80 FR 61433 - Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Information in Direct-to-Consumer Television Advertisements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 197 (October 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 197 (October 13, 2015)
| Page Range | 61433-61435 | |
| FR Document | 2015-25958 |
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)] [Notices] [Pages 61433-61435] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25958] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3543] Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Information in Direct-to-Consumer Television Advertisements 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 ``Quantitative Information in Direct-to-Consumer Television Advertisements.'' The objective of this research is to test consumers' understanding of quantitative information about prescription drugs in DTC television advertisements (ads). DATES: Submit either electronic or written comments on the collection of information by December 14, 2015. 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-2015-N-3543 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Quantitative Information in Direct-to-Consumer Television Advertisements.'' 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 [[Page 61434]] 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, [email protected]. 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. Quantitative Information in Direct-to-Consumer Television Advertisements 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(b)(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. A previous FDA study found that simple quantitative information could be conveyed in direct-to-consumer (DTC) television ads in ways that increased consumer's knowledge about the drug (OMB control number 0910-0663, ``Experimental Study: Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer (DTC) Television and Print Advertisements for Prescription Drugs'').\1\ However, this research only tested simple information (e.g., one clinical trial, comparison to placebo). Drug information can be much more complicated (e.g., complicated endpoints, multiple study arms). The following studies are designed to address the question of whether consumers can use more complicated information when assessing prescription drug information in television DTC ads. These studies will build on previous research by: (1) Examining more complicated quantitative information, (2) examining quantitative information for both benefits and risks, and (3) examining how visuals designed to represent efficacy interact with quantitative information. --------------------------------------------------------------------------- \1\ O'Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et al. ``Presenting efficacy information in direct-to-consumer prescription drug advertisements.'' Patient Education and Counseling, vol. 95(2), pp. 271-280, 2014. --------------------------------------------------------------------------- The objective of this project is to test consumers' understanding of quantitative information about prescription drugs in DTC television ads. In study 1, we plan to examine experimentally the presence and complexity of quantitative benefit and risk information in DTC television ads (table 1). We hypothesize that, replicating past studies, adding simple quantitative information about benefits and risks will lead to increased understanding among consumers. We will test whether adding complex quantitative information results in the same outcomes as simple quantitative information or whether it is too much quantitative information for consumers to process. In study 2, we plan to examine experimentally the presence of quantitative benefit information and how the ad visually represents efficacy (by having no images, images that accurately reflect the improvement in health that could be expected with treatment, or images that overstate the improvement in health that could be expected with treatment (table 2). We hypothesize that overstated images of improvement will lead consumers to overestimate the drug's efficacy; however, adding a quantitative claim may moderate this effect. To test these hypotheses, we will conduct inferential statistical tests such as analysis of variance (ANOVA). With the sample sizes described below, we will have sufficient power to detect small- to medium-sized effects in each study. All participants will be 60 years of age or older. We will exclude individuals who work in healthcare or marketing. We selected a sample of participants 60 years and older to increase the likelihood that participants will be interested in the fictitious study drug and therefore motivated to pay attention to the ad during the study. The studies will be conducted with an Internet panel. In both studies, participants will be randomly assigned to one experimental condition and view the corresponding television ad. The ad will be for a fictitious drug to treat cataracts. The ads will be created and pretested to ensure that consumers perceive different levels of complexity across the ads in study 1, and different levels of image accuracy in study 2. ``Pretests for a Study on Quantitative Information in Direct-to-Consumer Television Advertisements'' will be submitted under OMB control number 0910-0695. After viewing the ad twice, participants will complete a questionnaire that assesses consumers' understanding of the drug information, their retention of the information, and their perceptions of the drug. We will also measure covariates such as demographics and numeracy. The [[Page 61435]] questionnaires are available upon request. Table 1--Study 1 Design ---------------------------------------------------------------------------------------------------------------- Quantitative risk claim ---------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- No.............. Yes: General Yes: Frequencies Statement (e.g., for Each Risk seen in less than 1% of patients). Quantitative Efficacy Claim... No................... Yes: simple (e.g., reduced pain in 83% of patients). Yes: complex (e.g., reduced pain by 30% in 83% of patients). ---------------------------------------------------------------------------------------------------------------- Table 2--Study 2 Design ---------------------------------------------------------------------------------------------------------------- Images of improvement --------------------------------------------- ---------------------------------------------------------------------------------------------------------------- None............ Accurate improvement Overstated in health conveyed improvement in in images. health conveyed in images. Quantitative Benefit Claim.... No.............. Yes............. ---------------------------------------------------------------------------------------------------------------- FDA estimates the burden of this collection of information as follows: Table 3--Estimated Annual Reporting Burden \1\--Study 1 ---------------------------------------------------------------------------------------------------------------- No. of Activity No. of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Sample outgo.................... 15,130 .............. .............. .............. .............. Number to complete the screener 1,513 1 1,513 .05 (3 min.) 76 (10%).......................... Number eligible for survey (70%) 1,059 .............. .............. .............. .............. Number to complete the survey 900 1 900 .33 (20 min.) 297 (85%).......................... ------------------------------------------------------------------------------- Total....................... .............. .............. 2,413 .............. 373 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 4--Estimated Annual Reporting Burden \1\--Study 2 ---------------------------------------------------------------------------------------------------------------- No. of Activity No. of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Sample outgo.................... 15,130 .............. .............. .............. .............. Number to complete the screener 1,513 1 1,513 .05 (3 min.) 76 (10%).......................... Number eligible for survey (70%) 1,059 .............. .............. .............. .............. Number to complete the survey 900 1 900 .33 (20 min.) 297 (85%).......................... ------------------------------------------------------------------------------- Total....................... .............. .............. 2,413 .............. 373 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25958 Filed 10-9-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 61433
further assume that the 1,518 cosmetic subject to review by the Office of Comments submitted electronically,
product establishments may not Management and Budget (OMB) under including attachments, to http://
maintain all of the records the PRA (44 U.S.C. 3501–3521). The www.regulations.gov will be posted to
recommended by the draft guidance. collections of information in our recall the docket unchanged. Because your
Thus, for purposes of this analysis, we regulations in 21 CFR part 7 have been comment will be made public, you are
assume that 1,518 establishments will approved under OMB control number solely responsible for ensuring that your
keep the records recommended by the 0910–0249. The collection of comment does not include any
draft guidance, when it is finalized, as information in 21 CFR 70.25, which confidential information that you or a
reported in table 2, column 2. We requires that color additives subject to third party may not wish to be posted,
further assume that if multiple products certification be labeled with the lot such as medical information, your or
are produced in the same facility, the number assigned by the Color anyone else’s Social Security number, or
written procedures and recordkeeping Certification Branch, has been approved confidential business information, such
will be shared among the multiple under OMB control number 0910–0016. as a manufacturing process. Please note
products. Dated: October 7, 2015.
that if you include your name, contact
We base our estimates of the number information, or other information that
of records per recordkeeper and the Leslie Kux,
identifies you in the body of your
average burden per recordkeeping Associate Commissioner for Policy. comments, that information will be
reported in columns 3 and 5 of tables 1 [FR Doc. 2015–25957 Filed 10–9–15; 8:45 am] posted on http://www.regulations.gov.
and 2 on our experience with good BILLING CODE 4164–01–P • If you want to submit a comment
manufacturing practices used to control with confidential information that you
the identity and composition of food do not wish to be made available to the
and dietary supplements and to limit DEPARTMENT OF HEALTH AND public, submit the comment as a
contaminants and prevent adulteration, HUMAN SERVICES written/paper submission and in the
as well as our estimate of the burden of manner detailed (see ‘‘Written/Paper
similar recordkeeping activities Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
described in the dietary supplement [Docket No. FDA–2015–N–3543]
Written/Paper Submissions
final rule published in the Federal
Register of June 25, 2007 (72 FR 34752 Agency Information Collection Submit written/paper submissions as
at 34916) (the June 25, 2007, final rule), Activities; Proposed Collection; follows:
that established, in part 111 (21 CFR Comment Request; Quantitative • Mail/Hand delivery/Courier (for
part 111), the minimum good Information in Direct-to-Consumer written/paper submissions): Division of
manufacturing practices necessary for Television Advertisements Dockets Management (HFA–305), Food
dietary supplements. For the and Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
recordkeeping recommendations listed
in table 2, the recordkeeping occasions HHS. • For written/paper comments
consist of frequent brief entries of dates, ACTION: Notice. submitted to the Division of Dockets
temperatures, monitoring results, or Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments,
documentation that specific actions
Administration (FDA) is announcing an except for information submitted,
were taken. Information might be
opportunity for public comment on the marked and identified, as confidential,
recorded a few times a day, week, or
proposed collection of certain if submitted as detailed in
month. Because the records burden
information by the Agency. Under the ‘‘Instructions.’’
