Oncologic Drugs Advisory Committee; Notice of Meeting, 73326-73327 [2014-28847]
Download as PDF
<![CDATA[
73326
Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
questions through written comments
that can be submitted to the public
docket (see ADDRESSES). When
submitting comments, if you are
commenting on behalf of a child, please
indicate that and answer the following
questions as much as possible from the
patient’s perspective.
mstockstill on DSK4VPTVN1PROD with NOTICES
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. What worries you most about your
condition?
2. Do you experience symptoms
because of your condition? If so, of all
the symptoms that you experience,
which one to three symptoms have the
most significant impact on your life?
(Examples may include irregular
heartbeat, shortness of breath, difficulty
swallowing, stomach pain, or
constipation.)
3. 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, being
a blood or organ donor, or for women
in reproductive age concern about
getting pregnant and transmitting the
infection to your children, etc.)
4. How have your condition and its
symptoms changed over time?
5. Do your symptoms come and go? If
so, do you know of anything that makes
your symptoms better or worse?
Topic 2: Patient Perspectives on Current
Approaches To Treat Chagas Disease
1. What are you currently doing to
help treat your condition? (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. 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, length of
treatment, number of pills to take daily,
going to the hospital for frequent
checkups or treatment, restrictions on
driving, potential consequences to your
health and your child’s health during
pregnancy, etc.)
3. What specific things would you
look for in an ideal treatment for your
condition?
In the afternoon, discussion will be
related to scientific topics, with the goal
of understanding issues that may affect
the development of drugs for the
treatment of Chagas disease and
VerDate Sep<11>2014
17:48 Dec 09, 2014
Jkt 235001
identifying topics for future discussion.
Discussion topics for the afternoon will
include designs and endpoints for
clinical trials as well as appropriate trial
populations.
B. Meeting Attendance and
Participation
If you wish to attend the meeting,
visit https://
chagasdiseasepatientfocused.
eventbrite.com. Please register for the
meeting by April 20, 2015. If you are
unable to attend the meeting 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 a 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 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 April 10, 2015,
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 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 on a first-come, first-served
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 June 29, 2015. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
will be posted to the docket at https://
www.regulations.gov.
III. Transcripts
As soon as a transcript is available,
FDA will post it at https://www.fda.gov/
Drugs/NewsEvents/ucm420130.htm.
Dated: December 3, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28828 Filed 12–9–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Oncologic Drugs Advisory Committee;
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: Oncologic Drugs
Advisory Committee.
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 January 7, 2015, from 8 a.m. to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
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: Caleb Briggs, 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:
ODAC@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
E:\FR\FM\10DEN1.SGM
10DEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
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: The committee will discuss
biologics license application (BLA)
125553 for EP2006, a proposed
biosimilar to Amgen Inc.’s NEUPOGEN
(filgrastim), submitted by Sandoz, Inc.
The proposed indications (uses) for this
product are: (1) To decrease the
incidence of infection, as manifested by
febrile neutropenia, in patients with
nonmyeloid malignancies receiving
myelosuppressive anti-cancer drugs
associated with a significant incidence
of severe neutropenia with fever; (2) for
reducing the time to neutrophil recovery
and the duration of fever, following
induction or consolidation
chemotherapy treatment of adults with
acute myeloid leukemia; (3) to reduce
the duration of neutropenia and
neutropenia-related clinical sequelae,
e.g., febrile neutropenia in patients with
nonmyeloid malignancies undergoing
myeloablative chemotherapy followed
by marrow transplantation; (4) for the
mobilization of hematopoietic
progenitor cells into the peripheral
blood for collection by leukapheresis;
and (5) for chronic administration to
reduce the incidence and duration of
sequelae of neutropenia (e.g., fever,
infections, oropharyngeal ulcers) in
symptomatic patients with congenital
neutropenia, cyclic neutropenia, or
idiopathic neutropenia.
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 December 22, 2014.
Oral presentations from the public will
be scheduled between approximately
2:15 p.m. to 3:15 p.m. Those individuals
VerDate Sep<11>2014
17:48 Dec 09, 2014
Jkt 235001
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
December 12, 2014. 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 December 15, 2014.
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 Caleb Briggs
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: December 3, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–28847 Filed 12–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2032]
Request for Nominations for Voting
Members on the Food Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
73327
nominations for voting members to
serve on the Food Advisory Committee,
Office of Regulations, Policy, and Social
Sciences, Center for Food Safety and
Applied Nutrition. FDA seeks to include
the views of women and men, members
of all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before January 30, 2015, will be given
first consideration for membership on
the Food Advisory Committee.
Nominations received after January 30,
2015, will be considered for nomination
to the committee as later vacancies
occur.
ADDRESSES: All nominations for
membership should be submitted
electronically by logging into the FDA
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm, by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002, or by FAX to 301–847–
8640.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION: Regarding all
nominations questions for membership,
the primary contact is: Karen Strambler,
Office of Regulations, Policy, and Social
Sciences, Center for Food Safety and
Applied Nutrition, 5100 Paint Branch
Pkwy., Rm. 1C–016, College Park, MD
20740, 240–402–2589, FAX: 301–436–
2637, FoodAdvisoryCommittee@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on the Food Advisory
Committee.
I. General Description of the Committee
Duties
The Food Advisory Committee
provides advice to the Commissioner of
Food and Drugs and other appropriate
officials on emerging food safety, food
science, nutrition, and other foodrelated health issues that FDA considers
of primary importance for its food and
cosmetics programs. The Committee
may be charged with reviewing and
evaluating available data and making
recommendations on matters such as
those relating to: (1) Broad scientific and
technical food- or cosmetic-related
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73326-73327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28847]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Oncologic Drugs Advisory Committee; 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: Oncologic Drugs Advisory Committee.
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 January 7, 2015, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
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: Caleb Briggs, 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: ODAC@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
[[Page 73327]]
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: The committee will discuss biologics license application
(BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s NEUPOGEN
(filgrastim), submitted by Sandoz, Inc. The proposed indications (uses)
for this product are: (1) To decrease the incidence of infection, as
manifested by febrile neutropenia, in patients with nonmyeloid
malignancies receiving myelosuppressive anti-cancer drugs associated
with a significant incidence of severe neutropenia with fever; (2) for
reducing the time to neutrophil recovery and the duration of fever,
following induction or consolidation chemotherapy treatment of adults
with acute myeloid leukemia; (3) to reduce the duration of neutropenia
and neutropenia-related clinical sequelae, e.g., febrile neutropenia in
patients with nonmyeloid malignancies undergoing myeloablative
chemotherapy followed by marrow transplantation; (4) for the
mobilization of hematopoietic progenitor cells into the peripheral
blood for collection by leukapheresis; and (5) for chronic
administration to reduce the incidence and duration of sequelae of
neutropenia (e.g., fever, infections, oropharyngeal ulcers) in
symptomatic patients with congenital neutropenia, cyclic neutropenia,
or idiopathic neutropenia.
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
December 22, 2014. Oral presentations from the public will be scheduled
between approximately 2:15 p.m. to 3:15 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 December 12, 2014.
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 December 15, 2014.
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 Caleb Briggs 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: December 3, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-28847 Filed 12-8-14; 8:45 am]
BILLING CODE 4164-01-P
