10700 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Cardiovascular and Renal 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: Cardiovascular 

and Renal 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 15, 2015, from 8 a.m. to 

4 p.m. 

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/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Kristina Toliver, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20903–0002, 301–796–9001, FAX: 

301–847–8533, CRDAC@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: The committee will discuss 

new drug application New Drug 

Application 204958, cangrelor injection, 

submitted by The Medicines Company, 

for the proposed indication of reduction 

of thrombotic cardiovascular events 

including stent thrombosis (events 

related to blood clots in a stent, a device 

inserted to keep the artery open) in 

patients with coronary artery disease 

undergoing percutaneous coronary 

intervention (PCI). PCI refers to the 

opening of narrowed blood vessels 

supplying the heart muscle by a balloon 

inserted through an artery puncture 

with or without a stent. 

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 April 1, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 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 

24, 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 25, 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 Kristina 

Toliver 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/

AdvisoryCommittees/

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 24, 2015. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2015–04128 Filed 2–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

The 2015 Office of Regulatory Science 

and Innovation Science Symposium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: The 2015 Office of Regulatory 

Science and Innovation (ORSI) Science 

Symposium. 

The purpose of the public workshop 

is to increase scientific collaborations 

with government institutions, academia, 

industry and other stakeholders, 

working to improve science, training, 

and networking in accordance with the 

FDA mission of the advancement of 

regulatory science. This venue will also 

enhance knowledge and awareness of 

the FDA ORSI resources and provide 

guidance of its available services. 

Date and Time: The public workshop 

will be held on Monday, April 27, 2015, 

from 8:15 a.m. to 5:30 p.m. 

Location: The public workshop will 

be held at the FDA White Oak Campus 

located at 10903 New Hampshire Ave., 

Bldg. 31, Great Room, Silver Spring, MD 

20903. Entrance for the public 

workshop participants (non-FDA 

employees) is through Building 1 where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm or contact us at 

2015ORSIScienceSymposium@

fda.hhs.gov.] 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 10701 

Contact Person: Diane Rose, Food and 

Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 1, Rm. 4233, 

Silver Spring, MD 20993. 301–796– 

9600, diane.rose@fda.hhs.gov. 

Registration: On-line registration is 

required (including name, title, 

affiliation, address, email, telephone 

and FAX numbers) by April 15, 2015. 

Those without Internet access should 

contact Diane Rose (see Contact Person) 

to register. There is no fee for the public 

workshop. Early registration is 

recommended as seating is limited to 

the first 300 registrants. Registration on 

the day of the public workshop will be 

provided on a space available basis from 

7:45 a.m. to 8:15 a.m. provided the 300- 

person registration limit has not been 

met. Please register at: https://

www.eventbrite.com/e/2015-orsiscience-symposium-tickets14591440391?utm_campaign=new_

event_email&utm_medium=email&utm_

source=eb_email&utm_

term=viewmyevent_button or email us at 

2015ORSIScienceSymposium@

fda.hhs.gov if you have additional 

questions. A lite breakfast and lunch are 

available for pre-purchase. 

If you need special accommodations 

due to a disability, please contact Diane 

Rose (see Contact Person) at least 7 days 

in advance. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be Webcast. Persons interested in 

viewing the Webcast must register 

online or call us at 301–796–9600 by 

April 15, 2015. Early registration is 

recommended because Webcast lines 

are limited. Organizations are required 

to register all participants, but to view 

the Webcast using one connection per 

location. Webcast participants will be 

sent technical system requirements after 

registration and will be sent connection 

access information after April 23, 2015. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit http://

inside.fda.gov:9003/ora/

southwestregion/dallas/

ucm234468.htm. (FDA has verified the 

Web site addresses in this document, 

but FDA is not responsible for any 

subsequent changes to the Web sites 

after this document publishes in the 

Federal Register.) 

Dated: February 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04123 Filed 2–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings 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 material, 

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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Pathways, Biomarkers in Addiction 

and Schizophrenia. 

Date: March 12, 2015. 

Time: 2:00 p.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Julius Cinque, MS, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5186, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

1252, cinquej@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Synaptic Development and 

Function. 

Date: March 13, 2015. 

Time: 12:00 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Deborah L. Lewis, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4183, 

MSC 7850, Bethesda, MD 20892, 301–408– 

9129, lewisdeb@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: AIDS and Related 

Research Integrated Review Group; AIDS 

Discovery and Development of Therapeutics 

Study Section. 

Date: March 19, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Fairmont Washington, DC, 2401 

M Street NW., Washington, DC 20037. 

Contact Person: Shiv A. Prasad, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5220, 

MSC 7852, Bethesda, MD 20892, 301–443– 

5779, prasads@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Endocrinology, Metabolism, 

Nutrition and Reproductive Sciences. 

Date: March 24, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Dianne Hardy, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6175, 

MSC 7892, Bethesda, MD 20892, 301–435– 

1154, dianne.hardy@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: February 23, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–04057 Filed 2–26–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings 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 material, 

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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Cardiovascular Development Consortium. 

Date: March 19, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

mstockstill on DSK4VPTVN1PROD with NOTICES