Agency Information Collection Activities; Proposed Collection; Public Comment Request; Performance Data for the Senior Medicare Patrol (SMP) Program; OMB# 0985-0024, 31596-31597 [2019-14086]
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Federal Register / Vol. 84, No. 127 / Tuesday, July 2, 2019 / Notices
Quality Promotion (DHQP), the Director,
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
the Director, CDC, the Secretary, Health
and Human Services regarding (1) the
practice of healthcare infection
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related events in settings where
healthcare is provided; and (3) periodic
updating of CDC guidelines and other
policy statements regarding prevention
of healthcare-associated infections and
healthcare-related conditions.
Matters To Be Considered: The agenda
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HICPAC workgroups: The Healthcare
Personnel Guideline Workgroup and the
Neonatal Intensive Care Unit (NICU)
Guideline Workgroup. Agenda items are
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[FR Doc. 2019–14067 Filed 7–1–19; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request; Performance Data
for the Senior Medicare Patrol (SMP)
Program; OMB# 0985–0024
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
public comment in response to the
notice. This Extension without Change
(ICR Ext) solicits comments on the
information collection requirements
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:00 Jul 01, 2019
Jkt 247001
related to the Performance Data for the
Senior Medicare Patrol (SMP) Program.
DATES: Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (EST) or
postmarked by September 3, 2019.
ADDRESSES: Submit electronic
comments on the collection of
information to: Phillip McKoy,
Phillip.McKoy@acl.hhs.gov. Submit
written comments on the collection of
information to Administration for
Community Living, Washington, D.C.
20201, Attention: Phillip McKoy
FOR FURTHER INFORMATION CONTACT:
Phillip McKoy, Office of Healthcare
Information and Counseling (OHIC),
Administration for Community Living,
Washington, DC 20201, Phone: 202–
795–7397, Email: Phillip.Mckoy@
acl.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA, 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 and includes 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
when appropriate, and other forms of
information technology.
The purpose of this data collection is
to collect annual performance data from
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
grantees. This data collection is required
by Congress for program monitoring and
Government Performance Results Act
(GPRA) purposes. The data collected
through this request is used by ACL and
the SMP Programs to communicate with
Congress and the public on SMP
activities. There are 54 programs
nationally, one in all 50 states, the
District of Columbia, Puerto Rico, Guam
and the U.S. Virgin Islands. It is
imperative that data be collected to
ensure that grantees’ contacts are
captured and that Medicare
beneficiaries are given the tools to
prevent, detect and report health care
fraud, error and abuse. The respondents
for this data collection are grantees,
SMP team members, and volunteers
who meet with Medicare beneficiaries
in group settings and in one-on-one
sessions to educate them on the
importance of being aware of Medicare
fraud, error and abuse, and having the
knowledge to protect the Medicare
system.
Under Public Law 104–208, the
Omnibus Consolidated Appropriations
Act of 1997, Congress established the
Senior Medicare Patrol Projects in order
to further curb losses to the Medicare
program. The Senate Committee noted
that retired professionals, with
appropriate training, could serve as
educators and resources to assist
Medicare beneficiaries and others to
detect and report error, fraud and abuse.
Among other requirements, it directed
the Administration for Community
Living to work with the Office of
Inspector General (OIG) and the
Government Accountability Office
(GAO), to assess the performance of the
program. The Administration for
Community Living has worked with
HHS/OIG to develop project-level
performance measures. The HHS/OIG
has collected SMP performance data
and issued SMP performance reports
since 1997. The OIG changed the
reporting period from twice a year to
once a year in 2008.
This information is used by ACL as
the primary method for monitoring the
SMP Projects. This information
collection reports the number of active
team members, number of community
outreach activities, number of
beneficiaries reached by education and
outreach activities, and the number of
dollars recoverable for the Medicare
Trust Fund among other performance
measures. The information from the
current collection is reported by the OIG
to Congress and the public.
Measures as required by Congress and
the Government Performance Results
Modernization Act of 2010 (GPRMA),
are also supported in ACL tracking
E:\FR\FM\02JYN1.SGM
02JYN1
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Federal Register / Vol. 84, No. 127 / Tuesday, July 2, 2019 / Notices
performance outcomes and efficiency
measures with respect to the annual and
long-term performance targets
established in compliance with the
GPRAMA. The Performance Data for the
SMP data collection will continue to
provide data necessary to determine the
effectiveness of the program.
Estimated Program Burden
follows: The burden hours are based on
the number of projects for 54 SMP
grantees. With an estimated time of 138
burden hours per response for a total of
7,452 annual burden hours.
ACL estimates the burden associated
with this collection of information as
Type of respondent
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
SMP grantees ...................................
SMP Project annual Report Form ....
