Agency Information Collection Activities; Proposed Collection; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs, 12503-12506 [2016-05233]

Download as PDF 12503 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Information collected Number of respondents Number of responses per respondent Total annual responses Average burden per response Total .................................................................................................. 2. Testing of HPHC Quantities in Products: Cigarette Filler ......................................................................................... Roll-Your-Own ......................................................................................... Smokeless ............................................................................................... ........................ ........................ ........................ .............................. 123 78 39 52 0.79 0.21 0.21 62 8 11 9.42 ...................... 9.42 ...................... 12.06 .................... 584 75 133 Total .................................................................................................. 3. Testing of HPHC Quantities in Mainstream Smoke: Cigarette: International Oraganization for Standardization (ISO) Regimen. Cigarette: Health Canada Regimen ........................................................ ........................ ........................ ........................ .............................. 792 78 0.79 62 23.64 .................... 1,466 78 0.79 62 23.64 .................... 1,466 Total .................................................................................................. 4. Additional HPHC reports: 2 Cigarette Filler ......................................................................................... Roll-Your-Own ......................................................................................... Smokeless ............................................................................................... ........................ ........................ ........................ .............................. 2,932 78 39 52 2.56 5.12 3.84 200 200 200 1 ........................... 1 ........................... 1 ........................... 200 200 200 Total .................................................................................................. ........................ ........................ ........................ .............................. 600 Total Section 904(c)(1) Reporting Burden Hours ..................... ........................ ........................ ........................ .............................. 4,447 1 There Lhorne on DSK5TPTVN1PROD with NOTICES 2 HPHC Total hours are no capital costs or operating and maintenance costs associated with this collection of information. reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC measures will be the same as the original report. Table 1 contains estimates for new product information received annually under section 904(c)(1) of the FD&C Act. Manufacturers must report HPHC information under section 904(c)(1) of the FD&C Act at least 90 days prior to delivery for introduction into interstate commerce. The total annual burden for this collection of information is estimated to be 4,447 hours. The burden estimate for this collection of information includes the time it will take to test the products and prepare the HPHC report. Table 1 indicates that 169 respondents will submit HPHC reports when new products enter the market. Section 1 of the table addresses the time required for manufacturers to report their company information. We estimate that the time to report HPHC information is no more than 1.82 hours for cigarettes, 0.42 hours for roll-yourown, and 0.63 hours for smokeless tobacco products for each response regardless of whether the paper or electronic form (Form FDA 3787) is used. (The estimated times to report smokeless tobacco products (0.63 hour) and roll-your-own tobacco products (0.43 hour) are lower than the estimated reporting time for cigarette products because fewer HPHCs are normally reported for these two types of products. The total annual burden for reporting company and product information is 123 hours. Section 2 of the table addresses the time required for manufacturers to test quantities of HPHCs in their products. The burden hour estimates include the time needed to test the tobacco products, draft testing reports, and draft the report for FDA. For cigarette filler, VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 smokeless, and roll-your-own products, we estimate the burden to be 792 annual burden hours. The burden for each product type reflects our estimate of the time to test the tobacco products (i.e., carry out laboratory work). In addition to addressing the time required to report information and test quantities of HPHCs in tobacco products, section 3 of table 1 addresses the time required for manufacturers to test quantities of HPHCs in cigarette smoke. The burden estimates include testing the tobacco products, drafting testing reports, and drafting the report for FDA. We estimate the annualized burden for this section to be 2,932 hours. The annual burden reflects our estimate to test the tobacco products (i.e., carry out laboratory work). The burden estimate assumes that manufacturers report HPHC quantities in cigarette mainstream smoke according to the two smoking regimens described in the table. As stated previously, FDA expects to receive 600 additional HPHC reports at 1 hour per response for a total of 600 hours. The estimated total annual burden for the reporting of HPHC under section 904(c)(1) of the FD&C Act is 4,447 hours. Dated: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05213 Filed 3–8–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0735] Agency Information Collection Activities; Proposed Collection; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 ‘‘Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs.’’ This study will examine how the size and presentation of superimposed text (supers) influences the comprehension of direct-toconsumer (DTC) television advertisements for prescription drugs. SUMMARY: Submit either electronic or written comments on the collection of information by May 9, 2016. DATES: ADDRESSES: You may submit comments as follows: Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1 12504 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 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’’). Lhorne on DSK5TPTVN1PROD with NOTICES 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–0735 for ‘‘Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs.’’ 