Agency Forms Undergoing Paperwork Reduction Act Review, 56958-56961 [2022-20125]
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<![CDATA[
56958
Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
international laboratories in partnership
with the United Nations Office on Drugs
and Crimes (UNODC). The CDC vendor
will bulk ship these kits to UNODC for
international distribution, or the vendor
may direct ship these kits to select
international laboratories upon UNODC
request.
Over the past three years, CDC has
received 1,472 requests from interested
laboratories (approximately 490 requests
per year) and has distributed 3,007 TOM
Kits*. Based on this experience and
with the addition of EDP Kits, we
anticipate that up to 600 domestic
laboratories will request test kits per
year. Given that each application will
take six minutes, the annual time
burden for 600 domestic laboratories
will be 60 hours.
We will add 30 additional annual
burden hours for the international
distribution of test kits. We estimate that
300 international partner laboratories
will apply for test kits per year with
UNODC, assuming the same six minutes
per application. The UNODC will
compile and report this information to
CDC twice a year (15 burden hours per
response).
We estimate a total time burden of 90
hours per year, which is a decrease of
30 hours over the previously approved
120 hours. There is no cost to the
respondents other than their time to
participate.
* TRACEABLE OPIOID MATERIAL,
TOM KITS, and the TOM KITS logo are
marks of the U.S. Department of Health
and Human Services.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
U.S. Federal Laboratories .....
Test Kit Application and Questions for U.S.
Laboratories (online).
Test Kit Application and Questions for U.S.
Laboratories (online).
Test Kit Application and Questions for U.S.
Laboratories (online).
Test Kit Distribution Report for International
Laboratories.
State, Local, and Tribal Government Laboratories.
Private or Not-for-Profit U.S.
Institutions.
United Nations Office on
Drugs and Crimes
(UNODC).
Total ...............................
.......................................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–20122 Filed 9–15–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–22AW]
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 ‘‘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
VerDate Sep<11>2014
16:43 Sep 15, 2022
Jkt 256001
Number of
responses per
respondent
Number of
respondents
Frm 00033
Fmt 4703
Total burden
(in hours)
200
1
6/60
20
200
1
6/60
20
200
1
6/60
20
1
2
15
30
........................
........................
........................
90
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.
PO 00000
Average
burden per
response
(in hours)
Sfmt 4703
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),
E:\FR\FM\16SEN1.SGM
16SEN1
56959
Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
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 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
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
(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 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 threeyear Paperwork Reduction (PRA) Act
Clearance. There are no costs to the
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Number of
respondents
Form name
Number of
responses per
respondent
(in hours)
Average
burden per
response
(in hours)
CCB Accuracy-Based Laboratory Monitoring Programs (AMP)
Academic/University Research Lab
Private Research Lab ......................
Routine Clinical Lab .........................
AMP
AMP
AMP
AMP
AMP
AMP
Enrollment Section on Data Submission Form ...
Data Submission Form ........................................
Enrollment Section on Data Submission Form ...
Data Submission Form ........................................
Enrollment Section on Data Submission Form ...
Data Submission Form ........................................
10
10
3
3
20
20
1
4
1
4
1
4
25/60
45/60
25/60
45/60
25/60
45/60
20
20
7
7
40
40
1
4
1
4
1
4
25/60
45/60
25/60
45/60
25/60
45/60
15
1
10/60
CCB Lipid Standardization Program (LSP)
khammond on DSKJM1Z7X2PROD with NOTICES
Academic/University Research Lab
Private Research Lab ......................
Routine Clinical Lab .........................
LSP
LSP
LSP
LSP
LSP
LSP
Enrollment Section on Data Submission Form ....
Data Submission Form .........................................
Enrollment Section on Data Submission Form ....
Data Submission Form .........................................
Enrollment Section on Data Submission Form ....
Data Submission Form .........................................
CCB Cholesterol Reference Method Laboratory Network (CRMLN)
CRMLN Network Laboratories .........
VerDate Sep<11>2014
16:43 Sep 15, 2022
CRMLN Enrollment Webpage ......................................
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PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
E:\FR\FM\16SEN1.SGM
16SEN1
56960
Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of
respondent
Number of
responses per
respondent
(in hours)
Number of
respondents
Form name
CRMLN Data Submission Form ...................................
Average
burden per
response
(in hours)
15
2
2
HoSt Enrollment Section on Data Submission Form ...
HoSt Data Submission Form ........................................
HoSt Enrollment Section on Data Submission Form ...
60
60
40
1
4
1
30/60
1
30/60
HoSt Data Submission Form ........................................
HoSt Enrollment Section on Data Submission Form ...
HoSt Data Submission Form ........................................
40
20
20
4
1
4
1
30/60
1
VDSCP Enrollment Section on Data Submission Form
VDSCP Data Submission Form ....................................
VDSCP Enrollment Section on Data Submission Form
60
60
40
1
4
1
30/60
1
30/60
VDSCP Data Submission Form ....................................
VDSCP Enrollment Section on Data Submission Form
VDSCP Data Submission Form ....................................
