Agency Forms Undergoing Paperwork Reduction Act Review

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Published

September 16, 2022

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

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<title>Federal Register, Volume 87 Issue 179 (Friday, September 16, 2022)</title>
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[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56958-56961]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20125]

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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 non-substantive 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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),

[[Page 56959]]

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, accuracy-based 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.
<bullet> Clinical Chemistry Branch (CCB)
[cir] Accuracy-based Laboratory Monitoring Programs (AMP)
[cir] Lipid Standardization Program (LSP) for Clinical Biomarkers
[cir] Cholesterol Reference Method Laboratory Network (CRMLN)
[cir] Hormone Standardization (HoST) Program
[cir] Vitamin D Standardization Certification Program (VDSCP)
<bullet> Nutrition Biomarkers Branch (NBB)
[cir] Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
[cir] Quality Assurance Method Performance Verification (MPV) for
Folate Microbiologic Assay (MBA)
[cir] Quality Assurance Method Performance Verification (MPV) for
Micronutrients
<bullet> Organic Analytical Toxicology Branch (OATB)
[cir] Biomonitoring Quality Assurance Support Program (BQASP)
<bullet> Inorganic Radiation and Analytical Toxicology Branch (IRATB)
[cir] Proficiency in Arsenic Speciation (PAsS) Program
[cir] Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
[cir] Lead and Multielement Proficiency (LAMP) Testing Program
<bullet> Newborn Screening and Molecular Biology Branch (NSMBB)
[cir] 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
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Average burden
Type of respondent Form name respondents respondent (in per response
hours) (in hours)
----------------------------------------------------------------------------------------------------------------
CCB Accuracy-Based Laboratory Monitoring Programs (AMP)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab...... AMP Enrollment Section 10 1 25/60
on Data Submission Form.
AMP Data Submission Form 10 4 45/60
Private Research Lab.................. AMP Enrollment Section 3 1 25/60
on Data Submission Form.
AMP Data Submission Form 3 4 45/60
Routine Clinical Lab.................. AMP Enrollment Section 20 1 25/60
on Data Submission Form.
AMP Data Submission Form 20 4 45/60
----------------------------------------------------------------------------------------------------------------
CCB Lipid Standardization Program (LSP)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab...... LSP Enrollment Section 20 1 25/60
on Data Submission Form.
LSP Data Submission Form 20 4 45/60
Private Research Lab.................. LSP Enrollment Section 7 1 25/60
on Data Submission Form.
LSP Data Submission Form 7 4 45/60
Routine Clinical Lab.................. LSP Enrollment Section 40 1 25/60
on Data Submission Form.
LSP Data Submission Form 40 4 45/60
----------------------------------------------------------------------------------------------------------------
CCB Cholesterol Reference Method Laboratory Network (CRMLN)
----------------------------------------------------------------------------------------------------------------
CRMLN Network Laboratories............ CRMLN Enrollment Webpage 15 1 10/60

[[Page 56960]]

CRMLN Data Submission 15 2 2
Form.
----------------------------------------------------------------------------------------------------------------
CCB Hormone Standardization (HoST) Program
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers................... HoSt Enrollment Section 60 1 30/60
on Data Submission Form.
HoSt Data Submission 60 4 1
Form.
(LDT) Lab Developed Tests HoSt Enrollment Section 40 1 30/60
Manufacturers. on Data Submission Form.
HoSt Data Submission 40 4 1
Form.
End-user/Labs......................... HoSt Enrollment Section 20 1 30/60
on Data Submission Form.
HoSt Data Submission 20 4 1
Form.
----------------------------------------------------------------------------------------------------------------
CCB Vitamin D Standardization Certification Program (VDSCP)
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers................... VDSCP Enrollment Section 60 1 30/60
on Data Submission Form.
VDSCP Data Submission 60 4 1
Form.
(LDT) Lab Developed Tests VDSCP Enrollment Section 40 1 30/60
Manufacturers. on Data Submission Form.
VDSCP Data Submission 40 4 1
Form.
End-user/Labs......................... VDSCP Enrollment Section 20 1 30/60
on Data Submission Form.
VDSCP Data Submission 20 4 1
Form.
----------------------------------------------------------------------------------------------------------------
NBB Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab...... VITAL-EQA Enrollment 30 1 25/60
Form National.
VITAL-EQA Data 30 2 45/60
Submission Form.
Government/Ministry of Health Lab..... VITAL-EQA Enrollment 30 1 25/60
Form International.
VITAL-EQA Data 30 2 45/60
Submission Form.
Private Research Lab.................. VITAL-EQA Enrollment 15 1 25/60
Form National.
VITAL-EQA Data 15 2 45/60
Submission Form.
Clinical Lab.......................... VITAL-EQA Enrollment 15 1 25/60
Form National.
VITAL-EQA Data 15 2 45/60
Submission Form.
----------------------------------------------------------------------------------------------------------------
NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab...... MPV Folate MBA 15 1 25/60
Enrollment Section on
Data Submission Form.
MPV Folate MBA Data 15 4 45/60
Submission Form.
Government/Ministry of Health Lab..... MPV Folate MBA 15 1 25/60
Enrollment Section on
Data Submission Form.
MPV Folate MBA Data 15 4 45/60
Submission Form.
Private Research Lab.................. MPV Folate MBA 5 1 25/60
Enrollment Section on
Data Submission Form.
MPV Folate MBA Data 5 4 45/60
Submission Form.
Clinical Public Health Lab............ MPV Folate MBA 5 1 25/60
Enrollment Section on
Data Submission Form.
MPV Folate MBA Data 5 4 45/60
Submission Form.
----------------------------------------------------------------------------------------------------------------
NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab...... MPV Micronutrients 20 1 25/60
Enrollment Section on
Data Submission Form.
MPV Micronutrients Data 20 4 45/60
Submission Form.
Government/Ministry of Health Lab..... MPV Micronutrients 20 1 25/60
Enrollment Section on
Data Submission Form.
MPV Micronutrients Data 20 4 45/60
Submission Form.
Private Research Lab.................. MPV Micronutrients 10 1 25/60
Enrollment Section on
Data Submission Form.
MPV Micronutrients Data 10 4 45/60
Submission Form.
Clinical Public Health Lab............ MPV Micronutrients 10 1 25/60
Enrollment Section on
Data Submission Form.
MPV Micronutrients Data 10 4 45/60
Submission Form.
----------------------------------------------------------------------------------------------------------------
OATB Biomonitoring Quality Assurance Support Program (BQASP)
----------------------------------------------------------------------------------------------------------------
State Public Health Labs.............. BQASP Enrollment Email.. 10 1 5/60
BQASP Data Submission 10 1 45/60
Form.
----------------------------------------------------------------------------------------------------------------

[[Page 56961]]

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

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 9-15-22; 8:45 am]
BILLING CODE 4163-18-P

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