Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Professional Survey of Prescription Drug Promotion, 2299-2301 [2012-638]
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Federal Register / Vol. 77, No. 10 / Tuesday, January 17, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Child Support Enforcement;
Privacy Act of 1974; Computer
Matching Agreement
Office of Child Support
Enforcement (OCSE), ACF, HHS.
ACTION: Notice of a Computer Matching
Program.
AGENCY:
In accordance with the
Privacy Act of 1974 (5 U.S.C. 522a), as
amended, OCSE is publishing notice of
a computer matching program between
OCSE and state agencies administering
the Supplemental Nutrition Assistance
Program (SNAP).
DATES: HHS invites interested parties to
review, submit written data, comments
or arguments to the agency about the
matching program until February 16,
2012. As required by the Privacy Act
(5 U.S.C. 552a(r)), HHS on January 5,
2012, sent a report of a Computer
Matching Program to the Committee on
Homeland Security and Governmental
Affairs of the Senate, the Committee on
Oversight and Government Reform of
the House of Representatives and the
Office of Information and Regulatory
Affairs of the Office of Management and
Budget (OMB).
ADDRESSES: Interested parties may
submit written comment on this notice
by writing to Linda Deimeke, Director,
Division of Federal Systems, Office of
Child Support Enforcement,
Administration for Children and
Families, 370 L’Enfant Promenade SW.,
4th Floor East, Washington, DC 20447.
Comments received will be available for
public inspection at this address from
9 a.m. to 5 p.m. ET, Monday through
Friday.
SUMMARY:
srobinson on DSK4SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Linda Deimeke, Director, Division of
Federal Systems, Office of Child
Support Enforcement, Administration
for Children and Families, 370 L’Enfant
Promenade SW., 4th Floor East,
Washington, DC 20447, (202) 401–5439.
SUPPLEMENTARY INFORMATION: The
Privacy Act of 1974 (5 U.S.C. 552a), as
amended, provides for certain
protections for individuals applying for
and receiving federal benefits. The law
governs the use of computer matching
by federal agencies when records in a
system of records are matched with
other federal, state or local government
records. The Privacy Act requires
agencies involved in computer matching
programs to:
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Jkt 226001
1. Negotiate written agreements with
the other agency or agencies
participating in the matching programs;
2. Provide notification to applicants
and beneficiaries that their records are
subject to matching;
3. Verify information produced by
such matching program before reducing,
making a final denial of, suspending or
terminating an individual’s benefits or
payments;
4. Publish notice of the computer
matching program in the Federal
Register;
5. Furnish reports about the matching
program to Congress and OMB; and
6. Obtain the approval of the
matching agreement by the Data
Integrity Board of any Federal agency
participating in a matching program.
This matching program meets these
requirements.
Dated: December 16, 2011.
Vicki Turetsky,
Commissioner, Office of Child Support
Enforcement.
Notice of New Computer Matching
Program
A. Participating Agencies
The participating agencies are OCSE,
which is the ‘‘source agency,’’ and state
agencies administering the
Supplemental Nutrition Assistance
Program (SNAP), which are the ‘‘nonfederal agencies.’’
B. Purpose of the Matching Program
The purpose of the matching program
is to provide new hire, quarterly wage
(QW) and unemployment insurance (UI)
information from OCSE’s National
Directory of New Hires (NDNH) to state
agencies administering SNAP for the
purpose of establishing or verifying the
eligibility of SNAP applicants and
recipients. The state agencies
administering SNAP may also use the
NDNH information for the purpose of
updating the recipients’ reported
participation in work activities and
updating recipients’ and their
employers’ contact information
maintained by the state agencies
administering SNAP.
2299
have applied for SNAP benefits. The
system of records maintained by OCSE
from which records will be disclosed for
the purpose of this matching program is
the ‘‘OCSE National Directory of New
Hires’’ (NDNH), No. 09–80–0381, last
published in the Federal Register at 76
FR 560 on January 5, 2011. The NDNH
contains new hire, QW and UI
information. The disclosure of NDNH
information by OCSE to the state
agencies administering SNAP is a
‘‘routine use’’ under this system of
records. Records resulting from the
matching program and which are
disclosed to state agencies
administering the SNAP include names,
Social Security numbers, home
addresses and employment information.