involves frequent brief entries, we did
Paperwork Reduction Act of 1995 (the Instructions: All submissions received
not attempt to estimate the actual
PRA), Federal Agencies are required to must include the Docket No. FDA–
number of recordkeeping occasions for
publish notice in the Federal Register 2015–N–3543 for ‘‘Agency Information
these activities. We entered one as the
concerning each proposed collection of Collection Activities; Proposed
default for the number of records per
information and to allow 60 days for Collection; Comment Request;
recordkeeper and we calculated the
public comment in response to the Quantitative Information in Direct-to-
average burden per recordkeeping in
column 5 based on the reported burden notice. This notice solicits comments on Consumer Television Advertisements.’’
of similar provisions estimated in the research entitled ‘‘Quantitative Received comments will be placed in
June 25, 2007, final rule, averaged Information in Direct-to-Consumer the docket and, except for those
across the 1,460 firms covered by that Television Advertisements.’’ The submitted as ‘‘Confidential
final rule. objective of this research is to test Submissions,’’ publicly viewable at
The estimates for the recordkeeping consumers’ understanding of http://www.regulations.gov or at the
burdens presented here are averages. We quantitative information about Division of Dockets Management
anticipate that the time spent to develop prescription drugs in DTC television between 9 a.m. and 4 p.m., Monday
written procedures and recordkeeping advertisements (ads). through Friday.
would vary based on the type of DATES: Submit either electronic or • Confidential Submissions—To
cosmetic product manufactured. The written comments on the collection of submit a comment with confidential
estimated burdens for developing information by December 14, 2015. information that you do not wish to be
recordkeeping includes record ADDRESSES: You may submit comments made publicly available, submit your
mstockstill on DSK4VPTVN1PROD with NOTICES
maintenance, periodically reviewing as follows: comments only as a written/paper
records to determine if they may be submission. You should submit two
discarded, and any associated Electronic Submissions copies total. One copy will include the
documentation for that activity. Submit electronic comments in the information you claim to be confidential
This draft guidance also refers to following way: with a heading or cover note that states
previously approved collections of • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
information found in our regulations. www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
These collections of information are instructions for submitting comments. Agency will review this copy, including
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questionnaires are available upon
request.
TABLE 1—STUDY 1 DESIGN
Quantitative risk claim
No ... Yes: General Statement (e.g., seen Yes: Frequencies
in less than 1% of patients). for Each Risk
Quantitative Efficacy Claim ................ No.
Yes: simple (e.g., reduced pain in
83% of patients).
Yes: complex (e.g., reduced pain by
30% in 83% of patients).
TABLE 2—STUDY 2 DESIGN
Images of improvement
None .................... Accurate improvement in health con- Overstated improvement in health
veyed in images. conveyed in images.
Quantitative Benefit Claim .................. No.
Yes.
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—STUDY 1
No. of Average
No. of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Sample outgo ....................................................................... 15,130 ........................ ........................ ........................ ........................
Number to complete the screener (10%) ............................ 1,513 1 1,513 .05 (3 min.) 76
Number eligible for survey (70%) ........................................ 1,059 ........................ ........................ ........................ ........................
Number to complete the survey (85%) ................................ 900 1 900 .33 (20 min.) 297
Total .............................................................................. ........................ ........................ 2,413 ........................ 373
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1—STUDY 2
No. of Average
No. of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Sample outgo ....................................................................... 15,130 ........................ ........................ ........................ ........................
Number to complete the screener (10%) ............................ 1,513 1 1,513 .05 (3 min.) 76
Number eligible for survey (70%) ........................................ 1,059 ........................ ........................ ........................ ........................
Number to complete the survey (85%) ................................ 900 1 900 .33 (20 min.) 297
Total .............................................................................. ........................ ........................ 2,413 ........................ 373
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2015–25958 Filed 10–9–15; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2018-02-27 08:48:19
Document Modified: 2018-02-27 08:48:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by December 14, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 61433 |
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