40
20
20
4
1
4
1
30/60
1
1
2
1
2
1
2
1
2
25/60
45/60
25/60
45/60
25/60
45/60
25/60
45/60
CCB Hormone Standardization (HoST) Program
Assay Manufacturers .......................
(LDT) Lab Developed Tests Manufacturers.
End-user/Labs ..................................
CCB Vitamin D Standardization Certification Program (VDSCP)
Assay Manufacturers .......................
(LDT) Lab Developed Tests Manufacturers.
End-user/Labs ..................................
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
VITAL–EQA
VITAL–EQA
VITAL–EQA
VITAL–EQA
VITAL–EQA
VITAL–EQA
VITAL–EQA
Enrollment Form National ........................
Data Submission Form ............................
Enrollment Form International ..................
Data Submission Form ............................
Enrollment Form National ........................
Data Submission Form ............................
Enrollment Form National ........................
Data Submission Form ............................
30
30
30
30
15
15
15
15
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
sion Form.
MPV Folate MBA
MPV Folate MBA
sion Form.
MPV Folate MBA
MPV Folate MBA
sion Form.
MPV Folate MBA
MPV Folate MBA
sion Form.
MPV Folate MBA
Enrollment Section on Data Submis-
15
1
25/60
Data Submission Form ....................
Enrollment Section on Data Submis-
15
15
4
1
45/60
25/60
Data Submission Form ....................
Enrollment Section on Data Submis-
15
5
4
1
45/60
25/60
Data Submission Form ....................
Enrollment Section on Data Submis-
5
5
4
1
45/60
25/60
Data Submission Form ....................
5
4
45/60
NBB Quality Assurance Method Performance Verification (MPV) for Micronutrients
Academic/University Research Lab
Government/Ministry of Health Lab
khammond on DSKJM1Z7X2PROD with NOTICES
Private Research Lab ......................
Clinical Public Health Lab ................
MPV Micronutrients Enrollment Section on
mission Form.
MPV Micronutrients Data Submission Form
MPV Micronutrients Enrollment Section on
mission Form.
MPV Micronutrients Data Submission Form
MPV Micronutrients Enrollment Section on
mission Form.
MPV Micronutrients Data Submission Form
MPV Micronutrients Enrollment Section on
mission Form.
MPV Micronutrients Data Submission Form
Data Sub-
20
1
25/60
................
Data Sub-
20
20
4
1
45/60
25/60
................
Data Sub-
20
10
4
1
45/60
25/60
................
Data Sub-
10
10
4
1
45/60
25/60
................
10
4
45/60
1
1
5/60
45/60
OATB Biomonitoring Quality Assurance Support Program (BQASP)
State Public Health Labs .................
VerDate Sep<11>2014
16:43 Sep 15, 2022
BQASP Enrollment Email .............................................
BQASP Data Submission Form ....................................
Jkt 256001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
E:\FR\FM\16SEN1.SGM
10
10
16SEN1
56961
Federal Register / Vol. 87, No. 179 / Friday, September 16, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of
respondent
Number of
respondents
Form name
Number of
responses per
respondent
(in hours)
Average
burden per
response
(in hours)
IRATB Proficiency in Arsenic Speciation (PAsS) Program
Public Health Labs ...........................
PAsS Enrollment Form .................................................
PAsS Data Submission Form .......................................
28
28
1
4
10/60
10/60
240
240
1
3
10/60
10/60
1
4
10/60
10/60
71
71
71
1
2
3
10/60
45/60
45/60
71
568
568
568
568
32
32
32
32
3
1
2
3
3
1
2
3
3
45/60
10/60
45/60
45/60
45/60
10/60
45/60
45/60
45/60
IRATB Ensuring the Quality of Urinary Iodine Procedures (EQUIP)
Public Health Labs ...........................
EQUIP Enrollment Form ...............................................
EQUIP Data Submission Form .....................................
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 ..................
NSQAP Enrollment Form ..............................................
NSQAP Data Submission Portal Quality Control (QC)
NSQAP Data Submission Portal Biochemical (Proficiency Testing) PT.
NSQAP Data Submission Portal Molecular PT ............
NSQAP Enrollment Form ..............................................
NSQAP Data Submission Portal QC ............................
NSQAP Data Submission Portal Biochemical PT ........
NSQAP Data Submission Portal Molecular PT ............
NSQAP Enrollment Form ..............................................
NSQAP Data Submission Portal QC ............................
NSQAP Data Submission Portal Biochemical PT ........
NSQAP Data Submission 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–22FC]
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 ‘‘Assessing the
Capacity of Vector Management
Programs in the United States to Provide
Comprehensive Community-level Tick
Management Services’’ 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 May 13,
2022 to obtain comments from the
VerDate Sep<11>2014
16:43 Sep 15, 2022
Jkt 256001
public and affected agencies. CDC did
not receive 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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
(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:
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
Assessing the Capacity of Vector
Management Programs in the U.S. to
Provide Comprehensive Communitylevel Tick Management Services—
New—National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
E:\FR\FM\16SEN1.SGM
16SEN1
]]>Agencies
[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
