80 FR 51276 - Notice of Intent To Award a Single Source Non-Competing Continuation Cooperative Agreement for two Alzheimer's Disease Supportive Services Program (ADSSP) Projects
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living Federal Register Volume 80, Issue 163 (August 24, 2015)
Administration for Community Living
Federal Register Volume 80, Issue 163 (August 24, 2015)
| Page Range | 51276-51277 | |
| FR Document | 2015-20796 |
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)] [Notices] [Pages 51276-51277] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![51276 Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
DATES: Comments on the collection(s) of integral resource for oversight, satisfaction of the ECP standard. The
information must be received by the monitoring, compliance, and auditing HHS will collect data on qualified and
OMB desk officer by September 23, activities. Sponsors should retain available ECPs from providers.
2015. documentation and data records related Providers will submit an ECP petition to
ADDRESSES: When commenting on the to their data submissions. Data will be be added to the HHS ECP list or provide
proposed information collections, validated, analyzed, and utilized for required missing data fields to remain
please reference the document identifier trend reporting. For CY 2016 reporting, on the list. The degree of provider
or OMB control number. To be assured the following sections will be reported participation in this data collection
consideration, comments and and collected at the Contract-level or effort through the ECP provider petition
recommendations must be received by Plan-level: (1) Enrollment and will help inform HHS’s future proposals
the OMB desk officer via one of the disenrollment, (2) retail, home infusion, for counting issuers’ ECP write-ins
following transmissions: OMB, Office of and long-term care pharmacy access, (3) toward satisfaction of the ECP standard.
Information and Regulatory Affairs, medication therapy management Form Number: CMS–10561 (OMB
Attention: CMS Desk Officer, Fax programs, (4) grievances, (5) coverage control number: 0938–New); Frequency:
Number: (202) 395–5806 or, Email: determinations and redeterminations, Annually; Affected Public: Private
OIRA_submission@omb.eop.gov. (6) long term care utilization, (7) sector (Business or other for-profits and
To obtain copies of a supporting employer/union sponsored sponsors, Not-for-profit Institutions); Number of
statement and any related forms for the and (8) plan oversight of agents. Form Respondents: 31,634; Total Annual
proposed collection(s) summarized in Number: CMS–10185 (OMB control Responses: 31,634; Total Annual Hours:
this notice, you may make your request number 0938–0992); Frequency: 53,491. (For policy questions regarding
using one of following: Annually and semi-annually; Affected this collection contact Deborah Hunter
1. Access CMS’ Web site address at Public: Private sector (Business or other at 410–786–0625.)
http://www.cms.hhs.gov/ for-profits); Number of Respondents:
Dated: August 18, 2015.
PaperworkReductionActof1995. 694; Total Annual Responses: 6,875;
Total Annual Hours: 10,865. (For policy Martique Jones,
2. Email your request, including your
questions regarding this collection Director, Regulations Development Group,
address, phone number, OMB number,
contact Chanelle Jones at 410–786– Office of Strategic Operations and Regulatory
and CMS document identifier, to Affairs.
Paperwork@cms.hhs.gov. 8008).
2. Type of Information Collection [FR Doc. 2015–20787 Filed 8–21–15; 8:45 am]
3. Call the Reports Clearance Office at
(410) 786–1326. Request: Revision of a currently BILLING CODE 4120–01–P
FOR FURTHER INFORMATION CONTACT: approved collection; Title of
Reports Clearance Office at (410) 786– Information Collection: Part C Medicare
Advantage Reporting Requirements and DEPARTMENT OF HEALTH AND
1326. HUMAN SERVICES
Supporting Regulations; Use: There are
SUPPLEMENTARY INFORMATION: Under the a number of information users of Part C
Paperwork Reduction Act of 1995 (PRA) reporting data, including our central Administration for Community Living
(44 U.S.C. 3501–3520), federal agencies and regional office staff that use this
must obtain approval from the Office of Notice of Intent To Award a Single
information to monitor health plans and Source Non-Competing Continuation
Management and Budget (OMB) for each to hold them accountable for their
collection of information they conduct Cooperative Agreement for two
performance, researchers, and other Alzheimer’s Disease Supportive
or sponsor. The term ‘‘collection of government agencies such as the
information’’ is defined in 44 U.S.C. Services Program (ADSSP) Projects
Government Accounting Office. Health
3502(3) and 5 CFR 1320.3(c) and plans can use this information to Program Name: Alzheimer’s Disease
includes agency requests or measure and benchmark their Supportive Services Program.
requirements that members of the public performance. Form Number: CMS– Award Amount: $625,809.
submit reports, keep records, or provide 10261 (OMB control number 0938– Project Period: September 30, 2015
information to a third party. Section 1054); Frequency: Annually and semi- through September 29, 2016.
