[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26934-26936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0493]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Utilization of Adequate Provision Among Low to Non-
Internet Users

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 research entitled ``Utilization of Adequate 
Provision among Low to Non-Internet Users.''

DATES: Submit either electronic or written comments on the collection 
of information by August 11, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2017-N-0493 for ``Utilization of Adequate Provision among Low to 
Non-Internet Users.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For copies of the questionnaire: 
Office of Prescription Drug Promotion Research Team, 
[email protected]. For questions on the PRA: JonnaLynn Capezzuto, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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,

[[Page 26935]]

when appropriate, and other forms of information technology.

Utilization of Adequate Provision Among Low to Non-Internet Users; OMB 
Control Number 0910-NEW

I. Background

    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 (the 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.
    Prescription drug advertising regulations require that broadcast 
advertisements containing product claims present the product's major 
side effects and contraindications in either audio or audio and visual 
parts of the advertisement (21 CFR 202.1(e)(1)); this is often called 
the major statement. The regulations also require that broadcast 
advertisements contain a brief summary of all necessary information 
related to side effects and contraindications or that ``adequate 
provision'' be made for dissemination of the approved package labeling 
in connection with the broadcast (21 CFR 202.1(e)(1)). The requirement 
for adequate provision is generally fulfilled when a firm gives 
consumers the option of obtaining FDA-required labeling or other 
information via a toll-free telephone number, through print 
advertisements or product brochures, through information disseminated 
at health care provider offices or pharmacies, and through the Internet 
(Ref. 1). The purpose of including all four elements is to ensure that 
most of a potentially diverse audience can access the information.
    Internet accessibility is increasing, but many members of sensitive 
demographic groups (e.g., older adults, low socioeconomic status 
individuals) nonetheless report that the Internet is inaccessible to 
them either as a resource or due to limited knowledge, and so a Web 
site alone may not adequately serve all potential audiences (Refs. 2 
and 3). Similarly, some consumers may prefer to consult sources other 
than a health care provider to conduct initial research, for privacy 
reasons or otherwise (Refs. 1, 4, and 5). In light of these 
considerations, the 1-800 number and print ad may provide special value 
to consumers who are low to non-Internet users and/or those who value 
privacy when conducting initial research on a medication, though not 
necessarily unique value relative to one another. As such, a primary 
purpose of this research is to examine the value of including both the 
1-800 number and print ad as part of adequate provision in direct-to-
consumer (DTC) prescription drug broadcast ads. Secondarily, we will 
also investigate the ability and willingness of low to non-Internet 
users to make use of Internet resources if other options were 
unavailable. These questions will be assessed using a survey 
methodology administered via telephone.
    In addition, building on concurrent FDA research regarding drug 
risk information,\1\ we will assess risk perceptions as influenced by 
opening statements that could be used to introduce risks in DTC 
prescription drug broadcast ads. Opening statements may be used to 
frame risk information that follows. As such, consumers may interpret 
the likelihood, magnitude, and duration of risks differently depending 
on how those risks are introduced (Refs. 6-9). The intended outcome of 
this component of the research is to evaluate the influence of these 
opening statements within a sample of low to non-Internet users. This 
research question will be addressed using a 1 x 3 between-subjects 
experimental design embedded in the previously mentioned survey. This 
particular component of the research will serve as an exploratory test 
intended to inform FDA's future research efforts.
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    \1\ https://www.federalregister.gov/documents/2015/01/13/2015-00269/agency-information-collection-activities-submission-for-office-of-management-and-budget-review.
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    Sampling Frame. Given that older adults (i.e., those aged 65 and 
older) are among the largest consumers of prescription drugs (Ref. 10) 
and that approximately 41 percent of older adults do not use the 
Internet (Ref. 2), investigating use of adequate provision in this 
population is especially important. Also of concern, 34 percent of 
those with less than a high school education do not use the Internet, 
23 percent of individuals with household incomes lower than $30,000 per 
year do not use the Internet, and 22 percent of individuals living in 
rural areas do not use the Internet (Ref. 2). These estimates capture 
non-Internet users, and so consideration of low-Internet users warrants 
additional concern. Consistent with these citations, the present 
research will utilize a nationally representative sample of low to non-
Internet users from these and other relevant demographic groups.
    Data collection will utilize a random digit dialing (RDD) sample 
that has been pre-identified as being a non-Internet household, or 
having at least one non-Internet using member. This sample solution is 
ideal because it relies on a dual-frame (landline and cell phone) 
probability-sample, yet has the advantage of prior knowledge of those 
who are likely to be low to non-Internet users (re-screening will 
verify this). The Social Science Research Solutions (SSRS) Omnibus, 
within which this survey will be embedded, utilizes a sample designed 
to represent the entire adult U.S. population, including Hawaii and 
Alaska, and including bilingual (Spanish-speaking) respondents. As 
reflected in the overall population of low to non-Internet users, we 
intend to collect a small sample of Spanish-speaking individuals, which 
comprise a subsample of the regular landline and cell phone RDD 
sampling frames. We may also screen for past and present prescription 
drug use in order to ensure a motivated sample.
    Survey Protocol. This survey will be conducted by telephone on 
landline and cell phones, with an expected 50 to 60 percent of 
interviews conducted on cell phones. Interviewing for the pretest and 
main study will be conducted via SSRS's computer-assisted telephone 
interviewing (CATI) system. We expect to achieve a roughly 40 percent 
survey completion rate from the pre-identified respondents to be 
sampled in this study, given an 8-week field period and a maximum of 10 
attempts to reach respondents. The original SSRS Omnibus from which 
this sample is derived receives an approximately 8 to 12 percent 
response rate. These are not uncommon response rates for high-quality 
surveys and have been found to yield accurate estimates (Refs. 11 and 
12).
    As communicated earlier, the primary focus of interview questions 
concern the ability and willingness of low to non-Internet users to 
utilize the various components of adequate provision, particularly the 
1-800 number and print ad components. In addition to these questions, 
experimental manipulations will be embedded in the survey as an 
exploratory test to assess the impact of opening statements that could 
be used to introduce risks in DTC prescription drug broadcast ads, 
which is a related concept. To form the experimental manipulations, 
participants will be presented with a statement of major risks and side 
effects (``the major statement'') drawn from a real prescription drug 
product, but modified to include only serious and actionable risks. 
Preceding this description of major risks will be one of three opening 
statements: (1) ``[Drug] can cause severe, life threatening reactions. 
These include

