Agency Information Collection Activities; Proposed Collection; Comment Request; Process Evaluation of the Aging Network and Its Return on Investment; OMB #0985-New, 48428-48429 [2021-18588]
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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
when appropriate, and other forms of
information technology.
ACL contracts with a national legal
assistance resource center, the National
Center on Law and Elder Rights, to
provide the required services. Through
the contract, ACL provides aging,
disability, and related legal
professionals with training and complex
case consultations and support for
demonstration projects regarding
contractually identified priority legal
topics. The purpose of the information
requested is for ACL to ensure that the
resource center creates and prioritizes
the training, case consultations and
technical assistance resources it was
contracted to provide and to ensure that
the center targets the contractually
designated aging network practitioners
about the priority subject matters. This
approach enables ACL to make datainformed decisions about the
deployment of its resource center assets.
These data are necessary for ACL to
evaluate contractual compliance with
established performance indicators.
These metrics include quantifiable
increases in uptake by stakeholders of
training, case consultation and technical
assistance, and measures of satisfaction
with and perceived benefit from these
services. For example, the metrics
measure successful problem resolution
as a result of the services provided and
quantifiable data on fulfillment of
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows:
Number of
respondents
Respondent/data collection activity
Minutes
per response
Annual
burden hours
Resource Support Requests ....................................................................................................
Legal Training, Case Consultation, Technical Assistance Requests .......................................
Outcome Measurement ............................................................................................................
80
14,000
3,500
1 min 54 sec .....
1 min 42 sec .....
1 min 3 sec .......
2.53
397
61.25
Total ...................................................................................................................................
17,580
4 min 39 sec .....
460.78
Dated: August 23, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2021–18590 Filed 8–27–21; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Process Evaluation
of the Aging Network and Its Return on
Investment; OMB #0985–New
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
requests for training, technical
assistance, and consultation related to
the contractually designated legal and
systems development topic areas. The
information requested by ACL from
legal and aging/disability professionals
falls into the following areas: (1)
Requests for training, case consultation,
and technical assistance through an
online, secure Uniform Resource
Support Request Tool; (2) general
requests for Legal Training (including
the volume of Webinar registrations),
Case Consultation.
To comment on this information
collection please visit the ACL website:
https://www.acl.gov/about-acl/publicinput.
VerDate Sep<11>2014
18:40 Aug 27, 2021
Jkt 253001
public comment in response to the
notice. This notice solicits comments on
a revision to the information collection
requirements related to the Process
Evaluation of the Aging Network and its
Return on Investment.
DATES: Comments on the collection of
information submitted electronically by
11:59 p.m. (EST) or postmarked by
October 29, 2021.
ADDRESSES: Submit written comments
on the collection of information:
Attention: Caryn Bruyere,
Caryn.Bruyere@acl.hhs.gov.
Via U.S. Mail Attention: Caryn
Bruyere U.S. Department of Health and
Human Services, Administration for
Community Living, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT:
Caryn Bruyere, Office of Performance
and Evaluation. Administration for
Community Living Telephone: 202–
795–7393.
Email: caryn.bruyere@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
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.
‘‘Collection of information’’ is defined
as agency requests or requirements that
members of the public submit reports,
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
keep records, or provide information to
a third party. The PRA requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, ACL invites
comments on our burden estimates or
any other aspect of this collection of
information, including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(4) ways to minimize the burden of
the collection of information on
respondents, including through the use
of automated collection techniques
E:\FR\FM\30AUN1.SGM
30AUN1
Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices
when appropriate, and other forms of
information technology.
Background: Many older adults have
unmet health care and social service
needs, which require coordinated care
across a range of services, including
access to nutritious meals,
transportation, preventive health care,
home and community-based care, social
interaction, support for family
caregivers, and advocacy to help
maintain older adults’ safety, dignity,
and legal rights. This proposed data
collection for the Process Evaluation of
the Aging Network and its Return on
Investment is intended to provide
timely information on, (1) how agencies
in the Aging Network collaborate to
serve older adults and family caregivers,
and (2) how agencies measure the
effectiveness of their efforts with the
goal of strengthening their reach and
impact. Through this data collection
ACL will investigate how states differ in
their network structure, how agencies
work together, and potential strategies
48429
whose responses indicate that their
agency is evaluating ROI. The data
collection team will ask in-depth
questions about the costs and benefits
included in ROI calculations, successes
and challenges to evaluating ROI, and
lessons learned that could benefit other
agencies seeking to conduct their own
assessment of ROI.
