NCEH DLS Laboratory Quality Assurance Programs

Forms and Documents

Document Name	Status
NSQAP Data Submission Portal Molecular PT (Private) Form	New
NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (Private) Form	New
NSQAP Data Submission Portal Quality Control (QC) (Private) Form	New
NSQAP Enrollment Form (Private) Form	New
NSQAP Data Submission Portal Molecular PT (International) Form	New
NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (International) Form	New
NSQAP Data Submission Portal Quality Control (QC) (International) Form	New
NSQAP Enrollment Form (International) Form	New
NSQAP Data Submission Portal Molecular PT (Domestic) Form	New
NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (Domestic) Form	New
NSQAP Data Submission Portal Quality Control (QC) (Domestic) Form	New
NSQAP Enrollment Form (Domestic) Form	New
LAMP Data Submission Form Form	New
LAMP Enrollment Form Form	New
EQUIP Data Submission Form Form	New
EQUIP Enrollment Form Form	New
PAsS Data Submission Form Form	New
PAsS Enrollment Form Form	New
BQASP Data Submission Form Form	New
BQASP Enrollment Email Form	New
MPV Micronutrients MBA Data Submission Form (Clinical Lab) Form	New
MPV Micronutrients MBA Enrollment Section on Data Submission Form (Clinical Lab) Form	New
MPV Micronutrients MBA Data Submission Form (Private Research Lab) Form	New
MPV Micronutrients MBA Enrollment Section on Data Submission Form (Private Research Lab) Form	New
MPV Micronutrients MBA Data Submission Form (International) Form	New
MPV Micronutrients MBA Enrollment Section on Data Submission Form (International Form	New
MPV Micronutrients MBA Data Submission Form (Academic) Form	New
MPV Micronutrients MBA Enrollment Section on Data Submission Form (Academic) Form	New
MPV Folate MBA Data Submission Form (Clinical Lab) Form	New
MPV Folate MBA Enrollment Section on Data Submission Form (Clinical Lab) Form	New
MPV Folate MBA Data Submission Form (Private Research Lab) Form	New
MPV Folate MBA Enrollment Section on Data Submission Form (Private Research Lab) Form	New
MPV Folate MBA Data Submission Form (International) Form	New
MPV Folate MBA Enrollment Section on Data Submission Form (International) Form	New
MPV Folate MBA Data Submission Form (Academic) Form	New
MPV Folate MBA Enrollment Section on Data Submission Form (Academic) Form	New
VITAL-EQA Data Submission Form (Clinical Lab) Form	New
VITAL-EQA Enrollment Form National (Clinical Lab) Form	New
VITAL-EQA Data Submission Form (Private Research Lab) Form	New
VITAL-EQA Enrollment Form National (Private Research Lab) Form	New
VITAL-EQA Data Submission Form (International) Form	New
VITAL-EQA Enrollment Form International Form	New
VITAL-EQA Data Submission Form (Academic) Form	New
VITAL-EQA Enrollment Form National (Academic) Form	New
VDSCP Data Submission Form (End-user / Lab) Form	New
VDSCP Enrollment Section on Data Submission Form (End-user / Lab) Form	New
VDSCP Data Submission Form (LDT) Form	New
VDSCP Enrollment Section on Data Submission Form (LDT) Form	New
VDSCP Data Submission Form (Assay Manufacturer) Form	New
VDSCP Enrollment Section on Data Submission Form (Assay Manufacturer) Form	New
HoSt Data Submission Form (End-user / Labs) Form	New
HoSt Enrollment Section on Data Submission Form (End-user / Labs) Form	New
HoSt Data Submission Form (LDT) Form	New
HoSt Enrollment Section on Data Submission Form (LDT) Form	New
HoSt Data Submission Form (Assay Manufacturer) Form	New
HoSt Enrollment Section on Data Submission Form (Assay Manufacturer) Form	New
CRMLN Data Submission Form Form	New
CRMLN Enrollment Webpage Form	New
LSP Data Submission Form (Clinical Lab) Form	New
LSP Enrollment Section on Data Submission Form (Clinical Lab) Form	New
LSP Data Submission Form (Private Research Lab) Form	New
LSP Enrollment Section on Data Submission Form (Private Research Lab) Form	New
LSP Data Submission Form (Academic) Form	New
LSP Enrollment Section on Data Submission Form (Academic) Form	New
AMP Data Submission Form (Clinical Lab) Form	New
AMP Enrollment Section on Data Submission Form (Clinical Lab) Form	New
AMP Data Submission Form (Private Research Lab) Form	New
AMP Enrollment Section on Data Submission Form (Private Research Lab) Form	New
AMP Data Submission Form (Academic) Form	New
AMP Enrollment Section on Data Submission Form (Academic) Form	New
Att 5 Non-Research Determination.pdf Supplementary Document	2022-09-14
Att 4 PIA DLS QA.pdf Supplementary Document	2022-09-14
Att 2 60D FRN 2021-28033.pdf Supplementary Document	2022-09-14
Att 1a Regulations and Standards.pdf Supplementary Document	2022-09-14
Att 1 Authorizing Legislation.pdf Supplementary Document	2022-09-14
1 - List of Attachments DLS QA_20220829.docx Supplementary Document	2022-09-14
1 - SSB DLS Lab QA Programs_20220829.docx Supporting Statement B	2022-09-14
1 - SSA DLS Lab QA Programs_20220829_final.docx Supporting Statement A	2022-09-14

