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

11682 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Notices 

to learn about possible modifications 

before coming to the meeting. 

Agenda: On March 24, 2015, the 

Pediatric Advisory Committee (PAC) 

will meet to discuss pediatric-focused 

safety reviews, as mandated by the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109) and the Pediatric Research 

Equity Act (Pub. L. 108–155). The PAC 

will meet to discuss the following 

products: CYMBALTA (duloxetine 

hydrochloride), QUILLIVANT XR 

(methylphenidate hydrochloride), 

LUNESTA (eszopiclone), RISPERDAL 

(risperidone), OXTELLAR XR 

(oxcarbazepine), REVATIO (sildenafil), 

ADVAIR HFA (fluticasone propionate/

salmeterol), DYMISTA (azelastine 

hydrochloride/fluticasone proprionate), 

QNASL (beclomethasone dipropionate), 

VENOFER (iron sucrose), INVIRASE 

(saquinavir), ALTABAX Ointment 

(retapamulin), FluMist 

QUADRIVALENT (influenza vaccine 

live, intranasal), FLUARIX 

QUADRIVALENT (influenza virus 

vaccine), Medtronic ACTIVA 

DYSTONIA THERAPY, and 

LIPOSORBER LA–15 System. In 

addition, there will be a short 

presentation of the ethical issues 

discussed by the Pediatric Ethics 

Subcommittee of the PAC on March 23, 

2015. 

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 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 16, 2015. 

Oral presentations from the public will 

be scheduled on March 24, 2015, 

between approximately 9 a.m. and 10 

a.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 6, 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 9, 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 Walter 

Ellenberg 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. 2015–04394 Filed 3–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, March 

05, 2015, 11:00 a.m. to March 05, 2015, 

05:00 p.m., National Institutes of Health, 

6701 Rockledge Drive, Bethesda, MD, 

20892 which was published in the 

Federal Register on February 24, 2015, 

80 FR 9738. 

The meeting will be held on March 

12, 2015. The meeting location and time 

remain the same. The meeting is closed 

to the public. 

Dated: February 25, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–04408 Filed 3–3–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Neurological 

Disorders and Stroke Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Neurological Disorders and Stroke Council. 

Date: May 28–29, 2015. 

Open: May 28, 2015, 8:00 a.m. to 3:00 p.m. 

Agenda: Report by the Director, NINDS; 

Report by the Associate Director for 

Extramural Research; Administrative and 

Program Developments; and an Overview of 

the NINDS Intramural Program. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Closed: May 28, 2015, 3:00 p.m. to 4:45 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Closed: May 28, 2015, 4:45 p.m. to 5:15 

p.m. 

Agenda: To review and evaluate the 

Division of Intramural Research Board of 

Scientific Counselors’ Reports. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Closed: May 29, 2015, 8:00 a.m. to 11:00 

a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Contact Person: Robert Finkelstein, Ph.D., 

Associate Director for Extramural Research, 

mstockstill on DSK4VPTVN1PROD with NOTICES