Availability of Program Application Instructions for MIPPA Program Funds, 26059-26060 [2018-12046]
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Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2018–11976 Filed 6–4–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Community Living
Availability of Program Application
Instructions for MIPPA Program Funds
Administration for Community
Living, HHS.
Title: Medicare Improvements for
Patients and Providers Act: State Plans
for Medicare Savings Program, Low
Income Subsidy & Prescription Drug
Enrollment Outreach and Assistance.
Announcement Type: Initial.
Funding Opportunity Number: CIP–
MI–18–001.
Statutory Authority: The Medicare
Improvements for Patients and
Providers Act of 2008—Section 119,
Public Law (Pub. L.) 110–275 as
amended by the Patient Protection and
Affordable Care Act of 2010 (Affordable
Care Act), reauthorized by the American
Taxpayer Relief Act of 2012 (ATRA),
reauthorized by section 110 of the
Protecting Access to Medicare Act of
2014 and reauthorized by the Medicare
Access and CHIP Reauthorization Act of
2015, and was reauthorized for two
years under the Bipartisan Budget Act of
2018 (Pub. L. 115–123, BBA of 2018).
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.071.
Dates: The deadline for the
submission of MIPPA Program State
Plans is 11:59 p.m. EST August 3, 2018.
AGENCY:
amozie on DSK3GDR082PROD with NOTICES1
I. Funding Opportunity Description
The purpose of MIPPA funding is to
enhance state efforts to provide
assistance to Medicare beneficiaries
through statewide and local coalition
building focused on intensified outreach
activities to beneficiaries likely to be
eligible for the Low Income Subsidy
program (LIS) or the Medicare Savings
Program (MSP) and in assisting those
beneficiaries in applying for benefits.
ACL will provide MIPPA program
funding to State Health Insurance
Assistance Programs (SHIPs), Area
Agencies on Aging (AAAs), and Aging
and Disability Resource Center
programs (ADRCs), to inform Medicare
beneficiaries about available Medicare
program benefits. ACL seeks plans from
states that will describe how the MIPPA
VerDate Sep<11>2014
20:19 Jun 04, 2018
Jkt 241001
program funds will be used for
beneficiary outreach, education, and
one-on-one application assistance over
the next two years.
ACL requests that states submit a two
(2) year state plan with specific project
strategies to expand, extend, or enhance
their one-on-one assistance, education,
and group outreach efforts to Medicare
beneficiaries on Medicare and
assistance programs for those with
limited incomes. States should describe
how the SHIP, AAA, and ADRC efforts
will be coordinated to provide outreach
to beneficiaries with limited incomes
statewide. States that are eligible to
apply are asked to review previous
MIPPA plans and update these plans to
reflect successes achieved to date and
direct their efforts to enhance and
expand their MIPPA outreach activities.
State agencies may prepare either one
statewide plan or separate plans for
each eligible State agency. Program
Instructions will be available to
applicants through ACL. ACL will also
host an applicant teleconference on
Tuesday, June 19th, 2018 at 2:00 p.m.
Eastern. Call in number: 202–774–2300.
Meeting Number: 998 701 573.
II. Award Information
1. Funding Instrument Type
These awards will be made in the
form of grants to State Agencies for each
MIPPA Priority Area:
Priority Area 1—Grants to State
Agencies (the State Unit on Aging or the
State Department of Insurance) that
administer the State Health Insurance
Assistance Program (SHIP) to provide
enhanced outreach to eligible Medicare
beneficiaries regarding their benefits,
enhanced outreach and application
assistance to individuals who may be
eligible for the Medicare Low Income
Subsidy (LIS) or the Medicare Savings
Program (MSP), and for the purposes of
conducting outreach activities aimed at
preventing disease and promoting
wellness.
Priority Area 2—Grants to State Units
on Aging for Area Agencies on Aging to
provide enhanced outreach to eligible
Medicare beneficiaries regarding their
Medicare benefits, enhanced outreach
and one-on-one application assistance
to individuals who may be eligible for
the LIS or the MSP, and for the purposes
of conducting outreach activities aimed
at preventing disease and promoting
wellness.
