83 FR 31400 - Advisory Council on Alzheimer's Research, Care, and Services; Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 129 (July 5, 2018)

Page Range		31400-31401
FR Document		2018-14376

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.

Federal Register, Volume 83 Issue 129 (Thursday, July 5, 2018)

[Federal Register Volume 83, Number 129 (Thursday, July 5, 2018)]
[Notices]
[Pages 31400-31401]
From the Federal Register Online  [www.thefederalregister.org]
[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

31400 Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices

402–7930, elizabeth.giaquinto@ ‘‘ANDA Submissions—Amendments burden of Alzheimer’s disease and
fda.hhs.gov. and Easily Correctable Deficiencies related dementias on people with the
SUPPLEMENTARY INFORMATION:
Under GDUFA,’’ both of which will be disease and their caregivers. The
withdrawn. This guidance finalizes the Advisory Council will spend the
I. Background October 2017 draft guidance for majority of the July meeting considering
FDA is announcing the availability of industry ‘‘ANDA Submissions— recommendations made by each of the
a guidance for industry entitled ‘‘ANDA Amendments to Abbreviated New Drug three subcommittees to present to the
Submissions—Amendments to Applications Under GDUFA.’’ The final Secretary of HHS and Congress.
Abbreviated New Drug Applications guidance contains clarifications to the Additional presentations in the
Under GDUFA.’’ This guidance finalizes draft guidance of the same title that afternoon will include a presentation on
the October 2017 draft guidance for published in October 2017. a recent study by RAND on the health
industry ‘‘ANDA Submissions— This guidance is being issued care infrastructure, the CDC/
Amendments to Abbreviated New Drug consistent with FDA’s good guidance Alzheimer’s Association’s joint Healthy
Applications Under GDUFA.’’ This practices regulation (21 CFR 10.115). Brain Initiative Roadmap, federal
guidance is intended to assist applicants The guidance represents the current workgroup updates, and updates on
preparing to submit amendments to thinking of FDA on ‘‘ANDA work by the non-federal members.
ANDAs or to PASs to FDA under Submissions—Amendments to DATES: The meeting will be held on July
section 505(j) of the FD&C Act (21 Abbreviated New Drug Applications 30, 2018 from 9:00 a.m. to 5:00 p.m.
U.S.C. 355(j)) by explaining how the Under GDUFA.’’ It does not establish EDT.
review goals established as part of any rights for any person and is not ADDRESSES: The meeting will be held in
GDUFA II apply to these submissions. binding on FDA or the public. You can Room 800 in the Hubert H. Humphrey
In accordance with the GDUFA use an alternative approach if it satisfies Building, 200 Independence Avenue
Reauthorization Performance Goals and the requirements of the applicable SW, Washington, DC 20201.
Program Enhancements Fiscal Years statutes and regulations. This guidance Comments: Time is allocated in the
2018–2022 (GDUFA II Commitment is not subject to Executive Order 12866. afternoon on the agenda to hear public
Letter: https://www.fda.gov/downloads/ II. Paperwork Reduction Act of 1995 comments. The time for oral comments
ForIndustry/UserFees/GenericDrug will be limited to two (2) minutes per
This guidance refers to previously individual. In lieu of oral comments,
UserFees/ucm525234.pdf), FDA agreed
approved collections of information formal written comments may be
to certain review goals and procedures
found in FDA regulations. These submitted for the record to Rohini
for the review of amendments pending
collections of information are subject to Khillan, OASPE, 200 Independence
as of or received on or after the GDUFA
review by the Office of Management and Avenue SW, Room 424E, Washington,
II effective date.
Budget (OMB) under the Paperwork DC 20201. Comments may also be sent
The GDUFA II Commitment Letter
Reduction Act of 1995 (44 U.S.C. 3501– to napa@hhs.gov. Those submitting
reflects significant changes in the
3520). The collections of information in written comments should identify
classification of and review goals for
21 CFR 314.96 have been approved themselves and any relevant
amendments to ANDAs and PASs under
under OMB control number 0910–0001. organizational affiliations. Those
the Generic Drug User Fee Amendments
of 2012 (GDUFA I). Under GDUFA I, III. Electronic Access intending to make public comments at
amendments were classified into a the meeting must submit their
Persons with access to the internet comments either by mail or email ahead
complex Tier system based on the may obtain the guidance at either
following factors: (1) Whether the of time for the record. Comments are
https://www.fda.gov/Drugs/Guidance due no later than Monday, July 23,
amendment was solicited (submitted in ComplianceRegulatoryInformation/
response to a complete response letter) 2018.
Guidances/default.htm or https://
or unsolicited (submitted on the www.regulations.gov. FOR FURTHER INFORMATION CONTACT:
applicant’s own initiative); (2) whether Rohini Khillan (202) 690–5932,
the amendment was major or minor; the Dated: June 29, 2018.
rohini.khillan@hhs.gov. Note: Seating
number of amendments submitted to the Leslie Kux, may be limited. Those wishing to attend
ANDA or PAS; and (3) whether an Associate Commissioner for Policy. the meeting must send an email to
inspection was necessary to support the [FR Doc. 2018–14429 Filed 7–3–18; 8:45 am] napa@hhs.gov and put ‘‘July 30 Meeting
information contained in the BILLING CODE 4164–01–P Attendance’’ in the Subject line by
amendment. Friday, July 20, so that their names may
GDUFA II simplified the amendment be put on a list of expected attendees
review goals and no longer subjects DEPARTMENT OF HEALTH AND and forwarded to the security officers at
them to a Tier system; however, review HUMAN SERVICES the Department of Health and Human
goals are still dependent on several Services. Any interested member of the
factors. In general, under GDUFA II, Advisory Council on Alzheimer’s public who is a non-U.S. citizen should
amendments will be designated as Research, Care, and Services; Meeting include this information at the time of
either standard or priority; will be AGENCY: Assistant Secretary for registration to ensure that the
classified as major or minor, and will Planning and Evaluation, HHS. appropriate security procedure to gain
receive a goal date based on the factors ACTION: Notice of meeting.
entry to the building is carried out.
discussed in the draft guidance, Although the meeting is open to the
amozie on DSK3GDR082PROD with NOTICES1

