Proposed Data Collection Submitted for Public Comment and Recommendations

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Published

December 27, 2021

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

Abstract

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled NCEH DLS Laboratory Quality Assurance Programs. CDC's National Center for Environmental Health (NCEH) Division of Laboratory Science (DLS) provides quality assurance in the form of quality control samples and technical assistance to laboratories to improve analytical accuracy and reliability of tests. Participating laboratories return results to CDC to assess performance.

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<title>Federal Register, Volume 86 Issue 245 (Monday, December 27, 2021)</title>
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[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73280-73283]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28033]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22AW; Docket No. CDC-2021-0126]

Proposed Data Collection Submitted for Public Comment and
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled NCEH DLS Laboratory Quality
Assurance Programs. CDC's National Center for Environmental Health
(NCEH) Division of Laboratory Science (DLS) provides quality assurance
in the form of quality control samples and technical assistance to
laboratories to improve analytical accuracy and reliability of tests.
Participating laboratories return results to CDC to assess performance.

DATES: CDC must receive written comments on or before February 25,
2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0126 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to regulations.gov.
Please note: Submit all comments through the federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
<a href="/cdn-cgi/l/email-protection#9bf4f6f9dbf8fff8b5fcf4ed"><span class="__cf_email__" data-cfemail="16797b745675727538717960">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.

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 CDC 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

[[Page 73281]]

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 QA 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, and thyroid and hormone dysregulation.
The estimated annualized burden hours were determined as follows.
There are 1,720 participating laboratories across the 13 DLS QA
programs. A ``respondent'' refers to a single laboratory 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 burden
for these 13 programs to be 4,293 hours per year.

Estimated Annualized Burden Hours
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Number of Average burden Total
Type of respondent Form name Number of responses per per response burden
respondents respondent (in hours) hours
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CCB Accuracy-based Laboratory Monitoring Programs (AMP)
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Academic/University Research AMP Enrollment and 10 1 25/60 4
Lab. Data Submission
Form.
AMP Enrollment and 10 4 45/60 30
Data Submission
Form.
Private Research Lab........... AMP Enrollment and 3 1 25/60 1
Data Submission
Form.
AMP Enrollment and 3 4 45/60 9
Data Submission
Form.
Routine Clinical Lab........... AMP Enrollment and 20 1 25/60 8
Data Submission
Form.
AMP Enrollment and 20 4 45/60 60
Data Submission
Form.
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CCB Lipid Standardization Program (LSP)
----------------------------------------------------------------------------------------------------------------
Academic/University Research LSP Enrollment and 20 1 25/60 8
Lab. Data Submission
Form.
LSP Enrollment and 20 4 45/60 60
Data Submission
Form.
Private Research Lab........... LSP Enrollment and 7 1 25/60 3
Data Submission
Form.
LSP Enrollment and 7 4 45/60 21
Data Submission
Form.
Routine Clinical Lab........... LSP Enrollment and 40 1 25/60 17
Data Submission
Form.
LSP Enrollment and 40 4 45/60 120
Data Submission
Form.
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CCB Cholesterol Reference Method Laboratory Network (CRMLN)
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CRMLN Network Laboratories..... CRMLN Enrollment 15 1 10/60 3
Email.
CRMLN Data 15 2 2 60
Submission Form.
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CCB Hormone Standardization (HoST) Program
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers............ HoSt Enrollment 60 1 30/60 30
and Data
Submission Form.
HoSt Enrollment 60 4 1 240
and Data
Submission Form.
Lab Developed Tests (LDT) HoSt Enrollment 40 1 30/60 20
Manufacturers. and Data
Submission Form.
HoSt Enrollment 40 4 1 160
and Data
Submission Form.
End-user/Labs.................. HoSt Enrollment 20 1 30/60 10
and Data
Submission Form.
HoSt Enrollment 20 4 1 80
and Data
Submission Form.
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[[Page 73282]]

