Narcolepsy Public Meeting on Patient-Focused Drug Development, 43209-43210 [2013-17327]

Download as PDF Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices 43209 ANNUAL BURDEN ESTIMATES Reporting requirement Number of respondents Employers ......................................................... Non-IV–D CPs .................................................. e IWO Employers .............................................. Total ........................................................... Estimated Total Annual Burden Hours: 521,449 In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2013–17331 Filed 7–18–13; 8:45 am] BILLING CODE 4184–01–P emcdonald on DSK67QTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0815] Narcolepsy Public Meeting on PatientFocused Drug Development AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 15:33 Jul 18, 2013 Jkt 229001 1,283,965 2,436,312 4,763 3,721,508 Number of responses per respondent 7.44 1.00 131.75 ............................ Annual number of responses 9,552,699.60 2,436,312.00 627,525.25 12,052,319 Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for narcolepsy. 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 public meeting is intended to allow FDA to obtain patients’ perspectives on the impact of narcolepsy on daily life as well as the available therapies for narcolepsy. DATES: The public meeting will be held on September 24, 2013, from 1 p.m. to 5 p.m. Registration to attend the meeting must be received by September 13, 2013. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Submit electronic or written comments by November 25, 2013. ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Section A of the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants is through Building 1, where routine security check procedures will be performed. For more information on parking and security procedures, please refer to https:// 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: https://www.fda.gov/ForIndustry/ UserFees/PrescriptionDrugUserFee/ ucm359018.htm. FOR FURTHER INFORMATION CONTACT: Pujita Vaidya, Center for Drug SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Average burden hours per response 2 minutes .......... 5 minutes .......... 3 seconds ......... ........................... Total burden hours 318,423 203,026 523 521,449 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1170, Silver Spring, MD 20993, 301–796– 0684, FAX: 301–847–8443, email: Pujita.Vaidya@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background on Patient-Focused Drug Development FDA has selected narcolepsy to be 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 under Title I of the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112– 144). The full set of performance commitments is available on the FDA Web site at https://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 in the Federal Register (78 FR 22613) announcing the disease areas for meetings in fiscal years (FY) 2013–2015, the first 3 years of the 5-year PDUFA V timeframe. To develop the list of disease areas, the Agency used several criteria that were outlined in the April 11 notice. The Agency gathered 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 55849), and through a public meeting E:\FR\FM\19JYN1.SGM 19JYN1 43210 Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices held on October 25, 2012. In selecting the disease areas, FDA carefully considered the public comments received and the perspectives of its review divisions. By the end of FY 2015, FDA will initiate another 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 on FDA’s Web site at https://www.fda.gov/ ForIndustry/UserFees/ PrescriptionDrugUserFee/ ucm326192.htm. II. Public Meeting Information emcdonald on DSK67QTVN1PROD with NOTICES A. Purpose and Scope of the Meeting As part of Patient-Focused Drug Development, FDA will gather patient and patient stakeholder input on symptoms of narcolepsy that matter most to patients and on current approaches to treating narcolepsy. Narcolepsy is a chronic disorder of the central nervous system caused by the brain’s inability to control sleep-wake cycles and is characterized by excessive daytime sleepiness, cataplexy, hallucination, and disturbed nocturnal sleep. Although there is no cure for narcolepsy, medications and lifestyle modifications can help patients manage their symptoms. FDA is interested in obtaining a better understanding of patients’ perspectives on the severity of the disease and assessments of available therapies. 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 patient panel discussion will begin the dialogue, followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through the public docket (see ADDRESSES). Topic 1: Disease symptoms and daily impacts that matter most to patients: 1. 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 excessive daytime sleepiness, cataplexy, etc.) 2. 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, work and school performance, etc.) 3. How have your symptoms changed over time? VerDate Mar<15>2010 15:33 Jul 18, 2013 Jkt 229001 3.1. Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse? Topic 2: Patients’ perspectives on current approaches to treating narcolepsy: 1. What are you currently doing to help treat your condition or its symptoms? (Examples may include FDA-approved medicines, over-thecounter products, and other therapies including non-drug therapies such as lifestyle modifications.) 1.1. What specific symptoms do your therapies address? 1.2. How has your treatment regimen changed over time, and why? 2. How well does your current treatment regimen treat the most significant symptoms of your disease? 2.1. How well do these therapies improve your ability to do specific activities that are important to you in your daily life? 2.2. How well have these therapies worked for you as your condition has changed over time? 3. What are the most significant downsides to your current therapies, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, inconvenient dosing schedules, access issues, etc.) 4. Assuming there is no complete cure for your condition, what specific things would you look for in an ideal therapy for your condition? 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. They will also be asked to send a brief summary of responses to the topic questions to PatientFocused@fda.hhs.gov. Panelists will be notified of their selection soon after the close of registration on September 13, 2013. FDA 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. Interested members of the public, including those who attend the meeting in person or through the webcast, are invited to provide electronic or written responses to the questions pertaining to Topics 1 and 2 to the public docket (see ADDRESSES). Comments may be submitted until November 25, 2013. B. Meeting Attendance and/or Participation If you wish to attend this meeting, visit https://patientfocused narcolepsy.eventbrite.com. Please register by September 13, 2013. Those who are unable to attend the meeting in person can register to view a live webcast of the meeting. You will be asked to indicate in your registration whether you plan to attend in person or via the webcast. Your registration should also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. 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 meeting will be based on space availability. If you need special accommodations because of disability, please contact Pujita Vaidya (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. [Docket No. FDA–2013–N–0845] PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Dated: July 15, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–17327 Filed 7–18–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of 52 new drug applications (NDAs) and 77 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Effective August 19, 2013. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: The holders of the applications listed in SUMMARY: E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43209-43210]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17327]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0815]


Narcolepsy Public Meeting on Patient-Focused Drug Development

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 narcolepsy. 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 public meeting is 
intended to allow FDA to obtain patients' perspectives on the impact of 
narcolepsy on daily life as well as the available therapies for 
narcolepsy.

