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 December 27, 2021, to obtain comments from the public and affected agencies. CDC received four non-substantive comments 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—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 Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH), 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 improving and/or standardizing test performance.

• Clinical Chemistry Branch (CCB)

○ Accuracy-based Laboratory Monitoring Programs (AMP)

○ Lipid Standardization Program (LSP) for Clinical Biomarkers

○ Cholesterol Reference Method Laboratory Network (CRMLN)

○ Hormone Standardization (HoST) Program

○ Vitamin D Standardization Certification Program (VDSCP)

• Nutrition Biomarkers Branch (NBB)

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

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

○ Quality Assurance Method Performance Verification (MPV) for Micronutrients

• Organic Analytical Toxicology Branch (OATB)

○ Biomonitoring Quality Assurance Support Program (BQASP)

• Inorganic Radiation and Analytical Toxicology Branch (IRATB)

○ Proficiency in Arsenic Speciation (PAsS) Program

○ Ensuring the Quality of Urinary Iodine Procedures (EQUIP)

○ Lead and Multielement Proficiency (LAMP) Testing Program

• Newborn Screening and Molecular Biology Branch (NSMBB)

○ Newborn Screening and Quality Assurance Program (NSQAP)

All 13 CDC quality assurance 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, thyroid and hormone dysregulation.

The estimated annualized burden hours were determined, as follows. The respondents are participating laboratories that are 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 time burden for these 13 programs to be 6,513 hours per year. The annualized number of responses are estimated as 10,804 submissions to NCEH DLS. NCEH is requesting a three-year Paperwork Reduction (PRA) Act Clearance. There are no costs to the respondents other than their time.