Agency Forms Undergoing Paperwork Reduction Act Review, 70840-70841 [2021-26902]
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70840
Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Notices
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 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
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 selfassessment 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.
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Domestic Laboratory ...............
Participant Biosafety Compliance Letter of Agreement .........
MPEP Mycobacterium tuberculosis Results Worksheet ........
Online Survey Instrument .......................................................
MPEP Mycobacterium tuberculosis Minimum Inhibitory Concentration Results Form.
VerDate Sep<11>2014
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80
80
80
4
13DEN1
Number of
responses per
respondent
1
2
2
2
Average
burden per
response
(in hours)
5/60
30/60
15/60
15/60
Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–0891]
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 ‘‘World Trade
Center Health Program Enrollment,
Petitions, Designated Representative/
HIPAA Authorization, and Member
Satisfaction’’ 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 July 22,
2021 to obtain comments from the
public and affected agencies. CDC
received three comments related to the
previous notice but were unrelated to
the package. 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, using
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.
VerDate Sep<11>2014
16:50 Dec 10, 2021
Jkt 256001
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 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
World Trade Center Health Program
Enrollment, Petitions, Designated
Representative/HIPAA Authorization,
and Member Satisfaction (OMB Control
No. 0920–0891, Exp. 12/31/2021)—
Revision—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
NIOSH seeks to request OMB
approval to revise the currently
approved information collection
activities that support the World Trade
Center (WTC) Health Program. The
James Zadroga 9/11 Health and
Compensation Act of 2010 (Pub. L. 111–
347, as amended by Pub. L. 114–113)
created the WTC Health Program to
provide medical monitoring and
treatment benefits to eligible firefighters
and related personnel, law enforcement
officers, and rescue, recovery, and
cleanup workers who responded to the
September 11, 2001, attacks in New
York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders),
and to eligible persons who were
present in the dust or dust cloud on
September 11, 2001, or who worked,
resided, or attended school, childcare,
or adult daycare in the New York City
disaster area (survivors).
Since its inception in 2011, the WTC
Health Program has been approved to
collect information from applicants and
Program members concerning
enrollment, appointment of a designated
representative or third party, member
satisfaction, and petitions regarding
adding a new WTC-related health
condition to determine coverage under
the Program. The currently approved
total estimated burden is 14,063 hours
annually (see OMB Control No. 0920–
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
70841
0891, Exp. 12/31/2021). The WTC
Health Program has determined that
some existing forms need to be updated
and some need to be removed from the
burden table.
For this revision, the burden hours on
the WTC Health Program Applications
for Enrollment increased due to an
expected increase of application
volume. The Program updated the
enrollment applications for plain
language and improved processing. We
estimate 15,837 individuals will submit
either a FDNY, General Responder,
Pentagon/Shanksville Responder, or
WTC Survivor application annually.
The burden estimate for the applications
is 7,919 hours. This is an increase from
2018 when the estimated annualized
burden was 2,251. Of the Applications
for Enrollment, we expect to receive per
year, we estimate 3,830 of them are
General Responder applications from
the NY/NJ area and will have to select
which clinic they would like to visit. It
is expected that it will take the member
0.25 hours to complete the postcard.
The burden hours for the General
Responder Clinic Postcard are 958
hours.
The Program finds it necessary to
update and add new forms to allow
applicants and Program members to
grant permission to share information
with a designated representative or third
person about an individual’s application
or case. We estimate that 1,300
applicants and members will submit a
Designated Representative Appointment
Form and Designated Representative
HIPAA Authorization Form annually.
These forms will take approximately
0.25 hours to complete. The burden
estimate for these forms is 650 hours.
The Program proposes to extend this
information collection to account for
adding the WTCHP HIPAA
Authorization for Deceased Individuals,
WTCHP General HIPAA Authorization
to Third Parties, and Designated
Representative Revocation Form. The
WTCHP HIPAA Authorization for
Deceased Individuals was created so a
family member and/or personal
representative of a deceased applicant
or member can request program
documentation and/or medical records
related to the deceased applicant/
member. The WTCHP General HIPAA
Authorization to Third Parties was
created for members to give the Program
permission to share information about
their case with a third party, such as a
lawyer. The Designated Representative
Revocation Form was created for
members who wish to remove or replace
a currently appointed designated
representative. We estimate that 30
applicants or members will submit a
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70840-70841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
[[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
