Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 16743 

On November 22, 2021, Secura Bio, 

Inc. submitted a letter asking FDA to 

withdraw approval of NDA 205353 for 

FARYDAK (panobinostat) Capsules, 10 

mg, 15 mg, and 20 mg, pursuant to 

§ 314.150(d) (21 CFR 314.150(d)) and 

waiving its opportunity for a hearing. In 

the letter, Secura Bio, Inc. stated they 

are requesting withdrawal of approval of 

the NDA for FARYDAK because it was 

not feasible for them to complete the 

required postmarketing clinical trials. 

On November 26, 2021, FDA 

acknowledged Secura Bio, Inc.’s request 

for withdrawal of approval of the NDA 

and waiver of its opportunity for 

hearing. FDA also cancelled the ODAC 

meeting scheduled for December 2, 

2021, since the applicant’s withdrawal 

request made discussion at an advisory 

committee meeting moot. 

For the reasons discussed above, and 

in accordance with the applicant’s 

request, approval of NDA 205353 for 

FARYDAK (panobinostat) Capsules, 10 

mg, 15 mg, and 20 mg, and all 

amendments and supplements thereto, 

is withdrawn under § 314.150(d). 

Distribution of FARYDAK 

(panobinostat) Capsules, 10 mg, 15 mg, 

and 20 mg, into interstate commerce 

without an approved application is 

illegal and subject to regulatory action 

(see sections 505(a) and 301(d) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(a) and 331(d)). 

Dated: March 18, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06182 Filed 3–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0371] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Accelerated 

Approval Disclosures on Direct-toConsumer Prescription Drug Websites 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by April 25, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The title 

of this information collection is 

‘‘Accelerated Approval Disclosures on 

Direct-to-Consumer Prescription Drug 

Websites.’’ Also include the FDA docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Accelerated Approval Disclosures on 

Direct-to-Consumer Prescription Drug 

Websites 

OMB Control Number 0910–NEW 

Section 1701(a)(4) of the Public 

Health Service Act (PHS Act) (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA regulated products 

in carrying out the provisions of the 

FD&C Act. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have 

consistently conducted research to 

evaluate the aspects of prescription drug 

promotion that are most central to our 

mission, focusing in particular on three 

main topic areas: Advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and disease and 

product characteristics impact the 

communication and understanding of 

prescription drug risks and benefits. 

Focusing on target populations allows 

us to evaluate how understanding of 

prescription drug risks and benefits may 

vary as a function of audience, and our 

focus on research quality aims at 

maximizing the quality of our research 

data through analytical methodology 

development and investigation of 

sampling and response issues. This 

study will inform the first topic area, 

advertising features, including content 

and format; and the second topic area, 

target populations. 

Because we recognize the strength of 

data and the confidence in the robust 

nature of the findings is improved 

through the results of multiple 

converging studies, we continue to 

develop evidence to inform our 

thinking. We evaluate the results from 

our studies within the broader context 

of research and findings from other 

sources, and this larger body of 

knowledge collectively informs our 

policies as well as our research program. 

Our research is documented on our 

homepage, which can be found at: 

https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/ 

office-prescription-drug-promotionopdp-research. The website includes 

links to the latest Federal Register 

notices and peer-reviewed publications 

produced by our office. The website 

maintains information on studies we 

have conducted, dating back to a directto-consumer (DTC) survey conducted in 

1999. 

I. Background 

Pursuant to section 506(c) of the 

FD&C Act (21 U.S.C. 356(c)) and 21 CFR 

part 314, subpart H (or 21 CFR part 601, 

subpart E for biological products), FDA 

may grant accelerated approval to a drug 

product under section 505(c) of the 

FD&C Act (21 U.S.C. 355(c)) or a 

biological product under section 351(a) 

of the PHS Act (42 U.S.C. 262(a)). This 

pathway enables faster approval of 

prescription drugs intended to treat 

serious or life-threatening illnesses. 

