Agency Information Collection Activities; Proposed Collection; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising, 24997-25000 [2023-08686]
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or 360e) or section 351 of the PHS Act
(42 U.S.C. 262), or conditionally
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 2 concludes: (1) that an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that (A) the
product may be effective in diagnosing,
treating, or preventing (i) such disease
or condition; or (ii) a serious or lifethreatening disease or condition caused
by a product authorized under section
564, approved or cleared under the
FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating,
or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of
the product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product, taking
into consideration the material threat
posed by the agent or agents identified
in a declaration under section
564(b)(1)(D) of the FD&C Act, if
applicable; (3) that there is no adequate,
approved, and available alternative to
the product for diagnosing, preventing,
or treating such disease or condition; (4)
in the case of a determination described
in section 564(b)(1)(B)(ii), that the
request for emergency use is made by
the Secretary of Defense; and (5) that
such other criteria as may be prescribed
by regulation are satisfied. No other
criteria for issuance have been
prescribed by regulation under section
564(c)(4) of the FD&C Act.
III. The Authorization
Having concluded that the criteria for
the issuance of the following
Authorization under section 564(c) of
the FD&C Act are met, FDA has
authorized the emergency use of the
following product for diagnosing,
treating, or preventing COVID–19
subject to the terms of each
Authorization. The Authorization in its
entirety, including any authorized fact
sheets and other written materials, can
be accessed from the FDA web page
entitled ‘‘Emergency Use
Authorization,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The list includes the
Authorization issued on March 24,
2023, and we have included an
explanation of the reasons for the
issuance, as required by section
564(h)(1) of the FD&C Act. In addition,
any EUAs that have been reissued can
be accessed from FDA’s web page:
https://www.fda.gov/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/
emergency-use-authorization.
FDA is hereby announcing the
following Authorization for a molecular
diagnostic and antigen test for COVID–
19, excluding multianalyte tests: 3
• BioSynchronicity Corporation’s CSync COVID–19 Antigen Test, issued
March 24, 2023.
Dated: April 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08641 Filed 4–24–23; 8:45 am]
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2 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0795]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; A Survey on
Quantitative Claims in Direct-toConsumer Prescription Drug
Advertising
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 ‘‘A Survey on
Quantitative Claims in Direct-toConsumer Prescription Drug
Advertising.’’
SUMMARY:
Either electronic or written
comments on the collection of
information must be submitted by June
26, 2023.
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
June 26, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
II. Electronic Access
An electronic version of this
document and the full text of the
Authorization is available on the
internet and can be accessed from
https://www.fda.gov/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/
emergency-use-authorization.
24997
3 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19, and that the known and
potential benefits of the product, when used for
diagnosing COVID–19, outweigh the known and
potential risks of such product; and (3) there is no
adequate, approved, and available alternative to the
emergency use of the product.
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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
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Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
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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–
2023–N–0795 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; A Survey
on Quantitative Claims in Direct-toConsumer Prescription Drug
Advertising.’’ 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
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16:47 Apr 24, 2023
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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:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@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.
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
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collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
A Survey on Quantitative Claims in
Direct-to-Consumer Prescription Drug
Advertising
OMB Control Number 0910–NEW
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 mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the 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
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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-andresearch-cder/office-prescription-drugpromotion-opdp-research, which
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
Direct-to-consumer (DTC)
prescription drug advertising may make
quantitative claims about the drug’s
efficacy or risks (Ref. 1). Although there
is research and FDA guidance
(‘‘Presenting Quantitative Efficacy and
Risk Information in Direct-to-Consumer
Promotional Labeling and
Advertisements,’’ available at https://
www.fda.gov/media/117573/download)
that provides general guidelines for how
to present quantitative information, it is
not fully understood how consumers
will interpret specific quantitative
claims. We conducted a literature
review and found that while some types
of quantitative information are wellstudied (e.g., relative frequencies), many
questions remain on how best to
communicate certain quantitative
information about prescription drugs.
For example, we do not have sufficient
information about how consumers
interpret different claims describing
medians (e.g., ‘‘People treated with Drug
X lived for a median of 8 months’’ alone
or in combination with a definition such
as ‘‘In people receiving Drug X, this
means that about half lived more than
8 months and about half lived less than
8 months’’ or ‘‘A median is the middle
number in a group of numbers ordered
from smallest to largest’’). This study
aims to survey U.S. adults about their
interpretation of specific quantitative
claims.
