Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 82031-82032 [2010-32735]
Download as PDF
<![CDATA[
82031
Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Notices
Data to Support Food and Nutrition
Product Communications, as Used by
the Food and Drug Administration—21
U.S.C. 393(d)(2)(D) (OMB Control
Number 0910–NEW)
FDA plans to use the data collected
under this generic clearance to inform
its nutrition and foods communications
campaigns. FDA expects the data to
guide the formulation of its food and
nutrition communication objectives.
FDA also plans to use the data to help
tailor print, broadcast, and use
electronic media communications in
order for them to have powerful and
desired impacts on target audiences.
The data will not be used for the
purposes of making policy or regulatory
decisions.
The information collected will serve
two major purposes. First, as formative
research, it will provide the critical
knowledge needed about target
audiences. FDA must explore
audiences’ beliefs, perceptions, and
decisionmaking processes about
nutrition and food consumption in
order to formulate the basic objectives of
its risk communication campaigns. Such
knowledge will provide the needed
target audience understanding to design
effective communication strategies,
messages, and product labels. These
communications will aim to improve
public understanding of the risks and
benefits of consuming certain foods or
nutritional products by providing users
with a better context in which to place
risk information more completely.
Second, as initial testing, it will give
FDA some information about the
potential effectiveness of messages and
materials in reaching and successfully
communicating with their intended
audiences. Testing messages with a
sample of the target audience will allow
FDA to refine messages while still in the
developmental stage. Respondents may
be asked to give their reaction to the
messages in individual or group
settings.
FDA’s Center of Food Safety and
Applied Nutrition, Office of the
Commissioner, and other Centers or
Offices will use this mechanism to test
messages about regulated food and
nutrition products on a variety of
subjects related to consumer, patient, or
health care professional perceptions and
use of foods and related materials,
including but not limited to, food
advertising, food and nutrition labeling,
emerging risk communications, online
sales of food products, and consumer
and professional education. The data
will not be used for the purposes of
making policy or regulatory decisions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency
per response
Number of
respondents
Total
annual
responses
Hours per
response
Total
hours
Individual indepth interviews ............................................................
General public focus group interviews ............................................
Intercept interviews: central location ...............................................
Intercept interviews: telephone ........................................................
Self-administered surveys ................................................................
Gatekeeper reviews .........................................................................
Omnibus surveys .............................................................................
360
144
600
10,000 2
2,400
400
2,400
1
1
1
1
1
1
1
360
144
600
10,000
2,400
400
2,400
0.75
1.5
0.25
0.08
0.25
0.50
0.17
270
216
150
800
600
200
408
Total (general public) ................................................................
16,304
........................
16,304
........................
2,644
Total physician focus group interviews ....................................
144
1
144
1.5
216
Total (overall) ............................................................................
........................
........................
........................
........................
2,860
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Brief interviews with callers to test messages, concepts and strategies following their call-in request to an FDA Center 1–800 number.
Annually, FDA projects about 30
communication studies using the
variety of test methods listed in table 1.
FDA is requesting this burden so as not
to restrict the Agency’s ability to gather
information on public sentiment for its
proposals in its regulatory and
communications programs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
[FR Doc. 2010–32739 Filed 12–28–10; 8:45 am]
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: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
srobinson on DSKHWCL6B1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
02:10 Dec 29, 2010
Jkt 223001
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00067
Fmt 4703
Sfmt 4703
Date and Time: The meeting will be
held on March 8, 2011, from 8 a.m. to
5 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 ‘‘White Oak Conference Center
Parking and Transportation Information
for FDA Advisory Committee Meetings.’’
Please note that visitors to the White
Oak Campus must enter through Bldg 1.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave, Bldg. 31, rm. 2417, Silver Spring,
E:\FR\FM\29DEN1.SGM
29DEN1
srobinson on DSKHWCL6B1PROD with NOTICES
82032
Federal Register / Vol. 75, No. 249 / Wednesday, December 29, 2010 / Notices
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email:
kristine.khuc@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 March 8, 2011, the
committee will discuss new drug
application (NDA) 022–383, indacaterol
maleate (ARCAPTA NEOHALER), by
Novartis Pharmaceuticals Corp., for the
long-term once daily maintenance
bronchodilator treatment of airflow
obstruction in patients with chronic
obstructive pulmonary disease,
including chronic bronchitis and/or
emphysema.
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 February 22, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 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 February
VerDate Mar<15>2010
02:10 Dec 29, 2010
Jkt 223001
11, 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 February 14, 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 Kristine T.
Khuc 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: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–32735 Filed 12–28–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to OMB for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Ryan White HIV/
AIDS Program Allocation and
Expenditure Forms (OMB No. 0915–
0318)—[Extension]
The Ryan White HIV/AIDS Program
Allocation and Expenditure Reports will
enable the Health Resources and
Services Administration’s HIV/AIDS
Bureau to track spending requirements
for each program as outlined in the
legislation. Grantees funded under Parts
A, B, C, and D of the Ryan White HIV/
AIDS Program (codified under Title
XXVI of the Public Health Service Act)
would be required to report financial
data to HRSA at the beginning and end
of their grant cycle.
All parts of the Ryan White HIV/AIDS
Program specify HRSA’s responsibilities
in the administration of grant funds.
Accurate allocation and expenditure
records of the grantees receiving Ryan
White HIV/AIDS Program funding are
critical to the implementation of the
legislation and thus are necessary for
HRSA to fulfill its responsibilities.
The forms would require grantees to
report on how funds are allocated and
spent on core and non-core services,
and on various program components,
such as administration, planning,
evaluation, and quality management.
The two forms are identical in the types
of information that are collected.
However, the first report would track
the allocation of the award at the
beginning of the grant cycle and the
second report would track actual
expenditures (including carryover
dollars) at the end of the grant cycle.
The primary purposes of these forms
are to (1) provide information on the
number of grant dollars spent on various
services and program components, and
(2) oversee compliance with the intent
of Congressional appropriations in a
timely manner. In addition to meeting
the goal of accountability to the
Congress, clients, advocacy groups, and
the general public, information
collected on these reports is critical for
HRSA, state and local grantees, and
individual providers for the evaluation
of the effectiveness of these programs.
The response burden for grantees is
estimated as:
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Notices]
[Pages 82031-82032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32735]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Pulmonary-Allergy 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: Pulmonary-Allergy 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 March 8, 2011, from 8
a.m. to 5 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 ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings.''
Please note that visitors to the White Oak Campus must enter through
Bldg 1.
Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg.
31, rm. 2417, Silver Spring,
[[Page 82032]]
MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email:
kristine.khuc@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 March 8, 2011, the committee will discuss new drug
application (NDA) 022-383, indacaterol maleate (ARCAPTA NEOHALER), by
Novartis Pharmaceuticals Corp., for the long-term once daily
maintenance bronchodilator treatment of airflow obstruction in patients
with chronic obstructive pulmonary disease, including chronic
bronchitis and/or emphysema.
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
February 22, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 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 February 11, 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 February 14, 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 Kristine T. Khuc 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: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-32735 Filed 12-28-10; 8:45 am]
BILLING CODE 4160-01-P
