Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs, 23921-23924 [E6-6142]
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Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
Under the Federal Reserve Bank of
Kansas City heading, the entry for
Dickinson Financial Corporation II,
Kansas City, Missouri, is revised to read
as follows:
A. Federal Reserve Bank of Kansas
City (Donna J. Ward, Assistant Vice
President) 925 Grand Avenue, Kansas
City, Missouri 64198-0001:
1. Dickinson Financial Corporation II,
and Dickinson Financial Corporation,
both of Kansas City, Missouri; to acquire
100 percent of the voting shares of
Southern Commerce Bank, Tampa,
Florida.
Comments on this application must
be received by May 15, 2006.
Board of Governors of the Federal Reserve
System, April 20, 2006.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E6–6156 Filed 4–24–06; 8:45 am]
BILLING CODE 6210–01–S
FEDERAL RESERVE SYSTEM
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Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The application also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
Web site at https://www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
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16:59 Apr 24, 2006
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indicated or the offices of the Board of
Governors not later than May 19, 2006.
A. Federal Reserve Bank of New
York (Anne McEwen, Financial
Specialist) 33 Liberty Street, New York,
New York 10045-0001:
1. HSBC Holdings plc and HSBC
Overseas Holdings (UK) Limited, both of
London, United Kingdom, and their
direct and indirect subsidiaries, HSBC
North America Holdings, Inc., HSBC
Investments (North America), Inc.,
HSBC North America Inc., all of
Wilmington, Delaware, and HSBC USA
Inc., Baltimore, Maryland, to convert
their limited purpose and non–
depository trust bank subsidiary, HSBC
Trust Company (Delaware), N.A.,
Wilmington, Delaware, into a full
service bank.
B. Federal Reserve Bank of Chicago
(Patrick M. Wilder, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690-1414:
1. Alpha Bancorp, Inc., and
Metropolitan Bank Group, Inc., both of
Chicago, Illinois; to acquire 100 percent
of the voting shares of Community Bank
of DuPage, Westmont, Illinois (in
organization).
C. Federal Reserve Bank of Kansas
City (Donna J. Ward, Assistant Vice
President) 925 Grand Avenue, Kansas
City, Missouri 64198-0001:
1. First Fidelity Bancorp, Inc.,
Oklahoma City, Oklahoma; to acquire
100 percent of the voting shares of Apex
Mortgage Company, and thereby
indirectly acquire Edmond Bank and
Trust, both of Edmond, Oklahoma.
FOR FURTHER INFORMATION CONTACT:
Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office
of Board Members at 202–452–2955.
SUPPLEMENTARY INFORMATION: You may
call 202–452–3206 beginning at
approximately 5 p.m. two business days
before the meeting for a recorded
announcement of bank and bank
holding company applications
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
Board of Governors of the Federal Reserve
System, April 20, 2006.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. E6–6181 Filed 4–24–06; 8:45 am]
AGENCY:
BILLING CODE 6210–01–S
FEDERAL RESERVE SYSTEM
Sunshine Act Meeting
Board of
Governors of the Federal Reserve
System.
TIME AND DATE: 11:30 a.m., Monday, May
1, 2006.
PLACE: Marriner S. Eccles Federal
Reserve Board Building, 20th and C
Streets, N.W., Washington, D.C. 20551.
STATUS: Closed.
MATTERS TO BE CONSIDERED:
1. Personnel actions (appointments,
promotions, assignments,
reassignments, and salary actions)
involving individual Federal Reserve
System employees.
2. Any items carried forward from a
previously announced meeting.
AGENCY HOLDING THE MEETING:
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Board of Governors of the Federal Reserve
System, April 21, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 06–3951 Filed 4–21–06; 3:31 pm]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0133]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Evaluation of Variations in Content and
Format of the Brief Summary in Directto-Consumer Print Advertisements for
Prescription Drugs
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on a
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
two studies of consumer evaluations of
variations in content and format of the
brief summary in direct-to-consumer
(DTC) prescription drug print
advertisements.
Submit written or electronic
comments on the collection of
information by June 26, 2006.
ADDRESSES: Submit electronic
comments on the collection of
DATES:
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Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
information to: https://www.fda.gov/
dockets/ecomments. 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:
Karen Nelson, Office Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION:
I. Backround
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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,
including each proposed extension of an
existing 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 each of 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 Evaluation of Variations
in Content and Format of the Brief
Summary in DTC Print Advertisements
for Prescription Drugs
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
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300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 903(b)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and
other FDA-regulated products in
carrying out the provisions of the act.
