Nonsub change request memo

0875 Nonsub change request memo 2020.docx

Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces

Nonsub change request memo

OMB: 0910-0875

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Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces”

(OMB Control Number 0910-0875)



Change Request (83-C)

June 1, 2020



The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) for this project. The purpose of this project is to examine how physician perception of professional prescription drug communications is influenced by variations in information context, methodologic rigor of the underlying clinical study, and time pressure. This study will provide FDA with empirical information of the effects of these variables on physician perceptions and inform FDA’s regulatory approach to promotional materials of this type. We are requesting: (1) an amendment to adjust the number of participants by adding a second pretest; and (2) an adjustment to the estimated burden based on experience with the first pretest.  We are not seeking to change the study procedure.


The estimated annual reporting burden, formerly estimated as 267 hours, has increased by 131 hours to a new total estimated annual hourly burden of 397 hours. We are requesting an increase in the burden hours in order to conduct a second pretest and to reflect the experience of the first pretest. In the first pretest, a larger number of individuals were screened than estimated to achieve the final pretest sample size. We have adjusted the estimated screening burden for Pretest 1 and the Main study to reflect this experience.


Results of the first pretest revealed that one of the independent variables, time pressure, was not effective as operationalized; participants did not report perceiving to be under time pressure. Based on the results of the pretest, FDA is requesting an additional pretest to test other variations of the time pressure variable to ensure this variable is being successfully operationalized prior to proceeding with the main study, and to examine the appropriate amount of time pressure to apply in the main study.


A revised burden table is presented below.



Table 1.--Estimated Annual Reporting Burden1

Activity

No. of Respondents

No. of Responses per Respondent

Total Annual Responses

Average Burden per Response

Total Hours

Pretest 1 screener

443

1

443

.03 (2 minutes)

13

Pretest 2 screener

850

1

850

.03 (2 minutes)

26

Completes, Pretest 1

158

1

158

.33 (20 minutes)

52

Completes, Pretest 2

252

1

252

.33 (20 minutes)

83

Main Study screener

1,200

1

1,200

.03 (2 minutes)

36

Completes, Main Study

566

1

566

.33 (20 minutes)

187

Total

3,469


3,469


397

1 There are no capital costs or operating and maintenance costs associated with this collection of information.





Table 2.—Adjustments to Total Hours


Activity

Adjustment to Total Hours

Notes

Pretest 1 screener

7 additional hours

Adjustment based on experience

Pretest 2 screener

26 additional hours

New requested hours

Pretest 2 completes

83 additional hours

New requested hours

Main study screener

15 additional hours

Adjustment based on application of Pretest 1 experience

Total

131 additional hours



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorBetts, Kevin
File Modified0000-00-00
File Created2021-01-14

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