Agency Forms Undergoing Paperwork Reduction Act Review, 55393-55394 [2011-22788]
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55393
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
1.
2.
3.
4.
5.
Number of
responses per
respondent
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total
burden
hours
Screener Respondents ................................................................................
Interview Females .......................................................................................
Interview Males ............................................................................................
Verification Questions ..................................................................................
Testing questions ........................................................................................
14,000
2,750
2,250
1,400
250
1
1
1
1
1
3/60
1.5
1.0
5/60
1
700
4,125
2,250
117
250
Total ..........................................................................................................
........................
........................
........................
7,442
Dated: August 31, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–22790 Filed 9–6–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–11–11AO]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Children’s Health After the Storms
(CHATS)—New—National Center for
Environmental Health (NCEH) and
Agency for Toxic Substances and
Disease Registry (ATSDR)/Centers for
Disease Control and Prevention (CDC).
emcdonald on DSK5VPTVN1PROD with NOTICES
Background and Brief Description
This project involves research to
assess the potential adverse health
effects among children who resided in
Federal Emergency Management Agency
(FEMA)-provided temporary housing
units deployed in the Gulf Coast region
VerDate Mar<15>2010
17:37 Sep 06, 2011
Jkt 223001
following hurricanes Katrina and Rita.
The title of this study has changed since
publication of the initial 60-day Federal
Register Notice (FRN) (previous title
‘‘The Gulf Coast Children’s Health
Study’’); however, the goals remain the
same.
The Children’s Health Study After the
Storms (CHATS) addresses an important
public health need to assess the
potential short-term and long-term
health effects among children who lived
in FEMA-provided temporary housing
units following hurricanes Katrina and
Rita, and who were potentially exposed
to higher levels of indoor air pollutants
such as formaldehyde and other volatile
organic compounds compared to other
types of housing. These health effects
may include adverse acute and chronic
health conditions, primarily respiratory
and dermal, that may be associated with
their exposures. Plans involve a twoyear Feasibility Study to investigate the
association between exposure to
temporary housing units and health
conditions and to assess the practicality
of conducting a larger longitudinal
study. If certain feasibility objectives are
met, such as identifying a sufficient
number of eligible participants, a 6-year
Full Study will be conducted following
the same study design as the Feasibility
Study.
The Feasibility Study will be
conducted in the states of Louisiana and
Mississippi. The study will assess the
potential health impacts from exposures
to various indoor pollutants (e.g.,
formaldehyde and other volatile organic
compounds and plasticizers, including
phthalates) commonly found in higher
concentrations in the temporary housing
units compared with other types of
housing.
In the study, a 1:1 ratio of exposed
and unexposed children age 3–15 years
will be recruited. Children who resided
in temporary housing units will be
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
categorized into the ‘‘exposed’’ group
and children who did not reside in
temporary housing units will be
categorized into the ‘‘unexposed’’ group.
A screening questionnaire will be used
to assess eligibility and exposure to
temporary housing units. The screening
questionnaire will be conducted with
one adult resident of each selected
household. Based on responses to the
screening questions, one eligible child
will be selected for the study from each
participating household. To obtain the
desired sample size, we plan to screen
2,236 households in order to identify
625 eligible children. Of these, it is
expected that 80%, or 500 children, will
agree to participate in the study.
The Feasibility Study will involve a
baseline and a 6-month follow-up
assessment for each participant, and
each assessment is divided into two
sessions. The baseline assessment will
include a health questionnaire, clinical
assessment including biological sample
collection, and environmental exposure
measurement. The environmental
exposure assessment will be collecting
biomarkers of exposure and measuring
exposures to environmental pollutants
using personal and indoor sampling
devices over a 7-day period. In the 6month follow-up assessment, a shorter
version of the health questionnaire and
the same clinical and environmental
exposure assessments will be
conducted.
Accounting for a 10% loss to followup, the sample size for the 6-month
follow-up assessment is projected to be
450 children. If a determination is made
to conduct the Full Study, these 450
children will be part of the Full Study
and continue to participate in the rest of
follow-up assessments.
There is no cost to the participants
except their time. The total estimated
annual burden hours are 1,310.
E:\FR\FM\07SEN1.SGM
07SEN1
55394
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name or module
Household member 18 yrs or older ................
Children ages 3–15 .........................................
Eligibility Screener ..........................................
Baseline: Session 1 .......................................
(Child Modules) ..............................................
