Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Perceptions of Product Risks and Benefits, 76034-76037 [E8-29517]
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Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices
the address below, no later than 5 p.m.
on January 14, 2009.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, New Executive Office
Building, Room 10235, Washington,
DC 20503, Fax Number: (202) 395–
6974.
Date: December 5, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–29542 Filed 12–12–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10110, CMS–R–
250 and CMS–668B]
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Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Manufacturer
Submission of Average Sales Price
(ASP) data for Medicare Part B Drugs
and Biologicals; Use: Section 1847A of
the Social Security Act requires that the
Medicare Part B payment amounts for
covered drugs and biologicals not paid
on a cost or prospective payment basis
be based upon manufacturers’ average
sales price data submitted to CMS. CMS
will utilize the ASP data to determine
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the Medicare Part B drug payment
amounts. Form Number: CMS–10110
(OMB# 0938–0921); Frequency:
Quarterly; Affected Public: Business or
other for-profits; Number of
Respondents: 180; Total Annual
Responses: 720; Total Annual Hours:
28,800.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: MPAF Data and
Supporting Regulations in 42 CFR
413.337, 413.343, 424.32 and 483.20;
Use: Resident assessment information
that Skilled Nursing Facilities (SNFs)
are required to submit is described
under section 42 CFR 413.343 and
483.20. The manner necessary to
administer the payment rate
methodology is described under section
42 CFR 413.337. An assessment form
comprised of a subset of resident
assessment information has been
developed for use by SNFs to satisfy
Medicare payment requirements, in lieu
of a full Minimum Data Set. The
associated burden is the time the SNF
staff is required to complete the
Medicare PPS Assessment Form
(MPAF), SNF staff time to encode, and
SNF staff time spent in transmitting the
data. Form Number: CMS–R–250
(OMB# 0938–0739); Frequency:
Occasionally; Affected Public: Business
or other for-profits and Not-for-profit
institutions, State, Local, or Tribal
Governments, and Federal
Governments; Number of Respondents:
15,039; Total Annual Responses:
3,834,945; Total Annual Hours:
2,704,764.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Post Clinical
Laboratory Survey Questionnaire and
Supporting Regulations in 42 CFR
493.1771, 493.1773, and 493.1777; Use:
This form is used by the State agency to
determine a laboratory’s compliance
with the Clinical Laboratory
Improvement Amendments of 1988
(CLIA). This information is needed for
a laboratory’s CLIA certification and
recertification. Form Number: CMS–
668B (OMB# 0938–0653); Frequency:
Biennially; Affected Public: Business or
other for-profits and Not-for-profit
institutions. State, Local, or Tribal
Government, Federal Government;
Number of Respondents: 21,000; Total
Annual Responses: 10,500; Total
Annual Hours: 2,625.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
at https://www.cms.hhs.gov/
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PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by February 13, 2009:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: December 5, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–29543 Filed 12–12–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0602]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of the Impact of Coupons
Embedded in Direct-to-Consumer
Prescription Drug Print
Advertisements on Consumer
Perceptions of Product Risks and
Benefits
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
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Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices
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public comment in response to the
notice. This notice solicits comments on
a study of the impact of the presence of
coupons offering price incentives or
rebates on consumers’ perceptions of
product risks and benefits in direct-toconsumer (DTC) print ads.1 Notice of
proposed information collection for this
project was previously published on
February 6, 2006 (71 FR 6077) and
withdrawn. This revised notice replaces
the previous notice.
DATES: Submit written or electronic
comments on the collection of
information by February 13, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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
1 While the Federal Food, Drug, and Cosmetic Act
(the act) provides FDA with authority to regulate
prescription drug advertisements that are false or
misleading, the act does not provide FDA with the
authority to regulate the pricing of prescription
drugs. Thus, FDA is merely interested in studying
the impact, if any, of the presence of coupons in
DTC advertisements on consumers’ perceptions of
product risks and benefits, and recognizes that it
does not actually regulate the dollar or other
incentive amount of coupons, price incentives, or
rebate offers with respect to how they affect the
price of prescription drugs or biological products.