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 VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 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, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. 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. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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. Superimposed Text in Direct-toConsumer Promotion of Prescription Drugs—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. The proposed study seeks to extend previous research on the effects of supers in general print and television advertising to today’s modern DTC pharmaceutical promotion. Although earlier research on the effects of supers in other consumer settings suggests that altering text size can influence consumer comprehension of information, it is unclear if these findings extend to DTC promotion of prescription drugs and are applicable over 20 years later when viewing promotional materials using today’s modern technologies (e.g., tablets). Moreover, other factors such as text/ background contrast may also influence both the understanding of the superimposed information (Ref. 1) and the effects of text size. The proposed research seeks to update these earlier findings and also to answer new questions concerning presentation of supers. Part of FDA’s public health mission is to ensure the safe use of prescription drugs; therefore, it is important that the information provided in DTC promotion is clear and understandable for consumer audiences, avoids use of deceptive or misleading claims, and E:\FR\FM\09MRN1.SGM 09MRN1 12505 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices achieves ‘‘fair balance’’ in presentation of benefits and risks. For example, varying presentation formats including type size, bulleting, amount of white space, and use of ‘‘chunking’’ or headlines can all influence consumer perceptions of information (Ref. 2). A systematic review of presentation formats in prescription drug labeling found that these ‘‘clear communication’’ characteristics positively influenced consumer’s comprehension of information and prescription drug behaviors (i.e., adherence) (Ref. 3). In one randomized controlled study, young and older adults were presented with 12 otherwise identical over-the-counter drugs bottled with varied container labels along various dimensions, one of which was text size (7 vs. 10 point). While younger participants performed equally well with both font sizes, elderly populations had significantly reduced recall and comprehension when exposed to the smaller text size (Ref. 4). Another study found that both young and older populations preferred the larger text size and that patients read labels with larger font more rapidly and accurately than labels with smaller font (Ref. 5). Although these studies were specific to prescription drug container labels, it is plausible that the effects of font sizes would be applicable to drug promotion. Some early research in the late 1980s and 1990s examined the size of supers in print and television advertising topics outside of prescription drugs (Refs. 6, 7, and 8). These studies all generally found that the text size of the super was associated with comprehension, such that the larger text sizes increased understanding of the material (and, conversely, smaller text sizes interfered with comprehension). For example, Foxman and colleagues (Ref. 6) found that whereas ‘‘small’’ text size (> 1⁄2 inch size) was associated with accurate comprehension for 59 percent of respondents, ‘‘large’’ text size (> 1⁄2 inch size) was associated with comprehension for 79 percent of respondents. Studies by other researchers (Refs. 7 and 8) found similar patterns such that increasing the text size of supers generally corresponded with increased comprehension. We know of no studies that have examined other commonly variable factors, such as text/background contrast, that may interact with text size to influence comprehension. Early research on text readability determined that the contrast between text and background has a consistent but small effect. Specifically, while the contrast of color has a small effect (Ref. 9), the contrast in brightness, or luminance, makes the largest difference (Ref. 10). These studies showed that black text on a white background results in the highest readability (Ref. 11), but that other effects of color contrasts are unclear (Ref .1). Some studies have demonstrated that contrast interacts with text size, such that contrast becomes a more important discriminator as the text size decreases (Ref. 12). The earlier research on supers is limited in their applicability to today’s DTC promotion in several ways. None of these studies specifically focused on prescription drug promotion, but rather explored the effects of superimposed text in a variety of social and consumer advertising contexts. Another limitation is that these earlier studies were conducted with populations (i.e., undergraduate students) that are not representative of today’s prescription drug users. It is not clear if the effects of supers would translate to older adult populations, who represent the greatest proportion of prescription drug users (Ref. 13). Perhaps most importantly, it is unknown if the effects of supers would be found today, considering the prevalent use of modern technologies, including large (40+ inches) TV screens and personal tablets for online viewing. Our proposed study seeks to address these unanswered questions regarding the use of supers in prescription drug promotion. II. General Research Questions 1. Does the size of the superimposed text, the contrast behind the superimposed text, and/or the device type influence the noticeability, recall, and perceived importance of the super information? 2. Does the size of the superimposed text, the contrast behind the superimposed text, and/or the device type influence the recall of and attitudes toward the promoted drug? 3. Are there any interaction effects among any combination of independent variables? III. Design To test these research questions, we will conduct one randomized controlled study. We will examine reactions to supers in a fictitious DTC prescription drug promotional video on two types of viewing devices with a general population sample. The study design will be a 3 × 2 × 2 factorial design, where participants are randomly assigned to 1 of 12 experimental study arms differentiated by: • Super text size (small, medium, large); • Device type (television, tablet); • Super text contrast (high, low). TABLE 1—DESIGN AND CELL SIZES FOR MAIN STUDY 1 Device Type TV Tablet Total Super Size Small Medium Large Small Medium Large Contrast: High ................................................... Low ................................................... 