[Federal Register Volume 71, Number 36 (Thursday, February 23, 2006)]
[Notices]
[Pages 9346-9348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2583]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-06-06AR]


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-

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mail to [email protected]. Send written comments to CDC Desk Officer, Office 
of Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Home Medkit Evaluation Study (HoME Study)--New--Coordinating Office 
for Terrorism Preparedness and Emergency Response (COTPER), Centers for 
Disease Control and Prevention (CDC).
    The Coordinating Office for Terrorism Preparedness and Emergency 
Response (COTPER), Centers for Disease Control and Prevention (CDC) 
proposes to conduct a one-time-only study called the Home Medkit 
Evaluation Study (HoME Study). This pilot study will be conducted with 
selected St. Louis, Missouri area households who volunteer. Volunteers 
would receive in their homes FDA-approved medicines that are to be 
reserved for emergency use in the event of specific public health 
emergency conditions resulting from a bioterrorist threat.
    The proposed study will provide data on the extent to which people 
with diverse backgrounds are able to follow instructions concerning 
appropriate storage and to reserve the medicine for emergency use only.
    Approximately, 5,000 volunteer households will be recruited in the 
St. Louis, Missouri metropolitan area, and divided among three cohorts: 
(a) Public health emergency responders and their household members, (b) 
employees of a large corporate operation and their household members, 
and (c) clients of publicly-funded primary healthcare centers, their 
households, and surrounding community households.
    All will be medically screened for eligibility to receive a home 
MedKit and, if eligible, they will be recruited and enrolled for study 
participation with informed consent. After an initial in-person 
baseline interview, they will receive a MedKit bag with an antibiotic 
enclosed. The MedKit bag will consist of a transparent mylar, tamper-
evident sealed bag with FDA-approved patient instructions affixed to 
the outside and individual MedKits--cardboard notebook blister packs 
with doses for each household member and patient instructions, 
including FDA-approved crushing instructions for administration of 
emergency pediatric doses.
    The information collected from this study will be used to: (1) 
Assess the ability of volunteers from select populations to store and 
maintain household MedKits as directed and to refrain from 
inappropriate use; (2) explore attitudes, perceptions, and other social 
and psychological factors that influence participant behavior in 
relation to the MedKit; and (3) inform policy makers and national 
planners about the acceptability, safety, durability, and usefulness of 
the household MedKit strategy and supporting documentation.
    There are no previous or existing studies to provide the specific 
information to answer the research questions proposed in the HoME 
Study. There are no costs to the respondents other than their time. The 
total annualized burden hours are 7,253.

                                        Estimated Annualized Burden Hours
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                                                                     Number of     Frequency  of     Hours per
                  Form type/respondent category                     Respondents      response        response
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BEHAVIORAL STUDY:
    Recruiting HH Contacts......................................          20,000               1            2/60
    Prescreening & HH Roster....................................           4,914               1            5/60
Medical Screening:
    PH 1st responder HHs........................................           3,800               1           15/60
    Large business partner HHs..................................           3,800               1           15/60
    CHC client HHs..............................................           3,800               1           15/60
Baseline Questionnaire:
    PH 1st responder HHs........................................           1,227               1           20/60
    Large business partner HHs..................................           1,282               1           20/60
    PHC client HHs..............................................           1,430               1           20/60
Follow-Up Questionnaire:
    PH 1st responder HHs........................................           1,227               1           25/60
    Large business partner HHs..................................           1,282               1           25/60
    PHC client HHs..............................................           1,430               1           25/60
NESTED QUALITATIVE STUDIES: Screening & Recruitment calls:
    Study HHs focus groups......................................             180               1            5/60
    Non-English speakers focus groups...........................              40  ..............           15/60
    In-depth Interview..........................................              80               1            5/60
Focus Groups:
    PH 1st responders...........................................              40               1               2
    Large business partner employees............................              40               1               2
    PHC client..................................................              40               1               2
    Non-English speakers........................................              20               1               2
    In-depth Interviews.........................................              60               1              1
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Notes for Table A.12.1: HH=Household; PHC=Public Health Clinic.



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    Dated: February 15, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E6-2583 Filed 2-22-06; 8:45 am]
BILLING CODE 4163-18-P