[[Page 26936]]

. . .''; (2) ``[Drug] can cause serious reactions. These include . . 
.''; or (3) ``[Drug] can cause reactions. These include . . .'' All 
risk statements will conclude with the following language: ``This is 
not a full list of risks and side effects. Talk to your doctor and read 
the patient labeling for more information.'' Participants will be 
randomly assigned to experimental condition, and all manipulations will 
be pre-recorded to allow for consistent administration. Following 
exposure to these manipulations, participants will respond to several 
questions designed to assess risk perceptions.
    Before the main study, we will execute a pretest with a sample of 
25 participants from the same sampling frame as outlined in this 
document. The pretest questionnaire will take approximately 15 minutes 
to complete. The goal of the pretest will be to assess the 
questionnaire's format and the general protocol to ensure that the main 
study is ready for execution. To test the protocol among the target 
groups, we will seek to recruit a mix of participants based on 
demographic and other characteristics of interest. We do not plan to 
use incentives for the pretest or main study portions of this survey. 
However, upon request, cell phone respondents may be offered $5 to 
cover the cost of their cell phone minutes.
    Questionnaire development is an iterative process and so the main 
study questionnaire will include any changes from pretesting, as well 
as other outcomes, such as OMB and public comments, or cognitive 
interviewing. Like pretesting, the main study questionnaire should take 
approximately 15 minutes to complete. Based on a power analyses, the 
main study sample will include approximately 1,996 participants. This 
sample size will allow us to draw statistical comparisons between the 
various demographic groups in the sample.
    Measurement and Planned Analyses. Consistent with the larger 
purpose of the study, survey questions will examine access, technical 
ability, and willingness to use adequate provision options; preference 
for and experience using adequate provision options; privacy concerns; 
and potentially other secondary questions of interest. In addition, to 
assess the impact of the experimental manipulations, survey questions 
will assess perceived risk likelihood, perceived risk magnitude, and 
perceived risk duration. Demographic information will also be 
collected. To examine differences between experimental conditions, we 
will conduct inferential statistical tests such as analysis of 
variance. A copy of the draft questionnaire is available upon request.
    FDA estimates the burden of this collection of information as 
follows:

