Proposed Data Collections Submitted for Public Comment and Recommendations, 30297-30298 [E9-14989]
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Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Notices
administered or dispensed. Additional
persons who are qualified persons
pursuant to section 319F–3(i)(8)(B) are
the following: None.
VII. Additional Time Periods of
Coverage After Expiration of
Declaration (as Required by Section
319F–3(b)(3)(B) of the Act)
A. I have determined that, upon
expiration of the applicable time period
specified in Section III above, an
additional twelve (12) months is a
reasonable period to allow for the
manufacturer to arrange for disposition
of the Covered Countermeasure,
including the return of such product to
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).
sroberts on PROD1PC70 with NOTICES
VIII. Amendments
The Declaration for the Use of the
Public Readiness and Emergency
Preparedness Act for H5N1 vaccines
was published on January 26, 2007 and
amended on November 30, 2007 to add
H7 and H9 vaccines and on October 17,
2008 to add H2 and H6 vaccines. 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.
IX. Definitions
For the purposes of this declaration,
‘‘pre-pandemic phase’’ means 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. For the purposes of this
declaration, ‘‘pandemic phase’’ means
the following stages, as defined in the
VerDate Nov<24>2008
16:25 Jun 24, 2009
Jkt 217001
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.
Dated: June 15, 2009.
Kathleen Sebelius,
Secretary.
Appendix
I. List of U.S. Government Contracts—
Covered H5N1 Vaccine Contracts
[January 26, 2007]
1. HHSN266200400031C
2. HHSN266200400032C
3. HHSN266200300039C
4. HHSN266200400045C
5. HHSN266200205459C
6. HHSN266200205460C
7. HHSN266200205461C
8. HHSN266200205462C
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
[FR Doc. E9–14948 Filed 6–24–09; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–09–09BX]
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.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
30297
Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road,
NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by 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 a
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
clarify of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
Clostridium difficile Infection (CDI)
Surveillance—New—National Center for
Preparedness, Detection, and Control of
Infectious Diseases (NCPDCID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Steady increases in the rate and
severity of Clostridium difficile infection
(CDI) indicate a clear need to conduct
longitudinal assessments of the impact
of CDI in the United States. C. difficile
is an anaerobic, spore-forming, gram
positive bacillus that produces two
pathogenic toxins: A and B. CDI ranges
in severity from mild diarrhea to
fulminant colitis and death.
Transmission of C. difficile occurs
primarily in healthcare facilities, where
environmental contamination by C.
difficile spores and exposure to
antimicrobial drugs are common. No
longer limited to healthcare
environments, community-associated
CDI is the focus of increasing attention.
Recently, several cases of serious CDI
have been reported in what have been
considered low-risk populations,
including healthy persons living in the
community and peri-partum women.
For this proposed data collection, the
surveillance population will consist of
persons residing in the catchment area
of the participating Emerging Infections
Program (EIP) sites. This surveillance
poses no more than minimal risk to the
study participants as there will be no
interventions or modifications to the
care study participants receive. EIP
surveillance personnel will perform
active case finding from laboratory
reports of stool specimens testing
E:\FR\FM\25JNN1.SGM
25JNN1
30298
Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Notices
positive for C. difficile toxin and
abstract data on cases using a
standardized case report form. For a
subset of cases (e.g., communityassociated C. difficile cases) sites will
administer a health interview. Remnant
stool specimens from cases testing
positive for C. difficile toxin will be
submitted to reference laboratories for
culturing, and isolates will be sent to
CDC for confirmation and molecular
typing. Outcomes of this surveillance
project will include the populationbased incidence of community- and
healthcare-associated CDI among
participating EIP sites, characterization
of C. difficile strains that are responsible
for CDI in the population under
surveillance with a focus on strains
from community-associated cases, a
description of the epidemiology of
community- and healthcare-associated
CDI, and hypothesis-generation for
future activities using EIP CDI
surveillance infrastructure.
The proposed surveillance for CDI
through the Emerging Infections
Program will expand CDC capacity to
monitor incidence of C. difficile in
community and healthcare settings as
well as to monitor and detect
antimicrobial resistance. This activity
supports the HHS Action Plan for
elimination of healthcare-associated
infections.
CDC estimates that a total of 7,650
CDI Surveillance Case Report Forms
(CRFs) will be completed during a oneyear study period on incident CDI cases
within the EIP catchment area.
Approximately 3,825 cases will require
a completed CRF; the remaining 3,825
cases will only require a partially
completed CRF. CDC estimates that
1,700 CDI Surveillance Health
Interviews (HI) will be completed
during a one-year study period.
Surveillance Officers at the EIP sites
will complete and submit the case
report forms and health interviews.
There are no costs to respondents.
ESTIMATES OF ANNUALIZED BURDEN
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Respondents
CDI Surveillance Case Report
Form—Complete.
CDI Surveillance Case Report
Form—Partial.
CDI Surveillance Health Interview ....
EIP Surveillance Officer ...................
10
383
1
3,830
EIP Surveillance Officer ...................
10
382
15/60
955
EIP Surveillance Officer ...................
10
170
45/60
1,275
Total ...........................................
...........................................................
........................
........................
........................
