38912 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 

2016, requesting that Upsher-Smith 

provide the requested bioequivalence 

data within 30 calendar days or 

voluntarily seek withdrawal of ANDA 

078706 under section 314.150(d) (21 

CFR 314.150(d)). 

In a letter dated September 15, 2016, 

Upsher-Smith informed FDA that it did 

not intend to submit the requested 

bioequivalence data and requested that 

the Agency withdraw approval of 

ANDA 078706 for ZALEPLON Capsules 

under section 314.150(d). In that letter, 

Upsher-Smith also waived any 

opportunity for a hearing otherwise 

provided under section 314.150(a). 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(e)) and 

314.150(d), approval of ANDA 078706, 

and all amendments and supplements 

thereto, is withdrawn (see DATES). 

Distribution of this product in interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the FD&C Act (21 U.S.C. 

355(a) and 331(d)). 

Dated: August 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17301 Filed 8–15–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Solicitation of Nominations for 

Appointment to the Tick-Borne 

Disease Working Group; Amendment 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice; amendment. 

SUMMARY: A notice was published in the 

Federal Register on Monday, July 17, 

2017 (Vol. 82, No. 135, pages 32711– 

32712), to solicit nominations of 

individuals who are interested in being 

considered for appointment to the TickBorne Disease Working Group (Working 

Group). The nomination period is 

scheduled to end close of business on 

August 16, 2017. The notice is being 

amended to extend the solicitation 

period for one week to allow more time 

for interested individuals to submit 

nominations. 

DATES: The solicitation period has been 

extended. All nominations are due to be 

submitted on or before August 23, 2017. 

ADDRESSES: All nominations should be 

sent to: CAPT Richard Henry; Office of 

the Assistant Secretary for Health; 

Department of Health and Human 

Services; 330 C Street SW., Suite L100, 

Washington, DC 20024. Nomination 

materials, including attachments, also 

may be submitted electronically to 

tickbornedisease@hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Richard Henry, Office of the 

Assistant Secretary for Health; 

Department of Health and Human 

Services; Telephone: (202) 795–7615; 

Email address: richard.henry@hhs.gov. 

Dated: August 10, 2017. 

Donald Wright, 

Acting Assistant Secretary for Health. 

[FR Doc. 2017–17323 Filed 8–15–17; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on Combating AntibioticResistant Bacteria 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that a meeting is scheduled to be held 

for the Presidential Advisory Council on 

Combating Antibiotic-Resistant Bacteria 

(Advisory Council). The meeting will be 

open to the public; a public comment 

session will be held during the meeting. 

Pre-registration is required for members 

of the public who wish to attend the 

meeting and who wish to participate in 

the public comment session. Individuals 

who wish to attend the meeting and/or 

send in their public comment via email 

should send an email to CARB@hhs.gov. 

Registration information is available on 

the Web site http://www.hhs.gov/ash/ 

carb/ and must be completed by 

September 5, 2017; all in-person 

attendees must pre-register by this date. 

Additional information about registering 

for the meeting and providing public 

comment can be obtained at http://

www.hhs.gov/ash/carb/ on the Meetings 

page. 

DATES: The meeting is scheduled to be 

held on September 13, 2017, from 9:00 

a.m. to 5:00 p.m. ET, and September 14, 

2017, from 9:00 a.m. to 3:00 p.m. ET 

(times are tentative and subject to 

change). The confirmed times and 

agenda items for the meeting will be 

posted on the Web site for the Advisory 

Council at http://www.hhs.gov/ash/ 

carb/ when this information becomes 

available. Pre-registration for attending 

the meeting in person is required to be 

completed no later than September 5, 

2017; public attendance at the meeting 

is limited to the available space. 

ADDRESSES: U.S. Department of Health 

and Human Services, Hubert H. 

Humphrey Building, Great Hall, 200 

Independence Avenue SW., 

Washington, DC 20201. 

The meeting can also be accessed 

through a live webcast on the day of the 

meeting. For more information, visit 

http://www.hhs.gov/ash/carb/. 