Under the act, a drug is misbranded if
its labeling or advertising is false or
misleading. In addition, section 502(n)
of the act (21 U.S.C. 352(n)) specifies
that advertisements for prescription
drugs and biological products must
provide a true statement of information
‘‘in brief summary’’ about the advertised
product’s ‘‘side effects,
contraindications, and effectiveness.’’
The prescription drug advertising
regulations (§ 202.1(e)(3)(iii) (21 CFR
202.1(e)(3)(iii))) specify that the
information about risks must include
‘‘each specific side effect and
contraindication’’ from the advertised
drug’s approved labeling. The regulation
also specifies that the phrase ‘‘side
effect and contraindication’’ refers to all
of the categories of risk information
required in the approved product
labeling written for health professionals,
including the warnings, precautions,
and adverse reactions sections. Thus,
every risk in an advertised drug’s
approved labeling must be included to
meet these regulations.
In recent years, FDA has become
concerned about the adequacy of the
brief summary in DTC print
advertisements. Although advertising of
prescription drugs was once primarily
addressed to health professionals,
increasingly consumers have become a
target audience, as DTC advertising has
dramatically increased in the past few
years. Results of FDA’s 2002 survey on
DTC advertising (available at https://
www.fda.gov/cder/ddmac/
researchka.htm) show that 41 percent of
respondents in 2002 reported they do
not usually read any of the brief
summary that accompanies the main
print ad. Use of the brief summary was
a function of whether they have an
interest in the condition; about 45
percent of those having a particular
interest in the advertised drug read all
or almost all of the brief summary.
Despite their interest, about half of these
individuals described the brief summary
as somewhat or very hard to
understand.
Because the regulations do not specify
how to include each risk, sponsors can
use discretion in fulfilling the brief
summary requirement under
§ 202.1(e)(3)(iii). Frequently, sponsors
print in small type, verbatim, the riskrelated sections of the approved product
labeling (also called the package insert,
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professional labeling, or prescribing
information). This labeling is written for
health professionals, using medical
terminology. FDA believes that while
this is one reasonable way to fulfill the
brief summary requirement for print
advertisements directed toward health
professionals, this method is difficult
for consumers to understand and
therefore may not be the best approach
to communicate this important
information to them.
In 2004, FDA published a draft
guidance entitled ‘‘Brief Summary:
Disclosing Risk Information in
Consumer-Directed Print
Advertisements’’ (available at https://
www.fda.gov/cder/guidance/
5669dft.htm). This guidance outlined
possible options for improving the
communication of risk information to
consumers in specific promotional
pieces. When discussing the current
professional prescribing information
format, the guidance states that the
‘‘volume of the material, coupled with
the format in which it is presented...
discourages its use and makes the
information less comprehensible to
consumers.’’ The draft guidance
suggested three possible presentations
for the brief summary, including the
current prescribing information format,
an approved patient package insert, or
highlights from the physician labeling
rule.
In the content study, FDA plans to
investigate the role of context in
providing useful risk information to
consumers. It has been theorized that
long lists of minor risks may detract
from the understanding of more serious
risks, as stated in the draft guidance.
Nonetheless, if the risk information is
presented with proper supporting
context, people may find the
information facilitates rather than
distracts from the understanding of the
risk information. One of the two
proposed studies in this notice will
investigate the context that may
contribute to this facilitation.
In addition to context, format also
plays a role in the clarity and
understanding of the brief summary.
FDA proposes to collect information on
the usefulness of different formats
suggested in the draft guidance. In
addition to the patient package insert,
which is usually presented in a question
and answer format, FDA proposes to test
a consumer-friendly highlights format,
as well as a format based on the drug
facts labeling used for over-the-counter
drugs.
Data from these two studies will
converge to allow a better assessment of
various ways to present risk information
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Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
in a print advertisement for a
prescription drug.
II. Studies
A. Content Study
1. Design Overview
This study will employ a betweensubjects crossed factorial design using a
mall-intercept protocol. Ten print
advertisements will be created using
two levels of drug side effect
information and five levels of context.
