Proposed Data Collections Submitted for Public Comment and Recommendations, 27324-27325 [E9-13409]
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Federal Register / Vol. 74, No. 109 / Tuesday, June 9, 2009 / Notices
then 6 months afterwards. The survey
will assess outcome measures including,
but not limited to, changes in
knowledge, attitudes, beliefs, and
behaviors regarding various aspects of
fire safety and prevention; changes in
reported residential fire-related injuries
and deaths; increased or decreased
presence of functioning smoke alarms;
and the costs associated with the SAIFE
intervention. The evaluation will
measure these changes across time,
between groups and within groups,
among communities that will receive
the SAIFE intervention.
CDC programs are currently funded in
16 states to provide for home
installation of smoke alarms plus
general fire safety education in
households at high risk for fire and fire
related injury and death. Programs of
this type are intended to prevent fire
related injury and mortality, but have
not been studied scientifically to assess
their impact on fire-related injury
outcomes. The proposed study
represents the first formal effort to
evaluate the effectiveness and cost
implications of the SAIFE program as
implemented in North Carolina. The
data collected in this study will have
the potential to inform other smoke
alarm installation programs, as well as
indicate future priorities in prevention
and preparedness for residential
household fires. The only cost to the
participant is the time involved to
complete the surveys.
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
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
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.
Background and Brief Description
This project seeks a one year
extension of its OMB PRA clearance for
data collection. Due to early project
delays in obtaining clearances for data
collection, the project was unable to
start as planned and missed evaluating
one program cycle, with a program cycle
running for approximately one year.
This extension is necessary in order to
complete the projects original design of
evaluating three program cycles of the
SAIFE program as implemented in the
State of North Carolina. An extension
will allow completion of the evaluation
of the third and final cycle of the
program.
This project will use data from inperson interviews, paper and telephone
surveys to assess the effectiveness of the
Smoke Alarm Installation and Fire
Safety Education (SAIFE) program and
its efficacy in delivering fire safety
information. The data will be collected
from a convenience sample of adults 18
years of age or older who volunteer to
participate in the SAIFE program. A
total of 360 households will complete
the evaluation each year of the data
collection for a mass total of 1080
households over the next three years.
Participants will be asked to complete a
15-minute survey at two points, once
immediately before the intervention and
Proposed Project
Evaluation of the Effectiveness of the
Smoke Alarm Installation and Fire
Safety Education (SAIFE) Program—
Extension—National Center for Injury
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Estimated total
annual burden
(in hours)
Adult male and female (age 18+ years) screened ..........................................
Adult male and female (age 18+ years) Pre/Post Evaluation survey .............
Adult male and female (age 18+ years) household visit .................................
425
360
36
1
2
1
5/60
15/60
1
35
180
36
Total ..........................................................................................................
........................
........................
........................
251
Dated: June 3, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–13411 Filed 6–8–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[60Day–09–0780]
Centers for Disease Control and
Prevention
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
VerDate Nov<24>2008
14:45 Jun 08, 2009
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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 the CDC Reports
Clearance Officer at 404–639–5960 or
send comments to CDC/ATSDR
Assistant 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
E:\FR\FM\09JNN1.SGM
09JNN1
27325
Federal Register / Vol. 74, No. 109 / Tuesday, June 9, 2009 / Notices
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
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
National Survey of Residential Care
Facilities (NSRCF), (OMB No. 0920–
0780)—Revision— National Center for
Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, ‘‘shall collect
statistics on health resources * * *
[and] utilization of health care,
including extended care facilities, and
other institutions.’’
In 2008, NCHS sought approval for a
pretest and full survey of The National
Survey of Residential Care Facilities
(NSRCF). OMB approved only the
pretest which has been completed.
NCHS now seeks approval to collect the
full survey. The survey is designed to
complement data collected by other
federal surveys and to fill a significant
data gap about a major portion of the
long-term care population. Data from
NSRCF will provide information on
residential care facilities that
policymakers, providers, and
researchers can use to address a wide
array of policy and research questions.
The survey will utilize a computerassisted personal interviewing (CAPI)
system to collect information about
facility and resident characteristics.
This computerized system speeds the
flow of data and makes it possible to
release information on a timelier basis
and easier for respondents to participate
in the survey. The CAPI system may
also enhance data quality. Clearance for
two years is requested.
A stratified random sample of
residential care facilities across four
strata (small, medium, large and very
large) will be selected to participate in
NSRCF. Within each facility a random
sample of residents will be selected. To
be eligible a facility must be licensed,
registered, listed, certified, or otherwise
regulated by the State; provide room
and board with at least two meals a day;
provide around-the-clock on-site
supervision; help with activities of daily
living (e.g., bathing, eating, or dressing)
or medication supervision; serve
primarily an adult population; and have
at least four beds.
The facility questionnaire will collect
data about facility characteristics (e.g.,
size, age, types of rooms), services
offered, characteristics of the resident
population, facility policies and
services, charges for services, and
background of the director. The resident
questionnaire collects information on
resident demographics, current living
arrangements within the facility,
involvement in activities, use of
services, charges for care, health status,
and cognitive and physical functioning.
For the national survey, approximately
2,250 facilities will be surveyed for an
annual average of 1,125 facilities.
Information on an average of 4 residents
will be collected from an annual average
of 1,125 facility staff. Residents
themselves will not be interviewed.