FOR FURTHER INFORMATION CONTACT: 

Jomana Musmar, Acting Designated 

Federal Officer, Presidential Advisory 

Council on Combating AntibioticResistant Bacteria, Office of the 

Assistant Secretary for Health, U.S. 

Department of Health and Human 

Services, Room 715H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Washington, DC 20201. 

Phone: (202) 690–5566; email: CARB@

hhs.gov. 

SUPPLEMENTARY INFORMATION: Under 

Executive Order 13676, dated 

September 18, 2014, authority was given 

to the Secretary of HHS to establish the 

Advisory Council, in consultation with 

the Secretaries of Defense and 

Agriculture. Activities of the Advisory 

Council are governed by the provisions 

of Public Law 92–463, as amended (5 

U.S.C. App.), which sets forth standards 

for the formation and use of federal 

advisory committees. 

The Advisory Council will provide 

advice, information, and 

recommendations to the Secretary of 

HHS regarding programs and policies 

intended to support and evaluate the 

implementation of Executive Order 

13676, including the National Strategy 

for Combating Antibiotic-Resistant 

Bacteria and the National Action Plan 

for Combating Antibiotic-Resistant 

Bacteria. The Advisory Council shall 

function solely for advisory purposes. 

In carrying out its mission, the 

Advisory Council will provide advice, 

information, and recommendations to 

the Secretary regarding programs and 

policies intended to preserve the 

effectiveness of antibiotics by 

optimizing their use; advance research 

to develop improved methods for 

combating antibiotic resistance and 

conducting antibiotic stewardship; 

strengthen surveillance of antibioticresistant bacterial infections; prevent 

the transmission of antibiotic-resistant 

bacterial infections; advance the 

development of rapid point-of-care and 

agricultural diagnostics; further research 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 38913 

on new treatments for bacterial 

infections; develop alternatives to 

antibiotics for agricultural purposes; 

maximize the dissemination of up-todate information on the appropriate and 

proper use of antibiotics to the general 

public and human and animal 

healthcare providers; and improve 

international coordination of efforts to 

combat antibiotic resistance. 

The first day of the public meeting, 

September 13, 2017, will be dedicated 

to the topic of Stewardship of Antibiotic 

Prescription and Use. The three working 

groups on Incentives for Diagnostics, 

Therapeutics/Anti-Infectives, and 

Vaccines, will report their final findings 

to the full Advisory Council for 

deliberation on the second day of the 

public meeting, September 14, 2017, 

and the Advisory Council will 

deliberate and vote on the final report 

presented. Additionally, federal 

agencies will provide updates on their 

achievements as stipulated in the goals 

with corresponding objectives and 

milestones of the National Action Plan 

on Combating Antibiotic Resistant 

Bacteria. The meeting agenda will be 

posted on the Advisory Council Web 

site at http://www.hhs.gov/ash/carb/ 

when it has been finalized. All agenda 

items are tentative and subject to 

change. 

Public attendance at the meeting is 

limited to the available space. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Advisory Council at the 

address/telephone number listed above 

at least one week prior to the meeting. 

For those unable to attend in person, a 

live webcast will be available. More 

information on registration and 

accessing the webcast can be found at 

http://www.hhs.gov/ash/carb/. 

Members of the public will have the 

opportunity to provide comments prior 

to the Advisory Council meeting by 

emailing CARB@hhs.gov. Public 

comments should be sent in by 

midnight September 5, 2017, and 

should be limited to no more than one 

page. All public comments received 

prior to September 5, 2017, will be 

provided to Advisory Council members; 

comments are limited to two minutes 

per speaker. 

Dated: August 2, 2017. 

Jomana F. Musmar, 

Acting Designated Federal Officer, 

Presidential Advisory Council on Combating 

Antibiotic-Resistant Bacteria, Committee 

Manager. 

