[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6916-6917]
[FR Doc No: 2016-02440]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77045; File No. SR-NYSEArca-2015-113]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change Relating to the Index Underlying the WisdomTree
Put Write Strategy Fund

February 3, 2016.

I. Introduction

    On December 2, 2015, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposal to change a representation the Exchange made in support of a
prior proposed rule change. The proposed rule change was published for
comment in the Federal Register on December 21, 2015.\3\ The Commission
received no comments on the proposed rule change. This order approves
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 76646 (Dec. 15,
2015), 80 FR 79371 (``Notice'').
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II. The Exchange's Description of the Proposed Rule Change

A. The Prior Proposal

    The Commission approved the listing and trading on the Exchange of
shares (``Shares'') of the WisdomTree Put Write Strategy Fund
(``Fund'') under NYSE Arca Equities Rule 5.2(j)(3), which governs the
listing and trading of Investment Company Units.\4\ The Exchange filed
that proposed rule change because the Fund and the Shares did not meet
all of the ``generic'' listing requirements of Commentary .01(a)(A) to
NYSE Arca Equities Rule 5.2(j)(3), applicable to the listing of
Investment Company Units based upon an index of ``US Component
Stocks.'' \5\ The Exchange represented that the Shares would conform to
the initial and continued listing criteria under NYSE Arca Equities
Rules 5.2(j)(3) and 5.5(g)(2), except that the underlying index, the
CBOE S&P 500 Put Write Index (the ``Index''), would not meet the
requirements of NYSE Arca Equities Rule 5.2(j)(3), Commentary
.01(a)(A)(1)-(5). The Exchange, however, also represented that the
Index would (1) include a minimum of 20 components, and therefore (2)
meet the numerical requirements of NYSE Arca Equities Rule 5.2(j)(3),
Commentary .01(a)(A)(4), which requires a minimum of 13 index or
portfolio components.
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    \4\ See Securities Exchange Act Release Nos. 74290 (February 18,
2015), 80 FR 9818 (February 24, 2015) (SR-NYSEArca-2015-05) (``Prior
Notice''); 74675 (April 8, 2015), 80 FR 20038 (April 14, 2015) (SR-
NYSEArca-2015-05) (``Prior Order'' and, together with the Prior
Notice, the ``Prior Release'').
    \5\ NYSE Arca Equities Rule 5.2(j)(3) provides that the term
``US Component Stock'' shall mean an equity security that is
registered under Sections 12(b) or 12(g) of the Act and an American
Depositary Receipt, the underlying equity securities of which is
registered under Sections 12(b) or 12(g) of the Act.
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    The Exchange has not listed or commenced trading in the Shares.\6\
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    \6\ See Notice, supra note 3, 80 FR at 79371.
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B. The Instant Proposed Rule Change

    The Exchange submitted this proposal to correct two representations
made in support of its prior proposal to list and trade the Shares.
Specifically, the Exchange seeks to strike its representations that the
Index will (1) include a minimum of 20 components; and (2) meet the
numerical requirements of NYSE Arca Equities Rule 5.2(j)(3), Commentary
.01(a)(A)(4). At any given time, the Index consists of one component,
an ``SPX Put.'' \7\ Additionally, NYSE Arca clarifies that the
Commentary is inapplicable because the Index contains options
components.\8\
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    \7\ The Index is maintained by the Chicago Board Options
Exchange, Inc. (``CBOE'') and tracks the value of a passive
investment strategy, which consists of overlaying of S&P 500 Index
put options (``SPX Puts'') over a money market account, invested in
one and three-month Treasury bills. The SPX Puts are struck at-the-
money and are sold on a monthly basis, usually the third Friday of
the month (i.e., the ``Roll Date''), which matches the expiration
date of the SPX Puts. All SPX Puts are standardized options traded
on the CBOE.
    \8\ NYSE Arca Equities Rule 5.2(j)(3), Commentary .01(a)(A)(5)
provides that all securities in the applicable index or portfolio
shall be US Component Stocks listed on a national securities
exchange and shall be NMS Stocks as defined in Rule 600 under
Regulation NMS of the Act. Each component stock of the S&P 500 Index
is a US Component Stock that is listed on a national securities
exchange and is an NMS Stock. Options are excluded from the
definition of NMS Stock.
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    The Exchange asserts that the deletion of its prior representations
would not adversely affect investors or the public interest, because
the Index is based on CBOE-traded puts on the S&P 500, which are highly
liquid.\9\ The Exchange further estimates that, on the launch date, the
Fund would hold approximately $2.5-$5.0 million in cash and cash
equivalents. The Exchange also believes that sufficient protections are
in place to protect against market manipulation of the Fund's Shares
and SPX Puts because: (i) Trading in the Shares and the underlying Fund
instruments are subject to the federal securities laws and to the
Exchange's, CBOE's, and the Financial Industry Regulatory Authority's
rules and surveillance programs, which are designed to detect
violations; (ii) assets in the portfolio--which will primarily be
short-term U.S. Treasury bills \10\ and SPX Puts--will be acquired in
extremely liquid and highly regulated markets; and (iii) the exchange-
traded fund creation/redemption and arbitrage mechanisms are tied to
the large pool of liquidity of each of the Fund's underlying
investments.
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    \9\ See Notice, supra note 3, at 79372 and 79373 for the
Exchange's representation of the average daily trading volume of at-
the-money 30-day SPX Puts, the trading volume of the at-the-money
SPX Puts, and the daily high, low and last reported sales prices on
each of the Roll Dates for SPX Puts at-the-money.
    \10\ See Notice, supra note 3, at 79373. The Exchange states
that the short-term Treasury securities that the Fund will acquire
as part of its strategy are not readily susceptible to market
manipulation due to the liquidity and extensive oversight associated
with the short-term U.S. Treasury market.
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    The Exchange represents that trading in the Shares will be subject
to the existing trading surveillances and that these procedures are
adequate to properly monitor Exchange trading of the Shares in all
trading sessions and to deter and detect violations of Exchange rules
and federal securities laws. Furthermore, the Financial Industry

Regulatory Authority (``FINRA''), on behalf of the Exchange, or the
regulatory staff of the Exchange, will communicate as needed regarding
trading in the Shares and SPX Index options with other markets and
other entities that are members of the Intermarket Surveillance Group
(``ISG''), and FINRA, on behalf of the Exchange, or the regulatory
staff of the Exchange, may obtain trading information regarding trading
in the portfolio securities from these markets and other entities. In
addition, the regulatory staff of the Exchange may obtain information
regarding trading in the portfolio securities from markets and other
entities that are members of ISG or with which the Exchange has in
place a comprehensive surveillance sharing agreement.

