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

402–7930, elizabeth.giaquinto@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

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the October 2017 draft guidance for 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discussed in the draft guidance, 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2014 draft guidance for industry 

‘‘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 

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 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 129 / Thursday, July 5, 2018 / Notices 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 

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. 

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 

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 

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 

Grant. 

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 2- 

year 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 


amozie on DSK3GDR082PROD with NOTICES1