GenIC Request - HMTS Expedited Review

HMTS Expedited Review Form_OMB_Evaluation of Emergency Use Fact Sheets Regarding Medical Countermeasures 04FEB2019.pdf

CDC and ATSDR Health Message Testing System

GenIC Request - HMTS Expedited Review

OMB: 0920-0572

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Health Message Testing System Expedited Review Form
1. Title of Study: (Please append screener and questionnaire)

Evaluation of Emergency Use Fact Sheets Regarding Medical Countermeasures – Comprehension
Evaluation/Message Testing
2. Study Population: (Discuss study population and explain how they will be selected/recruited.)

General inclusion/exclusion requirements built into the screening protocol will ensure that participants
have not previously, nor do they currently, practice medicine, and have not participated in a research
interview and/or focus group within the last three months.
Respondent characteristics:
Number of subject: 190

Number of males:

47 (to online IDI)

Age range: 18-99

Number of females: 48 (to online IDI)

Racial/ethnic composition: All races and ethnicities are included
Special group status: (e.g., risk group, health care providers)
Type of group(s): General population of non-physician/medical/public health trained
adults
Geographic location(s): All of the United States

3. Incentives: (State what incentive will be offered and justify proposed incentives to be used in study.)

We will offer an incentive of $40 to participants for a 60-minute remote interview session. The $40
incentive encourages participation in a manner that reduces the likelihood of no-shows and increased
recruiting efforts and costs.

4. Study method: (Please check one below)
Central location intercept interview:
Online Interview:
Telephone interview:
Other (describe):

Focus group:
Individual in-depth interview (cognitive interview):

(CATI used: yes or no):

5. Purpose of the overall communication effort into which this health message(s) will fit:
(Please provide 2-3 sentences below.)

The Centers for Disease Control and Prevention (CDC) leads preparedness and responses to public health
emergencies, particularly infectious diseases or threat agents (e.g., acts of bioterrorism, pandemic
influenza) that may affect the public. The CDCs medical countermeasures (MCMs) fact sheets, describe
medical products that can prevent, treat, and mitigate these types of diseases and threats and include agents
such antimicrobials, antitoxins, and vaccines, as well as devices and personal protective equipment.
6. Category of time sensitivity: (Please check one below)
Health emergency:
Time-limited audience access:
Press coverage correction:
Time-limited congressional/administrative mandate:
Trend Tracking
Ineffective existing materials due to historical event/social trends:
7. Describe nature of time sensitivity: (Please provide 2-3 sentences below.)
This study is aimed at addressing/evaluating documents needed in time of health emergencies. These
outbreaks or epidemics could happen at any time and this study is to help ensure comprehension of
information being provided to the general public.

8. Number of burden hours requested: 119

BURDEN HOURS
No. of
Participation
Respondents Time

Category of Respondent

Burden

All Adults [Screener - (5 min)]

190

5 min

15.83 hrs

Non-medically/PH trained Adults [Consent form (5 min) & Interview (60 min)]

95

65 min

102.91 hrs

190

70 min

118.75 hrs

Totals
9. Are you using questions from the approved question bank?

Yes

If yes, please list the item number(s) for questions used from the question bank separated by a comma.
(e.g., 1a, 3c, 130d)
Screener: 2b, 4a, 5a, 6a, 8a, 13a

*** Items below to be completed by Office of Associate Director for Communication (OADC)***
1. Number of burden hours remaining in current year's allocation: 7210
2. OADC confirmation of time-sensitivity:
Yes:
No:

Dawn Beatrice Griffin
Project Officer
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