Agency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Professional Survey of Prescription Drug Promotion, 2299-2301 [2012-638]

Download as PDF 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: VerDate Mar<15>2010 16:12 Jan 13, 2012 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. VerDate Mar<15>2010 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 PO 00000 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
                                 -------------------------------------------------------------------------------
    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
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