To comment on this information
collection please visit the ACL website:
https://www.acl.gov/about-acl/publicinput.
for evaluating return on investments
(ROI) of ACL programs.
The Process Evaluation of the Aging
Network and its Return on Investment
will include: (1) A census of agencies in
the Aging Network, and (2) key
informant interviews with agencies that
are evaluating ROI. The survey seeks to
collect data from all State Units on
Aging (SUAs), Area Agencies on Aging
(AAAs) (including some Aging and
Disability Resource Centers), and Older
Americans Act Title VI Native American
tribal organizations. Surveying these
organizations will help ACL understand
how and with whom agencies in the
network collaborate to address the
needs of older adults and family
caregivers, partnerships that have
formed or expanded because of COVID–
19, and how agencies measure the
effectiveness and ROI of their various
programs.
The study will also include key
informant interviews with a subset of 10
agencies that responded to the survey
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows: The proposed data collection
estimates the average burden per
response to be 0.17 hours for the Aging
Network survey. The average burden per
response for the key informant
interviews estimated as 1 hour.
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS
Annual
number of
respondents
Data collection activity
Average
burden per
response
(in hours)
Total
number of
responses
Annual
estimated
burden hours
Aging Network survey .........................................
Key informant interview guide .............................
864
10
1 .....................
1 .....................
864
10
0.17 ................................
1 .....................................
144
10
Total .............................................................
874
Varies .............
874
0.18 (weighted mean) ....
154
Dated: August 24, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2021–18588 Filed 8–27–21; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0790]
Breckenridge Pharmaceutical, Inc.;
Withdrawal of Approval of Abbreviated
New Drug Application for Solifenacin
Succinate Tablets, 5 Milligrams and 10
Milligrams
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of the abbreviated new drug
application (ANDA) for solifenacin
succinate tablets, 5 milligrams (mg) and
10 mg, held by Breckenridge
SUMMARY:
VerDate Sep<11>2014
18:40 Aug 27, 2021
Jkt 253001
Pharmaceutical, Inc., 15 Massirio Dr.,
Berlin, CT 06037 (Breckenridge).
Breckenridge requested withdrawal of
this application and has waived its
opportunity for a hearing.
DATES: Approval is withdrawn as of
August 30, 2021.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
On May
20, 2019, FDA approved ANDA 209818
for solifenacin succinate tablets, 5 mg
and 10 mg, for the treatment of
overactive bladder with symptoms of
urge urinary incontinence, urgency, and
urinary frequency. On January 23, 2020,
Breckenridge issued a field alert report
that solifenacin succinate tablets, 5 mg
and 10 mg, may convert to solifenacin
tartrate tablets during manufacturing
due to an interaction between
solifenacin succinate and tartartic acid,
which is an inactive ingredient in this
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
drug product’s formulation. On January
24, 2020, Breckenridge executed a Class
II Recall (Retail-Level) of all solifenacin
succinate tablet product lots that were
distributed to market. Breckenridge
cannot market its solifenacin succinate
tablet product under the current
approval conditions for ANDA 209818.
To the extent that its active ingredient
has converted from solifenacin
succinate to solifenacin tartrate, the
product Breckenridge has distributed
under ANDA 209818 is misbranded.
