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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices claim, quantitative information about claim, not a treatment for claim and quantitative information about claim, or no disclosure, and two levels presence or absence of a comparative element
regarding the secondary claim, for a total of eight experimental conditions see table 1. Participants will be randomly assigned to one of these conditions; they will view one version
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of a website. This 4 2 design will be replicated across two target populations HCPs and consumers.

TABLE 1PHASE 1 STUDY DESIGN
Phase 1: Secondary Claim Disclosure by Comparative Secondary Claim in Online Prescription Drug Websites Secondary claim disclosure Comparative secondary claim
Drug X is not a treatment for claim
In a clinical trial, participants quantitative information on Drug X

Drug X is not a treatment for claim AND
In a clinical trial, participants quantitative information on Drug X

None no secondary claim disclosure
lotter on DSK11XQN23PROD with NOTICES1

HCPs:
Present: Compared to xx on Drug Y.
Absent.
Consumers:
Present: Compared to xx on Drug Y.
Absent.

The second, independent phase of the proposed research will examine disclosures about a biosimilar product.
In both consumer and HCP audiences, we will assess the impact of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars. Phase 2
will examine the impact of: 1 Adding a disclosure designating the product as a biosimilar; 2 adding general informational statements about biosimilars; and 3 naming a reference product. This approach allows us to examine the effect of disclosing biosimilar status; examines the additive effect of including one, two, or three additional basic statements of information about biosimilars; and measures the effect of naming the reference product. Our proposed main outcome measures are perceptions of and attitudes toward the biosimilar product and the disclosure.
We propose to examine seven different disclosure conditions plus a control with no disclosure for a total of eight test conditions. As a baseline, each of the seven disclosure conditions will include a statement that the drug is a biosimilar. Six of the seven disclosure conditions will include this baseline statement and will vary the amount of additional basic factual information about biosimilar products in the following way: 1 Two of the six conditions have the baseline +
statement A; 2, two of the six conditions have the baseline +
statement A + statement B; and 3 two of the six conditions have the baseline + statement A + statement B + statement C. Moreover, three of the six disclosure
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conditions will name the specific reference product while the other three will refer to a reference product generally for example, This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. The wording of the disclosure will be tailored to the audience; for example, the disclosures for the consumer audience will avoid technical terms. A
control condition will also be included in which no biosimilar statement or additional information disclosure is presented.
The pretest and main studies for Phase 2 will have the same design, will be conducted online, and will follow the same procedure. Both phases will be conducted concurrently. Sample sizes were determined on the basis of power analysis that will allow us to detect medium effect sizes.
In the Federal Register of July 7, 2020
85 FR 40659, FDA published a 60-day notice requesting public comment on the proposed collection of information.
FDA received eight submissions. Three submissions regulations.gov tracking numbers 1k49hohuskf, 1k49itufj33, and 1k49itsko9f were outside the scope of the research and are not addressed further. Within the remaining five submissions, FDA received multiple comments that the Agency has addressed below. For brevity, some public comments are paraphrased and therefore may not reflect the exact language used by the commenter. We assure commenters that the entirety of their comments was considered, even if not fully captured by our paraphrasing
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in this document. The following acronyms are used here: HCP =
healthcare provider; FDA and The Agency = Food and Drug Administration; DTC = direct-toconsumer; OPDP = FDAs Office of Prescription Drug Promotion.
Comment 1 Two comments were supportive of the study, and one comment was supportive of the studys inclusion of both HCP and consumer samples.
Response 1 We thank the commenters for their support of the research.
Comment 2 One comment asserted that FDA has not made the stimuli available for public comment.
Response 2 Our full stimuli are under development during the PRA
process. We do not make draft stimuli public during this time because of concerns that this may contaminate our participant pool and compromise our research. In our research proposals, we describe the purpose of the study, the design, the population of interest, and the estimated burden.
Comment 3 Two comments recommended FDA ensure the wording of the stimuli in both phases is appropriate to each audience HCP and consumer, and one comment suggested FDA partner with a health literacy organization.
Response 3 We assessed understanding of both the consumer and provider versions of statements through in-depth cognitive interviews and will also do so in our survey. Findings from our cognitive interviews suggest that most consumers understood the gist of this information, although they were not always familiar with some terminology.

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