[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2766-2768]
[FR Doc No: 2015-00703]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74045; File No. SR-BX-2015-003]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Regarding
the Extranet Access Fee

January 13, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 5, 2015, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend BX Rule 7025 (Extranet Access Fee)
of the Exchange's Pricing Schedule entitled ``Extranet Access Fee''
(``Pricing Schedule''), as well as to clarify the applicability of the
Extranet Access Fee and thereby conform it to the equivalent fee of
other markets.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwallstreet.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposal is to amend BX Rule 7025 of the
Exchange's Pricing Schedule, as well as to clarify the applicability of
the Extranet Access Fee and thereby conform it to the equivalent fee of
other markets.\3\
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    \3\ The Exchange, NASDAQ OMX PHLX LLC (``Phlx''), and The NASDAQ
Stock Market LLC (``NASDAQ'') are self-regulatory organizations
(``SROs'') that are wholly owned subsidiaries of The NASDAQ OMX
Group, Inc. (``NASDAQ OMX''). NOM (a facility of NASDAQ), BX, BX
Options (a facility of BX), Phlx, and PSX (a facility of Phlx)
(together with the Exchange known as the ``NASDAQ Markets''), are
independently filing proposals to conform their respective Extranet
Access Fee rules to NASDAQ Rule 7025.
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    Specifically, the Exchange proposes to modify BX Rule 7025 to
indicate that certain non-Exchange Customer Premises Equipment
(``CPE'') Products shall be assessed a monthly access fee of $1,000 per
CPE. The Exchange also proposes to conform the Extranet Access Fee to
that of another market, specifically NASDAQ Rule 7025, by substituting
``recipient'' for ``client organization'' and also indicating that if