E. Inclusive Dates of the Matching
Program
The computer matching agreement
will be effective and matching activity
may commence the later of the
following:
(1) 30 days after this notice is
published in the Federal Register or (2)
40 days after OCSE sends a report of the
matching program to the Congressional
committees of jurisdiction under 5
U.S.C. 552a(o)(2)(A); and to OMB,
unless OMB disapproves the agreement
within the 40-day review period or
grants a waiver of 10 days of the 40-day
review period. The matching agreement
will remain in effect for 18 months from
its effective date, unless one of the
parties to the agreement advises the
other by written request to terminate or
modify the agreement. The agreement is
subject to renewal by the HHS Data
Integrity Board for 12 additional months
if the matching program will be
conducted without any change and each
party to the agreement certifies to the
Board in writing that the program has
been conducted in compliance with the
agreement.
[FR Doc. 2012–627 Filed 1–13–12; 8:45 am]
BILLING CODE 4184–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
C. Authority for Conducting the Match
Food and Drug Administration
The authority for conducting the
matching program is contained in
Section 453(j)(10) of the Social Security
Act. 42 U.S.C. 653(j)(10).
[Docket No. FDA–2012–N–0018]
D. Categories of Individuals Involved
and Identification of Records Used in
the Matching Program
The categories of individuals involved
in the matching program are adult
members of households that receive or
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Healthcare
Professional Survey of Prescription
Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\17JAN1.SGM
Notice.
17JAN1
2300
Federal Register / Vol. 77, No. 10 / Tuesday, January 17, 2012 / Notices
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
the Healthcare Professional Survey of
Prescription Drug Promotion. This
survey is designed to explore the
opinions and perceptions of physicians,
nurse practitioners, and physician
assistants with regard to the promotion
of prescription drugs to consumers and
healthcare providers.
DATES: Submit either electronic or
written comments on the collection of
information by March 19, 2012.
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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.
PI50–400B, Rockville, MD 20850, (301)
796–7651, Juanmanuel.vilela@
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
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
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:12 Jan 13, 2012
Jkt 226001
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.
Healthcare Professional Survey of
Prescription Drug Promotion—(OMB
Control Number 0910—New)
I. Regulatory Background
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the Food and
Drug Administration (FDA) to conduct
research relating to health information.
Section 903(d)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (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.
II. Description
The rise of direct-to-consumer (DTC)
drug advertising and prescription drug
promotion has affected healthcare
professionals in a number of ways. First,
healthcare professionals regularly
encounter patients who have been
exposed to DTC ads. Second, healthcare
professionals also see and hear such ads
directly as mass media consumers
themselves. Since clarification of the
adequate provision requirement for
prescription drug broadcast ads in 1997,
FDA has faced numerous questions
about the influence of DTC
pharmaceutical marketing because such
advertising directly engages consumers
and potentially affects interactions
between patients and their physicians
(Refs. 1 and 2). Those questions have
grown more urgent with the growth of
DTC advertising in recent years (Refs. 3
and 4). In 2002, FDA considered this
form of promotion sufficiently
important as a force in the physicianpatient interaction that they surveyed
both patients and physicians regarding
their perceptions of DTC advertising
(Ref. 5). Now, nearly a decade later,
there are critical reasons to return to the
field to gather more evidence on the
influence of DTC advertising in the
examination room and on the
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
relationships between healthcare
professionals and patients.
One of the most noteworthy aspects of
the current healthcare environment in
2011 is the role now played by various
physician extenders. Naylor and
Kurtzman (Ref. 6) recently noted that
nurses are the single largest group of
healthcare providers in the United
States and they argue that nurse
practitioners will play an increasingly
vital role in primary care delivery.
Similarly, physician assistants also
bolster the ability of our healthcare
system to offer some types of care at
lower cost. The aforementioned 2002
FDA study did not include nurse
practitioners or physician assistants in
the sample; that study focused on
general practitioners and specialists in
several key areas targeted by DTC
advertising. Murray and colleagues (Ref.
7) also conducted a large-scale survey of
U.S. physicians regarding their
perceptions of DTC advertising, but they
also did not include nurse practitioners
or physician assistants in their sample.
