Agency Forms Undergoing Paperwork Reduction Act Review, 55393-55394 [2011-22788]

Download as PDF 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
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