an extranet provider uses multiple CPE Configurations \4\ to provide
market data feeds to any recipient the monthly fee shall apply to each
such CPE Configuration. This proposal conforms the Extranet Access Fee
in BX Rule 7025 to the equivalent fee in NASDAQ Rule 7025.
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    \4\ As defined in BX Rule 7025, a ``Customer Premises Equipment
Configuration'' means any line, circuit, router package, or other
technical configuration used by an extranet provider to provide a
direct access connection to the Exchange market data feeds to a
recipient's site.
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    The Extranet Access Fee was introduced a decade ago on NASDAQ Rule
7025.\5\ The Extranet Access Fee was introduced about five years ago on
BX Rule 7025, and is currently set at $750 per month.\6\ By this
proposal, the Exchange normalizes the cost and structure of its
Extranet Access Fee to that of the equivalent decade-old NASDAQ fee.
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    \5\ See Securities Exchange Act Release Nos. 50483 (October 1,
2004), 69 FR 60448 (October 8, 2004) (SR-NASD-2004-118)
(establishing the Extranet Access Fee on NASDAQ); and 71199
(December 30, 2013), 79 FR 686 (January 6, 2014) (SR-NASDAQ-2013-
159) (notice of filing and immediate effectiveness increasing the
Extranet Access Fee to $1,000).
    \6\ See Securities Exchange Act Release Nos. 59615 (March 20,
2009), 74 FR 14604 (March 31, 2009) (SR-BX-2009-005) (establishing
the Extranet Access Fee on BX); and 71841 (April 1, 2014), 79 FR
19129 (April 7, 2014) (SR-BX-2014-015) (notice of filing and
immediate effectiveness reinstating the Extranet Access Fee to
$750). The Extranet Access Fee was also established on PSX. See
Securities Exchange Act Release No. 71236 (January 6, 2014), 79 FR
1906 (January 10, 2014) (SR-Phlx-2014-01) (notice of filing and
immediate effectiveness establishing the Extranet Access Fee on PSX,
and clarifying that no fee is charged at the time of the filing).
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    BX Rule 7025 currently indicates that extranet providers that
establish a connection with the Exchange to offer direct access
connectivity to market data feeds shall be assessed a monthly access
fee of $750 per recipient client organization Customer Premises
Equipment (CPE) Configuration. As noted, this proposal indicates the
same fee as NASDAQ Rule 7025, namely $1,000 per CPE Configuration, and
adds to BX Rule 7025 verbatim clarifying language from NASDAQ Rule
7025. As proposed, BX Rule 7025 will read as follows: ``Extranet
providers that establish a connection with the Exchange to offer direct
access connectivity to market data feeds shall be assessed a monthly
access fee of $1,000 per recipient Customer Premises Equipment
(``CPE'') Configuration. If an extranet provider uses multiple CPE
Configurations to provide market data feeds to any recipient, the
monthly fee shall apply to each such CPE Configuration. For purposes of
this Rule 7025, the term ``Customer Premises Equipment Configuration''
shall mean any line, circuit, router package, or other technical
configuration used by an extranet provider to provide a direct access
connection to the Exchange market data feeds to a recipient's site. No
extranet access fee will be charged for connectivity to market data
feeds containing only consolidated data. For purposes of this rule,
consolidated data includes data disseminated by the UTP SIP. Extranet
providers that establish a connection with the Exchange pursuant to
this Rule 7025 as well as a connection pursuant to BX Options Chapter
XV, Section 3 shall be assessed a total monthly access fee of $1,000
per recipient CPE Configuration.'' The proposal thus conforms BX Rule
7025 to NASDAQ Rule 7025, and makes them substantively identical.\7\
The proposal also makes it clear that if an extranet provider
establishes a connection on BX (equities) as well as on BX Options, the
extranet provider will not need to pay a double $1,000 monthly access
fee per CPE, but rather only one total monthly access fee of $1,000 per
CPE.
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    \7\ The Exchange notes that while BX Rule 7025 and NASDAQ Rule
7025 each contain some language particular to the relevant exchange,
with this proposal the language of the two rules is substantively
identical.
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    The modified proposed Extranet Access Fee will, as on NASDAQ, be
used to help support the Exchange's costs associated with maintaining
multiple extranet connections with multiple providers. These costs
include those associated with overhead and technology infrastructure,
administrative, maintenance and operational costs. Since the inception
of Extranet Access there have been numerous network infrastructure
improvements and administrative controls enacted. Additionally, the
Exchange has implemented automated retransmission facilities for most
of its data clients that benefit extranet clients by reducing
operational costs associated with retransmissions.
    As the number of extranets has increased, the management of the
downstream customers has expanded and the Exchange has had to ensure
appropriate reporting and review processes, which has resulted in a
greater cost burden on the Exchange over time. The proposed fee will
also help to ensure that the Exchange is better able to closely review
reports and uncover reporting errors via audits thus minimizing
reporting issues.\8\ The network infrastructure has increased in order
to keep pace with the increased number of products, which, in turn, has
caused an increased administrative burden and higher operational costs
associated with delivery via extranets.
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    \8\ The Exchange will inform extranet providers of their
reporting responsibilities via its public Web site.
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    Thus, subsequent to the proposal extranet providers that establish
a connection with the Exchange to offer direct access connectivity to
market data feeds shall be assessed a monthly access fee of $1,000 per
CPE Configuration. If, as discussed below, an extranet provider uses
multiple CPE Configurations to provide market data feeds to any
recipient, the monthly fee shall apply to each such CPE Configuration.
    The Exchange proposes two clarifications to conform the language of
BX Rule 7025 to that of NASDAQ Rule 7025. Specifically, the Exchange
proposes to indicate that if an extranet provider uses multiple CPE
Configurations to provide market data feeds to any recipient, the
monthly fee shall apply to each such CPE Configuration; and to
substitute ``recipient'' for ``client organization.'' For purposes of
this rule, consolidated data includes data disseminated by the UTP SIP.
These proposed clarifications should serve to reduce any confusion as
to the applicability of the Extranet Access Fee. Moreover, the
clarifications would make the Exchange's Extranet Access Fee in BX Rule
7025 work the same as the equivalent fee in NASDAQ Rule 7025, and
complete the effort to conform the two rules.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\9\ in general, and with Section 6(b)(4)
of the Act,\10\ in particular, in that it provides for the equitable
allocation of reasonable dues, fees and other charges among members and
issuers and other persons using any facility or system which the
Exchange operates or controls.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that its proposal to amend BX Rule 7025, and
to clarify the applicability of the Extranet Access Fee if an extranet
provider has a connection on both the equity side through BX and the
options side through BX options conforms the fee on the BX markets and
the equivalent fee on Phlx and NASDAQ and is consistent with the Act.
    All similarly situated extranet providers, including the Exchange
operating its own extranet, that establish an extranet connection with
the Exchange to access market data feeds from the Exchange are subject
to the same fee structure. The fee will help the

