80 FR 42823 - Agency Information Collection Activities; Proposed Collection; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 138 (July 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 138 (July 20, 2015)
| Page Range | 42823-42825 | |
| FR Document | 2015-17725 |
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)] [Notices] [Pages 42823-42825] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17725] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2406] Agency Information Collection Activities; Proposed Collection; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads 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, ``Market Claims in Direct-to-Consumer Prescription Drug Print Ads.'' This study will examine the impact of market claim information in direct-to-consumer (DTC) print advertising for prescription drugs. DATES: Submit either electronic or written comments on the collection of information by September 18, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. 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 [[Page 42824]] 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. Market Claims in Direct-to-Consumer Prescription Drug Print Ads--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. The marketing literature divides product attributes (``cues'') into intrinsic and extrinsic. Intrinsic cues are physical characteristics of the product (e.g., size, shape), whereas extrinsic cues are product- related but not part of the product (e.g., price and brand name) (Refs. 1, 2). Research has found that both intrinsic and extrinsic cues can influence perceptions of product quality (Ref. 3). Consumers may rely on product cues in the absence of explicit quality information. The objective quality of prescription drugs is not easily obtained from promotional claims in DTC ads; thus consumers may rely upon extrinsic cues to inform their decisions. Market claims such as ``#1 prescribed'' and ``new'' may act as extrinsic cues about the product's quality, independent of the product's intrinsic characteristics. Prior research has found that market leadership claims can affect consumer beliefs about product efficacy, as well as their beliefs about doctors' judgments about product efficacy (Ref. 4). One limitation of these prior studies is the lack of quantitative information about product efficacy in the information provided to respondents. Research indicates that providing consumers with efficacy information generally improves understanding and facilitates decisionmaking (Refs. 5, 6). Efficacy information may moderate the effect of the extrinsic cue by providing insight into characteristics that would otherwise be unknown. Other research has shown that consumers are able to use information about efficacy to inform judgments about the product (Refs. 6, 7). The Office of Prescription Drug Promotion plans to investigate, through empirical research, the impact of market claims on prescription drug product perceptions with and without quantitative information about product efficacy. This will be investigated in DTC print advertising for prescription drugs. The project consists of two parts; a main study and a followup study. Pretesting will be conducted to assess and identify problems with the questionnaire, stimuli, and procedures. Participants will be consumers who self-identify as having been diagnosed with diabetes. All participants will be 18 years of age or older. We will exclude individuals from the consumer sample who work in healthcare or marketing settings because their knowledge and experiences may not reflect those of the average consumer. Recruitment and administration of the study will take place over the Internet. Participation is estimated to take no more than 30 minutes. In the main study, participants will be randomly assigned to view one of nine possible versions of an ad, as depicted in table 1. The two variables of interest are type of market claim (#1 Prescribed, New) and level of efficacy information (high, low, or none). Efficacy information will be operationalized in the form of simple quantitative information (for example, product X can provide 50 percent relief for up to 60 percent of patients). We will investigate memory, perception, and understanding of product risks and benefits; perception and understanding of the market claim; perception of product quality; perceptions of product acceptance by doctor, intention to seek more information about the product; and perceptions of trust/skepticism regarding product claims and the sponsor. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. With the sample size described below, we will have sufficient power to detect small- to medium-sized effects in the main study. Table 1--Main Study Design Type of Market Claim ---------------------------------------------------------------------------------------------------------------- #1 Prescribed New None (control) ---------------------------------------------------------------------------------------------------------------- Efficacy Level Information: High............................................ A B C Low............................................. D E F None (control).................................. G H I ---------------------------------------------------------------------------------------------------------------- The followup study will examine the tradeoff between efficacy level and market share claim using decision analysis techniques. Participants will be asked to choose between two different DTC print ads over 48 trials. One set of DTC ads will feature the two claims from the main study. The other set of DTC ads will depict 48 different levels of product efficacy. Participants will be asked to choose one product on one or more dependent measures. FDA estimates the burden of this collection of information as follows: [[Page 42825]] Table 2--Estimated Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent respondents -------------------------------------------------------------------------------------------------------------------------------------------------------- Sample outgo (pretests and main survey)........ 