80_FR_59346 80 FR 59156 - Joint Meeting of the Antimicrobial Drugs Advisory Committee (Formerly Known as the Anti-Infective Drugs Advisory Committee) and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

80 FR 59156 - Joint Meeting of the Antimicrobial Drugs Advisory Committee (Formerly Known as the Anti-Infective Drugs Advisory Committee) and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 190 (October 1, 2015)

Page Range59156-59156
FR Document2015-24836

Federal Register, Volume 80 Issue 190 (Thursday, October 1, 2015) 
[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Page 59156]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24836]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Joint Meeting of the Antimicrobial Drugs Advisory Committee 
(Formerly Known as the Anti-Infective Drugs Advisory Committee) and the 
Drug Safety and Risk Management 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 Committees: Antimicrobial Drugs Advisory Committee 
(formerly known as the Anti-Infective Drugs Advisory Committee) and the 
Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 5, 2015, from 8 
a.m. to 6 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: Jennifer Shepherd, 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, email: [email protected], 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 committees will discuss the risks and benefits of the 
systemic fluoroquinolone antibacterial drugs for the treatment of acute 
bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis 
in patients who have chronic obstructive pulmonary disease, and 
uncomplicated urinary tract infections in the context of available 
safety information and the treatment effect of antibacterial drugs in 
these clinical conditions.
    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 committees. 
Written submissions may be made to the contact person on or before 
October 22, 2015. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2:30 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 October 14, 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 October 15, 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 Jennifer Shepherd 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 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-24836 Filed 9-30-15; 8:45 am]
BILLING CODE 4164-01-P

59156 Federal Register / Vol. 80, No. 190 / Thursday, October 1, 2015 / Notices comments and suggestions submitted cannot always be published quickly Agency is not responsible for providing within 60 days of this publication. enough to provide timely notice. access to electrical outlets. Therefore, you should always check the FDA welcomes the attendance of the Robert Sargis, Agency’s Web site at http://www.fda. public at its advisory committee Reports Clearance Officer. gov/AdvisoryCommittees/default.htm meetings and will make every effort to [FR Doc. 2015–24863 Filed 9–30–15; 8:45 am] and scroll down to the appropriate accommodate persons with disabilities. BILLING CODE 4184–01–P advisory committee meeting link, or call If you require accommodations due to a the advisory committee information line disability, please contact Jennifer to learn about possible modifications Shepherd at least 7 days in advance of DEPARTMENT OF HEALTH AND before coming to the meeting. the meeting. HUMAN SERVICES Agenda: The committees will discuss FDA is committed to the orderly the risks and benefits of the systemic conduct of its advisory committee Food and Drug Administration fluoroquinolone antibacterial drugs for meetings. Please visit our Web site at [Docket No. FDA–2015–N–0001] the treatment of acute bacterial sinusitis, http://www.fda.gov/Advisory acute bacterial exacerbation of chronic Committees/AboutAdvisoryCommittees/ Joint Meeting of the Antimicrobial bronchitis in patients who have chronic ucm111462.htm for procedures on Drugs Advisory Committee (Formerly obstructive pulmonary disease, and public conduct during advisory Known as the Anti-Infective Drugs uncomplicated urinary tract infections committee meetings. Advisory Committee) and the Drug in the context of available safety Notice of this meeting is given under Safety and Risk Management Advisory information and the treatment effect of the Federal Advisory Committee Act (5 Committee; Notice of Meeting antibacterial drugs in these clinical U.S.C. app. 2). conditions. AGENCY: Food and Drug Administration, FDA intends to make background Dated: September 25, 2015. HHS. material available to the public no later Jill Hartzler Warner, ACTION: Notice. than 2 business days before the meeting. Associate Commissioner for Special Medical If FDA is unable to post the background Programs. This notice announces a forthcoming material on its Web site prior to the [FR Doc. 2015–24836 Filed 9–30–15; 8:45 am] meeting of a public advisory committee meeting, the background material will BILLING CODE 4164–01–P of the Food and Drug Administration be made publicly available at the (FDA). The meeting will be open to the location of the advisory committee public. meeting, and the background material DEPARTMENT OF HEALTH AND Name of Committees: Antimicrobial will be posted on FDA’s Web site after HUMAN SERVICES Drugs Advisory Committee (formerly the meeting. Background material is [Docket No. FDA–2015–N–0001] known as the Anti-Infective Drugs available at http://www.fda.gov/ Advisory Committee) and the Drug AdvisoryCommittees/Calendar/ Request for Nominations for Safety and Risk Management Advisory default.htm. Scroll down to the Individuals and Consumer Committee. appropriate advisory committee meeting Organizations for Advisory General Function of the Committees: link. Committees To provide advice and Procedure: Interested persons may recommendations to the Agency on present data, information, or views, AGENCY: Food and Drug Administration, FDA’s regulatory issues. orally or in writing, on issues pending HHS. Date and Time: The meeting will be before the committees. Written ACTION: Notice. held on November 5, 2015, from 8 a.m. submissions may be made to the contact to 6 p.m. person on or before October 22, 2015. SUMMARY: The Food and Drug Location: FDA White Oak Campus, Oral presentations from the public will Administration (FDA) is requesting that 10903 New Hampshire Ave., Bldg. 31 be scheduled between approximately 1 any consumer organizations interested Conference Center, the Great Room (Rm. p.m. and 2:30 p.m. Those individuals in participating in the selection of 1503), Silver Spring, MD 20993–0002. interested in making formal oral voting and/or nonvoting consumer Answers to commonly asked questions presentations should notify the contact representatives to serve on its advisory including information regarding special person and submit a brief statement of committees or panels notify FDA in accommodations due to a disability, the general nature of the evidence or writing. FDA is also requesting visitor parking, and transportation may arguments they wish to present, the nominations for voting and/or be accessed at: http://www.fda.gov/ names and addresses of proposed nonvoting consumer representatives to AdvisoryCommittees/AboutAdvisory participants, and an indication of the serve on advisory committees and/or Committees/ucm408555.htm. approximate time requested to make panels for which vacancies currently Contact Person: Jennifer Shepherd, their presentation on or before October exist or are expected to occur in the near Center for Drug Evaluation and 14, 2015. Time allotted for each future. Nominees recommended to serve Research, Food and Drug presentation may be limited. If the as a voting or nonvoting consumer Administration, 10903 New Hampshire number of registrants requesting to representative may be self-nominated or Ave., Bldg. 31, Rm. 2417, Silver Spring, speak is greater than can be reasonably may be nominated by a consumer MD 20993–0002, 301–796–9001, FAX: accommodated during the scheduled organization. Nominations will be mstockstill on DSK4VPTVN1PROD with NOTICES6 301–847–8533, email: AMDAC@ open public hearing session, FDA may accepted for current vacancies and for fda.hhs.gov, or FDA Advisory conduct a lottery to determine the those that will or may occur through Committee Information Line, 1–800– speakers for the scheduled open public December 31, 2015. 741–8138 (301–443–0572 in the hearing session. The contact person will DATES: Any consumer organization Washington, DC area). A notice in the notify interested persons regarding their interested in participating in the Federal Register about last minute request to speak by October 15, 2015. selection of an appropriate voting or modifications that impact a previously Persons attending FDA’s advisory nonvoting member to represent announced advisory committee meeting committee meetings are advised that the consumer interests on an FDA advisory VerDate Sep<11>2014 21:04 Sep 30, 2015 Jkt 238001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\01OCN1.SGM 01OCN1


Document Created: 2015-12-15 08:40:36
Document Modified: 2015-12-15 08:40:36
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 59156 
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