54
1
138
7,452
Dated: June 26, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019–14086 Filed 7–1–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1917]
Drug Abuse and Dependence Section
of Labeling for Human Prescription
Drug and Biological Products—
Content and Format; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Drug
Abuse and Dependence Section of
Labeling for Human Prescription Drug
and Biological Products—Content and
Format.’’ This guidance is intended to
assist applicants in writing the DRUG
ABUSE AND DEPENDENCE section of
the labeling, as described in the
regulations for the content and format of
labeling for human prescription drug
and biological products. The
recommendations in this draft guidance
will help ensure that the labeling is
clear, concise, useful and informative,
and, to the extent possible, consistent in
content and format within and across
drug and therapeutic classes.
DATES: Submit either electronic or
written comments on the draft guidance
by September 3, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
VerDate Sep<11>2014
17:00 Jul 01, 2019
Jkt 247001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–1917 for ‘‘Drug Abuse and
Dependence Section of Labeling for
Human Prescription Drug and Biological
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Products—Content and Format.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
E:\FR\FM\02JYN1.SGM
02JYN1
Agencies
[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Notices]
[Pages 31596-31597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14086]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Agency Information Collection Activities; Proposed Collection;
Public Comment Request; Performance Data for the Senior Medicare Patrol
(SMP) Program; OMB# 0985-0024
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 Extension without Change (ICR Ext) solicits comments on
the information collection requirements related to the Performance Data
for the Senior Medicare Patrol (SMP) Program.
DATES: Comments on the collection of information must be submitted
electronically by 11:59 p.m. (EST) or postmarked by September 3, 2019.
ADDRESSES: Submit electronic comments on the collection of information
to: Phillip McKoy, [email protected]. Submit written comments
on the collection of information to Administration for Community
Living, Washington, D.C. 20201, Attention: Phillip McKoy
FOR FURTHER INFORMATION CONTACT: Phillip McKoy, Office of Healthcare
Information and Counseling (OHIC), Administration for Community Living,
Washington, DC 20201, Phone: 202-795-7397, Email:
[email protected]
SUPPLEMENTARY INFORMATION: Under the PRA, 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 and includes 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 when appropriate, and other forms of information technology.
The purpose of this data collection is to collect annual
performance data from grantees. This data collection is required by
Congress for program monitoring and Government Performance Results Act
(GPRA) purposes. The data collected through this request is used by ACL
and the SMP Programs to communicate with Congress and the public on SMP
activities. There are 54 programs nationally, one in all 50 states, the
District of Columbia, Puerto Rico, Guam and the U.S. Virgin Islands. It
is imperative that data be collected to ensure that grantees' contacts
are captured and that Medicare beneficiaries are given the tools to
prevent, detect and report health care fraud, error and abuse. The
respondents for this data collection are grantees, SMP team members,
and volunteers who meet with Medicare beneficiaries in group settings
and in one-on-one sessions to educate them on the importance of being
aware of Medicare fraud, error and abuse, and having the knowledge to
protect the Medicare system.
Under Public Law 104-208, the Omnibus Consolidated Appropriations
Act of 1997, Congress established the Senior Medicare Patrol Projects
in order to further curb losses to the Medicare program. The Senate
Committee noted that retired professionals, with appropriate training,
could serve as educators and resources to assist Medicare beneficiaries
and others to detect and report error, fraud and abuse.
Among other requirements, it directed the Administration for
Community Living to work with the Office of Inspector General (OIG) and
the Government Accountability Office (GAO), to assess the performance
of the program. The Administration for Community Living has worked with
HHS/OIG to develop project-level performance measures. The HHS/OIG has
collected SMP performance data and issued SMP performance reports since
1997. The OIG changed the reporting period from twice a year to once a
year in 2008.
This information is used by ACL as the primary method for
monitoring the SMP Projects. This information collection reports the
number of active team members, number of community outreach activities,
number of beneficiaries reached by education and outreach activities,
and the number of dollars recoverable for the Medicare Trust Fund among
other performance measures. The information from the current collection
is reported by the OIG to Congress and the public.
Measures as required by Congress and the Government Performance
Results Modernization Act of 2010 (GPRMA), are also supported in ACL
tracking
[[Page 31597]]
performance outcomes and efficiency measures with respect to the annual
and long-term performance targets established in compliance with the
GPRAMA. The Performance Data for the SMP data collection will continue
to provide data necessary to determine the effectiveness of the
program.
The proposed data collection tools may be found on the ACL website
for review at https://www.acl.gov/about-acl/public-input.
Estimated Program Burden
ACL estimates the burden associated with this collection of
information as follows: The burden hours are based on the number of
projects for 54 SMP grantees. With an estimated time of 138 burden
hours per response for a total of 7,452 annual burden hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
SMP grantees.................................... SMP Project annual Report Form.... 54 1 138 7,452
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: June 26, 2019.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2019-14086 Filed 7-1-19; 8:45 am]
BILLING CODE 4154-01-P