Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Professional Survey of Professional Prescription Drug Promotion, 11539-11542 [2018-05235]
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Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Annual Report
on Home and Community Based
Services Waivers and Supporting
Regulations; Use: We use this report to
compare actual data to the approved
waiver estimates. In conjunction with
the waiver compliance review reports,
the information provided will be
compared to that in the Medicaid
Statistical Information System (MSIS)
(CMS–R–284; OMB control number
0938–0345) report and FFP claimed on
a state’s Quarterly Expenditure Report
(CMS–64; OMB control number 0938–
1265), to determine whether to continue
the state’s home and community-based
services waiver. States’ estimates of cost
and utilization for renewal purposes are
based upon the data compiled in the
CMS–372(S) reports. Form Number:
CMS–372(S) (OMB control number:
0938–0272); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
47; Total Annual Responses: 282; Total
Annual Hours: 12,126. (For policy
questions regarding this collection
contact Ralph Lollar at 410–786–0777).
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Survey of Retail
Prices; Use: This information collection
request provides for a survey of the
average acquisition costs of all covered
outpatient drugs purchased by retail
community pharmacies. CMS may
contract with a vendor to conduct
monthly surveys of retail prices for
covered outpatient drugs. Such prices
represent a nationwide average of
consumer purchase prices, net of
discounts and rebates. The contractor
shall provide notification when a drug
product becomes generally available
and that the contract include such terms
and conditions as the Secretary shall
specify, including a requirement that
the vendor monitor the marketplace.
CMS has developed a National Average
Drug Acquisition Cost (NADAC) for
states to consider when developing
reimbursement methodology. The
NADAC is a pricing benchmark that is
based on the national average costs that
pharmacies pay to acquire Medicaid
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covered outpatient drugs. This pricing
benchmark is based on drug acquisition
costs collected directly from pharmacies
through a nationwide survey process.
This survey is conducted on a monthly
basis to ensure that the NADAC
reference file remains current and up-todate. Form Number: CMS–10241 (OMB
control number 0938–1041); Frequency:
Monthly; Affected Public: Private sector
(Business or other for-profits); Number
of Respondents: 30,000; Total Annual
Responses: 30,000; Total Annual Hours:
15,000. (For policy questions regarding
this collection contact: Lisa Shochet at
410–786–5445.)
Dated: March 12, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–05296 Filed 3–14–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0215]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Health Care
Professional Survey of Professional
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 ‘‘Health Care
Professional Survey of Professional
Prescription Drug Promotion.’’ This
study will examine how health care
professionals experience and perceive
prescription drug promotion directed to
them.
DATES: Submit either electronic or
written comments on the collection of
information by May 14, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
SUMMARY:
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11539
considered. Electronic comments must
be submitted on or before May 14, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of May 14, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–0215 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Health
Care Professional Survey of Professional
Prescription Drug Promotion.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
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Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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
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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 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.
Health Care Professional Survey of
Professional Prescription Drug
Promotion
OMB Control Number 0910—NEW
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 1003(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.
As part of its federal mandate, FDA
regulates whether direct-to-consumer
(DTC) advertising of prescription drug
products is truthful, balanced, and
accurately communicated (see 21 U.S.C.
352(n)). Similarly, the FD&C Act
prohibits the dissemination of false or
misleading information about
medications in consumer-directed and
professional prescription drug
promotion. FDA regulates within the
framework of free speech and due
process principles of the United States
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Constitution. To inform current and
future policies, and to seek to enhance
audience comprehension, the Office of
Prescription Drug Promotion conducts
research focusing on (1) advertising
features including content and format,
(2) target populations, and (3) research
quality. This proposed research focuses
on the physician target population. FDA
surveyed physicians about their
attitudes toward DTC advertising and its
role in their relationships with their
patients in 2002 (Ref. 1) and again in
2013 (Refs. 2 and 3). The 2013 survey
included multiple types of prescribers:
Primary care physicians, specialists,
nurse practitioners, and physician
assistants. Whereas the focus of both
previous FDA surveys was on DTC
advertising and promotion, the current
study is designed to address issues
related to professional prescription drug
promotion. The goal is to query a
representative sample of health care
professionals (HCPs) about their
opinions of promotional materials and
procedures targeted at HCPs, clinical
trial design and knowledge, and FDA
approval status. We will also take this
opportunity to ask HCPs briefly about
their knowledge of abuse-deterrent
formulations for opioid products.
