80_FR_57188 80 FR 57006 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

80 FR 57006 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 182 (September 21, 2015)

Page Range57006-57006
FR Document2015-23556

Federal Register, Volume 80 Issue 182 (Monday, September 21, 2015) 
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Page 57006]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Pulmonary-Allergy 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 December 9, 2015, from 8 
a.m. to 5 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: Cindy Hong, 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, PADAC@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 biologics license application 
761033, reslizumab for injection, submitted by Teva Pharmaceutical 
Industries, Ltd., for the proposed indication to reduce exacerbations, 
relieve symptoms, and improve lung function in adults and adolescents 
12 years of age and above, with asthma and elevated blood eosinophils, 
who are inadequately controlled on inhaled corticosteroids.
    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 
November 24, 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 November 16, 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 November 17, 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 
disabilities. If you require accommodations due to a disability, please 
contact Cindy Hong 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: September 15, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-23556 Filed 9-18-15; 8:45 am]
 BILLING CODE 4164-01-P

57006 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices requested to make their presentation on Date and Time: The meeting will be before the committee. Written or before October 21, 2015. Time held on December 9, 2015, from 8 a.m. submissions may be made to the contact allotted for each presentation may be to 5 p.m. person on or before November 24, 2015. limited. If the number of registrants Location: FDA White Oak Campus, Oral presentations from the public will requesting to speak is greater than can 10903 New Hampshire Ave., Bldg. 31 be scheduled between approximately 1 be reasonably accommodated during the Conference Center, the Great Room (Rm. p.m. and 2 p.m. Those individuals scheduled open public hearing session, 1503), Silver Spring, MD 20993–0002. interested in making formal oral FDA may conduct a lottery to determine Answers to commonly asked questions presentations should notify the contact the speakers for the scheduled open including information regarding special person and submit a brief statement of public hearing session. The contact accommodations due to a disability, the general nature of the evidence or person will notify interested persons visitor parking, and transportation may be accessed at: http://www.fda.gov/ arguments they wish to present, the regarding their request to speak by names and addresses of proposed October 22, 2015. AdvisoryCommittees/ AboutAdvisoryCommittees/ participants, and an indication of the Persons attending FDA’s advisory ucm408555.htm. approximate time requested to make committee meetings are advised that the Agency is not responsible for providing Contact Person: Cindy Hong, Center their presentation on or before access to electrical outlets. for Drug Evaluation and Research, Food November 16, 2015. Time allotted for FDA welcomes the attendance of the and Drug Administration, 10903 New each presentation may be limited. If the public at its advisory committee Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to meetings and will make every effort to Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably accommodate persons with disabilities. 796–9001, FAX: 301–847–8533, accommodated during the scheduled If you require accommodations due to a PADAC@fda.hhs.gov, or FDA Advisory open public hearing session, FDA may disability, please contact Sujata Vijh at Committee Information Line, 1–800– conduct a lottery to determine the least 7 days in advance of the meeting. 741–8138 (301–443–0572 in the speakers for the scheduled open public FDA is committed to the orderly Washington, DC area). A notice in the hearing session. The contact person will conduct of its advisory committee Federal Register about last minute notify interested persons regarding their meetings. Please visit our Web site at modifications that impact a previously request to speak by November 17, 2015. http://www.fda.gov/ announced advisory committee meeting cannot always be published quickly Persons attending FDA’s advisory AdvisoryCommittees/ committee meetings are advised that the AboutAdvisoryCommittees/ enough to provide timely notice. Therefore, you should always check the Agency is not responsible for providing ucm111462.htm for procedures on access to electrical outlets. public conduct during advisory Agency’s Web site at http:// www.fda.gov/AdvisoryCommittees/ FDA welcomes the attendance of the committee meetings. default.htm and scroll down to the public at its advisory committee Notice of this meeting is given under appropriate advisory committee meeting meetings and will make every effort to the Federal Advisory Committee Act (5 link, or call the advisory committee accommodate persons with disabilities. U.S.C. app. 2). information line to learn about possible If you require accommodations due to a Dated: September 15, 2015. modifications before coming to the Jill Hartzler Warner, disability, please contact Cindy Hong at meeting. Agenda: The committee will discuss least 7 days in advance of the meeting. Associate Commissioner for Special Medical Programs. biologics license application 761033, FDA is committed to the orderly [FR Doc. 2015–23550 Filed 9–18–15; 8:45 am] reslizumab for injection, submitted by conduct of its advisory committee BILLING CODE 4164–01–P Teva Pharmaceutical Industries, Ltd., meetings. Please visit our Web site at for the proposed indication to reduce http://www.fda.gov/ exacerbations, relieve symptoms, and AdvisoryCommittees/ DEPARTMENT OF HEALTH AND improve lung function in adults and AboutAdvisoryCommittees/ HUMAN SERVICES adolescents 12 years of age and above, ucm111462.htm for procedures on with asthma and elevated blood public conduct during advisory Food and Drug Administration eosinophils, who are inadequately committee meetings. controlled on inhaled corticosteroids. [Docket No. FDA–2015–N–0001] Notice of this meeting is given under FDA intends to make background material available to the public no later the Federal Advisory Committee Act (5 Pulmonary-Allergy Drugs Advisory U.S.C. app. 2). Committee; Notice of Meeting than 2 business days before the meeting. If FDA is unable to post the background Dated: September 15, 2015. AGENCY: Food and Drug Administration, material on its Web site prior to the Jill Hartzler Warner, HHS. meeting, the background material will Associate Commissioner for Special Medical ACTION: Notice. be made publicly available at the Programs. location of the advisory committee [FR Doc. 2015–23556 Filed 9–18–15; 8:45 am] This notice announces a forthcoming meeting, and the background material meeting of a public advisory committee will be posted on FDA’s Web site after BILLING CODE 4164–01–P of the Food and Drug Administration the meeting. Background material is (FDA). The meeting will be open to the available at http://www.fda.gov/ rmajette on DSK7SPTVN1PROD with NOTICES public. AdvisoryCommittees/Calendar/ Name of Committee: Pulmonary- default.htm. Scroll down to the Allergy Drugs Advisory Committee. appropriate advisory committee meeting General Function of the Committee: link. To provide advice and Procedure: Interested persons may recommendations to the Agency on present data, information, or views, FDA’s regulatory issues. orally or in writing, on issues pending VerDate Sep<11>2014 15:14 Sep 18, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 E:\FR\FM\21SEN1.SGM 21SEN1


Document Created: 2015-12-15 09:39:14
Document Modified: 2015-12-15 09:39:14
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 57006 
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