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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices approved uses of biosimilars, not health conditions generally.
Response 31 We have removed this item from our survey.
Comment 32 One comment suggested revising Phase 2 Question 18
to ask about safety and efficacy separately because they may introduce bias if located in the same items.
Response 32 We acknowledge safety and efficacy are separate issues, and we assess beliefs about safety and efficacy separately in Questions 5 to 8. However, because biosimilars have no clinically meaningful differences in safety, purity, or potency safety and effectiveness from their reference product, we are also interested in the impact of the disclosure statement on participants perceptions of safety and efficacy as a
whole. Given this, we do not believe this question will introduce bias.
Comment 33 One comment suggested either deleting or revising questions about the biosimilar disclosure to make clear what same types of sources means.
Response 33 The wording of the biosimilar disclosure statement was crafted using terminology from FDAs Biosimilar Basics Patient Materials https www.fda.gov/drugs/biosimilars/
patient-materials, and we tested its meaning during our in-depth cognitive interviews. Both the consumer and provider groups sufficiently understood this statement.
Comment 34 One comment suggested only asking Phase 2 Question
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17 of participants who are currently receiving a biologic.
Response 34 The intent of the question is to understand whether participants would ask their doctor to switch their medication after viewing the ad. We provided a hypothetical scenario and asked participants to answer this question as if they were taking the reference medication or another prescription medication to treat RA. This question would not be feasible among only those with RA who are receiving a biologic, given the prevalence of RA in the population i.e., 0.6 percent as we only expect to have a few individuals diagnosed with RA, if any.
FDA estimates the burden of this collection of information as follows:

TABLE 2ESTIMATED ANNUAL REPORTING BURDEN 1
No. of respondents
Activity
Study Study Study Study Study Study Study Study Study Study Study Study Study Study Study Study
1 1
1 1
2 2
2 2
1 1
1 1
2 2
2 2

No. of responses per respondent
Average burden per response
Total annual responses
Pretest screener HCPs
Pretest screener consumers
Pretest completes HCPs
Pretest completes consumers
Pretest screener HCPs
Pretest screener consumers
Pretest completes HCPs
Pretest completes consumers
Main study screener HCPs
Main study screener consumers
Main study completes HCPs
Main study completes consumers
Main study screener HCPs
Main study screener consumers
Main study completes HCPs
Main study completes consumers

278
278
139
139
476
476
238
238
990
990
495
495
792
792
396
396

1
1 1
1 1
1 1
1 1
1 1
1 1
1 1
1

278
278
139
139
476
476
238
238
990
990
495
495
792
792
396
396

Total

7,608

7,608

0.08
0.08
0.33
0.33
0.08
0.08
0.33
0.33
0.08
0.08
0.33
0.33
0.08
0.08
0.33
0.33

Total hours
5 minutes ..
5 minutes ..
20 minutes 20 minutes 5 minutes ..
5 minutes ..
20 minutes 20 minutes 5 minutes ..
5 minutes ..
20 minutes 20 minutes 5 minutes ..
5 minutes ..
20 minutes 20 minutes
22.24
22.24
45.87
45.87
38.08
38.08
78.54
78.54
79.2
79.2
163.35
163.35
63.36
63.36
130.68
130.68

1,243

1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Note: With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached. Those participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With this in mind, we have included an additional 10 percent over our target number of valid completes to account for some overage.

lotter on DSK11XQN23PROD with NOTICES1

II. References The following references marked with an asterisk are on display with the Dockets Management Staff HFA305, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 2404027500 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these also are available electronically at https
www.regulations.gov. References without asterisks are not on public display at https www.regulations.gov because they have copyright restriction.
Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA

VerDate Sep<11>2014

17:39 Sep 10, 2021

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has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. Andrews, J.C. 2011. Warnings and Disclosures. In: Communicating Risks and Benefits: An Evidence-Based Users Guide. Fischhoff, B., N.T. Brewer, and J.S. Downs, Eds. FDA: Silver Spring, MD. pp. 149161.
2. Russo France, K. and P. Fitzgerald Bone 2005. Policy Makers Paradigms and Evidence from Consumer Interpretations of Dietary Supplement Labels. Journal of Consumer Affairs, 391, 2751.
3. Mason, M.J. and D.L. Scammon 2011.
Unintended Consequences of Health Supplement Information Regulations:
The Importance of Recognizing Consumer Motivations. Journal of Consumer Affairs, 452, 201223.

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4. Betts, K.R., K.J. Aikin, V. Boudewyns, et al. 2017. Physician Response to Contextualized Price-Comparison Claims in Prescription Drug Advertising.
Journal of Communication in Healthcare, 103, 195204.
5. Betts, K.R., V. Boudewyns, K.J. Aikin, et al. 2018. Serious and Actionable Risks, Plus Disclosure: Investigating an Alternative Approach for Presenting Risk Information in Prescription Drug Television Advertisements. Research in Social and Administrative Pharmacy, 1410, 951963.
6. Sullivan, H.W., A.C. ODonoghue, K.T.
David, et al. 2018. Disclosing Accelerated Approval on Direct-To-Consumer Prescription Drug websites. Pharmacoepidemiology and Drug Safety, 2711, 12771280.
7. Kaiser Family Foundation. 2020.
Professionally Active Specialist
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