III. Discussion and Commission's Findings

    After careful review, the Commission finds that the exchange's
proposal is consistent with the requirements of Section 6 of the Act
\11\ and the rules and regulations thereunder applicable to a national
securities exchange.\12\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\13\
which requires, among other things, that the Exchange's rules be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
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    \11\ 15 U.S.C. 78f.
    \12\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that it would be difficult to manipulate
the price of the Shares by manipulating the prices of its underlying
assets. The Fund's portfolio will comprise cash, short-term U.S.
Treasury bills, and SPX Puts.\14\ The Exchange contends that neither
short-term Treasury securities nor SPX Puts are readily susceptible to
market manipulation due to the deep liquidity in\15\ and extensive
oversight of those markets.\16\ With respect to SPX Puts, specifically,
the Exchange has provided data demonstrating that the average daily
trading volume (through expiration) of recent SPX Puts compares
favorably to the average daily trading volumes of at-the-money put
options on other major indexes and is, in fact, higher than that of at-
the-money puts on the Russell 2000 index.\17\
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    \14\ See Notice, supra note 3, 80 FR at 79373.
    \15\ The Exchange states: ``According to Federal Reserve Bank of
New York data as of September 2015, average daily trading volume for
U.S. Treasury bills totaled $67.8 billion. . . . SPX options are
among the most liquid index options in the U.S. and derive their
value from the actively traded S&P 500 Index components. SPX options
are cash-settled with no delivery of stocks or ETFs, and trade in
competitive auction markets with price and quote transparency. The
Exchange believes that the highly regulated S&P 500 options markets,
and the broad base and scope of the S&P 500 Index, make securities
that derive their value from that index, including S&P 500 options,
less susceptible to potential market manipulation in view of market
capitalization and liquidity of the S&P 500 Index components, price
and quote transparency, and arbitrage opportunities.'' Id.
    \16\ The Exchange states: ``In addition, the Treasury market and
its participants are subject to a wide range of oversight and
regulations, including requirements designed to prevent market
manipulation and other abuses. For example, Treasury market
participants and the Treasury market, itself, are subject to
significant oversight by a number of regulatory authorities,
including the Treasury, the Commission, federal bank regulators, and
the Financial Industry Regulatory Authority.'' Id., n.15. The
Exchange represents that the SPX Puts will be subject to CBOE and
FINRA surveillance programs. See id., 80 FR at 79374.
    \17\ See id., 80 FR at 79372-73.
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    For these reasons, the Commission believes that it would be
difficult to manipulate the price of the Shares by manipulating the
prices of its underlying assets. The Commission also notes that, except
as discussed above, all other representations made in support of the
Prior Release remain unchanged.
    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act \18\ and the
rules and regulations thereunder applicable to a national securities
exchange.
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    \18\ 15 U.S.C. 78f(b)(5).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\19\ that the proposed rule change (SR-NYSEArca-2015-113), be, and
it hereby is, approved.
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    \19\ 15 U.S.C. 78s(b)(2).
    \20\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-02440 Filed 2-8-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Proposed Rules]
[Pages 40072-40074]
[FR Doc No: 2013-15964]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0573; Directorate Identifier 2012-SW-042-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain serial-numbered Eurocopter France (Eurocopter) Model AS332C1
and AS332L1 helicopters. This proposed AD would require replacing the
rivets on the left-hand (LH) and right-hand (RH) Y350 longitudinal
beams (longitudinal beams Y350). This proposed AD is prompted by a
report that non-conforming rivets had been installed on an AS332
helicopter during a production modification. The proposed actions are
intended to prevent failure of the longitudinal beams Y350 and
subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by September 3,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
Regulations and Policy Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Emergency AD No.: 2012-0046-E, dated March 21, 2012 (EAD 2012-0046-E),
to correct an unsafe condition for Eurocopter Model AS332 C1 and AS332
L1 helicopters. EASA advises that an AS332 helicopter was found on the
production line with non-conforming rivets installed on the RH and LH
longitudinal beams Y350 of the bottom structure of the fuselage,
between sections X4780 and X5295. According to EASA, the investigation
revealed that a limited number of helicopters were documented as
receiving a production modification requiring the replacement of
certain 3.2 mm rivets with 4.8 mm rivets, but the actual replacement of
the rivets had not been performed. EASA states that this condition
leads to significant reduction in the safety margins during sling
operations and may cause failure of the web/flange assembly connections
of the longitudinal beams Y350, possibly resulting in loss of control
of the helicopter. For these reasons, EASA issued EAD 2012-0046-E,
which, pending inspection of the helicopter beams Y350 and replacement
of the affected rivets, prohibits sling operations or limits the 3-ton
sling to external loads of 2.28 tons or less.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral

agreement with France, EASA, its technical representative, has notified
us of the unsafe condition described in its AD. We are proposing this
AD because we evaluated all known relevant information and determined
that an unsafe condition is likely to exist or develop on other
products of the same type design.

Related Service Information

    We reviewed Eurocopter Emergency Alert Service Bulletin No.
01.00.81 Revision 0, dated March 19, 2012 (EASB 01.00.81) for Model
AS332 helicopters. The EASB describes procedures for temporarily
prohibiting sling operations or limiting the use of the 3-ton sling to
2.28 tons until the 3.2 mm diameter rivets are replaced with 4.8 mm
diameter rivets.

Proposed AD Requirements

    This proposed AD would require, within 10 hours time in service
(TIS), replacing the non-conforming 3.2 mm rivets, part-number (P/N)
212 15DC 3200J, on the longitudinal beams Y350 with airworthy 4.8 mm
rivets, P/N 212 15DC 4800J.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires limiting the use of the 3-ton sling,
inspecting the longitudinal beams Y350 for loose or missing rivets,
black marks around the rivets, and cracks, and, depending on the
accumulated sling operation cycles, replacing the rivets within a
period of up to 24 months. This proposed AD does not require the
inspections as it would require replacing the rivets within 10 hours
TIS, regardless of accumulated sling operation cycles.

Costs of Compliance

    We estimate that this proposed AD would affect 1 helicopter of U.S.
Registry. We estimate that operators may incur the following costs in
order to comply with this AD. Modifying the longitudinal beams Y350
with 4.8 mm rivets would require about 24 work-hours at an average
labor rate of $85 per hour and required parts would cost about $110,
for a total cost per helicopter of $2,150. Thus, the total cost to U.S.
operators to comply with the proposed AD would be about $2,150.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
Reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Eurocopter France: Docket No. FAA-2013-0573; Directorate Identifier
2012-SW-042-AD.

