80_FR_10739 80 FR 10700 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

80 FR 10700 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 39 (February 27, 2015)

Page Range10700-10700
FR Document2015-04128

Federal Register, Volume 80 Issue 39 (Friday, February 27, 2015) 
[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Page 10700]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04128]



[[Page 10700]]

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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

10700 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices DEPARTMENT OF HEALTH AND including stent thrombosis (events FDA is committed to the orderly HUMAN SERVICES related to blood clots in a stent, a device conduct of its advisory committee inserted to keep the artery open) in meetings. Please visit our Web site at Food and Drug Administration patients with coronary artery disease http://www.fda.gov/ [Docket No. FDA–2015–N–0001] undergoing percutaneous coronary AdvisoryCommittees/ intervention (PCI). PCI refers to the AboutAdvisoryCommittees/ Cardiovascular and Renal Drugs opening of narrowed blood vessels ucm111462.htm for procedures on Advisory Committee; Notice of Meeting supplying the heart muscle by a balloon public conduct during advisory inserted through an artery puncture committee meetings. AGENCY: Food and Drug Administration, with or without a stent. Notice of this meeting is given under HHS. FDA intends to make background the Federal Advisory Committee Act (5 ACTION: Notice. material available to the public no later U.S.C. app. 2). than 2 business days before the meeting. Dated: February 24, 2015. This notice announces a forthcoming If FDA is unable to post the background Jill Hartzler Warner, meeting of a public advisory committee material on its Web site prior to the of the Food and Drug Administration Associate Commissioner for Special Medical meeting, the background material will Programs. (FDA). The meeting will be open to the be made publicly available at the public. [FR Doc. 2015–04128 Filed 2–26–15; 8:45 am] Name of Committee: Cardiovascular location of the advisory committee BILLING CODE 4164–01–P and Renal Drugs Advisory Committee. meeting, and the background material General Function of the Committee: will be posted on FDA’s Web site after To provide advice and the meeting. Background material is DEPARTMENT OF HEALTH AND recommendations to the Agency on available at http://www.fda.gov/ HUMAN SERVICES FDA’s regulatory issues. AdvisoryCommittees/Calendar/ Date and Time: The meeting will be default.htm. Scroll down to the Food and Drug Administration held on April 15, 2015, from 8 a.m. to appropriate advisory committee meeting link. [Docket No. FDA–2015–N–0001] 4 p.m. Location: FDA White Oak Campus, Procedure: Interested persons may present data, information, or views, The 2015 Office of Regulatory Science 10903 New Hampshire Ave., Bldg. 31 and Innovation Science Symposium Conference Center, the Great Room (Rm. orally or in writing, on issues pending 1503), Silver Spring, MD 20993–0002. before the committee. Written AGENCY: Food and Drug Administration, Answers to commonly asked questions submissions may be made to the contact HHS. including information regarding special person on or before April 1, 2015. Oral ACTION: Notice of public workshop. accommodations due to a disability, presentations from the public will be visitor parking, and transportation may scheduled between approximately 1 The Food and Drug Administration be accessed at: http://www.fda.gov/ p.m. and 2 p.m. Those individuals (FDA) is announcing a public workshop AdvisoryCommittees/ interested in making formal oral entitled: The 2015 Office of Regulatory AboutAdvisoryCommittees/ presentations should notify the contact Science and Innovation (ORSI) Science ucm408555.htm. person and submit a brief statement of Symposium. Contact Person: Kristina Toliver, the general nature of the evidence or The purpose of the public workshop Center for Drug Evaluation and arguments they wish to present, the is to increase scientific collaborations Research, Food and Drug names and addresses of proposed with government institutions, academia, Administration, 10903 New Hampshire participants, and an indication of the industry and other stakeholders, Ave., Bldg. 31, Rm. 2417, Silver Spring, approximate time requested to make working to improve science, training, MD 20903–0002, 301–796–9001, FAX: their presentation on or before March and networking in accordance with the 301–847–8533, CRDAC@fda.hhs.gov, or 24, 2015. Time allotted for each FDA mission of the advancement of FDA Advisory Committee Information presentation may be limited. If the regulatory science. This venue will also Line, 1–800–741–8138 (301–443–0572 number of registrants requesting to enhance knowledge and awareness of in the Washington, DC area). A notice in speak is greater than can be reasonably the FDA ORSI resources and provide the Federal Register about last minute accommodated during the scheduled guidance of its available services. modifications that impact a previously open public hearing session, FDA may Date and Time: The public workshop announced advisory committee meeting conduct a lottery to determine the will be held on Monday, April 27, 2015, cannot always be published quickly speakers for the scheduled open public from 8:15 a.m. to 5:30 p.m. enough to provide timely notice. hearing session. The contact person will Location: The public workshop will Therefore, you should always check the notify interested persons regarding their be held at the FDA White Oak Campus Agency’s Web site at http:// request to speak by March 25, 2015. located at 10903 New Hampshire Ave., www.fda.gov/AdvisoryCommittees/ Persons attending FDA’s advisory Bldg. 31, Great Room, Silver Spring, MD default.htm and scroll down to the committee meetings are advised that the 20903. Entrance for the public appropriate advisory committee meeting Agency is not responsible for providing workshop participants (non-FDA link, or call the advisory committee access to electrical outlets. employees) is through Building 1 where information line to learn about possible FDA welcomes the attendance of the routine security check procedures will mstockstill on DSK4VPTVN1PROD with NOTICES modifications before coming to the public at its advisory committee be performed. For parking and security meeting. meetings and will make every effort to information, please refer to http:// Agenda: The committee will discuss accommodate persons with physical www.fda.gov/AboutFDA/ new drug application New Drug disabilities or special needs. If you WorkingatFDA/BuildingsandFacilities/ Application 204958, cangrelor injection, require special accommodations due to WhiteOakCampusInformation/ submitted by The Medicines Company, a disability, please contact Kristina ucm241740.htm or contact us at for the proposed indication of reduction Toliver at least 7 days in advance of the 2015ORSIScienceSymposium@ of thrombotic cardiovascular events meeting. fda.hhs.gov.] VerDate Sep<11>2014 18:05 Feb 26, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1


Document Created: 2015-12-18 13:14:14
Document Modified: 2015-12-18 13:14:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation80 FR 10700 
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