Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Health Promotion/Disease Prevention Grantee Survey, 74725-74726 [E8-28922]
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Federal Register / Vol. 73, No. 237 / Tuesday, December 9, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Blood Products Advisory Committee;
Notice of Meeting
pwalker on PROD1PC71 with NOTICES
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: Blood Products
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 January 9, 2009, from 8 a.m. to
6 p.m.
Location: Hilton Hotel, Washington,
D.C./Rockville Executive Meeting
Center, 1750 Rockville Pike, Rockville,
MD 20852.
Contact Person: William Freas or
Pearline K. Muckelvene, Center for
Biologics Evaluation and Research
(HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–0314, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014519516. 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 the morning of January 9,
2009, the Committee will discuss CSL
Behring’s Biologics License Application
for plasma-derived fibrinogen
concentrate for treatment of bleeding in
congenital fibrinogen deficiency. In the
afternoon, the Committee will hear an
update on the ‘‘Food and Drug
Administration Draft Guidance for
Industry on Regulation of Genetically
Engineered Animals Containing
Heritable Recombinant Deoxynucleic
Acid Constructs.’’ Following this
update, the Committee will discuss GTC
Biotherapeutics’ Biologics License
Application for recombinant
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Antithrombin III derived from
genetically engineered goats for
treatment of patients with hereditary
Antithrombin III deficiency to prevent
thrombosis during high risk situations
like surgery and obstetrical procedures.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and 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 December 30, 2008.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. and 11 a.m. and between
approximately 4 p.m. and 5 p.m. on
January 9, 2009. 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 December 19, 2008. 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
December 22, 2008.
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 William
Freas or Pearline K. Muckelvene 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/oc/advisory/
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74725
default.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 1, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–29105 Filed 12–8–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30-Day
Proposed Information Collection:
Indian Health Service Health
Promotion/Disease Prevention Grantee
Survey
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires
30 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
project was previously published in the
Federal Register (73 FR 23254) on
August 25, 2008 and allowed 60 days
for public comment. No public
comment was received in response to
the notice. The purpose of this notice is
to allow 30 days for public comment to
be submitted directly to OMB.
Proposed Collection: Title: 0917–
NEW, ‘‘Indian Health Service Health
Promotion/Disease Prevention Grantee
Survey.’’
Type of Information Collection
Request: This is a one-time survey to
fulfill an OMB request for an
independent external evaluation
collection, 0917–NEW, ‘‘Indian Health
Service Health Promotional Disease
Prevention (HP/DP) Grantee Survey.’’
Form Number(s): None.
Need and Use of Information
Collection: The IHS goal is to raise the
health status of the American Indian
and Alaska Native (AI/AN) people to the
highest possible level by providing
comprehensive health care and
preventive health services. HP/DP is one
of the three IHS Director’s initiatives to
reduce health disparities among AI/AN
populations through a coordinated and
systematic approach to enhance health
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74726
Federal Register / Vol. 73, No. 237 / Tuesday, December 9, 2008 / Notices
promotion and chronic disease
prevention approaches at the local,
regional, and national levels.
The HP/DP competitive grant was
established in 2005 to encourage Tribal
and urban Indian programs to fully
engage their local schools, communities,
health care providers, health centers,
faith-based/spiritual communities,
senior centers, youth programs, local
governments, academia, non-profit
organizations, and many other
community sectors to work together to
enhance and promote health and
prevent chronic disease in their
communities. Thirty-three Tribal/urban
Indian organizations and programs were
awarded competitive grants to expand
and enhance health promotion and
disease prevention to address health
disparities among AI/AN populations.
To conduct a thorough evaluation of
the grant program, 29 telephone and
four face-to-face interviews will be
conducted to collect information to
complete a quantitative and qualitative
evaluation of the HP/DP grant program.
The teleconference interviews may
include one staff member per site. Each
of the Tribal/urban organization/
programs will determine the number of
their staff members that will participate
in the interview. The evaluation will
include an assessment of whether HP/
DP grantees achieve measurable health
outcomes, synthesize the evaluation
findings, and include a written report
with recommendations to enhance
program effectiveness. The information
gathered will be used to prepare a final
report for OMB.
Affected Public: Individuals.
Type of Respondents: Tribal/urban
organizations program staff.
The table below provides: Types of
data collection instruments, estimated
number of respondents, number of
responses per respondent, average
burden hour per response, and total
annual burden hour(s).
ESTIMATED BURDEN HOURS
Estimated
number of
respondents
Data collection instrument
Responses
per
respondent
Average
burden hour
per response
Total annual
burden hours
231
1
1
231
Total ..........................................................................................................
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HP/DP Grantees Telephone and Face-to-Face Interview Survey ..................
231
........................
........................
231
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of the public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimates are logical; (e) ways to
enhance the quality, utility, and clarity
of the information being collected; and
(f) ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Direct Comments to OMB: Send your
written comments and suggestions
regarding the proposed information
collection contained in this notice,
especially regarding the estimated
public burden and associated response
time to: Office of Management and
Budget, Office of Regulatory Affairs,
New Executive Office Building, Room
10235, Washington, DC 20503,
Attention: Desk Officer for IHS.
To request more information on the
proposed collection or to obtain a copy
of the data collection instrument(s) and/
or instruction(s) contact: Ms. Janet
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17:00 Dec 08, 2008
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Ingersoll, Freedom of Information Act
Coordinator, 801 Thompson Avenue,
TMP Suite 450, Rockville, MD 20852–
1601; call non-toll free (301) 443–1116;
send via facsimile to (301) 443–9879; or
send your e-mail requests, comments,
and return address to:
Janet.Ingersoll@ihs.gov.
