[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78163-78166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3585]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Character-Space-Limited Online Prescription Drug 
Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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, ``Character-Space-
Limited Online Prescription Drug Communications.'' The objective of 
this research is to test whether a link to prescription drug risk 
information can effectively convey the risks associated with a drug 
when benefit claims about that drug are made within character-space-
limited communications used in prescription drug promotion.

DATES: Submit either electronic or written comments on the collection 
of information by January 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2016-N-3585 for ``Character-Space-Limited Online Prescription Drug 
Communications.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    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

[[Page 78164]]

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.

Character Space-Limited Online Prescription Drug Communications, OMB 
Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the 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 regulations require a fair balance of the content 
and prominence of risk and benefit information in prescription drug 
product claim promotion. The rise of Internet communications that have 
character space limitations, such as sponsored link promotion and 
microblog messaging, has led to questions about how to use these 
communications for prescription drug promotion while complying with the 
fair balance requirements. In 2014, FDA released a draft guidance 
entitled, ``Guidance for Industry Internet/Social Media Platforms with 
Character Space Limitations--Presenting Risk and Benefit Information 
for Prescription Drugs and Medical Devices,'' (Ref. 1) which states:

    Regardless of character space constraints that may be present on 
certain Internet/social media platforms, if a firm chooses to make a 
product benefit claim, the firm should also incorporate risk 
information within the same character-space-limited communication. 
The firm should also provide a mechanism to allow direct access to a 
more complete discussion of the risks associated with its product.

    The concept of linking to risk information by providing substantive 
product risk information on a landing page (``link to the risk 
information''), rather than presenting risk information together with 
product benefit information within the character-space-limited 
communication, has been the subject of legislation and has been 
discussed as an option by some in industry and media (for example, 
Refs. 2-5).
    The studies are designed to address the question of whether 
substantive risk information in the character-space-limited 
communications is effective in communicating risks when benefit claims 
are made, or whether a link to the risk information is sufficient. 
Within each study, we will manipulate whether or not substantive risk 
information appears in the character-space-limited communication.
    Another factor to consider is that when consumers turn to the 
Internet for information, they are driven by different goals. These 
goals can affect what information they pay attention to and what kind 
of information they find (Refs. 6-8). Therefore, we will also 
manipulate whether participants are instructed to browse the 
information or to search for specific information.
    Two pretests will be conducted to test the goal instructions, 
stimuli, questionnaire, and procedure. In Studies 1-4, participants 
will be randomly assigned to one experimental condition and will view 
the corresponding study materials (Tables 1-4). Across all studies, we 
will examine two different character-space-limited formats and two 
medical conditions. For Pretest 1 and Study 1, the study materials will 
be a character-space-limited communication about a fictional weight 
loss drug, embedded in a Google search page about weight loss. The 
Study 2 materials will be a character-space-limited communication about 
a fictional drug to treat migraine, embedded in a Google search page 
about migraine. The Study 3 materials will be a character-space-limited 
communication about a fictional weight loss drug, embedded in a Twitter 
search page about weight loss. The Pretest 2 and Study 4 materials will 
be a character-space-limited communication about a fictional drug to 
treat migraine, embedded in a Twitter search page about migraine.
    All study materials will allow for scrolling and clicking on any 
links. The study materials will be accessible by participants only. 
After viewing the study materials, participants will complete a 
questionnaire that assesses participants' retention of the risk 
information and their perceptions of the drug's risks and benefits. We 
will also measure covariates such as demographics and literacy. The 
questionnaires are available upon request.
    We hypothesize that participants who see substantive risk 
information in the character-space-limited communication, compared with 
link-only participants, will have greater retention of the risk 
included in the communication and higher perceived risk. We will 
explore whether including substantive risk information in the 
character-space-limited communication affects the likelihood that 
participants notice the communication or click the link to the risk 
information. We hypothesize that participants with a search goal, 
compared with a browse goal, will have greater retention of the benefit 
and risk information and higher perceived risk because they will be 
more likely to notice the character-space-limited communication and to 
click the link to the risk information. We will test these hypotheses 
in Studies 1-4 to determine whether these effects hold across different 
medical conditions and different character-space-limited platforms. To 
test these hypotheses, we will conduct inferential statistical tests 
such as logistic regression and analysis of variance.
    All participants will be 18 years of age or older. We will exclude 
individuals who work in healthcare or marketing. Half of the studies 
will have a sample of participants who self-report needing to lose 30 
pounds or more; the other half will have a sample of participants who 
self-report suffering from migraines. We selected these samples to 
increase the likelihood that participants will be interested in the 
fictitious study drugs and therefore motivated to pay attention during 
the study. The studies will be conducted with an Internet panel. With 
the sample sizes described below, we will have sufficient power to 
detect small-sized effects in Studies 1-4 (Table 5).