Accelerated approval may be based on 

a determination that a drug product has 

an effect on a surrogate endpoint (for 

example, a blood test result) that is 

reasonably likely to predict clinical 

benefit, or on a clinical endpoint that 

can be measured earlier than 

irreversible morbidity or mortality, that 

is reasonably likely to predict an effect 

on irreversible morbidity or mortality or 

other clinical benefit (i.e., an 

intermediate clinical endpoint). In 

approving a drug under the accelerated 


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approval pathway, the severity, rarity, 

or prevalence of a condition, and the 

availability or lack of alternative 

treatments, are taken into account. 

The accelerated approval pathway is 

limited to certain products intended to 

treat serious or life-threatening illnesses 

as there can be ‘‘[u]ncertainty about 

whether clinical benefit will be verified 

and the possibility of undiscovered 

risks’’ (FDA’s 2014 guidance for 

industry entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics,’’ available at https://

www.fda.gov/downloads/Drugs/ 

Guidances/UCM358301.pdf). Sponsors 

are generally required to conduct postapproval studies to verify and describe 

the predicted clinical benefit, but those 

confirmatory studies are not complete at 

the time that the accelerated approval is 

granted (Ref. 1). In the event that the 

required post-approval confirmatory 

studies fail to verify and describe the 

predicted effect or clinical benefit, a 

drug’s approval can be withdrawn using 

expedited procedures. 

Under FDA regulations governing 

physician labeling for prescription 

drugs, the INDICATIONS AND USAGE 

section of FDA-approved prescribing 

information for a drug approved under 

accelerated approval must include not 

only the indication (§ 201.57(c) (21 CFR 

201.57(c))) but also a ‘‘succinct 

description of the limitations of 

usefulness of the drug and any 

uncertainty about anticipated clinical 

benefits . . .’’ (§ 201.57(c)(2)(i)(B)). In a 

guidance, FDA recommended that in 

addition to these required elements, the 

INDICATIONS AND USAGE section for 

drugs approved under accelerated 

approval should generally acknowledge 

that continued approval for the drug or 

indication may be contingent on 

verification and description of clinical 

benefit in confirmatory trials (FDA 2019 

guidance for industry entitled ‘‘Labeling 

for Human Prescription Drug and 

Biological Products Approved Under 

the Accelerated Approval Regulatory 

Pathway,’’ available at https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM390058.pdf). 

Some DTC websites have included 

disclosures about accelerated approval, 

and of those, many included similar 

content to that seen in the 

INDICATIONS AND USAGE section of 

approved labeling. A content analysis of 

DTC websites for accelerated approval 

products found that 21 percent of the 

disclosures used language directly from 

the approved physician labeling, 79 

percent of the disclosures used at least 

some medical language, but 27 percent 

of the websites did not include any 

disclosure that the products attained 

approval through this pathway (Ref. 2). 

The same analysis found that 84 percent 

of accelerated approval disclosures on 

DTC websites mentioned the approval 

basis, 68 percent mentioned unknown 

outcomes, and 47 percent mentioned 

confirmatory trials (Ref. 2). 

OPDP recently conducted a generalpopulation study testing the disclosure 

of FDA accelerated approval 

information on a DTC prescription drug 

website (OMB control number 0910– 

0872—Experimental Study of an 

Accelerated Approval Disclosure; the 

0910–0872 Study). The study tested a 

control condition with no disclosure; a 

disclosure based on wording used in 

physician labeling, including more 

complex or technical terminology 

(physician-labeling disclosure); and a 

consumer-friendly disclosure drafted 

using simpler language intended to be 

suited for that audience (consumerfriendly disclosure). The disclosures 

had three elements: (1) Approval basis, 

(2) unknown outcomes, and (3) 

confirmatory trials. The physician 

labeling disclosure was ‘‘This indication 

is based on response rate. An 

improvement in survival or diseaserelated symptoms has not been 

established. Continued approval for this 

indication may be contingent upon 

verification of clinical benefit in 

subsequent trials.’’ The consumerfriendly disclosure was ‘‘In a clinical 

trial, [Drug X] returned blood counts to 

normal. However, we currently do not 

know if [Drug X] helps people live 

longer or feel better. We continue to 

study [Drug X] in clinical trials to learn 

more about [Drug X]’s benefits.’’ We also 

varied whether the physician-labeling 

and consumer-friendly disclosures were 

presented with low or high prominence 

(varying the size, color, and location of 

the disclosure). Preliminary results 

related to the comprehension of the 

disclosures tested in that study suggest 

that the consumer-friendly disclosure 

helped participants understand 

information related to the drug’s 

accelerated approval, but that 

participants’ understanding was low 

overall. 

