Agency Information Collection Activities; Proposed Collection; Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites, 31323-31327 [2021-12264]
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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices
year, less than once a year, have never
prescribed a drug for an off-label use).
For the second suggestion, we agree
that the frequency of prescribing within
the practice would be useful to capture
and have added a question to measure
this. No difficulties were identified with
this question during cognitive testing.
For the third suggestion, we agree that
this would be a useful measure. In
response to this comment and peer
review, we have revised the
questionnaire to ask about prescribing
likelihood for the specific off-label use.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Pretest screener ...........................................................
Pretest completes .........................................................
Main study screener .....................................................
Main study completes, Medical Condition 1 ................
Main study completes, Medical Condition 2 ................
290
180
2,526
510
1,090
1
1
1
1
1
290
180
2,526
510
1,090
Total ......................................................................
1,600
........................
........................
1 There
0.08
0.33
0.08
0.33
0.33
Total hours
(5 minutes) ....
(20 minutes) ..
(5 minutes) ....
(20 minutes) ..
(20 minutes) ..
23
59
202
168
360
...............................
812
are no capital costs or operating and maintenance costs associated with this collection of information.
II. 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.
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Number of
responses
per
respondent
*1. ‘‘Distributing Scientific and Medical
Publications on Unapproved New Uses—
Recommended Practices—Revised Draft
Guidance,’’ 2014. https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
UCM387652.pdf.
*2. ‘‘Responding to Unsolicited Requests for
Off-Label Information About Prescription
Drugs and Medical Devices Draft
Guidance,’’ 2011. https://www.fda.gov/
media/82660/download.
3. Ajzen, I. 1985. ‘‘From Intentions to
Actions: A Theory of Planned Behavior.’’
In: Action Control: From Cognition to
Behavior, edited by J. Kuhl and J.
Beckmann, pp. 11–39. Berlin, Heidelber,
New York: Springer-Verlag.
4. Murshid, M.A. and Z. Mohaidin. 2017.
‘‘Models and Theories of Prescribing
Decisions: A Review and Suggested a
New Model.’’ Pharmacy Practice, 15(2),
990.
*5. Sable M.R., L.R. Schwartz, P.J. Kelly, et
al. 2006. ‘‘Using the Theory of Reasoned
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Action to Explain Physician Intention to
Prescribe Emergency Contraception.’’
Perspectives on Sexual and Reproductive
Health, 38(1), pp. 20–27. https://
www.guttmacher.org/journals/psrh/
2006/using-theory-reasoned-actionexplain-physician-intention-prescribe.
6. Kesselheim, A.S., C.T. Robertson, J.A.
Myers, et al. 2012. ‘‘A Randomized
Study of How Physicians Interpret
Research Funding Disclosures.’’ New
England Journal of Medicine, 367(12),
pp. 1119–1127.
7. Schaeffer, N.C. and S. Presser. 2003. ‘‘The
Science of Asking Questions.’’ Annual
Review of Sociology, 29.
8. Fox, J., M. Earp, and R. Kaplan. 2020.
‘‘Item Scale Performance.’’ 75th Annual
American Association for Public
Opinion Research Virtual Conference.
9. Ozuru, Y., S. Briner, C.A. Kurby, et al.
2013. ‘‘Comparing Comprehension
Measured by Multiple-Choice and OpenEnded Questions. Canadian Journal of
Experimental Psychology = Revue
canadienne de psychologie
experimentale, 67(3), pp. 215–227.
10. Tanur, J.M. (Ed.). 1992. Questions About
Questions: Inquiries Into the Cognitive
Bases of Surveys. Russell Sage
Foundation.
Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12265 Filed 6–10–21; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0371]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Accelerated
Approval Disclosures on Direct-toConsumer Prescription Drug Websites
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the proposed
study entitled ‘‘Accelerated Approval
Disclosures on Direct-to-Consumer
Prescription Drug websites.’’
DATES: Submit either electronic or
written comments on the collection of
information by August 10, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 10,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 10, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
SUMMARY:
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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–N–0371 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Accelerated Approval Disclosures on
Direct-to-Consumer Prescription Drug
websites.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
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• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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. The questionnaire is
available upon request from
DTCResearch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
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Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 (42 U.S.C.
300u(a)(4)) authorizes the 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
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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.
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 or a biological product under
section 351(a) of the Public Health
Service 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
approval pathway, the severity, rarity,
or prevalence of a condition, and the
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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 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 post
approval 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 (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 . . .’’ (21 CFR
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 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
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31325
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
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 (consumer-friendly
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.
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
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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices
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.
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 health
care, 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
Physician-labeling version ........................
Consumer-friendly version .......................
High prominence
Low prominence
Absent
Condition 1 ..............................................
Condition 2 ..............................................
Condition 3 ..............................................
Condition 4.
Condition 5.
TABLE 2—STUDY 2 DESIGN
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Consumer-friendly disclosure elements
High prominence ....................
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Approval basis
Approval basis + unknown
outcomes
Approval basis +
confirmatory trials
Condition 6 .......................
Condition 7 .......................
Condition 8 .......................
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Approval basis + unknown
outcomes + confirmatory
trials
Study 1 Condition 2.
Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices
31327
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average burden
per response
Total hours
Pretest 1 and 2 screener .........................................
