Agency Forms Undergoing Paperwork Reduction Act Review, 66270-66271 [2018-27853]
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66270
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices
OMB approval is requested for three
years. Participation in this information
collection is required as a condition of
cooperative agreement funding. There
are no costs to respondents other than
their time. The total annualized burden
hours are 1,344.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hrs.)
Total burden
(in hrs.)
Form name
WISEWOMAN Awardees ..................
Screening and Assessment and
Lifestyle Program MDEs.
Annual Progress Report ...................
21
2
24
1,008
21
1
16
336
...........................................................
........................
........................
........................
1,344
Total ...........................................
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–27855 Filed 12–21–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
E60, Atlanta, Georgia 30333, (404) 718–8833,
gca5@cdc.gov.
The Chief Operating Officer, Centers for
Disease Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
Centers for Disease Control and
Prevention
[FR Doc. 2018–27893 Filed 12–21–18; 8:45 am]
Notice of Closed Meeting
BILLING CODE 4163–18–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Chief Operating Officer, CDC,
pursuant to Public Law 92–463. The
grant applications and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
amozie on DSK3GDR082PROD with NOTICES1
Number of
responses per
respondent
Type of respondents
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—CK19–002,
Quantifying Contact Rates and Mixing
Patterns in Workers in Non-Healthcare Work
Settings in the United States and CK19–004,
Study to Assess the Risk of Blood Borne
Transmission of Classic Forms of CreutzfeldtJakob Disease (CJD).
Date: May 7, 2019.
Time: 10:00 a.m.–5:00 p.m., (EDT).
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Gregory
Anderson, M.S., M.P.H., Scientific Review
Officer, CDC, 1600 Clifton Road NE, Mailstop
VerDate Sep<11>2014
20:07 Dec 21, 2018
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–0600]
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
Drug 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
28, 2018 to obtain comments from the
public and affected agencies. CDC
received one non-substantive
anonymous 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:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
(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 or
send an email to omb@cdc.gov. 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 Drug Susceptibility Testing
(OMB Control No.0920–0600, Expires 3/
31/2019)—Revision—National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention (NCHHSTP) Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
As part of the continuing effort to
support domestic public health
E:\FR\FM\26DEN1.SGM
26DEN1
66271
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices
objectives for treatment of tuberculosis
(TB), prevention of multi-drug
resistance, and surveillance programs,
CDC is requesting approval from the
Office of Management and Budget to
continue information collection from
participants in the Model Performance
Evaluation Program for Mycobacterium
tuberculosis Susceptibility Testing. This
revision request includes (a)
modification of the Participant Biosafety
Compliance Letter of Agreement to
contain language to ensure that
participants understand and comply
with biosafety guidelines using quality
management system practices; (b)
modification of Instructions to
Participants Letter to include detailed
instructions for online data entry of DST
results; (c) modification of MPEP
Mycobacterium tuberculosis Results
Worksheet to include fields for entering
methods used for conventional and
molecular DST; (d)addition of a MPEP
Mycobacterium tuberculosis Minimum
Inhibitory Concentration (MIC) Results
form for laboratories performing this
procedure to enter results manually and
submit by email to TBMPEP@cdc.gov;
and (e) reduction in request for burden
hours from 156 hours to 129 hours due
to fewer laboratories participating in the
program compared to the previous
submission request.
While the overall number of cases of
TB in the U.S. has decreased, rates still
remain high among foreign-born
persons, prisoners, 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 Drug
Susceptibility Testing is used to monitor
and evaluate performance and practices
among national 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.
Revision of this information
collection provides CDC with an
evaluation program to assess the ability
of the laboratories to test for drug
resistant M. tuberculosis strains,
laboratories also have 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, 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) samples.
The PE samples are sent to participants
twice a year. Participants also report
demographic data such as laboratory
type and the number of tests performed
annually.
There is no cost to respondents to
participate other than their time. Total
burden hours is 129.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Domestic Laboratories ....................................