Priority Area 3—Grants to State Units
on Aging that administer the Aging and
Disability Resource Centers to provide
outreach to individuals regarding their
Medicare Part D benefits, benefits
available under the LIS and MSP, and
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
26059
for the purposes of conducting outreach
activities aimed at preventing disease
and promoting wellness.
2. Anticipated Total Priority Area
Funding per Budget Period
ACL intends to make available, under
this program announcement, grant
awards for the three MIPPA priority
areas. Funding will be distributed
through a formula as identified in
statute. ACL will fund total project
periods of up to two (2) years,
contingent upon availability of federal
funds.
Priority Area 1—SHIP: Up to $13
million in Fiscal Year (FY) 2018 and
$13 million in FY 2019 for state
agencies that administer the SHIP
Program.
Priority Area 2—AAA: Up to $7.5
million in FY 2018 and $7.5 million in
FY 2019 for State Units on Aging for
Area Agencies on Aging and for Native
American programs. Funding for Native
American Programs ($270,000) is
deducted from Priority 2 and is being
allocated through a separate process.
Priority Area 3—ADRC: Up to $5
million in FY 2018 and $5 million in FY
2019 for State Agencies that received an
ACL, CMS, VHA Aging and Disability
Resource Center (ADRC)/No Wrong
Door System (NWD) grant at any point
in time to support the development of
their ADRC/NWD Systems.
III. Eligibility Criteria and Other
Requirements
1. Eligible Applicants MIPPA Priority
Areas 1, 2 and 3: Awards made under
this announcement, by statute, will be
made only to agencies of State
Governments.
Priority Area 1: Only existing SHIP
grant recipients are eligible to apply.
Priority Area 2: Only State Units on
Aging are eligible to apply.
Priority Area 3: Only State Agencies
that received an ACL, CMS, VHA Aging
and Disability Resource Center (ADRC)/
No Wrong Door System (NWD) grant to
support the development of their ADRC/
NWD Systems at any point in time are
eligible for MIPPA funding under this
priority area.
Eligibility may change if future
funding is made available.
2. Cost Sharing or Matching is not
required.
3. DUNS Number
All grant applicants must obtain and
keep current a D–U–N–S number from
Dun and Bradstreet. It is a nine-digit
identification number, which provides
unique identifiers of single business
entities. The D–U–N–S number can be
obtained from: https://iupdate.dnb.com/
iUpdate/viewiUpdateHome.htm.
E:\FR\FM\05JNN1.SGM
05JNN1
26060
Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices
4. A final narrative report will be due
at the end of the grant period. This final
report will replace the last semi-annual
narrative and must cover the entire life
of the grant. The final narrative report
is due 90 days after the end of the award
(December 31, 2020).
4. Intergovernmental Review
Executive Order 12372,
Intergovernmental Review of Federal
Programs, is not applicable to these
grant applications.
amozie on DSK3GDR082PROD with NOTICES1
IV. Reporting
1. MIPPA Grantees will be required to
report data in the SHIP Tracking and
Reporting System (STARS). STARS is
the nationwide, web-based data system
that facilitates reporting of activities
completed by SHIP and MIPPA
Grantees. All required data must be
submitted accurately, completely, and
on time, and in the format specified by
ACL. All reports shall be completed
according to instructions distributed by
ACL for grantees. States using
proprietary systems (and all proprietary
agencies operating within a state) must
submit data into a fully compliant data
system reflecting STARS Data System
specifications, with no unresolved
errors as a condition of eligibility for
continued MIPPA funding.
2. Financial Reporting Requirements:
ACL requires the submission of the SF–
425 (Federal Financial Report) semiannually. The reporting cycle will be
reflected in the Notice of Award. The
annual SF–425 is due 30 days after the
end of each semi-annual reporting
period. The final SF–425 report is due
90 days after the end of the project
period for each priority area. Grantees
are required to complete the federal
cash transactions portion of the SF–425
within the Payment Management
System (PMS) for each priority area as
identified in their award documents for
the calendar quarters ending 3/31, 6/30,
9/30. And 12/31 through the life of their
award. In addition, the fully completed
SF–425 will be required as denoted in
the Notice of Award terms and
conditions.