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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.
Experimental Study of the Impact of
Coupons Embedded in Direct-toConsumer Prescription Drug Print
Advertisements on Consumer
Perceptions of Product Risks and
Benefits
FDA recognizes that the
manufacturers, packers, and distributors
(sponsors) of prescription human and
animal drugs, including biological
products for humans, have a First
Amendment right to engage in the
truthful and non-misleading advertising
of their products. An advertisement is
misleading, however, if it fails to
disclose certain information about the
advertised product’s uses and risks.
Thus, for prescription drugs and
biologics, the act requires
advertisements to contain ‘‘information
in brief summary relating to side effects,
contraindications, and effectiveness’’
(21 U.S.C. 352(n)). FDA is responsible
for enforcing the act and implementing
regulations.
FDA regulations require that
prescription drug advertisements that
make claims about a product must also
include risk information in a
‘‘balanced’’ manner (21 CFR
202.1(e)(5)(ii)), both in terms of the
content and presentation of the
information. Advertisements that draw
attention to the name of the product but
do not make representations about the
product’s indication(s) or dosage
recommendations are called reminder
advertisements. As a general matter,
reminder ads may mention the
proprietary and established name of the
product and (optionally) contain
information about the product’s
ingredients, dosage form, quantity,
price, and manufacturer (21 CFR
202.1(e)(2)(i)). Other written, printed, or
graphic information is not prohibited in
reminder ads as long as that information
does not make a representation or
suggestion relating to the product
beyond those permitted.
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Reminder ads allow sponsors to
distribute price sheets, pens, notepads
and other minor giveaways featuring the
name of the drug product to physicians
and other healthcare professionals
without requiring a full disclosure of the
product’s risks. As DTC promotion has
increased, sponsors have chosen to
create reminder ads for consumers.
On November 1 and 2, 2005, the
agency held a part 15 public hearing (70
FR 54054, September 13, 2005) on the
topic of direct-to-consumer advertising
of prescription drugs and restricted
medical devices. During the hearing, the
agency received several comments in
connection with the potential impact of
coupons and other price incentives on
consumer perceptions of DTCadvertised products. Sponsors may use
ads as a vehicle to offer price incentives
to consumers (e.g., ‘‘free trial,’’ ‘‘buy six
get one free’’). Coupon promotions are
widely used in many product categories
and have been the topic of many
academic studies. Certain types of
coupons, most notably those that appear
in the body of an advertisement itself
(i.e., are embedded in the
advertisement), can positively affect
perceptions of the brand.2
People tend to rate owned objects
more favorably than those they do not
own, even when those objects have been
assigned to them at random.3 This has
been termed the ‘‘mere ownership’’ or
‘‘mere possession’’ effect. An interesting
extension of this effect is provided in
research by Sen and Johnson 4 which
has shown that consumers rate a
product more favorably when they are
simply given a gift certificate or a
coupon for that product or service.
Other research has examined the effect
of warranties. People who viewed an ad
with a high warranty perceived the
product as being less risky compared to
people who saw an ad with a medium
or low warranty.5
Based on this body of consumer
research, the inclusion of a coupon or
other price incentive in the body of a
DTC ad may affect consumers’
perceptions of the risks and benefits of
2 LeClerc, France and John D.C. Little, ‘‘Can
Advertising Copy Make FSI Coupons More
Effective?’’ Journal of Marketing Research, 34(4),
473-484, 1997.
3 Beggan, James K., ‘‘On the Social Nature of
Nonsocial Perception: The Mere Ownership Effect,’’
Journal of Personality and Social Psychology, 62(2),
229-237, 1992.
4 Sen, Sankar and Eric J. Johnson, ‘‘MerePossession Effects Without Possession in Consumer
Choice,’’ Journal of Consumer Research, 24 (June),
105-117, 1997.
