[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60254-60256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 
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: 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, 
[email protected].
    For copies of the questionnaire: Office of Prescription Drug 
Promotion (OPDP) Research Team, [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

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