Risk Communication Advisory Committee; Notice of Meeting, 44017-44018 [2011-18507]
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Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
regarding their request to speak by
September 2, 2011.
Closed Committee Deliberations: On
September 20, 2011, between
approximately 10:15 a.m. and 10:45
a.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss
the report of the intramural research
programs and make recommendations
regarding personnel staffing decisions.
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 Donald W.
Jehn or Denise Royster 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: July 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–18506 Filed 7–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Risk
Communication Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
VerDate Mar<15>2010
17:59 Jul 21, 2011
Jkt 223001
Date and Time: The meeting will be
held on August 15, 2011, from 8 a.m. to
5 p.m. and August 16, 2011, from 8 a.m.
to 2 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: Lee L. Zwanziger,
Office of Policy, Planning and Budget,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
3278, Silver Spring, MD 20993, 301–
796–9151, FAX: 301–847–8611, e-mail:
RCAC@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 August 15, 2011, the
Committee will discuss challenges of
communicating about evolving
methodology in the attribution of
foodborne illness. Estimating the
number of illnesses, hospitalizations,
and deaths caused by major pathogens
is the first step in the development of
disease prevention strategies. Estimating
the proportions of these illnesses due to
specific food sources (food source
attribution) is a necessary second step
towards identifying the sources that
cause substantial preventable human
illness and measuring progress toward
public health goals resulting from
public health interventions applied to
those food sources. Consequently, FDA,
the Centers for Disease Control and
Prevention, and the U.S. Department of
Agriculture/Food Safety Inspection
Service have begun a joint initiative,
called the Interagency Food Safety
Analytics Collaboration (IFSAC), to
improve our collective understanding of
source attribution of infections to
specific foods and settings. While the
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
44017
IFSAC works to improve methodology,
we are also committed to keeping
stakeholders informed and engaged, and
are seeking advice about how to
communicate most effectively. On
August 16, 2011, the Committee will
present ‘‘Communicating Risks and
Benefits: An Evidence-Based User’s
Guide.’’ This volume is the result of
work, as discussed in previous
meetings, by current and former
members of the Risk Communication
Advisory Committee.
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 August 10, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on August 15, 2011, and
10:30 a.m. and 11:30 a.m. on August 16,
2011. 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 2, 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 August 3, 2011.
Interested persons can also log on to
https://collaboration.fda.gov/rcac/ to
hear and see the proceedings.
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
E:\FR\FM\22JYN1.SGM
22JYN1
44018
Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Lee L.
Zwanziger 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 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–18507 Filed 7–21–11; 8:45 am]
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of Agency
functions; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information; (c)
the ways to enhance quality, utility, and
clarity of the information to be
collected; and (d) the ways to minimize
the burden of the collection of
information on respondents, through the
use of automated collection techniques
or other forms of information
technology.
BILLING CODE 4160–01–P
Proposed Project: ADAP Data Report—
[NEW]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HRSA’s AIDS Drug Assistance
Program (ADAP) is funded through The
Ryan White HIV/AIDS Program, Part B,
Title XXVI of the Public Health Service
Act, which provides grants to states and
territories. ADAP provides medications
for the treatment of HIV/AIDS. Program
funds may also be used to purchase
health insurance for eligible clients and
for services that enhance access,
adherence, and monitoring of drug
treatments.
Each of the 50 states, the District of
Columbia, Puerto Rico, and several
territories receive ADAP grants. As part
of the funding requirements, ADAP
grantees currently submit quarterly
reports concerning aggregate
information on patients served,
pharmaceuticals prescribed, pricing, as
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
well as other sources of support to
provide AIDS medication treatment,
eligibility requirements, cost data, and
coordination with Medicaid; however,
aggregate data cannot be analyzed with
the detail that is required to assess
quality of care or to sufficiently account
for the use of Ryan White HIV/AIDS
Program Funds.
