Notice2025-19252
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
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Published
October 2, 2025
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 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. The 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, allowing CDC to assess performance.
Full Text
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<title>Federal Register, Volume 90 Issue 189 (Thursday, October 2, 2025)</title>
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[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Notices]
[Pages 47756-47759]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19252]
[[Page 47756]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-1389; Docket No. CDC-2025-0586]
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 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. The 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, allowing CDC to
assess performance.
DATES: CDC must receive written comments on or before December 1, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0586 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#f59a9897b5969196db929a83"><span class="__cf_email__" data-cfemail="6f00020d2f0c0b0c41080019">[email 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 (OMB Control No. 0920-1389,
Exp. 3/31/2026)--Revision--National Center for Environmental Health
(NCEH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The CDC Division of Laboratory Science (DLS) Quality Assurance (QA)
and standardization programs operate out of multiple laboratories. They
establish baseline measurements and provide calibration and/or 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 and standardization program that fits their needs (i.e.: external
quality assurance/performance assessment, proficiency testing,
accuracy-based monitoring, or standardization/harmonization).
There are two points of information collection for participation in
any of the DLS QA and standardization programs. The first is an
enrollment/sample request form and the second is a result reporting
form. For programs with multiple rounds of QA each year (when CDC sends
materials to a participating laboratory to use in their quality
assurance testing), one enrollment form is collected for each year or
just one time at onset of request/participation and a result reporting
form is returned to CDC for each panel of samples sent and tested.
The collection of general laboratory information upon enrollment
application occurs via email, web-inquiry, or pdf form and includes
information such as lab name or identifier, shipping address, assay
information, and analytes of interest. The request/enrollment form will
assist the CDC QA and standardization programs to develop and ship
desired materials for laboratories' QA and standardization activities.
Participant data submission forms (some provided to participants
with some pre-populated information from the enrollment form) request
information on measurement results and assay characteristics (test
instrument and configuration/assay description, calibrators, and
reagent information), as well as sample result information (date of
analysis, values), and laboratory activities (expertise, relevant
research, providing reference materials to other laboratories). The
collection of laboratory results following participant receipt and use
of CDC quality control materials allows the CDC QA program to provide
each laboratory participant with statistical reports that evaluate the
performance of their analyses and methods. These reports are provided
back to participating laboratories to adjust and improve their tests,
and to provide expertise and TA as needed. CDC also uses the results to
assess and monitor trends of laboratory measurements over time, thus
contributing to the reliability and consistency of high-quality
laboratory testing for analytes of significant public health and
clinical decision-making.
[[Page 47757]]
DLS provides laboratory support that improves the detection,
diagnosis, treatment, and prevention of environmental, tobacco-related,
nutritional, newborn, selected chronic, and infectious diseases. CDC's
DLS Laboratory QA and Standardization Programs support these efforts by
improving the analytical accuracy and reliability of high priority
tests used in patient care, research, and public health. A key
component of quality assurance for laboratory testing is monitoring and
evaluating the performance of tests in clinical, research, commercial,
and public health laboratories. Some of the programs, like Accuracy-
based Laboratory Monitoring Programs (AMP) for Clinical Biomarkers,
include established assessment of analytical accuracy of measurements
among participating laboratories over time, while other programs
provide information about the analytical performance of a laboratory at
a point in time. The QA programs in DLS are foundational services
provided to meet CDC and DLS objectives and have received funding and
support for years, and for some, decades.
This is a Revision request for a currently approved collection,
under OMB Control No. 0920-1389. CDC requests the following changes to
the activities and estimated burden associated with the data
collection:
Clinical Chemistry Branch (CCB): Programs have been consolidated to
limit redundancies in efforts and enhance paper reduction. These
changes are editorial in nature and do not impact the total burden on
the public. Based on feedback from program respondents, the term
Enrollment Forms will be changed to Request Form, as not all requests
are from program participants. Additional changes are made to the
burden table to reflect the number of additional participants for the
different programs under the CCB Clinical Standardization Programs.
Nutrition Biomarkers Branch (NBB): Changes are made to the burden
table to reflect the number of respondents based on historical data for
the number of participants in the two NBB MPV programs, and a
correction to burden in the VITAL-EQA program.
CDC requests OMB approval for an estimated 6,674 annual burden
hours. There is no additional cost to respondents other than their time
to participate.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondent Form name respondents responses per response burden
respondent (in hours) hours
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Accuracy-based Laboratory Monitoring Programs (AMP) for Lipids and Other Chronic Disease Biomarkers
CCB AMP for Chronic Disease Biomarkers
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Academic/University Research Lab AMP Enrollment Section 10 1 25/60 4
on Data Submission Form. 10 4 45/60 30
AMP Data Submission Form
Private Research Lab............ AMP Enrollment Section 10 1 25/60 4
on Data Submission Form. 10 4 45/60 30
AMP Data Submission Form
Routine Clinical Lab............ AMP Enrollment Section 20 1 25/60 8
on Data Submission Form. 20 4 45/60 60
AMP Data Submission Form
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CCB AMP for Lipid Standardization Program (LSP)
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Academic/University Research Lab LSP Enrollment Section 20 1 25/60 8
on Data Submission Form. 20 4 45/60 60
LSP Data Submission Form
Private Research Lab............ LSP Enrollment Section 10 1 25/60 4
on Data Submission Form. 10 4 45/60 30
LSP Data Submission Form
Routine Clinical Lab............ LSP Enrollment Section 60 1 25/60 25
on Data Submission Form. 60 4 45/60 180
LSP Data Submission Form
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Reference Laboratory Network Programs for Lipid and Hormone
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Reference Network Laboratories.. CRMLN Enrollment Webpage 20 1 10/60 3
CRMLN Data Submission 20 2 2 80
Form.
