Billing Code: 4163-18-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-22AW]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the
Centers for Disease Control and Prevention (CDC) has submitted
the information collection request titled “NCEH DLS Laboratory
Quality Assurance Programs” to the Office of Management and
Budget (OMB) for review and approval. CDC previously published a
“Proposed Data Collection Submitted for Public Comment and
Recommendations” notice on December 27, 2021, to obtain comments
from the public and affected agencies. CDC received four nonsubstantive comments related to the previous notice. This notice
serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is
particularly interested in comments that:

(a) Evaluate whether the proposed collection of information
is necessary for the proper performance of the functions of
the agency, including whether the information will have
practical utility;
(b) Evaluate the accuracy of the agencies estimate of the
burden of the proposed collection of information, including
the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the
information to be collected;
(d) Minimize the burden of the collection of information on
those who are to respond, including, through the use of
appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of
information technology, e.g., permitting electronic
submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project
or to obtain a copy of the information collection plan and
instruments, call (404) 639-7570. Comments and recommendations
for the proposed information collection should be sent within 30
days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting "Currently under 30-day
Review - Open for Public Comments" or by using the search
function. Direct written comments and/or suggestions regarding
the items contained in this notice to the Attention: CDC Desk
Officer, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.

Proposed Project
NCEH DLS Quality Assurance Programs – Existing Collection in Use
Without an OMB Control Number – National Center for

Environmental Health (NCEH), Centers for Disease Control and
Prevention (CDC).

Background and Brief Description
Laboratory quality assurance (QA) encompasses a range of
activities that enable laboratories to achieve and maintain high
levels of accuracy and proficiency despite changes in test
methods, instrumentation, analytes, source materials, and the
volume of specimens tested. The Centers for Disease Control and
Prevention (CDC), National Center for Environmental Health
(NCEH), Division of Laboratory Sciences (DLS) QA programs
operate out of multiple laboratories within the Division. They
establish the baseline measurements and provide calibration
and/or quality control (QC) samples that laboratories around the
world rely on to develop and improve methods with acceptable
levels of accuracy and reliability and, in some cases, meet
certain required certifications or accreditation. Laboratories
use DLS-developed samples to test the quality and accuracy of
their methods/assays. Participating laboratories enroll in the
DLS QA program that fits their needs (i.e., external quality
assurance/performance assessment, proficiency testing, accuracybased monitoring, or standardization/harmonization). After the
laboratories receive DLS QA samples and perform their
measurements, they return test results to DLS. DLS then
evaluates the data using statistical methods and reports back to
the laboratories on their analytical performance. Laboratories

may receive additional technical assistance (TA)/troubleshooting
to improve their method performance as needed. DLS programs are
offered at different frequencies.
There are 13 DLS QA programs conducted by the following
five DLS branches. These programs provide materials and test
result analysis to laboratories for the purpose of improving
and/or standardizing test performance.
ï‚·

Clinical Chemistry Branch (CCB)
o Accuracy-based Laboratory Monitoring Programs (AMP)
o Lipid Standardization Program (LSP) for Clinical
Biomarkers
o Cholesterol Reference Method Laboratory Network
(CRMLN)
o Hormone Standardization (HoST) Program
o Vitamin D Standardization Certification Program
(VDSCP)

ï‚·

Nutrition Biomarkers Branch (NBB)
o Vitamin A Laboratory – External Quality Assurance
(VITAL-EQA)
o Quality Assurance Method Performance Verification
(MPV) for Folate Microbiologic Assay (MBA)
o Quality Assurance Method Performance Verification
(MPV) for Micronutrients

ï‚·

Organic Analytical Toxicology Branch (OATB)
o Biomonitoring Quality Assurance Support Program
(BQASP)

ï‚·

Inorganic Radiation and Analytical Toxicology Branch
(IRATB)
o Proficiency in Arsenic Speciation (PAsS) Program
o Ensuring the Quality of Urinary Iodine Procedures
(EQUIP)
o Lead and Multielement Proficiency (LAMP) Testing
Program

ï‚·

Newborn Screening and Molecular Biology Branch (NSMBB)
o Newborn Screening and Quality Assurance Program
(NSQAP)