5 Shimp, Terrence A. and William O. Bearden,
‘‘Warranty and Other Extrinsic Cue Effects on
Consumers’ Risk Perceptions,’’ Journal of Consumer
Research, 9 (June), 38-47, 1982.
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Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices
the prescription drug. For instance,
consumers may assign more weight to
benefit claims in cases where a coupon
or other price incentive is embedded in
the advertisement. For ‘‘simple’’
consumer products, coupons and free
trial offers may enable the customer to
test new products while minimizing
their financial risk of testing the
product. For products that consumers
can readily test and ones where
performance can be adequately verified
(termed ‘‘search’’ goods by economists),
coupons and free trial offers provide
both the consumer and manufacturer an
efficient mechanism for matching
consumers and products. For more
complex products such as prescription
drugs where supervision of a physician
is required to evaluate both
appropriateness and performance,
coupons and free trial offers may send
different signals.
The proposed exploratory study will
examine what impact, if any, the
presence of coupons in DTC
advertisements may have on consumers’
perceptions of product risks and
benefits and the overall impression of
the product in DTC full-product and
reminder advertisements.6
Design Overview
This study will employ a betweensubjects crossed factorial design and
will focus on consumer print
advertising. Fifteen print advertisements
will be created using three levels of ad
type and five levels of promotional
offer. Thus, the factors will be ad type
(DTC print reminder; DTC print full
product; over-the-counter (OTC) print
full product) and offer type (free trial
offer; buy one, get one free; money off
prescription/purchase cost; money back
guarantee; no promotion). Product name
and indication will be constant across
conditions. Side effect and risk
information will be constant across full
product DTC ad conditions. Participants
will be asked to read a single print
advertisement for a new drug. After
reading the advertisement, they will be
asked questions about their evaluation
of the information presented in the
advertisement.
Factors
1. Participants: Consumers will be
screened and recruited by the contractor
to be currently diagnosed with insomnia
or at risk of developing insomnia.
Participants will be randomly assigned
to experimental cells. Each condition
will be balanced with respect to gender.
Because this is the first investigation
of this issue with DTC ads, we chose to
limit our investigation to one disease
condition. We chose to accept this
decrease in generality to maximize our
ability to detect a subtle difference
between promotion types. Participants
will be screened to represent a range of
education levels (some college or less
vs. completed college or more). Because
the task presumes basic reading
abilities, all participants will have
English as their primary language and,
as appropriate, be required to have
reading glasses when participating in
the study.
2. Type of Ad: The following three
types of ads will be tested: (1) A fullproduct ad for a prescription drug, (2)
a reminder ad for a prescription drug,
and (3) an ad for an OTC drug. An ad
for an OTC drug, which typically
includes benefit but not risk
information, is included to see if prior
research findings in the area of
consumer package goods can be
replicated.
3. Type of Promotion: The following
five types of promotions will be tested:
(1) Free trial offer; (2) buy one, get one
free; (3) money-off prescription/
purchase cost; (4) money back
guarantee; and (5) a no promotion
condition. With the exception of buy
one, get one free, these are promotional
variations that have been used in drug
advertising. We ask for comment on
other promotional types that could be
tested.
Procedure
Participants will be shown one ad, for
example, a reminder ad for a
prescription drug with a free-trial offer
coupon embedded. Then the participant
will be asked to answer questions
examining a number of important
perceptions about the product,
including perceived riskiness of the
drug, likelihood of benefits, and
behavioral intent (talking to doctor,
product purchase). Finally,
demographic and health care utilization
information will be collected.
Interviews are expected to last
approximately 15 minutes. A total of
1,350 participants will be involved. This
will be a one-time (rather than annual)
collection of information.
FDA estimates the burden of this
collection of information as follows:
FDA estimates that 2,025 individuals
will need to be screened to obtain a
respondent sample of 1,350. The
screener is expected to take 30 seconds,
for a total screener burden of 17 hours.
