View Information Collection Request (ICR) Package
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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:
0920-1389
ICR Reference No:
202209-0920-008
Status:
Active
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/17/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/16/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2026
36 Months From Approved
Responses
10,804
0
0
Time Burden (Hours)
6,513
0
0
Cost Burden (Dollars)
0
0
0
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.
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: PHSA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
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
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.
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 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:
09/16/2022