3. MIPPA Performance Reporting
Requirements: All successful applicants
must submit a MIPPA narrative progress
report twice a year to ACL. The reports
shall include: A description of the
progress make toward meeting each of
the MIPPA objectives outlined in the
funding opportunity announcement. As
part of the narrative progress reports,
the grantee must provide details of how
the program expects to meet the goals
described in their state plan submission.
The narrative progress reports must be
uploaded through
www.grantsolutions.gov for each
priority area. The narrative progress
reports cover the following periods and
due dates annually: (a) September 30
through March 31—due April 30; (b)
April 1 through September 29—due
October 31.
VerDate Sep<11>2014
20:19 Jun 04, 2018
Jkt 241001
V. Submission Information
1. Application Kits
Application kits/Program Instructions
are available at www.grantsolutions.gov.
Instructions for completing the
application kit will be available on the
site. For help in locating this
information contact the ACL Agency
Contact identified below. Note:
Applicants must submit a separate SF–
424 for each priority area with their
application packages. Additional
detailed instructions will be available in
the Application Kit.
2. Submission Dates and Times
To receive consideration, applications
must be submitted by 11:59 p.m. Eastern
time on August 1, 2018, through
www.GrantSolutions.gov.
VI. Agency Contacts
Direct inquiries regarding
programmatic issues to U.S. Department
of Health and Human Services,
Administration for Community Living,
Office of Healthcare Information and
Counseling, Washington, DC 20201,
attention: Katie Glendening or by calling
202–795–7350 or by email
Katherine.Glendening@acl.hhs.gov.
Dated: May 30, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018–12046 Filed 6–4–18; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1922]
Formal Meetings Between the Food
and Drug Administration and Sponsors
or Applicants of Biosimilar User Fee
Act Products; 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 ‘‘Formal
Meetings Between the FDA and
Sponsors or Applicants of BsUFA
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
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Products.’’ This draft guidance provides
recommendations to industry on formal
meetings between FDA and sponsors or
applicants relating to the development
and review of biosimilar or
interchangeable biological products
regulated by the Center for Drug
Evaluation and Research (CDER) or the
Center for Biologics Evaluation and
Research (CBER). The previous
guidance for industry entitled ‘‘Formal
Meetings Between the FDA and
Biosimilar Biological Product Sponsors
or Applicants,’’ issued on November 18,
2015, has been withdrawn.
DATES: Submit either electronic or
written comments on the draft guidance
by September 4, 2018 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:
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
E:\FR\FM\05JNN1.SGM
05JNN1
Agencies
[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Pages 26059-26060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration on Community Living
Availability of Program Application Instructions for MIPPA
Program Funds
AGENCY: Administration for Community Living, HHS.
Title: Medicare Improvements for Patients and Providers Act: State
Plans for Medicare Savings Program, Low Income Subsidy & Prescription
Drug Enrollment Outreach and Assistance.
Announcement Type: Initial.
Funding Opportunity Number: CIP-MI-18-001.
Statutory Authority: The Medicare Improvements for Patients and
Providers Act of 2008--Section 119, Public Law (Pub. L.) 110-275 as
amended by the Patient Protection and Affordable Care Act of 2010
(Affordable Care Act), reauthorized by the American Taxpayer Relief Act
of 2012 (ATRA), reauthorized by section 110 of the Protecting Access to
Medicare Act of 2014 and reauthorized by the Medicare Access and CHIP
Reauthorization Act of 2015, and was reauthorized for two years under
the Bipartisan Budget Act of 2018 (Pub. L. 115-123, BBA of 2018).
Catalog of Federal Domestic Assistance (CFDA) Number: 93.071.
Dates: The deadline for the submission of MIPPA Program State Plans
is 11:59 p.m. EST August 3, 2018.