The 1,350 respondents will then be
asked to respond to a series of questions
about the advertisement. We estimate
the response burden for the survey to be
15 minutes, for a burden of 337.5 hours.
The estimated total burden for this data
collection effort is 354.5 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
2,025 (screener)
1
2,025
.008
17
1,350 (questionnaire)
1
1,350
.25
337.5
Total
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1 There
3,375
354.5
are no capital costs or operating and maintenance costs associated with this collection of information.
6 As noted previously in this document, FDA
does not have the authority to regulate prescription
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drug pricing and we will not be examining
prescription drug prices.
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Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29517 Filed 12–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Revised Amount of the
Average Cost of a Health Insurance
Policy
The Health Resources and Services
Administration (HRSA) is publishing an
updated monetary amount of the
average cost of a health insurance policy
as it relates to the National Vaccine
Injury Compensation Program (VICP).
Pursuant to section 100.2 of the
VICP’s implementing regulation (42 CFR
Part 100), the Secretary announces that
the revised average cost of a health
insurance policy under the VICP is
$382.30 per month. In accordance with
§ 100.2, the revised amount was
effective upon its delivery by the
Secretary to the United States Court of
Federal Claims. Such notice was
delivered to the Court on November 12,
2008.
Dated: December 8, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–29627 Filed 12–12–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
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The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Date: February 10, 2009.
Open: 8 a.m. to 12 p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C-Wing, Room
10, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C-Wing, Room
10, Bethesda, MD 20892.
Contact Person: Stephen C. Mockrin, PhD.,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260,
mockrins@nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
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76037
Dated: December 8, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–29537 Filed 12–12–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Inherited
Disease Research Access Committee.
Date: January 9, 2009.
Time: 8:30 a.m. to 4 p.m.
Agenda: To review and evaluate the
scientific and technical merit of applications
seeking to use the resources and facilities of
the CIDR.
Place: Embassy Suites Hotel, 4300 Military
Road, NW., Chevy Chase, MD 20015.
Contact Person: Camilla E. Day, PhD.,
Scientific Review Officer, CIDR National
Human Genome Research Institute, National
Institutes of Health, 5635 Fishers Lane, Suite
4075, Bethesda, MD 20892 301–402–8837,
camilla.day@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: December 5, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–29428 Filed 12–12–08; 8:45 am]
BILLING CODE 4140–01–M
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]]>Agencies
[Federal Register Volume 73, Number 241 (Monday, December 15, 2008)]
[Notices]
[Pages 76034-76037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29517]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0602]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of the Impact of Coupons Embedded
in Direct-to-Consumer Prescription Drug Print Advertisements on
Consumer Perceptions of Product Risks and Benefits
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
[[Page 76035]]
public comment in response to the notice. This notice solicits comments
on a study of the impact of the presence of coupons offering price
incentives or rebates on consumers' perceptions of product risks and
benefits in direct-to-consumer (DTC) print ads.\1\ Notice of proposed
information collection for this project was previously published on
February 6, 2006 (71 FR 6077) and withdrawn. This revised notice
replaces the previous notice.
---------------------------------------------------------------------------
\1\ While the Federal Food, Drug, and Cosmetic Act (the act)
provides FDA with authority to regulate prescription drug
advertisements that are false or misleading, the act does not
provide FDA with the authority to regulate the pricing of
prescription drugs. Thus, FDA is merely interested in studying the
impact, if any, of the presence of coupons in DTC advertisements on
consumers' perceptions of product risks and benefits, and recognizes
that it does not actually regulate the dollar or other incentive
amount of coupons, price incentives, or rebate offers with respect
to how they affect the price of prescription drugs or biological
products.
DATES: Submit written or electronic comments on the collection of
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information by February 13, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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.
