69498 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices 

understanding of various forms of 

evidence that could inform regulatory 

and medical decision making. The 

public workshop will help identify key 

components of such an evidence 

framework when therapeutic 

effectiveness is being evaluated in 

patients with molecular characteristics 

that are rare or have not been studied in 

clinical trials. 

II. Attendance and Registration 

The FDA Conference Center at the 

White Oak location is a Federal facility 

with security procedures and limited 

seating. Individuals who wish to attend 

the public workshop must register on or 

before December 1, 2014, by visiting: 

https://www.signup4.net/Public/

ap.aspx?OID=130&EID=DEVE96E. 

Early registration is recommended. 

Registration is free and will be on a firstcome, first-served basis. However, FDA 

may limit the number of participants 

from each organization based on space 

limitations. On-site registration on the 

day of the public workshop will be 

based on space availability. 

FDA will provide additional 

background information at the time the 

Federal Register notice is published and 

an agenda approximately 2 weeks before 

the public workshop at the FDA 

Meeting Information page, which is 

available online at: http://wcms.fda.

gov/FDAgov/Drugs/NewsEvents/

ucm416622.htm?SSContributor=true. 

If you need special accommodations 

because of disability, please contact 

Padmaja Mummaneni (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the public workshop. 

A live Webcast of this public 

workshop will be viewable 

on Adobe Connect at https://

collaboration.fda.gov/rsw2014/ on the 

day of the public workshop. 

Dated: November 17, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27523 Filed 11–20–14; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Anti-Infective 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: Anti-Infective 

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 January 22, 2015, from 8 a.m. 

to 5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

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: AIDAC@

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 applications (NDAs) 207–500 

and 207–501, isavuconazonium sulfate 

capsules and isavuconazonium sulfate 

for injection, sponsored by Astellas 

Pharma Global Development, Inc., 

respectively for the proposed 

indications of treatment of invasive 

aspergillosis and mucormycosis. 

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 January 7, 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 

December 29, 2014. 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 December 30, 2014. 

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 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/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: November 17, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–27573 Filed 11–20–14; 8:45 am] 

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