(a) Applicability

    This AD applies to Eurocopter France Model AS332C1 and AS332L1
helicopters with the following serial numbers, certificated in any
category: 2494, 2497, 2499, 2501, 2507, 2510, 2513, 2517, 2523,
2524, 2526, 2528, 2531, 2533, 2538, 2544, 2546, 2548, 2550, 2553,
2556, 2558, 2561, 2563, 2566, 2568, 2569, 2571, 2635, 2641, 2644,
2649, 2652, 2657, 2665, 2667, 2669, 2671, 2682, 2683, 2686, 2689,
2694, 2696, 2700, 2704, 2705, 2706, 2710, 2713, 2717, 2720, 2726,
2733, 2737, 2738, 2748, 2751, 2754, 2757, 2758, 2761, 2763, 2765,
2774, 2780, 2787, 2800, 2807, 2816, 2820, 2833, 9007, 9008, 9009 and
9010.

(b) Unsafe Condition

    This AD defines the unsafe condition as non-conforming rivets
installed on the left-hand (LH) and right-hand (RH) Y350
longitudinal beams (longitudinal beams Y350) of the bottom
structure. This condition could result in failure of the web/flange
assembly connections of the longitudinal beams Y350 and subsequent
loss of control of the helicopter.

(c) Comments Due Date

    We must receive comments by September 3, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 10 hours time-in-service, replace the 3.2 mm rivets,
part-number (P/N) 21215DC3200J, of the RH and LH longitudinal beams
Y350 of the bottom structure with 4.8 mm rivets, P/N 21215DC4800J,
as shown in Figures 2 and 3 of Eurocopter Emergency Alert Service
Bulletin No. 01.00.81, Revision 0, dated March 19, 2012.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Gary Roach, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) Emergency AD No.: 2012-0046-E, dated March 21, 2012.
You may view the EASA AD at www.regulations.gov in Docket No. FAA-
2013-0573.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 5314: Fuselage
Main, Keel.

    Issued in Fort Worth, Texas, on June 21, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-15964 Filed 7-2-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Notices]
[Pages 10855-10862]
[FR Doc No: 2018-04996]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0493]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Utilization of
Adequate Provision Among Low to Non-Internet Users

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit either electronic or written comments on the collection
of information by April 12, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-New and
title ``Utilization of Adequate Provision Among Low to Non-internet
Users.'' Also include the FDA docket number found in brackets in the
heading of this document.

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

    In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection of information to OMB for review and clearance.

Utilization of Adequate Provision Among Low to Non-Internet Users

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.
    Prescription drug advertising regulations require that broadcast
advertisements containing product claims present the product's major
side effects and contraindications in either audio or audio and visual
parts of the advertisement (21 CFR 202.1(e)(1)); this is often called
the major statement. The regulations also require that broadcast
advertisements contain a brief summary of all necessary information
related to side effects and contraindications or that ``adequate
provision'' be made for dissemination of the approved package labeling
in connection with the broadcast (Sec.  202.1(e)(1)). The requirement
for adequate provision is generally fulfilled when a firm gives
consumers the option of obtaining FDA-required labeling or other
information via a toll-free telephone number, through print
advertisements or product brochures, through information disseminated
at health care provider offices or pharmacies, and through the internet
(Ref. 1). The purpose of including all four elements is to ensure that
most of a potentially diverse audience can access the information.
    Internet accessibility is increasing, but many members of certain
demographic groups (e.g., older adults, low socioeconomic status
individuals) nonetheless report that the internet is inaccessible to
them either as a resource or due to limited knowledge, and so a website
alone may not adequately serve all potential audiences (Refs. 2 and 3).
Similarly, some consumers may prefer to consult sources other than a
health care provider to conduct initial research, for privacy reasons
or otherwise (Refs. 1, 4, and 5). In light of these considerations, the
toll-free number and print ad may provide special value to consumers
who are low to non-internet users and/or those who value privacy when
conducting initial research on a medication, though not necessarily
unique value relative to one another. As such, a primary purpose of
this research is to examine the value of including both the toll-free
number and print ad as part of adequate provision in direct-to-consumer
(DTC) prescription drug broadcast ads. We will also investigate the
ability and willingness of low to non-internet users to make use of
internet resources if other options were unavailable. These questions
will be assessed using a survey methodology administered via telephone.
    In addition, building on concurrent FDA research regarding drug
risk

