NCEH DLS Laboratory Quality Assurance Programs

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

Agency Contact: Kevin Joyce 404 639-1944 [email protected]

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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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