Antiviral Drugs Advisory Committee; Notice of Meeting, 56900-56901 [2013-22427]
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Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices
and Research (HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–1277 or 301–
827–1281, 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/Advisory
Committees/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 the morning of November 1,
2013, the committee will meet in open
session to discuss MP Biomedicals’ biologic
license application for the MP Diagnostics
HTLV Blot 2.4, a Western Blot intended for
use as a confirmatory test for blood donors.
In the afternoon, the committee will hear
update presentations on the following topics:
(1) The April 2013 FDA public workshop on
multiplex detection of transfusion
transmissible agents and blood cell antigens
in blood donations and (2) FDA safety
communications on new boxed warnings for
immune globulin products and hydroxyethyl
starch solutions. Following the update
presentations, the committee will meet in
open session to hear presentations on the
research programs of the Laboratory of
Biochemistry and Vascular Biology, Division
of Hematology, Office of Blood Research and
Review, Center for Biologics Evaluation and
Research, FDA.
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: On November 1, 2013, from 8
a.m. to approximately 4 p.m., the meeting is
open to the public. 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 24, 2013. Oral presentations from the
public will be scheduled between
approximately 11 a.m. and 11:30 a.m.
Afternoon presentations will be scheduled
between approximately 3:30 p.m. and 4 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 16, 2013. Time allotted for
each presentation may be limited. If the
number of registrants requesting to speak is
VerDate Mar<15>2010
18:30 Sep 13, 2013
Jkt 229001
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
17, 2013.
Closed Committee Deliberations: On
November 1, 2013, from approximately 4
p.m. to 4:30 p.m., the meeting will be closed
to permit discussion where disclosure would
constitute a clearly unwarranted invasion of
personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the site visit report of
the intramural research programs and make
recommendations regarding personnel
staffing decisions.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets. Seating for this
meeting may be limited, so the public is
encouraged to watch the free Web cast if you
are unable to attend. The Web cast will be
available at 8 a.m. on November 1, 2013, at
the link provided.
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 Bryan
Emery 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 meeting.
Notice of this meeting is given under the
Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: September 9, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–22423 Filed 9–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Antiviral 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: Antiviral Drugs
Advisory Committee.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 25, 2013, from 8 a.m. to 5 p.m.
Location: Sheraton Silver Spring Hotel,
Cypress Ballroom, 8777 Georgia Ave., Silver
Spring, MD. The hotel phone number is 301–
589–0800.
Contact Person: Karen Abraham-Burrell,
Food and Drug Administration, Center for
Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, email: AVAC@
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: The committee will discuss new
drug application (NDA) 204671, sofosbuvir
(an NS5B polymerase inhibitor),
manufactured by Gilead Sciences, Inc., with
a proposed indication for the treatment of
chronic hepatitis C infection, in combination
with other agents in adult patients with
genotypes 1 to 6 and/or adult patients
awaiting liver transplantation.
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 9, 2013. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 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 1, 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
E:\FR\FM\16SEN1.SGM
16SEN1
56901
Federal Register / Vol. 78, No. 179 / Monday, September 16, 2013 / Notices
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 2, 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 Karen
Abraham-Burrell 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 10, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–22427 Filed 9–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request: Family Life,
Activity, Sun, Health, and Eating
(FLASHE) Study (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
SUMMARY:
Control and Population Sciences,
National Cancer Institute, 9609 Medical
Center Drive, Room 3E102, Bethesda,
MD 20892–9671 or call non-toll-free
number 240–276–6855 or Email your
request, including your address to:
nebelinl@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: Family Life,
Activity, Sun, Health, and Eating
(FLASHE) Study (NCI), 0925–NEW,
Expiration Date xx/xx/xxxx, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The FLASHE study seeks to
examine psychosocial, generational
(parent-adolescent), and environmental
correlates of cancer preventive
behaviors. FLASHE will examine the
science of cancer and obesity prevention
by examining correlates of cancer
preventive behaviors, mainly diet,
activity, and sedentary behaviors (but
also examining other behaviors such as
sleep, sun-safety, and tobacco) in new
ways not previously addressed
comprehensively on other surveys. The
survey’s goal is to advance
understanding of the dynamic
relationship between the environment,
psychosocial factors, and behavior from
a dyadic perspective. Data collected will
ultimately be a public use dataset and
resource to the research community.
FLASHE will be collecting data from
parents and their adolescent children
through a web survey with a final
sample size of 2,500 dyads with motion
sensing data collected in a subsample of
900 adolescents.
OMB approval is requested for 2
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,243.
listed below. This proposed information
collection was previously published in
the Federal Register on June 28, 2013,
Vol. 78, No. 125, page 28996 and
allowed 60-days for public comment.
One public comment was received on
June 29, 2013 which commented on the
expense and topic of the study. An
email response was sent on July 8, 2013
stating ‘‘Your comments will be taken
into consideration. The Division of
Cancer Prevention at the NCI supports
research that studies the potential
impact from a cell, tissue or organism
and the pathways associated with
disease process.’’ The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Cancer Institute (NCI), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
For Further Information: To obtain a
copy of the data collection plans and
instruments or request more information
on the proposed project contact: Linda
Nebeling, Ph.D., Division of Cancer
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Type of respondent
Enrollment and Consent ....................
Parents (enrolling self) .....................
Parents (enrolling adolescent) .........
Adolescents (assenting self) ............
Parents .............................................
Adolescents .....................................
Parents .............................................
Adolescents .....................................
Adolescents .....................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Web survey with demographics ........
Web survey without demographics ...
Wear Log ...........................................
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18:30 Sep 13, 2013
Jkt 229001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1,250
1,250
1,250
1,250
1,250
1,250
1,250
450
E:\FR\FM\16SEN1.SGM
1
1
1
1
1
1
1
7
16SEN1
Average
burden per
response
(in hours)
10/60
10/60
5/60
20/60
20/60
15/60
15/60
5/60
Total annual
burden hours
208
208
104
417
417
313
313
263
Agencies
[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56900-56901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22427]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Antiviral 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: Antiviral 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 October 25, 2013,
from 8 a.m. to 5 p.m.
Location: Sheraton Silver Spring Hotel, Cypress Ballroom, 8777
Georgia Ave., Silver Spring, MD. The hotel phone number is 301-589-
0800.
Contact Person: Karen Abraham-Burrell, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,
301-796-9001, FAX: 301-847-8533, email: AVAC@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: The committee will discuss new drug application (NDA)
204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by
Gilead Sciences, Inc., with a proposed indication for the treatment
of chronic hepatitis C infection, in combination with other agents
in adult patients with genotypes 1 to 6 and/or adult patients
awaiting liver transplantation.
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 9, 2013. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 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 1, 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
[[Page 56901]]
hearing session. The contact person will notify interested persons
regarding their request to speak by October 2, 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 Karen Abraham-
Burrell 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 10, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-22427 Filed 9-13-13; 8:45 am]
BILLING CODE 4160-01-P