0821 Non Substantive Change Request 2018

Food and Drug Administration

Non-Substantive Change Request

Quantitative Information in Direct-to-Consumer Television Advertisements Survey

OMB CONTROL NUMBER: 0910-0821

Based on our pretesting, we would like to conduct Study 2 again, with a slightly revised questionnaire. This would increase our burden by 372.65 hours (see Table 1). The questionnaire remains largely the same; however, we changed the medical condition to plaque psoriasis. The revised questionnaire is similar in length to the original questionnaire. Tables 2 and 3 show the original burden estimates.

Table 1.—Estimated Annual Reporting Burden1 –Reconduct Study 2
Activity	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response	Total Hours
Number to complete the screener (10%)	1,513	1	1,513	.05 (3 min.)	75.65
Number to complete the survey (85%)	900	1	900	.33 (20 min.)	297.00
Total			2,413		372.65

Table 2.--Estimated Annual Reporting Burden1 –Study 1
Activity	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response	Total Hours
Sample outgo	15,130	--	--	--	--
Number to complete the screener (10%)	1,513	1	1513	.05 (3 min.)	75.65
Number eligible for survey (70%)	1,059	--		--
Number to complete the survey (85%)	900	1	900	.33 (20 min.)	297.00
Total			2,413		372.65

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

Table 3.--Estimated Annual Reporting Burden1 –Study 2
Activity	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response	Total Hours
Sample outgo	15,130	--	--	--	--
Number to complete the screener (10%)	1,513	1	1,513	.05 (3 min.)	75.65
Number eligible for survey (70%)	1,059	--		--
Number to complete the survey (85%)	900	1	900	.33 (20 min.)	297.00
Total			2,413		372.65

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