including whether a preapproval SUMMARY: This notice announces the public, procedures governing security
inspection is needed. This guidance public meeting of the Advisory Council and the entrance to Federal buildings
supersedes the December 2001 guidance on Alzheimer’s Research, Care, and may change without notice. If you wish
for industry ‘‘Major, Minor, and Services (Advisory Council). The to make a public comment, you must
Telephone Amendments to Abbreviated Advisory Council on Alzheimer’s note that within your email.
New Drug Applications’’ and the July Research, Care, and Services provides SUPPLEMENTARY INFORMATION: Notice of
2014 draft guidance for industry advice on how to prevent or reduce the these meetings is given under the

VerDate Sep<11>2014 16:43 Jul 03, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\05JYN1.SGM 05JYN1

Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices 31401

Federal Advisory Committee Act U.S.C. § 5322(e) of the Indian Self- Estimated Funds Available
(5 U.S.C. App. 2, section 10(a)(1) and Determination and Education The total amount of funding
(a)(2)). Topics of the Meeting: The Assistance Act (ISDEAA), Public Law identified for the current fiscal year (FY)
Advisory Council will spend the (P.L.) 93–638, as amended. This 2018 is approximately $2,412,000.
majority of the July meeting considering program is described in the Catalog of Individual award amounts are
recommendations made by each of the Federal Domestic Assistance (CFDA) anticipated to be between $50,000 and
three subcommittees to present to the under 93.228. $100,000. The amount of funding
Secretary of HHS and Congress. available for new and competing
Additional presentations in the Background
continuation awards issued under this
afternoon will include a presentation on The TMG Program is a competitive grant announcement is subject to the
a recent study by RAND on the health grant program that is capacity building availability of appropriations and
care infrastructure, the CDC/ budgetary priorities of the Agency. The
and developmental in nature and has
Alzheimer’s Association’s joint Healthy IHS is under no obligation to make
been available for federally recognized
Brain Initiative Roadmap, federal awards that are selected for funding
Indian Tribes and Tribal Organizations
workgroup updates, and updates on under this grant announcement.
(T/TOs) since shortly after enactment of
work by the non-federal members.
Procedure and Agenda: This meeting the ISDEAA in 1975. The TMG Program Anticipated Number of Awards
is open to the public. Please allow 30 was established to assist T/TOs to Approximately 16–18 awards will be
minutes to go through security and walk prepare for assuming all or part of issued under this grant announcement.
to the meeting room. The meeting will existing IHS programs, functions,
services, and activities (PFSAs) and Period of Performance
also be webcast at www.hhs.gov/live.
further develop and improve Tribal The Tribal Management Grant (TMG
Authority: 42 U.S.C. 11225; Section 2(e)(3)
health management capabilities. The Project) period of performance vary
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public TMG Program provides competitive based on the project type selected.
Law 92–463, as amended (5 U.S.C. Appendix grants to T/TOs to establish goals and Period of performance could run from 1
2), which sets forth standards for the performance measures for current health to 3 years and will run consecutively
formation and use of advisory committees. programs; assess current management from the earliest anticipated start date of
Dated: June 28, 2018. capacity to determine if new September 1, 2018 through August 31,
Brenda Destro,
components are appropriate; analyze 2019, for 1-year projects; September 1,
programs to determine if a Tribe or 2018, through August 31, 2020, for 2-
