Notice2021-23731
Agency Information Collection Activities; Proposed Collection; Comment Request; Text Analysis of Proprietary Drug Name Interpretations
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Published
November 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 a proposed study entitled "Text Analysis of Proprietary Drug Name Interpretations."
Full Text
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<title>Federal Register, Volume 86 Issue 208 (Monday, November 1, 2021)</title>
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[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60254-60256]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23731]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1026]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Text Analysis of Proprietary Drug Name Interpretations
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 a proposed study entitled ``Text Analysis
of Proprietary Drug Name Interpretations.''
DATES: Submit either electronic or written comments on the collection
of information by January 3, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 3, 2022. 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 January 3, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<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-2021-N-1026 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Text Analysis of Proprietary Drug
Name Interpretations.'' 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: 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#8bc2e7eaa5c6e2f1f9eae8e3e2cbedefeaa5e3e3f8a5ece4fd"><span class="__cf_email__" data-cfemail="b7fedbd699fadecdc5d6d4dfdef7d1d3d699dfdfc499d0d8c1">[email protected]</span></a>.
For copies of the questionnaire: Office of Prescription Drug
Promotion (OPDP) Research Team, <a href="/cdn-cgi/l/email-protection#7f3b2b3c2d1a0c1a1e0d1c173f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="1f5b4b5c4d7a6c7a7e6d7c775f797b7e3177776c31787069">[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 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
[[Page 60255]]
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.
Text Analysis of Proprietary Drug Name Interpretations
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 Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: (1) Advertising features,
including content and format; (2) target populations; and (3) 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 research data through
analytical methodology development and investigation of sampling and
response issues. This study will inform all three topic areas.
Because we recognize 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 home page,
which can be found 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>. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
As part of the prescription drug regulatory review process,
sponsors propose proprietary names for their products. These names
undergo a proprietary name review that involves the Office of Drug
Safety, the relevant medical office, and OPDP. OPDP reviews names to
assess for alignment with the FD&C Act, which provides, among other
things, that labeling can misbrand a product if false or misleading
representations are made (see 21 U.S.C. 321(n) and 352(a)). A
proprietary name that appears in labeling could result in such
misbranding if it is false or misleading. OPDP reviews, among other
things, whether names: (1) Overstate the efficacy or safety of the
drug; (2) suggest drug indications that are not accurate; (3) suggest
superiority without substantiation; or (4) are of a fanciful nature
that misleadingly implies unique effectiveness or composition. It would
be helpful in OPDP's review of promotional implications of proprietary
names for data on consumer and prescriber interpretations of proposed
proprietary names to be more readily available for consideration. The
proposed research will utilize text analysis (e.g., topic modeling and
sentiment analysis) to ascertain how consumer and primary care
physician (PCP) populations interpret prescription drug names, which
will assist OPDP's consideration of promotional implications.
This proposed research builds upon and extends OPDP research
entitled ``Empirical Study of Promotional Implications of Proprietary
Prescription Drug Names'' (86 FR 14440). That research involves an
experimental design intended to assess names that potentially overstate
the efficacy of a product. In contrast, the proposed research involves
a survey design that comprises primarily open-ended questions intended
to generate text for analysis, an approach that is unrestricted in its
ability to assess different types of promotional implications (e.g.,
minimization of risk and unsubstantiated superiority, in addition to
overstatement of efficacy). The proposed research will add to the depth
and breadth of knowledge we can draw from during the review of proposed
proprietary drug names.
The key objectives of the proposed research are as follows:
1. To apply new techniques such as topic modeling and sentiment
analysis (forms of text analysis) to answer OPDP's research
questions about consumer and PCP interpretations of proprietary
prescription drug names.
2. To help develop a methodological approach for assessing
consumer and prescriber interpretations of drug names, which can
potentially be used in the future as a standard assessment tool.
Our methodological approach will involve nationally representative
samples. Consumers will be recruited from Ipsos Public Affairs
KNOWLEDGEPANEL. PCPs will be recruited using a two-stage approach that
will begin with a purchased list of PCPs based on the American Medical
Association Physician Masterfile. These members will then be matched to
one or more sample provider lists to recruit PCP participants for this
study. We propose a sample of 300 consumers and 300 PCPs for the main
study. We have designed a within-subjects experiment in which
participants will be exposed to multiple drug names to maximize power
to find differences with this sample size. The stimuli will comprise 60
experimental names and 60 control names. Participants will be
randomized to 1 of 10 groups so that no one responds to more than 12
names in total. Each participant will see six experimental names and
six control names. The experimental names will be names with suspected
promotional implications, whereas the control names will not have
suspected promotional implications. Names will be viewed in random
order. Participants will respond in open-ended text boxes about their
perceptions of each drug name. Supplementary closed-ended questions may
also be presented. We will conduct text analysis of the responses and
present descriptive results for individual drug names by participant
cohort (i.e., consumers vs. PCPs), and
[[Page 60256]]
we will also code and compare responses across types of drug names.
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 respondents responses per Total annual responses Average burden per response Total
respondent hours
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General Consumer Population
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Pretest 1 screener (assumes 80% 22........................... 1 22.......................... 0.08 (5 minutes).............. 1.8
eligible).
Pretest 1 survey................. 15 + 10% \2\ = 17............ 1 15 + 10% \2\ = 17........... 0.33 (20 minutes)............. 5.6
Pretest 2 screener (assumes 80% 22........................... 1 22.......................... 0.08 (5 minutes).............. 1.8
eligible).
Pretest 2 survey................. 15 + 10% \2\ = 17............ 1 15 + 10% \2\ = 17........... 0.33 (20 minutes)............. 5.6
Main study screener completes 413.......................... 1 413......................... 0.08 (5 minutes).............. 33
(assumes 80% eligible).
Main study survey completes...... 300 + 10% \2\ = 330.......... 1 300 + 10% \2\ = 330......... 0.33 (20 minutes)............. 108.9
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PCP Population
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Pretest 1 screener (assumes 30% 57........................... 1 57.......................... 0.08 (5 minutes).............. 4.6
eligible).
Pretest 1 survey................. 15 + 10% \2\ = 17............ 1 15 + 10% \2\ = 17........... 0.33 (20 minutes)............. 5.6
Pretest 2 screener (assumes 30% 57........................... 1 57.......................... 0.08 (5 minutes).............. 4.6
eligible).
Pretest 2 survey................. 15 + 10% \2\ = 17............ 1 15 + 10% \2\ = 17........... 0.33 (20 minutes)............. 5.6
Main study screener completes 1,100........................ 1 1,100....................... 0.08 (5 minutes).............. 88
(assumes 30% eligible).
Main study survey completes...... 300 + 10% \2\ = 330.......... 1 300 + 10% \2\ = 330......... 0.33 (20 minutes)............. 108.9
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Total........................ ............................. .............. ............................ .............................. 374
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target
number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated
approximately 10 percent overage for both samples in the study.
Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23731 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P
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