[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73280-73283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22AW; Docket No. CDC-2021-0126]


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.

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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 proposed and/or 
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. CDC's National Center for Environmental Health 
(NCEH) 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. 
Participating laboratories return results to CDC to assess performance.

DATES: CDC must receive written comments on or before February 25, 
2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0126 by any of the following methods:
     Federal eRulemaking Portal: 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 regulations.gov.
    Please note: Submit all comments through the federal eRulemaking 
portal (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; phone: 404-639-7570; Email: 
[email protected].

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--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 CDC 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

[[Page 73281]]

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 QA 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, and thyroid and hormone dysregulation.
    The estimated annualized burden hours were determined as follows. 
There are 1,720 participating laboratories across the 13 DLS QA 
programs. A ``respondent'' refers to a single laboratory 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 burden 
for these 13 programs to be 4,293 hours per year.

                                        Estimated Annualized Burden Hours
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                                                                        Number of    Average burden     Total
       Type of respondent             Form name         Number of     responses per   per response      burden
                                                       respondents     respondent      (in hours)       hours
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                             CCB Accuracy-based Laboratory Monitoring Programs (AMP)
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Academic/University Research     AMP Enrollment and              10               1           25/60            4
 Lab.                             Data Submission
                                  Form.
                                 AMP Enrollment and              10               4           45/60           30
                                  Data Submission
                                  Form.
Private Research Lab...........  AMP Enrollment and               3               1           25/60            1
                                  Data Submission
                                  Form.
                                 AMP Enrollment and               3               4           45/60            9
                                  Data Submission
                                  Form.
Routine Clinical Lab...........  AMP Enrollment and              20               1           25/60            8
                                  Data Submission
                                  Form.
                                 AMP Enrollment and              20               4           45/60           60
                                  Data Submission
                                  Form.
----------------------------------------------------------------------------------------------------------------
                                     CCB Lipid Standardization Program (LSP)
----------------------------------------------------------------------------------------------------------------
Academic/University Research     LSP Enrollment and              20               1           25/60            8
 Lab.                             Data Submission
                                  Form.
                                 LSP Enrollment and              20               4           45/60           60
                                  Data Submission
                                  Form.
Private Research Lab...........  LSP Enrollment and               7               1           25/60            3
                                  Data Submission
                                  Form.
                                 LSP Enrollment and               7               4           45/60           21
                                  Data Submission
                                  Form.
Routine Clinical Lab...........  LSP Enrollment and              40               1           25/60           17
                                  Data Submission
                                  Form.
                                 LSP Enrollment and              40               4           45/60          120
                                  Data Submission
                                  Form.
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                           CCB Cholesterol Reference Method Laboratory Network (CRMLN)
----------------------------------------------------------------------------------------------------------------
CRMLN Network Laboratories.....  CRMLN Enrollment                15               1           10/60            3
                                  Email.
                                 CRMLN Data                      15               2               2           60
                                  Submission Form.
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                                   CCB Hormone Standardization (HoST) Program
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers............  HoSt Enrollment                 60               1           30/60           30
                                  and Data
                                  Submission Form.
                                 HoSt Enrollment                 60               4               1          240
                                  and Data
                                  Submission Form.
Lab Developed Tests (LDT)        HoSt Enrollment                 40               1           30/60           20
 Manufacturers.                   and Data
                                  Submission Form.
                                 HoSt Enrollment                 40               4               1          160
                                  and Data
                                  Submission Form.
End-user/Labs..................  HoSt Enrollment                 20               1           30/60           10
                                  and Data
                                  Submission Form.
                                 HoSt Enrollment                 20               4               1           80
                                  and Data
                                  Submission Form.
----------------------------------------------------------------------------------------------------------------

[[Page 73282]]

