Notice2021-12265
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug
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Published
June 11, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 (PRA).
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[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31318-31323]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1261]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Disclosures
to Healthcare Providers Regarding Data That Do Not Support Unapproved
Use of an Approved Prescription Drug
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2021.
[[Page 31319]]
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 ``Study of Disclosures to Healthcare
Providers Regarding Data That Do Not Support Unapproved Use of an
Approved Prescription Drug.'' 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,
<a href="/cdn-cgi/l/email-protection#96c6c4d7c5e2f7f0f0d6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="e7b7b5a6b493868181a7818386c98f8f94c9808891">[email protected]</span></a>.
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.
Study of Disclosures to Healthcare Providers Regarding Data That Do Not
Support Unapproved Use of an Approved Prescription Drug
OMB Control Number 0910-New
I. Background
Section 1701(a)(4) of the Public Health Service 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's) 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. Our research focuses 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 two topic areas: Advertising
features and target populations.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings is improved by utilizing 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: <a href="https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm">https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm</a>. 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 survey on direct-to-
consumer advertisements conducted in 1999.
The revised draft guidance entitled ``Distributing Scientific and
Medical Publications on Unapproved New Uses--Recommended Practices''
(2014; Ref. 1),\1\ recommends that scientific and medical journal
articles that discuss unapproved uses of approved drug products be
disseminated with a representative publication that reaches contrary or
different conclusions, when such information exists. Similarly, the
draft guidance entitled ``Responding to Unsolicited Requests for Off-
Label Information About Prescription Drugs and Medical Devices'' (2011;
Ref. 2) \1\ recommends that when conclusions of articles or texts that
are disseminated in response to an unsolicited request have been
specifically called into question by other articles or texts, a firm
should disseminate representative publications that reach contrary or
different conclusions regarding the use at issue.
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\1\ When final, this guidance will represent the FDA's current
thinking on this topic.
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Pharmaceutical firms sometimes choose to disseminate publications
to healthcare providers (HCPs) that include data that appear to support
an unapproved use of an approved product. At the same time, published
data that are not supportive of that unapproved use may also exist. For
example, unsupportive published information could describe an increased
risk of negative outcomes (e.g., death, relapse) from the unapproved
use of the approved product, suggesting that the unapproved use does
not have a positive benefit-risk ratio. The purpose of this research is
to examine physicians' perceptions and behavioral intentions about an
unapproved new use of an approved prescription drug when made aware of
other data that are not supportive of the unapproved use. This research
will also evaluate the effectiveness of various disclosure approaches
for communicating the unsupportive information. We will use the results
of this research to better understand: (1) Physicians' perceptions of
an unapproved use of a prescription drug; (2) physicians' perceptions
about an unapproved use of an approved prescription drug when they are
aware of the existence of unsupportive information about it; (3)
physicians' perceptions of disclosures referencing the existence of
unsupportive information about that particular use; and (4) to examine
the utility and effectiveness of various approaches to the
communication of this information. In particular, we plan to examine
how different approaches to the communication of unsupportive
information affect physicians' thoughts and attitudes about the
unapproved use. Five approaches will be examined: (1) The provision of
the unsupportive data in the form of a representative publication; (2)
a disclosure that summarizes, rather than provides, the unsupportive
data and includes a citation to the representative publication; (3) a
disclosure that does not provide or include a summary of the
unsupportive data but does acknowledge that unsupportive data exist and
includes a citation to the representative publication; (4) a general
disclosure that does not provide or include a summary of the
unsupportive data but acknowledges unsupportive data may exist, without
conceding that such data do exist; or (5) nothing--the absence of any
presentation of unsupportive data or any disclosure about such data
(control condition). We have four research questions:
RQ1: When considering a presentation of data about an unapproved
use of an approved drug product, how does the existence of unsupportive
data impact physicians'
[[Page 31320]]
perceptions and intentions with regard to that unapproved use?
RQ2: How does the way in which the existence of unsupportive data
is communicated, when the specific data is not presented, impact
physicians' perceptions and intentions with regard to an unapproved use
of an approved drug product?
RQ3: How are physicians' perceptions of and intentions toward an
unapproved use of an approved drug product affected by the disclosure
of specific unsupportive data versus disclosure statements about data
that is not presented?
RQ4: Do other variables (e.g., demographics) have an impact on
these effects? These research questions will be examined in two medical
conditions.
