Notice2021-18541
Proposed Data Collection Submitted for Public Comment and Recommendations
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
August 27, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for revision to the previously approved project used to monitor and evaluate performances and practices among national laboratories for M. tuberculosis susceptibility testing.
Full Text
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<title>Federal Register, Volume 86 Issue 164 (Friday, August 27, 2021)</title>
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[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Notices]
[Pages 48146-48147]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18541]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-21-0600; Docket No. CDC-2021-0087]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled CDC Model Performance Evaluation
Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing
information collection. CDC is requesting a three-year approval for
revision to the previously approved project used to monitor and
evaluate performances and practices among national laboratories for M.
tuberculosis susceptibility testing.
DATES: CDC must receive written comments on or before October 26, 2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0087 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://Regulations.gov">Regulations.gov</a>.
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-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
<a href="/cdn-cgi/l/email-protection#e48b8986a4878087ca838b92"><span class="__cf_email__" data-cfemail="2b4446496b484f48054c445d">[email protected]</span></a>.
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
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,
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC) is requesting
a revision to approved information collection from participants in the
CDC Model Performance for Mycobacterium tuberculosis Drug
Susceptibility Testing Program for a period of three years. Revision of
this information will not
[[Page 48147]]
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 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 an evaluation program to assess the ability of
laboratories to test for drug resistant M. tuberculosis strains, CDC
gives laboratories a self-assessment tool to aid 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, assess 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, and participants also report demographic
data such as laboratory type and the number of drug susceptibility
tests performed annually.
CDC requests approval for an estimated 129 burden hours annually.
There is no cost to respondents to participate 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 Total burden
respondents respondent (in hours) (in hours)
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Domestic Laboratory............................ Participant Biosafety Compliance Letter 80 1 5/60 7
of Agreement.
MPEP Mycobacterium tuberculosis Results 80 2 30/60 80
Worksheet.
Online Survey Instrument............... 80 2 15/60 40
MPEP Mycobacterium tuberculosis Minimum 4 2 15/60 2
Inhibitory Concentration Results Form.
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Total...................................... ....................................... .............. .............. .............. 129
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-18541 Filed 8-26-21; 8:45 am]
BILLING CODE 4163-18-P
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