Because DTC advertising likely affects
daily interactions between patients and
nurse practitioners and physician
assistants—similar to the 2002 FDA
study that suggested the influence of
advertising on physicians’ work lives—
including these groups in the new
sample will further understanding of
DTC advertising in the healthcare
system.
Another limitation of the 2002 FDA
study was the extent to which the
results were nationally representative.
As FDA has acknowledged, the initial
set of results as reported were
applicable to survey respondents but
were not weighted to reflect national
statistics as to the age, sex, and racial
composition of the healthcare
professional population. Similar to
many types of surveys that have
struggled in recent decades with
declines in cooperation rates (Ref. 8),
surveys of healthcare professionals in
general often can benefit from weighting
to reduce nonresponse bias. The current
survey will include weighted responses
from respondents that will reflect
national demographic patterns.
Over the past decade, researchers
have been able to better assess how DTC
advertising has unfolded in the United
States and determine the questions that
warrant further survey work. For
example, researchers have worried for a
number of years that DTC advertising
might produce adverse outcomes, such
as clinically inappropriate patient
requests for drugs or patient
overestimation of the efficacy of
advertised medications (Refs. 5, 7, 9,
and 10). At the same time, the 2002 FDA
E:\FR\FM\17JAN1.SGM
17JAN1
2301
Federal Register / Vol. 77, No. 10 / Tuesday, January 17, 2012 / Notices
survey found that roughly as many
physicians thought DTC advertising had
a positive effect on their practice as
those who thought there had been a
negative influence. Moreover, the 2002
FDA survey found that roughly a third
of physicians surveyed thought that
DTC advertising had essentially no
influence on their practice. The
question of whether a similar pattern
will emerge now, despite the growth of
DTC advertising, is a vital one.
Furthermore, FDA will benefit from
knowing more detail about the various
types of perceived effects DTC
advertising might have. For example,
some healthcare professionals might be
ambivalent rather than strongly in favor
of or opposed to DTC advertising. In
addition, with the proliferation of social
media platforms, the emergence of
online pharmaceutical marketing, and
the evolution of office detailing
practices (Refs. 11 and 12), FDA will
benefit by knowing more about
healthcare professionals’ awareness of
new and emerging drug promotion sites
and practices. The proposed survey will
address these issues.
III. Method Overview
We propose a nationally
representative sample of healthcare
professionals that will yield 2,000
responses from 500 general
practitioners, 500 specialists, 500 nurse
practitioners, and 500 physician
assistants. Such a design will help to
ensure our ability to discuss not only
healthcare professional perceptions
generally but also to assess potential
variation between different types of
healthcare professionals. This sample
will be recruited from a national
Internet healthcare professional panel
that includes over 70,000 individuals
originating from the American Medical
Association master file and other
medical organizations. Because there are
not enough individuals in this panel to
satisfy the needs of the proposed
project, nurse practitioners and
physician assistants will be specially
recruited from relevant professional
organizations.
Healthcare providers are a difficult
group to recruit, and so several
strategies will be put into place to
achieve a high response rate. These
include sending prenotification letters
before online invitation, lengthening the
data collection period to 8 weeks (from
the more typical 4 weeks), tailoring
contact materials, disclosing FDA
sponsorship on survey materials, and
conducting reminder telephone calls.
Appropriate weighting will be applied
to adjust for any survey nonresponse as
well as any noncoverage or
undersampling and oversampling
resulting from the sample design.
Participants who agree to participate
will answer questions online. The
survey is expected to take no longer
than 20 minutes. This will be a one-time
(versus annual) data collection.
FDA estimates the burden of this
collection of information as follows: The
total respondent sample for this data
collection is 2,025. We will sample 25
respondents for basic programming
pretesting and 2,000 respondents for the
full study. We estimate the response
burden to be 20 minutes, for a burden
of 1,008 hours.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Screener ...............................................................................
Pretest ..................................................................................
Main Study ...........................................................................
10,000
25
2,000
1
1
1
10,000
25
2,000
2/60
20/60
20/60
333
8
667
Total ..............................................................................
........................
........................
........................
........................
