Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting, 38668-38669 [2011-16576]
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38668
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
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 July 15, 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 July 18, 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 Bryan Emery
or Rosanna Harvey 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).
Dated: June 28, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–16574 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES6
[Docket No. FDA–2011–N–0002]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; 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
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
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 July 26, 2011, from 8 a.m. to
5:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
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: Yvette Waples, 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, e-mail:
ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
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 July 26, 2011, the
committee will discuss presentations by
the Office of Generic Drugs (OGD) on
bioequivalence issues and quality
standards relative to narrow therapeutic
index (NTI) drug products as a class. In
response to feedback during the April
13, 2010, Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology (ACPS–CP) meeting, the
committee will further discuss the
definition and list of NTI drugs, as well
as proposed bioequivalence standards
for these products. The committee will
also receive awareness presentations
relevant to OGD’s ongoing focus on
quality and safety of generic drug
products. Presentations will outline
current activities seeking to better
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
understand the impact of formulation
and quality on the performance of
generic drug products and current
thinking related to potential regulatory
pathways for these issues.
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 July 19, 2011. Oral
presentations from the public will be
scheduled between approximately 11
a.m. to 12 noon, and 4:30 p.m. to 5 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 July 12, 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 July 13, 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 Yvette
Waples 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
E:\FR\FM\01JYN1.SGM
01JYN1
38669
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
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: June 27, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–16576 Filed 6–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Food Reporting
Comparison Study (FORCS) and Food
and Eating Assessment Study (FEAST)
(NCI)
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
Participants and
study
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on April 15, 2011 (76 FR
21383). One public comment was
received on April 15 requesting a copy
of the data collection package. The
submission was sent to the requestor on
April 21. The purpose of this notice is
to allow an additional 30 days for public
comment. The 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.
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
Number of respondents
Questionnaire
Frequency of
response
Automated Self-Administered 24-Hour
Recall (ASA24) approach to collecting
24-hour recall (24HR) data with the
current standard, the intervieweradministered 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 2598 burden
hours over the 3-year data collection
period with a total cost to the
respondents $54,293. There are no
Capital costs, Operating costs, and/or
Maintenance costs to report.
Average time per response
minutes/hour
Annual hour
burden
mstockstill on DSK4VPTVN1PROD with NOTICES6
1
5/60 (0.083)
148
400
1
5/60 (0.083)
33
400
400
1.00
1.00
5/60 (0.083)
30/60 (0.50)
33
200
ASA24 (Attach 2) ................................
Demographics and Health Questionnaire (Attach 6).
Demographics, Health and Preference
Questionnaire (Attach 7).
Screener (Attach 8) .............................
Reminder Telephone Call (Attach 10)
Eating 3 meals ....................................
400
360
1.00
1.00
30/60 (0.50)
10/60 (0.167)
200
60
360
1.00
15/60 (0.25)
90
33
33
33
1.00
1.00
1.00
5/60 (0.083)
5/60 (0.083)
135/60 (2.25)
6
6
151
33
1.00
30/60 (0.50)
34
33
1.00
10/60 (0.167)
11
3485
General Public for
FEAST.
1770
Either AMPM or ASA24 (Attach 1 or
2).
Demographics and Health Questionnaire (Attach 12).
General Public for
FORCS.
Refusal Reasons and Demographics
(Attach 4A, Screen 8).
Contact Information (Attach 4A,
Screen 5).
Screener (Attach 5) .............................
AMPM (Attach 1) ................................
........................
..................................................
866
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information
VerDate Mar<15>2010
18:54 Jun 30, 2011
Jkt 223001
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
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Frm 00071
Fmt 4703
Sfmt 4703
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, Office of
Regulatory Affairs at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans, contact Frances E. Thompson,
E:\FR\FM\01JYN1.SGM
01JYN1
Agencies
[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38668-38669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16576]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; 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: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
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 July 26, 2011, from 8
a.m. to 5:30 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. 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: Yvette Waples, 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, e-mail: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), and follow the prompts to the desired center or product 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 July 26, 2011, the committee will discuss presentations
by the Office of Generic Drugs (OGD) on bioequivalence issues and
quality standards relative to narrow therapeutic index (NTI) drug
products as a class. In response to feedback during the April 13, 2010,
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
(ACPS-CP) meeting, the committee will further discuss the definition
and list of NTI drugs, as well as proposed bioequivalence standards for
these products. The committee will also receive awareness presentations
relevant to OGD's ongoing focus on quality and safety of generic drug
products. Presentations will outline current activities seeking to
better understand the impact of formulation and quality on the
performance of generic drug products and current thinking related to
potential regulatory pathways for these issues.
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 July
19, 2011. Oral presentations from the public will be scheduled between
approximately 11 a.m. to 12 noon, and 4:30 p.m. to 5 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 July
12, 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 July 13, 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 Yvette Waples 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
[[Page 38669]]
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: June 27, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16576 Filed 6-30-11; 8:45 am]
BILLING CODE 4160-01-P