IC Document Collections

IC ID	Document Title	Status
255962	NSQAP Data Submission Portal Molecular PT (Private) Form	New
255961	NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (Private) Form	New
255960	NSQAP Data Submission Portal Quality Control (QC) (Private) Form	New
255959	NSQAP Enrollment Form (Private) Form	New
255958	NSQAP Data Submission Portal Molecular PT (International) Form	New
255957	NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (International) Form	New
255956	NSQAP Data Submission Portal Quality Control (QC) (International) Form	New
255955	NSQAP Enrollment Form (International) Form	New
255954	NSQAP Data Submission Portal Molecular PT (Domestic) Form	New
255953	NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (Domestic) Form	New
255952	NSQAP Data Submission Portal Quality Control (QC) (Domestic) Form	New
255951	NSQAP Enrollment Form (Domestic) Form	New
255949	LAMP Data Submission Form Form	New
255948	LAMP Enrollment Form Form	New
255947	EQUIP Data Submission Form Form	New
255946	EQUIP Enrollment Form Form	New
255945	PAsS Data Submission Form Form	New
255944	PAsS Enrollment Form Form	New
255942	BQASP Data Submission Form Form	New
255941	BQASP Enrollment Email Form	New
255939	MPV Micronutrients MBA Data Submission Form (Clinical Lab) Form	New
255938	MPV Micronutrients MBA Enrollment Section on Data Submission Form (Clinical Lab) Form	New
255937	MPV Micronutrients MBA Data Submission Form (Private Research Lab) Form	New
255936	MPV Micronutrients MBA Enrollment Section on Data Submission Form (Private Research Lab) Form	New
255935	MPV Micronutrients MBA Data Submission Form (International) Form	New
255934	MPV Micronutrients MBA Enrollment Section on Data Submission Form (International Form	New
255933	MPV Micronutrients MBA Data Submission Form (Academic) Form	New
255931	MPV Micronutrients MBA Enrollment Section on Data Submission Form (Academic) Form	New
255930	MPV Folate MBA Data Submission Form (Clinical Lab) Form	New
255929	MPV Folate MBA Enrollment Section on Data Submission Form (Clinical Lab) Form	New
255928	MPV Folate MBA Data Submission Form (Private Research Lab) Form	New
255927	MPV Folate MBA Enrollment Section on Data Submission Form (Private Research Lab) Form	New
255926	MPV Folate MBA Data Submission Form (International) Form	New
255925	MPV Folate MBA Enrollment Section on Data Submission Form (International) Form	New
255924	MPV Folate MBA Data Submission Form (Academic) Form	New
255923	MPV Folate MBA Enrollment Section on Data Submission Form (Academic) Form	New
255922	VITAL-EQA Data Submission Form (Clinical Lab) Form	New
255920	VITAL-EQA Enrollment Form National (Clinical Lab) Form	New
255918	VITAL-EQA Data Submission Form (Private Research Lab) Form	New
255917	VITAL-EQA Enrollment Form National (Private Research Lab) Form	New
255916	VITAL-EQA Data Submission Form (International) Form	New
255915	VITAL-EQA Enrollment Form International Form	New
255914	VITAL-EQA Data Submission Form (Academic) Form	New
255913	VITAL-EQA Enrollment Form National (Academic) Form	New