Comment Due Date: Comments
regarding this information collection are
best assured of having full effect if
received within 30 days of the date of
this publication.
Dated: December 2, 2008.
Robert G. McSwain,
Director, Indian Health Service.
[FR Doc. E8–28922 Filed 12–8–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
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and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; MOSS
Continuous Receipt.
Date: December 18, 2008.
Time: 2 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Daniel F. McDonald, PhD,
Scientific Review Officer, Chief, MOSS IRG,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 4214, MSC 7814,Bethesda, MD 20892,
(301) 435–1215, mcdonald@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Oncological Sciences
Integrated Review Group; Cancer Molecular
Pathobiology Study Section.
Date: January 15–16, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Delfina, 530 West Pico
Boulevard, Santa Monica, CA 90405.
Contact Person: Elaine Sierra-Rivera, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health,6701 Rockledge Drive, Room 6184,
MSC 7804, Bethesda, MD 20892, 301–435–
1779, riverase@csr.nih.gov.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Psychosocial Risk and Disease Prevention
Study Section.
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[Federal Register Volume 73, Number 237 (Tuesday, December 9, 2008)]
[Notices]
[Pages 74725-74726]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30-Day Proposed Information
Collection: Indian Health Service Health Promotion/Disease Prevention
Grantee Survey
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires 30 days for public comment on
proposed information collection projects, the Indian Health Service
(IHS) has submitted to the Office of Management and Budget (OMB) a
request to review and approve the information collection listed below.
This proposed information collection project was previously published
in the Federal Register (73 FR 23254) on August 25, 2008 and allowed 60
days for public comment. No public comment was received in response to
the notice. The purpose of this notice is to allow 30 days for public
comment to be submitted directly to OMB.
Proposed Collection: Title: 0917-NEW, ``Indian Health Service
Health Promotion/Disease Prevention Grantee Survey.''
Type of Information Collection Request: This is a one-time survey
to fulfill an OMB request for an independent external evaluation
collection, 0917-NEW, ``Indian Health Service Health Promotional
Disease Prevention (HP/DP) Grantee Survey.''
Form Number(s): None.
Need and Use of Information Collection: The IHS goal is to raise
the health status of the American Indian and Alaska Native (AI/AN)
people to the highest possible level by providing comprehensive health
care and preventive health services. HP/DP is one of the three IHS
Director's initiatives to reduce health disparities among AI/AN
populations through a coordinated and systematic approach to enhance
health
[[Page 74726]]
promotion and chronic disease prevention approaches at the local,
regional, and national levels.
The HP/DP competitive grant was established in 2005 to encourage
Tribal and urban Indian programs to fully engage their local schools,
communities, health care providers, health centers, faith-based/
spiritual communities, senior centers, youth programs, local
governments, academia, non-profit organizations, and many other
community sectors to work together to enhance and promote health and
prevent chronic disease in their communities. Thirty-three Tribal/urban
Indian organizations and programs were awarded competitive grants to
expand and enhance health promotion and disease prevention to address
health disparities among AI/AN populations.
To conduct a thorough evaluation of the grant program, 29 telephone
and four face-to-face interviews will be conducted to collect
information to complete a quantitative and qualitative evaluation of
the HP/DP grant program. The teleconference interviews may include one
staff member per site. Each of the Tribal/urban organization/programs
will determine the number of their staff members that will participate
in the interview. The evaluation will include an assessment of whether
HP/DP grantees achieve measurable health outcomes, synthesize the
evaluation findings, and include a written report with recommendations
to enhance program effectiveness. The information gathered will be used
to prepare a final report for OMB.
Affected Public: Individuals.
Type of Respondents: Tribal/urban organizations program staff.
The table below provides: Types of data collection instruments,
estimated number of respondents, number of responses per respondent,
average burden hour per response, and total annual burden hour(s).
Estimated Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Average
Data collection instrument number of Responses per burden hour Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
HP/DP Grantees Telephone and Face-to-Face 231 1 1 231
Interview Survey...............................
---------------------------------------------------------------
Total....................................... 231 .............. .............. 231
----------------------------------------------------------------------------------------------------------------
There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
Request for Comments: Your written comments and/or suggestions are
invited on one or more of the following points: (a) Whether the
information collection activity is necessary to carry out an agency
function; (b) whether the agency processes the information collected in
a useful and timely fashion; (c) the accuracy of the public burden
estimate (the estimated amount of time needed for individual
respondents to provide the requested information); (d) whether the
methodology and assumptions used to determine the estimates are
logical; (e) ways to enhance the quality, utility, and clarity of the
information being collected; and (f) ways to minimize the public burden
through the use of automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
Direct Comments to OMB: Send your written comments and suggestions
regarding the proposed information collection contained in this notice,
especially regarding the estimated public burden and associated
response time to: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for IHS.
To request more information on the proposed collection or to obtain
a copy of the data collection instrument(s) and/or instruction(s)
contact: Ms. Janet Ingersoll, Freedom of Information Act Coordinator,
801 Thompson Avenue, TMP Suite 450, Rockville, MD 20852-1601; call non-
toll free (301) 443-1116; send via facsimile to (301) 443-9879; or send
your e-mail requests, comments, and return address to:
Janet.Ingersoll@ihs.gov.
Comment Due Date: Comments regarding this information collection
are best assured of having full effect if received within 30 days of
the date of this publication.
Dated: December 2, 2008.
Robert G. McSwain,
Director, Indian Health Service.
[FR Doc. E8-28922 Filed 12-8-08; 8:45 am]
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