60 Day FRN

Att 2 60D FRN 2021-28033.pdf

NCEH DLS Laboratory Quality Assurance Programs

60 Day FRN

OMB: 0920-1389

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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06 and FTR 21–02 remain rescinded.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.

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SUMMARY:

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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: [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;
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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(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

25/60

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

25/60

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 ........................

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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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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.