I. Funding Opportunity Description
The purpose of MIPPA funding is to enhance state efforts to provide
assistance to Medicare beneficiaries through statewide and local
coalition building focused on intensified outreach activities to
beneficiaries likely to be eligible for the Low Income Subsidy program
(LIS) or the Medicare Savings Program (MSP) and in assisting those
beneficiaries in applying for benefits. ACL will provide MIPPA program
funding to State Health Insurance Assistance Programs (SHIPs), Area
Agencies on Aging (AAAs), and Aging and Disability Resource Center
programs (ADRCs), to inform Medicare beneficiaries about available
Medicare program benefits. ACL seeks plans from states that will
describe how the MIPPA program funds will be used for beneficiary
outreach, education, and one-on-one application assistance over the
next two years.
ACL requests that states submit a two (2) year state plan with
specific project strategies to expand, extend, or enhance their one-on-
one assistance, education, and group outreach efforts to Medicare
beneficiaries on Medicare and assistance programs for those with
limited incomes. States should describe how the SHIP, AAA, and ADRC
efforts will be coordinated to provide outreach to beneficiaries with
limited incomes statewide. States that are eligible to apply are asked
to review previous MIPPA plans and update these plans to reflect
successes achieved to date and direct their efforts to enhance and
expand their MIPPA outreach activities. State agencies may prepare
either one statewide plan or separate plans for each eligible State
agency. Program Instructions will be available to applicants through
ACL. ACL will also host an applicant teleconference on Tuesday, June
19th, 2018 at 2:00 p.m. Eastern. Call in number: 202-774-2300. Meeting
Number: 998 701 573.
II. Award Information
1. Funding Instrument Type
These awards will be made in the form of grants to State Agencies
for each MIPPA Priority Area:
Priority Area 1--Grants to State Agencies (the State Unit on Aging
or the State Department of Insurance) that administer the State Health
Insurance Assistance Program (SHIP) to provide enhanced outreach to
eligible Medicare beneficiaries regarding their benefits, enhanced
outreach and application assistance to individuals who may be eligible
for the Medicare Low Income Subsidy (LIS) or the Medicare Savings
Program (MSP), and for the purposes of conducting outreach activities
aimed at preventing disease and promoting wellness.
Priority Area 2--Grants to State Units on Aging for Area Agencies
on Aging to provide enhanced outreach to eligible Medicare
beneficiaries regarding their Medicare benefits, enhanced outreach and
one-on-one application assistance to individuals who may be eligible
for the LIS or the MSP, and for the purposes of conducting outreach
activities aimed at preventing disease and promoting wellness.
Priority Area 3--Grants to State Units on Aging that administer the
Aging and Disability Resource Centers to provide outreach to
individuals regarding their Medicare Part D benefits, benefits
available under the LIS and MSP, and for the purposes of conducting
outreach activities aimed at preventing disease and promoting wellness.
2. Anticipated Total Priority Area Funding per Budget Period
ACL intends to make available, under this program announcement,
grant awards for the three MIPPA priority areas. Funding will be
distributed through a formula as identified in statute. ACL will fund
total project periods of up to two (2) years, contingent upon
availability of federal funds.
Priority Area 1--SHIP: Up to $13 million in Fiscal Year (FY) 2018
and $13 million in FY 2019 for state agencies that administer the SHIP
Program.
Priority Area 2--AAA: Up to $7.5 million in FY 2018 and $7.5
million in FY 2019 for State Units on Aging for Area Agencies on Aging
and for Native American programs. Funding for Native American Programs
($270,000) is deducted from Priority 2 and is being allocated through a
separate process.
Priority Area 3--ADRC: Up to $5 million in FY 2018 and $5 million
in FY 2019 for State Agencies that received an ACL, CMS, VHA Aging and
Disability Resource Center (ADRC)/No Wrong Door System (NWD) grant at
any point in time to support the development of their ADRC/NWD Systems.
III. Eligibility Criteria and Other Requirements
1. Eligible Applicants MIPPA Priority Areas 1, 2 and 3: Awards made
under this announcement, by statute, will be made only to agencies of
State Governments.