To educate themselves about
prescription drugs, HCPs sometimes
rely on professionally directed
promotional information (Refs. 4–8). In
2012, pharmaceutical companies spent
more than $24 billion on marketing to
physicians (Ref. 9). The industry
exposes health care professionals to
promotional materials through a variety
of mechanisms, including
communication with pharmaceutical
representatives, journal ads, prescribing
software, presentations at sponsored
meetings, and direct mail ads (Ref. 10).
Several studies indicate that data
presented in promotional materials may
not be fully comprehended and may
even potentially be misleading due to a
variety of causes, such as insufficient
information, unsupported claims, or a
failure to disclose limitations of the
information presented (Refs. 11–15).
Although HCPs are learned
intermediaries, like most people, they
may rely on heuristics in making
decisions and may have cognitive biases
in the type of information they attend to
at any given time. They may be
persuaded by strong statements and may
not have the time to ascertain accuracy
of such information (Ref. 16). The
proposed survey will provide further
insights about how professionally
targeted prescription drug promotion
might influence health care
professionals’ decision-making
processes and practices and how
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information may be communicated
more effectively. It is important to note
that FDA does not regulate the practice
of medicine. However, as previously
mentioned, FDA does regulate
prescription drug promotion. This
survey is designed to inform FDA of
various responses to and impacts of
prescription drug promotion of
prescription drugs.
The general research questions in the
survey are as follows:
1. What methods and/or channels are
used to disseminate prescription drug
promotional information to health care
professionals/prescribers?
2. How knowledgeable and interested
are HCPs in clinical trial data and its
presence in prescription drug
promotion?
3. How familiar are HCPs with the
FDA approval of prescription drugs and
how does this translate into practice?
In addition, given the critical nature
of the opioid situation in the United
States at this time, we plan to ask
several questions about prescription
drug promotion of opioid products.
HCPs who fall into one of four
categories will be recruited online
through WebMD’s Medscape subscriber
network. We propose to complete 700
primary care physician, 600 specialist,
350 nurse practitioner, and 350
physician assistant surveys. HCPs will
be included if they see patients at least
50 percent of the time. Both Doctors of
Medicine and Doctors of Osteopathy
will be included. Primary care
physicians will include those who
11541
indicate they work in general, family, or
internal medicine. Specialties were
chosen based on prevalence in the
United States and prescription drug
promotional activity. Specialists will
include cardiologists, dermatologists,
endocrinologists, neurologists,
obstetrician/gynecologists, oncologists,
ophthalmologists, psychiatrists,
rheumatologists, and urologists. The
data will be weighted to adjust for
differential coverage of select
characteristics such as region and
respondent age and gender. Pretesting
with 25 respondents will take place
before the main study to evaluate the
procedures and measures used in the
main study.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden per response
Total hours
Pretest Study
HCP screener ...................................
Informed Consent .............................
HCP Survey ......................................
63
25
25
1
1
1
63
25
25
0.08 (5 minutes) ...............................
0.08 (5 minutes) ...............................
0.33 (20 minutes) .............................
5
2
8
Main Study
HCP screener ...................................
Informed Consent .............................
HCP Survey ......................................
5,037
2,000
2,000
1
1
1
5,037
2,000
2,000
0.08 (5 minutes) ...............................
0.08 (5 minutes) ...............................
0.33 (20 minutes) .............................
403
160
660
Total ...........................................
........................
........................
........................
...........................................................
1,238
1 There
are no capital costs and maintenance costs associated with this collection of information.
II. References
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The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. Available at: https://www.fda.gov/
AboutFDA/CentersOffices/Officeof
MedicalProductsandTobacco/CDER/
ucm090276.htm. Last accessed January
26, 2018.
2. Betts, K.R., A.C. O’Donoghue, K.J. Aikin,
et al. (2016). ‘‘Healthcare Professional
Social Media Membership and
Participation: Findings From a
Nationally Representative Sample,’’
Journal of the American Association of
Nurse Practitioners. Doi: 10.1002/2327–
6924.12383.
3. O’Donoghue, A.C., V. Boudewyns, K.J.
Aikin, et al. (2015). ‘‘Awareness of FDA’s
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Bad Ad Program and Education
Regarding Pharmaceutical Advertising: A
National Survey of Prescribers in
Ambulatory Care Settings,’’ Journal of
Health Communication, vol. 20(11), pp.
1330–1336.