We plan to conduct one pretest with 180 voluntary adult
participants and one main study with 1,600 voluntary adult
participants. Participants in the main study will be 510 oncologists in
the oncology medical condition and 1,090 primary care physicians in the
insomnia \2\ medical condition. All participants will be physicians who
engage in patient care at least 50 percent of the time and do not work
for a pharmaceutical company, marketing firm, or the Department of
Health and Human Services. The gender, race/ethnicity, and ages of the
participating physicians will be self-identified by participants. We
will aim to include a mix of demographic segments to ensure a diversity
of viewpoints and backgrounds. Power analyses were conducted to ensure
adequate sample sizes to detect small to medium effects.
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\2\ This medical condition was changed from diabetes to insomnia
based on cognitive testing.
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The studies will be conducted online. The pretest and main studies
will have the same design and will follow the same procedure. The base
stimulus in both the pretest and main studies will consist of a sample
publication supporting an unapproved use of an approved drug product.
Within each medical condition, participants will be randomly assigned
to one of five test conditions (see figure 1). Following exposure to
the stimuli, they will be asked to complete a questionnaire that
assesses comprehension, perceptions, prescribing intentions, and
demographics. In the pretest, participants will also answer questions
about the study design and questionnaire.
Figure 1--Study Design
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Accompanied by
Accompanied by disclosure that
Accompanied by disclosure with unsupportive data Accompanied by
representative summary of exist and including a general disclosure No disclosure or
publication with unsupportive data and citation for that that unsupportive material about
unsupportive data including a citation data, but without a data may exist and no unsupportive data
for that data summary of the citation
unsupportive data
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Medical Condition 1
Medical Condition 2
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In the Federal Register of July 6, 2020 (85 FR 40300), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two submissions that were PRA-
related. Within these submissions FDA received multiple comments that
the Agency has addressed below. For brevity, some public comments are
paraphrased and, therefore, may not include the exact language used by
the commenter. We assure commenters that the entirety of their comments
was considered even if not fully captured by our paraphrasing in this
document. The following acronyms are used here: HCP = healthcare
provider; FDA and ``The Agency'' = Food and Drug Administration; OPDP =
FDA's Office of Prescription Drug Promotion.
(Comment 1) One comment asserted that FDA has not made the stimuli
available for public comment and requested FDA publish a new 60-day
notice after these comments have been addressed to give the public
another opportunity to review and comment.
(Response 1) We have provided the purpose of the study, the design,
the population of interest, and the questionnaire to individuals upon
request. These materials have proven sufficient for public comment and
for academic experts to peer review the study successfully. Our full
stimuli are under development during the PRA process. We do not make
draft stimuli public during this time because of concerns that this may
contaminate our participant pool and compromise the research.
(Comment 2) One comment suggested that due to the task of reading
the ``scientific publication'' stimuli and length of the questionnaire,
FDA's estimation of the time it will take to complete the study is too
low, and thus the burden of the information collection is inaccurate.
(Response 2) The scientific ``publications'' in this study are each
formatted as a one-page brief report. The text is presented in two
columns and has the following headings: Introduction, Methods, Results,
Discussion, and Limitations. The survey contains primarily closed-ended
questions with Likert scales, and there are five open-ended questions.
The expected time for the study is based on our prior experience
conducting studies using similar protocols. We will also test the time
during the pretest to ensure we stay within 20 minutes. If we determine
the average time for completing the survey is greater than 20 minutes,
we will revise the survey prior to fielding the main study.
(Comment 3) One comment asserts this proposed study overlaps with
other OPDP research currently in progress and references several
studies.
(Response 3) OPDP may conduct concurrent or overlapping studies on
similar topics. While the studies referenced by the comment contribute
to the evidence base for prescription drug promotion, prior studies had
a different focus than the current study. Prior disclosure studies
examined the effectiveness of disclosures in increasing understanding
of efficacy claims (``Disclosures in Professional and Consumer
Prescription Drug Promotion'') and the role of disclosures in
mitigating potentially misleading presentations of preliminary or
descriptive data about oncology drugs (``Disclosures of Descriptive
[[Page 31321]]
Presentations in Professional Oncology Prescription Drug Promotion'').
The third study mentioned by the comment (``Physician Interpretation of
Information About Prescription Drugs in Scientific Publications vs.