information,\1\ we will assess risk perceptions as influenced by
opening statements that could be used to introduce risks in DTC
prescription drug broadcast ads. Opening statements may be used to
frame risk information that follows. As such, consumers may interpret
the likelihood, magnitude, and duration of risks differently depending
on how those risks are introduced (Refs. 6-9). The intended outcome of
this component of the research is to evaluate the influence of these
opening statements within a sample of low to non-internet users. This
research question will be addressed using a 1 x 3 between-subjects
experimental design embedded in the previously mentioned survey. This
particular component of the research will serve as an exploratory test
intended to inform FDA's future research efforts.
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    \1\ https://www.federalregister.gov/documents/2015/01/13/2015-00269/agency-information-collection-activities-submission-for-office-of-management-and-budget-review.
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    Sampling Frame. Given that older adults (i.e., those aged 65 and
older) are among the largest consumers of prescription drugs (Ref. 10)
and that approximately 41 percent of older adults do not use the
internet (Ref. 2), investigating use of adequate provision in this
population is especially important. Also of concern, 34 percent of
those with less than a high school education do not use the internet,
23 percent of individuals with household incomes lower than $30,000 per
year do not use the internet, and 22 percent of individuals living in
rural areas do not use the internet (Ref. 2). These estimates capture
non-internet users, and so consideration of low-internet users warrants
additional concern. Consistent with these citations, the present
research will utilize a nationally representative sample of low to non-
internet users from these and other relevant demographic groups.
    Data collection will utilize a random digit dialing (RDD) sample
that has been pre-identified as being a non-internet household, or
having at least one non-internet using member. This sample solution is
ideal because it relies on a dual-frame (landline and cell phone)
probability sample, yet has the advantage of prior knowledge of those
who are likely to be low to non-internet users (re-screening will
verify this). The Social Science Research Solutions (SSRS) Omnibus,
within which this survey will be embedded, utilizes a sample designed
to represent the entire adult U.S. population, including Hawaii and
Alaska, and including bilingual (Spanish-speaking) respondents. As
reflected in the overall population of low to non-internet users, we
intend to collect a small sample of Spanish-speaking individuals, which
comprise a subsample of the regular landline and cell phone RDD
sampling frames. We will also screen for past and present prescription
drug use in order to ensure a motivated sample.
    Survey Protocol. This survey will be conducted by telephone on
landline and cell phones, with an expected 50 to 60 percent of
interviews conducted on cell phones. Interviewing for the pretest and
main study will be conducted via SSRS's computer-assisted telephone
interviewing system. We expect to achieve a roughly 40 percent survey
completion rate from the pre-identified respondents to be sampled in
this study, given an 8-week field period and a maximum of 10 attempts
to reach respondents. The original SSRS Omnibus from which this sample
is derived receives an approximately 8 to 12 percent response rate.
These are not uncommon response rates for high-quality surveys and have
been found to yield accurate estimates (Refs. 11 and 12).
    As communicated earlier, the primary focus of interview questions
concern the ability and willingness of low to non-internet users to
utilize the various components of adequate provision, particularly the
toll-free number and print ad components. In addition to these
questions, experimental manipulations will be embedded in the survey as
an exploratory test to assess the impact of opening statements that
could be used to introduce risks in DTC prescription drug broadcast
ads, which is a related concept. To form the experimental
manipulations, participants will be presented with a statement of major
risks and side effects (``the major statement'') drawn from a real
prescription drug product, but modified to include only serious and
actionable risks. Preceding this description of major risks will be one
of three opening statements: (1) ``[Drug] can cause severe, life
threatening reactions. These include . . .''; (2) ``[Drug] can cause
serious reactions. These include . . .''; or (3) ``[Drug] can cause
reactions. These include . . .'' All risk statements will conclude with
the following language: ``This is not a full list of risks and side
effects. Talk to your doctor and read the patient labeling for more
information.'' Participants will be randomly assigned to experimental
condition, and all manipulations will be pre-recorded to allow for
consistent administration. Following exposure to these manipulations,
participants will respond to several questions designed to assess risk
perceptions.
    Before the main study, we will execute a pretest with a sample of
25 participants from the same sampling frame as outlined. The pretest
questionnaire will take approximately 15 minutes to complete. The goal
of the pretest will be to assess the questionnaire's format and the
general protocol to ensure that the main study is ready for execution.
To test the protocol among the target groups, we will seek to recruit a
mix of participants based on demographic and other characteristics of
interest. We do not plan to use incentives for the pretest or main
study portions of this survey. However, upon request, cell phone
respondents may be offered $5 to cover the cost of their cell phone
minutes.
    Questionnaire development is an iterative process and so the main
study questionnaire will include any changes from pretesting, as well
as other outcomes, such as OMB and public comments. Like pretesting,
the main study questionnaire should take approximately 15 minutes to
complete. Based on a power analyses, the main study sample will include
approximately 1,996 participants. This sample size will allow us to
draw statistical comparisons between the various demographic groups in
the sample.
    Measurement and Planned Analyses. Consistent with the larger
purpose of the study, survey questions will examine access, technical
ability, and willingness to use adequate provision options; preference
for and experience using adequate provision options; privacy concerns;
and potentially other secondary questions of interest. In addition, to
assess the impact of the experimental manipulations, survey questions
will assess perceived risk likelihood, perceived risk magnitude, and
perceived risk duration. Demographic information will also be
collected. To examine differences between experimental conditions, we
will conduct inferential statistical tests such as analysis of
variance. A copy of the draft questionnaire is available upon request.
    In the Federal Register of June 12, 2017 (82 FR 26934), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Comments received along with our responses
to the comments are provided below. For brevity, some public comments
are paraphrased and therefore may not reflect the exact language used
by the commenter. We assure commenters that the entirety of their
comments was considered even if

not fully captured by our paraphrasing. The following acronyms are used
here: FRN = Federal Register Notice; DTC = direct-to-consumer; FDA and
``The Agency'' = Food and Drug Administration; OPDP = FDA's Office of
Prescription Drug Promotion.
    Comment 1a, regulations.gov tracking number 1k1-8y16-3nqx
(summarized): The commenter expresses support for FDA's collective
research and welcomes the Agency's current proposed survey examining
adequate provision.
    Response to Comment 1a: We appreciate and thank the commenter for
their support.
    Comment 1b (verbatim): Throughout the main survey questionnaire,
some questions ask about ability to obtain information on prescription
drugs after seeing an advertisement on television. These questions
presume access to a television. If understanding this process of first
seeing an ad on TV then searching for information is the key objective,
we suggest in the screening criteria ensuring all respondents have
access to a TV and/or watch television on a regular basis.
    Response to Comment 1b: We have added a screening question to
confirm that participants watch television at least occasionally.
    Comment 1c (verbatim): As currently outlined, the sample frame is
relatively broad in that it includes those who possibly do not have
experience with prescription medications or experience searching for
prescription medication information. Respondents without experience in
this area could provide speculative responses to many questions, and
thus, [the commenter] suggests that they are outside of the scope. To
address this, we recommend adding a screening question or questions to
include only those who have had at least one medical condition which
has required prescription medication within the last 12 months.
    Response to Comment 1c: To ensure a motivated sample, we included a
question to screen for past or present prescription drug use.
    Comment 1d (verbatim): The purpose of the secondary objective of
the study pertaining to risk statements is not entirely clear. Since
the sample frame is not restricted to those who suffer from a condition
which could be helped by the mock drug, responses have the possibility
to be speculative and reflect bias of people coming in to the study
rather than what is intended. For instance, respondents who happen to
be within a population targeted by the major statements are reasonably
more likely to report a higher likelihood of experiencing a stated side
effect and reporting a higher seriousness of them, biasing experiment
responses.
    Response to Comment 1d: The secondary objective of the study is
designed to assess the impact of opening statements that could be used
to introduce risks in DTC prescription drug broadcast ads. This
objective complements previously published research and adds value by
newly investigating the impact of framing statements among a sample of
low to non-internet users. Our approach involves random assignment to
experimental conditions which should lead to approximately equal
numbers of diagnosed versus undiagnosed individuals in each of the
conditions, lessening any concern about bias. Nonetheless, please
understand that this secondary objective is intended to provide a
preliminary assessment of the stated research questions for development
purposes. Procedurally, this objective will involve only a brief
presentation of a short audio broadcast followed by three questions,
allowing us to gather this valuable information with very low burden to
participants who are already engaged in our larger survey regarding
adequate provision.
    Comment 1e (verbatim): Additionally, information gained from the
experimental manipulations (E-1 through E-3) will only be applicable to
hearing the opening and major statement presented over the phone,
rather than versus being read through print or online. Interpretations
and understanding of this info could differ between the media. While
this could possibly be a useful supplement to current knowledge, the
learnings will likely not be directly applicable to the other media. If
comparison of interpretation between the media is the goal of this
section, [the commenter] suggests a stand-alone study would better
address that goal rather than an addendum to this one.
    Response to Comment 1e: We appreciate this limitation of our
preliminary assessment and intend to take it into consideration when
interpreting results.
    Comment 1f (verbatim): Screener: The current screener terminates
cell phone users who have not browsed the internet in the past month (S
I). It is not readily apparent why this group should not participate in
the survey. We would suggest that the termination criteria be removed
from this question as it may make incremental improvement to response
rates.
    Response to Comment 1f: The screener only excludes cell phone users
(T1 = 2) who choose ``don't know'' (- 98) or refuse the question (- 99)
(S1 < 0).
    Comment 1g (verbatim): As is, it is unclear what an independent
variable for the questionnaire is intended to be. One possibility [the
commenter] suggests is including a question aimed at understanding the
overall preference for source of information, which would serve as the
independent variable in the study or could be combined with the ability
and access questions to make a composite variable. (e.g., ``What is
your preferred medium in which to receive prescription drug
information: Print ads for the drug; the manufacturer's phone number or
website; or asking your healthcare provider?'')
    Response to Comment 1g: Please refer to the instruction set
preceding question 3. Our questionnaire attempts to learn about patient
preferences through questions about participant likelihood to seek
information via the various available sources, as well as past use,
ability, and willingness, among other constructs. We believe these
constructs to provide adequate assessment of consumer preference to
obtain additional information via the various available sources.
Moreover, we note that another commenter (see Comment 3n) takes the
position that we should not inquire about patient preferences. We have
considered both of the perspectives when deciding upon potential
revisions.
    Comment 1h (verbatim): Throughout the survey, [the commenter]
suggests defining each point on the 5 point scales used to avoid
confusion by respondents. In our consumer research efforts, we
customarily use 5 point scales that are defined at each point, such as
`Excellent, Very Good, Good, Poor, and Very Poor'.
    Response to Comment 1h: We concur that defining each point on 5
point scales helps mitigate confusion and have revised the
questionnaire to define each point of scales.
    Comment 1i (verbatim): It seems inappropriate to use a Likert scale
to answer ``Q1: Access to sources of information'', as it would seem
access could be defined more narrowly--No access, some access, or
complete access. We suggest using the pre-test to examine this question
in particular to ensure either that the current scale is interpreted
correctly or determine an appropriate re-wording. Additionally, it
could be helpful to include the more specific options as distinct
answer choices (e.g. an option for internet at a public library and a
separate option for internet at a coffee shop) in order to provide more
granular information which could be useful to the FDA as