We plan to use an address-based,
mixed-mode methodology that will
direct one randomly chosen member of
sampled households to complete a 20minute online survey, with
nonrespondents receiving a paper
questionnaire. The sample will be
representative of the U.S. population. A
sample of U.S. households will be
drawn from the U.S. Postal Service
Computerized Delivery Sequence File.
Adults aged 18 or over will be eligible
for participation. Up to four contacts
(mailings) will be sent to respondents by
U.S. mail. The contacts will include the
URL for the online survey and a unique
survey login. This unique survey login
will be used to track completed surveys
without the use of personally
identifying information. The contact
method, based on recent
recommendations (Ref. 2), includes a
prenotification letter (week 1), a web
survey invitation letter (soft launch in
week 2, full launch in week 3), a
reminder postcard sent to
nonresponders (week 5), and a final
mailing with the paper version of the
survey sent to nonresponders (Week 7).
We estimate a 40-percent response rate,
based on recent experience with similar
surveys. We estimate 1,100 respondents
will complete the main study (see table
1).
Based on previous research (Refs. 3, 4,
and 5), we plan to include a small
prepaid incentive in the second mailing
sent to the sampled addresses as a
gesture to encourage response and
maintain data quality. We expect that
approximately 5 percent of the sampled
addresses will be postal nondeliverable
returned letters from the first mailing
24999
(prenotification letter), so the second
mailing is estimated to go out to the
remaining addresses. We also will
conduct an experiment to assess the
efficacy of using a promised post-paid
incentive. Seventy-five percent of the
sample will be sent the promised
incentive upon completion of the
survey, and the remaining 25 percent of
the sample will not be notified of or
provided with any promised incentive.
We opted to split the sample 75–25
rather than 50–50 because the initial
evidence shows the benefits of
including a promised incentive (Refs. 4,
6, and 7), and we aimed to maximize
response rates.
The survey contains questions about
respondents’ perceptions and
understanding of several quantitative
claims drawn from DTC ads in the
marketplace. We will also measure other
potentially important variables, such as
demographics and numeracy. The
survey questions will be informed by
consumer feedback elicited in one-onone interviews (approved under OMB
control number 0910–0847). The survey
is available upon request from
DTCResearch@fda.hhs.gov.
We will test whether any variables
differed between modes (online versus
mail survey) and will account for any
mode effects in our analyses. We will
examine the descriptive statistics for the
survey items (e.g., frequencies and
percentages) and explore the
relationship between the survey items
and demographic and health
characteristics. We will weight the data
to account for different probability of
selection and nonresponse.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total
annual
responses
Read prenotification letter ...............................
Read web survey invitation letter 2 .................
Read reminder postcard .................................
Respond to survey (web and paper) ..............
2,993
2,843
2,585
1,100
1
1
1
1
2,993
2,843
2,585
1,100
Total .........................................................
........................
........................
........................
Average burden
per response
0.08
0.08
0.03
0.33
Total hours
(5 min.) .......................
(5 min.) .......................
(2 min.) .......................
(20 min.) .....................
239
227
78
363
.............................................
907
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
numbers assume around 5 percent postal nondeliverables from the prenotification letter and estimates nonrespondents for the subsequent mailings.
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2 The
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
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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.
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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
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Federal Register, but websites are
subject to change over time.
FOR FURTHER INFORMATION CONTACT:
* 1. Sullivan, H.W., K.J. Aikin, and L.B.
Squiers, ‘‘Quantitative Information on
Oncology Prescription Drug Websites,’’
Journal of Cancer Education vol. 33,
Issue 2, pp. 371–374, 2018. (https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC5334459/).
2. Dillman, D.A., J.D. Smyth, and L.M.
Christian, Internet, Phone, Mail, and
Mixed-Mode Surveys: The Tailored
Design Method, 4th ed., John Wiley &
Sons, Inc.: Hoboken, NJ, 2014.
* 3. Cheung, Y.T.D., X. Weng, M.P. Wang, et
al., ‘‘Effect of Prepaid and Promised
Financial Incentive on Follow-Up
Survey Response in Cigarette Smokers: A
Randomized Controlled Trial,’’ BMC
Medical Research Methodology, vol. 19,
Article 138, 2019. (https://
link.springer.com/article/10.1186/
s12874-019-0786-9)
4. Mercer, A., A. Caporaso, D. Cantor, et al.,
‘‘How Much Gets You How Much?
Monetary Incentives and Response Rates
in Household Surveys,’’ Public Opinion
Quarterly, vol. 79, pp. 105–129, 2015.
