7616 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http://

www.fda.gov/MedicalDevices/

ProductsandMedicalProcedures/

DeviceApprovalsandClearances/

PMAApprovals/default.htm. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02783 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0244] 

Patient-Focused Drug Development for 

Functional Gastrointestinal Disorders; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a public meeting and an 

opportunity for public comment on 

Patient-Focused Drug Development for 

functional gastrointestinal (GI) 

disorders, including irritable bowel 

syndrome, gastroparesis, chronic 

persistent symptomatic 

gastroesophageal reflux despite standard 

therapeutic interventions, and chronic 

idiopathic constipation. Patient-Focused 

Drug Development is part of FDA’s 

performance commitments made as part 

of the fifth authorization of the 

Prescription Drug User Fee Act (PDUFA 

V). The public meeting is intended to 

allow FDA to obtain patient 

perspectives on the impact of functional 

GI disorders on daily life and patient 

views on treatment approaches. 

DATES: The public meeting will be held 

on May 11, 2015, from 1 p.m. to 5 p.m. 

Registration to attend the meeting must 

be received by May 1, 2015 (see 

SUPPLEMENTARY INFORMATION for 

instructions). Submit electronic or 

written comments to the public docket 

by July 13, 2015. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Participants must enter through 

Building 1 and undergo security 

screening. For more information on 

parking and security procedures, please 

refer to http://www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Submit electronic comments to 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

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/ForIndustry/

UserFees/PrescriptionDrugUserFee/

ucm430885.htm. 

FOR FURTHER INFORMATION CONTACT: 

Pegah Mariani, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1146, 

Silver Spring, MD 20993–0002, 240– 

402–4513, FAX: 301–847–8443, 

Sayyedeh.Mariani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on Patient-Focused Drug 

Development 

FDA has selected functional GI 

disorders as the focus of a public 

meeting under Patient-Focused Drug 

Development, an initiative that involves 

obtaining a better understanding of 

patient perspectives on the severity of a 

disease and the available therapies for 

that condition. Patient-Focused Drug 

Development is being conducted to 

fulfill FDA performance commitments 

that are part of the reauthorization of the 

PDUFA under Title I of the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA) (Pub. L. 112– 

144). The full set of performance 

commitments is available at http://

www.fda.gov/downloads/forindustry/

userfees/prescriptiondruguserfee/

ucm270412.pdf. 

FDA committed to obtain the patient 

perspective on 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 

communities, and other interested 

stakeholders. 

On April 11, 2013, FDA published a 

document in the Federal Register (78 

FR 21613) announcing the disease areas 

for meetings in fiscal years (FYs) 2013– 

2015, the first 3 years of the 5-year 

PDUFA V timeframe. The Agency used 

several criteria outlined in that 

document to develop the list of disease 

areas. FDA obtained public comment on 

the Agency’s proposed criteria and 

potential disease areas through a public 

docket and a public meeting that was 

convened on October 25, 2012. In 

selecting the set of disease areas, FDA 

carefully considered the public 

comments received and the perspectives 

of review divisions at FDA. FDA has 

initiated a second public process for 

determining the disease areas for FY 

2016–2017. 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 

The purpose of this Patient-Focused 

Drug Development meeting is to obtain 

input on the symptoms and other 

impacts of functional GI disorders, such 

as irritable bowel syndrome, 

gastroparesis, chronic persistent 

symptomatic gastroesophageal reflux 

despite standard therapeutic 

interventions, and chronic idiopathic 

constipation, that matter most to 

patients, as well as perspectives on 

current approaches to treating these 

conditions. Functional GI disorders are 

common disorders that are 

characterized by persistent and 

recurring GI symptoms and occur as a 

result of abnormal functioning of the GI 

tract. These disorders are not caused by 

structural abnormalities, thus routine 

medical tests may be normal, and 

diagnosis is based primarily on 

symptoms. Functional GI disorders can 

affect any part of the GI tract, including 

the esophagus, bile duct, and intestines. 

Treatment for functional GI disorders 

focuses on management of different 

symptoms over a period of time. 

Treatments may include dietary 

management as well as over-the-counter 

and prescription medications (e.g., 

antispasmodics, pro-motility agents, 

antidiarrheals, and antidepressants). In 

addition, psychological treatments, such 

as relaxation therapy or cognitive 

behavioral therapy, may help manage 

the symptoms of functional GI 

disorders. 