Priority Area 1: Only existing SHIP grant recipients are eligible
to apply.
Priority Area 2: Only State Units on Aging are eligible to apply.
Priority Area 3: Only State Agencies that received an ACL, CMS, VHA
Aging and Disability Resource Center (ADRC)/No Wrong Door System (NWD)
grant to support the development of their ADRC/NWD Systems at any point
in time are eligible for MIPPA funding under this priority area.
Eligibility may change if future funding is made available.
2. Cost Sharing or Matching is not required.
3. DUNS Number
All grant applicants must obtain and keep current a D-U-N-S number
from Dun and Bradstreet. It is a nine-digit identification number,
which provides unique identifiers of single business entities. The D-U-
N-S number can be obtained from: https://iupdate.dnb.com/iUpdate/viewiUpdateHome.htm.
[[Page 26060]]
4. Intergovernmental Review
Executive Order 12372, Intergovernmental Review of Federal
Programs, is not applicable to these grant applications.
IV. Reporting
1. MIPPA Grantees will be required to report data in the SHIP
Tracking and Reporting System (STARS). STARS is the nationwide, web-
based data system that facilitates reporting of activities completed by
SHIP and MIPPA Grantees. All required data must be submitted
accurately, completely, and on time, and in the format specified by
ACL. All reports shall be completed according to instructions
distributed by ACL for grantees. States using proprietary systems (and
all proprietary agencies operating within a state) must submit data
into a fully compliant data system reflecting STARS Data System
specifications, with no unresolved errors as a condition of eligibility
for continued MIPPA funding.
2. Financial Reporting Requirements: ACL requires the submission of
the SF-425 (Federal Financial Report) semi-annually. The reporting
cycle will be reflected in the Notice of Award. The annual SF-425 is
due 30 days after the end of each semi-annual reporting period. The
final SF-425 report is due 90 days after the end of the project period
for each priority area. Grantees are required to complete the federal
cash transactions portion of the SF-425 within the Payment Management
System (PMS) for each priority area as identified in their award
documents for the calendar quarters ending 3/31, 6/30, 9/30. And 12/31
through the life of their award. In addition, the fully completed SF-
425 will be required as denoted in the Notice of Award terms and
conditions.
3. MIPPA Performance Reporting Requirements: All successful
applicants must submit a MIPPA narrative progress report twice a year
to ACL. The reports shall include: A description of the progress make
toward meeting each of the MIPPA objectives outlined in the funding
opportunity announcement. As part of the narrative progress reports,
the grantee must provide details of how the program expects to meet the
goals described in their state plan submission. The narrative progress
reports must be uploaded through www.grantsolutions.gov for each
priority area. The narrative progress reports cover the following
periods and due dates annually: (a) September 30 through March 31--due
April 30; (b) April 1 through September 29--due October 31.
4. A final narrative report will be due at the end of the grant
period. This final report will replace the last semi-annual narrative
and must cover the entire life of the grant. The final narrative report
is due 90 days after the end of the award (December 31, 2020).
V. Submission Information
1. Application Kits
Application kits/Program Instructions are available at
www.grantsolutions.gov. Instructions for completing the application kit
will be available on the site. For help in locating this information
contact the ACL Agency Contact identified below. Note: Applicants must
submit a separate SF-424 for each priority area with their application
packages. Additional detailed instructions will be available in the
Application Kit.
2. Submission Dates and Times
To receive consideration, applications must be submitted by 11:59
p.m. Eastern time on August 1, 2018, through www.GrantSolutions.gov.
VI. Agency Contacts
Direct inquiries regarding programmatic issues to U.S. Department
of Health and Human Services, Administration for Community Living,
Office of Healthcare Information and Counseling, Washington, DC 20201,
attention: Katie Glendening or by calling 202-795-7350 or by email
[email protected].
Dated: May 30, 2018.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2018-12046 Filed 6-4-18; 8:45 am]
BILLING CODE 4154-01-P