5. Sun, H., J. Newsome, J. McNulty, et al.,
‘‘What Works, What Doesn’t? Three
Studies Designed to Improve Survey
Response,’’ Field Methods, vol. 32, Issue
3, pp. 235–252, 2020. (https://doi.org/
10.1177/1525822X20915464).
6. Ellis, J., J. Charbonnier, C. Lowenstein, et
al., ‘‘Assessing the Impacts of Different
Incentives and Use of Postal Mail on
Response Rates,’’ American Association
for Public Opinion Research (AAPOR)
Conference, Chicago, IL, 2022, May.
* 7. Yu, S., H.E. Alper, A.M. Nguyen, et al.,
‘‘The Effectiveness of a Monetary
Incentive Offer on Survey Response
Rates and Response Completeness in a
Longitudinal Study,’’ BMC Medical
Research Methodology, vol. 17, Article
77, 2017. (https://bmcmedresmethodol.
biomedcentral.com/articles/10.1186/
s12874-017-0353-1).
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08686 Filed 4–24–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Modernization of Compliance Program
Guidance Documents
Office of Inspector General
(OIG), Department of Health and Human
Services (HHS).
ACTION: Notice.
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AGENCY:
This Federal Register notice
sets forth upcoming procedures for
issuing compliance program guidance
documents from HHS–OIG.
SUMMARY:
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Amanda Copsey, (202) 619–0335.
HHS–OIG is modernizing the
accessibility and usability of our
publicly available resources, including
OIG’s Compliance Program Guidances
(CPGs). OIG developed CPGs as
voluntary, nonbinding guidance
documents to encourage the
development and use of internal
controls to monitor adherence to
applicable statutes, regulations, and
program requirements. More
specifically, beginning in 1998, OIG
embarked on a major initiative to engage
the private health care community in
preventing the submission of erroneous
claims and in combating fraud and
abuse in Federal health care programs
through voluntary compliance efforts.
As part of that initiative, OIG developed
a series of CPGs directed at the
following segments of the health care
industry: (1) hospitals; 1 (2) home health
agencies; 2 (3) clinical laboratories; 3 (4)
third-party medical billing companies; 4
(5) the durable medical equipment,
prosthetics, orthotics, and supply
industry; 5 (6) hospices; 6 (7) Medicare
Advantage (formerly known as
Medicare+Choice) organizations; 7 (8)
nursing facilities; 8 (9) ambulance
suppliers; 9 (10) physicians; 10 and (11)
pharmaceutical manufacturers.11
Based on feedback received as part of
OIG’s Modernization Initiative and
other input,12 we understand that CPGs
have served as an important and
1 OIG Compliance Program Guidance for
Hospitals, 63 FR 8987 (Feb. 23, 1998);
Supplemental Compliance Program Guidance for
Hospitals, 70 FR 4858 (Jan. 31, 2005).
2 OIG Compliance Program Guidance for Home
Health Agencies, 63 FR 42410 (Aug. 7, 1998).
3 OIG Compliance Program Guidance for Clinical
Laboratories, 63 FR 45076 (Aug. 24, 1998).
4 OIG Compliance Program Guidance for ThirdParty Medical Billing Companies, 63 FR 70138 (Dec.
18, 1998).
5 OIG Compliance Program Guidance for the
Durable Medical Equipment, Prosthetics, Orthotics,
and Supply Industry, 64 FR 36368 (July 6, 1999).
6 OIG Compliance Program Guidance for
Hospices, 64 FR 54031 (Oct. 5, 1999).
7 OIG Compliance Program Guidance for
Medicare+Choice Organizations, 64 FR 61893 (Nov.
15, 1999).
8 OIG Compliance Program Guidance for Nursing
Facilities, 65 FR 14289 (Mar. 16, 2000); OIG
Supplemental Compliance Program Guidance for
Nursing Facilities, 73 FR 56832 (Sept. 30, 2008).
9 OIG Compliance Program Guidance for
Ambulance Suppliers, 68 FR 14245 (Mar. 24, 2003).
10 OIG Compliance Program Guidance for
Individual and Small Group Physician Practices, 65
FR 59434 (Oct. 5, 2000).
11 OIG Compliance Program Guidance for
Pharmaceutical Manufacturers, 68 FR 23731 (May
5, 2003).
12 See, e.g., Department of Health and Human
Services, Office of Inspector General, OIG
Modernization Initiative To Improve Its Publicly
Available Resources—Request for Information, 86
FR 53072 (Sept. 24, 2021).