Thus, the factors will be the amount of
side effect information (short; long) and
amount of supportive context for the
side effect information (paragraph only;
paragraph rate; paragraph rate plus
placebo rate; chart rate; chart rate plus
placebo rate). Other information will be
constant across conditions. Respondents
who self-identify as being in the target
market for the condition will be asked
to read a single print advertisement for
a new prescription drug. After reading
the advertisement, they will be asked
questions about their comprehension
and evaluation of the information
presented in the advertisement.
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2. Factors
a. Participants. Consumers will be
screened and recruited by the contractor
to be self-identified as being moderately
overweight or more. We chose to limit
our investigation to this one disease
condition (weight loss) because it has a
high prevalence rate in the population
(https://www.cdc.gov/nccdphp/dnpa/
obesity/faq.htm) and is likely to occur
both in males and females. We chose to
accept this decrease in generalizability
to maximize our ability to detect subtle
differences in content variation.
Participants will be screened to
represent a range of education levels
(some college or less; completed college
or more). Because the task presumes
basic reading abilities, all screened
participants will speak English as their
primary language and, as appropriate,
have reading glasses available when
participating in the study.
b. Amount of side effect information.
The number of side effects will be
varied to create ‘‘short’’ and ‘‘long’’
levels as follows:
Short: ‘‘Side effects include a, b, and
c. This is not a complete list. Talk to
your doctor for more information.’’
Long: ‘‘Side effects include a, b, c, d,
e, f, g, and h. Talk to your doctor for
more information.’’
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c. Context. The context for the side
effect information will be varied to
create five levels ranging from least
supportive to most supportive as
follows:
Paragraph only: Listing of side effects
in paragraph form.
Paragraph rate: Listing of side effects
and their rate of occurrence in
paragraph form.
Paragraph rate plus placebo rate:
Listing of side effects, their rate of
occurrence, and the rate of placebo
effects in paragraph form.
Chart rate: Listing of side effects and
their rate of occurrence in table form.
Chart rate plus placebo rate: Listing of
side effects, their rate of occurrence, and
the rate of placebo effects in table form.
3. Procedure
Participants will be shown one ad.
Then a structured interview will be
conducted with each participant to
examine a number of important
perceptions about the brief summary,
including perceived riskiness of the
drug, comprehension of information in
the brief summary, and perceived
usefulness of brief summary
information. Finally, demographic and
health care utilization information will
be collected. Interviews are expected to
last approximately 20 minutes. A total
of 900 participants will be involved.
This will be a one-time (rather than
annual) collection of information.
B. Format Study
1. Design Overview
This study will employ a betweensubjects crossed factorial design using a
mall-intercept protocol. Three print
advertisements will be created using
three different formats: Question and
answer, highlights (71 FR 3922, January
24, 2006), and drug facts (21 CFR 201.66
and Appendix A). The information in
the formats will be constant across
conditions. Participants who selfidentify as being in the target market for
the condition will be asked to read a
single print advertisement for a new
prescription drug. After reading the
advertisement, they will be asked
questions about their comprehension
and evaluation of the information
presented in the advertisement.
2. Factors
a. Participants. Consumers will be
screened and recruited by the contractor
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23923
to be self-identified as being moderately
overweight or more. As in the content
study described previously in this
document, we chose to limit our
investigation to one disease condition–
weight loss. Participants will be
screened to represent a range of
education levels (some college or less;
completed college or more). Because the
task presumes basic reading abilities, all
screened participants will speak English
as their primary language and, as
appropriate, have reading glasses
available when participating in the
study.
b. Type of format. The format of the
information in the brief summary will
be varied as follows: Question and
answer, highlights, and drug facts.
Please refer to Appendix A for examples
of the different format variations.
3. Procedure
Participants will be shown one ad.
Then a structured interview will be
conducted with each participant to
examine a number of important
perceptions about the brief summary,
including perceived riskiness of the
drug, comprehension of information in
the brief summary, and perceived
usefulness of brief summary
information. Finally, demographic and
health care utilization information will
be collected. Interviews are expected to
last approximately 20 minutes. A total
of 300 participants will be involved.
This will be a one-time (rather than
annual) collection of information.
