[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64923-64925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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: 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, 
[email protected].
    The draft survey instrument 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

[[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 
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, 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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[[Page 64925]]

 
    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 https://www.regulations.gov 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, https://www.fda.gov/news-events/speeches-fda-officials/speech-commissioner-robert-m-califf-house-medicine-06162023.

    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