1,008
There are no capital costs or operating and maintenance costs associated with this collection of information.
IV. References
srobinson on DSK4SPTVN1PROD with NOTICES
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.
1. Fintor, L., ‘‘Direct-to-Consumer
Marketing: How Has It Fared?,’’ Journal of
the National Cancer Institute, 94, 329–331,
2002.
2. Palumbo, F.B. and C.D. Mullins, ‘‘The
Development of Direct-to-Consumer
Prescription Drug Advertising Regulations,’’
Food and Drug Law Journal, 57, 423–443,
2002.
3. Curry, T.J., J. Jarosch, and S. Pacholok,
‘‘Are Direct to Consumer Advertisements of
Prescription Drugs Educational? Comparing
1992 to 2002,’’ Journal of Drug Education, 35,
2172–2232, 2005.
4. Government Accountability Office
(GAO), ‘‘Improvements Needed in FDA’s
Oversight of Direct-to-Consumer Advertising,
GAO–07–54, Washington, DC: GAO,
November 16, 2006.
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16:12 Jan 13, 2012
Jkt 226001
5. Aikin, K.J., J.L. Swasy, and A.C. Braman,
‘‘Patient and Physician Attitudes and
Behaviors Associated With DTC Promotion of
Prescription Drugs,’’ Washington, DC: Food
and Drug Administration, November 19,
2004.
6. Naylor, M.D. and E.T. Kurtman, ‘‘The
Role of Nurse Practitioners in Reinventing
Primary Care,’’ Health Affairs, 29, 893–899,
2010.
7. Murray, E., B. Lo, L. Pollack, et al.,
‘‘Direct-to-Consumer Advertising: Physicians’
Views of Its Effects on Quality of Care and
the Doctor-Patient Relationship,’’ Journal of
the American Board of Family Practice, 16,
513–524, 2003.
8. Dey, E.L., ‘‘Working With Low Survey
Response Rates: The Efficacy of Weighting
Adjustments,’’ Research in Higher Education,
38, 215–227, 1997.
9. Mintzes, B., M.L. Barer, R.L. Kravitz, et
al., ‘‘Influence of Direct-to-Consumer
Pharmaceutical Advertising and Patients’
Requests on Prescribing Decisions: Two Site
Cross Sectional Study,’’ British Medical
Journal, 324, 278–279, 2002.
10. Mitra, A., J. Swasy, and K. Aikin, ‘‘How
Do Consumers Interpret Market Leadership
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Frm 00045
Fmt 4703
Sfmt 9990
Claims in Direct-to-Consumer Advertising of
Prescription Drugs?,’’ Advances in Consumer
Research, 33, 381–387, 2006.
11. Donohue, J.M., M. Cevasco, and M.B.
Rosenthal, ‘‘A Decade of Direct-to-Consumer
Advertising of Prescription Drugs,’’ New
England Journal of Medicine, 357, 673–681,
2007.
12. Chew, L.D., T.S. O’Young, T.K. Hazlet,
et al., ‘‘A Physician Survey of the Effect of
Drug Sample Availability on Physician’s
Behavior,’’ Journal of General Internal
Medicine, 15, 478–483, 2000.
Dated: January 10, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–638 Filed 1–13–12; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\17JAN1.SGM
17JAN1
Agencies
[Federal Register Volume 77, Number 10 (Tuesday, January 17, 2012)]
[Notices]
[Pages 2299-2301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-638]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0018]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Healthcare Professional Survey of Prescription Drug
Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 2300]]
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 the Healthcare Professional Survey of
Prescription Drug Promotion. This survey is designed to explore the
opinions and perceptions of physicians, nurse practitioners, and
physician assistants with regard to the promotion of prescription drugs
to consumers and healthcare providers.
DATES: Submit either electronic or written comments on the collection
of information by March 19, 2012.
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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.
PI50-400B, Rockville, MD 20850, (301) 796-7651,
Juanmanuel.vilela@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 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.
Healthcare Professional Survey of Prescription Drug Promotion--(OMB
Control Number 0910--New)
I. Regulatory Background
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the Food and Drug Administration (FDA) to
conduct research relating to health information. Section 903(d)(2)(c)
of the Federal Food, Drug, and Cosmetic Act (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.