II. New Proposed Study 

The purpose of the current project is 

to replicate and extend our prior 

research through two studies by: (1) 

Testing the same experimental 

conditions with a different study 

population (cancer survivors and cancer 

caregivers in study 1) and, (2) testing 

additional consumer-friendly 

disclosures in study 2. Replication is an 

important part of science and, if 

confirmation of prior results is seen, can 

increase confidence in the results from 

our first study. 

With regard to proposed study 1, 

public comments for FDA’s previous 

accelerated approval disclosure study 

and other similar FDA studies have 

suggested conducting studies with 

people who have been diagnosed with 

the medical condition or who are 

caregivers to patients diagnosed with 

the medical condition that the fictitious 

drug in the study is intended to treat. 

Specifically, public comments on the 

previous study suggested enrolling 

participants who have been diagnosed 

with cancer (i.e., cancer survivors) or 

people who have cared for loved ones 

with cancer (i.e., cancer caregivers). 

Because a number of oncology products 

are granted accelerated approval, cancer 

survivors and cancer caregivers are 

more likely to seek out or be exposed to 

promotion for accelerated approval 

products than the general population. 

They may also be more familiar with 

cancer-related terms and concepts than 

the general population. Study 1 will 

involve cancer survivors and cancer 

caregivers, a different population than 

our prior study. It will test the ‘‘three 

element’’ version of the disclosure as 

noted above. We will also test the 

prominence of the disclosure (see table 

1). 

With regard to study 2, public 

comments on the original study (Docket 

No. FDA–2018–N–3138) expressed 

concern that over-disclosure could 

dissuade consumers from considering 

accelerated approval products. One 

public comment specifically suggested 

removing the ‘‘unknown outcomes’’ 

element in the consumer-friendly and 

physician-labeling disclosures. Based on 

these comments, in study 2, we propose 

testing four versions of the consumerfriendly disclosure (table 2): The ‘‘three 

element’’ version of the consumerfriendly disclosure as well as three other 

consumer-friendly disclosures that vary 

with respect to which of these three 

elements they address. This will allow 

us to evaluate the impact on 

participants’ comprehension of the 

disclosure and perception of the 

fictitious drug when they view a 

disclosure with only the approval basis, 

the approval basis plus information 

about the unknown outcomes, the 

approval basis plus information about 

confirmatory trials, and finally the 

approval basis plus information about 

both the unknown outcomes and 

confirmatory trials. In study 2, the 

prominence of all the test conditions 

will be the same and will be the same 

as the ‘‘high prominence’’ version tested 

in study 1. 


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Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 16745 

We plan to conduct two pretests not 

longer than 20 minutes, administered 

via internet panel, to pilot the main 

study procedures. We then plan to 

conduct two main studies not longer 

than 20 minutes, administered via 

internet panel. For the pretests and 

main studies, we will randomly assign 

the participants to one of the test 

conditions (see table 1 for the study 1 

design and table 2 for the study 2 

design). In both studies, participants 

will view a website for a fictitious 

oncology prescription drug. After 

viewing the website, participants will 

complete a questionnaire that assesses 

whether participants noticed the 

disclosure and their understanding of it, 

as well as perceptions of the drug’s risks 

and benefits. We will also measure 

covariates such as demographics and 

literacy. The questionnaire is available 

upon request from DTCresearch@

fda.hhs.gov. 