FDA estimates that 1,800 individuals
will need to be screened to obtain a
respondent sample of 900 for the
content study and that 600 individuals
will need to be screened to obtain a
respondent sample of 300 for the format
study. The screener is expected to take
30 seconds, for a total screener burden
of 41 hours. The 1,200 respondents in
the two studies will then be asked to
respond to a series of questions about
the advertisement. We estimate the
response burden for each of the two
studies to be 20 minutes, for a burden
of 396 hours. The estimated total burden
for this data collection effort is 437
hours. The respondent burden is listed
in table 1 of this document.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 71, No. 79 / Tuesday, April 25, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual Frequency
per Response
No. of Respondents
Total Annual
Responses
Hours per
Response
1,800 (content study: screener)
1
1,800
900 (content study: questionnaire)
1
600 (format study: screener)
300 (format study: questionnaire)
Total Hours
.017
31
900
.33
297
1
600
.017
10
1
300
.33
99
Total
437
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6142 Filed 4–24–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Industry Exchange Workshop on Food
and Drug Administration Clinical Trial
Requirements; Public Workshop;
Correction
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
[Docket No. 2004N–0408]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
April 11, 2006. The document
reannounced the invitation for
participation in its Regulatory Site Visit
Training Program. The document was
published with an incorrect e-mail
address. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Joyce A. Strong, Office of Policy (HF–
27), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: In FR Doc.
E6–5221, appearing on page 18340 in
the Federal Register of Tuesday, April
11, 2006, the following correction is
made:
1. On page 18340, in the third
column, in the last sentence under the
‘‘ADDRESSES’’ caption and under the
‘‘FOR FURTHER INFORMATION CONTACT’’
caption, the e-mail address is corrected
to read matt@cber.fda.gov.
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Notice of public workshop;
correction.
ACTION:
Regulatory Site Visit Training Program;
Correction
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6120 Filed 4–24–06; 8:45 am]
16:59 Apr 24, 2006
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Guidance for Sponsors, Institutional
Review Boards, Clinical Investigators,
and Food and Drug Administration
Staff; Guidance on Informed Consent
for In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That
Are Not Individually Identifiable;
Availability
AGENCY:
The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
March 7, 2006. The document
announced a workshop on FDA clinical
trial statutory and regulatory
requirements. The document was
published with an incorrect Internet
address. This document corrects that
error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Joyce A. Strong, Office of Policy (HF–
27), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 301–827–7010.
In FR Doc.
E6–3229, appearing on page 11434 in
the Federal Register of Tuesday, March
7, 2006, the following correction is
made:
1. On page 11434, in the second
column, under the ‘‘Registration’’
caption, the Internet address is
corrected to read https://www.socra.org/
html/FDA_Conference.htm.
SUPPLEMENTARY INFORMATION:
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6119 Filed 4–24–06; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
VerDate Aug<31>2005
[Docket No. 2006D–0150]
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Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable.’’ This
guidance is intended to inform
sponsors, institutional review boards,
clinical investigators, and agency staff
that under circumstances described in
the guidance, that FDA does not intend
to object to the use in device
investigations, without informed
consent, of leftover human specimens
that are not individually identifiable.
FDA intends to include in this policy
leftover specimens that are remnants of
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded, specimens
obtained from specimen repositories,
and specimens that are leftover from
specimens previously collected for other
unrelated research. This guidance
document will be implemented
immediately, but it remains subject to
comment in accordance with the
agency’s good guidance practices
(GGPs).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
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]]>Agencies
[Federal Register Volume 71, Number 79 (Tuesday, April 25, 2006)]
[Notices]
[Pages 23921-23924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6142]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0133]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Evaluation of Variations in Content and
Format of the Brief Summary in Direct-to-Consumer Print Advertisements
for Prescription Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on a 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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on two studies of consumer
evaluations of variations in content and format of the brief summary in
direct-to-consumer (DTC) prescription drug print advertisements.
DATES: Submit written or electronic comments on the collection of
information by June 26, 2006.
ADDRESSES: Submit electronic comments on the collection of
[[Page 23922]]
information to: https://www.fda.gov/dockets/ecomments. 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: Karen Nelson, Office Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION:
I. Backround
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, including each
proposed extension of an existing 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 each of 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 Evaluation of Variations in Content and Format of the
Brief Summary in DTC Print Advertisements for Prescription Drugs
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 903(b)(2)(c) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the act. Under the act, a drug is
misbranded if its labeling or advertising is false or misleading. In
addition, section 502(n) of the act (21 U.S.C. 352(n)) specifies that
advertisements for prescription drugs and biological products must
provide a true statement of information ``in brief summary'' about the
advertised product's ``side effects, contraindications, and
effectiveness.'' The prescription drug advertising regulations (Sec.