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
Tribal Organization’s management is year projects; and September 1, 2018,
practicable; and develop infrastructure through August 31, 2021, for 3-year
[FR Doc. 2018–14376 Filed 7–3–18; 8:45 am]
systems to manage or organize PFSAs. projects. Please refer to ‘‘Eligible TMG
BILLING CODE 4150–05–P
Project Types, Maximum Funding
Purpose Levels, and Periods of Performance,’’ for
DEPARTMENT OF HEALTH AND The purpose of this IHS grant additional details. State the number of
HUMAN SERVICES announcement is to announce the years for the period of performance and
availability of the TMG Program to include the exact dates.
Indian Health Service enhance and develop health III. Eligibility Information
management infrastructure and assist T/
Office of Direct Service and I.
TOs in assuming all or part of existing
Contracting Tribes; Tribal Management IHS PFSAs through a Title I contract 1. Eligibility
Grant Program and assist established Title I contractors Eligible Applicants: ‘‘Indian Tribes’’
Announcement Type: New and and Title V compactors to further and ‘‘Tribal Organizations’’ (T/TOs) as
Competing Continuation. develop and improve management defined by the ISDEAA are eligible to
Funding Announcement Number: capability. In addition, Tribal apply for the TMG Program. The
HHS–2018–IHS–TMD–0001. Management Grants are available to T/ definitions for each entity type are
Catalog of Federal Domestic TOs under the authority of 25 U.S.C. outlined below. Only one application
Assistance Number (CFDA): 93.228. 5322(e) for the following: (1) Obtaining per Tribe/Tribal organization is allowed.
technical assistance from providers Definitions: ‘‘Indian Tribe’’ means any
Key Dates
designated by the Tribe/Tribal Indian tribe, band, nation, or other
Application Deadline Date: August Organization (including T/TOs that organized group or community,
17, 2018. operate mature contracts) for the including any Alaska Native village or
Review Date: August 20–24, 2018. purposes of program planning and regional or village corporation as
Earliest Anticipated Start Date: evaluation, including the development defined in or established pursuant to the
September 1, 2018. of any management systems necessary Alaska Native Claims Settlement Act (85
Signed Tribal Resolutions Due Date: for contract management, and the Stat. 688) [43 U.S.C. 1601 et seq.], which
August 17, 2018. development of cost allocation plans for is recognized as eligible for the special
Proof of Non-Profit Status Due Date: indirect cost rates; and (2) planning, programs and services provided by the
August 17, 2018. designing, monitoring, and evaluating United States to Indians because of their
I. Funding Opportunity Description Federal programs serving T/TOs, status as Indians. 25 U.S.C. 5304(e).
amozie on DSK3GDR082PROD with NOTICES1

including Federal administrative ‘‘Tribal organization’’ means the
Statutory Authority recognized governing body of any
functions.
The Indian Health Service (IHS) is Indian Tribe; any legally established
accepting competitive grant applications II. Award Information organization of Indians which is
for the Tribal Management Grant (TMG) Type of Award controlled, sanctioned, or chartered by
Program. This program is authorized such governing body or which is
under 25 U.S.C. § 5322(b)(2) and 25 Grant. democratically elected by the adult

VerDate Sep<11>2014 16:43 Jul 03, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\05JYN1.SGM 05JYN1

Document Created: 2018-07-03 23:40:34
Document Modified: 2018-07-03 23:40:34

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
Action		Notice of meeting.
Dates		The meeting will be held on July 30, 2018 from 9:00 a.m. to 5:00 p.m. EDT.
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.
FR Citation		83 FR 31400