For study 1, we hypothesize that 

participants will be more likely to 

notice the disclosure when it is 

presented more, rather than less, 

prominently. In turn, we expect that 

participants’ perceptions of the drug are 

more likely to be affected by the 

disclosure in the high prominence 

condition. We also hypothesize that 

participants will be more likely to 

notice and understand the disclosure 

and use it to form their perceptions of 

the drug if they view the consumerfriendly language. For study 2, we 

hypothesize that participants will be 

more likely to understand each 

accelerated approval concept (i.e., 

confirmatory trials, unknown outcomes) 

when the disclosure directly addresses 

the concept, compared with when the 

disclosure does not directly address the 

concept. Finally, we will explore 

whether the inclusion of the concepts of 

confirmatory trials and unknown 

outcomes in the disclosure affects 

participants’ perceived risk, perceived 

risk-benefit tradeoff, perceptions of the 

website, or information-seeking 

intentions. To test these hypotheses, we 

will conduct inferential statistical tests 

such as logistic regression and analysis 

of variance. 

For the pretests and main studies, we 

plan to recruit individuals who report a 

diagnosis with any cancer (except for 

certain non-melanoma skin cancers) for 

half the sample and individuals who 

report being a caregiver for someone 

with a diagnosis with any cancer 

(except for certain non-melanoma skin 

cancers) for the other half of the sample. 

We will exclude individuals who work 

for the U.S. Department of Health and 

Human Services or work in the 

healthcare, marketing, advertising, or 

pharmaceutical industries. With the 

sample sizes described below, we will 

have sufficient power to detect smallsized effects in the main study (table 3). 

TABLE 1—STUDY 1 DESIGN

High prominence Low prominence Absent 

Physician-labeling version ................................ Condition 1 ............................. Condition 3 ............................. Condition 5. 

Consumer-friendly version ................................ Condition 2 ............................. Condition 4.

TABLE 2—STUDY 2 DESIGN

[Consumer-friendly disclosure elements] 

Approval basis Approval basis + unknown 

outcomes 

Approval basis + 

confirmatory trials 

Approval basis + unknown 

outcomes + confirmatory 

trials 

High prominence ............... Condition 6 ........................ Condition 7 ........................ Condition 8 ........................ Study 1 Condition 2. 

In the Federal Register of June 11, 

2021 (86 FR 31323), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

submission that was PRA-related. 

Within the submission, 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 the commenter that the entirety 

of their comments was considered even 

if not fully captured by our 

paraphrasing in this document. The 

following acronyms are used here: DTC 

= direct-to-consumer; HCP = healthcare 

professional; FDA and the Agency = 

Food and Drug Administration; OPDP = 

FDA’s Office of Prescription Drug 

Promotion. 

(Comment 1) Comment 1 expressed 

concern that this research will duplicate 

a prior FDA study and lack practical 

utility. The comment asserts that while 

the 60-day PRA notice provided a 

statement of ‘‘preliminary results’’ of the 

prior study, full study materials, results, 

and conclusions of that prior study have 

not been published. It requested that the 

results of the prior study be published 

before this study is conducted, 

suggesting that, without publishing the 

results of the prior study, FDA has not 

addressed how the new proposed 

research would address open research 

issues or limitations of the prior study. 

(Response 1) Contrary to the 

comment’s suggestion, we do not plan 

to duplicate the prior research, although 

there often is value in that undertaking. 

Rather, the present research seeks to 

replicate the previous study in a new 

patient population and extend the 

previous study by testing additional 

versions of the disclosure. The new 

research is directly informed by open 

research issues and limitations raised in 

the public comments from the previous 

study. The proposed studies will be 

conducted in a new cancer survivor and 

caregiver sample, which differs from the 

sample in the prior study, which was 

conducted with a general population 

sample. As noted above, cancer 

survivors and cancer caregivers are 

more likely to seek out or be exposed to 

promotion for accelerated approval 

products than the general population. 

They may also be more familiar with 

cancer-related terms and concepts than 

the general population. Replications in 

different study samples are often 

proposed. Indeed, at the time of the 

previously proposed study (0910–0872 

Study), public comments suggested 

conducting the study with cancer 

survivors who had used oncology 

products. Also, in response to public 

comments on the prior study design, we 

will extend the prior research by testing 

additional versions of the disclosure. 

