Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction, 57942-57944 [2014-22983]
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57942
Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices
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submissions may be made to the contact
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Oral presentations from the public will
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p.m. and 2 p.m. Those individuals
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speak is greater than can be reasonably
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notify interested persons regarding their
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Date: September 22, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–22905 Filed 9–25–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1413]
Patient-Focused Drug Development
Public Meeting and Scientific
Workshop on Female Sexual
Dysfunction
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Notice of public meeting and
workshop; request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting and scientific workshop,
both of which will provide an
opportunity for public comment on the
topic of Female Sexual Interest/Arousal
Disorder (FSIAD), the most common
form of female sexual dysfunction.
FSIAD is a diagnosis that combines two
previously distinct disorders—
hypoactive sexual desire disorder
(HSDD) and female sexual arousal
disorder (FSAD). The public meeting
will take place on October 27, 2014, and
is part of FDA’s Patient-Focused Drug
Development performance
commitments made as part of the fifth
authorization of the Prescription Drug
User Fee Act (PDUFA V). At this
meeting, FDA will obtain patients’
perspectives on the impact that FSIAD
(or a prior diagnosis of HSDD or FSAD)
has on their daily lives, as well as their
perspectives on the available therapies
for these conditions. The scientific
workshop will take place on October 28,
2014, and will provide an opportunity
for FDA to seek input from experts on
scientific issues important to the
clinical development of drug products
intended to treat FSIAD.
DATES: The meeting will be held on
October 27, 2014, from 12 p.m. to 5 p.m.
and the workshop will be held on
October 28, 2014, from 8 a.m. to 5 p.m.
Registration to attend either the meeting
or the workshop must be received by
October 17, 2014. See the
SUPPLEMENTARY INFORMATION section for
information on how to register for either
the meeting or the workshop. Submit
electronic or written comments by
December 29, 2014.
ADDRESSES: The meeting and workshop
will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave.,
Bldg. 31 Conference Center, Sections B/
C of the Great Room (rm. 1503), Silver
Spring, MD 20993. Entrance for the
public meeting and workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, 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,
Room 1061, Rockville, MD 20852. All
comments should be identified with the
SUMMARY:
E:\FR\FM\26SEN1.SGM
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Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices
docket number found in brackets in the
heading of this document. Please
indicate whether the comments are
relevant to the October 27 meeting or
the October 28 workshop. FDA will post
the agenda approximately 5 days before
the meeting at https://www.fda.gov/
Drugs/NewsEvents/ucm401167.htm.
FOR FURTHER INFORMATION CONTACT:
For questions regarding the October
27 Patient-Focused Drug Development
meeting: 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.
For questions regarding the October
28 scientific workshop: Charlene
Williamson, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5332, Silver Spring,
MD 20993, 301–796–1025,
Charlene.Williamson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background on Patient-Focused Drug
Development
FDA has selected female sexual
dysfunction as the focus of a meeting
under Patient-Focused Drug
Development initiative that involves
obtaining a better understanding of
patients’ perspectives on the severity of
the disease and the available therapies
for the condition. This Patient-Focused
Drug Development meeting 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 (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/prescriptiondrug
userfee/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
21613) announcing the disease areas for
meetings in fiscal years (FYs) 2013
through 2015, the first 3 years of the 5-
VerDate Sep<11>2014
19:14 Sep 25, 2014
Jkt 232001
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. By
the end of FY 2015, FDA will initiate
another public process to determine the
disease areas for FYs 2016 through
2017. More information, including the
list of disease areas and a general
schedule of meetings, is posted at
https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm326192.htm.
II. Public Meeting and Workshop
Information
A. Purpose and Scope of the Meeting
and Workshop
On October 27, 2014, as part of
Patient-Focused Drug Development,
FDA will obtain patient and patient
stakeholder input on symptoms of
female sexual dysfunction that matter
most to patients and on current
approaches to treating female sexual
dysfunction. The most common form of
female sexual dysfunction, FSIAD,
refers to absent or reduced sexual
interest/arousal that causes clinically
significant distress and is not caused by
another condition (such as another
medical disorder or the effects of
medications). There are no FDAapproved drug therapies to treat FSIAD.
FDA is committed to working with all
stakeholders to foster the development
of safe and effective therapies for
affected women.
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
questions through written comments
that can be submitted to the public
docket (see ADDRESSES).
1. Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
• Have you ever received a diagnosis
from a healthcare provider of sexual
interest/arousal disorder, hypoactive
PO 00000
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57943
sexual desire disorder, or sexual arousal
disorder?
• How was the diagnosis made? For
example, what type of healthcare
provider made the diagnosis? Were any
tests or questionnaires used to help
make the diagnosis?
• Of all the symptoms that you
experience because of your condition,
which 1 to 3 symptoms have the most
significant impact on your life? Please
describe each symptom in detail,
including how this symptom
specifically affects your sexual
experiences.