106 106 106 106 106 106 106 106 106 106 106 106 636 636 Total ........................................... 212 212 212 212 212 212 1,272 Lhorne on DSK5TPTVN1PROD with NOTICES 1 The sample will be split evenly across 3 cities (Los Angeles, CA; Cincinnati, OH; and Tampa, FL), with 424 participants per city. For both the pretest and main study, we will work with two market research firms to recruit adult participants and conduct in-person data collection in three U.S. cities: Los Angeles, CA; Cincinnati, OH; and Tampa, FL. In addition to our aim for regional variation, we selected these three cities VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 with the aim of recruiting a sample that is diverse on gender, race/ethnicity, education, and age characteristics. Participants from the general population will be invited to a market research facility to watch one video for a fictional prescription drug that treats asthma. In-person administration of PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 study procedures will enable us to control the television and tablet watching experience in terms of size, distance, and other variables. Participants will watch the video twice and then answer questions addressing recall of risks and benefits, perceptions of risks and benefits, and questions E:\FR\FM\09MRN1.SGM 09MRN1 12506 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices regarding the salience of information in text. The questionnaire is available upon request. Participation is estimated to take approximately 20 minutes. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. Pretesting will take place before the main study to select super sizes for the main study and to evaluate the procedures and measures that will be used. We will exclude individuals who work in health care or marketing settings because their knowledge and experiences may not reflect those of the average consumer. We conducted a priori power analyses to determine sample sizes for the pretest and the main study. FDA estimates the burden of this collection of information as follows: TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Pretesting No. to complete the screener (assumes 50% eligible). No. of completes .................................................. 338 1 338 0.08 (5 minutes) ............ 27 240 1 240 0.33 (20 minutes) .......... 79 Main Study No. to complete the screener (assumes 50% eligible). No. of completes .................................................. 1,785 1 1,785 0.08 (5 minutes) ............ 143 1,272 1 1,272 0.33 (20 minutes) .......... 420 Total .............................................................. ........................ ........................ ........................ ....................................... 669 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Lhorne on DSK5TPTVN1PROD with NOTICES IV. References 1. Hall, R.H. and P. Hanna, ‘‘The Impact of Web page Text-Background Colour Combinations on Readability, Retention, Aesthetics and Behavioural Intention,’’ Behaviour & Information Technology, 2004;23:183–195. 2. Baur, C. and C. Prue, ‘‘The CDC Clear Communication Index Is a New Evidence-Based Tool to Prepare and Review Health Information,’’ Health Promotion Practice, 2014;15:629–637. 3. Shrank, W., J. Avorn, C. Rolon, et al., ‘‘Effect of Content and Format of Prescription Drug Labels on Readability, Understanding, and Medication Use: A Systematic Review,’’ The Annals of Pharmacotherapy, 2007;41:783–801. 4. Wogalter, M.S. and W.J. Vigilante, Jr., ‘‘Effects of Label Format on Knowledge Acquisition and Perceived Readability by Younger and Older Adults,’’ Ergonomics, 2003;46:327–344. 5. Smither, J.A.A. and C.C. Braun, ‘‘Readability of Prescription Drug Labels by Older and Younger Adults,’’ Journal of Clinical Psychology in Medicine Settings, 1994;1:149–159. 6. Foxman, E.R., D.D. Muehling, and P.A. Moore, ‘‘Disclaimer Footnotes in Ads: Discrepancies Between Purpose and Performance,’’ Journal of Public Policy & Marketing, 1988;7:127–137. 7. Murray, N.M., L.A. Manrai, and A.K. Manrai, ‘‘Public Policy Relating to Consumer Comprehension of Television Commercials: A Review and Some Empirical Results,’’ Journal of Consumer Policy, 1993;16:145–170. 8. Manrai, L.A., A.K. Manrai, and N. Murray, ‘‘Comprehension of Info-Aid Supers in Television Advertising for Social Ideas: Implications for Public Policy,’’ Journal of Business Research, 1994;30:75–84. VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 9. Hill, A. and L. Scharff, ‘‘Readability of Computer Displays as a Function of Colour, Saturation, and Background Texture.’’ In: D. Harns (Ed.) Engineering Psychology and Cognitive Ergonomics, (Vol. 4) Ashgate, Aldershot, United Kingdom. 10. Shieh, K.-K. and C.-C. Lin, ‘‘Effects of Screen Type, Ambient Illumination, and Color Combination on VDT Visual Performance and Subjective Preference,’’ International Journal of Industrial Ergonomics, 2000;26:527–536. 11. Tinker, M.A. and D.G. Paterson, ‘‘Studies of Typographical Factors Influencing Speed of Reading. VII. Variations in Color of Print and Background,’’ Journal of Applied Psychology, 1931;15:471–479. 12. Legge, G.E., G.S. Rubin, and A. Luebner, ‘‘Psychophysics of Reading—V. The Role of Contrast in Normal Vision,’’ Vision Research, 1987;27:1165–1177. 13. Kaufman, D.W., J.P. Kelly, L. Rosenberg, et al., ‘‘Recent Patterns of Medication Use in the Ambulatory Adult Population of the United States: The Slone Survey,’’ The Journal of the American Medical Association, 2002;287:337–344. Dated: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05233 Filed 3–8–16; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–0712] Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use.’’ This draft guidance provides a statement of qualification for exploratory use for the evaluating respiratory symptoms in chronic obstructive pulmonary disease (E–RS: COPD), a patient-reported outcome instrument, and summarizes the concept of interest and context of use (COU) for which the tool is qualified through the Center for Drug Evaluation SUMMARY: E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12503-12506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0735]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Superimposed Text in Direct-to-Consumer Promotion of 
Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 ``Superimposed Text in 
Direct-to-Consumer Promotion of Prescription Drugs.'' This study will 
examine how the size and presentation of superimposed text (supers) 
influences the comprehension of direct-to-consumer (DTC) television 
advertisements for prescription drugs.

