Advisory Council on Alzheimer's Research, Care, and Services; Meeting, 31400-31401 [2018-14376]
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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices
402–7930, elizabeth.giaquinto@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘ANDA
Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ This guidance finalizes
the October 2017 draft guidance for
industry ‘‘ANDA Submissions—
Amendments to Abbreviated New Drug
Applications Under GDUFA.’’ This
guidance is intended to assist applicants
preparing to submit amendments to
ANDAs or to PASs to FDA under
section 505(j) of the FD&C Act (21
U.S.C. 355(j)) by explaining how the
review goals established as part of
GDUFA II apply to these submissions.
In accordance with the GDUFA
Reauthorization Performance Goals and
Program Enhancements Fiscal Years
2018–2022 (GDUFA II Commitment
Letter: https://www.fda.gov/downloads/
ForIndustry/UserFees/GenericDrug
UserFees/ucm525234.pdf), FDA agreed
to certain review goals and procedures
for the review of amendments pending
as of or received on or after the GDUFA
II effective date.
The GDUFA II Commitment Letter
reflects significant changes in the
classification of and review goals for
amendments to ANDAs and PASs under
the Generic Drug User Fee Amendments
of 2012 (GDUFA I). Under GDUFA I,
amendments were classified into a
complex Tier system based on the
following factors: (1) Whether the
amendment was solicited (submitted in
response to a complete response letter)
or unsolicited (submitted on the
applicant’s own initiative); (2) whether
the amendment was major or minor; the
number of amendments submitted to the
ANDA or PAS; and (3) whether an
inspection was necessary to support the
information contained in the
amendment.
GDUFA II simplified the amendment
review goals and no longer subjects
them to a Tier system; however, review
goals are still dependent on several
factors. In general, under GDUFA II,
amendments will be designated as
either standard or priority; will be
classified as major or minor, and will
receive a goal date based on the factors
discussed in the draft guidance,
including whether a preapproval
inspection is needed. This guidance
supersedes the December 2001 guidance
for industry ‘‘Major, Minor, and
Telephone Amendments to Abbreviated
New Drug Applications’’ and the July
2014 draft guidance for industry
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‘‘ANDA Submissions—Amendments
and Easily Correctable Deficiencies
Under GDUFA,’’ both of which will be
withdrawn. This guidance finalizes the
October 2017 draft guidance for
industry ‘‘ANDA Submissions—
Amendments to Abbreviated New Drug
Applications Under GDUFA.’’ The final
guidance contains clarifications to the
draft guidance of the same title that
published in October 2017.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘ANDA
Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 314.96 have been approved
under OMB control number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14429 Filed 7–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. The
Advisory Council will spend the
majority of the July meeting considering
recommendations made by each of the
three subcommittees to present to the
Secretary of HHS and Congress.
Additional presentations in the
afternoon will include a presentation on
a recent study by RAND on the health
care infrastructure, the CDC/
Alzheimer’s Association’s joint Healthy
Brain Initiative Roadmap, federal
workgroup updates, and updates on
work by the non-federal members.
DATES: The meeting will be held on July
30, 2018 from 9:00 a.m. to 5:00 p.m.
EDT.
ADDRESSES: The meeting will be held in
Room 800 in the Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Washington, DC 20201.
Comments: Time is allocated in the
afternoon on the agenda to hear public
comments. The time for oral comments
will be limited to two (2) minutes per
individual. In lieu of oral comments,
formal written comments may be
submitted for the record to Rohini
Khillan, OASPE, 200 Independence
Avenue SW, Room 424E, Washington,
DC 20201. Comments may also be sent
to napa@hhs.gov. Those submitting
written comments should identify
themselves and any relevant
organizational affiliations. Those
intending to make public comments at
the meeting must submit their
comments either by mail or email ahead
of time for the record. Comments are
due no later than Monday, July 23,
2018.
FOR FURTHER INFORMATION CONTACT:
Rohini Khillan (202) 690–5932,
rohini.khillan@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
napa@hhs.gov and put ‘‘July 30 Meeting
Attendance’’ in the Subject line by
Friday, July 20, so that their names may
be put on a list of expected attendees
and forwarded to the security officers at
the Department of Health and Human
Services. Any interested member of the
public who is a non-U.S. citizen should
include this information at the time of
registration to ensure that the
appropriate security procedure to gain
entry to the building is carried out.
Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given under the
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Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices
Federal Advisory Committee Act
(5 U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The
Advisory Council will spend the
majority of the July meeting considering
recommendations made by each of the
three subcommittees to present to the
Secretary of HHS and Congress.
Additional presentations in the
afternoon will include a presentation on
a recent study by RAND on the health
care infrastructure, the CDC/
Alzheimer’s Association’s joint Healthy
Brain Initiative Roadmap, federal
workgroup updates, and updates on
work by the non-federal members.
Procedure and Agenda: This meeting
is open to the public. Please allow 30
minutes to go through security and walk
to the meeting room. The meeting will
also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: June 28, 2018.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
[FR Doc. 2018–14376 Filed 7–3–18; 8:45 am]
BILLING CODE 4150–05–P
U.S.C. § 5322(e) of the Indian SelfDetermination and Education
Assistance Act (ISDEAA), Public Law
(P.L.) 93–638, as amended. This
program is described in the Catalog of
Federal Domestic Assistance (CFDA)
under 93.228.
Background
The TMG Program is a competitive
grant program that is capacity building
and developmental in nature and has
been available for federally recognized
Indian Tribes and Tribal Organizations
(T/TOs) since shortly after enactment of
the ISDEAA in 1975. The TMG Program
was established to assist T/TOs to
prepare for assuming all or part of
existing IHS programs, functions,
services, and activities (PFSAs) and
further develop and improve Tribal
health management capabilities. The
TMG Program provides competitive
grants to T/TOs to establish goals and
performance measures for current health
programs; assess current management
capacity to determine if new
components are appropriate; analyze
programs to determine if a Tribe or
Tribal Organization’s management is
practicable; and develop infrastructure
systems to manage or organize PFSAs.
Purpose
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Direct Service and
Contracting Tribes; Tribal Management
Grant Program
Announcement Type: New and
Competing Continuation.
Funding Announcement Number:
HHS–2018–IHS–TMD–0001.
Catalog of Federal Domestic
Assistance Number (CFDA): 93.228.
amozie on DSK3GDR082PROD with NOTICES1
Key Dates
Application Deadline Date: August
17, 2018.
Review Date: August 20–24, 2018.
Earliest Anticipated Start Date:
September 1, 2018.
Signed Tribal Resolutions Due Date:
August 17, 2018.
Proof of Non-Profit Status Due Date:
August 17, 2018.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting competitive grant applications
for the Tribal Management Grant (TMG)
Program. This program is authorized
under 25 U.S.C. § 5322(b)(2) and 25
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The purpose of this IHS grant
announcement is to announce the
availability of the TMG Program to
enhance and develop health
management infrastructure and assist T/
TOs in assuming all or part of existing
IHS PFSAs through a Title I contract
and assist established Title I contractors
and Title V compactors to further
develop and improve management
capability. In addition, Tribal
Management Grants are available to T/
TOs under the authority of 25 U.S.C.
5322(e) for the following: (1) Obtaining
technical assistance from providers
designated by the Tribe/Tribal
Organization (including T/TOs that
operate mature contracts) for the
purposes of program planning and
evaluation, including the development
of any management systems necessary
for contract management, and the
development of cost allocation plans for
indirect cost rates; and (2) planning,
designing, monitoring, and evaluating
Federal programs serving T/TOs,
including Federal administrative
functions.
II. Award Information
Type of Award
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Grant.
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31401
Estimated Funds Available
The total amount of funding
identified for the current fiscal year (FY)
2018 is approximately $2,412,000.
Individual award amounts are
anticipated to be between $50,000 and
$100,000. The amount of funding
available for new and competing
continuation awards issued under this
grant announcement is subject to the
availability of appropriations and
budgetary priorities of the Agency. The
IHS is under no obligation to make
awards that are selected for funding
under this grant announcement.
Anticipated Number of Awards
Approximately 16–18 awards will be
issued under this grant announcement.
Period of Performance
The Tribal Management Grant (TMG
Project) period of performance vary
based on the project type selected.
Period of performance could run from 1
to 3 years and will run consecutively
from the earliest anticipated start date of
September 1, 2018 through August 31,
2019, for 1-year projects; September 1,
2018, through August 31, 2020, for 2year projects; and September 1, 2018,
through August 31, 2021, for 3-year
projects. Please refer to ‘‘Eligible TMG
Project Types, Maximum Funding
Levels, and Periods of Performance,’’ for
additional details. State the number of
years for the period of performance and
include the exact dates.
