Proposed Data Collections Submitted for Public Comment and Recommendations, 51157-51158 [E9-23883]
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Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
the manufacturer, and for covered
persons to take such other actions as are
appropriate to limit the administration
or use of the Covered Countermeasure,
and the liability protection of section
319F–3(a) of the Act shall extend for
that period.
B. The Federal Government shall
purchase the entire production of
Covered Countermeasures under the
contracts specifically listed by contract
number in section I for the stockpile
under section 319F–2 of the Act, and
shall be subject to the time-period
extension of section 319F–3(b)(3)(C).
Production under future contracts for
the same vaccine will also be subject to
the time-period extension of section
319F–3(b)(3)(C).
VIII. Compensation Fund
In addition to conferring immunity to
manufacturers, distributors, and
administrators of the Covered
Countermeasures, the Act provides
benefits to certain individuals who
sustain a covered injury as the direct
result of the administration of the
Covered Countermeasure. The
Countermeasure Injury Compensation
Program (CICP) within the Health
Resources and Services Administration
(HRSA) administers the Act’s
compensation program. Information
about the CICP is available at 1–888–
275–4772 or https://www.hrsa.gov/
countermeasurescomp/default.htm.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
IX. Amendments
The Declaration for the Use of the
Public Readiness and Emergency
Preparedness Act for H5N1 was
published on January 26, 2007;
amended on November 30, 2007 to add
H7 and H9 vaccines; amended on
October 17, 2008 to add H2 and H6
vaccines; amended on June 15, 2009 to
add 2009 H1N1 vaccines and
republished in its entirety. This
Declaration incorporates all
amendments prior to the date of its
publication in the Federal Register. Any
future amendment to this Declaration
will be published in the Federal
Register, pursuant to section 319F–
2(b)(4) of the Act.
X. Definitions
For the purpose of this Declaration,
including any claim for loss brought in
accordance with section 319F–3 of the
PHS Act against any covered persons
defined in the Act or this Declaration,
the following definitions will be used:
Administration of a Covered
Countermeasure: As used in section
319F–3(a)(2)(B) of the Act includes, but
is not limited to, public and private
delivery, distribution, and dispensing
VerDate Nov<24>2008
14:59 Oct 02, 2009
Jkt 220001
activities relating to physical
administration of the countermeasures
to recipients, management and
operation of delivery systems, and
management and operation of
distribution and dispensing locations.
Authority Having Jurisdiction: Means
the public agency or its delegate that has
legal responsibility and authority for
responding to an incident, based on
political or geographical (e.g., city,
county, Tribal, State, or Federal
boundary lines) or functional (e.g., law
enforcement, public health) range or
sphere of authority.
Covered Persons: As defined at
section 319F–3(i)(2) of the Act, include
the United States, manufacturers,
distributors, program planners, and
qualified persons. The terms
‘‘manufacturer,’’ ‘‘distributor,’’
‘‘program planner,’’ and ‘‘qualified
person’’ are further defined at sections
319F–3(i)(3), (4), (6), and (8) of the Act.
Declaration of Emergency: A
declaration by any authorized local,
regional, State, or Federal official of an
emergency specific to events that
indicate an immediate need to
administer and use pandemic
countermeasures, with the exception of
a Federal declaration in support of an
emergency use authorization under
section 564 of the FDCA unless such
declaration specifies otherwise.
Pandemic Phase: The following
stages, as defined in the National
Strategy for Pandemic Influenza:
Implementation Plan (Homeland
Security Council, May 2006): (4) First
Human Case in North America; and (5)
Spread Throughout United States.
Pre-pandemic Phase: The following
stages, as defined in the National
Strategy for Pandemic Influenza:
Implementation Plan (Homeland
Security Council, May 2006): (0) New
Domestic Animal Outbreak in At-Risk
Country; (1) Suspected Human Outbreak
Overseas; (2) Confirmed Human
Outbreak Overseas; and (3) Widespread
Human Outbreaks in Multiple Locations
Overseas.
Dated: September 28, 2009.
Kathleen Sebelius,
Secretary.