Promotional Pieces'') investigates how physician perception of
professional prescription drug communications is influenced by
variations in information context, methodologic rigor of the clinical
study, and time pressure.
The current study uses an experimental design to compare various
disclosure approaches for communicating unsupportive information about
an unapproved new use. The findings of this study will help inform
FDA's understanding about when disclosures about unsupportive data
might be useful and what types of information should be included.
(Comment 4) One comment expressed concern that the way in which the
proposed research is described in the notice suggests that
pharmaceutical firms disseminate supportive data but do not adequately
disclose unsupportive data and that this ``implied bias'' may taint the
collection and interpretation of the data.
(Response 4) The sentences referred to in this comment appear in
the Federal Register notices for the study to provide background and do
not suggest that any firms are not following the recommendations in the
two guidance documents referenced in that same background section.
Rather, the background outlines the current FDA recommendations around
disclosure of unsupportive data with these types of communications and
the intent of the study to evaluate alternative approaches to the
disclosure of unsupportive data. These background statements are not
part of the materials that will be provided to study participants.
Rather, study instructions tell participants only that they will be
reviewing informational material about a prescription drug. No
instructional materials provided to participants mention a
pharmaceutical manufacturer. Therefore, we do not believe the
collection and interpretation of study findings will be tainted or
biased.
(Comment 5) One comment suggested deleting or amending all
questions about HCPs' prescribing decisions (Questions 4, 5, 10, 11, 14
to 23) because these decisions are likely to be influenced by many
factors and are outside of FDA's jurisdiction. This comment also
asserted Question 10 is biased and worded to suggest that
pharmaceutical firms disseminate supportive data but do not adequately
disclose unsupportive data and suggests deleting or amending the
question.
(Response 5) As explained earlier, the Public Health Service Act
authorizes FDA to conduct research relating to health information, and
the FD&C Act authorizes FDA to conduct research relating to drugs and
other FDA-regulated products in carrying out the provisions of the FD&C
Act. The purpose of the current experimental study is to examine
physicians' perceptions and behavioral intentions about an unapproved
new use of an approved prescription drug when made aware of other data
that are not supportive of the unapproved use and to evaluate the
effectiveness of various disclosure approaches for communicating the
unsupportive information. The study is within FDA's authority, and it
will help to inform OPDP's work to help ensure that prescription drug
information is truthful, balanced, and accurately communicated so that
HCPs and consumers can make informed decisions.
Questions 4 and 5 were intended to assess the impact of various
disclosure manipulations on hypothetical prescribing decisions.
Measuring behavioral intention is a common method of assessing
knowledge and attitudes. There is substantial theoretical and empirical
support for our approach, and strong behavioral intention has been
shown to be predictive across a wide range of behaviors, including
prescribing (Refs. 3 to 5). Based on the results of cognitive
interviews, we have revised the measurement of behavioral intention to
the following: ``If you were considering prescribing [DRUG] to a
patient with [DISEASE], how important would the information in the
[DISPLAY FILL] be in your decision making?''
Questions 14 to 23 provide important information to address the
research questions for this study, including sources of information for
studies that do not support an off-label use as well as what aspects of
the study would be most important to prescribers.
Questions 10 and 11 are intended to evaluate whether there is
enough information for the participants to make a prescribing decision
based on the information in the brief study report and disclosure
condition, not to assess the adequacy of pharmaceutical firms'
disclosure of unsupportive data generally. Pharmaceutical firms are not
referenced in any study materials, and these questions do not imply
anything about their dissemination activities.
(Comment 6) One comment recommended that the stimuli used to
represent publications that reach contrary or different conclusions
regarding the unapproved use be held to the same standards as the
publication about the unapproved use. The comment suggests that this
should include being considered scientifically sound by experts with
scientific training and expertise to evaluate the safety or
effectiveness of the drug or device.
(Response 6) Both the supportive and unsupportive data provided to
study participants either in the form of publications or summary
information were reviewed by FDA experts with the requisite scientific
training and experience to ensure they are appropriate, realistic, and
of similar quality.
(Comment 7) One comment recommended that the disclosure summary
include specific information about the study design (i.e., study
population and control group, key clinical endpoints (patient
outcomes)), statistical significance (i.e., 95 percent confidence
interval (CI), hazard ratio (HR) and p value) and other key data needed
to determine benefit-risk ratio, and to include the product
manufacturer and study sponsor.
