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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-0199 Standard Application Form initial	Form and Instruction	Modified	Available
Form 0920-0199 Information Collection Provisions in 42 CFR Part 84 - (Standard Application fro the Approval of Resiporators)	Form and Instruction	Modified	Repair queued
Form 0920-0109 Standard Application Form for Respirator Approval	Form and Instruction	Modified	Available
Form 0920-0109 Standard Application for the Approval of PAPR class PAPR100	Form	Removed	Available
Form 0920-0109 Standard Application for the Approval of PAPR class PAPR100	Form	Removed	Repair queued
Form 0920-0109 Audit Form	Form	Modified	Available
Form 0920-0109 Respiratory Protective Devices-42 CFR part 84-Regulation (Audit)	Form	Modified	Repair queued
Atch_6_IRB determination.pdf	Supplementary Document	Uploaded 2020-10-07	Repair queued
Atch 3b.pdf	Supplementary Document	Uploaded 2020-10-07	Repair queued
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
SupportingStatement_B_16Sep2020_Clean final.docx	Supporting Statement B	Uploaded 2020-10-07	Repair queued
SupportingStatement_A_23Sep2020 ICRO.docx	Supporting Statement A	Uploaded 2020-10-07	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6639	Information Collection Provisions in 42 CFR Part 84 - (Standard Application fro the Approval of Resiporators)	Form and Instruction	Modified	Standard Application Form initial
6639	Information Collection Provisions in 42 CFR Part 84 - (Standard Application fro the Approval of Resiporators)	Form and Instruction	Modified
6639	Information Collection Provisions in 42 CFR Part 84 - (Standard Application fro the Approval of Resiporators)	Form and Instruction	Modified	Standard Application Form for Respirator Approval
241447	Standard Application for the Approval of PAPR class PAPR100	Form	Removed	Standard Application for the Approval of PAPR class PAPR100
241447	Standard Application for the Approval of PAPR class PAPR100	Form	Removed
197842	Respiratory Protective Devices-42 CFR part 84-Regulation (Audit)	Form	Modified	Audit Form
197842	Respiratory Protective Devices-42 CFR part 84-Regulation (Audit)	Form	Modified

ICR Details

OMB Control No: 0920-0109	ICR Reference No: 202009-0920-023
Status: Historical Active	Previous ICR Reference No: 202004-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0109
Title: 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 without change	Conclusion Date: 03/09/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/14/2020
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	36 Months From Approved	03/31/2021
Responses	630	0	593
Time Burden (Hours)	129,920	0	123,702
Cost Burden (Dollars)	0	0	0

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Abstract: Information is collected to enable 42 CFR Part 84 respirator approval certification activities. 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).

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Authorizing Statute(s): 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: 30 USC 7 Name of Law: Fees for Tests or Investigations
   US Code: 29 USC 657 Name of Law: Inspections and Recordkeeping
   US Code: 42 USC 84 Name of Law: Approval of Respiratory Protective Devices
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0920-AA69	Final or interim final rulemaking	85 FR 20598	04/14/2020

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 43840	07/20/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 64472	10/13/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Information Collection Provisions in 42 CFR Part 84 - (Standard Application fro the Approval of Resiporators)	0920-0109, 0920-0199	Standard Application Form for Respirator Approval ,   Standard Application Form initial
Respiratory Protective Devices-42 CFR part 84-Regulation (Audit)	0920-0109	Audit Form
Standard Application for the Approval of PAPR class PAPR100	0920-0109	Standard Application for the Approval of PAPR class PAPR100

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ICR Summary of Burden

table that charts list 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	630	593	0	60	-23	0
Annual Time Burden (Hours)	129,920	123,702	0	11,485	-5,267	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: No

Burden Reduction Due to:

Short Statement: The new class of respirators added to the project increased the potential respondents.

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Annual Cost to Federal Government: $490,522

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: 10/14/2020

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