Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, 40761-40762 [2014-16358]
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Federal Register / Vol. 79, No. 134 / Monday, July 14, 2014 / Notices
in each iteration in response to
emerging and current events or issues.
In the next 3 years, we plan to field the
survey 2 to 3 times. We will use the
information from the Health and Diet
Survey to evaluate and develop
strategies and programs to encourage
and help consumers adopt healthy diets
and lifestyles. The information will also
help FDA evaluate and track consumer
awareness and behavior as outcome
measures of their achievement in
improving public health.
40761
Description of Respondents: The
respondents are adults, age 18 and
older, drawn from the 50 States and the
District of Columbia. Participation will
be voluntary.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Cognitive interview screener .............
Cognitive interview ............................
Pretest screener ................................
Pretest ...............................................
Survey screener ................................
Survey ...............................................
100
18
2,000
200
30,000
3,000
1
1
1
1
1
1
100
18
2,000
200
30,000
3,000
0.083 (5 minutes) .............................
1 .......................................................
0.033 (2 minutes) .............................
0.25 (15 minutes) .............................
0.033 (2 minutes) .............................
0.25 (15 minutes) .............................
8
18
66
50
990
750
Total ...........................................
........................
........................
........................
...........................................................
1,882
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of respondents and the average burden
per response on our experience with
previous Health and Diet Surveys. We
will use a cognitive interview screener
with 100 individuals to recruit
prospective interview participants. We
estimate that it will take a screener
respondent approximately 5 minutes
(0.083 hours) to complete the cognitive
interview screener, for a total of 8 hours,
rounded down from 8.3 hours. We will
conduct cognitive interviews with 18
participants. We estimate that it will
take a participant approximately 1 hour
to complete the interview, for a total of
18 hours. Prior to the administration of
the Health and Diet Survey, the Agency
plans to conduct a pretest to identify
and resolve potential survey
administration problems. We will use a
pretest screener with 2,000 individuals;
we estimate that it will take a
respondent approximately 2 minutes
(0.033 hours) to complete the pretest
screener, for a total of 66 hours. The
pretest will be conducted with 200
participants; we estimate that it will
take a participant 15 minutes (0.25
hours) to complete the pretest, for a total
of 50 hours. We will use a survey
screener to select an eligible adult
respondent in each household reached
by landline telephone numbers to
participate in the survey. A total of
30,000 individuals in the 50 states and
the District of Columbia will be
screened by telephone. We estimate that
it will take a respondent 2 minutes
(0.033 hours) to complete the screening,
for a total of 990 hours. We estimate that
3,000 eligible adults will participate in
the survey, each taking 15 minutes (0.25
hours), for a total of 750 hours. Thus,
VerDate Mar<15>2010
19:25 Jul 11, 2014
Jkt 232001
the total estimated burden is 1,882
hours.
We are requesting this burden for
unplanned surveys so as not to restrict
our ability to gather information on
consumer attitudes, awareness,
knowledge, and behavior regarding
various topics related to health,
nutrition, physical activity, and product
labeling. This ability will help the
Agency identify and respond to
emerging issues in a more timely
manner.
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16384 Filed 7–11–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Joint Meeting of the Bone,
Reproductive and Urologic Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee
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 Committees: Bone,
Reproductive and Urologic Drugs
Advisory Committee and the Drug
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Safety and Risk Management Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 17, 2014, from 8 a.m.
to 5 p.m.
Location: College Park Marriott Hotel
and Conference Center, 3501 University
Blvd., Hyattsville, MD 20783. The
hotel’s telephone number is 301–985–
7300.
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,
BRUDAC@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 committees will discuss
the appropriate indicated population for
testosterone replacement therapy and
the potential for adverse cardiovascular
outcomes associated with this use.
FDA intends to make background
material available to the public no later
E:\FR\FM\14JYN1.SGM
14JYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
40762
Federal Register / Vol. 79, No. 134 / Monday, July 14, 2014 / Notices
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 3, 2014.
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 August
25, 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 August 26, 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 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/Advisory
Committees/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).
VerDate Mar<15>2010
19:25 Jul 11, 2014
Jkt 232001
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16358 Filed 7–11–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Dermatologic and Ophthalmic Drugs
Advisory Committee 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: Dermatologic
and Ophthalmic 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 20, 2014, 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: Moon Hee V. Choi,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2147, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, DODAC@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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
the advisory committee information line
to learn about possible modifications
before coming to the meeting.
Agenda: The committee will discuss
biologics license application (BLA)
125504, secukinumab, a human
monoclonal antibody, submitted by
Novartis, proposed for the treatment of
moderate to severe plaque psoriasis in
adult patients who are candidates for
systemic therapy or phototherapy.
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 3, 2014.
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
September 25, 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 September 26, 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 Moon Hee V.
Choi at least 7 days in advance of the
meeting.
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Pages 40761-40762]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Joint Meeting of the Bone, Reproductive and Urologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee
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 Committees: Bone, Reproductive and Urologic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 17, 2014, from
8 a.m. to 5 p.m.
Location: College Park Marriott Hotel and Conference Center, 3501
University Blvd., Hyattsville, MD 20783. The hotel's telephone number
is 301-985-7300.
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, BRUDAC@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 committees will discuss the appropriate indicated
population for testosterone replacement therapy and the potential for
adverse cardiovascular outcomes associated with this use.
FDA intends to make background material available to the public no
later
[[Page 40762]]
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 3, 2014. 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 August 25, 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 August 26, 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 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: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16358 Filed 7-11-14; 8:45 am]
BILLING CODE 4164-01-P
