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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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:
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
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).
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0920-AA69
Final or interim final rulemaking
85 FR 20598
04/14/2020
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
Number of Information Collection (IC) in this ICR:
2
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
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
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.
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
Agency Contact:
Kevin Joyce 404 639-1944 kdj7@cdc.gov
Common Form ICR:
No
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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