[FR Doc. 2017–17322 Filed 8–15–17; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Division of Epidemiology and Disease 

Prevention Epidemiology Program for 

American Indian/Alaska Native Tribes 

and Urban Indian Communities 

Announcement Type: Competing 

Supplement 

Funding Announcement Number: HHS– 

2017–IHS–EPI–0001 

Catalog of Federal Domestic Assistance 

Number: 93.231 

Key Dates 

Application Deadline Date: September 

19, 2017 

Review Date: September 21, 2017 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) 

Office of Public Health Support, 

Division of Epidemiology and Disease 

Prevention (DEDP), is accepting 

applications for a cooperative agreement 

for competitive supplemental funds to 

enhance activities in the Epidemiology 

Program for American Indian/Alaska 

Native (AI/AN) Tribes and Urban Indian 

communities. This program is 

authorized under: The Public Health 

Service Act, at 42 U.S.C. 241, 247b(k)(2), 

282, 284 and 285t. Funding for this 

award will be provided by: The Centers 

for Disease Control and Prevention’s 

(CDC) National Center for 

Environmental Health (NCEH) and the 

National Institutes of Health’s (NIH) 

National Institute on Minority Health 

and Health Disparities (NIMHD). The 

authorities will be exercised through an 

Intra-Departmental Delegation of 

Authority (IDDA) with IHS to create a 

new funding opportunity for Tribal 

Epidemiology Centers: This program is 

described in the Catalog of Federal 

Domestic Assistance (CFDA) under 

93.231. 

Background 

The Tribal Epidemiology Center (TEC) 

program was authorized by Congress in 

1998 as a way to provide public health 

support to multiple Tribes and Urban 

Indian communities in each of the IHS 

Areas. The funding opportunity 

announcement is open to eligible 

Tribes, Tribal organizations, Indian 

organizations, intertribal consortia, and 

Urban Indian organizations, including 

currently-funded TECs. 

TECs are uniquely positioned within 

Tribes, Tribal and Urban Indian 

organizations to conduct disease 

surveillance, research, prevention and 

control of disease, injury, or disability, 

and to assess the effectiveness of AI/AN 

public health programs. In addition, 

they can fill gaps in data needed for 

Government Performance and Results 

Act and Healthy People 2020 measures. 

Some of the existing TECs have already 

developed innovative strategies to 

monitor the health status of Tribes and 

Urban Indian communities, including 

development of Tribal health registries 

and use of sophisticated record linkage 

computer software to correct existing 

state data sets for racial 

misclassification. TECs work in 

partnership with IHS DEDP to provide 

a more accurate national picture of 

Indian health status. This program will 

utilize CDC and NIH funding to further 

the ongoing work of IHS and the TECs. 

The mission of NIMHD is to promote 

minority health and to lead, coordinate, 

support, and assess the NIH effort to 

reduce and ultimately eliminate health 

disparities. 

The NCEH has identified a public 

health gap in the nation’s ability to link 

environmental hazards and exposure to 

chronic disease issues, and to provide 

information to a variety of audiences 

from a nationwide network of integrated 

health and environmental data that 

drives actions to improve health 

outcomes. The NCEH is seeking, 

through this announcement, to support 

the creation of a mechanism by which 

Tribal data can be submitted to the 

Environmental Public Health Tracking 

Network and further explore the 

application of Tribal data to 

environmental public health. 

Purpose 

The purpose of this cooperative 

agreement is to strengthen public health 

capacity and to fund Tribes, Tribal and 

Urban Indian organizations, and 

intertribal consortia in identifying 

relevant health status indicators and 

priorities using sound epidemiologic 

principles. Work-plans submitted in 

response to this announcement must 

clearly state the grantee’s desired 

objectives and address at least one of the 

Recipient Activities under this 

announcement. Recipient Activities 

may address one or all of the below two 

groups of activities: 

A. NIH, NIMHD Activities 

(1) Development and implementation 

of data collection efforts to identify and 

document health disparities 

experienced by AI/AN populations; 

(2) Compilation of existing data (e.g., 

healthcare utilization, vital statistics 

data) to generate health profiles and 

document health disparities in AI/AN 

populations; 


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