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valuable OIG resource for the health
care compliance community and
industry stakeholders over the last 25
years. OIG has carefully considered
ways to improve and update existing
CPGs and to deliver new CPGs specific
to segments of the health care industry
or entities involved in the health care
industry that have emerged in the last
two decades. In modernizing OIG’s
CPGs, our goal is to produce useful,
informative resources—as timely as
possible—to help advance the industry’s
voluntary compliance efforts in
preventing fraud, waste, and abuse in
the health care system.
Through this Notice, OIG is notifying
the public of the following:
• OIG will no longer publish updated
or new CPGs in the Federal Register.
All current, updated, and new CPGs
will be available on our website.13
• OIG has developed a new format for
CPGs:
Æ We will publish a General CPG
(GCPG) that applies to all individuals
and entities involved in the health care
industry. The GCPG will address topics
such as: federal fraud and abuse laws,
compliance program basics, operating
effective compliance programs, and OIG
processes and resources. We anticipate
updating the GCPG as changes in
compliance practices or legal
requirements warrant. OIG plans to
publish the GCPG by the end of
calendar year 2023.
Æ Second, we will publish industryspecific CPGs (ICPGs) for different types
of providers, suppliers, and other
participants in health care industry
subsectors or ancillary industry sectors
relating to Federal health care programs.
ICPGs will be tailored to fraud and
abuse risk areas for each industry
subsector and will address compliance
measures that the industry subsector
participants can take to reduce these
risks. ICPGs are intended to be updated
periodically to address newly identified
risk areas and compliance measures and
to ensure timely and meaningful
guidance from OIG. OIG expects to
begin publishing ICPGs in calendar year
2024. Currently, OIG anticipates that the
first two ICPGs will address Medicare
Advantage and nursing facilities.
• When the new GCPG and ICPGs,
along with any updates to these
documents, are published on OIG’s
website, OIG will notify the public
using our public listserv 14 and other
communications platforms.
13 All CPGs issued to date are currently available
on the Compliance Guidance page of our website
at https://oig.hhs.gov/compliance/complianceguidance/ (last visited Mar. 6, 2023).
14 To join OIG’s listserv, visit https://
cloud.connect.hhs.gov/OIG/.
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24997-25000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0795]
Agency Information Collection Activities; Proposed Collection;
Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer
Prescription Drug Advertising
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 ``A Survey on
Quantitative Claims in Direct-to-Consumer Prescription Drug
Advertising.''
DATES: Either electronic or written comments on the collection of
information must be submitted by June 26, 2023.
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 June 26, 2023. 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
[[Page 24998]]
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-2023-N-0795 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; A Survey on Quantitative Claims
in Direct-to-Consumer Prescription Drug Advertising.'' 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug
Advertising
OMB Control Number 0910-NEW
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 mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the 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
[[Page 24999]]
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.
Direct-to-consumer (DTC) prescription drug advertising may make
quantitative claims about the drug's efficacy or risks (Ref. 1).
Although there is research and FDA guidance (``Presenting Quantitative
Efficacy and Risk Information in Direct-to-Consumer Promotional
Labeling and Advertisements,'' available at https://www.fda.gov/media/117573/download) that provides general guidelines for how to present
quantitative information, it is not fully understood how consumers will
interpret specific quantitative claims. We conducted a literature
review and found that while some types of quantitative information are
well-studied (e.g., relative frequencies), many questions remain on how
best to communicate certain quantitative information about prescription
drugs. For example, we do not have sufficient information about how
consumers interpret different claims describing medians (e.g., ``People
treated with Drug X lived for a median of 8 months'' alone or in
combination with a definition such as ``In people receiving Drug X,
this means that about half lived more than 8 months and about half
lived less than 8 months'' or ``A median is the middle number in a
group of numbers ordered from smallest to largest''). This study aims
to survey U.S. adults about their interpretation of specific
quantitative claims.
We plan to use an address-based, mixed-mode methodology that will
direct one randomly chosen member of sampled households to complete a
20-minute online survey, with nonrespondents receiving a paper
questionnaire. The sample will be representative of the U.S.
population. A sample of U.S. households will be drawn from the U.S.