II. Description
The rise of direct-to-consumer (DTC) drug advertising and
prescription drug promotion has affected healthcare professionals in a
number of ways. First, healthcare professionals regularly encounter
patients who have been exposed to DTC ads. Second, healthcare
professionals also see and hear such ads directly as mass media
consumers themselves. Since clarification of the adequate provision
requirement for prescription drug broadcast ads in 1997, FDA has faced
numerous questions about the influence of DTC pharmaceutical marketing
because such advertising directly engages consumers and potentially
affects interactions between patients and their physicians (Refs. 1 and
2). Those questions have grown more urgent with the growth of DTC
advertising in recent years (Refs. 3 and 4). In 2002, FDA considered
this form of promotion sufficiently important as a force in the
physician-patient interaction that they surveyed both patients and
physicians regarding their perceptions of DTC advertising (Ref. 5).
Now, nearly a decade later, there are critical reasons to return to the
field to gather more evidence on the influence of DTC advertising in
the examination room and on the relationships between healthcare
professionals and patients.
One of the most noteworthy aspects of the current healthcare
environment in 2011 is the role now played by various physician
extenders. Naylor and Kurtzman (Ref. 6) recently noted that nurses are
the single largest group of healthcare providers in the United States
and they argue that nurse practitioners will play an increasingly vital
role in primary care delivery. Similarly, physician assistants also
bolster the ability of our healthcare system to offer some types of
care at lower cost. The aforementioned 2002 FDA study did not include
nurse practitioners or physician assistants in the sample; that study
focused on general practitioners and specialists in several key areas
targeted by DTC advertising. Murray and colleagues (Ref. 7) also
conducted a large-scale survey of U.S. physicians regarding their
perceptions of DTC advertising, but they also did not include nurse
practitioners or physician assistants in their sample. Because DTC
advertising likely affects daily interactions between patients and
nurse practitioners and physician assistants--similar to the 2002 FDA
study that suggested the influence of advertising on physicians' work
lives--including these groups in the new sample will further
understanding of DTC advertising in the healthcare system.
Another limitation of the 2002 FDA study was the extent to which
the results were nationally representative. As FDA has acknowledged,
the initial set of results as reported were applicable to survey
respondents but were not weighted to reflect national statistics as to
the age, sex, and racial composition of the healthcare professional
population. Similar to many types of surveys that have struggled in
recent decades with declines in cooperation rates (Ref. 8), surveys of
healthcare professionals in general often can benefit from weighting to
reduce nonresponse bias. The current survey will include weighted
responses from respondents that will reflect national demographic
patterns.
Over the past decade, researchers have been able to better assess
how DTC advertising has unfolded in the United States and determine the
questions that warrant further survey work. For example, researchers
have worried for a number of years that DTC advertising might produce
adverse outcomes, such as clinically inappropriate patient requests for
drugs or patient overestimation of the efficacy of advertised
medications (Refs. 5, 7, 9, and 10). At the same time, the 2002 FDA
[[Page 2301]]
survey found that roughly as many physicians thought DTC advertising
had a positive effect on their practice as those who thought there had
been a negative influence. Moreover, the 2002 FDA survey found that
roughly a third of physicians surveyed thought that DTC advertising had
essentially no influence on their practice. The question of whether a
similar pattern will emerge now, despite the growth of DTC advertising,
is a vital one. Furthermore, FDA will benefit from knowing more detail
about the various types of perceived effects DTC advertising might
have. For example, some healthcare professionals might be ambivalent
rather than strongly in favor of or opposed to DTC advertising. In
addition, with the proliferation of social media platforms, the
emergence of online pharmaceutical marketing, and the evolution of
office detailing practices (Refs. 11 and 12), FDA will benefit by
knowing more about healthcare professionals' awareness of new and
emerging drug promotion sites and practices. The proposed survey will
address these issues.