• Do your symptoms wax and wane
over time? For example, do you have
better days and worse days? If your
symptoms wax and wane, please answer
the following questions:
• Which symptoms vary the most,
and in what ways?
• How do your symptoms and their
negative impacts on your sexual
experiences compare between your
‘‘best days’’ and your ‘‘worst days’’?
• Do the changes in your symptoms
typically happen over a period of
minutes, hours, days, weeks, or months?
• If you were asked today to
accurately rate how good or how bad
your symptoms have been over time,
would you be able to accurately
remember how your symptoms felt one
day ago? Over the past 3 days? Over the
past week? Over the past 2 weeks? Over
the past 3 weeks? Over the past month?
• Is there anything else that you
believe makes your symptoms better? Is
there anything that you believe makes
your symptoms worse? For example,
menstruation, stress, etc.
• Overall, have you experienced your
condition and its symptoms getting
progressively worse, improving, or
remaining stable over the past few
years?
• What worries you most about your
condition?
2. Topic 2: Patient perspectives on
Current Approaches To Treat FSIAD
• What are you currently doing to
help treat your condition or its
symptoms? (Examples may include
prescription medicines, over-thecounter products, physical or other
therapies, support groups, and lifestyle
changes.)
• How well do your current
treatments specifically treat the most
significant symptoms of your condition?
• How well have your treatments
improved your sexual experience?
• How has your treatment regimen
changed over time, and why?
• Are there any downsides to the
treatments you have used? (Examples of
downsides may include bothersome
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Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices
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side effects, difficulty identifying
appropriate healthcare providers, etc.)
• What specific things would you
look for in an ideal treatment for your
condition? For example, which
symptom would you most like a
treatment to target and what would you
consider to be a meaningful
improvement in this symptom?
The scientific workshop on October
28, 2014 will include a discussion of
scientific challenges related to:
• Diagnosis of the condition for
clinical trials and in clinical practice
and
• ensuring valid patient-reported
outcome measures for the key efficacy
endpoints used in clinical trials.
B. Meeting and Workshop Attendance
and Participation
If you wish to attend the PatientFocused Drug Development meeting or
scientific workshop, visit https://
fsdpatientfocused.eventbrite.com.
Please register for either the meeting or
workshop by October 17, 2014. If you
are unable to attend the meeting or
workshop 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 disability,
please contact Pujita Vaidya or Charlene
Williamson (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 during the
October 27 meeting 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 October 3,
2014, 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 during the October 27
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meeting and the October 28 workshop 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 and
workshop on a first-come, first-serve
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 December 29, 2014.
Please indicate whether the comments
are relevant to the October 27 meeting
or the October 28 workshop. 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 https://
www.regulations.gov.
IV. Transcripts
As soon as a transcript is available,
FDA will post it at https://www.fda.gov/
Drugs/NewsEvents/ucm401167.htm.
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22983 Filed 9–25–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
SUMMARY:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593.
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. This Table
lists for each covered childhood vaccine
the conditions which may lead to
compensation and, for each condition,
the time period for occurrence of the
first symptom or manifestation of onset
or of significant aggravation after
vaccine administration. Compensation
may also be awarded for conditions not
listed in the Table and for conditions
that are manifested outside the time
periods specified in the Table, but only
if the petitioner shows that the
condition was caused by one of the
listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
August 1, 2014, through August 31,
2014. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26SEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57942-57944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22983]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1413]
Patient-Focused Drug Development Public Meeting and Scientific
Workshop on Female Sexual Dysfunction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and scientific workshop, both of which will provide an
opportunity for public comment on the topic of Female Sexual Interest/
Arousal Disorder (FSIAD), the most common form of female sexual
dysfunction. FSIAD is a diagnosis that combines two previously distinct
disorders--hypoactive sexual desire disorder (HSDD) and female sexual
arousal disorder (FSAD). The public meeting will take place on October
27, 2014, and is part of FDA's Patient-Focused Drug Development
performance commitments made as part of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will
obtain patients' perspectives on the impact that FSIAD (or a prior
diagnosis of HSDD or FSAD) has on their daily lives, as well as their
perspectives on the available therapies for these conditions. The
scientific workshop will take place on October 28, 2014, and will
provide an opportunity for FDA to seek input from experts on scientific
issues important to the clinical development of drug products intended
to treat FSIAD.
DATES: The meeting will be held on October 27, 2014, from 12 p.m. to 5
p.m. and the workshop will be held on October 28, 2014, from 8 a.m. to
5 p.m. Registration to attend either the meeting or the workshop must
be received by October 17, 2014. See the SUPPLEMENTARY INFORMATION
section for information on how to register for either the meeting or
the workshop. Submit electronic or written comments by December 29,
2014.