4. Crigger, N.J. (2005). ‘‘Pharmaceutical
Promotions and Conflict of Interest in
Nurse Practitioner’s Decision Making:
The Undiscovered Country,’’ Journal of
the American Academy of Nurse
Practitioners, vol. 17(6), pp. 207–212.
5. Fischer, M.A., M.E. Keough, J.L. Baril, et
al. (2009). ‘‘Prescribers and
Pharmaceutical Representatives: Why
Are We Still Meeting?’’ Journal of
General Internal Medicine, vol. 24(7), pp.
795–801.
6. C. Robertson, S. Rose, and A.S.
Kesselheim. (2012). ‘‘Effect of Financial
Relationships on the Behaviors of Health
Care Professionals: A Review of the
Evidence,’’ The Journal of Law, Medicine
& Ethics, vol. 40(3), pp. 452–466.
7. Srivastava, V., M. Handa, and A. Vohra.
(2014). ‘‘Promotional Tools: Do
Physicians Really Bite the Hook?’’
Drishtikon: A Management Journal, vol.
5(2).
8. Austad, K.E., J. Avorn, J.M. Franklin, et al.
(2014). ‘‘Association of Marketing
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Interactions With Medical Trainees’
Knowledge About Evidence-Based
Prescribing: Results From a National
Survey,’’ JAMA Internal Medicine, vol.
174(8), pp. 1283–1290.
9. Cegedim Strategic Data. (2013). ‘‘2012 U.S.
Pharmaceutical Company Promotion
Spending.’’ Available at: https://
www.skainfo.com/health_care_market_
reports/2012_promotional_spending.pdf.
10. Spurling, G.K., P.R. Mansfield, B.D.
Montgomery, et al. (2010). ‘‘Information
From Pharmaceutical Companies and the
Quality, Quantity, and Cost of
Physicians’ Prescribing: A Systematic
Review,’’ PLoS Medicine, vol. 7(10),
e1000352. doi: 10.1371/jounal.pmed.
1000352.
´
11. Villanueva, P., S. Peiro, J. Librero, et al.
(2003). ‘‘Accuracy of Pharmaceutical
Advertisements in Medical Journals,’’
Lancet, vol. 361(9351), pp. 27–32.
12. Cooper, R.J. and D.L. Schriger. (2005).
‘‘The Availability of References and the
Sponsorship of Original Research Cited
in Pharmaceutical Advertisements,’’
Canadian Medical Association Journal,
vol. 172(4), pp. 487–491.
13. Jureidini, J.N., L.B. McHenry, and P.R.
Mansfield. (2008). ‘‘Clinical Trials and
Drug Promotion: Selective Reporting of
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Study 329,’’ International Journal of Risk
& Safety in Medicine, vol. 20(1–2), pp.
73–81.
14. Garcia-Retamero, R. and M. Galesic.
(2010). ‘‘Who Profits From Visual Aids:
Overcoming Challenges in People’s
Understanding of Risks,’’ Social Science
& Medicine, vol. 70(7), pp. 1019–1025.
15. Cooper, R.J., D.L. Schriger, R.C. Wallace,
et al. (2003). ‘‘The Quantity and Quality
of Scientific Graphs in Pharmaceutical
Advertisements,’’ Journal of General
Internal Medicine, vol. 18(4), pp. 294–
297.
16. Sah, S. and A. Fugh-Berman. (2013).
‘‘Physicians Under the Influence: Social
Psychology and Industry Marketing
Strategies,’’ The Journal of Law,
Medicine & Ethics, vol. 41(3), pp. 665–
672. doi: 10.1111/jlme.12076.
Dated: March 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05235 Filed 3–14–18; 8:45 am]
BILLING CODE 4164–01–P
Announcing Budget Period
Extensions with Funding for the Health
Center Program.
ACTION:
HRSA provided additional
grant funds during extended budget
periods to prevent interruptions in the
provision of critical health care services
for funded service areas until new
awards could be made to eligible
Service Area Competition (SAC)
applicants or HRSA could conduct an
orderly phase-out of Health Center
Program activities by the current award
recipients.
SUPPLEMENTARY INFORMATION:
Recipients of the Award: Health
Center Program award recipients for
service areas that were threatened with
a lapse in services due to service area reannouncement or transitioning award
recipients, as listed in Table 1.
Amount of Non-Competitive Awards:
33 awards for $17,248,966.
Period of Supplemental Funding:
Fiscal years 2016 and 2017.
CFDA Number: 93.224
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: Section 330 of the Public
Health Service Act, as amended (42 U.S.C.
254b, as amended).