After discussions with FDA, on April
21, 2020, Breckenridge requested that
FDA withdraw approval of ANDA
209818 for solifenacin succinate tablets
under § 314.150(d) (21 CFR 314.150(d))
and waived its opportunity for a
hearing. For the reasons discussed
above, and in accordance with the
applicant’s request, approval of ANDA
209818 solifenacin succinate tablets,
and all amendments and supplements
thereto, is withdrawn under
§ 314.150(d). Distribution of solifenacin
succinate tablets into interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48428-48429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Comment Request; Process Evaluation of the Aging Network and Its Return
on Investment; OMB #0985-New
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
information listed above. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish a notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on a revision to the information
collection requirements related to the Process Evaluation of the Aging
Network and its Return on Investment.
DATES: Comments on the collection of information submitted
electronically by 11:59 p.m. (EST) or postmarked by October 29, 2021.
ADDRESSES: Submit written comments on the collection of information:
Attention: Caryn Bruyere, [email protected].
Via U.S. Mail Attention: Caryn Bruyere U.S. Department of Health
and Human Services, Administration for Community Living, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT: Caryn Bruyere, Office of Performance
and Evaluation. Administration for Community Living Telephone: 202-795-
7393.
Email: [email protected]
SUPPLEMENTARY INFORMATION: Under the 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.
``Collection of information'' is defined as agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. The PRA requires Federal
agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
ACL is publishing a notice of the proposed collection of information
set forth in this document.
With respect to the following collection of information, ACL
invites comments on our burden estimates or any other aspect of this
collection of information, including:
(1) Whether the proposed collection of information is necessary for
the proper performance of ACL's functions, including whether the
information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used to determine burden estimates;
(3) ways to enhance the quality, utility, and clarity of the
information to be collected; and
(4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques
[[Page 48429]]
when appropriate, and other forms of information technology.
Background: Many older adults have unmet health care and social
service needs, which require coordinated care across a range of
services, including access to nutritious meals, transportation,
preventive health care, home and community-based care, social
interaction, support for family caregivers, and advocacy to help
maintain older adults' safety, dignity, and legal rights. This proposed
data collection for the Process Evaluation of the Aging Network and its
Return on Investment is intended to provide timely information on, (1)
how agencies in the Aging Network collaborate to serve older adults and
family caregivers, and (2) how agencies measure the effectiveness of
their efforts with the goal of strengthening their reach and impact.
Through this data collection ACL will investigate how states differ in
their network structure, how agencies work together, and potential
strategies for evaluating return on investments (ROI) of ACL programs.
The Process Evaluation of the Aging Network and its Return on
Investment will include: (1) A census of agencies in the Aging Network,
and (2) key informant interviews with agencies that are evaluating ROI.
The survey seeks to collect data from all State Units on Aging (SUAs),
Area Agencies on Aging (AAAs) (including some Aging and Disability
Resource Centers), and Older Americans Act Title VI Native American
tribal organizations. Surveying these organizations will help ACL
understand how and with whom agencies in the network collaborate to
address the needs of older adults and family caregivers, partnerships
that have formed or expanded because of COVID-19, and how agencies
measure the effectiveness and ROI of their various programs.
The study will also include key informant interviews with a subset
of 10 agencies that responded to the survey whose responses indicate
that their agency is evaluating ROI. The data collection team will ask
in-depth questions about the costs and benefits included in ROI
calculations, successes and challenges to evaluating ROI, and lessons
learned that could benefit other agencies seeking to conduct their own
assessment of ROI.
To comment on this information collection please visit the ACL
website: https://www.acl.gov/about-acl/public-input.
Estimated Program Burden
ACL estimates the burden associated with this collection of
information as follows: The proposed data collection estimates the
average burden per response to be 0.17 hours for the Aging Network
survey. The average burden per response for the key informant
interviews estimated as 1 hour.
Table 1--Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Data collection activity Annual number Number of responses per Total number Average burden per response (in hours) estimated
of respondents respondent of responses burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aging Network survey................ 864 1......................... 864 0.17.................................. 144
Key informant interview guide....... 10 1......................... 10 1..................................... 10
-------------------------------------------------------------------------------------------------------------------
Total........................... 874 Varies.................... 874 0.18 (weighted mean).................. 154
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: August 24, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary for Aging.
[FR Doc. 2021-18588 Filed 8-27-21; 8:45 am]
BILLING CODE 4154-01-P