255912	VDSCP Data Submission Form (End-user / Lab) Form	New
255911	VDSCP Enrollment Section on Data Submission Form (End-user / Lab) Form	New
255910	VDSCP Data Submission Form (LDT) Form	New
255904	VDSCP Enrollment Section on Data Submission Form (LDT) Form	New
255903	VDSCP Data Submission Form (Assay Manufacturer) Form	New
255902	VDSCP Enrollment Section on Data Submission Form (Assay Manufacturer) Form	New
255901	HoSt Data Submission Form (End-user / Labs) Form	New
255900	HoSt Enrollment Section on Data Submission Form (End-user / Labs) Form	New
255898	HoSt Data Submission Form (LDT) Form	New
255897	HoSt Enrollment Section on Data Submission Form (LDT) Form	New
255896	HoSt Data Submission Form (Assay Manufacturer) Form	New
255895	HoSt Enrollment Section on Data Submission Form (Assay Manufacturer) Form	New
255891	CRMLN Data Submission Form Form	New
255890	CRMLN Enrollment Webpage Form	New
255888	LSP Data Submission Form (Clinical Lab) Form	New
255887	LSP Enrollment Section on Data Submission Form (Clinical Lab) Form	New
255885	LSP Data Submission Form (Private Research Lab) Form	New
255884	LSP Enrollment Section on Data Submission Form (Private Research Lab) Form	New
255883	LSP Data Submission Form (Academic) Form	New
255880	LSP Enrollment Section on Data Submission Form (Academic) Form	New
255879	AMP Data Submission Form (Clinical Lab) Form	New
255878	AMP Enrollment Section on Data Submission Form (Clinical Lab) Form	New
255877	AMP Data Submission Form (Private Research Lab) Form	New
255876	AMP Enrollment Section on Data Submission Form (Private Research Lab) Form	New
255875	AMP Data Submission Form (Academic) Form	New
255868	AMP Enrollment Section on Data Submission Form (Academic) Form	New

ICR Details

OMB Control No:	ICR Reference No: 202209-0920-008
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22AW
Title: NCEH DLS Laboratory Quality Assurance Programs
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/16/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	10,804	0
Time Burden (Hours)	6,513	0
Cost Burden (Dollars)	0	0

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Abstract: Accuracy and reliability of laboratory tests is important to identify and to monitor exposures and health biomarkers, which in turn improves diagnosis and treatment. Laboratories that conduct biomonitoring or test for certain environmental or nutritional chemicals participate in quality assurance (QA) activities for many reasons: to assess internal test performance, calibrate methods to standards among other laboratories, receive certification of proficiency to comply with certain regulations, or simply improve quality. Participation may help a laboratory to verify the accuracy of their methods and results or ensure accurate and consistent test results across multiple laboratories.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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:
	86 FR 73280	12/27/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 56958	09/16/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 70