Exchange to offset some of the rising overhead and technology
infrastructure, administrative, maintenance and operational costs it
incurs in support of the service.
    If such costs are covered, the service may provide the Exchange
with a profit. As such, the Exchange believes that the proposed fee is
reasonable and notes that this proposal conforms to similarly-situated
Extranet Access Fee rules on Phlx and NASDAQ. The extranet costs are
separate and different from the colocation facility that is able to
recoup these fees by charging for servers within the associated data
centers. Additionally, the Exchange believes that the proposed change
is equitable and not unreasonably discriminatory. The monthly fee is
assessed uniformly to all extranet providers that establish a
connection with the Exchange to offer direct access connectivity to
market data feeds, and is the same for all at $1,000 per recipient CPE
Configuration. Thus, any burden arising from the fees is necessary in
the interest of promoting the equitable allocation of a reasonable fee.
Moreover, firms make decisions on how much and what types of data to
consume on the basis of the total cost of interacting with the Exchange
or other markets and, of course, the Extranet Access Fee is but one
factor in a total platform analysis.
    Additionally, BX Rule 7025 will be clarified by stating that if an
extranet provider uses multiple CPE Configurations to provide market
data feeds to any recipient, the monthly fee shall apply to each such
CPE Configuration, and by replacing non-conforming language. This
clarification should serve to reduce any confusion as to the
applicability of this fee.
    The proposal provides for the equitable allocation of reasonable
dues, fees and other charges among members and issuers and other
persons using any facility or system which the Exchange operates or
controls, and is consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.
    The proposed fees are applied uniformly among extranet providers,
which are not compelled to establish a connection with the Exchange to
offer access connectivity to market data feeds. For these reasons, any
burden arising from the fees is necessary in the interest of promoting
the equitable allocation of a reasonable fee. Additionally, firms make
decisions on how much and what types of data to consume on the basis of
the total cost of interacting with the Exchange or other exchanges and,
of course, the Extranet Access Fee is but one factor in a total
platform analysis.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Pursuant to Section 19(b)(3)(A)(ii) of the Act,\11\ the Exchange
has designated this proposal as establishing or changing a due, fee, or
other charge imposed by the self-regulatory organization on any person,
whether or not the person is a member of the self-regulatory
organization, which renders the proposed rule change effective upon
filing.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2015-003 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2015-003. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-BX-2015-003,
and should be submitted on or before February 10, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-00703 Filed 1-16-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11539-11542]
[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

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,<PHONE_NUMBER>,
[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

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).
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8. Austad, K.E., J. Avorn, J.M. Franklin, et al. (2014).
``Association of Marketing Interactions With Medical Trainees'
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    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


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Page 34428]
[FR Doc No: 2016-12634]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Air Traffic Procedures Advisory Committee

AGENCY: Federal Aviation Administration (FAA), DOT.
SUMMARY: The FAA is issuing this notice to advise the public that a
meeting of the Federal Aviation Administration Air Traffic Procedures
Advisory Committee (ATPAC) will be held to review present air traffic
control procedures and practices for standardization, revision,
clarification, and upgrading of terminology and procedures.

DATES: The meeting will be held Monday, July 11, 2016, from 1 p.m. to
4:30 p.m., and Tuesday, July 12, 2016, from 9 a.m. to 4:30 p.m.

ADDRESSES: The meeting will be held at the FAA Air Traffic Control
System Command Center, 3701 Macintosh Dr., Warrenton, VA 20187.

FOR FURTHER INFORMATION CONTACT: Ms. Heather Hemdal, ATPAC Executive
Director, 600 Independence Avenue SW., Washington, DC 20591.

SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. App.2), notice is
hereby given of a meeting of the ATPAC to be held Monday, July 11,
2016, from 1 p.m. to 4:30 p.m., and Tuesday, July 12, 2016, from 9 a.m.
to 4:30 p.m.
    The agenda for this meeting will cover a continuation of the
ATPAC's review of present air traffic control procedures and practices
for standardization, revision, clarification, and upgrading of
terminology and procedures. It will also include:
    1. Call for Safety Items.
    2. Approval of minutes of the previous meeting.
    3. Introduction of New Areas of Concern or Miscellaneous items.
    4. Items of Interest.
    5. Discussion and agreement of location and dates for subsequent
meetings.
    Attendance is open to the interested public but limited to space
available. With the approval of the Chairperson, members of the public
may present oral statements at the meeting. Persons desiring to attend
and persons desiring to present oral statements should notify Ms.
Heather Hemdal no later than July 1, 2016. Any member of the public may
present a written statement to the ATPAC at any time at the address
given above.

    Issued in Washington, DC, on May 23, 2016.
Heather Hemdal,
Executive Director, Air Traffic Procedures Advisory Committee.
[FR Doc. 2016-12634 Filed 5-27-16; 8:45 am]
 BILLING CODE 4910-13-P