Agency Forms Undergoing Paperwork Reduction Act Review, 26519-26521 [2021-10144]
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26519
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
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
National HIV Prevention Program
Monitoring and Evaluation (NHM&E)
(OMB Control No. 0920–0696, Exp. 10/
31/2021)—Revision—National Center
for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC seeks to request a three-year
Office of Management and Budget
(OMB) approval to revise the previously
approved project and continue the
collection of standardized HIV
prevention program evaluation data
from health departments and
community-based organizations (CBOs)
who receive federal funds for HIV
prevention activities. Health department
grantees have the options to key-enter or
upload data to a CDC-provided webbased software application
(EvaluationWeb®). CBO grantees may
only key-enter data to the CDC-provided
web-based software application. The
evaluation and reporting process is
necessary to ensure that CDC receives
standardized, accurate, thorough
evaluation data from both health
department and CBO grantees. For these
reasons, CDC developed standardized
NHM&E variables through extensive
consultation with representatives from
health departments, CBOs, and national
partners (e.g., The National Alliance of
State and Territorial AIDS Directors and
Urban Coalition of HIV/AIDS
Prevention Services). This revision
includes changes to the data variables to
adjust to the different monitoring and
evaluation needs of new funding
announcements without a substantial
change in burden.
CDC requires CBOs and health
departments who receive federal funds
for HIV prevention to report
nonidentifying, client-level and
aggregate level, standardized evaluation
data to: (1) Accurately determine the
extent to which HIV prevention efforts
are carried out, what types of agencies
are providing services, what resources
are allocated to those services, to whom
services are being provided, and how
these efforts have contributed to a
reduction in HIV transmission; (2)
Improve ease of reporting to better meet
these data needs; and (3) Be accountable
to stakeholders by informing them of
HIV prevention activities and use of
funds in HIV prevention nationwide.
CDC HIV prevention program grantees
will collect, enter or upload, and report
agency-identifying information, budget
data, intervention information, and
client demographics and behavioral risk
characteristics with an estimate of
204,498 burden hours, representing no
change from the previously approved
burden hours. Data collection will
include searching existing data sources,
gathering and maintaining data,
document compilation, review of data,
and data entry or upload into the webbased system. There are no additional
costs to respondents other than their
time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Health Departments ........................................
Community-based Organizations ....................
Health Department Reporting ........................
Community-based Organization Reporting ....
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–10145 Filed 5–13–21; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–20PJ]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
VerDate Sep<11>2014
19:58 May 13, 2021
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Number of
responses per
respondent
66
150
2
2
Average
burden per
response
(in hours)
1,427
54
has submitted the information
collection request titled ‘‘Formative
Research on Community-Level Factors
that Promote the Primary Prevention of
Adverse Childhood Experiences (ACEs)
and Opioid Misuse Among Children,
Youth, and Families in Tribal American
Indian and Alaska Native (AI/AN)
Communities’’ to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
E:\FR\FM\14MYN1.SGM
14MYN1
26520
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
Recommendations’’ notice on July
2,2020 to obtain comments from the
public and affected agencies. CDC
received three comments 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
Formative Research on CommunityLevel Factors that Promote the Primary
Prevention of Adverse Childhood
Experiences (ACEs) and Opioid Misuse
Among Children, Youth, and Families
in Tribal American Indian and Alaska
Native (AI/AN) Communities—New—
National Center for Injury Prevention
and Control (NCIPC), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Adverse childhood experiences
(ACEs) are preventable, potentially
traumatic events that occur in
childhood (0–17 years) such as
experiencing violence, abuse, or neglect;
witnessing violence in the home; and
having a family member attempt or die
by suicide. There is a robust evidence
base linking ACEs to a variety of poor
health outcomes across the life span,
including depression, alcohol and
substance use disorder, and violence
perpetration and victimization. The
ongoing opioid epidemic is a complex
and significant public health crisis that
exposes children to opioid misuse,
violence, and other ACEs, and
challenges the ability of Health and
Human Service (HHS) systems to
mitigate the effects of opioid misuse and
ACEs on children and families across
the U.S. American Indian/Alaska Native
(AI/AN) populations experience a
disproportionate burden of opioid
misuse and ACEs, and ACE-related
health outcomes, including opioid
overdose, sexual assault, and suicide
attempts. The nature and consequences
of ACEs in Tribal communities is
unique because of historical trauma and
stark socioeconomic disparities. In
addition, there are gaps in the provision
of adequate healthcare.