 
                           CCB Vitamin D Standardization Certification Program (VDSCP)
----------------------------------------------------------------------------------------------------------------
Assay Manufacturers............  VDSCP Enrollment                60               1           30/60           30
                                  and Data
                                  Submission Form.
                                 VDSCP Enrollment                60               4               1          240
                                  and Data
                                  Submission Form.
LDT Manufacturers..............  VDSCP Enrollment                40               1           30/60           20
                                  and Data
                                  Submission Form.
                                 VDSCP Enrollment                40               4               1          160
                                  and Data
                                  Submission Form.
End-user/Labs..................  VDSCP Enrollment                20               1           30/60           10
                                  and Data
                                  Submission Form.
                                 VDSCP Enrollment                20               4               1           80
                                  and Data
                                  Submission Form.
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                        NBB Vitamin A Laboratory--External Quality Assurance (VITAL-EQA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research     VITAL-EQA                       30               1           25/60           13
 Lab.                             Enrollment Form.
                                 Data Submission                 30               2           45/60           45
                                  Form.
Government/Ministry of Health    VITAL-EQA                       30               1           25/60           13
 Lab.                             Enrollment Form
                                  International.
                                 Data Submission                 30               2           45/60           45
                                  Form.
Private Research Lab...........  VITAL-EQA                       15               1           25/60            6
                                  Enrollment Form.
                                 Data Submission                 15               2           45/60           23
                                  Form.
Clinical Lab...................  VITAL-EQA                       15               1           25/60            6
                                  Enrollment Form.
                                 Data Submission                 15               2           45/60           23
                                  Form.
----------------------------------------------------------------------------------------------------------------
        NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)
----------------------------------------------------------------------------------------------------------------
Academic/University Research     MPV Folate MBA                  15               1           25/60            6
 Lab.                             Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Folate MBA                  15               4           45/60           45
                                  Enrollment and
                                  Data Submission
                                  Form.
Government/Ministry of Health    MPV Folate MBA                  15               1           25/60            6
 Lab.                             Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Folate MBA                  15               4           45/60           45
                                  Enrollment and
                                  Data Submission
                                  Form.
Private Research Lab...........  MPV Folate MBA                   5               1           25/60            2
                                  Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Folate MBA                   5               4           45/60           15
                                  Enrollment and
                                  Data Submission
                                  Form.
Clinical Public Health Lab.....  MPV Folate MBA                   5               1           25/60            2
                                  Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Folate MBA                   5               4           45/60           15
                                  Enrollment and
                                  Data Submission
                                  Form.
----------------------------------------------------------------------------------------------------------------
                 NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
----------------------------------------------------------------------------------------------------------------
Academic/University Research     MPV Micronutrients              20               1           25/60            8
 Lab.                             Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Micronutrients              20               4           45/60           60
                                  Enrollment and
                                  Data Submission
                                  Form.
Government/Ministry of Health    MPV Micronutrients              20               1           25/60            8
 Lab.                             Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Micronutrients              20               4           45/60           60
                                  Enrollment and
                                  Data Submission
                                  Form.
Private Research Lab...........  MPV Micronutrients              10               1           25/60            4
                                  Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Micronutrients              10               4           45/60           30
                                  Enrollment and
                                  Data Submission
                                  Form.
Clinical Public Health Lab.....  MPV Micronutrients              10               1           25/60            4
                                  Enrollment and
                                  Data Submission
                                  Form.
                                 MPV Micronutrients              10               4           45/60           30
                                  Enrollment and
                                  Data Submission
                                  Form.
----------------------------------------------------------------------------------------------------------------
                          OATB Biomonitoring Quality Assurance Support Program (BQASP)
----------------------------------------------------------------------------------------------------------------
State Public Health Labs.......  BQASP Enrollment                10               1            5/60            1
                                  Email.

[[Page 73283]]

 
                                 BQASP Data                      10               1           45/60            8
                                  Submission Form.
----------------------------------------------------------------------------------------------------------------
                             IRATB Proficiency in Arsenic Speciation (PAsS) Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs.............  PAsS Enrollment                 28               1           10/60            5
                                  Form.
                                 PAsS Data                       28               4           10/60           19
                                  Submission Form.
----------------------------------------------------------------------------------------------------------------
                         IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
----------------------------------------------------------------------------------------------------------------
Public Health Labs.............  EQUIP Enrollment               240               1           10/60           41
                                  Form.
                                 EQUIP Data                     240               3           10/60          122
                                  Submission Form.
----------------------------------------------------------------------------------------------------------------
                         IRATB Lead and Multielement Proficiency (LAMP) Testing Program
----------------------------------------------------------------------------------------------------------------
Public Health Labs.............  LAMP Enrollment                226               1           10/60           39
                                  Form.
                                 LAMP Data                      226               4           10/60          154
                                  Submission Form.
----------------------------------------------------------------------------------------------------------------
                          NSMBB Newborn Screening and Quality Assurance Program (NSQAP)
----------------------------------------------------------------------------------------------------------------
Domestic NBS Labs..............  NSQAP Enrollment                71               1           10/60           12
                                  Form.
                                 NSQAP Data                      71               2           45/60          107
                                  Submission Portal
                                  Quality Control
                                  (QC).
                                 NSQAP Data                      71               3           45/60          160
                                  Submission Portal
                                  Biochemical &
                                  Molecular
                                  Proficiency Tests
                                  (PT).
International NBS Labs.........  NSQAP Enrollment               568               1           10/60           95
                                  Form.
                                 NSQAP Data                     568               2           45/60          129
                                  Submission Portal
                                  QC.
                                 NSQAP Data                     568               3           45/60        1,278
                                  Submission Portal
                                  Biochemical &
                                  Molecular PT.
NBS Test Manufacturers.........  NSQAP Enrollment                32               1           10/60            5
                                  Form.
                                 NSQAP Data                      32               2           45/60           48
                                  Submission Portal
                                  QC.
                                 NSQAP Data                      32               3           45/60           72
                                  Submission Portal
                                  Biochemical &
                                  Molecular PT.
                                --------------------------------------------------------------------------------
    Total......................  ..................           1,720  ..............  ..............        4,293
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-28033 Filed 12-23-21; 8:45 am]
BILLING CODE 4163-18-P