DATES: The public meeting will be held on September 24, 2013, from 1 
p.m. to 5 p.m. Registration to attend the meeting must be received by 
September 13, 2013. See the SUPPLEMENTARY INFORMATION section for 
information on how to register for the meeting. Submit electronic or 
written comments by November 25, 2013.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., Building 31 Conference Center, Section A of the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
meeting participants is through Building 1, where routine security 
check procedures will be performed. For more information on parking and 
security procedures, please refer to https://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: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm359018.htm.

FOR FURTHER INFORMATION CONTACT: Pujita Vaidya, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1170, Silver Spring, MD 20993, 301-796-
0684, FAX: 301-847-8443, email: Pujita.Vaidya@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected narcolepsy to be the focus of a meeting under 
Patient-Focused 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 under Title I of 
the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112-144). 
The full set of performance commitments is available on the FDA Web 
site at https://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 in the Federal Register 
(78 FR 22613) announcing the disease areas for meetings in fiscal years 
(FY) 2013-2015, the first 3 years of the 5-year PDUFA V timeframe. To 
develop the list of disease areas, the Agency used several criteria 
that were outlined in the April 11 notice. The Agency gathered 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 55849), and through a public meeting

[[Page 43210]]

held on October 25, 2012. In selecting the disease areas, FDA carefully 
considered the public comments received and the perspectives of its 
review divisions. By the end of FY 2015, FDA will initiate another 
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 on FDA's Web site at https://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 gather 
patient and patient stakeholder input on symptoms of narcolepsy that 
matter most to patients and on current approaches to treating 
narcolepsy. Narcolepsy is a chronic disorder of the central nervous 
system caused by the brain's inability to control sleep-wake cycles and 
is characterized by excessive daytime sleepiness, cataplexy, 
hallucination, and disturbed nocturnal sleep. Although there is no cure 
for narcolepsy, medications and lifestyle modifications can help 
patients manage their symptoms. FDA is interested in obtaining a better 
understanding of patients' perspectives on the severity of the disease 
and assessments of available therapies.
    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 patient panel discussion will begin the 
dialogue, followed by a facilitated discussion inviting comments from 
other patient and patient stakeholder participants. In addition to 
input generated through this public meeting, FDA is interested in 
receiving patient input addressing these questions through the public 
docket (see ADDRESSES).
    Topic 1: Disease symptoms and daily impacts that matter most to 
patients:
    1. 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 excessive daytime sleepiness, 
cataplexy, etc.)
    2. 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, work and school performance, etc.)
    3. How have your symptoms changed over time?
    3.1. Do your symptoms come and go? If so, do you know of anything 
that makes your symptoms better? Worse?
    Topic 2: Patients' perspectives on current approaches to treating 
narcolepsy:
    1. What are you currently doing to help treat your condition or its 
symptoms? (Examples may include FDA-approved medicines, over-the-
counter products, and other therapies including non-drug therapies such 
as lifestyle modifications.)
    1.1. What specific symptoms do your therapies address?
    1.2. How has your treatment regimen changed over time, and why?
    2. How well does your current treatment regimen treat the most 
significant symptoms of your disease?
    2.1. How well do these therapies improve your ability to do 
specific activities that are important to you in your daily life?
    2.2. How well have these therapies worked for you as your condition 
has changed over time?
    3. What are the most significant downsides to your current 
therapies, and how do they affect your daily life? (Examples of 
downsides may include bothersome side effects, inconvenient dosing 
schedules, access issues, etc.)
    4. Assuming there is no complete cure for your condition, what 
specific things would you look for in an ideal therapy for your 
condition?

B. Meeting Attendance and/or Participation

    If you wish to attend this meeting, visit https://patientfocusednarcolepsy.eventbrite.com. Please register by September 
13, 2013. Those who are unable to attend the meeting in person can 
register to view a live webcast of the meeting. You will be asked to 
indicate in your registration whether you plan to attend in person or 
via the webcast. Your registration should also contain your complete 
contact information, including name, title, affiliation, address, email 
address, and phone number.
    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 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 will be asked to indicate in their 
registration which topic(s) they wish to address. They will also be 
asked to send a brief summary of responses to the topic questions to 
PatientFocused@fda.hhs.gov. Panelists will be notified of their 
selection soon after the close of registration on September 13, 2013. 
FDA 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.
    Interested members of the public, including those who attend the 
meeting in person or through the webcast, are invited to provide 
electronic or written responses to the questions pertaining to Topics 1 
and 2 to the public docket (see ADDRESSES). Comments may be submitted 
until November 25, 2013.

    Dated: July 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17327 Filed 7-18-13; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.