Agency Information Collection Activities; Proposed Collection; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads, 42823-42825 [2015-17725]

Download as PDF 42823 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Accomplishments of the Domestic Violence Hotline, Online Connections and Text (ADVHOCaT) Study. OMB No.: New Collection. Description: The National Domestic Violence Hotline (NDVH) and the National Dating Abuse Helpline or Love Is Respect (NDAH/LIR), which are supported by the Division of Family Violence Prevention and Services within the Family and Youth Services Bureau of the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), serve as partners in the intervention, prevention, and resource assistance efforts of the network of family violence, domestic violence, and dating violence service providers. In order to describe the activities and accomplishments of the NDVH and NDAH/LIR and develop potential new or revised performance measures, the Office of Planning, Research and Evaluation (OPRE), within ACF/HHS is proposing data collection activity as part of the Accomplishments of the Domestic Violence Hotline, Online Connections and Text (ADVHOCaT) Study. This study will primarily analyze data previously collected by the NDVH and NDAH/LIR as part of their ongoing program activities and monitoring. ACF proposes to collect additional information, including information about the preferred mode (phone, chat, text), ease of use, and perceived safety of each mode of contact. This data is to be collected through voluntary web-based surveys that are to be completed by those who access the NDVH and NDAH/LIR Web sites. This information will be critical to informing future efforts to monitor and improve the performance of domestic violence hotlines and provide hotline services. Respondents: Individuals who access the NDVH and NDAH/LIR Web sites. ANNUAL BURDEN ESTIMATES Total/annual number of respondents Number of responses per respondent Average burden hours per response Annual burden hours NDVH/LIR Preference of Use Survey ..................................... mstockstill on DSK4VPTVN1PROD with NOTICES Instrument 5000 1 0.041 hours (150 seconds) .... 205 Estimated Total Annual Burden Hours: 205 hours. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email address: OPREinfocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to VerDate Sep<11>2014 16:30 Jul 17, 2015 Jkt 235001 comments and suggestions submitted within 60 days of this publication. Karl Koerper, Reports Clearance Officer. [FR Doc. 2015–17687 Filed 7–17–15; 8:45 am] BILLING CODE 4184–01–P 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. 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 SUMMARY: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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, PRAStaff@ fda.hhs.gov. 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\20JYN1.SGM 20JYN1 42824 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 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 selfidentify 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 mstockstill on DSK4VPTVN1PROD with NOTICES Efficacy Level Information: High .................................................................................................................... Low ..................................................................................................................... None (control) ..................................................................................................... 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 VerDate Sep<11>2014 16:30 Jul 17, 2015 Jkt 235001 New None (control) A D G B E H C F I 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 asked to choose one product on one or more dependent measures. FDA estimates the burden of this collection of information as follows: E:\FR\FM\20JYN1.SGM 20JYN1 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices 42825 TABLE 2—ESTIMATED BURDEN 1 Number of responses per respondent Number of respondents Activity Total annual respondents Average burden per response Total hours Sample outgo (pretests and main survey) ....................... Screener completes .......................................................... Eligible ............................................................................... Completes, Pretest 1 ........................................................ Completes, Pretest 2 ........................................................ Completes, Main Study ..................................................... Completes, Pretest 3 ........................................................ Completes, Followup Study .............................................. 16,384 1,638 1,556 252 252 495 108 216 ........................ 1 ........................ 1 1 1 1 1 ........................ 1,638 ........................ 252 252 495 108 216 ........................... .03 (2 minutes) ........................... .5 (30 minutes) .5 (30 minutes) .5 (30 minutes) .25 (15 minutes) .25 (15 minutes) ........................ 49 ........................ 126 126 248 27 54 Total ........................................................................... ........................ ........................ ........................ ........................... 630 1 There are no capital costs or operating and maintenance costs associated with this collection of information. mstockstill on DSK4VPTVN1PROD with NOTICES 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-toConsumer 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 VerDate Sep<11>2014 16:30 Jul 17, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0128] Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate AGENCY: Food and Drug Administration, HHS. Notice; request for notification of participation. ACTION: The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders—including patient and consumer advocacy groups, health care professionals, and scientific and academic experts—notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation. DATES: Submit notification of intention to participate in these series of meetings by August 28, 2015. Stakeholder SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 meetings will be held monthly. It is anticipated that they will commence in September or October 2015. ADDRESSES: Submit notification of intention to participate in monthly stakeholder meetings by email to PDUFAReauthorization@fda.hhs.gov. The meetings will be held at the FDA campus, 10903 New Hampshire Ave., Silver Spring, MD 20993. FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301–796– 5003, FAX: 301–847–8443. SUPPLEMENTARY INFORMATION: I. Background FDA is requesting that public stakeholders—including patient and consumer advocacy groups, health care professionals, and scientific and academic experts—notify the Agency of their intent to participate in periodic stakeholder consultation meetings on the reauthorization of PDUFA. PDUFA authorizes FDA to collect user fees from the regulated industry for the process for the review of human drugs. The authorization for the current program (PDUFA V) expires in September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human drug review process. Section 736B(d) of the FD&C Act (21 U.S.C. 379h–2(d)) requires that FDA consult with a range of stakeholders, including representatives from patient and consumer groups, health care professionals, and scientific and academic experts, in developing recommendations for the next PDUFA program. FDA will initiate the reauthorization process by holding a public meeting on July 15, 2015, where stakeholders and other members of the public will be given an opportunity to E:\FR\FM\20JYN1.SGM 20JYN1

Agencies

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42823-42825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 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

[[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