6,060
Dated: June 17, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–14989 Filed 6–24–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
sroberts on PROD1PC70 with NOTICES
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
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
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16:25 Jun 24, 2009
Jkt 217001
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (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
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.
Proposed Project: HRSA/Bureau of
Primary Health Care Capital
Improvement Program Application
Electronic Health Records (EHR)
Readiness Checklist (OMB No. 0915–
0325)—Extension
The American Recovery and
Reinvestment Act (ARRA) provides $1.5
billion in grants to support
‘‘construction, renovation and
equipment’’, and ‘‘the acquisition of
health information technology systems,
for health centers including health
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Frm 00035
Fmt 4703
Sfmt 4703
center controlled networks receiving
operating grants under section 330’’ of
the Public Health Service (PHS) Act, as
amended (42 U.S.C. 254b). HRSA is
requesting extension of the approval of
the Electronic Health Records (EHR)
Readiness Checklist portion of the
application where applicants must
provide information to demonstrate
readiness for electronic health records if
they propose to use funds for electronic
health record (EHR) related purchases.
Of the $1.5 billion, HRSA will award
approximately $850 million, through
limited competition grants, for one-time
Capital Improvement Program (CIP)
grant funding in fiscal year (FY) 2009 to
support existing section 330 funded
health centers. Funding under this
opportunity will address pressing
capital improvement needs in health
centers, such as construction, repair,
renovation, and equipment purchases,
including health information technology
systems. Applicants must provide
information using the EHR Readiness
Checklist that demonstrates
comprehensive planning and readiness
for implementing EHRs.
The estimated annual burden is as
follows:
E:\FR\FM\25JNN1.SGM
25JNN1
Agencies
[Federal Register Volume 74, Number 121 (Thursday, June 25, 2009)]
[Notices]
[Pages 30297-30298]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14989]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-09-09BX]
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.
Alternatively, to obtain a copy of the data collection plans and
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar,
CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta,
Georgia 30333; comments may also be sent by 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 a 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 clarify of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of information technology. Written comments
should be received within 60 days of this notice.
Proposed Project
Clostridium difficile Infection (CDI) Surveillance--New--National
Center for Preparedness, Detection, and Control of Infectious Diseases
(NCPDCID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Steady increases in the rate and severity of Clostridium difficile
infection (CDI) indicate a clear need to conduct longitudinal
assessments of the impact of CDI in the United States. C. difficile is
an anaerobic, spore-forming, gram positive bacillus that produces two
pathogenic toxins: A and B. CDI ranges in severity from mild diarrhea
to fulminant colitis and death. Transmission of C. difficile occurs
primarily in healthcare facilities, where environmental contamination
by C. difficile spores and exposure to antimicrobial drugs are common.
No longer limited to healthcare environments, community-associated CDI
is the focus of increasing attention. Recently, several cases of
serious CDI have been reported in what have been considered low-risk
populations, including healthy persons living in the community and
peri-partum women.
For this proposed data collection, the surveillance population will
consist of persons residing in the catchment area of the participating
Emerging Infections Program (EIP) sites. This surveillance poses no
more than minimal risk to the study participants as there will be no
interventions or modifications to the care study participants receive.
EIP surveillance personnel will perform active case finding from
laboratory reports of stool specimens testing
[[Page 30298]]
positive for C. difficile toxin and abstract data on cases using a
standardized case report form. For a subset of cases (e.g., community-
associated C. difficile cases) sites will administer a health
interview. Remnant stool specimens from cases testing positive for C.
difficile toxin will be submitted to reference laboratories for
culturing, and isolates will be sent to CDC for confirmation and
molecular typing. Outcomes of this surveillance project will include
the population-based incidence of community- and healthcare-associated
CDI among participating EIP sites, characterization of C. difficile
strains that are responsible for CDI in the population under
surveillance with a focus on strains from community-associated cases, a
description of the epidemiology of community- and healthcare-associated
CDI, and hypothesis-generation for future activities using EIP CDI
surveillance infrastructure.
The proposed surveillance for CDI through the Emerging Infections
Program will expand CDC capacity to monitor incidence of C. difficile
in community and healthcare settings as well as to monitor and detect
antimicrobial resistance. This activity supports the HHS Action Plan
for elimination of healthcare-associated infections.
CDC estimates that a total of 7,650 CDI Surveillance Case Report
Forms (CRFs) will be completed during a one-year study period on
incident CDI cases within the EIP catchment area. Approximately 3,825
cases will require a completed CRF; the remaining 3,825 cases will only
require a partially completed CRF. CDC estimates that 1,700 CDI
Surveillance Health Interviews (HI) will be completed during a one-year
study period. Surveillance Officers at the EIP sites will complete and
submit the case report forms and health interviews. There are no costs
to respondents.
Estimates of Annualized Burden
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
CDI Surveillance Case Report EIP Surveillance 10 383 1 3,830
Form--Complete. Officer.
CDI Surveillance Case Report EIP Surveillance 10 382 15/60 955
Form--Partial. Officer.
CDI Surveillance Health EIP Surveillance 10 170 45/60 1,275
Interview. Officer.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 6,060
----------------------------------------------------------------------------------------------------------------
Dated: June 17, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-14989 Filed 6-24-09; 8:45 am]
BILLING CODE 4163-18-P