well as industry as a whole. We suggest using the pre-test to produce a
full list of options as well as any appropriate re-wordings.
    Response to Comment 1i: We agree that defining access more narrowly
may be sufficient for this question and so we have adopted this
approach in our revised survey. We will also evaluate responses to this
narrowed scale in our analysis of pretest data. We also appreciate the
value of assessing locations of access; however, we consider such
questions to be of lesser relevance to our key objectives, and we have
sought to limit the duration of the survey to less than 15 minutes.
Consequently, we do not adopt this recommendation.
    Comment 1j (verbatim): Throughout the survey, we suggest adding in
``Talked with your doctor'' as an answer choice among the options for
sources of information. Physicians are a major source of product
information and ``talking with a doctor'' are what drug advertisements
generally suggest to consumers, so inclusion of this option is
appropriate.
    Response to Comment 1j: We agree that health care providers are one
important source for adequate provision. Nonetheless, the current
investigation is designed to assess the utility of the various options
for disseminating additional product risk information, and speaking
with a health care provider is not under reevaluation. Consequently, we
ask participants to respond under the premise that they are seeking
information prior to approaching a health care professional.
    Comment 1k (verbatim): As currently worded, question 13 has the
possibility to lead the respondent by stating that ``Some people change
their approach . . .'' The current wording could bias respondents to be
overly critical. [The commenter] would suggest either changing the
question or adding in a new question prior to the current Q 13 to
ascertain a rating of the level of privacy offered by each information
source. This new question would provide the respondents current
perceptions of privacy, something which the survey omits. For example,
a newly worded question could be as follows: ``On a 5-point scale, in
which 1 is Very Low Privacy and 5 is Very High Privacy, what is the
level of privacy offered by each of the following information sources
when getting full prescription-drug product information?'' The current
question 13 could then follow this question.
    Response to Comment 1k: Our intention with this question (and its
wording) is to facilitate comparisons between baseline likelihood to
use the various sources of adequate provision (see Q3) and likelihood
to use the various options in cases where privacy is a concern. By
stating ``Some people change their approach . . . '' we hoped to give
participants permission to respond differently than they had in the
earlier question, if they felt a change in their response was
appropriate. Nonetheless, we recognize that this language could be
leading and so we have eliminated it from our revised questionnaire. We
are hopeful that the revised question will still allow us to draw the
intended comparisons.
    Comment 1l (verbatim): In addition to our concerns regarding the
goal of the experiment questions (E 1-E2), the purpose in the
variations of the major statements is unclear. The objectives state
that varying opening statements (E I) are the secondary focus of this
research, not major statements. We suggest choosing an appropriate
major statement in the pre-tests and then using that in the broader
fielding of the study.
    Response to Comment 1l: The purpose of varying the major statements
was to add to the generalizability of our findings. The revised version
of our survey adopts this commenter's recommendation and includes only
one version of the major statement.
    Comment 1m (verbatim): We suggest adding a ``Don't know'' option
for EI-E3 as respondents might not be able to assess how long lasting,
serious, or likely the side effects would be. The current range of
answer choices may force inaccurate or speculative responses; a ``Don't
Know'' answer would be a legitimate choice and informative for the
study. Our standard practice is to provide a ``Don't Know'' option
whenever it could be a valid answer.
    Response to Comment 1m: The items used in this section were
developed through scale validation research and thus we prefer to
retain them in their original form. Nonetheless, we have added labels
to each point on the scales in response to Comment 1h, and the midpoint
(``neutral'') of these scales may be treated similarly to a ``Don't
Know'' option.
    Comment 2a, regulations.gov tracking number 1k1-8xz6-t7bj
(verbatim): The practical utility of this study is unclear. Currently,
industry is broadly executing on making labeling available via both IN
[internet] and non-IN based options to a diverse audience.
Historically, there were many options available to enable patients to
locate drug-related labeling, even before the IN became available. When
added to the three options mentioned above, the IN provides patients
with a fourth option, one that is increasingly at a patient's fingertip
via tablet, cell phone, or laptop. Hence, it is unclear how results
from this study will enhance consumer access to information or be
applied to modify current practices.
    Response to Comment 2a: As stated in the 60-day FRN (82 FR 26934),
our intention is to assess the utility of the various sources of
adequate provision among a sample of low to non-internet users. For
example, it may not be necessary to include both a print ad reference
and toll free number reference. We have received inquiries along these
lines from stakeholders. Additionally, we may find that low to non-
internet users would be willing to use the internet themselves or with
the help of a friend or family member if non-internet options were
unavailable. This research will provide insights to inform our approach
to the adequate provision requirement.
    Comment 2b (verbatim): The sampling frame focuses on those ``not
likely to have IN access'' as defined by FDA and includes older adults,
with less than a high school education, who make less than $30,000/
year, and live in rural areas; it also includes bilingual Spanish
speakers. Yet it is not clear how persons not likely to have IN access
would be able to inform FDA about how they would behave if they had
access to the IN and other options were not available. Rather than
speculate about how their behavior might change if faced with IN access
and no other options, it would be better to design a study that focuses
on understanding the effectiveness of non-IN options to provide
information in general.
    Response to Comment 2b: To be clear, we intend to sample from the
above referenced populations separately, as opposed to sampling from
one population with all these attributes.
    As indicated in the 60-day FRN (82 FR 26934), we do intend to
assess the effectiveness of non-internet options. However, as a
secondary objective, it seems to us worthwhile to also consider how low
to non-internet users may respond if non-internet options were
unavailable. As another commenter indicates (see Comment 3b), internet
use is widespread and technological sources of adequate provision may
suffice (when combined with recommendation to speak to a health care
professional). We hope to shed light on this question through our
research.
    Comment 2c (verbatim): Questions 1-5 and 13: The current choices do
not assess the respondent's willingness or ability to visit their
healthcare provider

