73326 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 

questions through written comments 

that can be submitted to the public 

docket (see ADDRESSES). When 

submitting comments, if you are 

commenting on behalf of a child, please 

indicate that and answer the following 

questions as much as possible from the 

patient’s perspective. 

Topic 1: Disease Symptoms and Daily 

Impacts That Matter Most to Patients 

1. What worries you most about your 

condition? 

2. Do you experience symptoms 

because of your condition? If so, of all 

the symptoms that you experience, 

which one to three symptoms have the 

most significant impact on your life? 

(Examples may include irregular 

heartbeat, shortness of breath, difficulty 

swallowing, stomach pain, or 

constipation.) 

3. Are there specific activities that are 

important to you but that you cannot do 

at all or as fully as you would like 

because of your condition? (Examples of 

activities may include sleeping through 

the night, daily hygiene, driving, being 

a blood or organ donor, or for women 

in reproductive age concern about 

getting pregnant and transmitting the 

infection to your children, etc.) 

4. How have your condition and its 

symptoms changed over time? 

5. Do your symptoms come and go? If 

so, do you know of anything that makes 

your symptoms better or worse? 

Topic 2: Patient Perspectives on Current 

Approaches To Treat Chagas Disease 

1. What are you currently doing to 

help treat your condition? (Examples 

may include prescription medicines, 

over-the-counter products, and other 

therapies including non-drug therapies 

such as diet modification.) 

a. What specific symptoms do your 

treatments address? 

b. How has your treatment regimen 

changed over time, and why? 

2. What are the most significant 

downsides to your current treatments, 

and how do they affect your daily life? 

(Examples of downsides may include 

bothersome side effects, length of 

treatment, number of pills to take daily, 

going to the hospital for frequent 

checkups or treatment, restrictions on 

driving, potential consequences to your 

health and your child’s health during 

pregnancy, etc.) 

3. What specific things would you 

look for in an ideal treatment for your 

condition? 

In the afternoon, discussion will be 

related to scientific topics, with the goal 

of understanding issues that may affect 

the development of drugs for the 

treatment of Chagas disease and 

identifying topics for future discussion. 

Discussion topics for the afternoon will 

include designs and endpoints for 

clinical trials as well as appropriate trial 

populations. 

B. Meeting Attendance and 

Participation 

If you wish to attend the meeting, 

visit http://

chagasdiseasepatientfocused.

eventbrite.com. Please register for the 

meeting by April 20, 2015. If you are 

unable to attend the meeting in person, 

you can register to view a live Webcast. 

You will be asked to indicate in your 

registration whether you plan to attend 

in person or via the Webcast. 

Seating will be limited, so 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. Registrants will receive 

confirmation once they have been 

accepted. Onsite registration on the day 

of the meetings will be based on space 

availability. If you need special 

accommodations because of a disability, 

please contact Pujita Vaidya (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days before the meeting. 

Patients who are interested in 

presenting comments as part of the 

initial panel discussions must indicate 

in their registration which topic(s) they 

wish to address. These patients also 

must send a brief summary of responses 

to the topic questions by April 10, 2015, 

to PatientFocused@fda.hhs.gov. 

Panelists will be notified of their 

selection approximately 7 days before 

the public meeting. We will try to 

accommodate all patients and patient 

stakeholders who wish to speak, either 

through the panel discussion or 

audience participation; however, the 

duration of comments may be limited by 

time constraints. 

FDA will hold an open public 

comment period to give the public an 

opportunity to comment. Registration 

for open public comment will occur at 

the registration desk on the day of the 

meeting on a first-come, first-served 

basis. 

III. Comments 

Regardless of attendance at the 

Patient-Focused Drug Development 

meeting, you can submit electronic or 

written comments, including responses 

to the questions pertaining to Topics 1 

and 2, to the public docket (see 

ADDRESSES) by June 29, 2015. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Transcripts 

As soon as a transcript is available, 

FDA will post it at http://www.fda.gov/ 

Drugs/NewsEvents/ucm420130.htm. 

Dated: December 3, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28828 Filed 12–9–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Oncologic 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: Oncologic 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 7, 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: Caleb Briggs, 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: 

ODAC@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 

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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73327 

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 (BLA) 

125553 for EP2006, a proposed 

biosimilar to Amgen Inc.’s NEUPOGEN 

(filgrastim), submitted by Sandoz, Inc. 

The proposed indications (uses) for this 

product are: (1) To decrease the 

incidence of infection, as manifested by 

febrile neutropenia, in patients with 

nonmyeloid malignancies receiving 

myelosuppressive anti-cancer drugs 

associated with a significant incidence 

of severe neutropenia with fever; (2) for 

reducing the time to neutrophil recovery 

and the duration of fever, following 

induction or consolidation 

chemotherapy treatment of adults with 

acute myeloid leukemia; (3) to reduce 

the duration of neutropenia and 

neutropenia-related clinical sequelae, 

e.g., febrile neutropenia in patients with 

nonmyeloid malignancies undergoing 

myeloablative chemotherapy followed 

by marrow transplantation; (4) for the 

mobilization of hematopoietic 

progenitor cells into the peripheral 

blood for collection by leukapheresis; 

and (5) for chronic administration to 

reduce the incidence and duration of 

sequelae of neutropenia (e.g., fever, 

infections, oropharyngeal ulcers) in 

symptomatic patients with congenital 

neutropenia, cyclic neutropenia, or 

idiopathic neutropenia. 

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 December 22, 2014. 

Oral presentations from the public will 

be scheduled between approximately 

2:15 p.m. to 3:15 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 12, 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 15, 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 Caleb Briggs 

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: December 3, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–28847 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2032] 

Request for Nominations for Voting 

Members on the Food Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Food Advisory Committee, 

Office of Regulations, Policy, and Social 

Sciences, Center for Food Safety and 

Applied Nutrition. FDA seeks to include 

the views of women and men, members 

of all racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before January 30, 2015, will be given 

first consideration for membership on 

the Food Advisory Committee. 

Nominations received after January 30, 

2015, will be considered for nomination 

to the committee as later vacancies 

occur. 

ADDRESSES: All nominations for 

membership should be submitted 

electronically by logging into the FDA 

Advisory Committee Membership 

Nomination Portal: https://

www.accessdata.fda.gov/scripts/

FACTRSPortal/FACTRS/index.cfm, by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002, or by FAX to 301–847– 

8640. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

Web site at http://www.fda.gov/

AdvisoryCommittees/default.htm. 

FOR FURTHER INFORMATION: Regarding all 

nominations questions for membership, 

the primary contact is: Karen Strambler, 

Office of Regulations, Policy, and Social 

Sciences, Center for Food Safety and 

Applied Nutrition, 5100 Paint Branch 

Pkwy., Rm. 1C–016, College Park, MD 

20740, 240–402–2589, FAX: 301–436– 

2637, FoodAdvisoryCommittee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members on the Food Advisory 

Committee. 

I. General Description of the Committee 

Duties 

The Food Advisory Committee 

provides advice to the Commissioner of 

Food and Drugs and other appropriate 

officials on emerging food safety, food 

science, nutrition, and other foodrelated health issues that FDA considers 

of primary importance for its food and 

cosmetics programs. The Committee 

may be charged with reviewing and 

evaluating available data and making 

recommendations on matters such as 

those relating to: (1) Broad scientific and 

technical food- or cosmetic-related 

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