Participant Biosafety Compliance Letter of
Agreement.
MPEP Mycobacterium tuberculosis Results
Worksheet.
Online Survey Instrument ..............................
Minimum Inhibitory Concentration (MIC) Results Form.
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–27853 Filed 12–21–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4188–PN]
amozie on DSK3GDR082PROD with NOTICES1
Number of
respondents
Type of respondents
Medicare Program; Request for
Renewal of Deeming Authority of the
Utilization Review Accreditation
Commission (URAC) for Health
Maintenance Organizations and
Preferred Provider Organizations
Centers for Medicare &
Medicaid Services (CMS), HHS.
AGENCY:
VerDate Sep<11>2014
20:07 Dec 21, 2018
Jkt 247001
ACTION:
Proposed notice.
This proposed notice
announces that CMS is considering
granting approval of the Utilization
Review Accreditation Commission’s
(URAC) renewal application for
Medicare Advantage ‘‘deeming
authority’’ of Health Maintenance
Organizations and Preferred Provider
Organizations. This new 6-year term of
approval would begin on the date of
publication of the final notice. This
notice also announces a 30-day period
for the public to submit comments on
CMS’ renewal of the application.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. January 25, 2019.
ADDRESSES: In commenting, refer to file
code CMS–4188–PN. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
SUMMARY:
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Number of
responses
per
respondent
Average
burden per
response
(in hours)
80
1
5/60
80
2
30/60
80
4
2
2
15/60
15/60
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–4188–PN, P.O. Box 8016,
Baltimore, MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–4188–PN,
E:\FR\FM\26DEN1.SGM
26DEN1
]]>Agencies
[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66270-66271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27853]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-0600]
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 Drug 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 28, 2018 to obtain
comments from the public and affected agencies. CDC received one non-
substantive anonymous 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 or send an email to omb@cdc.gov. 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 Drug Susceptibility Testing (OMB Control No.0920-0600,
Expires 3/31/2019)--Revision--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP) Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
As part of the continuing effort to support domestic public health
[[Page 66271]]
objectives for treatment of tuberculosis (TB), prevention of multi-drug
resistance, and surveillance programs, CDC is requesting approval from
the Office of Management and Budget to continue information collection
from participants in the Model Performance Evaluation Program for
Mycobacterium tuberculosis Susceptibility Testing. This revision
request includes (a) modification of the Participant Biosafety
Compliance Letter of Agreement to contain language to ensure that
participants understand and comply with biosafety guidelines using
quality management system practices; (b) modification of Instructions
to Participants Letter to include detailed instructions for online data
entry of DST results; (c) modification of MPEP Mycobacterium
tuberculosis Results Worksheet to include fields for entering methods
used for conventional and molecular DST; (d)addition of a MPEP
Mycobacterium tuberculosis Minimum Inhibitory Concentration (MIC)
Results form for laboratories performing this procedure to enter
results manually and submit by email to TBMPEP@cdc.gov; and (e)
reduction in request for burden hours from 156 hours to 129 hours due
to fewer laboratories participating in the program compared to the
previous submission request.
While the overall number of cases of TB in the U.S. has decreased,
rates still remain high among foreign-born persons, prisoners, 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 Drug Susceptibility
Testing is used to monitor and evaluate performance and practices among
national 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.
Revision of this information collection provides CDC with an
evaluation program to assess the ability of the laboratories to test
for drug resistant M. tuberculosis strains, laboratories also have 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, 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) samples. The PE samples are sent to
participants twice a year. Participants also report demographic data
such as laboratory type and the number of tests performed annually.
There is no cost to respondents to participate other than their
time. Total burden hours is 129.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratories................. 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
Minimum Inhibitory 4 2 15/60
Concentration (MIC)
Results Form.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018-27853 Filed 12-21-18; 8:45 am]
BILLING CODE 4163-18-P