DATES:  Submit either electronic or written comments on the collection 
of information by May 9, 2016.

ADDRESSES: You may submit comments as follows:

[[Page 12504]]

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-0735 for ``Superimposed Text in Direct-to-Consumer Promotion 
of Prescription Drugs.'' 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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, when 
appropriate, and other forms of information technology.

Superimposed Text in Direct-to-Consumer Promotion of Prescription 
Drugs--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.
    The proposed study seeks to extend previous research on the effects 
of supers in general print and television advertising to today's modern 
DTC pharmaceutical promotion. Although earlier research on the effects 
of supers in other consumer settings suggests that altering text size 
can influence consumer comprehension of information, it is unclear if 
these findings extend to DTC promotion of prescription drugs and are 
applicable over 20 years later when viewing promotional materials using 
today's modern technologies (e.g., tablets). Moreover, other factors 
such as text/background contrast may also influence both the 
understanding of the superimposed information (Ref. 1) and the effects 
of text size. The proposed research seeks to update these earlier 
findings and also to answer new questions concerning presentation of 
supers.
    Part of FDA's public health mission is to ensure the safe use of 
prescription drugs; therefore, it is important that the information 
provided in DTC promotion is clear and understandable for consumer 
audiences, avoids use of deceptive or misleading claims, and

[[Page 12505]]

