Notice of Intent To Award a Single Source Non-Competing Continuation Cooperative Agreement for two Alzheimer's Disease Supportive Services Program (ADSSP) Projects, 51276-51277 [2015-20796]
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51276
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
Comments on the collection(s) of
information must be received by the
OMB desk officer by September 23,
2015.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 or, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
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: Revision of a currently
approved collection; Title of
Information Collection: Medicare Part D
Reporting Requirements and Supporting
Regulations; Use: To ensure quality
provision of the Medicare Prescription
Drug Benefit to beneficiaries, the
collected information will serve as an
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DATES:
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integral resource for oversight,
monitoring, compliance, and auditing
activities. Sponsors should retain
documentation and data records related
to their data submissions. Data will be
validated, analyzed, and utilized for
trend reporting. For CY 2016 reporting,
the following sections will be reported
and collected at the Contract-level or
Plan-level: (1) Enrollment and
disenrollment, (2) retail, home infusion,
and long-term care pharmacy access, (3)
medication therapy management
programs, (4) grievances, (5) coverage
determinations and redeterminations,
(6) long term care utilization, (7)
employer/union sponsored sponsors,
and (8) plan oversight of agents. Form
Number: CMS–10185 (OMB control
number 0938–0992); Frequency:
Annually and semi-annually; Affected
Public: Private sector (Business or other
for-profits); Number of Respondents:
694; Total Annual Responses: 6,875;
Total Annual Hours: 10,865. (For policy
questions regarding this collection
contact Chanelle Jones at 410–786–
8008).
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Part C Medicare
Advantage Reporting Requirements and
Supporting Regulations; Use: There are
a number of information users of Part C
reporting data, including our central
and regional office staff that use this
information to monitor health plans and
to hold them accountable for their
performance, researchers, and other
government agencies such as the
Government Accounting Office. Health
plans can use this information to
measure and benchmark their
performance. Form Number: CMS–
10261 (OMB control number 0938–
1054); Frequency: Annually and semiannually; Affected Public: Private sector
(Business or other for-profits); Number
of Respondents: 561; Total Annual
Responses: 3,508; Total Annual Hours:
201,503. (For policy questions regarding
this collection contact Terry Lied at
410–786–8973).
3. Type of Information Collection
Request: New collection (Request for
new OMB control number); Title of
Information Collection: Essential
Community Provider Data Collection to
Support QHP Certification for PY 2017;
Use: For plan years beginning on or after
January 1, 2017, Health and Human
Services (HHS) intends to collect more
complete provider data for inclusion on
the HHS Essential Community Provider
(ECP) list to ensure a more accurate
reflection of the universe of qualified
available ECPs in a given service area
that can be counted toward an issuer’s
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satisfaction of the ECP standard. The
HHS will collect data on qualified and
available ECPs from providers.
Providers will submit an ECP petition to
be added to the HHS ECP list or provide
required missing data fields to remain
on the list. The degree of provider
participation in this data collection
effort through the ECP provider petition
will help inform HHS’s future proposals
for counting issuers’ ECP write-ins
toward satisfaction of the ECP standard.
Form Number: CMS–10561 (OMB
control number: 0938–New); Frequency:
Annually; Affected Public: Private
sector (Business or other for-profits and
Not-for-profit Institutions); Number of
Respondents: 31,634; Total Annual
Responses: 31,634; Total Annual Hours:
53,491. (For policy questions regarding
this collection contact Deborah Hunter
at 410–786–0625.)
Dated: August 18, 2015.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–20787 Filed 8–21–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Notice of Intent To Award a Single
Source Non-Competing Continuation
Cooperative Agreement for two
Alzheimer’s Disease Supportive
Services Program (ADSSP) Projects
Program Name: Alzheimer’s Disease
Supportive Services Program.
Award Amount: $625,809.
Project Period: September 30, 2015
through September 29, 2016.
Award Type: Cooperative Agreement.
Statutory Authority: Public Law 78–
410: 42 U.S.C. 280c–3. It was amended
by Public Law 101–557 and by Public
Law 105–392.
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.051.
Program Description
The Administration for Community
Living (ACL) is announcing its intent to
award single source non-competing
continuation cooperative agreements to
two Alzheimer’s Disease Supportive
Services Program (ADSSP) projects.
Resources dedicated to the ADSSP grant
program are restricted to the support of
grants to states designed to expand the
availability of dementia-capable support
services for persons with Alzheimer’s
disease and related dementias (ADRD),
their families and caregivers.
E:\FR\FM\24AUN1.SGM
24AUN1
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
There are currently 15 active ADSSP
grantees engaged in the development of
dementia-capable systems in their state
to support individuals with ADRD and
their caregivers. ACL will provide
additional resources to support the
expansion of promising program
activities under existing ADSSP projects
in the states of Minnesota and Ohio.
Both the Minnesota and Ohio grantees
are engaged in projects that are building
the dementia-capability of their state
systems that merit expansion. The state
of Minnesota will expand on their
existing program efforts to build strong
linkages between a Health Care Partner
(HCP) and Community Based
Organizations (CBO). The state of Ohio
will expand on their existing ADSSP
project goal to enrich the lives of
veterans suffering from cognitive and
physical challenges and their caregivers
by expanding Ohio’s Music &
MemorySM program living in their
homes and communities.