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CCB Chronic Disease Standardization Programs for Clinical Biomarkers
CCB Hormone Standardization (HoST) Programs
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Assay Manufacturers............. HoSt Enrollment Section 60 1 30/60 30
on Data Submission Form. 60 4 1 240
HoSt Data Submission
Form.
(LDT) Lab Developed Tests HoSt Enrollment Section 50 1 30/60 25
Manufacturers. on Data Submission Form. 50 4 1 200
HoSt Data Submission
Form.
End-user/Labs................... HoSt Enrollment Section 30 1 30/60 15
on Data Submission Form. 30 4 1 120
HoSt Data Submission
Form.
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CCB Vitamin D Standardization Certification Program (VDSCP)
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Assay Manufacturers............. VDSCP Enrollment Section 60 1 30/60 30
on Data Submission Form. 60 4 1 240
VDSCP Data Submission
Form.
(LDT) Lab Developed Tests VDSCP Enrollment Section 50 1 30/60 25
Manufacturers. on Data Submission Form. 50 4 1 200
VDSCP Data Submission
Form.
End-user/Labs................... VDSCP Enrollment Section 30 1 30/60 15
on Data Submission Form. 30 4 1 120
VDSCP Data Submission
Form.
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NBB Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
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Academic/University Research Lab VITAL-EQA Enrollment 30 1 25/60 13
Form National. 30 2 45/60 45
VITAL-EQA Data
Submission Form.
Government/Ministry of Health VITAL-EQA Enrollment 30 1 25/60 13
Lab. Form International. 30 2 45/60 45
VITAL-EQA Data
Submission Form.
Private Research Lab............ VITAL-EQA Enrollment 15 1 25/60 6
Form. 15 2 45/60 22
VITAL-EQA Data
Submission Form.
Clinical Lab.................... VITAL-EQA Enrollment 15 1 25/60 6
Form. 15 2 45/60 22
VITAL-EQA Data
Submission Form.
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NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)
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Academic/University Research Lab MPV Folate MBA 10 1 25/60 4
Enrollment Section on 10 1 45/60 30
Data Submission Form.
MPV Folate MBA Data
Submission Form.
Government/Ministry of Health MPV Folate MBA 10 1 25/60 4
Lab. Enrollment Section on 10 1 45/60 30
Data Submission Form.
MPV Folate MBA Data
Submission Form.
Private Research Lab............ MPV Folate MBA 2 1 25/60 1
Enrollment Section on 2 1 45/60 6
Data Submission Form.
MPV Folate MBA Data
Submission Form.
Clinical Public Health Lab...... MPV Folate MBA 2 1 25/60 1
Enrollment Section on 2 1 45/60 6
Data Submission Form.
MPV Folate MBA Data
Submission Form.
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NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
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Academic/University Research Lab MPV Micronutrients 15 1 25/60 6
Enrollment Section on 15 1 45/60 45
Data Submission Form.
MPV Micronutrients Data
Submission Form.
Government/Ministry of Health MPV Micronutrients 15 1 25/60 6
Lab. Enrollment Section on 15 1 45/60 45
Data Submission Form.
MPV Micronutrients Data
Submission Form.
Private Research Lab............ MPV Micronutrients 7 1 25/60 3
Enrollment Section on 7 1 45/60 21
Data Submission Form.
MPV Micronutrients Data
Submission Form.
Clinical Public Health Lab...... MPV Micronutrients 7 1 25/60 3
Enrollment Section on 7 1 45/60 21
Data Submission Form.
MPV Micronutrients Data
Submission Form.
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OATB Biomonitoring Quality Assurance Support Program (BQASP)
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State Public Health Labs........ BQASP Enrollment Email.. 10 1 5/60 1
BQASP Data Submission 10 1 45/60 8
Form.
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IRATB Proficiency in Arsenic Speciation (PAsS) Program
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Public Health Labs.............. PAsS Enrollment Form.... 28 1 10/60 5
PAsS Data Submission 28 4 10/60 19
Form.
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IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
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Public Health Labs.............. EQUIP Enrollment Form... 240 1 10/60 40
EQUIP Data Submission 240 3 10/60 120
Form.
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IRATB Lead and Multielement Proficiency (LAMP) Testing Program
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Public Health Labs.............. LAMP Enrollment Form.... 226 1 10/60 38
LAMP Data Submission 226 4 10/60 151
Form.
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NSMBB Newborn Screening and Quality Assurance Program (NSQAP)
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Domestic NBS Labs............... NSQAP Enrollment Form... 71 1 10/60 12
NSQAP Data Submission 71 2 45/60 106
Portal Quality Control 71 3 45/60 160
(QC). 71 3 45/60 160
NSQAP Data Submission
Portal Biochemical
(Proficiency Testing)
PT.
NSQAP Data Submission
Portal Molecular PT.
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[[Page 47759]]
International NBS Labs.......... NSQAP Enrollment Form... 568 1 10/60 95
NSQAP Data Submission 568 2 45/60 852
Portal QC. 568 3 45/60 1,278
NSQAP Data Submission 568 3 45/60 1,278
Portal Biochemical PT.
NSQAP Data Submission
Portal Molecular PT.
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NBS Test Manufacturers.......... NSQAP Enrollment Form... 32 1 10/60 5
NSQAP Data Submission 32 2 45/60 48
Portal QC. 32 3 45/60 72
NSQAP Data Submission 32 3 45/60 72
Portal Biochemical PT.
NSQAP Data Submission
Portal Molecular PT.
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Total....................... ........................ .............. .............. ........... 6,674
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-19252 Filed 10-1-25; 8:45 am]
BILLING CODE 4163-18-P
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