III. Eligibility Information
I.
1. Eligibility
Eligible Applicants: ‘‘Indian Tribes’’
and ‘‘Tribal Organizations’’ (T/TOs) as
defined by the ISDEAA are eligible to
apply for the TMG Program. The
definitions for each entity type are
outlined below. Only one application
per Tribe/Tribal organization is allowed.
Definitions: ‘‘Indian Tribe’’ means any
Indian tribe, band, nation, or other
organized group or community,
including any Alaska Native village or
regional or village corporation as
defined in or established pursuant to the
Alaska Native Claims Settlement Act (85
Stat. 688) [43 U.S.C. 1601 et seq.], which
is recognized as eligible for the special
programs and services provided by the
United States to Indians because of their
status as Indians. 25 U.S.C. 5304(e).
‘‘Tribal organization’’ means the
recognized governing body of any
Indian Tribe; any legally established
organization of Indians which is
controlled, sanctioned, or chartered by
such governing body or which is
democratically elected by the adult
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Agencies
[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31400-31401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14376]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Council on Alzheimer's Research, Care, and Services;
Meeting
AGENCY: Assistant Secretary for Planning and Evaluation, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the public meeting of the Advisory
Council on Alzheimer's Research, Care, and Services (Advisory Council).
The Advisory Council on Alzheimer's Research, Care, and Services
provides advice on how to prevent or reduce the burden of Alzheimer's
disease and related dementias on people with the disease and their
caregivers. The Advisory Council will spend the majority of the July
meeting considering recommendations made by each of the three
subcommittees to present to the Secretary of HHS and Congress.
Additional presentations in the afternoon will include a presentation
on a recent study by RAND on the health care infrastructure, the CDC/
Alzheimer's Association's joint Healthy Brain Initiative Roadmap,
federal workgroup updates, and updates on work by the non-federal
members.
DATES: The meeting will be held on July 30, 2018 from 9:00 a.m. to 5:00
p.m. EDT.
ADDRESSES: The meeting will be held in Room 800 in the Hubert H.
Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
Comments: Time is allocated in the afternoon on the agenda to hear
public comments. The time for oral comments will be limited to two (2)
minutes per individual. In lieu of oral comments, formal written
comments may be submitted for the record to Rohini Khillan, OASPE, 200
Independence Avenue SW, Room 424E, Washington, DC 20201. Comments may
also be sent to [email protected]. Those submitting written comments should
identify themselves and any relevant organizational affiliations. Those
intending to make public comments at the meeting must submit their
comments either by mail or email ahead of time for the record. Comments
are due no later than Monday, July 23, 2018.
FOR FURTHER INFORMATION CONTACT: Rohini Khillan (202) 690-5932,
[email protected]. Note: Seating may be limited. Those wishing to
attend the meeting must send an email to [email protected] and put ``July 30
Meeting Attendance'' in the Subject line by Friday, July 20, so that
their names may be put on a list of expected attendees and forwarded to
the security officers at the Department of Health and Human Services.
Any interested member of the public who is a non-U.S. citizen should
include this information at the time of registration to ensure that the
appropriate security procedure to gain entry to the building is carried
out. Although the meeting is open to the public, procedures governing
security and the entrance to Federal buildings may change without
notice. If you wish to make a public comment, you must note that within
your email.
SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
[[Page 31401]]
Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The Advisory Council will spend the
majority of the July meeting considering recommendations made by each
of the three subcommittees to present to the Secretary of HHS and
Congress. Additional presentations in the afternoon will include a
presentation on a recent study by RAND on the health care
infrastructure, the CDC/Alzheimer's Association's joint Healthy Brain
Initiative Roadmap, federal workgroup updates, and updates on work by
the non-federal members.
Procedure and Agenda: This meeting is open to the public. Please
allow 30 minutes to go through security and walk to the meeting room.
The meeting will also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section 2(e)(3) of the National
Alzheimer's Project Act. The panel is governed by provisions of
Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets
forth standards for the formation and use of advisory committees.
Dated: June 28, 2018.
Brenda Destro,
Deputy Assistant Secretary for Planning and Evaluation, Office of Human
Services Policy.
[FR Doc. 2018-14376 Filed 7-3-18; 8:45 am]
BILLING CODE 4150-05-P