Appendix
I. List of U.S. Government Contracts—
Covered H5N1, H2, H6, H9, and 2009–H1N1
Vaccine Contracts
1. HHSN266200400031C
2. HHSN266200400032C
3. HHSN266200300039C
4. HHSN266200400045C
5. HHSN266200205459C
6. HHSN266200205460C
7. HHSN266200205461C
8. HHSN266200205462C
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
51157
9. HHSN266200205463C
10. HHSN266200205464C
11. HHSN266200205465C
12. HHSN266199905357C
13. HHSN266200300068C
14. HHSN266200005413C
15. HHSO100200600021C (formerly
200200409981)
16. HHSO100200500004C
17. HHSO100200500005I
18. HHSO100200700026I
19. HHSO100200700027I
20. HHSO100200700028I
21. HHSO100200600010C
22. HHSO100200600011C
23. HHSO100200600012C
24. HHSO100200600013C
25. HHSO100200600014C
26. HHSO100200600022C (formerly
200200511758)
27. HHSO100200600023C (formerly
200200410431)
28. CRADA No. AI–0155 NIAID/MedImmune
29. HHSO100200700029C
30. HHSO100200700030C
31. HHSO100200700031C
32. All present, completed and future
Government H5N1, H2, H6, H9, and
2009–H1N1 vaccine contracts not
otherwise listed.
[FR Doc. E9–23844 Filed 10–2–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-09–09CV]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
E:\FR\FM\05OCN1.SGM
05OCN1
51158
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
All-Hazards Public Health Emergency
Preparedness and Response Generic
Data Collection—New—Coordinating
Office for Terrorism Preparedness and
Emergency Response (COTPER), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Data from agencies and individuals
are needed to assist CDC in responding
to and planning for domestic and
international all-hazards public health
emergencies. According to the glossary
from the National Response Framework
Resource Center, ‘‘all-hazards’’ is
defined as ‘‘describing an incident,
natural or manmade, that warrants
action to protect life, property,
environment, and public health or
safety, and to minimize disruptions of
government, social, or economic
activities.’’ This generic IC requests the
authority to collect a wide array of data
from traditional and non-traditional
public health sources to assist in this
effort. This generic IC will enable CDC
to collect data during public health
emergencies (as the response is taking
place) and after public health
emergencies (as the recovery is taking
place) to aid response and recovery
efforts and to answer pre-determined
research questions. These data may be
used to inform our preparedness for
subsequent emergencies that may
potentially occur and also inform
decisions made by CDC Director.
All-hazards public health emergencies
are those events that are formally
declared emergencies by Federal, State
or local jurisdictions. Declarations can
be made by the Secretary of the
Department of Health and Human
Services (DHHS) under Section 319 of
the Public Health Service Act and at the
state or local levels by the Governor,
state public health officer, city or county
council or mayor and the local public
health officer respectively. During and
after these emergencies, assistance may
be needed to supplement State and local
efforts and capabilities to save lives and
to protect property and public health
and safety, or to lessen or avert the
threat of a catastrophe. Also, CDC may
have to assist the State and local, tribal,
and territorial levels of government with
critical data collection to support
immediate data needs for situational
awareness. Situational Awareness has
been defined as ‘‘the perception of
elements in the environment within a
volume of time and space, the
comprehension of their meaning, and
the projection of their status in the near
future.’’
A three-year OMB approval is
requested to allow CDC to collect data
during and after emergencies. Data
collected under this generic IC will use
a variety of data collection methods.
Some of the methods include but are not
limited to: Personal interviews,
telephone interviews, focus groups,
institutional record reviews, medical
record reviews, and paper or Internet
questionnaires and other secure
electronic data exchange. Each proposed
data collection submitted under this
generic IC will provide information
pertaining to that particular public
health emergency. Respondents will be
advised of the nature of the activity, the
length of time required for participation
and that their participation is voluntary.
There are no costs to respondents
except their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
General Public .................................................................................................
50,000
Total ..........................................................................................................
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Administration on Children, Youth and
Families
AGENCY: Family and Youth Services
Bureau, ACYF, ACF, HHS.
VerDate Nov<24>2008
14:59 Oct 02, 2009
Jkt 220001
ACTION: Notice to Award Five Expansion
Supplement Grants.
CFDA Number: 93.592.