Health Resources and Services
Administration
Justification: Targeting the nation’s
high need populations and geographic
areas, the Health Center Program
currently funds nearly 1,400 health
centers that operate more than 11,000
service delivery sites in every state, the
District of Columbia, Puerto Rico, the
Virgin Islands, and the Pacific Basin.
Health Center Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
Nearly 26 million people received
accessible, affordable, quality primary
health care services through the Health
Center Program award recipients in
2016.
Approximately one-third of Health
Center Program award recipients’
service areas are competed each year,
and each competition has the potential
to result in a change in award recipient.
SACs are also held prior to the current
grant’s project period end date when (1)
a grant is voluntarily relinquished, or (2)
a program noncompliance enforcement
action taken by HRSA terminates the
grant. If the SAC draws no fundable
applications, HRSA may extend the
current award recipient’s budget period
to ensure primary health care services
remain available while a new
competition is conducted for the service
area.
The amount of additional grant funds
is calculated by pro-rating HRSA’s
annual funding commitment to the
service area. Approximately 6 months is
required to announce and conduct a
SAC and select a new award recipient.
In all cases, current fiscal year funds are
used to extend the award recipient’s
existing budget period award. Through
these actions, award recipients receive
consistent levels of funding to support
uninterrupted primary health care
services to the nation’s underserved
populations and communities during
service area award recipient transition.
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
sradovich on DSK3GMQ082PROD with NOTICES
Grant number
H80CS06641
H80CS26606
H80CS26604
H80CS00851
H80CS26560
H80CS00048
H80CS00001
H80CS00384
H80CS26631
H80CS00400
H80CS00013
H80CS26632
H80CS00054
H80CS00055
H80CS26587
H80CS26620
H80CS26513
H80CS08770
H80CS00872
H80CS00622
H80CS10606
H80CS06078
H80CS17251
H80CS00722
H80CS01443
H80CS00054
H80CS00299
H80CS00814
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17:34 Mar 14, 2018
Extension
award date
Award recipient name
Ko’olauloa Community Health and Wellness Center, Inc .........................
Horizon Health and Wellness, Inc .............................................................
Neighborhood Outreach Access to Health ...............................................
Duval County Health Department .............................................................
East Central Missouri Behavioral Health Services, Inc. ...........................
Santa Cruz County ....................................................................................
City of Springfield, Massachusetts ............................................................
Monroe County Health Center ..................................................................
La Casa de Salud, Inc ..............................................................................
Circle Family Healthcare Network, Inc ......................................................
Covenant House (Under 21) .....................................................................
Whitman-Walker Clinic, Inc .......................................................................
Metropolitan Development Council ...........................................................
White Bird Clinic ........................................................................................
Saint Hope Foundation .............................................................................
Korean Health, Education, Information and Research Center .................
FirstMed Health and Wellness Center ......................................................
Health Center of Southeast Texas ............................................................
Madison County Community Health Center .............................................
The Hunter Health Clinic, Inc ....................................................................
St. Vincent de Paul Village, Inc ................................................................
Yakima Neighborhood Health Services ....................................................
Upper Room Aids Ministry, Inc. Health Care Center ................................
Community Clinic of Maui, Inc ..................................................................
Lane County ..............................................................................................
Metropolitan Development Council ...........................................................
Brazos Valley Community Action Agency, Inc ..........................................
Kalihi-Palama Health Center .....................................................................
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02/12/16
02/12/16
03/01/16
03/08/16
04/06/16
04/06/16
04/06/16
04/06/16
05/15/16
06/14/16
01/17/17
01/17/17
Award amount
($)
235,116
182,771
192,815
480,066
281,845
672,655
606,761
640,737
563,753
501,296
279,116
423,273
457,843
412,985
229,491
504,386
596,025
737,066
467,855
450,569
334,418
1,025,892
738,043
570,042
649,218
228,922
1,520,645
1,105,506
]]>Agencies
[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11539-11542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0215]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Health Care Professional Survey of Professional
Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 ``Health Care Professional
Survey of Professional Prescription Drug Promotion.'' This study will
examine how health care professionals experience and perceive
prescription drug promotion directed to them.
DATES: Submit either electronic or written comments on the collection
of information by May 14, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of May 14, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-0215 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Health Care Professional Survey
of Professional Prescription Drug Promotion.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed
[[Page 11540]]
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
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 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.
Health Care Professional Survey of Professional Prescription Drug
Promotion
OMB Control Number 0910--NEW
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 1003(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.