Postal Service Computerized Delivery Sequence File. Adults aged 18 or
over will be eligible for participation. Up to four contacts (mailings)
will be sent to respondents by U.S. mail. The contacts will include the
URL for the online survey and a unique survey login. This unique survey
login will be used to track completed surveys without the use of
personally identifying information. The contact method, based on recent
recommendations (Ref. 2), includes a prenotification letter (week 1), a
web survey invitation letter (soft launch in week 2, full launch in
week 3), a reminder postcard sent to nonresponders (week 5), and a
final mailing with the paper version of the survey sent to
nonresponders (Week 7). We estimate a 40-percent response rate, based
on recent experience with similar surveys. We estimate 1,100
respondents will complete the main study (see table 1).
Based on previous research (Refs. 3, 4, and 5), we plan to include
a small prepaid incentive in the second mailing sent to the sampled
addresses as a gesture to encourage response and maintain data quality.
We expect that approximately 5 percent of the sampled addresses will be
postal nondeliverable returned letters from the first mailing
(prenotification letter), so the second mailing is estimated to go out
to the remaining addresses. We also will conduct an experiment to
assess the efficacy of using a promised post-paid incentive. Seventy-
five percent of the sample will be sent the promised incentive upon
completion of the survey, and the remaining 25 percent of the sample
will not be notified of or provided with any promised incentive. We
opted to split the sample 75-25 rather than 50-50 because the initial
evidence shows the benefits of including a promised incentive (Refs. 4,
6, and 7), and we aimed to maximize response rates.
The survey contains questions about respondents' perceptions and
understanding of several quantitative claims drawn from DTC ads in the
marketplace. We will also measure other potentially important
variables, such as demographics and numeracy. The survey questions will
be informed by consumer feedback elicited in one-on-one interviews
(approved under OMB control number 0910-0847). The survey is available
upon request from [email protected].
We will test whether any variables differed between modes (online
versus mail survey) and will account for any mode effects in our
analyses. We will examine the descriptive statistics for the survey
items (e.g., frequencies and percentages) and explore the relationship
between the survey items and demographic and health characteristics. We
will weight the data to account for different probability of selection
and nonresponse.
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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Read prenotification letter.............. 2,993 1 2,993 0.08 (5 min.)................................ 239
Read web survey invitation letter \2\.... 2,843 1 2,843 0.08 (5 min.)................................ 227
Read reminder postcard................... 2,585 1 2,585 0.03 (2 min.)................................ 78
Respond to survey (web and paper)........ 1,100 1 1,100 0.33 (20 min.)............................... 363
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Total................................ .............. .............. .............. ............................................. 907
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The numbers assume around 5 percent postal nondeliverables from the prenotification letter and estimates nonrespondents for the subsequent mailings.
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
[[Page 25000]]
Federal Register, but websites are subject to change over time.
* 1. Sullivan, H.W., K.J. Aikin, and L.B. Squiers, ``Quantitative
Information on Oncology Prescription Drug Websites,'' Journal of
Cancer Education vol. 33, Issue 2, pp. 371-374, 2018. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5334459/).
2. Dillman, D.A., J.D. Smyth, and L.M. Christian, Internet, Phone,
Mail, and Mixed-Mode Surveys: The Tailored Design Method, 4th ed.,
John Wiley & Sons, Inc.: Hoboken, NJ, 2014.
* 3. Cheung, Y.T.D., X. Weng, M.P. Wang, et al., ``Effect of Prepaid
and Promised Financial Incentive on Follow-Up Survey Response in
Cigarette Smokers: A Randomized Controlled Trial,'' BMC Medical
Research Methodology, vol. 19, Article 138, 2019. (https://link.springer.com/article/10.1186/s12874-019-0786-9)
4. Mercer, A., A. Caporaso, D. Cantor, et al., ``How Much Gets You
How Much? Monetary Incentives and Response Rates in Household
Surveys,'' Public Opinion Quarterly, vol. 79, pp. 105-129, 2015.
5. Sun, H., J. Newsome, J. McNulty, et al., ``What Works, What
Doesn't? Three Studies Designed to Improve Survey Response,'' Field
Methods, vol. 32, Issue 3, pp. 235-252, 2020. (https://doi.org/10.1177/1525822X20915464).
6. Ellis, J., J. Charbonnier, C. Lowenstein, et al., ``Assessing the
Impacts of Different Incentives and Use of Postal Mail on Response
Rates,'' American Association for Public Opinion Research (AAPOR)
Conference, Chicago, IL, 2022, May.
* 7. Yu, S., H.E. Alper, A.M. Nguyen, et al., ``The Effectiveness of
a Monetary Incentive Offer on Survey Response Rates and Response
Completeness in a Longitudinal Study,'' BMC Medical Research
Methodology, vol. 17, Article 77, 2017. (https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-017-0353-1).
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08686 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P