achieves ``fair balance'' in presentation of benefits and risks. For 
example, varying presentation formats including type size, bulleting, 
amount of white space, and use of ``chunking'' or headlines can all 
influence consumer perceptions of information (Ref. 2). A systematic 
review of presentation formats in prescription drug labeling found that 
these ``clear communication'' characteristics positively influenced 
consumer's comprehension of information and prescription drug behaviors 
(i.e., adherence) (Ref. 3). In one randomized controlled study, young 
and older adults were presented with 12 otherwise identical over-the-
counter drugs bottled with varied container labels along various 
dimensions, one of which was text size (7 vs. 10 point). While younger 
participants performed equally well with both font sizes, elderly 
populations had significantly reduced recall and comprehension when 
exposed to the smaller text size (Ref. 4). Another study found that 
both young and older populations preferred the larger text size and 
that patients read labels with larger font more rapidly and accurately 
than labels with smaller font (Ref. 5). Although these studies were 
specific to prescription drug container labels, it is plausible that 
the effects of font sizes would be applicable to drug promotion.
    Some early research in the late 1980s and 1990s examined the size 
of supers in print and television advertising topics outside of 
prescription drugs (Refs. 6, 7, and 8). These studies all generally 
found that the text size of the super was associated with 
comprehension, such that the larger text sizes increased understanding 
of the material (and, conversely, smaller text sizes interfered with 
comprehension). For example, Foxman and colleagues (Ref. 6) found that 
whereas ``small'' text size (> \1/2\ inch size) was associated with 
accurate comprehension for 59 percent of respondents, ``large'' text 
size (> \1/2\ inch size) was associated with comprehension for 79 
percent of respondents. Studies by other researchers (Refs. 7 and 8) 
found similar patterns such that increasing the text size of supers 
generally corresponded with increased comprehension.
    We know of no studies that have examined other commonly variable 
factors, such as text/background contrast, that may interact with text 
size to influence comprehension. Early research on text readability 
determined that the contrast between text and background has a 
consistent but small effect. Specifically, while the contrast of color 
has a small effect (Ref. 9), the contrast in brightness, or luminance, 
makes the largest difference (Ref. 10). These studies showed that black 
text on a white background results in the highest readability (Ref. 
11), but that other effects of color contrasts are unclear (Ref .1). 
Some studies have demonstrated that contrast interacts with text size, 
such that contrast becomes a more important discriminator as the text 
size decreases (Ref. 12).
    The earlier research on supers is limited in their applicability to 
today's DTC promotion in several ways. None of these studies 
specifically focused on prescription drug promotion, but rather 
explored the effects of superimposed text in a variety of social and 
consumer advertising contexts. Another limitation is that these earlier 
studies were conducted with populations (i.e., undergraduate students) 
that are not representative of today's prescription drug users. It is 
not clear if the effects of supers would translate to older adult 
populations, who represent the greatest proportion of prescription drug 
users (Ref. 13). Perhaps most importantly, it is unknown if the effects 
of supers would be found today, considering the prevalent use of modern 
technologies, including large (40+ inches) TV screens and personal 
tablets for online viewing. Our proposed study seeks to address these 
unanswered questions regarding the use of supers in prescription drug 
promotion.

II. General Research Questions

    1. Does the size of the superimposed text, the contrast behind the 
superimposed text, and/or the device type influence the noticeability, 
recall, and perceived importance of the super information?
    2. Does the size of the superimposed text, the contrast behind the 
superimposed text, and/or the device type influence the recall of and 
attitudes toward the promoted drug?
    3. Are there any interaction effects among any combination of 
independent variables?

III. Design

    To test these research questions, we will conduct one randomized 
controlled study. We will examine reactions to supers in a fictitious 
DTC prescription drug promotional video on two types of viewing devices 
with a general population sample. The study design will be a 3 x 2 x 2 
factorial design, where participants are randomly assigned to 1 of 12 
experimental study arms differentiated by:
     Super text size (small, medium, large);
     Device type (television, tablet);
     Super text contrast (high, low).

                                                    Table 1--Design and Cell Sizes for Main Study \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Device Type                                             TV                                   Tablet
--------------------------------------------------------------------------------------------------------------------------------------------    Total
                          Super Size                              Small        Medium       Large        Small        Medium       Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contrast:
    High.....................................................          106          106          106          106          106          106          636
    Low......................................................          106          106          106          106          106          106          636
                                                              ------------------------------------------------------------------------------------------
        Total................................................          212          212          212          212          212          212        1,272
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The sample will be split evenly across 3 cities (Los Angeles, CA; Cincinnati, OH; and Tampa, FL), with 424 participants per city.

    For both the pretest and main study, we will work with two market 
research firms to recruit adult participants and conduct in-person data 
collection in three U.S. cities: Los Angeles, CA; Cincinnati, OH; and 
Tampa, FL. In addition to our aim for regional variation, we selected 
these three cities with the aim of recruiting a sample that is diverse 
on gender, race/ethnicity, education, and age characteristics.
    Participants from the general population will be invited to a 
market research facility to watch one video for a fictional 
prescription drug that treats asthma. In-person administration of study 
procedures will enable us to control the television and tablet watching 
experience in terms of size, distance, and other variables. 
Participants will watch the video twice and then answer questions 
addressing recall of risks and benefits, perceptions of risks and 
benefits, and questions