3506(c)(2)(A) of the PRA (44 U.S.C. annually; Affected Public: Private sector Award Type: Cooperative Agreement.
3506(c)(2)(A)) requires federal agencies (Business or other for-profits); Number Statutory Authority: Public Law 78–
to publish a 30-day notice in the of Respondents: 561; Total Annual 410: 42 U.S.C. 280c–3. It was amended
Federal Register concerning each Responses: 3,508; Total Annual Hours: by Public Law 101–557 and by Public
proposed collection of information, 201,503. (For policy questions regarding Law 105–392.
including each proposed extension or this collection contact Terry Lied at Catalog of Federal Domestic
reinstatement of an existing collection 410–786–8973). Assistance (CFDA) Number: 93.051.
of information, before submitting the 3. Type of Information Collection
collection to OMB for approval. To Program Description
Request: New collection (Request for
comply with this requirement, CMS is new OMB control number); Title of The Administration for Community
publishing this notice that summarizes Information Collection: Essential Living (ACL) is announcing its intent to
the following proposed collection(s) of Community Provider Data Collection to award single source non-competing
information for public comment: Support QHP Certification for PY 2017; continuation cooperative agreements to
1. Type of Information Collection Use: For plan years beginning on or after two Alzheimer’s Disease Supportive
Request: Revision of a currently January 1, 2017, Health and Human Services Program (ADSSP) projects.
tkelley on DSK3SPTVN1PROD with NOTICES
approved collection; Title of Services (HHS) intends to collect more Resources dedicated to the ADSSP grant
Information Collection: Medicare Part D complete provider data for inclusion on program are restricted to the support of
Reporting Requirements and Supporting the HHS Essential Community Provider grants to states designed to expand the
Regulations; Use: To ensure quality (ECP) list to ensure a more accurate availability of dementia-capable support
provision of the Medicare Prescription reflection of the universe of qualified services for persons with Alzheimer’s
Drug Benefit to beneficiaries, the available ECPs in a given service area disease and related dementias (ADRD),
collected information will serve as an that can be counted toward an issuer’s their families and caregivers.
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![Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices 51277
There are currently 15 active ADSSP ACTION: Notice. Dated: August 19, 2015.
grantees engaged in the development of Leslie Kux,
dementia-capable systems in their state SUMMARY: The Food and Drug
Associate Commissioner for Policy.
to support individuals with ADRD and Administration (FDA) is announcing the
[FR Doc. 2015–20833 Filed 8–21–15; 8:45 am]
their caregivers. ACL will provide recent approval of a drug product under
an application for which the sponsor BILLING CODE 4164–01–P
additional resources to support the
expansion of promising program redeemed a rare pediatric disease
activities under existing ADSSP projects priority review voucher. The Federal
Food, Drug, and Cosmetic Act (the DEPARTMENT OF HEALTH AND
in the states of Minnesota and Ohio. HUMAN SERVICES
Both the Minnesota and Ohio grantees FD&C Act), as amended by the Food and
are engaged in projects that are building Drug Administration Safety and Food and Drug Administration
the dementia-capability of their state Innovation Act (FDASIA), authorizes
systems that merit expansion. The state FDA to redeem priority review vouchers [Docket No. FDA–2015–N–2489]
of Minnesota will expand on their submitted by sponsors of product
applications that might otherwise not Receipt of Notice That a Patent
existing program efforts to build strong Infringement Complaint Was Filed
linkages between a Health Care Partner qualify for priority review. These
vouchers entitle the holder of such a Against a Biosimilar Applicant
(HCP) and Community Based
Organizations (CBO). The state of Ohio voucher to priority review of a single AGENCY: Food and Drug Administration,
will expand on their existing ADSSP human drug application submitted HHS.
project goal to enrich the lives of under the FD&C Act or the Public
Health Service Act. FDA has approved ACTION: Notice.
veterans suffering from cognitive and
physical challenges and their caregivers PRALUENT (alirocumab), manufactured SUMMARY: The Food and Drug
by expanding Ohio’s Music & by Sanofi-Aventis U.S. Inc., under a Administration (FDA) is publishing
MemorySM program living in their priority review. notice that an applicant for a proposed
homes and communities. FOR FURTHER INFORMATION CONTACT: biosimilar product notified FDA that a
Justification: ACL is committed to the Larry Bauer, Rare Diseases Program, patent infringement action was filed in
success, continued expansion and Center for Drug Evaluation and connection with the applicant’s
sustainability of ADSSP projects. Each Research, Food and Drug biologics license application (BLA).