IC Title	Form No.	Form Name
AMP Data Submission Form (Academic)	n/a	AMP Data Submission Form
AMP Data Submission Form (Clinical Lab)	n/a	AMP Data Submission Form
AMP Data Submission Form (Private Research Lab)	n/a	AMP Data Submission Form
AMP Enrollment Section on Data Submission Form (Academic)	n/a	AMP Enrollment Section on Data Submission Form
AMP Enrollment Section on Data Submission Form (Clinical Lab)	n/a	AMP Enrollment Section on Data Submission Form
AMP Enrollment Section on Data Submission Form (Private Research Lab)	n/a	AMP Enrollment Section on Data Submission Form
BQASP Data Submission Form	n/a, n/a, n/a, n/a, n/a, n/a, n/a	BQASP Data Submission Form Perchlorate ,   BQASP Data Submission Form Cotinine ,   BQASP Data Submission Form Pesticides ,   BQASP Data Submission Form PFAS ,   BQASP Data Submission Form Phenols ,   BQASP Data Submission Form Phthalates ,   BQASP Data Submission Form PAH
BQASP Enrollment Email	n/a	BQASP Enrollment Email
CRMLN Data Submission Form	n/a	CRMLN Data Submission Form
CRMLN Enrollment Webpage	n/a	CRMLN Enrollment Webpage
EQUIP Data Submission Form	n/a	EQUIP Data Submission Form
EQUIP Enrollment Form	n/a	EQUIP Enrollment Form
HoSt Data Submission Form (Assay Manufacturer)	n/a	HoSt Data Submission Form
HoSt Data Submission Form (End-user / Labs)	n/a	HoSt Data Submission Form
HoSt Data Submission Form (LDT)	n/a	HoSt Data Submission Form
HoSt Enrollment Section on Data Submission Form (Assay Manufacturer)	n/a	HoSt Enrollment Section on Data Submission Form
HoSt Enrollment Section on Data Submission Form (End-user / Labs)	n/a	HoSt Enrollment Section on Data Submission Form
HoSt Enrollment Section on Data Submission Form (LDT)	n/a	HoSt Enrollment Section on Data Submission Form
LAMP Data Submission Form	n/a	LAMP Data Submission Form
LAMP Enrollment Form	n/a	LAMP Enrollment Form
LSP Data Submission Form (Academic)	n/a	LSP Data Submission Form
LSP Data Submission Form (Clinical Lab)	n/a	LSP Data Submission Form
LSP Data Submission Form (Private Research Lab)	n/a	LSP Data Submission Form
LSP Enrollment Section on Data Submission Form (Academic)	n/a	LSP Enrollment Section on Data Submission Form
LSP Enrollment Section on Data Submission Form (Clinical Lab)	n/a	LSP Enrollment Section on Data Submission Form
LSP Enrollment Section on Data Submission Form (Private Research Lab)	n/a	LSP Enrollment Section on Data Submission Form
MPV Folate MBA Data Submission Form (Academic)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Folate MBA Data Submission Form (Clinical Lab)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Folate MBA Data Submission Form (International)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Folate MBA Data Submission Form (Private Research Lab)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Folate MBA Enrollment Section on Data Submission Form (Academic)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Folate MBA Enrollment Section on Data Submission Form (Clinical Lab)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Folate MBA Enrollment Section on Data Submission Form (International)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Folate MBA Enrollment Section on Data Submission Form (Private Research Lab)	n/a	MPV Folate MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Data Submission Form (Academic)	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Data Submission Form (Clinical Lab)	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Data Submission Form (International)	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Data Submission Form (Private Research Lab)	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Enrollment Section on Data Submission Form (Academic)	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Enrollment Section on Data Submission Form (Clinical Lab)	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Enrollment Section on Data Submission Form (International	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
MPV Micronutrients MBA Enrollment Section on Data Submission Form (Private Research Lab)	n/a	MPV Micronutrients MBA Enrollment Section on Data Submission Form
NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (Domestic)	n/a	NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT
NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (International)	n/a	NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT
NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT (Private)	n/a	NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT
NSQAP Data Submission Portal Molecular PT (Domestic)	n/a	NSQAP Data Submission Portal Molecular PT
NSQAP Data Submission Portal Molecular PT (International)	n/a	NSQAP Data Submission Portal Molecular PT
NSQAP Data Submission Portal Molecular PT (Private)	n/a	NSQAP Data Submission Portal Molecular PT
NSQAP Data Submission Portal Quality Control (QC) (Domestic)	n/a	NSQAP Data Submission Portal Quality Control (QC)
NSQAP Data Submission Portal Quality Control (QC) (International)	n/a	NSQAP Data Submission Portal Quality Control (QC)
NSQAP Data Submission Portal Quality Control (QC) (Private)	n/a	NSQAP Data Submission Portal Quality Control (QC)
NSQAP Enrollment Form (Domestic)	n/a	NSQAP Enrollment Form
NSQAP Enrollment Form (International)	n/a	NSQAP Enrollment Form
NSQAP Enrollment Form (Private)	n/a	NSQAP Enrollment Form
PAsS Data Submission Form	n/a	PAsS Data Submission Form
PAsS Enrollment Form	n/a	PAsS Enrollment Form
VDSCP Data Submission Form (Assay Manufacturer)	n/a	VDSCP Data Submission Form
VDSCP Data Submission Form (End-user / Lab)	n/a	VDSCP Data Submission Form
VDSCP Data Submission Form (LDT)	n/a	VDSCP Data Submission Form
VDSCP Enrollment Section on Data Submission Form (Assay Manufacturer)	n/a	VDSCP Enrollment Section on Data Submission Form
VDSCP Enrollment Section on Data Submission Form (End-user / Lab)	n/a	VDSCP Enrollment Section on Data Submission Form
VDSCP Enrollment Section on Data Submission Form (LDT)	n/a	VDSCP Enrollment Section on Data Submission Form
VITAL-EQA Data Submission Form (Academic)	n/a, n/a, n/a, n/a, n/a, n/a, n/a	Data Submission Form Folate ,   Data Submission Form Vit B12 ,   Data Submission Form CRP ,   Data Submission Form Ferritin ,   Data Submission Form sTfR ,   Data Submission Form Vit D ,   Data Submission Form Vit A
VITAL-EQA Data Submission Form (Clinical Lab)	n/a, n/a, n/a, n/a, n/a, n/a, n/a	Data Submission Form Folate ,   Data Submission Form Vit B12 ,   Data Submission Form CRP ,   Data Submission Form Ferritin ,   Data Submission Form sTfR ,   Data Submission Form Vit D ,   Data Submission Form Vit A
VITAL-EQA Data Submission Form (International)	n/a, n/a, n/a, n/a, n/a, n/a, n/a	Data Submission Form Folate ,   Data Submission Form Vit B12 ,   Data Submission Form CRP ,   Data Submission Form Ferritin ,   Data Submission Form sTfR ,   Data Submission Form Vit D ,   Data Submission Form Vit A
VITAL-EQA Data Submission Form (Private Research Lab)	n/a, n/a, n/a, n/a, n/a, n/a, n/a	Data Submission Form Folate ,   Data Submission Form Vit B12 ,   Data Submission Form CRP ,   Data Submission Form Ferritin ,   Data Submission Form sTfR ,   Data Submission Form Vit D ,   Data Submission Form Vit A
VITAL-EQA Enrollment Form International	n/a	VITAL-EQA Enrollment Form International
VITAL-EQA Enrollment Form National (Academic)	n/a	VITAL-EQA Enrollment Form National
VITAL-EQA Enrollment Form National (Clinical Lab)	n/a	VITAL-EQA Enrollment Form National
VITAL-EQA Enrollment Form National (Private Research Lab)	n/a	VITAL-EQA Enrollment Form National

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ICR Summary of Burden

	Total Request	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	10,804	0	0	4,328	6,476	0
Annual Time Burden (Hours)	6,513	0	0	2,090	4,423	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a New collection.

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Annual Cost to Federal Government: $1,762,845

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     Yes

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? No

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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: 09/16/2022

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