Proposed Data Collection Submitted for Public Comment and Recommendations

Federal RegisterOct 2, 2025

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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.

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:

•

Federal eRulemaking Portal: www.regulations.gov.

Follow the instructions for submitting comments.

•

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

www.regulations.gov.

Please note:

Submit all comments through the Federal eRulemaking portal (

www.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; Telephone: 404-639-7570; Email:

omb@cdc.gov.

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.

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

Type of respondent

Form name

Number of

respondents

Number of

responses per

respondent

Average

burden per

response

(in hours)

Total

burden

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 Data Submission Form

AMP Data Submission Form

25/60

45/60

Private Research Lab

AMP Enrollment Section on Data Submission Form

AMP Data Submission Form

25/60

45/60

Routine Clinical Lab

AMP Enrollment Section on Data Submission Form

AMP Data Submission Form

25/60

45/60

CCB AMP for Lipid Standardization Program (LSP)

Academic/University Research Lab

LSP Enrollment Section on Data Submission Form

LSP Data Submission Form

25/60

45/60

Private Research Lab

LSP Enrollment Section on Data Submission Form

LSP Data Submission Form

25/60

45/60

Routine Clinical Lab

LSP Enrollment Section on Data Submission Form

LSP Data Submission Form

25/60

45/60

180

Reference Laboratory Network Programs for Lipid and Hormone

Reference Network Laboratories

CRMLN Enrollment Webpage

CRMLN Data Submission Form

10/60

CCB Chronic Disease Standardization Programs for Clinical Biomarkers

CCB Hormone Standardization (HoST) Programs

Assay Manufacturers

HoSt Enrollment Section on Data Submission Form

HoSt Data Submission Form

30/60

240

(LDT) Lab Developed Tests Manufacturers

HoSt Enrollment Section on Data Submission Form

HoSt Data Submission Form

30/60

200

End-user/Labs

HoSt Enrollment Section on Data Submission Form

HoSt Data Submission Form

30/60

120

CCB Vitamin D Standardization Certification Program (VDSCP)

Assay Manufacturers

VDSCP Enrollment Section on Data Submission Form

VDSCP Data Submission Form

30/60

240

(LDT) Lab Developed Tests Manufacturers

VDSCP Enrollment Section on Data Submission Form

VDSCP Data Submission Form

30/60

200

End-user/Labs

VDSCP Enrollment Section on Data Submission Form

VDSCP Data Submission Form

30/60

120

NBB Vitamin A Laboratory—External Quality Assurance (VITAL-EQA)

Academic/University Research Lab

VITAL-EQA Enrollment Form National

VITAL-EQA Data Submission Form

25/60

45/60

Government/Ministry of Health Lab

VITAL-EQA Enrollment Form International

VITAL-EQA Data Submission Form

25/60

45/60

Private Research Lab

VITAL-EQA Enrollment Form

VITAL-EQA Data Submission Form

25/60

45/60

Clinical Lab

VITAL-EQA Enrollment Form

VITAL-EQA Data Submission Form

25/60

45/60

NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)

Academic/University Research Lab

MPV Folate MBA Enrollment Section on Data Submission Form

MPV Folate MBA Data Submission Form

25/60

45/60

Government/Ministry of Health Lab

MPV Folate MBA Enrollment Section on Data Submission Form

MPV Folate MBA Data Submission Form

25/60

45/60

Private Research Lab

MPV Folate MBA Enrollment Section on Data Submission Form

MPV Folate MBA Data Submission Form

25/60

45/60

Clinical Public Health Lab

MPV Folate MBA Enrollment Section on Data Submission Form

MPV Folate MBA Data Submission Form

25/60

45/60

NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients

Academic/University Research Lab

MPV Micronutrients Enrollment Section on Data Submission Form

MPV Micronutrients Data Submission Form

25/60

45/60

Government/Ministry of Health Lab

MPV Micronutrients Enrollment Section on Data Submission Form

MPV Micronutrients Data Submission Form

25/60

45/60

Private Research Lab

MPV Micronutrients Enrollment Section on Data Submission Form

MPV Micronutrients Data Submission Form

25/60

45/60

Clinical Public Health Lab

MPV Micronutrients Enrollment Section on Data Submission Form

MPV Micronutrients Data Submission Form

25/60

45/60

OATB Biomonitoring Quality Assurance Support Program (BQASP)

State Public Health Labs

BQASP Enrollment Email

BQASP Data Submission Form

5/60

45/60

IRATB Proficiency in Arsenic Speciation (PAsS) Program

Public Health Labs

PAsS Enrollment Form

PAsS Data Submission Form

10/60

IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)

Public Health Labs

EQUIP Enrollment Form

EQUIP Data Submission Form

240

10/60

120

IRATB Lead and Multielement Proficiency (LAMP) Testing Program

Public Health Labs

LAMP Enrollment Form

LAMP Data Submission Form

226

10/60

151

NSMBB Newborn Screening and Quality Assurance Program (NSQAP)

Domestic NBS Labs

NSQAP Enrollment Form

NSQAP Data Submission Portal Quality Control (QC)

NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT

NSQAP Data Submission Portal Molecular PT

10/60

45/60

106

160

International NBS Labs

NSQAP Enrollment Form

NSQAP Data Submission Portal QC

NSQAP Data Submission Portal Biochemical PT

NSQAP Data Submission Portal Molecular PT

568

10/60

45/60

852

1,278

NBS Test Manufacturers

NSQAP Enrollment Form

NSQAP Data Submission Portal QC

NSQAP Data Submission Portal Biochemical PT

NSQAP Data Submission Portal Molecular PT

10/60

45/60

Total

6,674

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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