Experimental Study of the Impact of Coupons Embedded in Direct-to-
Consumer Prescription Drug Print Advertisements on Consumer Perceptions
of Product Risks and Benefits
FDA recognizes that the manufacturers, packers, and distributors
(sponsors) of prescription human and animal drugs, including biological
products for humans, have a First Amendment right to engage in the
truthful and non-misleading advertising of their products. An
advertisement is misleading, however, if it fails to disclose certain
information about the advertised product's uses and risks. Thus, for
prescription drugs and biologics, the act requires advertisements to
contain ``information in brief summary relating to side effects,
contraindications, and effectiveness'' (21 U.S.C. 352(n)). FDA is
responsible for enforcing the act and implementing regulations.
FDA regulations require that prescription drug advertisements that
make claims about a product must also include risk information in a
``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the
content and presentation of the information. Advertisements that draw
attention to the name of the product but do not make representations
about the product's indication(s) or dosage recommendations are called
reminder advertisements. As a general matter, reminder ads may mention
the proprietary and established name of the product and (optionally)
contain information about the product's ingredients, dosage form,
quantity, price, and manufacturer (21 CFR 202.1(e)(2)(i)). Other
written, printed, or graphic information is not prohibited in reminder
ads as long as that information does not make a representation or
suggestion relating to the product beyond those permitted.
Reminder ads allow sponsors to distribute price sheets, pens,
notepads and other minor giveaways featuring the name of the drug
product to physicians and other healthcare professionals without
requiring a full disclosure of the product's risks. As DTC promotion
has increased, sponsors have chosen to create reminder ads for
consumers.
On November 1 and 2, 2005, the agency held a part 15 public hearing
(70 FR 54054, September 13, 2005) on the topic of direct-to-consumer
advertising of prescription drugs and restricted medical devices.
During the hearing, the agency received several comments in connection
with the potential impact of coupons and other price incentives on
consumer perceptions of DTC-advertised products. Sponsors may use ads
as a vehicle to offer price incentives to consumers (e.g., ``free
trial,'' ``buy six get one free''). Coupon promotions are widely used
in many product categories and have been the topic of many academic
studies. Certain types of coupons, most notably those that appear in
the body of an advertisement itself (i.e., are embedded in the
advertisement), can positively affect perceptions of the brand.\2\
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\2\ LeClerc, France and John D.C. Little, ``Can Advertising Copy
Make FSI Coupons More Effective?'' Journal of Marketing Research,
34(4), 473-484, 1997.
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People tend to rate owned objects more favorably than those they do
not own, even when those objects have been assigned to them at
random.\3\ This has been termed the ``mere ownership'' or ``mere
possession'' effect. An interesting extension of this effect is
provided in research by Sen and Johnson \4\ which has shown that
consumers rate a product more favorably when they are simply given a
gift certificate or a coupon for that product or service. Other
research has examined the effect of warranties. People who viewed an ad
with a high warranty perceived the product as being less risky compared
to people who saw an ad with a medium or low warranty.\5\
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\3\ Beggan, James K., ``On the Social Nature of Nonsocial
Perception: The Mere Ownership Effect,'' Journal of Personality and
Social Psychology, 62(2), 229-237, 1992.
\4\ Sen, Sankar and Eric J. Johnson, ``Mere-Possession Effects
Without Possession in Consumer Choice,'' Journal of Consumer
Research, 24 (June), 105-117, 1997.
\5\ Shimp, Terrence A. and William O. Bearden, ``Warranty and
Other Extrinsic Cue Effects on Consumers' Risk Perceptions,''
Journal of Consumer Research, 9 (June), 38-47, 1982.
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Based on this body of consumer research, the inclusion of a coupon
or other price incentive in the body of a DTC ad may affect consumers'
perceptions of the risks and benefits of
[[Page 76036]]
the prescription drug. For instance, consumers may assign more weight
to benefit claims in cases where a coupon or other price incentive is
embedded in the advertisement. For ``simple'' consumer products,
coupons and free trial offers may enable the customer to test new
products while minimizing their financial risk of testing the product.
