E6-2583. Agency Forms Undergoing Paperwork Reduction Act Review

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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

Form type/respondent category	Number of Respondents	Frequency of response	Hours per response
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
Notes for Table A.12.1: HH=Household; PHC=Public Health Clinic.

Dated: February 15, 2006.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.