Legislative Authority: The Family
Violence Prevention and Services Act,
42 U.S.C. 10401 through 10421, as
extended by the Department of Health
and Human Services Appropriations
Act, 2009, Public Law 111–8.
Total Amount of Awards: $400,000.
Project Period: September 30, 2009—
September 29, 2010.
SUMMARY: This notice announces the
award of expansion supplement grants
to five grantees under the Family and
Youth Services Bureau (FYSB)/Family
Violence Prevention and Services
Program. Expansion supplement awards
are made to four technical assistance
(TA) providers to support their capacity
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Frm 00046
Fmt 4703
Sfmt 4703
1
Average
burden per
response
(in hours)
Total
burden
(in hours)
50,000
Dated: September 26, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–23883 Filed 10–2–09; 8:45 am]
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Number of responses per
respondent
1
50,000
to enhance victim services by providing
more extensive TA to local domestic
violence programs and State domestic
violence coalitions under the Open
Doors to Safety: Capacity-Building Grant
(Capacity-Building) project. The
supplemental funds, coupled with the
TA providers’ expertise, will enable
Open Doors Safety Capacity-Building
project grantees to receive more training
and site-specific consultation, so that
they may build program capacity. The
awards will also support State-level
collaboration between domestic
violence organizations and child welfare
agencies. These combined efforts will
strengthen the ability of domestic
violence programs and their partners to
better serve survivors who have diverse
backgrounds, experiences, and abilities.
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Pages 51157-51158]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23883]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-09-09CV]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be
[[Page 51158]]
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology. Written
comments should be received within 60 days of this notice.
Proposed Project
All-Hazards Public Health Emergency Preparedness and Response
Generic Data Collection--New--Coordinating Office for Terrorism
Preparedness and Emergency Response (COTPER), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Data from agencies and individuals are needed to assist CDC in
responding to and planning for domestic and international all-hazards
public health emergencies. According to the glossary from the National
Response Framework Resource Center, ``all-hazards'' is defined as
``describing an incident, natural or manmade, that warrants action to
protect life, property, environment, and public health or safety, and
to minimize disruptions of government, social, or economic
activities.'' This generic IC requests the authority to collect a wide
array of data from traditional and non-traditional public health
sources to assist in this effort. This generic IC will enable CDC to
collect data during public health emergencies (as the response is
taking place) and after public health emergencies (as the recovery is
taking place) to aid response and recovery efforts and to answer pre-
determined research questions. These data may be used to inform our
preparedness for subsequent emergencies that may potentially occur and
also inform decisions made by CDC Director.
All-hazards public health emergencies are those events that are
formally declared emergencies by Federal, State or local jurisdictions.
Declarations can be made by the Secretary of the Department of Health
and Human Services (DHHS) under Section 319 of the Public Health
Service Act and at the state or local levels by the Governor, state
public health officer, city or county council or mayor and the local
public health officer respectively. During and after these emergencies,
assistance may be needed to supplement State and local efforts and
capabilities to save lives and to protect property and public health
and safety, or to lessen or avert the threat of a catastrophe. Also,
CDC may have to assist the State and local, tribal, and territorial
levels of government with critical data collection to support immediate
data needs for situational awareness. Situational Awareness has been
defined as ``the perception of elements in the environment within a
volume of time and space, the comprehension of their meaning, and the
projection of their status in the near future.''
A three-year OMB approval is requested to allow CDC to collect data
during and after emergencies. Data collected under this generic IC will
use a variety of data collection methods. Some of the methods include
but are not limited to: Personal interviews, telephone interviews,
focus groups, institutional record reviews, medical record reviews, and
paper or Internet questionnaires and other secure electronic data
exchange. Each proposed data collection submitted under this generic IC
will provide information pertaining to that particular public health
emergency. Respondents will be advised of the nature of the activity,
the length of time required for participation and that their
participation is voluntary.
There are no costs to respondents except their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Respondents respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
General Public.................................. 50,000 1 1 50,000
---------------------------------------------------------------
Total....................................... 50,000
----------------------------------------------------------------------------------------------------------------
Dated: September 26, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-23883 Filed 10-2-09; 8:45 am]
BILLING CODE 4163-18-P
