Pediatric Advisory Committee; Notice of Meeting, 21381-21382 [2011-9150]
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21381
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
reading the news article, participants
will complete a questionnaire assessing
their emotional response, appraisals,
attribution of responsibility, perceptions
about the safety of the affected produce,
intentions to grow, sell, or buy the
affected produce, perceived probability
of a repeat event, and a measure of their
innate ability to effectively respond to
the information in the article.
To help design and refine the
questionnaire, we will recruit 25
participants in order to conduct 10
cognitive interviews. We estimate
cognitive interview recruitment will
take 5 minutes (0.083 hours), for a total
of 2 hours. The cognitive interviews are
estimated at 1 hour per response for a
total of 10 hours for the cognitive
interview activities. We expect to send
screeners to 800 members of a consumer
panel, each taking 2 minutes (0.03
hours) to complete, for a total of 24
hours for the consumer panel screener
activity. We also expect to administer
360 screeners to growers and retailers,
each taking 2 minutes (0.033 hours) to
complete, for a total of 24 hours (11 +
11 = 22). Twenty-four participants (20
consumers, 2 growers, 2 retailers) will
complete the pre-test. Each pre-test will
take 10 minutes (0.17 hours) for a total
of 5 hours for the pre-test activity. We
estimate that 900 individuals (540
consumers, 180 growers, and 180
retailers) will complete the
questionnaire for the experiment, each
taking 10 minutes (0.17 hours) for a total
of 153 hours for the experimental study
activities. The estimated total hour
burden of the collection of information
is 215 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
(in hours) 2
Total hours
Cognitive Interview Recruitment ..........................................
Cognitive Interviews .............................................................
Consumer Panel Screener ..................................................
Grower Screener ..................................................................
Retailer Screener .................................................................
Pre-tests ...............................................................................
Experiment ...........................................................................
25
10
800
360
360
24
900
1
1
1
1
1
1
1
25
10
800
360
360
24
900
5/60
1
2/60
2/60
2/60
10/60
10/60
2
10
24
11
11
5
153
Total ..............................................................................
........................
........................
........................
........................
216
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
II. References
11. Olsen, S., L. MacKinon, et al.,
‘‘Surveillance for Foodborne Disease
Outbreaks—United States, 1993 to1997,’’
Morbidity and Mortality Weekly Report
49(SS01), pp. 1 through 51, 2000.
2. FDA 101: Product Recalls—From First
Alert to Effectiveness Checks, Available
at https://www.fda.gov/ForConsumers/
ConsumerUpdates/ucm049070.htm.
3. Calvin, L., ‘‘Outbreak Linked to Spinach
Forces Reassessment of Food Safety
Practices,’’ Amber Waves 5(3), pp. 24
through 31, 2007.
4. Lucier, G. and R. Dettmann, ‘‘Vegetables
and Melons Outlook,’’ A Report From the
United States Department of Agriculture,
Economic Research Service, VGS–327,
June 26, 2008.
Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9155 Filed 4–14–11; 8:45 am]
BILLING CODE 4160–01–P
[Docket No. FDA–2009–E–0241]
21, 2011, the following correction is
made:
1. On page 15323, in the first column,
in the Docket No. heading, ‘‘[Docket No.
FDA–2010–E–0241]’’ is corrected to read
‘‘[Docket No. FDA–2009–E–0241]’’.
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ATRYN; Correction
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2011–9153 Filed 4–14–11; 8:45 am]
AGENCY:
Food and Drug Administration,
BILLING CODE 4160–01–P
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of March 21, 2011 (76 FR
15323). The document announced the
determination of the regulatory review
period for ATRYN. The document was
published with an incorrect docket
number. This document corrects that
error.
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Planning
and Budget, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3208, Silver Spring,
MD 20993–0002, 301–796–9138.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–6509, appearing on page 15323, in
the Federal Register of Monday, March
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16:58 Apr 14, 2011
Jkt 223001
ACTION:
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: Pediatric
Advisory Committee.
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Notice.
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srobinson on DSKHWCL6B1PROD with NOTICES
21382
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
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 Monday, May 16, 2011, from
8 a.m. to 3 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel’s telephone number is 301–589–
5200.