This collection addresses critical
research gaps and extends efforts to
prevent violence and other ACEs before
they occur and to build evidence of
effectiveness of community-level
strategies and approaches at the outer
levels of the social ecology to Tribal
communities. Results from this data
collection will be communicated to
relevant public health officials and
community stakeholders in the study
locations. These local public health
officials and community stakeholders
will use the study results to guide
strategies to further strengthen their
local prevention efforts within their
regions.
Data collection methods used in this
qualitative study include wellestablished qualitative methods,
including in-depth open-ended
individual interviews and focus groups.
Quantitative methods include brief
structured surveys. There will be a total
of six Tribal communities (three urban
and three rural) in regions identified
with higher opioid overdose mortality
rates relative to other areas in Indian
Country. Due to COVID–19, at the time
of the focus groups/interviews, social
distancing and public health safety
measures will be implemented,
including considerations for phone/
virtual meetings instead of in-person
sessions.
The total estimated annualized
burden hours are 441. There are no costs
to respondents other than their time.
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Adults 18 years or older affected by the opioid epidemic
(e.g., parents/caregivers of AI/AN children, Tribal Elders)
living in Tribal urban and rural/reservation communities.
Information Letter .....................
Telephone screening ................
Confirmation email/letter ...........
...................................................
Reminder email ........................
Informed Consent .....................
Demographic Survey ................
Focus group/interview ..............
Focus group/interview ..............
Focus group/interview ..............
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19:58 May 13, 2021
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E:\FR\FM\14MYN1.SGM
Number of
responses per
respondent
Average
burden
per response
(in hours)
160
160
1
1
5/60
25/60
120
120
120
120
44
64
12
1
1
1
1
1
1
1
5/60
5/60
25/60
25/60
2
2
2
14MYN1
Federal Register / Vol. 86, No. 92 / Friday, May 14, 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. 2021–10144 Filed 5–13–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10054 and CMS–
10396]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by June 14, 2021.
ADDRESSES: Written 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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
this notice, you may make your request
using one of following:
1. Access CMS’ website address at:
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: New
Technology Services for Ambulatory
Payment Classifications under the
Outpatient Prospective Payment
System; Use: Section 1833(t)(6) of the
Social Security Act (the Act) states,
‘‘The Secretary shall provide for an
additional payment under this
paragraph for any of the following that
are provided as part of a covered OPD
service (or group of services).’’ In
accordance with the Act, CMS needs to
keep pace with emerging new
technologies and make them accessible
to Medicare beneficiaries in a timely
manner. It is necessary that we continue
to collect appropriate information from
interested parties such as hospitals,
medical device manufacturers,
pharmaceutical companies and others
that bring to our attention specific
services that they wish us to evaluate for
New Technology APC payment.
The information that we seek to
continue to collect is necessary to
determine whether certain new services
are eligible for payment in New
Technology APCs, to determine
appropriate coding and to set an
appropriate payment rate for the new
technology service. The intent of these
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26521
provisions is to ensure timely
beneficiary access to new and
appropriate technologies.
Both the New Technology APC
provision and the transitional passthrough provisions provide ways for
ensuring appropriate payment for new
technologies for which the use and costs
are not adequately represented in the
base year claims data on which the
outpatient PPS is constructed. Although
individual drugs and biologicals and
categories of medical devices will
receive transitional pass-through
payments for 2 to 3 years from the date
payment is initiated for the specific item
or category, the underlying statutory
provision is permanent and provides an
on-going mechanism for reflecting the
introduction of new items into the
payment structure in a timely manner.
New Technology APCs are designed to
allow appropriate payment for new
technology services that are not covered
by the transitional pass-through
provisions. Form Number: CMS–10054
(OMB control number: 0938–0272);
Frequency: Yearly; Affected Public:
Private Sector, Business or other forprofits; Number of Respondents: 10;
Total Annual Responses: 10; Total
Annual Hours: 160. (For policy
questions regarding this collection
contact Allison Bramlett at 410–786–
6556.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medication
Therapy Management Program
Improvements; Use: Information
collected by Part D MTM programs as
required by the Standardized Format for
the CMR summary is used by
beneficiaries or their authorized
representatives, caregivers, and their
healthcare providers to improve
medication use and achieve better
healthcare outcomes. Members in a Part
D sponsors’ plan who are eligible are
enrolled in the sponsors’ MTM program
and offered a CMR which is a
consultation between the MTM provider
(such as a pharmacist) with the
beneficiary to review their medications.