[[Page 78165]]



          Table 1--Study 1: Google Sponsored Link, Weight Loss
------------------------------------------------------------------------
                                                       Goal
                                         -------------------------------
                                              Browse          Search
------------------------------------------------------------------------
Risk Location:
    In character-space-limited            ..............  ..............
     communication......................
    On landing page only................  ..............  ..............
------------------------------------------------------------------------


            Table 2--Study 2: Google Sponsored Link, Migraine
------------------------------------------------------------------------
                                                       Goal
                                         -------------------------------
                                              Browse          Search
------------------------------------------------------------------------
Risk Location:
    In character-space-limited            ..............  ..............
     communication......................
    On landing page only................  ..............  ..............
------------------------------------------------------------------------


                 Table 3--Study 3: Twitter, Weight Loss
------------------------------------------------------------------------
                                                       Goal
                                         -------------------------------
                                              Browse          Search
------------------------------------------------------------------------
Risk Location:
    In character-space-limited            ..............  ..............
     communication......................
    On landing page only................  ..............  ..............
------------------------------------------------------------------------


                   Table 4--Study 4: Twitter, Migraine
------------------------------------------------------------------------
                                                       Goal
                                         -------------------------------
                                              Browse          Search
------------------------------------------------------------------------
Risk Location:
    In character-space-limited            ..............  ..............
     communication......................
    On landing page only................  ..............  ..............
------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 5--Estimated Annual Reporting Burden \1\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Pretest 1 screener............             464               1               1  .08 (5 min.)....              39
Pretest 2 screener............             464               1               1  .08 (5 min.)....              39
Study 1 screener..............             786               1               1  .08 (5 min.)....              66
Study 2 screener..............             786               1               1  .08 (5 min.)....              66
Study 3 screener..............             786               1               1  .08 (5 min.)....              66
Study 4 screener..............             786               1               1  .08 (5 min.)....              66
Pretest 1.....................             277               1               1  .33 (20 min.)...              93
Pretest 2.....................             277               1               1  .33 (20 min.)...              93
Study 1.......................             469               1               1  .33 (20 min.)...             157
Study 2.......................             469               1               1  .33 (20 min.)...             157
Study 3.......................             469               1               1  .33 (20 min.)...             157
Study 4.......................             469               1               1  .33 (20 min.)...             157
                               ------------------------------------------------                  ---------------
    Total.....................           6,502  ..............  ..............  ................           1,156
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.


[[Page 78166]]


1. Guidance for Industry: Internet/Social Media Platforms with 
Character Space Limitations--Presenting Risk and Benefit Information 
for Prescription Drugs and Medical Devices, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401087.pdf.
2. https://www.congress.gov/bill/114th-congress/house-bill/2479/text.
3. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htm.
4. http://www.politico.com/story/2015/06/at-the-fda-drugs-and-tweets-dont-mix-118693.
5. http://www.dtcperspectives.com/is-one-click-in-the-cards/.
6. Detlor, B., S. Sproule, and C. Gupta, ``Pre-Purchase Online 
Information Seeking: Search Versus Browse.'' Journal of Electronic 
Commerce Research, vol. 4, pp. 72-84, 2003.
7. Pieters, R. and M. Wedel, ``Goal Control of Attention to 
Advertising: The Yarbus Implication.'' Journal of Consumer Research, 
vol. 34, pp. 224-233, 2007.
8. Schlosser, A. E., ``Experiencing Products in the Virtual World: 
The Role of Goal and Imagery in Influencing Attitudes Versus 
Purchase Intentions.'' Journal of Consumer Research, vol. 30, pp. 
184-198, 2003, http://dx.doi.org/10.1086/376807.

    Dated: October 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26793 Filed 11-4-16; 8:45 am]
 BILLING CODE 4164-01-P