Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73325 

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. 

Dated: December 4, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–28881 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–1998] 

Patient-Focused Drug Development 

Public Meeting on Chagas Disease 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting and an opportunity for 

public comment on Patient-Focused 

Drug Development for Chagas disease. 

Patient-Focused Drug Development is 

part of FDA’s performance 

commitments in the fifth authorization 

of the Prescription Drug User Fee Act 

(PDUFA V). The meeting is intended to 

allow FDA to obtain patients’ 

perspectives on the impact that Chagas 

disease has on their daily lives, as well 

as their perspectives on the available 

therapies for Chagas disease. FDA is 

also interested in discussing issues 

related to scientific challenges in 

developing drugs to treat Chagas 

disease. In the afternoon, FDA will 

provide information for and gain 

perspective from patients and patient 

advocacy organizations, health care 

providers, academic experts, and 

industry on various aspects of clinical 

development of drug products intended 

to treat Chagas disease. The input from 

this public meeting will help in 

developing topics for further discussion. 

DATES: The meeting will be held on 

April 28, 2015, from 9 a.m. to 5 p.m. 

Registration to attend the meeting must 

be received by April 20, 2015. See the 

SUPPLEMENTARY INFORMATION section for 

information on how to register for the 

meeting. Submit electronic or written 

comments by June 29, 2015. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, Sections B and C of 

the Great Room (Rm. 1503), Silver 

Spring, MD 20993. Participants must 

enter through Building 1 and undergo 

security screening. For more 

information on parking and security 

procedures, please visit http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Room 1061, Rockville, MD 20852. 

All comments should be identified with 

the docket number found in brackets in 

the heading of this document. 

FDA will post the agenda 

approximately 5 days before the meeting 

at http://www.fda.gov/Drugs/

NewsEvents/ucm420130.htm. 

FOR FURTHER INFORMATION CONTACT: 

Pujita Vaidya, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1144, 

Silver Spring, MD 20993, 301–796– 

0684, FAX: 301–847–8443, 

Pujita.Vaidya@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on Patient-Focused Drug 

Development 

FDA has selected Chagas disease as 

the focus of a meeting under PatientFocused Drug Development, an 

initiative that involves obtaining a better 

understanding of patients’ perspectives 

on the severity of the disease and the 

available therapies for the condition. 

Patient-Focused Drug Development is 

being conducted to fulfill FDA’s 

performance commitments made as part 

of the authorization of PDUFA V under 

Title I of the Food and Drug Safety and 

Innovation Act (Public Law 112–144). 

The full set of performance 

commitments is available on the FDA 

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

downloads/forindustry/userfees/

prescriptiondruguserfee/

ucm270412.pdf. 

FDA has committed to obtain the 

patient perspective in 20 disease areas 

during the course of PDUFA V. For each 

disease area, the Agency will conduct a 

public meeting to discuss the disease 

and its impact on patients’ daily lives, 

the types of treatment benefit that 

matter most to patients, and patients’ 

perspectives on the adequacy of the 

available therapies. These meetings will 

include participation of FDA review 

divisions, the relevant patient 

community, and other interested 

stakeholders. 

On April 11, 2013, FDA published a 

notice (78 FR 21613) in the Federal 

Register announcing the disease areas 

for meetings in fiscal years (FYs) 2013 

through 2015, the first 3 years of the 5- 

year PDUFA V time frame. To develop 

the list of disease areas, the Agency 

used several criteria that were outlined 

in the April 11 notice. The Agency 

obtained public comment on these 

criteria and potential disease areas 

through a notice for public comment 

published in the Federal Register on 

September 24, 2012 (77 FR 58849), and 

through a public meeting held on 

October 25, 2012. In selecting the 

disease areas, FDA carefully considered 

the public comments received and the 

perspectives of its review divisions. On 

October 8, 2014, FDA published a notice 

in the Federal Register to initiate 

another public process to determine the 

disease areas for FYs 2016 through 2017 

(79 FR 60857). More information, 

including the list of disease areas and a 

general schedule of meetings, is posted 

at http://www.fda.gov/ForIndustry/

UserFees/PrescriptionDrugUserFee/

ucm326192.htm. 

II. Public Meeting Information 

A. Purpose and Scope of the Meeting 

As part of Patient-Focused Drug 

Development, FDA will obtain patient 

and patient stakeholder input on 

symptoms of Chagas disease (American 

trypanosomiasis) that matter most to 

patients and on current approaches to 

treating Chagas disease. When left 

untreated, acute Chagas disease may 

progress to chronic Chagas disease. 

There are currently no FDA-approved 

drug therapies to treat acute or chronic 

Chagas disease. FDA is committed to 

working with all stakeholders to 

develop safe and effective therapies for 

affected individuals. 

The questions that will be asked of 

patients and patient stakeholders at the 

meeting are listed in this section and 

organized by topic. For each topic, a 

brief patient panel discussion will begin 

the dialogue, followed by a facilitated 

discussion inviting comments from 

other patients and patient stakeholders. 

In addition to input received through 

this public meeting, FDA is interested in 

receiving patient input addressing these 

mstockstill on DSK4VPTVN1PROD with NOTICES

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 

mstockstill on DSK4VPTVN1PROD with NOTICES