III. Method Overview
We propose a nationally representative sample of healthcare
professionals that will yield 2,000 responses from 500 general
practitioners, 500 specialists, 500 nurse practitioners, and 500
physician assistants. Such a design will help to ensure our ability to
discuss not only healthcare professional perceptions generally but also
to assess potential variation between different types of healthcare
professionals. This sample will be recruited from a national Internet
healthcare professional panel that includes over 70,000 individuals
originating from the American Medical Association master file and other
medical organizations. Because there are not enough individuals in this
panel to satisfy the needs of the proposed project, nurse practitioners
and physician assistants will be specially recruited from relevant
professional organizations.
Healthcare providers are a difficult group to recruit, and so
several strategies will be put into place to achieve a high response
rate. These include sending prenotification letters before online
invitation, lengthening the data collection period to 8 weeks (from the
more typical 4 weeks), tailoring contact materials, disclosing FDA
sponsorship on survey materials, and conducting reminder telephone
calls. Appropriate weighting will be applied to adjust for any survey
nonresponse as well as any noncoverage or undersampling and
oversampling resulting from the sample design.
Participants who agree to participate will answer questions online.
The survey is expected to take no longer than 20 minutes. This will be
a one-time (versus annual) data collection.
FDA estimates the burden of this collection of information as
follows: The total respondent sample for this data collection is 2,025.
We will sample 25 respondents for basic programming pretesting and
2,000 respondents for the full study. We estimate the response burden
to be 20 minutes, for a burden of 1,008 hours.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Screener........................ 10,000 1 10,000 2/60 333
Pretest......................... 25 1 25 20/60 8
Main Study...................... 2,000 1 2,000 20/60 667
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Total....................... .............. .............. .............. .............. 1,008
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.
IV. 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.
1. Fintor, L., ``Direct-to-Consumer Marketing: How Has It
Fared?,'' Journal of the National Cancer Institute, 94, 329-331,
2002.
2. Palumbo, F.B. and C.D. Mullins, ``The Development of Direct-
to-Consumer Prescription Drug Advertising Regulations,'' Food and
Drug Law Journal, 57, 423-443, 2002.
3. Curry, T.J., J. Jarosch, and S. Pacholok, ``Are Direct to
Consumer Advertisements of Prescription Drugs Educational? Comparing
1992 to 2002,'' Journal of Drug Education, 35, 2172-2232, 2005.
4. Government Accountability Office (GAO), ``Improvements Needed
in FDA's Oversight of Direct-to-Consumer Advertising, GAO-07-54,
Washington, DC: GAO, November 16, 2006.
5. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and
Physician Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs,'' Washington, DC: Food and Drug Administration,
November 19, 2004.
6. Naylor, M.D. and E.T. Kurtman, ``The Role of Nurse
Practitioners in Reinventing Primary Care,'' Health Affairs, 29,
893-899, 2010.
7. Murray, E., B. Lo, L. Pollack, et al., ``Direct-to-Consumer
Advertising: Physicians' Views of Its Effects on Quality of Care and
the Doctor-Patient Relationship,'' Journal of the American Board of
Family Practice, 16, 513-524, 2003.
8. Dey, E.L., ``Working With Low Survey Response Rates: The
Efficacy of Weighting Adjustments,'' Research in Higher Education,
38, 215-227, 1997.
9. Mintzes, B., M.L. Barer, R.L. Kravitz, et al., ``Influence of
Direct-to-Consumer Pharmaceutical Advertising and Patients' Requests
on Prescribing Decisions: Two Site Cross Sectional Study,'' British
Medical Journal, 324, 278-279, 2002.
10. Mitra, A., J. Swasy, and K. Aikin, ``How Do Consumers
Interpret Market Leadership Claims in Direct-to-Consumer Advertising
of Prescription Drugs?,'' Advances in Consumer Research, 33, 381-
387, 2006.
11. Donohue, J.M., M. Cevasco, and M.B. Rosenthal, ``A Decade of
Direct-to-Consumer Advertising of Prescription Drugs,'' New England
Journal of Medicine, 357, 673-681, 2007.
12. Chew, L.D., T.S. O'Young, T.K. Hazlet, et al., ``A Physician
Survey of the Effect of Drug Sample Availability on Physician's
Behavior,'' Journal of General Internal Medicine, 15, 478-483, 2000.
Dated: January 10, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-638 Filed 1-13-12; 8:45 am]
BILLING CODE 4160-01-P