Notice2024-17646
Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Provider Survey of Topics Related to Prescription Drug Promotion
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Published
August 8, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) 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 information collection associated with a proposed study entitled "Healthcare Provider Survey of Topics Related to Prescription Drug Promotion."
Full Text
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<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
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[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64923-64925]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17646]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2603]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Healthcare Provider Survey of Topics Related to
Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection associated with a proposed
study entitled ``Healthcare Provider Survey of Topics Related to
Prescription Drug Promotion.''
DATES: Either electronic or written comments on the collection of
information must be submitted by October 7, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 7, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2024-N-2603 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Healthcare Provider Survey of
Topics Related to Prescription Drug Promotion.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#a9f9fbe8faddc8cfcfe9cfcdc887c1c1da87cec6df"><span class="__cf_email__" data-cfemail="b5e5e7f4e6c1d4d3d3f5d3d1d49bddddc69bd2dac3">[email protected]</span></a>.
The draft survey instrument is available upon request from
<a href="/cdn-cgi/l/email-protection#591d0d1a2b3c2a3c382b3a31193f3d387731312a773e362f"><span class="__cf_email__" data-cfemail="17534354657264727665747f57717376397f7f6439707861">[email protected]</span></a>.
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
[[Page 64924]]
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.
Healthcare Provider Survey of Topics Related to Prescription Drug
Promotion
OMB Control Number 0910--NEW
I. Background
This information collection request supports Agency research
authorized by section 1701(a)(4) of the Public Health Service Act (42
U.S.C. 300u(a)(4)) and section 1003(d)(2)(C) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)).
The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated, so that
patients and healthcare providers can make informed decisions about
treatment options. 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 the characteristics of the disease and
product 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. 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.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings are 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 at
<a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research</a>, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
This current project will be a survey with a selection of
prescribers examining a variety of topics of interest to OPDP. The
prescriber sample will be primary care physicians (PCPs) (in family
practice, general practice, or internal medicine), nurse practitioners
and physician assistants (NP/PAs), and specialists (cardiology,
dermatology, endocrinology, neurology, obstetrics/gynecology, oncology,
ophthalmology, psychiatry, rheumatology, and urology). Topics we plan
to assess include, but are not limited to, awareness and use of the Bad
Ad program (Refs. 1 and 2), understanding of quantitative data displays
that may appear in prescription drug promotion (Refs. 3 and 4),
perceptions of trust in FDA, perceptions of medical misinformation
(Refs. 5 and 6), and attitudes about prescription drug promotion on
social media (Refs. 7 and 8). These topics were selected to extend
previous FDA work on healthcare provider understanding of quantitative
data displays, provide an updated snapshot of social media attitudes
and Bad Ad program awareness, and help inform FDA's role in addressing
medical misinformation (Ref. 9).
We estimate that participation in the survey will take
approximately 20 minutes. Our target respondents are adult voluntary
participants who are PCPs, NP/PAs, or specialists engaging in patient
care at least half time, with a range of gender, race and ethnicity,
and ages that reflects the composition of the American Medical
Association. Participants will be recruited by email through an
internet panel, and participant eligibility will be determined with a
screener at the beginning of the online survey. We will exclude
individuals who are employees of the Department of Health and Human
Services and individuals who work for a marketing, advertising, or
pharmaceutical firm.
The target sample size for the survey is 2,410 respondents. Before
conducting the survey, we will conduct up to two pretests. If the first
pretest wave reveals that changes to the measurement instruments,
stimuli, or procedures are required, a second pretest wave will be
conducted with revised materials. The target sample size for Pretest 1
is 75 respondents and for Pretest 2 is 50 respondents.