Users of NSRCF data include, but are
not limited to CDC; other Department of
Health and Human Services (DHHS)
agencies, such as the Office of the
Assistant Secretary for Planning and
Evaluation and the Agency for
Healthcare Research and Quality; and
associations, such as the American
Association of Homes and Services for
the Aging, National Center for Assisted
Living, American Seniors Housing
Association, Assisted Living Federation
of America; universities; foundations;
and other private sector organizations.
There is no cost to respondents other
than their time to participate.
ESTIMATED ANNUALIZED BURDEN TABLE
Type of respondent
Facility
Facility
Facility
Facility
Facility
Director
Director
Director
Director
Director
Number of
respondents
Name of form
Average
burden/
response
(in hours)
Number of
responses/
respondent
Response
burden
in hours
.....................................
.....................................
.....................................
.....................................
or Staff Member ..........
Facility Screener ..................................
Resident Selection ...............................
Pre-Interview Worksheet ......................
Facility Questionnaire ...........................
Resident Questionnaire ........................
1125
1125
1125
1125
1125
1
1
1
1
4
10/60
10/60
15/60
1.25
20/60
188
188
281
1,406
1,500
Total ...............................................
...............................................................
......................
......................
......................
3,563
Dated: June 3, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Office of
the Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–13409 Filed 6–8–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0148] (formerly
Docket No. 2007D–0493)
International Conference on
Harmonisation; Guidance on Q8(R1)
Pharmaceutical Development; Addition
of Annex; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Nov<24>2008
14:45 Jun 08, 2009
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Notice.
Frm 00050
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Sfmt 4703
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Q8(R1) Pharmaceutical Development.’’
The guidance was prepared under the
auspices of the International Conference
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The ICH Q8(R1) guidance includes the
previously published parent guidance
entitled ‘‘Q8 Pharmaceutical
Development’’ (Q8 parent guidance) (71
FR 29344; May 22, 2006) and a newly
added annex. The annex provides
E:\FR\FM\09JNN1.SGM
09JNN1
]]>Agencies
[Federal Register Volume 74, Number 109 (Tuesday, June 9, 2009)]
[Notices]
[Pages 27324-27325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13409]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-09-0780]
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 the CDC Reports
Clearance Officer at 404-639-5960 or send comments to CDC/ATSDR
Assistant 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
[[Page 27325]]
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 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
National Survey of Residential Care Facilities (NSRCF), (OMB No.
0920-0780)--Revision-- National Center for Health Statistics (NCHS),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, ``shall collect statistics on
health resources * * * [and] utilization of health care, including
extended care facilities, and other institutions.''
In 2008, NCHS sought approval for a pretest and full survey of The
National Survey of Residential Care Facilities (NSRCF). OMB approved
only the pretest which has been completed. NCHS now seeks approval to
collect the full survey. The survey is designed to complement data
collected by other federal surveys and to fill a significant data gap
about a major portion of the long-term care population. Data from NSRCF
will provide information on residential care facilities that
policymakers, providers, and researchers can use to address a wide
array of policy and research questions. The survey will utilize a
computer-assisted personal interviewing (CAPI) system to collect
information about facility and resident characteristics. This
computerized system speeds the flow of data and makes it possible to
release information on a timelier basis and easier for respondents to
participate in the survey. The CAPI system may also enhance data
quality. Clearance for two years is requested.
A stratified random sample of residential care facilities across
four strata (small, medium, large and very large) will be selected to
participate in NSRCF. Within each facility a random sample of residents
will be selected. To be eligible a facility must be licensed,
registered, listed, certified, or otherwise regulated by the State;
provide room and board with at least two meals a day; provide around-
the-clock on-site supervision; help with activities of daily living
(e.g., bathing, eating, or dressing) or medication supervision; serve
primarily an adult population; and have at least four beds.
The facility questionnaire will collect data about facility
characteristics (e.g., size, age, types of rooms), services offered,
characteristics of the resident population, facility policies and
services, charges for services, and background of the director. The
resident questionnaire collects information on resident demographics,
current living arrangements within the facility, involvement in
activities, use of services, charges for care, health status, and
cognitive and physical functioning. For the national survey,
approximately 2,250 facilities will be surveyed for an annual average
of 1,125 facilities. Information on an average of 4 residents will be
collected from an annual average of 1,125 facility staff. Residents
themselves will not be interviewed.
Users of NSRCF data include, but are not limited to CDC; other
Department of Health and Human Services (DHHS) agencies, such as the
Office of the Assistant Secretary for Planning and Evaluation and the
Agency for Healthcare Research and Quality; and associations, such as
the American Association of Homes and Services for the Aging, National
Center for Assisted Living, American Seniors Housing Association,
Assisted Living Federation of America; universities; foundations; and
other private sector organizations. There is no cost to respondents
other than their time to participate.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden/ Response
Type of respondent Name of form respondents responses/ response (in burden in
respondent hours) hours
----------------------------------------------------------------------------------------------------------------
Facility Director................. Facility Screener... 1125 1 10/60 188
Facility Director................. Resident Selection.. 1125 1 10/60 188
Facility Director................. Pre-Interview 1125 1 15/60 281
Worksheet.
Facility Director................. Facility 1125 1 1.25 1,406
Questionnaire.
Facility Director or Staff Member. Resident 1125 4 20/60 1,500
Questionnaire.
-------------------------------------------------------
Total......................... .................... ............ ............ ............ 3,563
----------------------------------------------------------------------------------------------------------------
Dated: June 3, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Office of the Chief Science Officer,
Centers for Disease Control and Prevention.
[FR Doc. E9-13409 Filed 6-8-09; 8:45 am]
BILLING CODE 4163-18-P