(Response 7) The proposed experimental study design includes five
conditions to examine disclosure approaches for communicating
unsupportive information. One of the five conditions provides study
details as recommended by the comment. The other conditions have
varying levels of detail about the unsupportive information about the
unapproved new use of the prescription drug. There is also a control
condition. We have purposely omitted the product manufacturer and study
sponsor, as we know from other research this may unduly influence
physicians' beliefs about the quality of the study (Ref. 6).
(Comment 8) One comment suggested the disclosure correlate with the
unapproved use described in the brief study report.
(Response 8) We agree with this point. The disclosure and
unsupportive data provided to participants are relevant to the
unapproved use information participants initially review.
(Comment 9) One comment suggested including hyperlinks to a
citation for the data and including a representative publication with
unsupportive data. This comment also suggested keeping track of how
many study participants utilize the hyperlink.
(Response 9) We developed the stimuli for this study using
information from multiple scientific publications. Thus, the content
does not represent one particular study, and we are unable
[[Page 31322]]
to provide hyperlinks. The revised design suggested in the comment may
be a good suggestion for future research.
Several comments suggested changes to the proposed questionnaire.
(Comment 10) One comment suggested the instructions and lack of a
``don't know'' response option may lead to forced guessing, which may
undermine the utility of the study.
(Response 10) We have deleted Question 10 and revised Question 11
to read, ``What additional information, if any, did you need in order
to consider prescribing [DRUG] for [DISEASE]?'' and deleted the
instructions to ``give us your best guess on answers you do not know.''
(Comment 11) One comment recommends FDA focus on HCPs'
understanding of the data rather than asking about HCPs' preference for
receiving information (Q19 and Q20).
(Response 11) In response to the comment, we have removed Questions
19 and 20 from the survey. Question 3 (now Q4) assesses physician
understanding of the disclosure.
(Comment 12) One comment suggested deleting or revising Questions 6
and 9 because outside influences could skew the results.
(Response 12) We are examining the impact of the various levels of
information disclosure on participants' ratings of how informative they
find the information and how likely they would be to search for
additional information about the drug. Participants will be randomly
assigned to a condition, and any individual differences or potential
biases should be spread across experimental conditions. Thus, if we
find differences between and among conditions, we can be reasonably
certain that the study manipulations caused the differences. In
consideration of this comment and feedback from peer reviewers, we have
revised Question 6 (now Q7) to read, ``If you were considering
prescribing [DRUG] for [DISEASE], how useful would the information
[DISPLAY FILL] be?''
(Comment 13) One comment suggested deleting or revising Question 8
because it is unclear what it means for information to be ``credible''
in this context, and assessing credibility is very subjective.
(Response 13) To clarify, this question reads, ``How credible is
the information presented [DISPLAY FILL]?'' where [DISPLAY FILL] in
Condition 1 is ``on page 2,'' in Conditions 2, 3, and 4 is the text of
the disclosure condition to which they have been assigned, and in
Condition 5 is ``the material.'' Thus, the information on which
participants are being asked to give their opinion is specified. This
question has been used in other studies without difficulty. Cognitive
testing did not identify any difficulty with respondents' understanding
of ``credible'' in this context.
(Comment 14) One comment suggested amending questions that are
worded ``contradict or do not support'' because physicians may view a
lack of support (inconclusive findings) as different from contradictory
findings.
(Response 14) We did not intend for ``do not support'' to mean that
the findings are inconclusive, although we acknowledge that it could be
interpreted in such a way. Our intention was to refer to any findings
that do not support the off-label use, such as findings that the drug
is not effective for the off-label use or had increased risks. We
explored potential confusion by asking separate questions on the
concepts of ``contradict'' and ``inconclusive'' in cognitive testing.
Cognitive testing suggested that respondents generally considered
``findings that contradict'' and ``findings that have inconclusive
support'' to be very similar concepts. While respondents agreed that
the two were technically distinct, they tended to assess the two
similarly in this context. To gather additional empirical data, we will
retain these as separate items in the pretest.
(Comment 15) One comment suggests many of the questions use
unbalanced answer scales and recommends the answer scales should be
balanced. For example, it may be difficult for participants to
distinguish between ``A little'' and ``Somewhat'' or ``Very'' and
``Extremely.'' Relatedly, the positive and negative options are not
necessarily opposites (e.g., ``Agree'' or ``Disagree'') or parallel in
intensity (e.g., ``Strongly Agree'' or ``Strongly Disagree'').