We estimate 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 Total
respondents respondent responses response \2\ hours
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Pretest 1 Screener \3\........ 150 1 150 0.08 (5 minutes)........ 12
Pretest 1..................... 75 1 75 0.33 (20 minutes)....... 25
Pretest 2 Screener 3 4........ 100 1 100 0.08 (5 minutes)........ 8
Pretest 2 \4\................. 50 1 50 0.33 (20 minutes)....... 17
Survey Screener \3\........... 4,820 1 4,820 0.08 (5 minutes)........ 386
Survey \5\.................... 2,410 1 2,410 0.33 (20 minutes)....... 795
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Total..................... 5,070 .............. .............. ........................ 1,243
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
\3\ Number of screener respondents assumes a 50 percent eligibility rate with targeted recruitment.
\4\ Pretest 2 will be conducted only if changes to study materials are made in response to the findings of
Pretest 1.
\5\ Sample size is based on power analysis and designed to accommodate a within-survey test of recruitment
language.
II. References
The following references 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; these are not
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a> as these
references are copyright protected. Some may be available at the
website address, if listed. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.
1. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al.,
``Awareness of the Food and Drug Administration's Bad Ad Program and
Education Regarding Pharmaceutical Advertising: A National Survey of
Prescribers in Ambulatory Care Settings,'' Journal of Health
Communication, vol. 20, issue 11, pp. 1330-1336, 2015, doi:10.1080/
10810730.2015.1018649.
2. Betts, K.R., A.C. O'Donoghue, M. Johnson, et al., ``Detecting
and Reporting Deceptive Prescription Drug Promotion: Differences
Across Consumer and Physician Audiences and by Number and Type of
Deceptive Claims and Tactics,'' Health Communication, vol. 37, issue
13, pp. 1609-1621, 2022, doi:10.1080/10410236.2021.1909264.
3. Thompson, J., M. Lynch, H.W. Sullivan, et al., ``Complexity
of Data Displays in Prescription Drug Advertisements for Healthcare
Providers,'' Therapeutic Innovation & Regulatory Science, vol. 57,
issue 4, pp. 712-716, 2023, doi:10.1007/s43441-023-00523-3.
4. Thompson, J., R.C. Wines, M. Brewington, et al., ``Healthcare
Providers' Understanding of Data Displays of Clinical Trial
Information: A Scoping Review of the Literature,'' Journal of
Communication in Healthcare, vol. 16, issue 3, pp. 260-267, 2023,
doi:10.1080/17538068.2022.2150236.
5. Goldwire, M.A., S.T. Johnson, M. Abdalla, et al., ``Medical
Misinformation: A Primer and Recommendations for Pharmacists,''
Journal of the American College of Clinical Pharmacy, vol. 6, issue
5, pp. 497-511, 2023, doi:10.1002/jac5.1760.
6. Boudewyns, V., B.G. Southwell, K.R. Betts, et al.,
``Awareness of Misinformation in Health-Related Advertising: A
Narrative Review of the Literature,'' Misinformation and Mass
Audiences, edited by B.G. Southwell, E.A. Thorson, and L. Sheble,
University of Texas Press, 2018.
7. Campbell, B.C. and C.M. Craig, ``Social Media and Health:
Current and Future Healthcare Provider Perspectives,'' Journal of
Contemporary Medical Education, vol. 2, issue 2, pp. 128-133, 2014,
doi:10.5455/jcme.20140515123200.
8. Betts, K.R., A.C. O'Donoghue, K.J. Aikin, et al.,
``Professional Online Community Membership and Participation Among
Healthcare Providers: An Extension to Nurse Practitioners and
Physician Assistants,'' Journal of the American Association of Nurse
Practitioners, vol. 28, issue 12, pp. 639-645, 2016, doi:10.1002/
2327-6924.12383.
9. Califf, R.M., ``Speech by Commissioner Robert M. Califf to
the House of Medicine,'' June 16, 2023, <a href="https://www.fda.gov/news-events/speeches-fda-officials/speech-commissioner-robert-m-califf-house-medicine-06162023">https://www.fda.gov/news-events/speeches-fda-officials/speech-commissioner-robert-m-califf-house-medicine-06162023</a>.
Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17646 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P
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