[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56958-56961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20125]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-22AW]


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),

[[Page 56959]]

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)
    [cir] Accuracy-based Laboratory Monitoring Programs (AMP)
    [cir] Lipid Standardization Program (LSP) for Clinical Biomarkers
    [cir] Cholesterol Reference Method Laboratory Network (CRMLN)
    [cir] Hormone Standardization (HoST) Program
    [cir] Vitamin D Standardization Certification Program (VDSCP)
 Nutrition Biomarkers Branch (NBB)
    [cir] Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
    [cir] Quality Assurance Method Performance Verification (MPV) for 
Folate Microbiologic Assay (MBA)
    [cir] Quality Assurance Method Performance Verification (MPV) for 
Micronutrients
 Organic Analytical Toxicology Branch (OATB)
    [cir] Biomonitoring Quality Assurance Support Program (BQASP)
 Inorganic Radiation and Analytical Toxicology Branch (IRATB)
    [cir] Proficiency in Arsenic Speciation (PAsS) Program
    [cir] Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
    [cir] Lead and Multielement Proficiency (LAMP) Testing Program
 Newborn Screening and Molecular Biology Branch (NSMBB)
    [cir] 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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
                                                                     Number of     responses per  Average burden
          Type of respondent                    Form name           respondents   respondent (in   per response
                                                                                      hours)        (in hours)
----------------------------------------------------------------------------------------------------------------
                             CCB Accuracy-Based Laboratory Monitoring Programs (AMP)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab......  AMP Enrollment Section                10               1           25/60
                                         on Data Submission Form.
                                        AMP Data Submission Form              10               4           45/60
Private Research Lab..................  AMP Enrollment Section                 3               1           25/60
                                         on Data Submission Form.
                                        AMP Data Submission Form               3               4           45/60
Routine Clinical Lab..................  AMP Enrollment Section                20               1           25/60
                                         on Data Submission Form.
                                        AMP Data Submission Form              20               4           45/60
----------------------------------------------------------------------------------------------------------------
                                     CCB Lipid Standardization Program (LSP)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab......  LSP Enrollment Section                20               1           25/60
                                         on Data Submission Form.
                                        LSP Data Submission Form              20               4           45/60
Private Research Lab..................  LSP Enrollment Section                 7               1           25/60
                                         on Data Submission Form.
                                        LSP Data Submission Form               7               4           45/60
Routine Clinical Lab..................  LSP Enrollment Section                40               1           25/60
                                         on Data Submission Form.
                                        LSP Data Submission Form              40               4           45/60
----------------------------------------------------------------------------------------------------------------
                           CCB Cholesterol Reference Method Laboratory Network (CRMLN)
----------------------------------------------------------------------------------------------------------------
CRMLN Network Laboratories............  CRMLN Enrollment Webpage              15               1           10/60

[[Page 56960]]