16,384 .............. .............. ....................................... .............. Screener completes............................. 1,638 1 1,638 .03 (2 minutes)........................ 49 Eligible....................................... 1,556 .............. .............. ....................................... .............. Completes, Pretest 1........................... 252 1 252 .5 (30 minutes)........................ 126 Completes, Pretest 2........................... 252 1 252 .5 (30 minutes)........................ 126 Completes, Main Study.......................... 495 1 495 .5 (30 minutes)........................ 248 Completes, Pretest 3........................... 108 1 108 .25 (15 minutes)....................... 27 Completes, Followup Study...................... 216 1 216 .25 (15 minutes)....................... 54 -------------------------------------------------------------------------------------------------------- Total...................................... .............. .............. .............. ....................................... 630 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. 1. Lee, M. and Y.C. Lou, ``Consumer Reliance on Intrinsic and Extrinsic Cues in Product Evaluations: A Conjoint Approach,'' Journal of Applied Business Research, 12(1), pp. 21-29 (2011). 2. Teas, R.K. and S. Agarwal, ``The Effects of Extrinsic Product Cues on Consumers' Perceptions of Quality, Sacrifice, and Value,'' Journal of the Academy of Marketing Science, 28(2), pp. 278-290 (2000). 3. Rao, A.R. and K.B. Monroe, ``The Effect of Price, Brand Name, and Store Name on Buyers' Perceptions of Product Quality: An Integrative Review,'' Journal of Marketing Research, pp. 351-357 (1989). 4. Mitra, A., J.L. Swasy, and K.J. Aikin, ``How Do Consumers Interpret Market Leadership Claims in Direct-to-Consumer Advertising of Prescription Drugs?'' Advances in Consumer Research, 33, pp. 381- 387 (2006). 5. O'Donoghue, A., H.K. Sullivan, D. Aikin, R. Chowdhury, et al., ``Presenting Efficacy Information in Direct to Consumer Prescription Drug Advertisements,'' Patient Education Counsel, 95(2), pp. 271-80 (2014). 6. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug Facts Box to Communicate Drug Benefits and Harmstwo Randomized Trials,'' Annals of Internal Medicine, 150(8), pp. 516-527 (2009). 7. Sullivan, H.W., A. C. O'Donoghue, and K.J. Aikin, ``Presenting Quantitative Information About Placebo Rates to Patients,'' JAMA Internal Medicine, doi: 10.1001/jamainternmed.2013.10399 (2013). Dated: July 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-17725 Filed 7-17-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42823
DEPARTMENT OF HEALTH AND within the Family and Youth Services This study will primarily analyze data
HUMAN SERVICES Bureau of the Administration for previously collected by the NDVH and
Children and Families (ACF), U.S. NDAH/LIR as part of their ongoing
Administration for Children and Department of Health and Human program activities and monitoring. ACF
Families Services (HHS), serve as partners in the proposes to collect additional
intervention, prevention, and resource information, including information
Proposed Information Collection assistance efforts of the network of about the preferred mode (phone, chat,
Activity; Comment Request family violence, domestic violence, and text), ease of use, and perceived safety
dating violence service providers. of each mode of contact.
Title: Accomplishments of the In order to describe the activities and
Domestic Violence Hotline, Online accomplishments of the NDVH and This data is to be collected through
Connections and Text (ADVHOCaT) NDAH/LIR and develop potential new voluntary web-based surveys that are to
Study. or revised performance measures, the be completed by those who access the
OMB No.: New Collection. Office of Planning, Research and NDVH and NDAH/LIR Web sites. This
Description: The National Domestic Evaluation (OPRE), within ACF/HHS is information will be critical to informing
Violence Hotline (NDVH) and the proposing data collection activity as future efforts to monitor and improve
National Dating Abuse Helpline or Love part of the Accomplishments of the the performance of domestic violence
Is Respect (NDAH/LIR), which are Domestic Violence Hotline, Online hotlines and provide hotline services.
supported by the Division of Family Connections and Text (ADVHOCaT) Respondents: Individuals who access
Violence Prevention and Services Study. the NDVH and NDAH/LIR Web sites.
ANNUAL BURDEN ESTIMATES
Total/annual Number of Average burden hours per Annual burden
Instrument number of responses per response hours
respondents respondent
NDVH/LIR Preference of Use Survey ..................................... 5000 1 0.041 hours (150 seconds) .... 205
Estimated Total Annual Burden comments and suggestions submitted impact of market claim information in
Hours: 205 hours. within 60 days of this publication. direct-to-consumer (DTC) print
In compliance with the requirements advertising for prescription drugs.
Karl Koerper,
of Section 3506(c)(2)(A) of the DATES: Submit either electronic or
Reports Clearance Officer.
Paperwork Reduction Act of 1995, the written comments on the collection of
[FR Doc. 2015–17687 Filed 7–17–15; 8:45 am]
Administration for Children and information by September 18, 2015.
