Pediatric Ethics Subcommittee; Notice of Meeting, 21382-21383 [2011-9149]
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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
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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
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
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 hotline/
phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On May 11, 2011, the
Pediatric Ethics Subcommittee of the
Pediatric Advisory Committee will meet
to discuss the general topic of the ethics
of administering subtherapeutic doses of
investigational products to children for
the purpose of determining, for
example, drug metabolism, disposition,
and targeting (e.g., exploratory
investigational new drug (IND) studies).
In this context, the subcommittee will
also discuss the referral of such
protocols by an Institutional Review
Board for review by a Federal panel
under 21 CFR 50.54.
The subcommittee’s
recommendations will then be
presented to the FDA Pediatric Advisory
Committee on Monday, May 16, 2011.
The announcement of the May 16, 2011,
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 subcommittee. Written
submissions may be made to the contact
person on or before April 28, 2011. Oral
presentations from the public will be
scheduled between approximately
11 a.m. and 12 noon on May 11, 2011.
Those desiring to make 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 20,
VerDate Mar<15>2010
16:58 Apr 14, 2011
Jkt 223001
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 21, 2011.
Comments: FDA is opening a docket
to allow for additional public comments
to be submitted to the Agency on issues
before the Pediatric Ethics
Subcommittee beginning April 15, 2011,
and closing May 5, 2011. All comments
received on or before May 5, 2011, will
be provided to the committee members.
All comments received after May 5,
2011, will be taken into consideration
by the Agency. Interested persons are
encouraged to use the docket to submit
either electronic or written comments
regarding this meeting (see ADDRESSES).
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to Division of Dockets
Management (see ADDRESSES). It is
necessary to submit only one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets management between 9 a.m.
and 4 p.m. Monday through Friday.
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. 2011–9149 Filed 4–14–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Food Reporting Comparison
Study (FORCS) and Food and Eating
Assessment Study (FEAST) (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Food
Reporting Comparison Study (FORCS)
and Food and Eating Assessment Study
(FEAST) (NCI). Type of Information
Collection Request: Extension. Need and
Use of Information Collection: The title
of this collection was previously, ‘‘24hour Dietary Recall Method Comparison
and the National Cancer Institute (NCI)
Observational Feeding Studies.’’ The
objective of the two studies is to
compare the performance of the newly
developed computerized Automated
Self-Administered 24-Hour Recall
(ASA24) approach to collecting 24 hour
recall (24HR) data with the current
standard, the interviewer-administered
Automated Multiple Pass Method
(AMPM). The ultimate goal is to
determine to what extent the new
automated instrument can be used
instead of the more expensive
interviewer-administered instrument in
the collection of dietary intake data.
Frequency of Response: Twice. Affected
Public: Individuals. Type of
Respondents: For the FORCS study,
approximately 1,200 adult members
from three health maintenance
organization plans (in Minnesota,
California, and Michigan) between ages
20 and 70 years. For the FEAST study,
approximately 90 adult residents from
the Washington, DC metropolitan area
between ages 20 and 70 years. The
annual reporting burden is estimated at
866 hours (see table below). This
amounts to an estimated 2,598 burden
hours over the 3-year data collection
period with a total cost to the
respondents of $54,293. There are no
Capital costs, Operating costs, and/or
Maintenance Costs to report.
SUMMARY:
BILLING CODE 4160–01–P
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21383
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]]>Agencies
[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21382-21383]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9149]
-----------------------------------------------------------------------
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
[[Page 21383]]
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 hotline/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On May 11, 2011, the Pediatric Ethics Subcommittee of the
Pediatric Advisory Committee will meet to discuss the general topic of
the ethics of administering subtherapeutic doses of investigational
products to children for the purpose of determining, for example, drug
metabolism, disposition, and targeting (e.g., exploratory
investigational new drug (IND) studies). In this context, the
subcommittee will also discuss the referral of such protocols by an
Institutional Review Board for review by a Federal panel under 21 CFR
50.54.
The subcommittee's recommendations will then be presented to the
FDA Pediatric Advisory Committee on Monday, May 16, 2011. The
announcement of the May 16, 2011, 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 subcommittee.
Written submissions may be made to the contact person on or before
April 28, 2011. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 noon on May 11, 2011. Those
desiring to make 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 20, 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 21, 2011.
Comments: FDA is opening a docket to allow for additional public
comments to be submitted to the Agency on issues before the Pediatric
Ethics Subcommittee beginning April 15, 2011, and closing May 5, 2011.
All comments received on or before May 5, 2011, will be provided to the
committee members. All comments received after May 5, 2011, will be
taken into consideration by the Agency. Interested persons are
encouraged to use the docket to submit either electronic or written
comments regarding this meeting (see ADDRESSES). Submit electronic
comments to https://www.regulations.gov. Submit written comments to
Division of Dockets Management (see ADDRESSES). It is necessary to
submit only one set of comments. It is no longer necessary to send two
copies of mailed comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets management between 9 a.m. and 4
p.m. Monday through Friday.
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. 2011-9149 Filed 4-14-11; 8:45 am]
BILLING CODE 4160-01-P
