Proposed Data Collection Submitted for Public Comment and Recommendations, 73280-73283 [2021-28033]
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73280
Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices
and time remaining in a second tour of
duty upon return from renewal
agreement travel (RAT). GSA Bulletin
FTR 21–04 and the waiver provisions
therein is set to expire on December 31,
2021.
As COVID–19 has continued to
produce uncertainty and create
difficulties for relocating individuals,
GSA is extending certain FTR waivers
by rescinding GSA Bulletin FTR 21–04
and re-establishing the information
therein by issuance of this new GSA
Bulletin FTR 22–04 with a later
expiration date. GSA Bulletins FTR 20–
06 and FTR 21–02 remain rescinded.
The new GSA Bulletin FTR 22–04 can
be viewed at https://www.gsa.gov/
ftrbulletins.
Dated: December 21, 2021.
Krystal J. Brumfield,
Associate Administrator, Office of
Government-wide Policy.
[FR Doc. 2021–28044 Filed 12–23–21; 8:45 am]
BILLING CODE P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:11 Dec 23, 2021
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CDC must receive written
comments on or before February 25,
2022.
DATES:
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: 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;
ADDRESSES:
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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 DLSdeveloped 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
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Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices
(PAsS) Program
Æ Ensuring the Quality of Urinary
Iodine Procedures (EQUIP)
Æ Lead and Multielement Proficiency
(LAMP) Testing Program
• Newborn Screening and Molecular
Biology Branch (NSMBB)
Æ 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
improving and/or standardizing test
performance.
• Clinical Chemistry Branch (CCB)
Æ Accuracy-based Laboratory
Monitoring Programs (AMP)
Æ Lipid Standardization Program
(LSP) for Clinical Biomarkers
Æ Cholesterol Reference Method
Laboratory Network (CRMLN)
Æ Hormone Standardization (HoST)
Program
Æ Vitamin D Standardization
Certification Program (VDSCP)
• Nutrition Biomarkers Branch (NBB)
Æ Vitamin A Laboratory—External
Quality Assurance (VITAL–EQA)
Æ Quality Assurance Method
Performance Verification (MPV) for
Folate Microbiologic Assay (MBA)
Æ Quality Assurance Method
Performance Verification (MPV) for
Micronutrients
• Organic Analytical Toxicology Branch
(OATB)
Æ Biomonitoring Quality Assurance
Support Program (BQASP)
• Inorganic Radiation and Analytical
Toxicology Branch (IRATB)
Æ Proficiency in Arsenic Speciation
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
Type of respondent
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden hours
CCB Accuracy-based Laboratory Monitoring Programs (AMP)
Academic/University Research
Lab.
Private Research Lab .............
Routine Clinical Lab ...............
AMP Enrollment and Data Submission Form
10
1
25/60
4
AMP
AMP
AMP
AMP
AMP
10
3
3
20
20
4
1
4
1
4
45/60
25/60
45/60
25/60
45/60
30
1
9
8
60
Enrollment
Enrollment
Enrollment
Enrollment
Enrollment
and
and
and
and
and
Data
Data
Data
Data
Data
Submission
Submission
Submission
Submission
Submission
Form
Form
Form
Form
Form
CCB Lipid Standardization Program (LSP)
Academic/University Research
Lab.
Private Research Lab .............
Routine Clinical Lab ...............
LSP Enrollment and Data Submission Form
20
1
25/60
8
LSP
LSP
LSP
LSP
LSP
20
7
7
40
40
4
1
4
1
4
45/60
25/60
45/60
25/60
45/60
60
3
21
17
120
1
2
10/60
2
3
60
Enrollment
Enrollment
Enrollment
Enrollment
Enrollment
and
and
and
and
and
Data
Data
Data
Data
Data
Submission
Submission
Submission
Submission
Submission
Form
Form
Form
Form
Form
CCB Cholesterol Reference Method Laboratory Network (CRMLN)
CRMLN Network Laboratories
CRMLN Enrollment Email ...............................
CRMLN Data Submission Form .....................
15
15
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CCB Hormone Standardization (HoST) Program
Assay Manufacturers ..............
Lab Developed Tests (LDT)
Manufacturers.
End-user/Labs ........................
VerDate Sep<11>2014
19:11 Dec 23, 2021
HoSt Enrollment and Data Submission Form
HoSt Enrollment and Data Submission Form
HoSt Enrollment and Data Submission Form
60
60
40
1
4
1
30/60
1
30/60
30
240
20
HoSt Enrollment and Data Submission Form
HoSt Enrollment and Data Submission Form
HoSt Enrollment and Data Submission Form
40
20
20
4
1
4
1
30/60
1
160
10
80
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Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total burden hours
CCB Vitamin D Standardization Certification Program (VDSCP)
Assay Manufacturers ..............
LDT Manufacturers .................
End-user/Labs ........................
VDSCP
Form.
VDSCP
Form.
VDSCP
Form.
VDSCP
Form.
VDSCP
Form.
VDSCP
Form.
Enrollment and Data Submission
60
1
30/60
30
Enrollment and Data Submission
60
4
1
240
Enrollment and Data Submission
40
1
30/60
20
Enrollment and Data Submission
40
4
1
160
Enrollment and Data Submission
20
1
30/60
10
Enrollment and Data Submission
20
4
1
80
NBB Vitamin A Laboratory—External Quality Assurance (VITAL-EQA)
Academic/University Research
Lab.