(Response 15) We are not using a bipolar scale measuring opposites.
Bipolar scales are typically used when there are two opposing
possibilities (e.g., ``Strongly Agree'' or ``Strongly Disagree''). We
chose a unipolar scale (e.g., ``not at all important'' to ``extremely
important'') because the questions are asking about the relative
presence or absence of a quality. In the case of usefulness, for
instance, it makes more sense for the scale to begin with the absence
of usefulness (``not at all useful'') rather than the opposite of
usefulness (``extremely useless''). By beginning with ``Not at all,''
the order of the scale balances out the unidimensional nature of the
question (Ref. 7). In fact, a key advantage of a unipolar scale is that
it does not depend on defining opposites. The scale labels (i.e., ``Not
at all,'' ``A little,'' ``Somewhat,'' ``Very,'' and ``Extremely'') have
been tested in multiple studies, and evidence shows that participants
are able to distinguish between the response options (see, for example,
Ref. 8).
(Comment 16) One comment expressed a lack of clarity on how
Question 3 could yield interpretable responses and recommended
replacing this open-ended question with closed-ended questions.
(Response 16) Open-ended items are often used when the intention is
to understand respondents' comprehension (Ref. 9). By asking
respondents to rephrase the disclosure in their own words (as if
explaining to a colleague), we can assess whether respondents
understand the disclosure language as intended (Ref. 10). The responses
to open-ended items are qualitative data and will be analyzed to assess
what respondents feel to be key information (information included in
their summary), what they feel is extraneous information (information
not included in their summary), and any information that is confusing
or unclear (information summarized incorrectly in the summary).
(Comment 17) One comment suggested adding the following questions
to the questionnaire:
1. How often do you research and study off-label uses of approved
drugs in a given week? With possible answer choices being ``never,
rarely, occasionally, frequently.''
2. How often are drug products used off-label in your practice?
With possible answer choices being ``never, rarely, occasionally,
frequently.''
3. Would you prescribe this drug for (unapproved use of an approved
drug product)? With possible answer choices being: ``yes, no, need more
information.''
(Response 17) For the first suggested question, we currently assess
frequency of prescribing a drug off label (Q14) and the sources used to
learn about off-label uses (old Q15 and old Q16, now Q17, Q18, and
Q19). We think this combination of questions adequately covers the
concept of how often participants prescribe and look for information
about off-label uses. Regarding the response choices, the timeframe of
a week is very narrow, and would be difficult to answer for those who
prescribe off-label infrequently (e.g., a few times a year). In
response to the comment and external peer review comment, we have
revised response options for Q14 to be more specific (once a week or
more often, several times each month, several times each
[[Page 31323]]
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\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Pretest screener.............................. 290 1 290 0.08 (5 minutes)........................ 23
Pretest completes............................. 180 1 180 0.33 (20 minutes)....................... 59
Main study screener........................... 2,526 1 2,526 0.08 (5 minutes)........................ 202
Main study completes, Medical Condition 1..... 510 1 510 0.33 (20 minutes)....................... 168
Main study completes, Medical Condition 2..... 1,090 1 1,090 0.33 (20 minutes)....................... 360
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Total..................................... 1,600 .............. .............. ........................................ 812
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\1\ There 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without
asterisks are not on public display at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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. ``Distributing Scientific and Medical Publications on Unapproved
New Uses--Recommended Practices--Revised Draft Guidance,'' 2014.
<a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf">https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf</a>.
*2. ``Responding to Unsolicited Requests for Off-Label Information
About Prescription Drugs and Medical Devices Draft Guidance,'' 2011.
<a href="https://www.fda.gov/media/82660/download">https://www.fda.gov/media/82660/download</a>.
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 Action to Explain Physician Intention to
Prescribe Emergency Contraception.'' Perspectives on Sexual and
Reproductive Health, 38(1), pp. 20-27. <a href="https://www.guttmacher.org/journals/psrh/2006/using-theory-reasoned-action-explain-physician-intention-prescribe">https://www.guttmacher.org/journals/psrh/2006/using-theory-reasoned-action-explain-physician-intention-prescribe</a>.
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-
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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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