Nonsub change request memo

0885 Nonsub change request memo 2021.docx

Study of Oncology Indications in Direct-to-Consumer Television Advertising

Nonsub change request memo

OMB: 0910-0885

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UNITED STATES FOOD & DRUG ADMINISTRATION


Study of Oncology Indications in Direct-to-Consumer Television Advertising


OMB Control Number: 0910-0885



Non-substantive Change Request:


Based on cognitive interviews and pretesting, we made several revisions to the study materials.


  1. We revised the screener to include a “prefer not to answer” option for the questions about sex, ethnicity, race, and education (see revised Appendix G).


  1. We revised the Study 1 questionnaire: we revised the wording for the instructions and several items (Q2, Q3_E, Q5, Q7-Q10a, Q11, Q11b, Q20, and Q23) and deleted several others (Q10b, Q19, Q21, and Q22; see revised Appendix C).


  1. We revised the Study 2 questionnaire: we revised the wording for the instructions and several items (Q2b-Q4, Q10, Q11, Q13, and Q22a) and deleted several others (Q2, Q5-Q8, Q12b, Q101a, Q101b, Q19, and Q22c; see revised Appendix D).


  1. We revised the consent form to reflect the change from an estimated 20-minute survey to an estimated 15-minute survey (see revised Appendix A and revised burden chart below).


In addition to these revisions, we updated the burden chart to reflect the actual pretest burden and the revised estimated burden for the main studies. We revised the main study estimates based on (1) shorter survey time seen in the pretest (an average burden of 15 minutes per person); and (2) an anticipated increase in the number of respondents to be screened and to complete the main studies. Together, the revisions add 15.4 hours to the total estimated burden time (see Tables 1 and 2).


















Table 1.--Estimated Annual Reporting Burden1

Activity

No. of Respondents

No. of Responses per Respondent

Total Annual Responses

Average Burden per Response

Total Hours

Cognitive Interview screener

30

1

30

0.08

(5 minutes)

2.4

Cognitive Interviews

18

1

18

1

(60 minutes)

18

Pretests 1 and 2 screener

298

1

298

0.08

(5 minutes)

23.84

Pretests 1 and 2

149

1

149

0.25

(15 minutes)

37.25

Study 1 screener

1,610

1

1,610

0.08

(5 minutes)

128.8

Study 1

805

1

805

0.25

(15 minutes)

201.25

Study 2 screener

1,196

1

1,196

0.08

(5 minutes)

95.68

Study 2

598

1

598

0.25

(15 minutes)

149.5

Total





656.72



Table 2.—Adjustments to Total Hours


Activity

Adjustment to Total Hours

Notes

Pretests 1 and 2 screener

7.84 additional hours

Based on screening more participants than expected

Pretests 1 and 2

2.35 fewer hours

Based on more participants but shorter survey length than expected

Study 1 screener

35.44 additional hours

Adjustment based on application of pretests 1 and 2 screener experience

Study 1

29.75 fewer hours

Adjustment based on application of pretests 1 and 2 experience

Study 2 screener

26.32 additional hours

Adjustment based on application of pretests 1 and 2 screener experience

Study 2

22.1 fewer hours

Adjustment based on application of pretests 1 and 2 experience

Total

15.40 additional hours




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AuthorKaren Stein
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File Created2021-04-06

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