to obtain the approved package labeling. This option should be added.
    Response to Comment 2c: Please refer to Comment 1j and our
associated response.
    Comment 2d (verbatim): Question 15: Given the length of the package
labeling making it impractical to receive the information verbally, it
would be likely that callers would prefer an option, Mail the
prescription drug product information to me, even when faced with
privacy concerns.
    Response to Comment 2d: This response option has been added to our
revised questionnaire.
    Comment 2e (verbatim): Instructions for Experimental Manipulations,
E1/E2: E2 includes three different versions of the major statements. If
the intended outcome of this component of the research is to evaluate
the influence of these opening statements within a sample of low to
non-IN users, and risk perceptions will be assessed as influenced by
opening statements that could be used to introduce risks, it is unclear
why the major statements (E2: A, B, C) differ when assessing whether or
not opening statements (E1: 1, 2, 3) influence risk perceptions.
    Response to Comment 2e: Please refer to Comment 1l and our
associated response.
    Comment 3a, regulations.gov tracking number 1k1-8y13-m7td: FDA is
conducting too much research without ``articulating a clear,
overarching research agenda or adequate rationales on how the proposed
research related to the goal of further protecting public health.''
``The Agency should publish a comprehensive list of its prescription
drug advertising and promotion studies from the past five years and
articulate a clear vision for its research priorities for the near
future.''
    Response to Comment 3a: OPDP's mission is to protect the public
health by helping to ensure that prescription drug information is
truthful, balanced, and accurately communicated, so that patients and
health care providers can make informed decisions about treatment
options. OPDP's research program supports this mission by providing
scientific evidence to help ensure that our policies related to
prescription drug promotion will have the greatest benefit to public
health. Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that we believe are
most central to our mission, focusing in particular on three main topic
areas: Advertising features, including content and format; target
populations; and research quality. Through the evaluation of
advertising features we assess how elements such as graphics, format,
and disease and product characteristics impact the communication and
understanding of prescription drug risks and benefits; focusing on
target populations allows us to evaluate how understanding of
prescription drug risks and benefits may vary as a function of
audience; and our focus on research quality aims at maximizing the
quality of research data through analytical methodology development and
investigation of sampling and response issues.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our homepage, which
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest FRNs and peer-reviewed publications
produced by our office. The website maintains information on all
studies we have conducted, dating back to a DTC survey conducted in
1999.
    Comment 3b; the commenter provided a summary of their comments
followed by a more detailed description of the same comments. For
brevity, only the summary of comments (verbatim) is provided below.
Full comments may be accessed at regulations.gov via tracking number
1k1-8y13-m7td.
    First, FDA's proposed research appears to offer limited practical
utility in several ways:
     The Agency proposes research based on an outdated, 18-
year-old guidance document that fails to recognize adequately the
societal and technological changes of the last two decades, including
the many options now available to satisfy the adequate provision
requirement.
     FDA regulations require adequate, not complete, provision.
Given the prevalence of the internet and smartphones across all U.S.
demographic groups, we believe that biopharmaceutical manufacturers can
satisfy adequate provision simply through information dissemination at
health care provider offices or pharmacies, a 1-800 number, and/or the
internet.
     FDA fails to recognize existing research that demonstrates
the pervasiveness of the internet and smartphones in the United States.
This research limits any potential utility of the proposed study. The
Agency's proposal mainly relies on data from six to 16 years ago. The
smartphone is dramatically increasing internet connectivity for
traditionally low to non-internet use demographic groups. Further, FDA
does not acknowledge that older adults (with or without internet
access) tend to rely on others, including family and health care
personnel, for drug information.
    Response to Comment 3b: FDA recognizes that a large proportion of
the U.S. population utilizes the internet. It is specifically for this
reason that we are conducting research to inform our current guidance
recommendations. Nonetheless, as indicated in the 60-day FRN (82 FR
26934), certain segments of the U.S. population are unlikely to use the
internet. For example, 41 percent of individuals aged 65 and older do
not use the internet, yet are the largest consumers of prescription
drugs. As the commenter states, some individuals from this demographic
rely on others to obtain drug information, but this perspective does
not take into account the desire for privacy in obtaining such
information, or the availability of these other individuals. The
proposed research will provide empirical assessment of how vulnerable
populations such as older adults may be impacted by changes to
regulatory policy.
    The assertion that the requirement for ``adequate'' provision can
be fulfilled by disseminating information through ``health care
provider offices or pharmacies, a 1-800 number, and/or the internet''
may be correct, and FDA invites the commenter to submit data supportive
of this perspective. FDA maintains a science-based approach to its
regulatory decisionmaking, and as such, the current research is
designed to inform our thinking in this area.
    We disagree with the assertion that our proposal relied mainly on
data from 6 to 16 years ago. A more careful review of the FRN will show
that our key citations range from 2013 to the present. By necessity, we
also cite the relevant 1999 guidance, as well as a few other references
which speak to general patterns of human behavior.
    Comment 3c (summarized): The commenter recommends removal of the
second proposed study concerning opening statements to frame risk
information on the grounds that (a) questions regarding adequate
provision may impact responding in the second

