Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 42505-42506 [2015-17559]
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
• Do your symptoms come and go? If
so, do you know of anything that makes
your symptoms better? Worse?
4. How has your condition affected
your social interactions, including
relationships with family and friends?
5. How has your condition affected
your mood (for example: depression,
apathy, patience/tolerance for
frustration)?
3. How has your ability to cope with
symptoms changed over time?
• 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?
5. How has your condition affected
your social interactions, including
relationships with family and friends?
Topic 2: Patients’ Perspectives on
Current Approaches To Treating HD
Topic 2: Patients’ Perspectives on
Current Approaches To Treating PD
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 and exercise.)
• What specific symptoms do your
treatments address (for example:
depression, constipation, memory
difficulty, sleepiness, ability to move)?
2. How well does your current
treatment regimen treat the most
significant symptoms of your disease?
• How well do these treatments
improve your ability to do specific
activities that are important to you in
your daily life?
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, need to visit
your doctor or take medications
frequently, cause sleepiness, etc.)
4. Assuming there is no complete cure
for your condition, what would you
look for in an ideal treatment for your
condition or a specific aspect of your
condition?
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 and exercise.)
(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, interacts with
other medications, need to visit your
doctor more frequently, etc.)
4. Assuming there is no complete cure
for your condition, what would you
look for in an ideal treatment for your
condition or a specific aspect of your
condition?
C. Parkinson’s Disease Discussion
Questions
srobinson on DSK5SPTVN1PROD 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 one to three symptoms have the
most significant impact on your life?
(Examples may include difficulty
moving, pain, constipation, difficulty
concentrating or remembering, daytime
sleepiness, 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 daily hygiene,
feeding, dressing, etc.)
• How do your symptoms affect your
daily life on the best days? On the worst
days?
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III. Meeting Attendance and
Participation
If you wish to attend this meeting,
visit https://pfddhuntingtonparkinson.
eventbrite.com. Please register by
September 14, 2015. If you are unable to
attend the meeting in person, you can
register to view a live webcast of the
meeting. When you register, you can
indicate whether you plan to attend the
morning session on HD, the afternoon
session on PD, or both. You will also 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
PO 00000
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42505
accommodations because of a 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 also must send to
PatientFocused@fda.hhs.gov a brief
summary of responses to the topic
questions by September 8, 2015.
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.
IV. Comments
Regardless if you attend the public
meeting, you can submit electronic or
written responses to the questions
pertaining to HD Topics 1 and 2 and PD
Topics 1 and 2 to the public docket (see
ADDRESSES) by November 23, 2015.
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.
V. Transcripts
As soon as a transcript is available,
FDA will post it at https://www.fda.gov/
Drugs/NewsEvents/ucm451807.htm.
Dated: July 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17556 Filed 7–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Vaccines and Related Biological
Products 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.
E:\FR\FM\17JYN1.SGM
17JYN1
srobinson on DSK5SPTVN1PROD with NOTICES
42506
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
Name of Committee: Vaccines and
Related Biological Products 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 September 15, 2015, from 8:30
a.m. to 2:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
For those unable to attend in person,
the meeting will also be webcast and
will be available at the following link
https://collaboration.fda.gov/
cbervrbpac0915/.
Contact Person: Sujata Vijh or Denise
Royster, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6128, Silver Spring,
MD 20993–0002, 240–402–7107 or 240–
402–8158, 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: On September 15, 2015, from
8:30 a.m. to 2:30 p.m., the committee
will meet in open session to discuss and
make recommendations on the safety
and immunogenicity of Seasonal
Trivalent Influenza Vaccine, Surface
Antigen, Inactivated, Adjuvanted with
MF59 (FLUAD) manufactured by
Novartis.
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
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20:59 Jul 16, 2015
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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 September 8, 2015.
Oral presentations from the public will
be scheduled between approximately
12:15 p.m. to 1:15 p.m. on September
15, 2015. 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 August 31, 2015. 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 September 1, 2015.
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 Sujata Vijh 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: July 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17559 Filed 7–16–15; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than September 15, 2015.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Bureau of Health Workforce (BHW)
Uniform Data System (UDS).
OMB No. 0915–XXXX—NEW.
Abstract: The UDS is the Bureau of
Primary Health Care’s (BPHC’s) annual
reporting system for HRSA-supported
health centers. The UDS is a program
performance reporting system that
tracks a variety of information,
including patient demographics,
services provided, staffing, clinical
indicators, utilization rates, costs, and
revenues. BHW proposes that HRSA
Nurse Managed Health Clinic (NMHC)
grantees and Interprofessional
Collaborative Practice (IPCP) program
cooperative agreement awardees also
submit data into the UDS.
SUMMARY:
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Agencies
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42505-42506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17559]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Vaccines and Related Biological Products 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.
[[Page 42506]]
Name of Committee: Vaccines and Related Biological Products
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 September 15, 2015, from
8:30 a.m. to 2:30 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
For those unable to attend in person, the meeting will also be
webcast and will be available at the following link https://collaboration.fda.gov/cbervrbpac0915/.
Contact Person: Sujata Vijh or Denise Royster, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, 240-
402-7107 or 240-402-8158, 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: On September 15, 2015, from 8:30 a.m. to 2:30 p.m., the
committee will meet in open session to discuss and make recommendations
on the safety and immunogenicity of Seasonal Trivalent Influenza
Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD)
manufactured by Novartis.
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
September 8, 2015. Oral presentations from the public will be scheduled
between approximately 12:15 p.m. to 1:15 p.m. on September 15, 2015.
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
August 31, 2015. 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 September 1,
2015.
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 Sujata Vijh 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: July 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17559 Filed 7-16-15; 8:45 am]
BILLING CODE 4164-01-P