BILLING CODE 4184–01–P
Families is soliciting public comment ADDRESSES: Submit electronic
on the specific aspects of the comments on the collection of
information collection described above. DEPARTMENT OF HEALTH AND information to http://
Copies of the proposed collection of HUMAN SERVICES www.regulations.gov. Submit written
information can be obtained and comments on the collection of
comments may be forwarded by writing Food and Drug Administration information to the Division of Dockets
to the Administration for Children and [Docket No. FDA–2015–N–2406]
Management (HFA–305), Food and Drug
Families, Office of Planning, Research Administration, 5630 Fishers Lane, Rm.
and Evaluation, 370 L’Enfant Agency Information Collection 1061, Rockville, MD 20852. All
Promenade SW., Washington, DC 20447, Activities; Proposed Collection; comments should be identified with the
Attn: OPRE Reports Clearance Officer. Comment Request; Market Claims in docket number found in brackets in the
Email address: OPREinfocollection@ Direct-to-Consumer Prescription Drug heading of this document.
acf.hhs.gov. All requests should be Print Ads FOR FURTHER INFORMATION CONTACT: FDA
identified by the title of the information PRA Staff, Office of Operations, Food
collection. AGENCY: Food and Drug Administration, and Drug Administration, 8455
HHS. Colesville Rd., COLE–14526, Silver
The Department specifically requests
ACTION: Notice. Spring, MD 20993–0002, PRAStaff@
comments on (a) whether the proposed
collection of information is necessary SUMMARY: The Food and Drug fda.hhs.gov.
for the proper performance of the Administration (FDA) is announcing an SUPPLEMENTARY INFORMATION: Under the
functions of the agency, including opportunity for public comment on the PRA (44 U.S.C. 3501–3520), Federal
whether the information shall have proposed collection of certain Agencies must obtain approval from the
practical utility; (b) the accuracy of the information by the Agency. Under the Office of Management and Budget
agency’s estimate of the burden of the Paperwork Reduction Act of 1995 (the (OMB) for each collection of
proposed collection of information; (c) PRA), Federal Agencies are required to information they conduct or sponsor.
the quality, utility, and clarity of the
mstockstill on DSK4VPTVN1PROD with NOTICES
publish notice in the Federal Register ‘‘Collection of information’’ is defined
information to be collected; and (d) concerning each proposed collection of in 44 U.S.C. 3502(3) and 5 CFR
ways to minimize the burden of the information and to allow 60 days for 1320.3(c) and includes Agency requests
collection of information on public comment in response to the or requirements that members of the
respondents, including through the use notice. This notice solicits comments on public submit reports, keep records, or
of automated collection techniques or research entitled, ‘‘Market Claims in provide information to a third party.
other forms of information technology. Direct-to-Consumer Prescription Drug Section 3506(c)(2)(A) of the PRA (44
Consideration will be given to Print Ads.’’ This study will examine the U.S.C. 3506(c)(2)(A)) requires Federal
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![Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42825
TABLE 2—ESTIMATED BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents respondents per response
respondent
Sample outgo (pretests and main survey) ....................... 16,384 ........................ ........................ ........................... ........................
Screener completes .......................................................... 1,638 1 1,638 .03 (2 minutes) 49
Eligible ............................................................................... 1,556 ........................ ........................ ........................... ........................
Completes, Pretest 1 ........................................................ 252 1 252 .5 (30 minutes) 126
Completes, Pretest 2 ........................................................ 252 1 252 .5 (30 minutes) 126
Completes, Main Study ..................................................... 495 1 495 .5 (30 minutes) 248
Completes, Pretest 3 ........................................................ 108 1 108 .25 (15 minutes) 27
Completes, Followup Study .............................................. 216 1 216 .25 (15 minutes) 54
Total ........................................................................... ........................ ........................ ........................ ........................... 630
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
References DEPARTMENT OF HEALTH AND meetings will be held monthly. It is
The following references have been HUMAN SERVICES anticipated that they will commence in
placed on display in the Division of September or October 2015.
Dockets Management (see ADDRESSES) Food and Drug Administration ADDRESSES: Submit notification of
and may be seen by interested persons [Docket No. FDA–2010–N–0128] intention to participate in monthly
between 9 a.m. and 4 p.m., Monday stakeholder meetings by email to
through Friday, and are available Prescription Drug User Fee Act; PDUFAReauthorization@fda.hhs.gov.
electronically at http:// Stakeholder Consultation Meetings on The meetings will be held at the FDA
www.regulations.gov. the Prescription Drug User Fee Act campus, 10903 New Hampshire Ave.,
Reauthorization; Request for Silver Spring, MD 20993.