This study therefore has practical utility 

to expand our information regarding 

website disclosures regarding 

accelerated approval drugs, both by 

extending to additional versions of the 


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disclosure related to our overall 

questions, and to determine if results 

are consistent with those of the earlier 

study. We intend to publish the results 

of the current study as well as the prior 

study. 

(Comment 2) Comment 2 stated that 

establishing mandates to unduly 

emphasize a product’s accelerated 

approval status could deter appropriate 

usage and lead to misconception and 

confusion among patients. The 

comment specifically referred to one 

statement in the disclosure, ‘‘we 

currently do not know if [Drug X] helps 

people live longer or feel better’’ to 

suggest that the disclosure may 

oversimplify the benefits of the product 

and thus discourage patients from 

getting needed treatments. The 

comment later stated that the 

availability of FDA prior review of 

promotional pieces for accelerated 

approval means there is less need to 

prescribe specific overarching new rules 

for disclosures because FDA can 

consider disclosures on a case-by-case 

basis. 

(Response 2) This notice proposes a 

data collection for research purposes 

and does not establish a mandate or 

propose a new rule. Instead, it proposes 

research that may inform FDA and 

stakeholder thinking on accelerated 

approval product disclosures in DTC 

promotional materials. The research 

will specifically investigate patient 

understanding of and reaction to the 

disclosure language about a product’s 

accelerated approval status. Study 2 was 

designed in direct response to public 

comment on the previously proposed 

study (0910–0872 Study) raising 

concerns about over-disclosure. Study 2 

will test several conditions based on 

disclosures found in the marketplace, 

two of which will not include the 

statement ‘‘we currently do not know if 

[Drug X] helps people live longer or feel 

better’’ (see table 2). 

(Comment 3) Comment 3 suggested 

that DTC promotional materials are not 

the best venue for providing information 

about prescription drugs, given the role 

of healthcare professionals (HCPs) in 

discussing and prescribing treatments. 

Based on this, the comment suggested 

modifying the study to focus on 

prescriber-patient interactions rather 

than DTC promotion by including a 

component to evaluate patient 

understanding of accelerated approval 

after consultation with a prescriber. 

(Response 3) We agree that the 

prescriber-patient interaction is 

important. Consumers often wish to 

participate in shared decision-making 

with HCPs when selecting prescription 

drugs and may request specific 

prescription drugs from their HCPs 

based on promotions they have seen in 

the marketplace. Because information 

consumers receive through DTC 

prescription drug promotion can impact 

these requests, it is important to 

investigate how the information in 

prescription drug promotional pieces 

impacts consumer attention, 

understanding, and perceptions. 

(Comment 4) Comment 4 suggested 

conducting qualitative interviews or a 

blended approach of qualitative and 

quantitative research rather than a 

quantitative study. In addition, the 

comment recommended that the 

interviews include showing the stimuli 

to participants, asking them questions 

about the stimuli, and then showing 

them the stimuli again so they can read 

the disclosure and have it in front of 

them while answering questions. 

(Response 4) We plan to conduct nine 

1-hour interviews to cognitively test the 

stimuli and questionnaire. These 

interviews will allow for indepth 

discussions with participants, and the 

findings from the interviews will help 

improve the study materials. In 

addition, the questionnaire follows the 

approach the commenter suggested: 

Participants view the stimuli and 

answer questions, then see the 

disclosure again for questions 16 and 

17. This will allow us to test what 

participants remember and understand 

after visiting a website for an 

accelerated approval product, as well as 

their understanding of the disclosure 

language while it is in front of them. We 

will use the cognitive interviews and 

pretesting to determine whether 

participants will be able to view the 

stimuli when answering more of the 

questions in study 2. 

(Comment 5) Comment 5 suggested 

screening for patients who have a 

personal experience with Acute 

Lymphoblastic Leukemia (ALL) (the 

cancer referred to in the study stimuli) 

and who have received accelerated 

approval products from their 

prescribers. 