Government/Ministry of Health
Lab.
Private Research Lab .............
Clinical Lab .............................
VITAL-EQA Enrollment Form .........................
30
1
25/60
13
Data Submission Form ...................................
VITAL-EQA Enrollment Form International ....
30
30
2
1
45/60
25/60
45
13
Data Submission Form
VITAL-EQA Enrollment
Data Submission Form
VITAL-EQA Enrollment
Data Submission Form
30
15
15
15
15
2
1
2
1
2
45/60
25/60
45/60
25/60
45/60
45
6
23
6
23
...................................
Form .........................
...................................
Form .........................
...................................
NBB Quality Assurance Method Performance Verification (MPV) for Folate Microbiologic Assay (MBA)
Academic/University Research
Lab.
Government/Ministry of Health
Lab.
Private Research Lab .............
Clinical Public Health Lab ......
MPV Folate MBA
mission Form.
MPV Folate MBA
mission Form.
MPV Folate MBA
mission Form.
MPV Folate MBA
mission Form.
MPV Folate MBA
mission Form.
MPV Folate MBA
mission Form.
MPV Folate MBA
mission Form.
MPV Folate MBA
mission Form.
Enrollment and Data Sub-
15
1
25/60
6
Enrollment and Data Sub-
15
4
45/60
45
Enrollment and Data Sub-
15
1
25/60
6
Enrollment and Data Sub-
15
4
45/60
45
Enrollment and Data Sub-
5
1
25/60
2
Enrollment and Data Sub-
5
4
45/60
15
Enrollment and Data Sub-
5
1
25/60
2
Enrollment and Data Sub-
5
4
45/60
15
NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
Academic/University Research
Lab.
Government/Ministry of Health
Lab.
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Private Research Lab .............
Clinical Public Health Lab ......
MPV Micronutrients
Submission Form.
MPV Micronutrients
Submission Form.
MPV Micronutrients
Submission Form.
MPV Micronutrients
Submission Form.
MPV Micronutrients
Submission Form.
MPV Micronutrients
Submission Form.
MPV Micronutrients
Submission Form.
MPV Micronutrients
Submission Form.
Enrollment and Data
20
1
25/60
8
Enrollment and Data
20
4
45/60
60
Enrollment and Data
20
1
25/60
8
Enrollment and Data
20
4
45/60
60
Enrollment and Data
10
1
25/60
4
Enrollment and Data
10
4
45/60
30
Enrollment and Data
10
1
25/60
4
Enrollment and Data
10
4
45/60
30
1
5/60
1
OATB Biomonitoring Quality Assurance Support Program (BQASP)
State Public Health Labs ........
VerDate Sep<11>2014
19:11 Dec 23, 2021
BQASP Enrollment Email ...............................
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Federal Register / Vol. 86, No. 245 / Monday, December 27, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Number of
respondents
Form name
BQASP Data Submission Form .....................
Number of
responses per
respondent
10
Average
burden per
response
(in hours)
Total burden hours
1
45/60
8
1
4
10/60
10/60
5
19
1
3
10/60
10/60
41
122
1
4
10/60
10/60
39
154
71
71
1
2
10/60
45/60
12
107
IRATB Proficiency in Arsenic Speciation (PAsS) Program
Public Health Labs .................
PAsS Enrollment Form ...................................
PAsS Data Submission Form .........................
28
28
IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
Public Health Labs .................
EQUIP Enrollment Form .................................
EQUIP Data Submission Form .......................
240
240
IRATB Lead and Multielement Proficiency (LAMP) Testing Program
Public Health Labs .................
LAMP Enrollment Form ..................................
LAMP Data Submission Form ........................
226
226
NSMBB Newborn Screening and Quality Assurance Program (NSQAP)
Domestic NBS Labs ...............
International NBS Labs ..........
NBS Test Manufacturers ........
Total .................................
NSQAP Enrollment Form ...............................
NSQAP Data Submission Portal Quality Control (QC).
NSQAP Data Submission Portal Biochemical
& Molecular Proficiency Tests (PT).
NSQAP Enrollment Form ...............................
NSQAP Data Submission Portal QC ..............
NSQAP Data Submission Portal Biochemical
& Molecular PT.
NSQAP Enrollment Form ...............................
NSQAP Data Submission Portal QC ..............
NSQAP Data Submission Portal Biochemical
& Molecular PT.
71
3
45/60
160
568
568
568
1
2
3
10/60
45/60
45/60
95
129
1,278
32
32
32
1
2
3
10/60
45/60
45/60
5
48
72
.........................................................................
1,720
........................
........................
4,293
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–1235]
khammond on DSKJM1Z7X2PROD with NOTICES
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 ‘‘Assessments
to Inform Program Refinement for HIV,
other STD, and Pregnancy Prevention
among Middle and High-School Aged
Youth’’ to the Office of Management and
Budget (OMB) for review and approval.
CDC previously published a ‘‘Proposed
Data Collection Submitted for Public
VerDate Sep<11>2014
19:11 Dec 23, 2021
Jkt 256001
Comment and Recommendations’’
notice on August 2, 2021, to obtain
comments from the public and affected
agencies. CDC received two 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
PO 00000
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Fmt 4703
Sfmt 4703
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.
E:\FR\FM\27DEN1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden Total
Type of respondent Form name Number of responses per per response burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
CCB Accuracy-based Laboratory Monitoring Programs (AMP)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
