Agency Forms Undergoing Paperwork Reduction Act Review

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Published

February 18, 2026

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

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<title>Federal Register, Volume 91 Issue 32 (Wednesday, February 18, 2026)</title>
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[Federal Register Volume 91, Number 32 (Wednesday, February 18, 2026)]
[Notices]
[Pages 7485-7488]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-26-1389]

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 October 2,
2025 to obtain comments from the public and affected agencies. CDC
received one public comment 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 (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 purpose of this information collection is general purpose
statistics. 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.

[[Page 7486]]

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.
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. Additionally, changes have been made
to the estimated burden and cost table to reflect updated average
hourly wage.
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.
Clinical Chemistry Branch (CCB)--Clinical Standardization Programs
<bullet> Accuracy-based Laboratory Monitoring Programs (AMP), covering
Lipid Standardization Program (LSP) and AMP for Clinical Biomarkers
<bullet> Reference Laboratory Networks for Lipids and Other Chronic
Disease Biomarkers, covering Cholesterol Reference Method Laboratory
Network (CRMLN) and Hormone Reference Networks)
<bullet> Chronic Disease Standardization Programs for Clinical
Biomarkers, covering Hormone Standardization (HoST) Programs and
Vitamin D Standardization Certification Program (VDSCP)

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.
NBB: Changes were 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 change in frequency of reporting. The
MPV reports are now reported once a year rather than quarterly. The
average burden per response was adjusted to account for 1 form
submission per year and the total burden hours and total respondent
costs were adjusted accordingly. The only change to the VITAL-EQA
program entailed the correction of a previous rounding error (12.5 and
22.5 should have been rounded to 13 and 23). The cost to the government
table was updated to reflect respondent updates and personnel changes.
The cost to government for the start-up and survey kits was removed
because they are not part of the MPV Folate MBA QA program and require
no data collection.
CDC has estimated the annualized burden for these 11 programs to be
6,428 hours per year. There is no cost to respondents other than their
time to participate.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response
respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Accuracy-based Laboratory Monitoring Programs (AMP) for Lipids and Other Chronic Disease Biomarkers
----------------------------------------------------------------------------------------------------------------
CCB AMP for Chronic Disease Biomarkers
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab........ AMP Enrollment Section on 10 1 25/60
Data Submission Form.
AMP Data Submission Form... 10 4 45/60
Private Research Lab.................... AMP Enrollment Section on 10 1 25/60
Data Submission Form.
AMP Data Submission Form... 10 4 45/60
Routine Clinical Lab.................... AMP Enrollment Section on 20 1 25/60
Data Submission Form.
AMP Data Submission Form... 20 4 45/60
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CCB AMP for Lipid Standardization Program (LSP)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab........ LSP Enrollment Section on 20 1 25/60
Data Submission Form.
LSP Data Submission Form... 20 4 45/60
Private Research Lab.................... LSP Enrollment Section on 10 1 25/60
Data Submission Form.
LSP Data Submission Form... 10 4 45/60
Routine Clinical Lab.................... LSP Enrollment Section on 60 1 25/60
Data Submission Form.
LSP Data Submission Form... 60 4 45/60
----------------------------------------------------------------------------------------------------------------

[[Page 7487]]