(Response 5) We will ask participants 

about the type of cancer and type of 

treatment(s) they or their loved one had. 

In this study, we will not ask if they 

used an accelerated approval product, 

because participants are unlikely to 

know this information. In the pretest, 

we will examine the feasibility of quotas 

aiming for a broad range of cancer 

diagnoses in the sample, including 

blood cancers like ALL. We will also 

use the pretest to examine the feasibility 

of restricting recruitment to cancer 

survivors, and caregivers for cancer 

survivors, who have received a systemic 

therapy (e.g., chemotherapy, hormonal 

therapy, immune therapy, targeted 

therapy). 

(Comment 6) Comment 6 questioned 

why caregivers are included in the 

sample and noted that it is unclear what 

direct role caregivers have in drug 

prescribing decisions. 

(Response 6) We included caregivers 

in part because previous public 

comments have encouraged FDA to 

include caregivers in DTC research (for 

example, Docket No. FDA–2019–N– 

2313). Prior research also supports the 

inclusion of caregivers in a study on 

consumer understanding of health 

information on a DTC prescription drug 

website. Surveys have found that many 

people searching for health information 

online are doing so on behalf of 

someone else (e.g., Refs. 3 and 4). These 

‘‘surrogate seekers’’ are more likely to be 

caregivers (Ref. 5). In addition, 

caregivers are a known audience for 

DTC prescription drug websites. For 

instance, to enter some DTC 

prescription drug websites, people must 

select whether they are ‘‘a patient or 

caregiver’’ or a ‘‘healthcare provider.’’ 

Other DTC prescription drug websites 

specifically include information for 

caregivers. 

(Comment 7) Comment 7 stated that 

information on the proposed number of 

study participants was not observed in 

the 60-day notice, and suggested a 

minimum of 200–300 participants, with 

400–500 being optimal. The comment 

also suggested considering quotas for 

demographic variables such as age and 

education to allow for subgroup 

analyses. 

(Response 7) The proposed number of 

participants can be found in table 3 of 

this notice. Specifically, we propose 630 

participants in study 1 and 400 

participants in study 2. We have not 

proposed any planned subgroup 

analyses; however, we will have quotas 

for age, sex, race, and education to 

ensure a diverse sample. 

(Comment 8) Comment 8 suggested 

that, for study participants to 

understand the disclosures being tested, 

they must first be told that the drug 

received an accelerated approval; 

accelerated approval is based on an FDA 

determination that the drug is likely to 

provide meaningful therapeutic benefits 

to patients over existing treatments and 

likely addresses a significant unmet 

medical need; and the drug is approved 

based on adequate and well-controlled 

clinical trial(s) on surrogate or 

intermediate clinical endpoints that are 

reasonably likely to predict clinical 

benefit, but that the drug’s effects need 

to be verified with additional data. 

(Response 8) Consumers encountering 

DTC websites for accelerated approval 


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products would not have this 

background information, so giving this 

information to participants would defeat 

the purpose of testing what perceptions 

these consumers form from the website 

disclosures. 

(Comment 9) Comment 9 suggested 

testing an alternative disclosure that 

would include background information 

about accelerated approval, described in 

the last comment, along with the 

disclosures currently proposed to be 

tested. 

(Response 9) We acknowledge that we 

cannot test all possible disclosure 

language. We based the disclosures we 

plan to test on FDA-approved labeling 

for accelerated approval products and 

on disclosures found in the marketplace 

(Ref. 2). We encourage research on 

alternate disclosures. 

(Comment 10) Comment 10 stated that 

question 9, which asks participants 

about their understanding of the 

confirmatory trials concept from the 

disclosure, is unclear and suggested 

deleting the question or refining the 

answer options. 

(Response 10) We will delete this 

question in study 1. As noted in the 

questionnaire, we plan to test two 

versions of question 9 in the study 2 

pretests. We will refine or delete this 

question in study 2 based on findings 

from the cognitive interviews and 

pretesting. 