To address this limitation, HRSA’s
HIV/AIDS Bureau (HAB) is developing
a client-level data system for ADAP
grantees called the ADAP Data Report
(ADR). The ADR consists of a grantee
report and a client-level data file that
will be submitted once every six
months. Data collected through the
ADR: Will enable HAB to answer
specific questions about the utility of
ADAP; will more precisely address
program needs; and will monitor
program performance.
Discussions were held with nine
volunteer grantee agencies representing
a variety of ADAP models, as a basis for
the burden estimates for the ADR that
are included. These burden estimates
are presented in two tables. The first
table represents the estimated burden
for the first year, including the
estimated time to adjust existing or
develop new data collection systems to
collect the elements that HAB is
requesting. In the first year, grantees
will be required to report the grantee
and client reports twice. Therefore, the
total number of grantees (57) is
multiplied by the total number of times
that each grantee must submit the
specified report (2) to arrive at the total
responses in a one year period (114).
This total is multiplied by the number
of hours to complete each report for
each six month submission to calculate
the total burden hours.
TABLE 1—ESTIMATE OF BURDEN FOR THE FIRST YEAR
Number of
respondents
Instrument
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
57
57
57
2
2
1
114
114
57
12.50
34.19
826.00
1,425.00
3,897.66
47,082.00
Total ..............................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Grantee Report ....................................................................
Client Report ........................................................................
Data Collection System .......................................................
........................
........................
........................
........................
52,404.66
The second table represents the
estimated burden for subsequent years.
Given that data collection system
updates only impact the first six month
reporting period, it is not included in
the subsequent years’ total burden. The
VerDate Mar<15>2010
17:59 Jul 21, 2011
Jkt 223001
grantee report burden remains
unchanged, as the submission is
consistent with current reporting
requirements. The client report burden
will decrease slightly in subsequent
years as grantees become more
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
proficient with reporting client level
data, based on feedback they receive, as
well as technical assistance resources
that HRSA will provide.
E:\FR\FM\22JYN1.SGM
22JYN1
]]>Agencies
[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44017-44018]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Risk Communication 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: Risk Communication 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 August 15, 2011, from 8
a.m. to 5 p.m. and August 16, 2011, from 8 a.m. to 2 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: Lee L. Zwanziger, Office of Policy, Planning and
Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, rm. 3278, Silver Spring, MD 20993, 301-796-9151, FAX: 301-847-8611,
e-mail: RCAC@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 August 15, 2011, the Committee will discuss challenges
of communicating about evolving methodology in the attribution of
foodborne illness. Estimating the number of illnesses,
hospitalizations, and deaths caused by major pathogens is the first
step in the development of disease prevention strategies. Estimating
the proportions of these illnesses due to specific food sources (food
source attribution) is a necessary second step towards identifying the
sources that cause substantial preventable human illness and measuring
progress toward public health goals resulting from public health
interventions applied to those food sources. Consequently, FDA, the
Centers for Disease Control and Prevention, and the U.S. Department of
Agriculture/Food Safety Inspection Service have begun a joint
initiative, called the Interagency Food Safety Analytics Collaboration
(IFSAC), to improve our collective understanding of source attribution
of infections to specific foods and settings. While the IFSAC works to
improve methodology, we are also committed to keeping stakeholders
informed and engaged, and are seeking advice about how to communicate
most effectively. On August 16, 2011, the Committee will present
``Communicating Risks and Benefits: An Evidence-Based User's Guide.''
This volume is the result of work, as discussed in previous meetings,
by current and former members of the Risk Communication Advisory
Committee.
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
August 10, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on August 15, 2011, and 10:30
a.m. and 11:30 a.m. on August 16, 2011. 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 2, 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 August 3, 2011. Interested persons can also
log on to https://collaboration.fda.gov/rcac/ to hear and see the
proceedings.
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
[[Page 44018]]
disabilities or special needs. If you require special accommodations
due to a disability, please contact Lee L. Zwanziger 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 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-18507 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P