of the identified existing cooperative Administration, 10903 New Hampshire Under the Public Health Service Act
agreement projects has components Ave., Silver Spring, MD 20993–0002, (PHS Act), an applicant for a proposed
within them from which the 301–796–4842, FAX: 301–796–9858, biosimilar product or interchangeable
communities that they serve will benefit email: larry.bauer@fda.hhs.gov. product must notify FDA within 30 days
and merit uninterrupted expansion. To SUPPLEMENTARY INFORMATION: FDA is after the applicant was served with a
ensure uninterrupted continuation announcing the recent approval of a complaint in a patent infringement
toward achieving and exceeding their drug product under an application for action described under the PHS Act.
goals and objectives and expansion of which the sponsor redeemed a rare FDA is required to publish notice of the
program efforts, ACL plans to issue one- pediatric disease priority review complaint in the Federal Register.
year non-competing awards to both the voucher. Under section 529 of the FD&C
FOR FURTHER INFORMATION CONTACT:
Minnesota Board on Aging and the Ohio Act (21 U.S.C. 360ff), added by FDASIA,
Daniel Orr, Center for Drug Evaluation
Department on Aging. FDA will grant a priority review for a
and Research, Food and Drug
new drug or biological product
I. Agency Contact Administration, 10903 New Hampshire
application that redeems a priority
For further information or comments Ave., Bldg. 51, Rm. 6208, Silver Spring,
review voucher, even if that product
regarding this action, contact Erin Long, MD 20993–0002, 240–402–0979,
might not otherwise qualify for a
U.S. Department of Health and Human daniel.orr@fda.hhs.gov.
priority review. FDA has recently
Services, Administration for approved PRALUENT (alirocumab), SUPPLEMENTARY INFORMATION: The
Community Living, Administration on manufactured by Sanofi-Aventis U.S. Biologics Price Competition and
Aging, Washington, DC 20201; Inc., under a priority review. Innovation Act of 2009 (BPCI Act) was
telephone (202) 357–3448; fax (202) PRALUENT (alirocumab) is indicated as enacted as part of the Patient Protection
357–3549; email Erin.Long@acl.hhs.gov. an adjunct to diet and maximally and Affordable Care Act (Pub. L. 111–
Dated: August 11, 2015. tolerated statin therapy for the treatment 148) on March 23, 2010. The BPCI Act
Kathy Greenlee, of adults with heterozygous familial amended the PHS Act and created an
hypercholesterolemia or clinical abbreviated licensure pathway for
Assistant Secretary for Aging.
atherosclerotic cardiovascular disease, biological products shown to be
[FR Doc. 2015–20796 Filed 8–21–15; 8:45 am]
who require additional lowering of low- biosimilar to, or interchangeable with,
BILLING CODE 4154–01–P
density lipoprotein cholesterol. an FDA-licensed biological reference
For further information about the Rare product. Section 351(k) of the PHS Act
Pediatric Disease Priority Review (42 U.S.C. 262(k)), added by the BPCI
DEPARTMENT OF HEALTH AND
Voucher Program and for a link to the Act, describes the requirements for a
HUMAN SERVICES
full text of section 529 of the FD&C Act, BLA for a proposed biosimilar product
Food and Drug Administration go to http://www.fda.gov/ForIndustry/ or a proposed interchangeable product
DevelopingProductsforRareDiseases (351(k) BLA). Section 351(l) of the PHS
[Docket No. FDA–2014–N–0229]
tkelley on DSK3SPTVN1PROD with NOTICES
Conditions/RarePediatricDiseasePriority Act, also added by the BPCI Act,
VoucherProgram/default.htm. describes certain procedures for
Use of Rare Pediatric Disease Priority
For further information about exchanging patent information and
Review Voucher; Approval of a Drug
PRALUENT (alirocumab), go to the resolving patent disputes between a
Product
Drugs@FDA Web site at http:// 351(k) BLA applicant and the holder of
AGENCY: Food and Drug Administration, www.accessdata.fda.gov/scripts/cder/ the BLA reference product. If a 351(k)
HHS. drugsatfda/index.cfm. applicant is served with a complaint for
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Document Created: 2015-12-15 10:55:03
Document Modified: 2015-12-15 10:55:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 51276 |
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