All 13 CDC quality assurance programs help improve the accuracy
and reliability of tests performed by laboratories in patient
care, research, commercial and public health settings. They also
help to make measurement results among research studies and
among clinical laboratories more comparable.
Collectively, these programs improve the quality of
laboratory tests that measure environmental exposures and
chronic disease biomarkers (including nutritional indicators and
hormones) to better inform critical patient care and public
health decisions for an expansive host of health outcomes such
as rare heritable disorders in newborns, endocrine disorders,
maternal health and risk of birth defects, bone, kidney and
cardiovascular disease, cancers (including breast cancer),
diabetes, thyroid and hormone dysregulation.
The estimated annualized burden hours were determined, as
follows. The respondents are participating laboratories that are

represented by an individual laboratory analyst who would record
the data from their testing results in the supplied data
submission form(s). Depending on the program, the average burden
per response for the enrollment and data submission forms was
determined to be five minutes up to two hours through firsthand
experience in testing usability/data entry of forms. The number
of respondents fluctuates minimally each year and an average
number of participants per program was estimated by each program
based on previous years’ participation and trends in
participation rate since the inception of each program. CDC has
estimated the annualized time burden for these 13 programs to be
6,513 hours per year. The annualized number of responses are
estimated as 10,804 submissions to NCEH DLS. NCEH is requesting
a three-year Paperwork Reduction (PRA) Act Clearance. There are
no costs to the respondents other than their time.

Estimated Annualized Burden Hours

Type of
Respondent

Form Name

No. of
Responses
No. of
per
Respondents
Respondent
(in hours)

Average
Burden
per
Response
(in
hours)

CCB Accuracy-based Laboratory Monitoring Programs (AMP)
AMP Enrollment
Section on Data 10
1
25/60
Academic/
Submission Form
University
Research Lab
AMP Data
10
4
45/60
Submission Form
AMP Enrollment
Section on Data 3
1
25/60
Private
Submission Form
Research Lab
AMP Data
3
4
45/60
Submission Form
Routine
AMP Enrollment
20
1
25/60

Clinical Lab

Section on Data
Submission Form
AMP Data
20
Submission Form
CCB Lipid Standardization Program (LSP)
LSP Enrollment
Section on Data 20
Academic/
Submission Form
University
Research Lab
LSP Data
20
Submission Form
LSP Enrollment
Section on Data 7
Private
Submission Form
Research Lab
LSP Data
7
Submission Form
LSP Enrollment
Section on Data 40
Routine
Submission Form
Clinical Lab
LSP Data
40
Submission Form
CCB Cholesterol Reference Method Laboratory
CRMLN
Enrollment
15
CRMLN Network
Webpage
Laboratories
CRMLN Data
15
Submission Form
CCB Hormone Standardization (HoST) Program
HoSt Enrollment
Section on Data 60
Assay
Submission Form
Manufacturers
HoSt Data
60
Submission Form
HoSt Enrollment
(LDT) Lab
Section on Data 40
Developed
Submission Form
Tests
HoSt Data
Manufacturers
40
Submission Form
HoSt Enrollment
Section on Data 20
End-user/
Submission Form
Labs
HoSt Data
20
Submission Form
CCB Vitamin D Standardization Certification
VDSCP
Enrollment
60
Section on Data
Assay
Manufacturers Submission Form
VDSCP Data
60
Submission Form
(LDT) Lab
VDSCP
Developed
Enrollment
40
Tests
Section on Data