Baseline: Session 1 (Parent Modules) ..........
Baseline: Session 2 .......................................
(Child Modules) ..............................................
Baseline: Session 2 .......................................
(Parent Modules) ............................................
6-month Follow-up: Session 1 (Child Modules).
6-month Follow-up: Session 1 (Parent Modules).
6-month Follow-up: Session 2 (Child Modules).
6-month Follow-up: Session 2 (Parent Modules).
Verification Questionnaire for Eligibility
Screener (10% subsample).
Verification Questionnaire for Baseline and
6-month Follow-up Visits (9% subsample).
Mail Verification Form for Baseline and 6month Follow-up Visits (1% subsample).
Parents of children ages 3–15 ........................
Children ages 3–15 .........................................
Parents of children ages 3–15 ........................
Children ages 3–15 .........................................
Parents of children ages 3–15 ........................
Children ages 3–15 .........................................
Parents of children ages 3–15 ........................
Household member 18 yrs or older ................
Household member 18 yrs or older ................
Household member 18 yrs or older ................
Dated: August 30, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)
announces the next meeting of the
Community Preventive Services Task
Force (Task Force). The Task Force—an
independent, nonfederal body of
nationally known leaders in public
health practice, policy, and research
who are appointed by the CDC
Director—was convened in 1996 by the
Department of Health and Human
Services (HHS) to assess the
effectiveness of community,
environmental, population, and
healthcare system interventions in
public health and health promotion.
During this meeting, the Task Force will
consider the findings of systematic
reviews and issue recommendations and
emcdonald on DSK5VPTVN1PROD with NOTICES
Jkt 223001
1
1
10/60
15/60
250
250
1
1
1
1
250
1
30/60
225
1
7/60
225
1
40/60
225
1
37/60
225
1
30/60
112
1
2/60
43
1
5/60
5
1
5/60
findings to help inform decision making
about policy, practice, and research in a
wide range of U.S. settings. The Task
Force’s recommendations, along with
the systematic reviews of the scientific
evidence on which they are based, are
compiled in the Guide to Community
Preventive Services (Community Guide).
practice, and research in a wide range
of U.S. settings.
Matters to be discussed: Updates on
Tobacco, Skin Cancer, Health Equity
and Cardiovascular Disease.
Meeting Accessibility: This meeting is
open to the public, limited only by
space availability.
Dated: August 25, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
The Task Force Meeting
will be held at the Centers for Disease
Control and Prevention, Century Center,
2500 Century Parkway, Conference
Rooms 1200/1201, Atlanta, Georgia
30345. Information regarding logistics
will be available on the Community
Guide Web site (https://
www.thecommunityguide.org),
Wednesday, September 14, 2011.
[FR Doc. 2011–22801 Filed 9–6–11; 8:45 am]
ADDRESSES:
Meeting of the Task Force on
Community Preventive Services
17:37 Sep 06, 2011
1,118
250
The meeting will be held on
Monday, October 3, 2011 from 8:30 a.m.
to 5:30 p.m., EST and Tuesday, October
4, 2011 from 8:30 a.m. to 1 p.m. EST.
BILLING CODE 4163–18–P
VerDate Mar<15>2010
Average
burden per
response
(in hours)
DATES:
[FR Doc. 2011–22788 Filed 9–6–11; 8:45 am]
SUMMARY:
Number of
responses per
respondent
Number of
respondents
Respondent
FOR FURTHER INFORMATION CONTACT:
Linda Shelton, The Community Guide
Branch, Epidemiology and Analysis
Program Office, Office of Surveillance,
Epidemiology, and Laboratory Services,
Centers for Disease Control and
Prevention, 1600 Clifton Road, MS–E–
69, Atlanta, Georgia 30333, phone: (404)
498–1194), e-mail:
communityguide@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The purpose of the meeting
is for the Task Force to consider the
findings of systematic reviews and issue
recommendations and findings to help
inform decision making about policy,
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0619]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
SUMMARY:
E:\FR\FM\07SEN1.SGM
07SEN1
Agencies
[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55393-55394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-11-11AO]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this
notice.
Proposed Project
Children's Health After the Storms (CHATS)--New--National Center
for Environmental Health (NCEH) and Agency for Toxic Substances and
Disease Registry (ATSDR)/Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
This project involves research to assess the potential adverse
health effects among children who resided in Federal Emergency
Management Agency (FEMA)-provided temporary housing units deployed in
the Gulf Coast region following hurricanes Katrina and Rita. The title
of this study has changed since publication of the initial 60-day
Federal Register Notice (FRN) (previous title ``The Gulf Coast
Children's Health Study''); however, the goals remain the same.
