Public Meeting on Patient-Focused Drug Development for Sarcopenia; Request for Comments, 90361-90363 [2016-29998]
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Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices
Review Improvement Act of 1982
amended Title XI of the Social Security
Act to create the Utilization and Quality
Control Peer Review Organization (PRO)
program which replaces the Professional
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program and streamlines peer review
activities. The term PRO has been
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Number: CMS–R–71 (OMB Control
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Respondents: 6,939; Total Annual
Responses: 44,015; Total Annual Hours:
100,065. (For policy questions regarding
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at 410–786–3472.)
[FR Doc. 2016–30024 Filed 12–13–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–N–2016–4198]
Public Meeting on Patient-Focused
Drug Development for Sarcopenia;
Request for Comments
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
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
Sarcopenia.’’ 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
sarcopenia on daily life as well as
patient views on treatment approaches
for sarcopenia.
DATES: The public meeting will be held
on April 6, 2017, from 1 p.m. to 5 p.m.
Registration to attend the meeting must
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Jkt 241001
The public 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. Entrance for the public meeting
participants (non-FDA employees) 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.
You may submit comments as
follows:
ADDRESSES:
Electronic Submissions
Dated: December 9, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
AGENCY:
be received by March 27, 2017 (see
for
instructions). Public comments will be
accepted through June 6, 2017. See the
ADDRESSES section for information about
submitting comments to the public
docket.
SUPPLEMENTARY INFORMATION
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
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90361
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–4198 for ‘‘Public Meeting on
Patient-Focused Drug Development for
Sarcopenia; Request for Comments.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA will post the agenda
approximately 5 days before the meeting
E:\FR\FM\14DEN1.SGM
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90362
Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices
Register on July 2, 2015 (80 FR 38216),
announcing the selection of eight
disease areas. 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.
sradovich on DSK3GMQ082PROD with NOTICES
at: https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm527587.htm.
FOR FURTHER INFORMATION CONTACT:
Meghana Chalasani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 240–
402–6525, FAX: 301–847–8443,
Meghana.Chalasani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected sarcopenia as the
focus of a public meeting under PatientFocused 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 (Pub. L. 112–144). The full set of
performance commitments is available
at https://www.fda.gov/downloads/
forindustry/userfees/
prescriptiondruguserfee/
ucm270412.pdf.
FDA committed to obtain the patient
perspective on at least 20 disease areas
during the course of PDUFA V. For each
disease area, the Agency is conducting
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
notice 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 time frame. The Agency used
several criteria outlined in that notice 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 initiated a
second public process for determining
the disease areas for FY 2016–2017, and
published a notice in the Federal
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II. Public Meeting Information
As part of Patient-Focused Drug
Development, FDA will obtain patient
and patient stakeholder input on the
symptoms of sarcopenia that matter
most to patients and on current
approaches to treating sarcopenia.
Sarcopenia is a condition characterized
by loss of muscle mass and loss of
muscle function or strength that occurs
with age. While there is currently no
cure, treatments for sarcopenia are
primarily non-drug therapies including
exercise and nutrition. FDA is interested
in the perspectives of patients with
sarcopenia on (1) symptoms and the
daily impacts of their condition, (2)
current approaches to treatment, and (3)
decision factors taken into account
when selecting a treatment.
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
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
(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 difficulty
walking, feeling unsteady and falling
frequently, having a decreased level of
activity, 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 participation in
social activities, household chores, daily
hygiene, etc.)
(3) How do your symptoms and their
negative impacts affect your daily life
on the best days? On the worst days?
(4) How have your condition and its
symptoms changed over time?
(a) Would you define your condition
today as being well managed?
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(5) What worries you most about your
condition?
Topic 2: Patients’ Perspectives on
Current Approaches to Treatment
(1) 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 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) How well does your current
treatment regimen control your
condition?
(a) How well do your treatments
address specific activities that are
important to you in your daily life?
(b) How well have these treatments
worked for you as your condition has
changed over time?
(3) What are the most significant
downsides to your current treatments,
and how do they affect your daily life?
(Examples of downsides may include
going to the hospital or clinic for
treatment, time devoted to treatment,
etc.)
(4) What specific things would you
look for in an ideal treatment for your
condition?
(a) What would you consider to be a
meaningful improvement (for example,
symptom improvements or functional
improvements) in your condition that a
treatment could provide?
III. Meeting Attendance and
Participation
If you wish to attend this meeting,
visit https://
sarcopeniapfdd.eventbrite.com. Please
register by March 27, 2017. 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 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 a disability, please contact
Meghana Chalasani (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
E:\FR\FM\14DEN1.SGM
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Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices
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 March 20, 2017. 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.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Division of Dockets
Management (see ADDRESSES). A link to
the transcript will also be available on
the Internet at https://www.fda.gov/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm527587.htm.
90363
Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
[FR Doc. 2016–29998 Filed 12–13–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0375; FDA–
2013–N–0370; FDA–2013–N–0134; FDA–
2009–N–0511; FDA–1997–N–0020; FDA–
2011–N–0902; FDA–2013–N–0662; FDA–
2013–N–0450; FDA–2012–N–0477; FDA–
2013–N–0519]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Agreement for Shipments of Devices for Sterilization ............................................................................................
Export of Medical Devices—Foreign Letters of Approval .......................................................................................
Mammography Facilities, Standards, and Lay Summaries for Patients .................................................................