1. Lee, M. and Y.C. Lou, ‘‘Consumer Reliance
on Intrinsic and Extrinsic Cues in
Notification of Stakeholder Intention FOR FURTHER INFORMATION CONTACT:
Product Evaluations: A Conjoint To Participate Graham Thompson, Center for Drug
Approach,’’ Journal of Applied Business AGENCY: Food and Drug Administration, Evaluation and Research, Food and
Research, 12(1), pp. 21–29 (2011). Drug Administration, 10903 New
2. Teas, R.K. and S. Agarwal, ‘‘The Effects of
HHS.
Extrinsic Product Cues on Consumers’ ACTION: Notice; request for notification Hampshire Ave., Bldg. 51, Rm. 1146,
Perceptions of Quality, Sacrifice, and of participation. Silver Spring, MD 20993, 301–796–
Value,’’ Journal of the Academy of 5003, FAX: 301–847–8443.
Marketing Science, 28(2), pp. 278–290 SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION:
(2000). Administration (FDA or Agency) is
3. Rao, A.R. and K.B. Monroe, ‘‘The Effect of issuing this notice to request that public I. Background
Price, Brand Name, and Store Name on stakeholders—including patient and
Buyers’ Perceptions of Product Quality:
FDA is requesting that public
consumer advocacy groups, health care stakeholders—including patient and
An Integrative Review,’’ Journal of professionals, and scientific and
Marketing Research, pp. 351–357 (1989). consumer advocacy groups, health care
4. Mitra, A., J.L. Swasy, and K.J. Aikin, ‘‘How academic experts—notify FDA of their professionals, and scientific and
Do Consumers Interpret Market intent to participate in periodic academic experts—notify the Agency of
Leadership Claims in Direct-to- consultation meetings on the their intent to participate in periodic
Consumer Advertising of Prescription reauthorization of the Prescription Drug stakeholder consultation meetings on
Drugs?’’ Advances in Consumer User Fee Act (PDUFA). The statutory the reauthorization of PDUFA. PDUFA
Research, 33, pp. 381–387 (2006). authority for PDUFA expires in
5. O’Donoghue, A., H.K. Sullivan, D. Aikin, authorizes FDA to collect user fees from
September 2017. At that time, new the regulated industry for the process
R. Chowdhury, et al., ‘‘Presenting
Efficacy Information in Direct to
legislation will be required for FDA to for the review of human drugs. The
Consumer Prescription Drug continue collecting user fees for the authorization for the current program
Advertisements,’’ Patient Education prescription drug program. The Federal (PDUFA V) expires in September 2017.
Counsel, 95(2), pp. 271–80 (2014). Food, Drug, and Cosmetic Act (the Without new legislation, FDA will no
6. Schwartz, L.M., S. Woloshin, and H.G. FD&C Act) requires that FDA consult longer be able to collect user fees for
Welch, ‘‘Using a Drug Facts Box to with a range of stakeholders in
Communicate Drug Benefits and
future fiscal years to fund the human
developing recommendations for the drug review process.
Harmstwo Randomized Trials,’’ Annals
next PDUFA program. The FD&C Act Section 736B(d) of the FD&C Act (21
of Internal Medicine, 150(8), pp. 516–527
(2009). also requires that FDA hold discussions U.S.C. 379h–2(d)) requires that FDA
7. Sullivan, H.W., A. C. O’Donoghue, and K.J. (at least every month) with patient and consult with a range of stakeholders,
Aikin, ‘‘Presenting Quantitative consumer advocacy groups during including representatives from patient
Information About Placebo Rates to FDA’s negotiations with the regulated and consumer groups, health care
Patients,’’ JAMA Internal Medicine, doi: industry. The purpose of this request for
mstockstill on DSK4VPTVN1PROD with NOTICES
professionals, and scientific and
10.1001/jamainternmed.2013.10399 notification is to ensure continuity and
(2013). academic experts, in developing
progress in these monthly discussions recommendations for the next PDUFA
Dated: July 15, 2015. by establishing consistent stakeholder program. FDA will initiate the
Leslie Kux, representation. reauthorization process by holding a
Associate Commissioner for Policy. DATES: Submit notification of intention public meeting on July 15, 2015, where
[FR Doc. 2015–17725 Filed 7–17–15; 8:45 am] to participate in these series of meetings stakeholders and other members of the
BILLING CODE 4164–01–P by August 28, 2015. Stakeholder public will be given an opportunity to
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Document Created: 2015-12-15 12:57:53
Document Modified: 2015-12-15 12:57:53
| 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 September 18, 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 42823 |
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