(Comment 11) Comment 11 suggested 

clarifying ‘‘quality of life’’ in consumerfriendly terms and defining specific 

quality of life measures in question 10. 

(Response 11) Question 10 does not 

refer to a specific quality of life 

measure. In a recent survey of metastatic 

breast cancer patients, most participants 

(89 percent) reported understanding the 

term ‘‘quality of life’’ (Ref. 6). We expect 

participants in this study will also 

understand the term ‘‘quality of life’’ 

without further clarification, but we will 

cognitively test and pretest the question 

to determine if any clarification is 

needed. 

(Comment 12) Comment 12 stated that 

questions 11 and 12, which ask about 

risk-benefit tradeoffs, are redundant and 

too general, not sufficient to study overdisclosure, and that these questions 

typically require consumers and HCPs 

to arrive at the answer together. The 

comment suggested that instead, the 

study ask whether, based on 

information on the website, participants 

intend to ask to take the drug, not ask 

to take the drug, speak with a doctor 

about whether the drug is right for them, 

or none of these. 

(Response 12) We disagree that 

consumers do not form their own 

perceptions about risk-benefits tradeoffs 

after seeing DTC promotional materials 

and prior to any discussion with a HCP. 

Thus, we plan to ask participants about 

their perceptions of the risk-benefit 

tradeoff through question 11, which is a 

common and validated item in DTC 

research. We will delete question 12 to 

reduce redundancy (Ref. 7). We will 

also ask about behavioral intentions. 

Participants do not necessarily have the 

type of cancer the fictitious drug is 

indicated to treat; therefore, it would 

not make sense to ask them about their 

intentions to ask about the drug for 

themselves. Instead, similar to what the 

comment requests, question 14 asks 

whether participants would recommend 

that a loved one diagnosed with the 

cancer that the fictitious drug is 

indicated to treat ask a doctor about 

taking the drug. 

(Comment 13) Comment 13 

recommended deleting question 13, 

which asks about the drug side effects, 

because it is too general and does not 

test the disclosure. 

(Response 13) Question 13 is intended 

to measure the effect of the disclosure 

on participants’ risk perceptions. We 

will assess this question in cognitive 

interviews and pretesting and will 

refine it if needed. 

(Comment 14) Comment 14 suggested 

deleting or refining question 14, which 

asks participants to select all actions 

they would suggest a loved one take 

(i.e., asking a doctor about taking the 

drug, asking about the drug’s risks, its 

benefits, and its FDA approval). The 

comment stated that because all options 

may be applicable, it is unclear how the 

item would yield meaningful data for 

this research. 

(Response 14) We revised question 14 

from ‘‘select all that apply’’ to separate 

‘‘yes/no’’ items for each action. We will 

assess the utility of asking about each of 

these actions in cognitive interviews 

and pretesting. At a minimum, we will 

retain the ‘‘taking [Drug X]’’ item to 

assess intentions as discussed in a 

previous comment. 

(Comment 15) Comment 15 suggested 

that participants are unlikely to have the 

information to provide yes or no 

answers to question 19, which asks 

participants whether they used any 

accelerated approval products for their 

own cancer, and questioned why it is 

important for a patient to understand 

the regulatory approval pathway for a 

drug, as opposed to information about 

the drug’s safety and effectiveness for 

use in discussion with an HCP. 

(Response 15) We agree that 

participants are unlikely to know 

whether the product they used was an 

accelerated approval product and will 

delete this question in this study. 

(Comment 16) Comment 16 suggested 

deleting question 21, which asks how 

similar the study website was to other 

DTC websites the participant has seen, 

because it seems vague and not directly 

related to the research question. 