Medicated Fee Mill License Application ..................................................................................................................
Substances Generally Recognized as Safe: Notification Procedure ......................................................................
Prescription Drug Product Labeling; Medication Guide Requirements ...................................................................
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug is Invalid or Will Not be Infringed ......................................................................................................
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed ..........
Investigational Device Exemptions Reports and Records—21 CFR 812 ...............................................................
Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine
Using the FDA Electronic Submission Gateway .................................................................................................
Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30035 Filed 12–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2016–N–4119]
Food Safety Modernization Act ThirdParty Certification Program User Fee
Rate for Fiscal Year 2017
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:45 Dec 13, 2016
Jkt 241001
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2017 fee rate for
accreditation bodies applying to be
recognized in the third-party
certification program that is authorized
by the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the FDA Food Safety
Modernization Act (FSMA).
FOR FURTHER INFORMATION CONTACT:
Sylvia Kim, Office of Foods and
Veterinary Medicine, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3212, Silver Spring,
MD 20993, 301–796–7599.
DATES: This fee is effective January 13,
2017, and will remain in effect through
September 30, 2017.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Date
approval
expires
0910–0131
0910–0264
0910–0309
0910–0337
0910–0342
0910–0393
9/30/2019
9/30/2019
9/30/2019
9/30/2019
9/30/2019
9/30/2019
0910–0513
0910–0339
0910–0078
9/30/2016
10/31/2019
11/30/2019
0910–0454
11/30/2019
I. Background
Section 307 of FSMA, Accreditation
of Third-Party Auditors, amends the
FD&C Act to create a new provision,
section 808, under the same name.
Section 808 of the FD&C Act (21 U.S.C.
384d) directs us to establish a new
program for accreditation of third-party
certification bodies 1 conducting food
safety audits and issuing food and
facility certifications to eligible foreign
entities (including registered foreign
1 For the reasons explained in the third-party
certification final rule (80 FR74570 at 74578–74579,
November 27, 2015), and for consistency with the
implementing regulations for the third-party
certification program in 21 CFR parts 1, 11, and 16,
this notice uses the term ‘‘third-party certification
body’’ rather than the term ‘‘third-party auditor’’
used in section 808(a)(3) of the FD&C Act.
E:\FR\FM\14DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Notices]
[Pages 90361-90363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29998]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-N-2016-4198]
Public Meeting on Patient-Focused Drug Development for
Sarcopenia; 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 Sarcopenia.'' 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 sarcopenia on daily life as well as
patient views on treatment approaches for sarcopenia.
DATES: The public meeting will be held on April 6, 2017, from 1 p.m. to
5 p.m. Registration to attend the meeting must be received by March 27,
2017 (see SUPPLEMENTARY INFORMATION for instructions). Public comments
will be accepted through June 6, 2017. See the ADDRESSES section for
information about submitting comments to the public docket.
ADDRESSES: The public 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. Entrance for the public
meeting participants (non-FDA employees) 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.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No. FDA-
2016-N-4198 for ``Public Meeting on Patient-Focused Drug Development
for Sarcopenia; Request for Comments.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FDA will post the agenda approximately 5 days before the meeting
[[Page 90362]]
at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm527587.htm.
FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX: 301-847-8443, Meghana.Chalasani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected sarcopenia 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
(Pub. L. 112-144). The full set of performance commitments is available
at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA committed to obtain the patient perspective on at least 20
disease areas during the course of PDUFA V. For each disease area, the
Agency is conducting 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 notice 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 time frame.
The Agency used several criteria outlined in that notice 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
initiated a second public process for determining the disease areas for
FY 2016-2017, and published a notice in the Federal Register on July 2,
2015 (80 FR 38216), announcing the selection of eight disease areas.
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 Information
As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on the symptoms of sarcopenia
that matter most to patients and on current approaches to treating
sarcopenia. Sarcopenia is a condition characterized by loss of muscle
mass and loss of muscle function or strength that occurs with age.
While there is currently no cure, treatments for sarcopenia are
primarily non-drug therapies including exercise and nutrition. FDA is
interested in the perspectives of patients with sarcopenia on (1)
symptoms and the daily impacts of their condition, (2) current
approaches to treatment, and (3) decision factors taken into account
when selecting a treatment.
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 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
(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 difficulty walking, feeling
unsteady and falling frequently, having a decreased level of activity,
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 participation in social
activities, household chores, daily hygiene, etc.)
(3) How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days?
(4) How have your condition and its symptoms changed over time?
(a) Would you define your condition today as being well managed?
(5) What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treatment
(1) What are you currently doing to help treat your condition or
its symptoms? (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) How well does your current treatment regimen control your
condition?
(a) How well do your treatments address specific activities that
are important to you in your daily life?
(b) How well have these treatments worked for you as your condition
has changed over time?
(3) What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include going to the hospital or clinic for treatment,
time devoted to treatment, etc.)
(4) What specific things would you look for in an ideal treatment
for your condition?
(a) What would you consider to be a meaningful improvement (for
example, symptom improvements or functional improvements) in your
condition that a treatment could provide?
III. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://sarcopeniapfdd.eventbrite.com. Please register by March 27, 2017. 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 Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting.
[[Page 90363]]
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 March 20, 2017. 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.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm527587.htm.
Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29998 Filed 12-13-16; 8:45 am]
BILLING CODE 4164-01-P
