11680 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices 

ACTION: Notice. 

SUMMARY: The Administration on Aging 

(AoA) is announcing that the proposed 

collection of information listed below 

has been submitted to the Office of 

Management and Budget (OMB) for 

review and clearance under the 

Paperwork Reduction Act of 1995. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 4, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: louise.ryan@acl.gov. 

Submit written comments on the 

collection of information to Louise 

Ryan, U.S. Administration for 

Community Living, 1 Massachusetts 

Avenue, Washington, DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

Louise Ryan, telephone: (202) 357–3503; 

email: louise.ryan@acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, AoA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

States provide the following data and 

narrative information in the report: 

1. Numbers and descriptions of cases 

filed and complaints made on behalf of 

long-term care facility residents to the 

statewide ombudsman program; 

2. Major issues identified impacting 

on the quality of care and life of longterm care facility residents; 

3. Statewide program operations; and 

4. Ombudsman activities in addition 

to complaint investigation. 

The report form and instructions have 

been in continuous use, with minor 

modifications, since they were first 

approved by OMB for the FY 1995 

reporting period. This request is for 

approval to extend use of the current 

form and instructions, with no 

modifications, for three years, covering 

the FY 2015–2017 reporting periods. 

The data collected on complaints filed 

with Ombudsman programs and 

narrative on long-term care issues 

provide information to Centers for 

Medicare and Medicaid Services and 

others on patterns of concerns and 

major long-term care issues affecting 

residents of long-term care facilities. 

Both the complaint and program data 

collected assist the states and local 

Ombudsman programs in planning 

strategies and activities, providing 

training and technical assistance and 

developing performance measures. 

A reporting form and instructions 

may be viewed in the ombudsman 

section of the AoA Web site, http://

www.aoa.acl.gov/AoA_Programs/Elder_

Rights/Ombudsman/NORS.aspx. AoA 

estimates the burden of this collection 

and entering the report information as 

follows: Approximately 7,702.3 hours, 

with 52 State Long-Term Care 

Ombudsman programs responding 

annually. 

Dated: February 26, 2015. 

Kathy Greenlee, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2015–04470 Filed 3–3–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Notice of Intent To Award a Single 

Source Non-Competing Continuation 

Cooperative Agreement to Amputee 

Coalition 

AGENCY: Administration for Community 

Living, HHS. 

SUMMARY: The Administration for 

Community Living (ACL) is proud to 

announce the Center for Improved 

Health of Persons with Limb Loss (Limb 

Loss Program) is moving to ACL as a 

result of the 2015 budget recently signed 

by President Obama. 

The Limb Loss Program supports a 

national resource center and related 

activities that provides comprehensive 

information and resources to assist 

individuals and families dealing with 

Limb Loss. The Limb Loss Program 

currently operates through a cooperative 

agreement between the Amputee 

Coalition and the U.S. Department of 

Health and Human Services (HHS) 

Centers for Disease Control and 

Prevention (CDC). ACL will be working 

with the CDC on transitioning the 

program to ACL. 

Program Name: Limb Loss Program 

Award Amount: $2,730,000 

Project Period: 4/1/2015 to 3/31/2016 

Award Type: Cooperative Agreement 

Statutory Authority: This program is 

authorized under Section 317 of the Public 

Health Service Act (42 U.S.C. 247(b–4)); 

Consolidated and Further Continuing 

Appropriations Act, 2015, Public Law 113– 

235 (Dec. 16, 2014). 

Catalog of Federal Domestic Assistance 

(CFDA) Number: 93.325 Discretionary 

Projects 

DATES: Estimated Project Period—April 

1, 2015 through March 31, 2016. 

I. Program Description 

The purpose of this cooperative 

agreement is to continue existing 

activities to promote health, wellness 

and the adoption of healthy behaviors 

with the objective of preventing and/or 

reducing chronic conditions associated 

with limb loss. The grantee will 

continue to use both traditional and 

innovative approaches that will educate 

and inform people with disabilities, 

their family members, health care 

providers, policy makers, community 

members, and the general public. 

Justification: The Limb Loss Program 

currently operates through a cooperative 

agreement between the Amputee 

Coalition and the U.S. Department of 

Health and Human Services (HHS) 

Centers for Disease Control and 

Prevention (CDC). ACL will be working 

with the CDC on transitioning the 

program to ACL. To ensure 

uninterrupted continuation of the grant 

goals and objectives, ACL plans to issue 

a one year non-competing award to the 

incumbent Limb Loss Program grantee, 

Amputee Coalition. 

II. Agency Contact 

For further information or comments 

regarding this action, contact Ophelia 

M. McLain, U.S. Department of Health 

and Human Services, Administration for 

Community Living, Administration on 

Intellectual and Developmental 

Disabilities, Office of Innovation, One 

Massachusetts Avenue NW., 

Washington, DC 20001; telephone (202) 

690–7025; fax (202) 357–3560; email 

Ophelia.McLain@acl.hhs.gov. 

Dated: February 26, 2015. 

Kathy Greenlee, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2015–04460 Filed 3–3–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 14, 2015, from 7:30 a.m. 

to 5:15 p.m. 

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Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices 11681 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

Contact Person: Philip Bautista, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, EMDAC@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

to learn about possible modifications 

before coming to the meeting. 

Agenda: During the morning session, 

the committee will discuss the results of 

the cardiovascular outcomes trial 

(CVOT), Saxagliptin Assessment of 

Vascular Outcomes Recorded in Patients 

with Diabetes Mellitus, for new drug 

application (NDA) 22350, Onglyza 

(saxagliptin) and NDA 200678, 

Kombiglyze XR (saxagliptin and 

metformin HCl extended-release) tablets 

manufactured/marketed by AstraZeneca 

AB. 

During the afternoon session, the 

committee will discuss the results of the 

CVOT, Examination of Cardiovascular 

Outcomes with Alogliptin versus 

Standard of Care, for NDA 22271, 

Nesina (ALOGLIPTIN); NDA 022426, 

Oseni (ALOGLIPTIN and 

PIOGLITAZONE); and NDA 203414, 

Kazano (ALOGLIPTIN and 

METFORMIN) tablets marketed by 

Takeda Pharmaceutical U.S.A., Inc. 

Saxagliptin and ALOGLIPTIN are 

dipeptidyl peptidase-4 inhibitors, both 

indicated as an adjunct to diet and 

exercise to improve glycemic control in 

adults with type 2 diabetes mellitus. 

Both CVOTs were submitted in 

accordance with the 2008 FDA Draft 

Guidance, ‘‘Diabetes Mellitus— 

Evaluating Cardiovascular Risk in New 

Antidiabetic Therapies to Treat Type 2 

Diabetes,’’ to demonstrate that a new 

antidiabetic therapy to treat type 2 

diabetes is not associated with an 

unacceptable increase in cardiovascular 

risk. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 31, 2015. 

Oral presentations from the public will 

be scheduled between approximately 

10:10 a.m. to 10:40 a.m., and 3:30 p.m. 

to 4 p.m. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before March 23, 2015. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 24, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Philip 

Bautista at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 26, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–04395 Filed 3–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 24, 2015, from 8 a.m. to 

5:30 p.m. 

Location: Double Tree by Hilton, 8727 

Colesville Rd., Silver Spring, MD 20910, 

301–589–5200. Answers to commonly 

asked questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Walter Ellenberg, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5154, 

Silver Spring, MD 20993, 301–796– 

0885, email: walter.ellenberg@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

mstockstill on DSK4VPTVN1PROD with NOTICES