The Children's Health Study After the Storms (CHATS) addresses an
important public health need to assess the potential short-term and
long-term health effects among children who lived in FEMA-provided
temporary housing units following hurricanes Katrina and Rita, and who
were potentially exposed to higher levels of indoor air pollutants such
as formaldehyde and other volatile organic compounds compared to other
types of housing. These health effects may include adverse acute and
chronic health conditions, primarily respiratory and dermal, that may
be associated with their exposures. Plans involve a two-year
Feasibility Study to investigate the association between exposure to
temporary housing units and health conditions and to assess the
practicality of conducting a larger longitudinal study. If certain
feasibility objectives are met, such as identifying a sufficient number
of eligible participants, a 6-year Full Study will be conducted
following the same study design as the Feasibility Study.
The Feasibility Study will be conducted in the states of Louisiana
and Mississippi. The study will assess the potential health impacts
from exposures to various indoor pollutants (e.g., formaldehyde and
other volatile organic compounds and plasticizers, including
phthalates) commonly found in higher concentrations in the temporary
housing units compared with other types of housing.
In the study, a 1:1 ratio of exposed and unexposed children age 3-
15 years will be recruited. Children who resided in temporary housing
units will be categorized into the ``exposed'' group and children who
did not reside in temporary housing units will be categorized into the
``unexposed'' group. A screening questionnaire will be used to assess
eligibility and exposure to temporary housing units. The screening
questionnaire will be conducted with one adult resident of each
selected household. Based on responses to the screening questions, one
eligible child will be selected for the study from each participating
household. To obtain the desired sample size, we plan to screen 2,236
households in order to identify 625 eligible children. Of these, it is
expected that 80%, or 500 children, will agree to participate in the
study.
The Feasibility Study will involve a baseline and a 6-month follow-
up assessment for each participant, and each assessment is divided into
two sessions. The baseline assessment will include a health
questionnaire, clinical assessment including biological sample
collection, and environmental exposure measurement. The environmental
exposure assessment will be collecting biomarkers of exposure and
measuring exposures to environmental pollutants using personal and
indoor sampling devices over a 7-day period. In the 6-month follow-up
assessment, a shorter version of the health questionnaire and the same
clinical and environmental exposure assessments will be conducted.
Accounting for a 10% loss to follow-up, the sample size for the 6-
month follow-up assessment is projected to be 450 children. If a
determination is made to conduct the Full Study, these 450 children
will be part of the Full Study and continue to participate in the rest
of follow-up assessments.
There is no cost to the participants except their time. The total
estimated annual burden hours are 1,310.
[[Page 55394]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondent Form name or module respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Household member 18 yrs or older...... Eligibility Screener.... 1,118 1 10/60
Children ages 3-15.................... Baseline: Session 1..... 250 1 15/60
(Child Modules).........
Parents of children ages 3-15......... Baseline: Session 1 250 1 1
(Parent Modules).
Children ages 3-15.................... Baseline: Session 2..... 250 1 1
(Child Modules).........
Parents of children ages 3-15......... Baseline: Session 2..... 250 1 30/60
(Parent Modules)........
Children ages 3-15.................... 6-month Follow-up: 225 1 7/60
Session 1 (Child
Modules).
Parents of children ages 3-15......... 6-month Follow-up: 225 1 40/60
Session 1 (Parent
Modules).
Children ages 3-15.................... 6-month Follow-up: 225 1 37/60
Session 2 (Child
Modules).
Parents of children ages 3-15......... 6-month Follow-up: 225 1 30/60
Session 2 (Parent
Modules).
Household member 18 yrs or older...... Verification 112 1 2/60
Questionnaire for
Eligibility Screener
(10% subsample).
Household member 18 yrs or older...... Verification 43 1 5/60
Questionnaire for
Baseline and 6-month
Follow-up Visits (9%
subsample).
Household member 18 yrs or older...... Mail Verification Form 5 1 5/60
for Baseline and 6-
month Follow-up Visits
(1% subsample).
----------------------------------------------------------------------------------------------------------------
Dated: August 30, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-22788 Filed 9-6-11; 8:45 am]
BILLING CODE 4163-18-P