# 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 *www.reginfo.gov/public/do/PRAMain.* 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. 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**
• Accuracy-based Laboratory Monitoring Programs (AMP), covering Lipid Standardization Program (LSP) and AMP for Clinical Biomarkers
• Reference Laboratory Networks for Lipids and Other Chronic Disease Biomarkers, covering Cholesterol Reference Method Laboratory Network (CRMLN) and Hormone Reference Networks)
• 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.
| Type of respondent | Form name | Number of | Number of | Average |
| --- | --- | --- | --- | --- |
| | | | | |
| | | | | |
| Academic/University Research Lab | AMP Enrollment Section on Data Submission Form | 10 | 1 | 25/60 |
| | AMP Data Submission Form | 10 | 4 | 45/60 |
| Private Research Lab | AMP Enrollment Section on Data Submission Form | 10 | 1 | 25/60 |
| | AMP Data Submission Form | 10 | 4 | 45/60 |
| Routine Clinical Lab | AMP Enrollment Section on Data Submission Form | 20 | 1 | 25/60 |
| | AMP Data Submission Form | 20 | 4 | 45/60 |
| | | | | |
| Academic/University Research Lab | LSP Enrollment Section on Data Submission Form | 20 | 1 | 25/60 |
| | LSP Data Submission Form | 20 | 4 | 45/60 |
| Private Research Lab | LSP Enrollment Section on Data Submission Form | 10 | 1 | 25/60 |
| | LSP Data Submission Form | 10 | 4 | 45/60 |
| Routine Clinical Lab | LSP Enrollment Section on Data Submission Form | 60 | 1 | 25/60 |
| | LSP Data Submission Form | 60 | 4 | 45/60 |
| | | | | |
| Reference Network Laboratories | CRMLN Enrollment Webpage | 20 | 1 | 10/60 |
| | CRMLN Data Submission Form | 20 | 2 | 2 |
| | | | | |
| | | | | |
| Assay Manufacturers | HoSt Enrollment Section on Data Submission Form | 60 | 1 | 30/60 |
| | HoSt Data Submission Form | 60 | 4 | 1 |
| (LDT) Lab Developed Tests Manufacturers | HoSt Enrollment Section on Data Submission Form | 50 | 1 | 30/60 |
| | HoSt Data Submission Form | 50 | 4 | 1 |
| End-user/Labs | HoSt Enrollment Section on Data Submission Form | 30 | 1 | 30/60 |
| | HoSt Data Submission Form | 30 | 4 | 1 |
| | | | | |
| Assay Manufacturers | VDSCP Enrollment Section on Data Submission Form | 60 | 1 | 30/60 |
| | VDSCP Data Submission Form | 60 | 4 | 1 |
| (LDT) Lab Developed Tests Manufacturers | VDSCP Enrollment Section on Data Submission Form | 50 | 1 | 30/60 |
| | VDSCP Data Submission Form | 50 | 4 | 1 |
| End-user/Labs | VDSCP Enrollment Section on Data Submission Form | 30 | 1 | 30/60 |
| | VDSCP Data Submission Form | 30 | 4 | 1 |
| | | | | |
| Academic/University Research Lab | VITAL-EQA Enrollment Form National | 30 | 1 | 25/60 |
| | VITAL-EQA Data Submission Form | 30 | 2 | 45/60 |
| Government/Ministry of Health Lab | VITAL-EQA Enrollment Form International | 30 | 1 | 25/60 |
| | VITAL-EQA Data Submission Form | 30 | 2 | 45/60 |
| Private Research Lab | VITAL-EQA Enrollment Form | 15 | 1 | 25/60 |
| | VITAL-EQA Data Submission Form | 15 | 2 | 45/60 |
| Clinical Lab | VITAL-EQA Enrollment Form | 15 | 1 | 25/60 |
| | VITAL-EQA Data Submission Form | 15 | 2 | 45/60 |
| | | | | |
| Academic/University Research Lab | MPV Folate MBA Enrollment Section on Data Submission Form | 10 | 1 | 25/60 |
| | MPV Folate MBA Data Submission Form | 10 | 1 | 90/60 |
| Government/Ministry of Health Lab | MPV Folate MBA Enrollment Section on Data Submission Form | 10 | 1 | 25/60 |
| | MPV Folate MBA Data Submission Form | 10 | 1 | 90/60 |
| Private Research Lab | MPV Folate MBA Enrollment Section on Data Submission Form | 2 | 1 | 25/60 |
| | MPV Folate MBA Data Submission Form | 2 | 1 | 90/60 |
| Clinical Public Health Lab | MPV Folate MBA Enrollment Section on Data Submission Form | 2 | 1 | 25/60 |
| | MPV Folate MBA Data Submission Form | 2 | 1 | 90/60 |
| | | | | |
| Academic/University Research Lab | MPV Micronutrients Enrollment Section on Data Submission Form | 15 | 1 | 25/60 |
| | MPV Micronutrients Data Submission Form | 15 | 1 | 90/60 |
| Government/Ministry of Health Lab | MPV Micronutrients Enrollment Section on Data Submission Form | 15 | 1 | 25/60 |
| | MPV Micronutrients Data Submission Form | 15 | 1 | 90/60 |
| Private Research Lab | MPV Micronutrients Enrollment Section on Data Submission Form | 7 | 1 | 25/60 |
| | MPV Micronutrients Data Submission Form | 7 | 1 | 90/60 |
| Clinical Public Health Lab | MPV Micronutrients Enrollment Section on Data Submission Form | 7 | 1 | 25/60 |
| | MPV Micronutrients Data Submission Form | 7 | 1 | 90/60 |
| | | | | |
| State Public Health Labs | BQASP Enrollment Email | 10 | 1 | 5/60 |
| | BQASP Data Submission Form | 10 | 1 | 45/60 |
| | | | | |
| Public Health Labs | PAsS Enrollment Form | 28 | 1 | 10/60 |
| | PAsS Data Submission Form | 28 | 4 | 10/60 |
| | | | | |
| Public Health Labs | EQUIP Enrollment Form | 240 | 1 | 10/60 |
| | EQUIP Data Submission Form | 240 | 3 | 10/60 |
| | | | | |
| Public Health Labs | LAMP Enrollment Form | 226 | 1 | 10/60 |
| | LAMP Data Submission Form | 226 | 4 | 10/60 |
| | | | | |
| Domestic NBS Labs | NSQAP Enrollment Form | 3 | 1 | 10/60 |
| | NSQAP Data Submission Portal Quality Control (QC) | 78 | 2 | 45/60 |
| | NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT | 78 | 3 | 45/60 |
| | NSQAP Data Submission Portal Molecular PT | 78 | 3 | 45/60 |
| International NBS Labs | NSQAP Enrollment Form | 44 | 1 | 10/60 |
| | NSQAP Data Submission Portal QC | 568 | 2 | 45/60 |
| | NSQAP Data Submission Portal Biochemical PT | 568 | 3 | 45/60 |
| | NSQAP Data Submission Portal Molecular PT | 568 | 3 | 45/60 |
| NBS Test Manufacturers | NSQAP Enrollment Form | 3 | 1 | 10/60 |
| | NSQAP Data Submission Portal QC | 18 | 2 | 45/60 |
| | NSQAP Data Submission Portal Biochemical PT | 18 | 3 | 45/60 |
| | NSQAP Data Submission Portal Molecular PT | 4 | 3 | 45/60 |
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.