As part of its federal mandate, FDA regulates whether direct-to-
consumer (DTC) advertising of prescription drug products is truthful,
balanced, and accurately communicated (see 21 U.S.C. 352(n)).
Similarly, the FD&C Act prohibits the dissemination of false or
misleading information about medications in consumer-directed and
professional prescription drug promotion. FDA regulates within the
framework of free speech and due process principles of the United
States Constitution. To inform current and future policies, and to seek
to enhance audience comprehension, the Office of Prescription Drug
Promotion conducts research focusing on (1) advertising features
including content and format, (2) target populations, and (3) research
quality. This proposed research focuses on the physician target
population. FDA surveyed physicians about their attitudes toward DTC
advertising and its role in their relationships with their patients in
2002 (Ref. 1) and again in 2013 (Refs. 2 and 3). The 2013 survey
included multiple types of prescribers: Primary care physicians,
specialists, nurse practitioners, and physician assistants. Whereas the
focus of both previous FDA surveys was on DTC advertising and
promotion, the current study is designed to address issues related to
professional prescription drug promotion. The goal is to query a
representative sample of health care professionals (HCPs) about their
opinions of promotional materials and procedures targeted at HCPs,
clinical trial design and knowledge, and FDA approval status. We will
also take this opportunity to ask HCPs briefly about their knowledge of
abuse-deterrent formulations for opioid products.
To educate themselves about prescription drugs, HCPs sometimes rely
on professionally directed promotional information (Refs. 4-8). In
2012, pharmaceutical companies spent more than $24 billion on marketing
to physicians (Ref. 9). The industry exposes health care professionals
to promotional materials through a variety of mechanisms, including
communication with pharmaceutical representatives, journal ads,
prescribing software, presentations at sponsored meetings, and direct
mail ads (Ref. 10). Several studies indicate that data presented in
promotional materials may not be fully comprehended and may even
potentially be misleading due to a variety of causes, such as
insufficient information, unsupported claims, or a failure to disclose
limitations of the information presented (Refs. 11-15).
Although HCPs are learned intermediaries, like most people, they
may rely on heuristics in making decisions and may have cognitive
biases in the type of information they attend to at any given time.
They may be persuaded by strong statements and may not have the time to
ascertain accuracy of such information (Ref. 16). The proposed survey
will provide further insights about how professionally targeted
prescription drug promotion might influence health care professionals'
decision-making processes and practices and how
[[Page 11541]]
information may be communicated more effectively. It is important to
note that FDA does not regulate the practice of medicine. However, as
previously mentioned, FDA does regulate prescription drug promotion.
This survey is designed to inform FDA of various responses to and
impacts of prescription drug promotion of prescription drugs.
The general research questions in the survey are as follows:
1. What methods and/or channels are used to disseminate
prescription drug promotional information to health care professionals/
prescribers?
2. How knowledgeable and interested are HCPs in clinical trial data
and its presence in prescription drug promotion?
3. How familiar are HCPs with the FDA approval of prescription
drugs and how does this translate into practice?
In addition, given the critical nature of the opioid situation in
the United States at this time, we plan to ask several questions about
prescription drug promotion of opioid products.
HCPs who fall into one of four categories will be recruited online
through WebMD's Medscape subscriber network. We propose to complete 700
primary care physician, 600 specialist, 350 nurse practitioner, and 350
physician assistant surveys. HCPs will be included if they see patients
at least 50 percent of the time. Both Doctors of Medicine and Doctors
of Osteopathy will be included. Primary care physicians will include
those who indicate they work in general, family, or internal medicine.
Specialties were chosen based on prevalence in the United States and
prescription drug promotional activity. Specialists will include
cardiologists, dermatologists, endocrinologists, neurologists,
obstetrician/gynecologists, oncologists, ophthalmologists,
psychiatrists, rheumatologists, and urologists. The data will be
weighted to adjust for differential coverage of select characteristics
such as region and respondent age and gender. Pretesting with 25
respondents will take place before the main study to evaluate the
procedures and measures used in the main study.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Pretest Study
----------------------------------------------------------------------------------------------------------------
HCP screener.................. 63 1 63 0.08 (5 minutes) 5
Informed Consent.............. 25 1 25 0.08 (5 minutes) 2
HCP Survey.................... 25 1 25 0.33 (20 8
minutes).