                                                         Table 1--Estimated 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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Pretest Screener...............................              63               1              63  0.05 (3 minutes).......................            3.15
Pretest Survey.................................              25               1              25  0.25 (15 minutes)......................            6.25
Main Study Screener............................           4,990               1           4,990  0.05 (3 minutes).......................           249.5
Main Study Survey..............................           1,996               1           1,996  0.25 (15 minutes)......................             499
                                                --------------------------------------------------------------------------------------------------------
    Total Hours................................  ..............  ..............  ..............  .......................................           757.9
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

II. References

1. U.S. Department of Health and Human Services, Food and Drug 
Administration (1999). ``Guidance for Industry: Consumer-Directed 
Broadcast Advertisements.'' Available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125039.htm.
2. Anderson, M. and A. Perrin (2016). ``13% of Americans Don't Use 
the Internet: Who Are They?'' Pew Research Center. Available at 
http://www.pewresearch.org/fact-tank/2016/09/07/some-americans-dont-use-the-internet-who-are-they/.
3. U.S. Department of Commerce, U.S. Census Bureau (2013). 
``Computer and Internet Use in the United States: Population 
Characteristics.'' Available at https://www.census.gov/prod/2013pubs/p20-569.pdf.
4. Fox, S. and L. Rainie (2002). ``Vital Decisions: How Internet 
Users Decide What Information to Trust When They or Their Loved Ones 
Are Sick. Pew Internet & American Life Project.'' Available at 
http://www.pewinternet.org/2002/05/22/main-report-the-search-for-online-medical-help/.
5. DeLorme, D. E., J. Huh, and L. N. Reid (2011). ``Source Selection 
in Prescription Drug Information Seeking and Influencing Factors: 
Applying the Comprehensive Model of Information Seeking in an 
American Context.'' Journal of Health Communication, 16: pp. 766-
787.
6. O'Donoghue, A. C., H. W. Sullivan, K. J. Aikin, et al. (2014). 
``Important Safety Information or Important Risk Information? A 
Question of Framing in Prescription Drug Advertisements.'' 
Therapeutic Innovation and Regulatory Science, 48: pp. 305-307. doi: 
10.1177/2168479013510306
7. Kahneman, D. (2011). Thinking, Fast and Slow. New York, NY: 
Farrar, Straus, and Giroux.
8. Rothman, A. J. and P. Salovey (1997). ``Shaping Perceptions To 
Motivate Healthy Behavior: The Role of Message Framing.'' 
Psychological Bulletin, 121: pp. 3-19.
9. Armstrong, K., J. S. Schwartz, G. Fitzgerald, et al. (2002). 
``Effect of Framing as Gain Versus Loss on Understanding and 
Hypothetical Treatment Choices: Survival and Mortality Curves.'' 
Medical Decision Making, 22: pp. 76-83.
10. National Center for Health Statistics. ``Health, United States, 
2015: With Special Feature on Racial and Ethnic Health 
Disparities.'' Hyattsville, MD. 2016.
11. Brick, J. M. and D. Williams (2013). ``Explaining Rising 
Nonresponse Rates in Cross-Sectional Surveys.'' The Annals of the 
American Academy of Political and Social Science, 645: pp. 36-59.
12. Groves, R. M. (2006). ``Nonresponse Rates and Nonresponse Bias 
in Household Surveys.'' Public Opinion Quarterly, 70: pp. 646-675.

    Dated: June 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12067 Filed 6-9-17; 8:45 am]
 BILLING CODE 4164-01-P