Contact Person: Walter Ellenberg,
Office of Pediatric Therapeutics, Office
of the Commissioner, Food and Drug
Administration, Bldg. 32, rm. 5154,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–0885,
e-mail: Walter.Ellenberg@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). Please call
the Information Line for up-to-date
information on this meeting. 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 and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On May 16, 2011, the
Pediatric Advisory Committee will meet
to discuss pediatric-focused safety
reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act (Pub. L. 110–85) for Bepreve
(bepotastine besliate), Besivance
(besifloxacin hydrochloride), Cetraxal
(ciprofloxacin hydrochloride), Patanase
Spray (olopatadine hydrochloride),
Astepro Spray (azelastine
hydrocholoride), Crestor (rosuvastatin
calcium), Welchol (colesevelam
hydrochloride), Intuniv (guanfacine),
Lexapro (escitalopram oxalate), Actonel
(risedronate), Hiberix [Haemophilus b
Conjugate Vaccine (Tetanus Toxoid
Conjugate)], and Valcyte
(valganciclovir). The committee will
also receive further followup on Topical
Calcineurin Inhibitors: Elidel
(pimecrolimus) and Protopic
(tacrolimus).
The Pediatric Advisory Committee
will hear and discuss the
recommendation of the Pediatric Ethics
Subcommittee from its meeting on May
11, 2011, regarding the Institutional
Review Board process for clinical
investigations that involve both an FDA
regulated product and research
involving children as subjects that is
conducted or supported by HHS. The
VerDate Mar<15>2010
16:58 Apr 14, 2011
Jkt 223001
announcement of the May 11, 2011,
Pediatric Ethics Subcommittee of the
Pediatric Advisory Committee meeting
can be found elsewhere in this issue of
the Federal Register.
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 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 May 2, 2011. 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 April 25,
2011. 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 April 26, 2011.
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 Walter
Ellenberg 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
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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: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9150 Filed 4–14–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0184]
Pediatric Ethics Subcommittee; 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: Pediatric Ethics
Subcommittee of the Pediatric Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Pediatric
Advisory Committee on FDA and
certain Department of Health and
Human Services regulatory issues.
DATES: The meeting will be held on
Wednesday, May 11, 2011, from 8 a.m.
to 3 p.m.
FDA is opening a docket to allow for
additional public comments to be
submitted to the Agency on the issues
before the Pediatric Ethics
Subcommittee. Submit either electronic
or written comments by May 5, 2011.
ADDRESSES: The meeting will be held at
the North Marriott Hotel & Conference
Center, 5701 Marinelli Rd., Bethesda,
MD 20852.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993–0002, 301–
796–0885, or by e-mail: Walter.Ellenberg
@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
E:\FR\FM\15APN1.SGM
15APN1
]]>Agencies
[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21381-21382]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9150]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Pediatric 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: Pediatric Advisory Committee.
[[Page 21382]]
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 Monday, May 16, 2011,
from 8 a.m. to 3 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel's telephone number is 301-
589-5200.
Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics,
Office of the Commissioner, Food and Drug Administration, Bldg. 32, rm.
5154, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
0885, e-mail: Walter.Ellenberg@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). Please call the Information Line for up-to-date information on
this meeting. 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 and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On May 16, 2011, the Pediatric Advisory Committee will meet
to discuss pediatric-focused safety reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric
Research Equity Act (Pub. L. 110-85) for Bepreve (bepotastine
besliate), Besivance (besifloxacin hydrochloride), Cetraxal
(ciprofloxacin hydrochloride), Patanase Spray (olopatadine
hydrochloride), Astepro Spray (azelastine hydrocholoride), Crestor
(rosuvastatin calcium), Welchol (colesevelam hydrochloride), Intuniv
(guanfacine), Lexapro (escitalopram oxalate), Actonel (risedronate),
Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)],
and Valcyte (valganciclovir). The committee will also receive further
followup on Topical Calcineurin Inhibitors: Elidel (pimecrolimus) and
Protopic (tacrolimus).
The Pediatric Advisory Committee will hear and discuss the
recommendation of the Pediatric Ethics Subcommittee from its meeting on
May 11, 2011, regarding the Institutional Review Board process for
clinical investigations that involve both an FDA regulated product and
research involving children as subjects that is conducted or supported
by HHS. The announcement of the May 11, 2011, Pediatric Ethics
Subcommittee of the Pediatric Advisory Committee meeting can be found
elsewhere in this issue of the Federal Register.
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 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 May
2, 2011. 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 April 25, 2011. 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 April 26, 2011.
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 Walter Ellenberg 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: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9150 Filed 4-14-11; 8:45 am]
BILLING CODE 4160-01-P