After a CMR is performed, the sponsor
creates and sends a summary of the
CMR to the beneficiary that includes a
medication action plan and personal
medication list using the Standardized
Format; Form Number: CMS–10396
(OMB control number 0938–1154);
Frequency: Occasionally; Affected
Public: Business or other for-profits;
Number of Respondents: 807; Total
Annual Responses: 2,386,955; Total
Annual Hours: 1,591,383. (For policy
questions regarding this collection
contact Victoria Dang at 410–786–3991.)
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26519-26521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10144]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-20PJ]
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 ``Formative Research on Community-Level
Factors that Promote the Primary Prevention of Adverse Childhood
Experiences (ACEs) and Opioid Misuse Among Children, Youth, and
Families in Tribal American Indian and Alaska Native (AI/AN)
Communities'' to the Office of Management and Budget (OMB) for review
and approval. CDC previously published a ``Proposed Data Collection
Submitted for Public Comment and
[[Page 26520]]
Recommendations'' notice on July 2,2020 to obtain comments from the
public and affected agencies. CDC received three comments 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
Formative Research on Community-Level Factors that Promote the
Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid
Misuse Among Children, Youth, and Families in Tribal American Indian
and Alaska Native (AI/AN) Communities--New--National Center for Injury
Prevention and Control (NCIPC), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Adverse childhood experiences (ACEs) are preventable, potentially
traumatic events that occur in childhood (0-17 years) such as
experiencing violence, abuse, or neglect; witnessing violence in the
home; and having a family member attempt or die by suicide. There is a
robust evidence base linking ACEs to a variety of poor health outcomes
across the life span, including depression, alcohol and substance use
disorder, and violence perpetration and victimization. The ongoing
opioid epidemic is a complex and significant public health crisis that
exposes children to opioid misuse, violence, and other ACEs, and
challenges the ability of Health and Human Service (HHS) systems to
mitigate the effects of opioid misuse and ACEs on children and families
across the U.S. American Indian/Alaska Native (AI/AN) populations
experience a disproportionate burden of opioid misuse and ACEs, and
ACE-related health outcomes, including opioid overdose, sexual assault,
and suicide attempts. The nature and consequences of ACEs in Tribal
communities is unique because of historical trauma and stark
socioeconomic disparities. In addition, there are gaps in the provision
of adequate healthcare.
This collection addresses critical research gaps and extends
efforts to prevent violence and other ACEs before they occur and to
build evidence of effectiveness of community-level strategies and
approaches at the outer levels of the social ecology to Tribal
communities. Results from this data collection will be communicated to
relevant public health officials and community stakeholders in the
study locations. These local public health officials and community
stakeholders will use the study results to guide strategies to further
strengthen their local prevention efforts within their regions.
Data collection methods used in this qualitative study include
well-established qualitative methods, including in-depth open-ended
individual interviews and focus groups. Quantitative methods include
brief structured surveys. There will be a total of six Tribal
communities (three urban and three rural) in regions identified with
higher opioid overdose mortality rates relative to other areas in
Indian Country. Due to COVID-19, at the time of the focus groups/
interviews, social distancing and public health safety measures will be
implemented, including considerations for phone/virtual meetings
instead of in-person sessions.
The total estimated annualized burden hours are 441. There are no
costs to respondents 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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 18 years or older affected by the Information Letter...................................... 160 1 5/60
opioid epidemic (e.g., parents/caregivers of Telephone screening..................................... 160 1 25/60
AI/AN children, Tribal Elders) living in Confirmation email/letter...............................
Tribal urban and rural/reservation
communities.
........................................................ 120 1 5/60
Reminder email.......................................... 120 1 5/60
Informed Consent........................................ 120 1 25/60
Demographic Survey...................................... 120 1 25/60
Focus group/interview................................... 44 1 2
Focus group/interview................................... 64 1 2
Focus group/interview................................... 12 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 26521]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-10144 Filed 5-13-21; 8:45 am]
BILLING CODE 4163-18-P