 
                                        CRMLN Data Submission                 15               2               2
                                         Form.
----------------------------------------------------------------------------------------------------------------
                                   CCB Hormone Standardization (HoST) Program
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers...................  HoSt Enrollment Section               60               1           30/60
                                         on Data Submission Form.
                                        HoSt Data Submission                  60               4               1
                                         Form.
(LDT) Lab Developed Tests               HoSt Enrollment Section               40               1           30/60
 Manufacturers.                          on Data Submission Form.
                                        HoSt Data Submission                  40               4               1
                                         Form.
End-user/Labs.........................  HoSt Enrollment Section               20               1           30/60
                                         on Data Submission Form.
                                        HoSt Data Submission                  20               4               1
                                         Form.
----------------------------------------------------------------------------------------------------------------
                           CCB Vitamin D Standardization Certification Program (VDSCP)
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers...................  VDSCP Enrollment Section              60               1           30/60
                                         on Data Submission Form.
                                        VDSCP Data Submission                 60               4               1
                                         Form.
(LDT) Lab Developed Tests               VDSCP Enrollment Section              40               1           30/60
 Manufacturers.                          on Data Submission Form.
                                        VDSCP Data Submission                 40               4               1
                                         Form.
End-user/Labs.........................  VDSCP Enrollment Section              20               1           30/60
                                         on Data Submission Form.
                                        VDSCP Data Submission                 20               4               1
                                         Form.
----------------------------------------------------------------------------------------------------------------
                        NBB Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab......  VITAL-EQA Enrollment                  30               1           25/60
                                         Form National.
                                        VITAL-EQA Data                        30               2           45/60
                                         Submission Form.
Government/Ministry of Health Lab.....  VITAL-EQA Enrollment                  30               1           25/60
                                         Form International.
                                        VITAL-EQA Data                        30               2           45/60
                                         Submission Form.
Private Research Lab..................  VITAL-EQA Enrollment                  15               1           25/60
                                         Form National.
                                        VITAL-EQA Data                        15               2           45/60
                                         Submission Form.
Clinical Lab..........................  VITAL-EQA Enrollment                  15               1           25/60
                                         Form National.
                                        VITAL-EQA Data                        15               2           45/60
                                         Submission Form.
----------------------------------------------------------------------------------------------------------------
        NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab......  MPV Folate MBA                        15               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Folate MBA Data                   15               4           45/60
                                         Submission Form.
Government/Ministry of Health Lab.....  MPV Folate MBA                        15               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Folate MBA Data                   15               4           45/60
                                         Submission Form.
Private Research Lab..................  MPV Folate MBA                         5               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Folate MBA Data                    5               4           45/60
                                         Submission Form.
Clinical Public Health Lab............  MPV Folate MBA                         5               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Folate MBA Data                    5               4           45/60
                                         Submission Form.
----------------------------------------------------------------------------------------------------------------
                 NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
----------------------------------------------------------------------------------------------------------------
Academic/University Research Lab......  MPV Micronutrients                    20               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Micronutrients Data               20               4           45/60
                                         Submission Form.
Government/Ministry of Health Lab.....  MPV Micronutrients                    20               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Micronutrients Data               20               4           45/60
                                         Submission Form.
Private Research Lab..................  MPV Micronutrients                    10               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Micronutrients Data               10               4           45/60
                                         Submission Form.
Clinical Public Health Lab............  MPV Micronutrients                    10               1           25/60
                                         Enrollment Section on
                                         Data Submission Form.
                                        MPV Micronutrients Data               10               4           45/60
                                         Submission Form.
----------------------------------------------------------------------------------------------------------------
                          OATB Biomonitoring Quality Assurance Support Program (BQASP)
----------------------------------------------------------------------------------------------------------------
State Public Health Labs..............  BQASP Enrollment Email..              10               1            5/60
                                        BQASP Data Submission                 10               1           45/60
                                         Form.
----------------------------------------------------------------------------------------------------------------

[[Page 56961]]

 
                             IRATB Proficiency in Arsenic Speciation (PAsS) Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs....................  PAsS Enrollment Form....              28               1           10/60
                                        PAsS Data Submission                  28               4           10/60
                                         Form.
----------------------------------------------------------------------------------------------------------------
                         IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
----------------------------------------------------------------------------------------------------------------
Public Health Labs....................  EQUIP Enrollment Form...             240               1           10/60
                                        EQUIP Data Submission                240               3           10/60
                                         Form.
----------------------------------------------------------------------------------------------------------------
                         IRATB Lead and Multielement Proficiency (LAMP) Testing Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs....................  LAMP Enrollment Form....             226               1           10/60
                                        LAMP Data Submission                 226               4           10/60
                                         Form.
----------------------------------------------------------------------------------------------------------------
                          NSMBB Newborn Screening and Quality Assurance Program (NSQAP)
----------------------------------------------------------------------------------------------------------------
Domestic NBS Labs.....................  NSQAP Enrollment Form...              71               1           10/60
                                        NSQAP Data Submission                 71               2           45/60
                                         Portal Quality Control
                                         (QC).
                                        NSQAP Data Submission                 71               3           45/60
                                         Portal Biochemical
                                         (Proficiency Testing)
                                         PT.
                                        NSQAP Data Submission                 71               3           45/60
                                         Portal Molecular PT.
International NBS Labs................  NSQAP Enrollment Form...             568               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...              32               1           10/60
                                        NSQAP Data Submission                 32               2           45/60
                                         Portal QC.
                                        NSQAP Data Submission                 32               3           45/60
                                         Portal Biochemical PT.
                                        NSQAP Data Submission                 32               3           45/60
                                         Portal Molecular PT.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-20125 Filed 9-15-22; 8:45 am]
BILLING CODE 4163-18-P