ADDRESSES: The meeting and workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Sections
B/C of the Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for
the public meeting and workshop participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, 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, Room 1061, Rockville, MD 20852. All
comments should be identified with the
[[Page 57943]]
docket number found in brackets in the heading of this document. Please
indicate whether the comments are relevant to the October 27 meeting or
the October 28 workshop. FDA will post the agenda approximately 5 days
before the meeting at https://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.
FOR FURTHER INFORMATION CONTACT:
For questions regarding the October 27 Patient-Focused Drug
Development meeting: 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.
For questions regarding the October 28 scientific workshop:
Charlene Williamson, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5332,
Silver Spring, MD 20993, 301-796-1025, Charlene.Williamson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected female sexual dysfunction as the focus of a
meeting under Patient-Focused Drug Development initiative that involves
obtaining a better understanding of patients' perspectives on the
severity of the disease and the available therapies for the condition.
This Patient-Focused Drug Development meeting 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
(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 21613) 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. By the end of FY 2015, FDA will initiate another
public process to determine the disease areas for FYs 2016 through
2017. More information, including the list of disease areas and a
general schedule of meetings, is posted at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.
II. Public Meeting and Workshop Information
A. Purpose and Scope of the Meeting and Workshop
On October 27, 2014, as part of Patient-Focused Drug Development,
FDA will obtain patient and patient stakeholder input on symptoms of
female sexual dysfunction that matter most to patients and on current
approaches to treating female sexual dysfunction. The most common form
of female sexual dysfunction, FSIAD, refers to absent or reduced sexual
interest/arousal that causes clinically significant distress and is not
caused by another condition (such as another medical disorder or the
effects of medications). There are no FDA-approved drug therapies to
treat FSIAD. FDA is committed to working with all stakeholders to
foster the development of safe and effective therapies for affected
women.
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 questions through written comments that can be
submitted to the public docket (see ADDRESSES).
1. Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
Have you ever received a diagnosis from a healthcare
provider of sexual interest/arousal disorder, hypoactive sexual desire
disorder, or sexual arousal disorder?
How was the diagnosis made? For example, what type of
healthcare provider made the diagnosis? Were any tests or
questionnaires used to help make the diagnosis?
Of all the symptoms that you experience because of your
condition, which 1 to 3 symptoms have the most significant impact on
your life? Please describe each symptom in detail, including how this
symptom specifically affects your sexual experiences.
Do your symptoms wax and wane over time? For example, do
you have better days and worse days? If your symptoms wax and wane,
please answer the following questions:
Which symptoms vary the most, and in what ways?
How do your symptoms and their negative impacts on your
sexual experiences compare between your ``best days'' and your ``worst
days''?
Do the changes in your symptoms typically happen over a
period of minutes, hours, days, weeks, or months?
If you were asked today to accurately rate how good or how
bad your symptoms have been over time, would you be able to accurately
remember how your symptoms felt one day ago? Over the past 3 days? Over
the past week? Over the past 2 weeks? Over the past 3 weeks? Over the
past month?
Is there anything else that you believe makes your
symptoms better? Is there anything that you believe makes your symptoms
worse? For example, menstruation, stress, etc.
Overall, have you experienced your condition and its
symptoms getting progressively worse, improving, or remaining stable
over the past few years?
What worries you most about your condition?
2. Topic 2: Patient perspectives on Current Approaches To Treat FSIAD
What are you currently doing to help treat your condition
or its symptoms? (Examples may include prescription medicines, over-
the-counter products, physical or other therapies, support groups, and
lifestyle changes.)
How well do your current treatments specifically treat the
most significant symptoms of your condition?
How well have your treatments improved your sexual
experience?
How has your treatment regimen changed over time, and why?
Are there any downsides to the treatments you have used?
(Examples of downsides may include bothersome
[[Page 57944]]
side effects, difficulty identifying appropriate healthcare providers,
etc.)
What specific things would you look for in an ideal
treatment for your condition? For example, which symptom would you most
like a treatment to target and what would you consider to be a
meaningful improvement in this symptom?
The scientific workshop on October 28, 2014 will include a
discussion of scientific challenges related to:
Diagnosis of the condition for clinical trials and in
clinical practice and
ensuring valid patient-reported outcome measures for the
key efficacy endpoints used in clinical trials.
B. Meeting and Workshop Attendance and Participation
If you wish to attend the Patient-Focused Drug Development meeting
or scientific workshop, visit https://fsdpatientfocused.eventbrite.com.
Please register for either the meeting or workshop by October 17, 2014.
If you are unable to attend the meeting or workshop 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 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 meetings will be based on space availability. If you need
special accommodations because of disability, please contact Pujita
Vaidya or Charlene Williamson (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 during the October 27 meeting 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 October 3, 2014, 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 during the October 27
meeting and the October 28 workshop 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 and workshop on a first-
come, first-serve 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 December 29, 2014. Please indicate whether
the comments are relevant to the October 27 meeting or the October 28
workshop. 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 https://www.regulations.gov.
IV. Transcripts
As soon as a transcript is available, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.
Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22983 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P