202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) specify that the
information about risks must include ``each specific side effect and
contraindication'' from the advertised drug's approved labeling. The
regulation also specifies that the phrase ``side effect and
contraindication'' refers to all of the categories of risk information
required in the approved product labeling written for health
professionals, including the warnings, precautions, and adverse
reactions sections. Thus, every risk in an advertised drug's approved
labeling must be included to meet these regulations.
In recent years, FDA has become concerned about the adequacy of the
brief summary in DTC print advertisements. Although advertising of
prescription drugs was once primarily addressed to health
professionals, increasingly consumers have become a target audience, as
DTC advertising has dramatically increased in the past few years.
Results of FDA's 2002 survey on DTC advertising (available at https://
www.fda.gov/cder/ddmac/researchka.htm) show that 41 percent of
respondents in 2002 reported they do not usually read any of the brief
summary that accompanies the main print ad. Use of the brief summary
was a function of whether they have an interest in the condition; about
45 percent of those having a particular interest in the advertised drug
read all or almost all of the brief summary. Despite their interest,
about half of these individuals described the brief summary as somewhat
or very hard to understand.
Because the regulations do not specify how to include each risk,
sponsors can use discretion in fulfilling the brief summary requirement
under Sec. 202.1(e)(3)(iii). Frequently, sponsors print in small type,
verbatim, the risk-related sections of the approved product labeling
(also called the package insert, professional labeling, or prescribing
information). This labeling is written for health professionals, using
medical terminology. FDA believes that while this is one reasonable way
to fulfill the brief summary requirement for print advertisements
directed toward health professionals, this method is difficult for
consumers to understand and therefore may not be the best approach to
communicate this important information to them.
In 2004, FDA published a draft guidance entitled ``Brief Summary:
Disclosing Risk Information in Consumer-Directed Print Advertisements''
(available at https://www.fda.gov/cder/guidance/5669dft.htm). This
guidance outlined possible options for improving the communication of
risk information to consumers in specific promotional pieces. When
discussing the current professional prescribing information format, the
guidance states that the ``volume of the material, coupled with the
format in which it is presented... discourages its use and makes the
information less comprehensible to consumers.'' The draft guidance
suggested three possible presentations for the brief summary, including
the current prescribing information format, an approved patient package
insert, or highlights from the physician labeling rule.
In the content study, FDA plans to investigate the role of context
in providing useful risk information to consumers. It has been
theorized that long lists of minor risks may detract from the
understanding of more serious risks, as stated in the draft guidance.
Nonetheless, if the risk information is presented with proper
supporting context, people may find the information facilitates rather
than distracts from the understanding of the risk information. One of
the two proposed studies in this notice will investigate the context
that may contribute to this facilitation.
In addition to context, format also plays a role in the clarity and
understanding of the brief summary. FDA proposes to collect information
on the usefulness of different formats suggested in the draft guidance.
In addition to the patient package insert, which is usually presented
in a question and answer format, FDA proposes to test a consumer-
friendly highlights format, as well as a format based on the drug facts
labeling used for over-the-counter drugs.
Data from these two studies will converge to allow a better
assessment of various ways to present risk information
[[Page 23923]]
in a print advertisement for a prescription drug.
II. Studies
A. Content Study
1. Design Overview
This study will employ a between-subjects crossed factorial design
using a mall-intercept protocol. Ten print advertisements will be
created using two levels of drug side effect information and five
levels of context. Thus, the factors will be the amount of side effect
information (short; long) and amount of supportive context for the side
effect information (paragraph only; paragraph rate; paragraph rate plus
placebo rate; chart rate; chart rate plus placebo rate). Other
information will be constant across conditions. Respondents who self-
identify as being in the target market for the condition will be asked
to read a single print advertisement for a new prescription drug. After
reading the advertisement, they will be asked questions about their
comprehension and evaluation of the information presented in the
advertisement.