Study 1 and 2 screener ...........................................
Pretest 1 ...................................................................
Main Study 1 ............................................................
Pretest 2 ...................................................................
Main Study 2 ............................................................
3,600
20,600
100
630
80
400
1
1
1
1
1
1
1
1
1
1
1
1
0.08 (5 minutes) ........
0.08 (5 minutes) ........
0.33 (20 minutes) ......
0.33 (20 minutes) ......
.33 (20 minutes) ........
0.33 (20 minutes) ......
288
1,648
33
208
26
132
Total ..................................................................
........................
........................
........................
....................................
2,335
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES), 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.J., L. Pelosof L,
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. doi:10.1001/
jamaoncol.2017.5618
2. Sullivan H.W., A.C. O’Donoghue, K.T.
David, N.J. Patel. ‘‘Disclosing
Accelerated Approval on Direct-toConsumer Prescription Drug Websites.’’
Pharmacoepidemiology and Drug Safety.
2018;27:1277–1280. https://doi.org/
10.1002/pds.4664
Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
[FR Doc. 2021–12264 Filed 6–10–21; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:14 Jun 10, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0369]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations Under
the Federal Import Milk Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, 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 July 12,
2021.
SUMMARY:
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 OMB
control number for this information
collection is 0910–0212. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Regulations Under the Federal Import
Milk Act (FIMA)—21 CFR Part 1210
OMB Control Number 0910–0212—
Extension
This information collection supports
FDA regulations. Under FIMA (21
U.S.C. 141–149), milk or cream may be
imported into the United States only by
the holder of a valid import milk permit
(21 U.S.C. 141). Before such permit is
issued: (1) All cows from which import
milk or cream is produced must be
physically examined and found healthy;
(2) if the milk or cream is imported raw,
all such cows must pass a tuberculin
test; (3) the dairy farm and each plant
in which the milk or cream is processed
or handled must be inspected and found
to meet certain sanitary requirements;
(4) bacterial counts of the milk at the
time of importation must not exceed
specified limits; and (5) the temperature
of the milk or cream at time of
importation must not exceed 50 °F (21
U.S.C. 142).
Our regulations in part 1210 (21 CFR
part 1210) implement the provisions of
FIMA. Sections 1210.11 and 1210.14
require reports on the sanitary
conditions of, respectively, dairy farms
and plants producing milk and/or cream
to be shipped to the United States.
Section 1210.12 requires reports on the
physical examination of herds, while
§ 1210.13 requires the reporting of
tuberculin testing of the herds. In
addition, the regulations in part 1210
require that dairy farmers and plants
maintain pasteurization records
(§ 1210.15) and that each container of
milk or cream imported into the United
States bear a tag with the product type,
permit number, and shipper’s name and
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31323-31327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0371]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer
Prescription Drug Websites
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed study entitled ``Accelerated
Approval Disclosures on Direct-to-Consumer Prescription Drug
websites.''
DATES: Submit either electronic or written comments on the collection
of information by August 10, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 10, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 10, 2021. Comments
received by mail/hand delivery/courier (for written/paper
[[Page 31324]]
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0371 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Accelerated Approval Disclosures
on Direct-to-Consumer Prescription Drug websites.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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,
[email protected]. The questionnaire is available upon request from
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 (42 U.S.C.
300u(a)(4)) authorizes the 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
[[Page 31325]]
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/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-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 direct-to-
consumer (DTC) survey conducted in 1999.
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 or a biological product
under section 351(a) of the Public Health Service 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 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 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
post approval 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 (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 . . .'' (21 CFR
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 Pathway,'' available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/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 general-population 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 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 (consumer-friendly 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
disease-related symptoms has not been established. Continued approval
for this indication may be contingent upon verification of clinical
benefit in subsequent trials.'' The consumer-friendly 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.
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
[[Page 31326]]
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 consumer-friendly disclosure (table 2):
The ``three element'' version of the consumer-friendly 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.
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 [email protected]
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 consumer-friendly
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 health care, marketing, advertising, or
pharmaceutical industries. With the sample sizes described below, we
will have sufficient power to detect small-sized 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 + Approval basis + unknown outcomes +
Approval basis unknown outcomes confirmatory confirmatory
trials trials
----------------------------------------------------------------------------------------------------------------
High prominence................. Condition 6....... Condition 7....... Condition 8....... Study 1 Condition
2.
----------------------------------------------------------------------------------------------------------------
[[Page 31327]]
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 1 and 2 screener.................... 3,600 1 1 0.08 (5 minutes).......................... 288
Study 1 and 2 screener...................... 20,600 1 1 0.08 (5 minutes).......................... 1,648
Pretest 1................................... 100 1 1 0.33 (20 minutes)......................... 33
Main Study 1................................ 630 1 1 0.33 (20 minutes)......................... 208
Pretest 2................................... 80 1 1 .33 (20 minutes).......................... 26
Main Study 2................................ 400 1 1 0.33 (20 minutes)......................... 132
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 2,335
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES), 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.J., L. Pelosof L, 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. doi:10.1001/
jamaoncol.2017.5618
2. Sullivan H.W., A.C. O'Donoghue, K.T. David, N.J. Patel.
``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
Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12264 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P