(Response 16) Question 21 is for 

pretesting purposes only and is 

intended to assess the quality of the 

stimuli. We will keep question 21 for 

pretesting but will not ask it in the main 

studies. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Pretest 1 and 2 screener .......................................... 3,600 1 3,600 0.08 (5 minutes) ....... 288 

Study 1 and 2 screener ............................................ 20,600 1 20,600 0.08 (5 minutes) ....... 1,648 

Pretest 1 ................................................................... 100 1 100 0.33 (20 minutes) ..... 33 

Main Study 1 ............................................................. 630 1 630 0.33 (20 minutes) ..... 208 

Pretest 2 ................................................................... 80 1 80 0.33 (20 minutes) ..... 26 

Main Study 2 ............................................................. 400 1 400 0.33 (20 minutes) ..... 132 

Total ................................................................... ........................ ........................ ........................ ................................... 2,335 

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


khammond on DSKJM1Z7X2PROD with NOTICES
16748 Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices 

III. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, 240–402–7500, and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they 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 

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. Beaver J.A., L.J. Howie, L. Pelosof, et al., 

‘‘A 25-Year Experience of U.S. Food and 

Drug Administration Accelerated 

Approval of Malignant Hematology and 

Oncology Drugs and Biologics: A 

Review.’’ JAMA Oncology. 2018; 

4(6):849–856. 

2. Sullivan H.W., A.C. O’Donoghue, K.T. 

David, et al., ‘‘Disclosing Accelerated 

Approval on Direct-to-Consumer 

Prescription Drug websites.’’ 

Pharmacoepidemiology and Drug Safety. 

2018;27:1277–1280. https://doi.org/ 

10.1002/pds.4664. 

3. Cutrona, S.L., K.M. Mazor, S.N. Vieux, et 

al., ‘‘Health Information-Seeking on 

Behalf of Others: Characteristics of 

‘Surrogate Seekers’.’’ Journal of Cancer 

Education. 2015;30:12–19. https://

www.ncbi.nlm.nih.gov/pmc/articles/ 

PMC4282983/. 

4. Sadasivam, R.S., R.L. Kinney, S.C. Lemon, 

et al., ‘‘Internet Health Information 

Seeking Is a Team Sport: Analysis of the 

Pew Internet Survey.’’ International 

Journal of Medical Informatics. 

2013;82:193–200. 

* 5. Bangerter, L.R., J. Griffin, K. Harden, et 

al., ‘‘Health Information-Seeking 

Behaviors of Family Caregivers: Analysis 

of the Health Information National 

Trends Survey.’’ JMIR Aging. 

2019;2:e11237. https://aging.jmir.org/ 

2019/1/e11237/. 

6. von Itzstein, M.S., E. Railey, M.L. Smith, 

et al., ‘‘Patient Familiarity with, 

Understanding of, and Preferences for 

Clinical Trial Endpoints and 

Terminology.’’ Cancer. 2021;126:1605– 

1613. 

7. Kelly, B.J., D.J. Rupert, K.J. Aikin, et al., 

‘‘Development and Validation of 

Prescription Drug Risk, Efficacy, and 

Benefit Perception Measures in the 

Context of Direct-to-Consumer 

Prescription Drug Advertising.’’ 

Research in Social and Administrative 

Pharmacy. 2021;17:942–955. 

Dated: March 17, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06220 Filed 3–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

Section 2112(b)(2) of the Public Health 

Service (PHS) Act, as amended. While 

the Secretary of HHS is named as the 

respondent in all proceedings brought 

by the filing of petitions for 

compensation under the Program, the 

United States Court of Federal Claims is 

charged by statute with responsibility 

for considering and acting upon the 

petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

February 1, 2022, through February 28, 

2022. This list provides the name of 

petitioner, city and state of vaccination 

(if unknown then city and state of 

person or attorney filing claim), and 

case number. In cases where the Court 

has redacted the name of a petitioner 

and/or the case number, the list reflects 

such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 

injury, condition, or death described in 

the petition is due to factors unrelated 

to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

a. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition not set forth in the 

Vaccine Injury Table but which was 

caused by’’ one of the vaccines referred 

to in the Table, or 

b. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition set forth in the 

Vaccine Injury Table the first symptom 

or manifestation of the onset or 

significant aggravation of which did not 

occur within the time period set forth in 

the Table but which was caused by a 

vaccine’’ referred to in the Table. 


khammond on DSKJM1Z7X2PROD with NOTICES