2. Factors
a. Participants. Consumers will be screened and recruited by the
contractor to be self-identified as being moderately overweight or
more. We chose to limit our investigation to this one disease condition
(weight loss) because it has a high prevalence rate in the population
(https://www.cdc.gov/nccdphp/dnpa/obesity/faq.htm) and is likely to
occur both in males and females. We chose to accept this decrease in
generalizability to maximize our ability to detect subtle differences
in content variation. Participants will be screened to represent a
range of education levels (some college or less; completed college or
more). Because the task presumes basic reading abilities, all screened
participants will speak English as their primary language and, as
appropriate, have reading glasses available when participating in the
study.
b. Amount of side effect information. The number of side effects
will be varied to create ``short'' and ``long'' levels as follows:
Short: ``Side effects include a, b, and c. This is not a complete
list. Talk to your doctor for more information.''
Long: ``Side effects include a, b, c, d, e, f, g, and h. Talk to
your doctor for more information.''
c. Context. The context for the side effect information will be
varied to create five levels ranging from least supportive to most
supportive as follows:
Paragraph only: Listing of side effects in paragraph form.
Paragraph rate: Listing of side effects and their rate of
occurrence in paragraph form.
Paragraph rate plus placebo rate: Listing of side effects, their
rate of occurrence, and the rate of placebo effects in paragraph form.
Chart rate: Listing of side effects and their rate of occurrence in
table form.
Chart rate plus placebo rate: Listing of side effects, their rate
of occurrence, and the rate of placebo effects in table form.
3. Procedure
Participants will be shown one ad. Then a structured interview will
be conducted with each participant to examine a number of important
perceptions about the brief summary, including perceived riskiness of
the drug, comprehension of information in the brief summary, and
perceived usefulness of brief summary information. Finally, demographic
and health care utilization information will be collected. Interviews
are expected to last approximately 20 minutes. A total of 900
participants will be involved. This will be a one-time (rather than
annual) collection of information.
B. Format Study
1. Design Overview
This study will employ a between-subjects crossed factorial design
using a mall-intercept protocol. Three print advertisements will be
created using three different formats: Question and answer, highlights
(71 FR 3922, January 24, 2006), and drug facts (21 CFR 201.66 and
Appendix A). The information in the formats will be constant across
conditions. Participants who self-identify as being in the target
market for the condition will be asked to read a single print
advertisement for a new prescription drug. After reading the
advertisement, they will be asked questions about their comprehension
and evaluation of the information presented in the advertisement.
2. Factors
a. Participants. Consumers will be screened and recruited by the
contractor to be self-identified as being moderately overweight or
more. As in the content study described previously in this document, we
chose to limit our investigation to one disease condition-weight loss.
Participants will be screened to represent a range of education levels
(some college or less; completed college or more). Because the task
presumes basic reading abilities, all screened participants will speak
English as their primary language and, as appropriate, have reading
glasses available when participating in the study.
b. Type of format. The format of the information in the brief
summary will be varied as follows: Question and answer, highlights, and
drug facts. Please refer to Appendix A for examples of the different
format variations.
3. Procedure
Participants will be shown one ad. Then a structured interview will
be conducted with each participant to examine a number of important
perceptions about the brief summary, including perceived riskiness of
the drug, comprehension of information in the brief summary, and
perceived usefulness of brief summary information. Finally, demographic
and health care utilization information will be collected. Interviews
are expected to last approximately 20 minutes. A total of 300
participants will be involved. This will be a one-time (rather than
annual) collection of information.
FDA estimates that 1,800 individuals will need to be screened to
obtain a respondent sample of 900 for the content study and that 600
individuals will need to be screened to obtain a respondent sample of
300 for the format study. The screener is expected to take 30 seconds,
for a total screener burden of 41 hours. The 1,200 respondents in the
two studies will then be asked to respond to a series of questions
about the advertisement. We estimate the response burden for each of
the two studies to be 20 minutes, for a burden of 396 hours. The
estimated total burden for this data collection effort is 437 hours.
The respondent burden is listed in table 1 of this document.
FDA estimates the burden of this collection of information as
follows:
[[Page 23924]]
Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
1,800 (content study: screener) 1 1,800 .017 31
----------------------------------------------------------------------------------------------------------------
900 (content study: 1 900 .33 297
questionnaire)
----------------------------------------------------------------------------------------------------------------
600 (format study: screener) 1 600 .017 10
----------------------------------------------------------------------------------------------------------------
300 (format study: 1 300 .33 99
questionnaire)
----------------------------------------------------------------------------------------------------------------
Total 437
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6142 Filed 4-24-06; 8:45 am]
BILLING CODE 4160-01-S
