Notice2021-26902
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 13, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 236 (Monday, December 13, 2021)</title>
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[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70840-70841]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26902]
[[Page 70840]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-0600]
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 ``CDC Model Performance Evaluation Program
(MPEP) for Mycobacterium tuberculosis Susceptibility testing'' 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 August 27, 2021 to obtain
comments from the public and affected agencies. CDC received one
comment 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
CDC Model Performance Evaluation Program (MPEP) for Mycobacterium
tuberculosis Susceptibility testing (OMB Control No. 0920-0600, Exp. 2/
20/2022)--Revision--National Center for HIV/AIDS, Viral Hepatitis, STD,
TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The CDC is requesting a Revision to approved information collection
from participants in the CDC Model Performance for Mycobacterium
tuberculosis Drug Susceptibility Testing for a period of three years.
Revision of this information will not require changes in the scope of
the project. This Revision includes (a) modification of the
Instructions to Participants Letter; (b) modification of the MPEP
Mycobacterium tuberculosis Results Worksheet; (c) modification of
online data collection instrument; (d) modification of the MPEP
Mycobacterium tuberculosis Minimum Inhibitory Concentration Results
Worksheet; (e) removal of Reminder Telephone Script; and (f)
modification of Aggregate Report Letter.
While the overall number of cases of TB in the U.S. has decreased,
rates still remain high among foreign-born persons, corrections,
homeless populations, and individuals infected with HIV in major
metropolitan areas. To reach the goal of eliminating TB, the Model
Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis
Susceptibility Testing is used to monitor and evaluate performance and
practices among US laboratories performing M. tuberculosis
susceptibility testing. Participation in this program is one way
laboratories can ensure high-quality laboratory testing, resulting in
accurate and reliable testing results.
By providing laboratories a self-assessment tool to test for drug
resistant M. tuberculosis strains, the program aids laboratories in
optimizing their skills in susceptibility testing. The information
obtained from the laboratories on susceptibility practices and
procedures is used to establish variables related to good performance,
assessing training needs, and aid with the development of practice
standards. Participants in this program include domestic clinical and
public health laboratories. Data collection from laboratory
participants occurs twice per year. The data collected in this program
will include the susceptibility test results of primary and secondary
drugs, drug concentrations, and test methods performed by laboratories
on a set of performance evaluation (PE) isolates. The PE isolates are
sent to participants twice a year. Participants also report demographic
data such as laboratory type and the number of drug susceptibility
tests performed annually.
CDC is requesting OMB approval for an estimated 129 annual burden
hours. Participation of respondents is voluntary, and there is no cost
to participants other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Domestic Laboratory................ Participant Biosafety 80 1 5/60
Compliance Letter of
Agreement.
MPEP Mycobacterium 80 2 30/60
tuberculosis Results
Worksheet.
Online Survey Instrument... 80 2 15/60
MPEP Mycobacterium 4 2 15/60
tuberculosis Minimum
Inhibitory Concentration
Results Form.
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[[Page 70841]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-26902 Filed 12-10-21; 8:45 am]
BILLING CODE 4163-18-P
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