CCB Vitamin D Standardization Certification Program (VDSCP)
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers............ VDSCP Enrollment 60 1 30/60 30
and Data
Submission Form.
VDSCP Enrollment 60 4 1 240
and Data
Submission Form.
LDT Manufacturers.............. VDSCP Enrollment 40 1 30/60 20
and Data
Submission Form.
VDSCP Enrollment 40 4 1 160
and Data
Submission Form.
End-user/Labs.................. VDSCP Enrollment 20 1 30/60 10
and Data
Submission Form.
VDSCP Enrollment 20 4 1 80
and Data
Submission Form.
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NBB Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research VITAL-EQA 30 1 25/60 13
Lab. Enrollment Form.
Data Submission 30 2 45/60 45
Form.
Government/Ministry of Health VITAL-EQA 30 1 25/60 13
Lab. Enrollment Form
International.
Data Submission 30 2 45/60 45
Form.
Private Research Lab........... VITAL-EQA 15 1 25/60 6
Enrollment Form.
Data Submission 15 2 45/60 23
Form.
Clinical Lab................... VITAL-EQA 15 1 25/60 6
Enrollment Form.
Data Submission 15 2 45/60 23
Form.
----------------------------------------------------------------------------------------------------------------
NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research MPV Folate MBA 15 1 25/60 6
Lab. Enrollment and
Data Submission
Form.
MPV Folate MBA 15 4 45/60 45
Enrollment and
Data Submission
Form.
Government/Ministry of Health MPV Folate MBA 15 1 25/60 6
Lab. Enrollment and
Data Submission
Form.
MPV Folate MBA 15 4 45/60 45
Enrollment and
Data Submission
Form.
Private Research Lab........... MPV Folate MBA 5 1 25/60 2
Enrollment and
Data Submission
Form.
MPV Folate MBA 5 4 45/60 15
Enrollment and
Data Submission
Form.
Clinical Public Health Lab..... MPV Folate MBA 5 1 25/60 2
Enrollment and
Data Submission
Form.
MPV Folate MBA 5 4 45/60 15
Enrollment and
Data Submission
Form.
----------------------------------------------------------------------------------------------------------------
NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
----------------------------------------------------------------------------------------------------------------
Academic/University Research MPV Micronutrients 20 1 25/60 8
Lab. Enrollment and
Data Submission
Form.
MPV Micronutrients 20 4 45/60 60
Enrollment and
Data Submission
Form.
Government/Ministry of Health MPV Micronutrients 20 1 25/60 8
Lab. Enrollment and
Data Submission
Form.
MPV Micronutrients 20 4 45/60 60
Enrollment and
Data Submission
Form.
Private Research Lab........... MPV Micronutrients 10 1 25/60 4
Enrollment and
Data Submission
Form.
MPV Micronutrients 10 4 45/60 30
Enrollment and
Data Submission
Form.
Clinical Public Health Lab..... MPV Micronutrients 10 1 25/60 4
Enrollment and
Data Submission
Form.
MPV Micronutrients 10 4 45/60 30
Enrollment and
Data Submission
Form.
----------------------------------------------------------------------------------------------------------------
OATB Biomonitoring Quality Assurance Support Program (BQASP)
----------------------------------------------------------------------------------------------------------------
State Public Health Labs....... BQASP Enrollment 10 1 5/60 1
Email.

[[Page 73283]]

BQASP Data 10 1 45/60 8
Submission Form.
----------------------------------------------------------------------------------------------------------------
IRATB Proficiency in Arsenic Speciation (PAsS) Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs............. PAsS Enrollment 28 1 10/60 5
Form.
PAsS Data 28 4 10/60 19
Submission Form.
----------------------------------------------------------------------------------------------------------------
IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
----------------------------------------------------------------------------------------------------------------
Public Health Labs............. EQUIP Enrollment 240 1 10/60 41
Form.
EQUIP Data 240 3 10/60 122
Submission Form.
----------------------------------------------------------------------------------------------------------------
IRATB Lead and Multielement Proficiency (LAMP) Testing Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs............. LAMP Enrollment 226 1 10/60 39
Form.
LAMP Data 226 4 10/60 154
Submission Form.
----------------------------------------------------------------------------------------------------------------
NSMBB Newborn Screening and Quality Assurance Program (NSQAP)
----------------------------------------------------------------------------------------------------------------
Domestic NBS Labs.............. NSQAP Enrollment 71 1 10/60 12
Form.
NSQAP Data 71 2 45/60 107
Submission Portal
Quality Control
(QC).
NSQAP Data 71 3 45/60 160
Submission Portal
Biochemical &
Molecular
Proficiency Tests
(PT).
International NBS Labs......... NSQAP Enrollment 568 1 10/60 95
Form.
NSQAP Data 568 2 45/60 129
Submission Portal
QC.
NSQAP Data 568 3 45/60 1,278
Submission Portal
Biochemical &
Molecular PT.
NBS Test Manufacturers......... NSQAP Enrollment 32 1 10/60 5
Form.
NSQAP Data 32 2 45/60 48
Submission Portal
QC.
NSQAP Data 32 3 45/60 72
Submission Portal
Biochemical &
Molecular PT.
--------------------------------------------------------------------------------
Total...................... .................. 1,720 .............. .............. 4,293
----------------------------------------------------------------------------------------------------------------

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-28033 Filed 12-23-21; 8:45 am]
BILLING CODE 4163-18-P

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