Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting, 58314-58315 [2013-23021]
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Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
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 that can be
submitted to the public docket (see
ADDRESSES).
emcdonald on DSK67QTVN1PROD with NOTICES
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 1–3 symptoms have the most
significant impact on your life?
(Examples may include chronic pain,
fatigue, difficulty concentrating, sleep
disorders, 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, daily hygiene, driving,
household chores, etc.)
(a) How do your symptoms and their
negative impacts affect your daily life
on the best days? On the worst days?
(3) How have your condition and its
symptoms changed over time?
(a) Do your symptoms come and go?
If so, do you know of anything that
makes your symptoms better? Worse?
(4) What worries you most about your
condition?
Topic 2: Patients’ Perspectives on
Current Approaches to Treating
Fibromyalgia
(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
exercise or acupuncture)
(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 treat the most
significant symptoms of your disease?
(a) How well do these treatments
improve your ability to do 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
bothersome side effects, going to the
hospital for treatment, restrictions on
driving, etc.)
(4) What specific things would you
look for in an ideal treatment for your
condition?
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20:16 Sep 20, 2013
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B. Meeting Attendance and/or
Participation
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
If you wish to attend this meeting,
visit https://patientfocusedfibromyalgia.
eventbrite.com. Please register by
November 27, 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 Graham Thompson (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 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 November 27, 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 February 10, 2013.
Food and Drug Administration
Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23019 Filed 9–20–13; 8:45 am]
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[Docket No. FDA–2013–N–0001]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 30, 2013, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: There will be two topics
presented to the committee for their
E:\FR\FM\23SEN1.SGM
23SEN1
emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
discussion and consideration. During
the first session, the Office of
Pharmaceutical Science and the Office
of Compliance will discuss with the
committee the use of statistical methods
for the evaluation of pharmaceutical
product quality. The committee will
receive presentations from the Agency
on the need for objective metrics of
product quality and some of the
available statistical methods used by
other industries in their quality
assurance programs. Representatives
from the pharmaceutical industry will
provide the manufacturers’ perspective.
During the second session, the
committee will receive an update and
status on research activities within the
Office of Pharmaceutical Science
supporting regulatory decision making.
There will be presentations from the
Office of Generic Drugs, the Office of
Testing and Research, and the Office of
Biotechnology Products. This will be an
awareness topic and there will not be
formal committee discussion or
recommendation.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 16, 2013.
Oral presentations from the public will
be scheduled between approximately
11:15 a.m. to 12:15 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 7, 2013. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
VerDate Mar<15>2010
20:16 Sep 20, 2013
Jkt 229001
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 8, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Kalyani
Bhatt at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–23021 Filed 9–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 31, 2013, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (Rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
58315
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCcommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: There will be two topics
presented to the committee for their
discussion and consideration. During
the first session, the Office of New Drug
Quality Assessment will lead a
discussion on the challenges and
opportunities of continuous
manufacturing for pharmaceutical
products. Speakers from the Agency,
academia, and industry will provide
their thoughts on scientific and
regulatory challenges for implementing
continuous processes for drug substance
and drug product manufacturing.
During the second session, the
committee will receive an informational
only update from the Office of Generic
Drugs on what Agency actions/changes
have taken place following previous
discussions with the committee
pertaining to quality and bioequivalence
concerns for narrow therapeutic index
drug products. This will be an
awareness topic and there will not be
formal committee discussion or
recommendation.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58314-58315]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23021]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on October 30, 2013, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, email: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: There will be two topics presented to the committee for
their
[[Page 58315]]
discussion and consideration. During the first session, the Office of
Pharmaceutical Science and the Office of Compliance will discuss with
the committee the use of statistical methods for the evaluation of
pharmaceutical product quality. The committee will receive
presentations from the Agency on the need for objective metrics of
product quality and some of the available statistical methods used by
other industries in their quality assurance programs. Representatives
from the pharmaceutical industry will provide the manufacturers'
perspective.
During the second session, the committee will receive an update and
status on research activities within the Office of Pharmaceutical
Science supporting regulatory decision making. There will be
presentations from the Office of Generic Drugs, the Office of Testing
and Research, and the Office of Biotechnology Products. This will be an
awareness topic and there will not be formal committee discussion or
recommendation.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 16, 2013. Oral presentations from the public will be scheduled
between approximately 11:15 a.m. to 12:15 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 7, 2013. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 8, 2013.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kalyani Bhatt at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-23021 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P