Reference Laboratory Network Programs for Lipid and Hormone
----------------------------------------------------------------------------------------------------------------
Reference Network Laboratories.......... CRMLN Enrollment Webpage... 20 1 10/60
CRMLN Data Submission Form. 20 2 2
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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 on 60 1 30/60
Data Submission Form.
HoSt Data Submission Form.. 60 4 1
(LDT) Lab Developed Tests Manufacturers. HoSt Enrollment Section on 50 1 30/60
Data Submission Form.
HoSt Data Submission Form.. 50 4 1
End-user/Labs........................... HoSt Enrollment Section on 30 1 30/60
Data Submission Form.
HoSt Data Submission Form.. 30 4 1
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CCB Vitamin D Standardization Certification Program (VDSCP)
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers..................... VDSCP Enrollment Section on 60 1 30/60
Data Submission Form.
VDSCP Data Submission Form. 60 4 1
(LDT) Lab Developed Tests Manufacturers. VDSCP Enrollment Section on 50 1 30/60
Data Submission Form.
VDSCP Data Submission Form. 50 4 1
End-user/Labs........................... VDSCP Enrollment Section on 30 1 30/60
Data Submission Form.
VDSCP Data Submission Form. 30 4 1
----------------------------------------------------------------------------------------------------------------
NBB Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab........ VITAL-EQA Enrollment Form 30 1 25/60
National.
VITAL-EQA Data Submission 30 2 45/60
Form.
Government/Ministry of Health Lab....... VITAL-EQA Enrollment Form 30 1 25/60
International.
VITAL-EQA Data Submission 30 2 45/60
Form.
Private Research Lab.................... VITAL-EQA Enrollment Form.. 15 1 25/60
VITAL-EQA Data Submission 15 2 45/60
Form.
Clinical Lab............................ VITAL-EQA Enrollment Form.. 15 1 25/60
VITAL-EQA Data Submission 15 2 45/60
Form.
----------------------------------------------------------------------------------------------------------------
NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab........ MPV Folate MBA Enrollment 10 1 25/60
Section on Data Submission
Form.
MPV Folate MBA Data 10 1 90/60
Submission Form.
Government/Ministry of Health Lab....... MPV Folate MBA Enrollment 10 1 25/60
Section on Data Submission
Form.
MPV Folate MBA Data 10 1 90/60
Submission Form.
Private Research Lab.................... MPV Folate MBA Enrollment 2 1 25/60
Section on Data Submission
Form.
MPV Folate MBA Data 2 1 90/60
Submission Form.
Clinical Public Health Lab.............. MPV Folate MBA Enrollment 2 1 25/60
Section on Data Submission
Form.
MPV Folate MBA Data 2 1 90/60
Submission Form.
----------------------------------------------------------------------------------------------------------------
NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab........ MPV Micronutrients 15 1 25/60
Enrollment Section on Data
Submission Form.
MPV Micronutrients Data 15 1 90/60
Submission Form.
Government/Ministry of Health Lab....... MPV Micronutrients 15 1 25/60
Enrollment Section on Data
Submission Form.
MPV Micronutrients Data 15 1 90/60
Submission Form.
Private Research Lab.................... MPV Micronutrients 7 1 25/60
Enrollment Section on Data
Submission Form.
MPV Micronutrients Data 7 1 90/60
Submission Form.
Clinical Public Health Lab.............. MPV Micronutrients 7 1 25/60
Enrollment Section on Data
Submission Form.
MPV Micronutrients Data 7 1 90/60
Submission Form.
----------------------------------------------------------------------------------------------------------------
OATB Biomonitoring Quality Assurance Support Program (BQASP)
----------------------------------------------------------------------------------------------------------------
State Public Health Labs................ BQASP Enrollment Email..... 10 1 5/60
BQASP Data Submission Form. 10 1 45/60
----------------------------------------------------------------------------------------------------------------
IRATB Proficiency in Arsenic Speciation (PAsS) Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs...................... PAsS Enrollment Form....... 28 1 10/60
PAsS Data Submission Form.. 28 4 10/60
----------------------------------------------------------------------------------------------------------------
IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
----------------------------------------------------------------------------------------------------------------
Public Health Labs...................... EQUIP Enrollment Form...... 240 1 10/60

[[Page 7488]]

EQUIP Data Submission Form. 240 3 10/60
----------------------------------------------------------------------------------------------------------------
IRATB Lead and Multielement Proficiency (LAMP) Testing Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs...................... LAMP Enrollment Form....... 226 1 10/60
LAMP Data Submission Form.. 226 4 10/60
----------------------------------------------------------------------------------------------------------------
NSMBB Newborn Screening and Quality Assurance Program (NSQAP)
----------------------------------------------------------------------------------------------------------------
Domestic NBS Labs....................... NSQAP Enrollment Form...... 3 1 10/60
NSQAP Data Submission 78 2 45/60
Portal Quality Control
(QC).
NSQAP Data Submission 78 3 45/60
Portal Biochemical
(Proficiency Testing) PT.
NSQAP Data Submission 78 3 45/60
Portal Molecular PT.
International NBS Labs.................. NSQAP Enrollment Form...... 44 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...... 3 1 10/60
NSQAP Data Submission 18 2 45/60
Portal QC.
NSQAP Data Submission 18 3 45/60
Portal Biochemical PT.
NSQAP Data Submission 4 3 45/60
Portal Molecular PT.
----------------------------------------------------------------------------------------------------------------

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. 2026-03101 Filed 2-17-26; 8:45 am]
BILLING CODE 4163-18-P

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