proposed study and (b) a low to non-internet user sample is not
sufficiently diverse.
    Response to Comment 3c: Please refer to Comment 1d and our
associated response.
    Comment 3d (summarized): The commenter provides several
recommendations pertaining to subject enrollment. The first comment on
this topic ``recommends that FDA ensure that the subject sample
includes representative portions of alleged subpopulations of low to
non-internet users, including older adults, low socioeconomic status
individuals, people with less than a high school education, and
individuals living in rural areas.''
    Response to Comment 3d: To obtain a nationally representative
sample of the target population of adult low to non-internet users who
are also prescription drug users, the research team will use a sample
sourced from a dual frame. This approach involves using a random digit
dialing sample that has been pre-identified as being a non-internet
household (or having at least one non-internet using member). The
demographics within this frame of low to non-internet users fall within
the expected range of subpopulations with respect to older adults, low
socioeconomic status, and people with less than a high school education
or some college. The sample is designed to represent the adult U.S.
population (including Hawaii and Alaska) and will include rural areas.
This sample solution is ideal because it relies on a dual-frame
probability-sample, yet has the advantage of already knowing who are
likely to be low to non-internet users.
    Comment 3e (summarized): In the second comment pertaining to
subject enrollment, the commenter recommends that participants reached
via smartphone not be included in the sample.
    Response to Comment 3e: We agree that smartphone use is increasing
internet access for traditionally low to non-internet use demographics
and appreciate the importance of confirming our sample are low to non-
internet users. Notwithstanding, we are screening based on self-
reported internet browsing, such that individuals who report browsing
the internet three or more times in the past month--regardless of
medium--will not be asked to participate in the survey. Further, the
current approach supports that only households which have been pre-
identified as having at least one non-internet using member will be
screened for participation, adding an additional layer of assurance
that only low to non-internet users will be asked to participate in the
questionnaire.
    Comment 3f (summarized): In the third comment pertaining to subject
enrollment, the commenter recommends collecting data in-person because
data collection via phone may impact responses regarding the 1-800
number.
    Response to Comment 3f: We acknowledge that in-person data
collection would add value to the proposed research but cost
implications bar us from pursuing it. We will consider implications of
our protocol for survey administration when interpreting results.
    Comment 3g (summarized): In the final comment pertaining to subject
enrollment, the commenter indicates agreement with the proposed
approach to screen for past and present prescription drug use in order
to ensure a motivated sample.
    Response to Comment 3g: We appreciate the support for this planned
approach.
    Comment 3h: Remaining comments pertain to the draft study
questionnaire. The first comment on this topic suggests that certain
items may lead participants to respond in certain ways. Examples
(abbreviated for brevity) include:
     The instructions for Q3 of the Main Study Survey state:
``Prescription drugs advertised on television provide only limited
product information. For example, not all of the product's risks and
side effects are described. Imagine you wanted to obtain additional
product information before seeing your health care provider.'' As
previously mentioned, while research ``reveal[s] consumers engage in
some prescription drug information seeking . . . most takes place after
visiting a doctor, not before'' (emphasis added [by commenter]). The
question prompt does not reflect common practice and may lead to a
misleading answer. Both the prompt and question itself should be
revised to reflect that subjects may look specifically to their
healthcare provider for this information.
     Further, the Main Study Survey introduces questions about
privacy by stating: ``Next, I will ask about privacy concerns you might
have when getting full prescription-drug product information.'' Such
phrasing suggests that a subject should have ``concerns'' in this
context. Q12 asks subjects to ``rate the extent to which you value
privacy . . . '' (emphasis added [by commenter]). Such language
suggests subjects should indeed ``value'' privacy.
     The prompt for Q13 is also leading by introducing the
question with: ``Some people change their approach to getting
information about prescription drugs when privacy is a concern.''
    Response to Comment 3h: As the commenter indicates in the first
comment, there is evidence to suggest that consumers seek information
both before and after visiting with a health care professional.
Moreover, the ubiquity of DTC prescription drug advertising suggests
that pharmaceutical companies are well aware of the advantages of
introducing products to consumers prior to the consumer-health care
provider interaction. The proposed research is concerned with how low
to non-internet users access full product information prior to
approaching a health care professional. As such, we need to provide
this context to participants before they can respond regarding their
interest and experiences within this context. We disagree that our
presentation here is leading as the commenter describes, and
consequently, we retain our current approach with these questions.
    Likewise, in response to the second comment, we cannot inquire
about privacy concerns without referencing privacy concerns.
Nonetheless, we have revised Q12 to read ``How much value do you place
on privacy . . .''
    In response to the third comment, please see Comment 1k and our
associated response.
    Comment 3i (summarized): The second comment pertaining to the study
questionnaire concerned definitions and terms. The commenter states,
``The questionnaires do not define certain key terms (e.g., side
effect, risk, serious, reference, full product information, partial
information). Subjects may interpret these terms based on different
standards. For example, for Q16 of the Main Study Survey, FDA may wish
to provide context for what could constitute ``complete prescription-
drug product information. FDA should consider providing user-friendly
definitions or terms throughout the questionnaires.''
    Response to Comment 3i: We appreciate the importance of ensuring
uniform interpretation of terms. In cognitive interviews preceding this
work, we assessed whether individuals interpret key terms similarly and
made revisions where necessary. We have also considered the additional
time (burden) that would be required to complete the survey if every
term were defined in the pretest and main study. We have targeted to
keep the current information collection to under 15 minutes per
respondent. With these factors in mind, we have chosen not to provide
additional definitions.