[[Page 12506]]

regarding the salience of information in text. The questionnaire is 
available upon request. Participation is estimated to take 
approximately 20 minutes.
    To examine differences between experimental conditions, we will 
conduct inferential statistical tests such as analysis of variance.
    Pretesting will take place before the main study to select super 
sizes for the main study and to evaluate the procedures and measures 
that will be used. We will exclude individuals who work in health care 
or marketing settings because their knowledge and experiences may not 
reflect those of the average consumer. We conducted a priori power 
analyses to determine sample sizes for the pretest and the main study.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
                                                   Pretesting
----------------------------------------------------------------------------------------------------------------
No. to complete the screener               338               1             338  0.08 (5 minutes)              27
 (assumes 50% eligible).
No. of completes..............             240               1             240  0.33 (20                      79
                                                                                 minutes).
----------------------------------------------------------------------------------------------------------------
                                                   Main Study
----------------------------------------------------------------------------------------------------------------
No. to complete the screener             1,785               1           1,785  0.08 (5 minutes)             143
 (assumes 50% eligible).
No. of completes..............           1,272               1           1,272  0.33 (20                     420
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             669
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

IV. References

1. Hall, R.H. and P. Hanna, ``The Impact of Web page Text-Background 
Colour Combinations on Readability, Retention, Aesthetics and 
Behavioural Intention,'' Behaviour & Information Technology, 
2004;23:183-195.
2. Baur, C. and C. Prue, ``The CDC Clear Communication Index Is a 
New Evidence-Based Tool to Prepare and Review Health Information,'' 
Health Promotion Practice, 2014;15:629-637.
3. Shrank, W., J. Avorn, C. Rolon, et al., ``Effect of Content and 
Format of Prescription Drug Labels on Readability, Understanding, 
and Medication Use: A Systematic Review,'' The Annals of 
Pharmacotherapy, 2007;41:783-801.
4. Wogalter, M.S. and W.J. Vigilante, Jr., ``Effects of Label Format 
on Knowledge Acquisition and Perceived Readability by Younger and 
Older Adults,'' Ergonomics, 2003;46:327-344.
5. Smither, J.A.A. and C.C. Braun, ``Readability of Prescription 
Drug Labels by Older and Younger Adults,'' Journal of Clinical 
Psychology in Medicine Settings, 1994;1:149-159.
6. Foxman, E.R., D.D. Muehling, and P.A. Moore, ``Disclaimer 
Footnotes in Ads: Discrepancies Between Purpose and Performance,'' 
Journal of Public Policy & Marketing, 1988;7:127-137.
7. Murray, N.M., L.A. Manrai, and A.K. Manrai, ``Public Policy 
Relating to Consumer Comprehension of Television Commercials: A 
Review and Some Empirical Results,'' Journal of Consumer Policy, 
1993;16:145-170.
8. Manrai, L.A., A.K. Manrai, and N. Murray, ``Comprehension of 
Info-Aid Supers in Television Advertising for Social Ideas: 
Implications for Public Policy,'' Journal of Business Research, 
1994;30:75-84.
9. Hill, A. and L. Scharff, ``Readability of Computer Displays as a 
Function of Colour, Saturation, and Background Texture.'' In: D. 
Harns (Ed.) Engineering Psychology and Cognitive Ergonomics, (Vol. 
4) Ashgate, Aldershot, United Kingdom.
10. Shieh, K.-K. and C.-C. Lin, ``Effects of Screen Type, Ambient 
Illumination, and Color Combination on VDT Visual Performance and 
Subjective Preference,'' International Journal of Industrial 
Ergonomics, 2000;26:527-536.
11. Tinker, M.A. and D.G. Paterson, ``Studies of Typographical 
Factors Influencing Speed of Reading. VII. Variations in Color of 
Print and Background,'' Journal of Applied Psychology, 1931;15:471-
479.
12. Legge, G.E., G.S. Rubin, and A. Luebner, ``Psychophysics of 
Reading--V. The Role of Contrast in Normal Vision,'' Vision 
Research, 1987;27:1165-1177.
13. Kaufman, D.W., J.P. Kelly, L. Rosenberg, et al., ``Recent 
Patterns of Medication Use in the Ambulatory Adult Population of the 
United States: The Slone Survey,'' The Journal of the American 
Medical Association, 2002;287:337-344.

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05233 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P