----------------------------------------------------------------------------------------------------------------
Main Study
----------------------------------------------------------------------------------------------------------------
HCP screener.................. 5,037 1 5,037 0.08 (5 minutes) 403
Informed Consent.............. 2,000 1 2,000 0.08 (5 minutes) 160
HCP Survey.................... 2,000 1 2,000 0.33 (20 660
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 1,238
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs and maintenance costs associated with this collection of information.
II. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. Available at: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm. Last accessed
January 26, 2018.
2. Betts, K.R., A.C. O'Donoghue, K.J. Aikin, et al. (2016).
``Healthcare Professional Social Media Membership and Participation:
Findings From a Nationally Representative Sample,'' Journal of the
American Association of Nurse Practitioners. Doi: 10.1002/2327-
6924.12383.
3. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al. (2015).
``Awareness of FDA's Bad Ad Program and Education Regarding
Pharmaceutical Advertising: A National Survey of Prescribers in
Ambulatory Care Settings,'' Journal of Health Communication, vol.
20(11), pp. 1330-1336.
4. Crigger, N.J. (2005). ``Pharmaceutical Promotions and Conflict of
Interest in Nurse Practitioner's Decision Making: The Undiscovered
Country,'' Journal of the American Academy of Nurse Practitioners,
vol. 17(6), pp. 207-212.
5. Fischer, M.A., M.E. Keough, J.L. Baril, et al. (2009).
``Prescribers and Pharmaceutical Representatives: Why Are We Still
Meeting?'' Journal of General Internal Medicine, vol. 24(7), pp.
795-801.
6. C. Robertson, S. Rose, and A.S. Kesselheim. (2012). ``Effect of
Financial Relationships on the Behaviors of Health Care
Professionals: A Review of the Evidence,'' The Journal of Law,
Medicine & Ethics, vol. 40(3), pp. 452-466.
7. Srivastava, V., M. Handa, and A. Vohra. (2014). ``Promotional
Tools: Do Physicians Really Bite the Hook?'' Drishtikon: A
Management Journal, vol. 5(2).
8. Austad, K.E., J. Avorn, J.M. Franklin, et al. (2014).
``Association of Marketing Interactions With Medical Trainees'
Knowledge About Evidence-Based Prescribing: Results From a National
Survey,'' JAMA Internal Medicine, vol. 174(8), pp. 1283-1290.
9. Cegedim Strategic Data. (2013). ``2012 U.S. Pharmaceutical
Company Promotion Spending.'' Available at: https://www.skainfo.com/health_care_market_reports/2012_promotional_spending.pdf.
10. Spurling, G.K., P.R. Mansfield, B.D. Montgomery, et al. (2010).
``Information From Pharmaceutical Companies and the Quality,
Quantity, and Cost of Physicians' Prescribing: A Systematic
Review,'' PLoS Medicine, vol. 7(10), e1000352. doi: 10.1371/
jounal.pmed. 1000352.
11. Villanueva, P., S. Peir[oacute], J. Librero, et al. (2003).
``Accuracy of Pharmaceutical Advertisements in Medical Journals,''
Lancet, vol. 361(9351), pp. 27-32.
12. Cooper, R.J. and D.L. Schriger. (2005). ``The Availability of
References and the Sponsorship of Original Research Cited in
Pharmaceutical Advertisements,'' Canadian Medical Association
Journal, vol. 172(4), pp. 487-491.
13. Jureidini, J.N., L.B. McHenry, and P.R. Mansfield. (2008).
``Clinical Trials and Drug Promotion: Selective Reporting of
[[Page 11542]]
Study 329,'' International Journal of Risk & Safety in Medicine,
vol. 20(1-2), pp. 73-81.
14. Garcia-Retamero, R. and M. Galesic. (2010). ``Who Profits From
Visual Aids: Overcoming Challenges in People's Understanding of
Risks,'' Social Science & Medicine, vol. 70(7), pp. 1019-1025.
15. Cooper, R.J., D.L. Schriger, R.C. Wallace, et al. (2003). ``The
Quantity and Quality of Scientific Graphs in Pharmaceutical
Advertisements,'' Journal of General Internal Medicine, vol. 18(4),
pp. 294-297.
16. Sah, S. and A. Fugh-Berman. (2013). ``Physicians Under the
Influence: Social Psychology and Industry Marketing Strategies,''
The Journal of Law, Medicine & Ethics, vol. 41(3), pp. 665-672. doi:
10.1111/jlme.12076.
Dated: March 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05235 Filed 3-14-18; 8:45 am]
BILLING CODE 4164-01-P