For products that consumers can readily test and ones where performance
can be adequately verified (termed ``search'' goods by economists),
coupons and free trial offers provide both the consumer and
manufacturer an efficient mechanism for matching consumers and
products. For more complex products such as prescription drugs where
supervision of a physician is required to evaluate both appropriateness
and performance, coupons and free trial offers may send different
signals.
The proposed exploratory study will examine what impact, if any,
the presence of coupons in DTC advertisements may have on consumers'
perceptions of product risks and benefits and the overall impression of
the product in DTC full-product and reminder advertisements.\6\
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\6\ As noted previously in this document, FDA does not have the
authority to regulate prescription drug pricing and we will not be
examining prescription drug prices.
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Design Overview
This study will employ a between-subjects crossed factorial design
and will focus on consumer print advertising. Fifteen print
advertisements will be created using three levels of ad type and five
levels of promotional offer. Thus, the factors will be ad type (DTC
print reminder; DTC print full product; over-the-counter (OTC) print
full product) and offer type (free trial offer; buy one, get one free;
money off prescription/purchase cost; money back guarantee; no
promotion). Product name and indication will be constant across
conditions. Side effect and risk information will be constant across
full product DTC ad conditions. Participants will be asked to read a
single print advertisement for a new drug. After reading the
advertisement, they will be asked questions about their evaluation of
the information presented in the advertisement.
Factors
1. Participants: Consumers will be screened and recruited by the
contractor to be currently diagnosed with insomnia or at risk of
developing insomnia. Participants will be randomly assigned to
experimental cells. Each condition will be balanced with respect to
gender.
Because this is the first investigation of this issue with DTC ads,
we chose to limit our investigation to one disease condition. We chose
to accept this decrease in generality to maximize our ability to detect
a subtle difference between promotion types. Participants will be
screened to represent a range of education levels (some college or less
vs. completed college or more). Because the task presumes basic reading
abilities, all participants will have English as their primary language
and, as appropriate, be required to have reading glasses when
participating in the study.
2. Type of Ad: The following three types of ads will be tested: (1)
A full-product ad for a prescription drug, (2) a reminder ad for a
prescription drug, and (3) an ad for an OTC drug. An ad for an OTC
drug, which typically includes benefit but not risk information, is
included to see if prior research findings in the area of consumer
package goods can be replicated.
3. Type of Promotion: The following five types of promotions will
be tested: (1) Free trial offer; (2) buy one, get one free; (3) money-
off prescription/purchase cost; (4) money back guarantee; and (5) a no
promotion condition. With the exception of buy one, get one free, these
are promotional variations that have been used in drug advertising. We
ask for comment on other promotional types that could be tested.
Procedure
Participants will be shown one ad, for example, a reminder ad for a
prescription drug with a free-trial offer coupon embedded. Then the
participant will be asked to answer questions examining a number of
important perceptions about the product, including perceived riskiness
of the drug, likelihood of benefits, and behavioral intent (talking to
doctor, product purchase). Finally, demographic and health care
utilization information will be collected.
Interviews are expected to last approximately 15 minutes. A total
of 1,350 participants will be involved. This will be a one-time (rather
than annual) collection of information.
FDA estimates the burden of this collection of information as
follows:
FDA estimates that 2,025 individuals will need to be screened to
obtain a respondent sample of 1,350. The screener is expected to take
30 seconds, for a total screener burden of 17 hours. The 1,350
respondents will then be asked to respond to a series of questions
about the advertisement. We estimate the response burden for the survey
to be 15 minutes, for a burden of 337.5 hours. The estimated total
burden for this data collection effort is 354.5 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
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2,025 (screener) 1 2,025 .008 17
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1,350 (questionnaire) 1 1,350 .25 337.5
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Total ................. 3,375 ................. 354.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 76037]]
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: December 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29517 Filed 12-12-08; 8:45 am]
BILLING CODE 4160-01-S
