form	Unchanged
Form 0920-0109 Att 11Pre-test Questionnaire for Respirator Fit Testing Form	Unchanged
Form 0920-0109 Att 11Pre-test Questionnaire for Respirator Fit Testing Form	Unchanged
Form 0920-0109 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form	Unchanged
Form 0920-0109 Att 10 OSHA/NPPTL Medical Evaluation: Annually for all Test Participants_Rev 1 (10.25.2023) Form	Unchanged
Form 0920-0109 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form	Modified
Form 0920-0109 Att 9 Pre- and Post-Test Session Participant Questionnaire and Examination Form	Modified
Form 0920-0109 Att 8_Test Participant Information Sheet Form	Modified
Form 0920-0109 Att 8_Test Participant Information Sheet Form	Modified
Form 0920-0109 Att 7c_Site audits,Site audits (completed for each corrective action) Form	Unchanged
Form 0920-0109 Att 7c_Site audits,Site audits (completed for each corrective action) Form	Unchanged
Form 0920-0109 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form	Unchanged
Form 0920-0109 Att 7b_Site audits, Part 2_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form	Unchanged
Form 0920-0109 Att 5_Request manufacturing code Form and Instruction	Unchanged
Form 0920-0109 Att 5_Request manufacturing code Form and Instruction	Unchanged
Form 0920-0109 Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form	Unchanged
Form 0920-0109 Att 7_Site audits, Part 1_Respiratory Protective Devices-42 CFR part 84-Regulation (Audit) Form	Unchanged
Change request justification_0920-0109_09.23.2024.docx Justification for No Material/Nonsubstantive Change	2024-10-18
Change request justification_0920-0109_09.23.2024.docx Justification for No Material/Nonsubstantive Change	2024-10-18
Atch_6_IRB determination.pdf Supplementary Document	2020-10-07
Atch_6_IRB determination.pdf Supplementary Document	2020-10-07
Atch_3_60-day Federal Register Notice.pdf Supplementary Document	2023-11-06
Atch_3_60-day Federal Register Notice.pdf Supplementary Document	2023-11-06
Atch_2_42 CFR part 84.docx Supplementary Document	2020-10-07
Atch_2_42 CFR part 84.docx Supplementary Document	2020-10-07
Atch_1_OSH Act.docx Supplementary Document	2020-10-07
Atch_1_OSH Act.docx Supplementary Document	2020-10-07
SupportingStatement_B_23November_1.docx Supporting Statement B	2023-11-15
SupportingStatement_B_23November_1.docx Supporting Statement B	2023-11-15
SupportingStatement_A_24September_17_Clean-2 (1).docx Supporting Statement A	2024-10-18
SupportingStatement_A_24September_17_Clean-2 (1).docx Supporting Statement A	2024-10-18

IC Document Collections

IC ID	Document Title	Status
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

OMB Control No: 0920-0109	ICR Reference No: 202410-0920-021
Status: Active	Previous ICR Reference No: 202311-0920-004
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/21/2024
	Date Received in OIRA: 10/18/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2027	01/31/2027	01/31/2027
Responses	2,978	0	2,978
Time Burden (Hours)	131,060	0	131,060
Cost Burden (Dollars)	0	0	0

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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 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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, 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

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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	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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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

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Common Form ICR:  No

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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: 10/18/2024

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