    Comment 3j (summarized): The third comment pertaining to the study
questionnaire concerned the sliding scale format of certain questions:
``FDA should consider replacing the sliding scale format (especially
for Q1-Q3 of the Main Study Survey) with a binary or ``Yes-No-Neutral''
scheme. The sliding-scale format is at times confusing in form,
inappropriately frames certain questions, and could potentially
introduce error.''
    Response to Comment 3j: Please see Comment 1i and our associated
response.
    Comment 3k: The final comments pertaining to the questionnaire were
characterized by the commenter as miscellany. The first comment read,
``As previously mentioned in Section II.A, E1-E3 of the Main Study
Survey should be eliminated. (reference omitted) Similarly, we would
also recommend that elimination of ``Other Questions of Interest''
(Q16-Q20) of the Main Study Survey, which appear to have limited
applicability to the study of adequate provision.''
    Response to Comment 3k: In regards to E1-E3, please see Comment 1d
and our associated response. In regards to Q16-Q20, all these items
provide potentially valuable information relevant to the topic of
interest, and therefore we prefer to retain them.
    Comment 3l: The next comment characterized as miscellany read:
``The Study Screener introduction should not state that the survey is
being conducted ``on behalf of the Food and Drug Administration'' and
that study results ``will be used in the consideration of important
policy decisions.'' These statements could potentially influence
subjects' responses to study questions. Instead, this information might
be provided at the conclusion of the study.''
    Response to Comment 3l: Such statements are intended to communicate
the legitimacy of the study to potential participants, and thus
validate participation. Upon further consideration, we concur that
these statements may potentially influence responses, and we have
removed them.
    Comment 3m: The next comment characterized as miscellany read:
``The Main Study Survey should include a similar question to Q5,
inquiring about if a toll-free number was not available.''
    Response to Comment 3m: We acknowledge the potential value of this
question, but given the key objectives of the research, and concerns
about participant burden, we decline to adopt this recommendation. We
have targeted to keep the current information collection to under 15
minutes per respondent.
    Comment 3n: Continuing under the miscellany category: ``There are
several questions of the Main Study Survey (e.g., questions associated
with Instructions_2) that inquire about a subject's preferences
regarding the provision of product labeling. We do not understand the
utility of these questions. Again, FDA's regulation concerns adequate,
not preferred, provision.''
    Response to Comment 3n: In deciding upon potential revisions, we
have considered both this commenter's views and those of another
commenter (see Comment 1g) which recommend utilizing consumer
preferences as an independent variable. We agree with the first
commenter that consumer preferences are crucial for understanding the
issues at hand as articulated in the 60-day FRN (82 FR 26934).
Consequently, we have retained these questions.
    Comment 3o: The next miscellany comment read: ``Certain questions,
like Q4 and Q5 of the Main Study Survey, should include the option of
asking a health care provider. Such a choice is part of FDA's adequate
provision recommendation in the Guidance Document.''
    Response to Comment 3o: Please see Comment 1j and our associated
response.
    Comment 3p: The next miscellany comment read: ``The ordering of the
questions (web page, toll-free number, print ad) of the Main Study
Survey could potentially introduce bias. FDA may want to randomize the
ordering of questions (e.g., Q6-Q11) to eliminate such bias.''
    Response to Comment 3p: We accept this recommendation and will
randomize the ordering of questions Q6 to Q11 pertaining to web page,
toll-free number, and print ad.
    Comment 3q: The final comment characterized as miscellany read:
``Q15 of the Main Study Survey should include an option of mailing
information to the customer.''
    Response to Comment 3q: Please see Comment 2d and our associated
response.
    FDA estimates the burden of this collection of information as
follows:

                                                         Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                   Activity                        Number of     responses per   Total annual         Average  burden per  response         Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Screener..............................              63               1              63  .05 (3 minutes).........................            3.15
Pretest Survey................................              25               1              25  .25 (15 minutes)........................            6.25
Main Study Screener...........................           4,990               1           4,990  .05 (3 minutes).........................           249.5
Main Study Survey.............................           1,996               1           1,996  .25 (15 minutes)........................             499
                                               ---------------------------------------------------------------------------------------------------------
    Total Hours...............................  ..............  ..............  ..............  ........................................           757.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating 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. U.S. Department of Health and Human Services, Food and Drug
Administration (1999). ``Guidance for Industry: Consumer-Directed
Broadcast Advertisements.'' Available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125039.htm.
2. Anderson, M. and A. Perrin (2016). ``13% of Americans Don't Use
the internet: Who Are They?'' Pew Research Center. Available at
http://www.pewresearch.org/fact-tank/2016/09/07/some-americans-dont-use-the-internet-who-are-they/.
3. U.S. Department of Commerce, U.S. Census Bureau (2013).
``Computer and internet Use in the United States: Population
Characteristics.'' Available at https://www.census.gov/prod/2013pubs/p20-569.pdf.

4. Fox, S. and L. Rainie (2002). ``Vital Decisions: How internet
Users Decide What Information to Trust When They or Their Loved Ones
Are Sick. Pew internet & American Life Project.'' Available at
http://www.pewinternet.org/2002/05/22/main-report-the-search-for-online-medical-help/.
5. DeLorme, D.E., J. Huh, and L.N. Reid (2011). ``Source Selection
in Prescription Drug Information Seeking and Influencing Factors:
Applying the Comprehensive Model of Information Seeking in an
American Context.'' Journal of Health Communication, 16: pp. 766-
787.
6. O'Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et al. (2014).
``Important Safety Information or Important Risk Information? A
Question of Framing in Prescription Drug Advertisements.''
Therapeutic Innovation and Regulatory Science, 48: pp. 305-307. doi:
10.1177/2168479013510306
7. Kahneman, D. (2011). Thinking, Fast and Slow. New York, NY:
Farrar, Straus, and Giroux.
8. Rothman, A.J. and P. Salovey (1997). ``Shaping Perceptions To
Motivate Healthy Behavior: The Role of Message Framing.''
Psychological Bulletin, 121: pp. 3-19.
9. Armstrong, K., J.S. Schwartz, G. Fitzgerald, et al. (2002).
``Effect of Framing as Gain Versus Loss on Understanding and
Hypothetical Treatment Choices: Survival and Mortality Curves.''
Medical Decision Making, 22: pp. 76-83.
10. National Center for Health Statistics (2016). ``Health, United
States, 2015: With Special Feature on Racial and Ethnic Health
Disparities.'' Hyattsville, MD.
11. Brick, J.M. and D. Williams (2013). ``Explaining Rising
Nonresponse Rates in Cross-Sectional Surveys.'' The Annals of the
American Academy of Political and Social Science, 645: pp. 36-59.
12. Groves, R.M. (2006). ``Nonresponse Rates and Nonresponse Bias in
Household Surveys.'' Public Opinion Quarterly, 70: pp. 646-675.
13. Betts, K.R., V. Boudewyns, K.J. Aikin, C. Squire, et al. (2017).
``Serious and Actionable Risks, Plus Disclosure: Investigating an
Alternative Approach for Presenting Risk Information in Prescription
Drug Television Advertisements.'' Research in Social &
Administrative Pharmacy. doi: 10.1016/j.sapharm.2017.07.015.

    Dated: March 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04996 Filed 3-12-18; 8:45 am]
 BILLING CODE 4164-01-P