Justification: ACL is committed to the
success, continued expansion and
sustainability of ADSSP projects. Each
of the identified existing cooperative
agreement projects has components
within them from which the
communities that they serve will benefit
and merit uninterrupted expansion. To
ensure uninterrupted continuation
toward achieving and exceeding their
goals and objectives and expansion of
program efforts, ACL plans to issue oneyear non-competing awards to both the
Minnesota Board on Aging and the Ohio
Department on Aging.
I. Agency Contact
For further information or comments
regarding this action, contact Erin Long,
U.S. Department of Health and Human
Services, Administration for
Community Living, Administration on
Aging, Washington, DC 20201;
telephone (202) 357–3448; fax (202)
357–3549; email Erin.Long@acl.hhs.gov.
Dated: August 11, 2015.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2015–20796 Filed 8–21–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2014–N–0229]
Use of Rare Pediatric Disease Priority
Review Voucher; Approval of a Drug
Product
AGENCY:
Food and Drug Administration,
HHS.
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16:48 Aug 21, 2015
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
recent approval of a drug product under
an application for which the sponsor
redeemed a rare pediatric disease
priority review voucher. The Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Food and
Drug Administration Safety and
Innovation Act (FDASIA), authorizes
FDA to redeem priority review vouchers
submitted by sponsors of product
applications that might otherwise not
qualify for priority review. These
vouchers entitle the holder of such a
voucher to priority review of a single
human drug application submitted
under the FD&C Act or the Public
Health Service Act. FDA has approved
PRALUENT (alirocumab), manufactured
by Sanofi-Aventis U.S. Inc., under a
priority review.
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4842, FAX: 301–796–9858,
email: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the recent approval of a
drug product under an application for
which the sponsor redeemed a rare
pediatric disease priority review
voucher. Under section 529 of the FD&C
Act (21 U.S.C. 360ff), added by FDASIA,
FDA will grant a priority review for a
new drug or biological product
application that redeems a priority
review voucher, even if that product
might not otherwise qualify for a
priority review. FDA has recently
approved PRALUENT (alirocumab),
manufactured by Sanofi-Aventis U.S.
Inc., under a priority review.
PRALUENT (alirocumab) is indicated as
an adjunct to diet and maximally
tolerated statin therapy for the treatment
of adults with heterozygous familial
hypercholesterolemia or clinical
atherosclerotic cardiovascular disease,
who require additional lowering of lowdensity lipoprotein cholesterol.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm.
For further information about
PRALUENT (alirocumab), go to the
Drugs@FDA Web site at https://
www.accessdata.fda.gov/scripts/cder/
drugsatfda/index.cfm.
SUMMARY:
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51277
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20833 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2489]
Receipt of Notice That a Patent
Infringement Complaint Was Filed
Against a Biosimilar Applicant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6208, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
SUMMARY:
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51276-51277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20796]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Notice of Intent To Award a Single Source Non-Competing
Continuation Cooperative Agreement for two Alzheimer's Disease
Supportive Services Program (ADSSP) Projects
Program Name: Alzheimer's Disease Supportive Services Program.
Award Amount: $625,809.
Project Period: September 30, 2015 through September 29, 2016.
Award Type: Cooperative Agreement.
Statutory Authority: Public Law 78-410: 42 U.S.C. 280c-3. It was
amended by Public Law 101-557 and by Public Law 105-392.
Catalog of Federal Domestic Assistance (CFDA) Number: 93.051.
Program Description
The Administration for Community Living (ACL) is announcing its
intent to award single source non-competing continuation cooperative
agreements to two Alzheimer's Disease Supportive Services Program
(ADSSP) projects. Resources dedicated to the ADSSP grant program are
restricted to the support of grants to states designed to expand the
availability of dementia-capable support services for persons with
Alzheimer's disease and related dementias (ADRD), their families and
caregivers.
[[Page 51277]]
There are currently 15 active ADSSP grantees engaged in the
development of dementia-capable systems in their state to support
individuals with ADRD and their caregivers. ACL will provide additional
resources to support the expansion of promising program activities
under existing ADSSP projects in the states of Minnesota and Ohio. Both
the Minnesota and Ohio grantees are engaged in projects that are
building the dementia-capability of their state systems that merit
expansion. The state of Minnesota will expand on their existing program
efforts to build strong linkages between a Health Care Partner (HCP)
and Community Based Organizations (CBO). The state of Ohio will expand
on their existing ADSSP project goal to enrich the lives of veterans
suffering from cognitive and physical challenges and their caregivers
by expanding Ohio's Music & Memory\SM\ program living in their homes
and communities.
Justification: ACL is committed to the success, continued expansion
and sustainability of ADSSP projects. Each of the identified existing
cooperative agreement projects has components within them from which
the communities that they serve will benefit and merit uninterrupted
expansion. To ensure uninterrupted continuation toward achieving and
exceeding their goals and objectives and expansion of program efforts,
ACL plans to issue one-year non-competing awards to both the Minnesota
Board on Aging and the Ohio Department on Aging.
I. Agency Contact
For further information or comments regarding this action, contact
Erin Long, U.S. Department of Health and Human Services, Administration
for Community Living, Administration on Aging, Washington, DC 20201;
telephone (202) 357-3448; fax (202) 357-3549; email
Erin.Long@acl.hhs.gov.
Dated: August 11, 2015.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2015-20796 Filed 8-21-15; 8:45 am]
BILLING CODE 4154-01-P
