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 0920-0109 Standard Application Form for Respirator Approval	Form	Unchanged	Available
Form 0920-0109 Standard Application for the Approval of PAPR class PAPR100	Form	New	Available
Form 0920-0109 Audit Form	Form	Modified	Available
Att 5 IRB determination.pdf	Supplementary Document	Uploaded 2020-04-20	Available
Att 1_OSH 29CFR671 Sec20.docx	Supplementary Document	Uploaded 2020-04-20	Available
SupportingStatementB-12.14.17.doc	Supporting Statement B	Uploaded 2018-02-21	Available
SupportingStatement A 20April2020.docx	Supporting Statement A	Uploaded 2020-04-20	Available
Att 3 60-day FRN.pdf	Supplementary Document	Uploaded 2018-02-20	Available
Att 1 USCODE-2011-title29-chap15-sec657.pdf	Supplementary Document	Uploaded 2018-02-20	Available

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	Unchanged	Standard Application Form for Respirator Approval
241447	Standard Application for the Approval of PAPR class PAPR100	Form	New	Standard Application for the Approval of PAPR class PAPR100
197842	Respiratory Protective Devices-42 CFR part 84-Regulation (Audit)	Form	Modified	Audit Form

ICR Details

OMB Control No: 0920-0109	ICR Reference No: 202004-0920-013
Status: Historical Active	Previous ICR Reference No: 201801-0920-002
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: Emergency	Approval Requested By: 05/01/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/30/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/21/2020
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2020	6 Months From Approved	04/30/2021
Responses	593	0	570
Time Burden (Hours)	123,702	0	118,435
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 in burden hours from 118,435 to 123,702 which accounts for an increase in the number of respondents. Emergency approval is requested for reasons described in the associated interim final rulemaking entitled “Approval Tests and Standards for Air-Purifying Particulate Respirators”. This submission allows 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).

Emergency Justfication: Emergency approval is requested for reasons described in the associated Interim Final Rulemaking (IFR) titled “Approval Tests and Standards for Air-Purifying Particulate Respirators.” The IFR allows 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 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 844 Name of Law: Rock, Dust, and Gas Hazards, Controls
   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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

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	Standard Application Form for Respirator Approval
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	593	570	0	23	0	0
Annual Time Burden (Hours)	123,702	118,435	0	5,267	0	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: Submission results in an increase in burden hours from 118,435 to 123,702 which accounts for an increase in the number of 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: 04/21/2020

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