45/60

25/60

45/60

25/60

45/60

25/60

45/60

Network (CRMLN)
10/60

2

30/60

1

30/60

1

30/60

1

Program (VDSCP)
30/60

1

30/60

Manufacturers Submission Form
VDSCP Data
40
4
1
Submission Form
VDSCP
Enrollment
20
1
30/60
Section on Data
End-user/
Submission Form
Labs
VDSCP Data
20
4
1
Submission Form
NBB Vitamin A Laboratory – External Quality Assurance (VITALEQA)
VITAL-EQA
Enrollment Form 30
1
25/60
Academic/
National
University
Research Lab
VITAL-EQA Data
30
2
45/60
Submission Form
VITAL-EQA
Enrollment Form 30
1
25/60
Government/
International
Ministry of
Health Lab
VITAL-EQA Data
30
2
45/60
Submission Form
VITAL-EQA
Enrollment Form 15
1
25/60
Private
National
Research Lab
VITAL-EQA Data
15
2
45/60
Submission Form
VITAL-EQA
Enrollment Form 15
1
25/60
National
Clinical Lab
VITAL-EQA Data
15
2
45/60
Submission Form
NBB Quality Assurance Method Performance Verification (MPV) for
Folate Microbiologic Assay (MBA)
MPV Folate MBA
Enrollment
15
1
25/60
Section on Data
Academic/
Submission Form
University
Research Lab
MPV Folate MBA
Data Submission 15
4
45/60
Form
MPV Folate MBA
Enrollment
15
1
25/60
Section on Data
Government/
Submission Form
Ministry of
Health Lab
MPV Folate MBA
Data Submission 15
4
45/60
Form
MPV Folate MBA
Enrollment
5
1
25/60
Private
Section on Data
Research Lab
Submission Form
MPV Folate MBA
5
4
45/60

Data Submission
Form
MPV Folate MBA
Enrollment
5
1
25/60
Section on Data
Clinical
Submission Form
Public
Health Lab
MPV Folate MBA
Data Submission 5
4
45/60
Form
NBB Quality Assurance Method Performance Verification (MPV) for
Micronutrients
MPV
Micronutrients
Enrollment
20
1
25/60
Section on Data
Academic/
Submission Form
University
Research Lab
MPV
Micronutrients
45/60
20
4
Data Submission
Form
MPV
Micronutrients
25/60
Enrollment
20
1
Section on Data
Government/
Submission Form
Ministry of
Health Lab
MPV
Micronutrients
45/60
20
4
Data Submission
Form
MPV
Micronutrients
25/60
Enrollment
10
1
Section on Data
Private
Submission Form
Research Lab
MPV
Micronutrients
45/60
10
4
Data Submission
Form
MPV
Micronutrients
25/60
Enrollment
10
1
Section on Data
Clinical
Public Health Submission Form
Lab
MPV
Micronutrients
45/60
10
4
Data Submission
Form
OATB Biomonitoring Quality Assurance Support Program (BQASP)
BQASP
Enrollment
10
1
5/60
State Public
Email
Health Labs
BQASP Data
10
1
45/60

Submission Form
IRATB Proficiency in Arsenic Speciation (PAsS) Program
PAsS Enrollment
28
1
10/60
Public Health Form
Labs
PAsS Data
28
4
10/60
Submission Form
IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
EQUIP
240
1
10/60
Public Health Enrollment Form
Labs
EQUIP Data
240
3
10/60
Submission Form
IRATB Lead and Multielement Proficiency (LAMP) Testing Program
LAMP Enrollment
226
1
10/60
Public Health Form
Labs
LAMP Data
226
4
10/60
Submission Form
NSMBB Newborn Screening and Quality Assurance Program (NSQAP)
NSQAP
71
1
10/60
Enrollment Form
NSQAP Data
Submission
71
2
45/60
Portal Quality
Control (QC)
NSQAP Data
Domestic NBS
Submission
Labs
Portal
71
3
45/60
Biochemical
(Proficiency
Testing) PT
NSQAP Data
Submission
71
3
45/60
Portal
Molecular PT
NSQAP
568
1
10/60
Enrollment Form
NSQAP Data
Submission
568
2
45/60
Portal QC
NSQAP Data
International
Submission
NBS Labs
568
3
45/60
Portal
Biochemical PT
NSQAP Data
Submission
568
3
45/60
Portal
Molecular PT
NSQAP
32
1
10/60
Enrollment Form
NBS Test
NSQAP Data
Manufacturers Submission
32
2
45/60
Portal QC
NSQAP Data
32
3
45/60

Submission
Portal
Biochemical PT
NSQAP Data
Submission
Portal
Molecular PT

3

Jeffrey M. Zirger,
Lead,
Information Collection Review Office,
Office of Scientific Integrity,
Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022-20125 Filed: 9/15/2022 8:45 am; Publication Date: 9/16/2022]

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