NCEH DLS Laboratory Quality Assurance Programs

ICR 202209-0920-008

OMB:

Federal Form Document

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Supplementary Document
2022-09-14
Supplementary Document
2022-09-14
Supplementary Document
2022-09-14
Supplementary Document
2022-09-14
Supplementary Document
2022-09-14
Supplementary Document
2022-09-14
Supporting Statement B
2022-09-14
Supporting Statement A
2022-09-14
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ICR Details
202209-0920-008
Received in OIRA
HHS/CDC 0920-22AW
NCEH DLS Laboratory Quality Assurance Programs
Existing collection in use without an OMB Control Number   No
Regular 09/16/2022
  Requested Previously Approved
36 Months From Approved
10,804 0
6,513 0
0 0

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.

US Code: 42 USC 241 Name of Law: PHSA
  
None

Not associated with rulemaking

  86 FR 73280 12/27/2021
87 FR 56958 09/16/2022
Yes

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

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This is a New collection.

$1,762,845
Yes Part B of Supporting Statement
    Yes
    No
No
No
No
No
Kevin Joyce 404 639-1944 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
09/16/2022


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