The questions that will be asked of 

patients and patient stakeholders at the 

meeting are listed in this section, 

organized by topic. For each topic, a 

brief initial patient panel discussion 

will begin the dialogue. This will be 

followed by a facilitated discussion 

inviting comments from other patient 

and patient stakeholder participants. In 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7617 

addition to input generated through this 

public meeting, FDA is interested in 

receiving patient input addressing these 

questions through written comments, 

which can be submitted to the public 

docket (see ADDRESSES). 

Topic 1: Disease Symptoms and Daily 

Impacts That Matter Most to Patients 

• Have you received a diagnosis of a 

functional GI disorder from a health 

care provider? If so, please state the 

condition. 

• Of all the symptoms that you 

experience because of your condition, 

which one to three symptoms have the 

most significant impact on your life? 

(Examples may include pain, bloating, 

constipation, vomiting) 

• 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) 

Æ How do your symptoms and their 

negative impacts affect your daily life 

on the best days? On the worst days? 

• How has your condition and its 

symptoms changed over time? 

Æ Do your symptoms come and go or 

are they ongoing? If so, do you know of 

anything that worsens your symptoms? 

• What worries you most about your 

condition? 

Topic 2: Patients’ Perspectives on 

Current Approaches To Treating 

Functional GI Disorders 

• What are you currently doing to 

help treat your condition or its 

symptoms? (Examples may include 

prescription medicines, over-thecounter products, and other therapies 

including nondrug therapies such as 

diet modification.) 

Æ What specific symptoms do your 

treatments address? 

Æ How has your treatment regimen 

changed over time, and why? 

• How well does your current 

treatment regimen treat the most 

significant symptoms of your disease? 

Æ How well do these treatments stop 

or slow the progression of your 

condition? 

Æ How well do these therapies 

improve your ability to do specific 

activities that are important to you in 

your daily life? 

Æ How well have these treatments 

worked for you as your condition has 

changed over time? 

• 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, going to the 

hospital for treatment, restrictions on 

driving, etc.) 

• Assuming there is no complete cure 

for your condition, what specific things 

would you look for in an ideal treatment 

for your condition? 

B. Meeting Attendance and 

Participation 

If you wish to attend this meeting, 

visit http://pfddfunctionalgi

disorders.eventbrite.com. Please register 

by May 1, 2015. If you are unable to 

attend the meeting in person, you can 

register to view a live Webcast of the 

meeting. You will be asked to indicate 

in your registration if 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 first-come, 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 meeting 

will be based on space availability. If 

you need special accommodations 

because of a disability, please contact 

Pegah Mariani (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 will be asked 

to indicate in their registration which 

topic(s) they wish to address. These 

patients also must send to 

PatientFocused@fda.hhs.gov a brief 

summary of responses to the topic 

questions by April 24, 2015. 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. 

III. Comments 

Regardless of whether you attend the 

public meeting, you can submit 

electronic or written responses to the 

questions pertaining to Topics 1 and 2 

to the public docket (see ADDRESSES) by 

July 13, 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. 

IV. Transcripts 

As soon as a transcript is available, 

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

ForIndustry/UserFees/Prescription

DrugUserFee/ucm430885.htm. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02804 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

039 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (‘‘FDA Recognized 

Consensus Standards’’). Specifically, 

this publication announces the addition 

of a list of recognized standards that are 

relevant to safety considerations to 

mitigate the risks of misconnections 

with small-bore connectors intended for 

enteral applications. This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 039’’ (‘‘Recognition List 

Number: 039’’), will assist 

manufacturers who elect to declare 

conformity with consensus standards to 

meet certain requirements for medical 

devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VI for 

the effective date of the recognition of 

standards announced in this document. 

ADDRESSES: An electronic copy of 

Recognition List Number: 039 is 

available on the Internet at http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

V for electronic access to the searchable 

database for the current list of FDA 

recognized consensus standards, 

including Recognition List Number: 039 

modifications and other standards 

related information. 

Submit written requests for single 

copies of the document entitled 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

039’’ to the Division of Industry and 

Consumer Education, Center for Devices 

and Radiological Health, Food and Drug 


tkelley on DSK3SPTVN1PROD with NOTICES