[Federal Register: September 8, 2009 (Volume 74, Number 172)]
[Notices]
[Page 46261-46264]
[DOCID:fr08se09-137]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60595; File No. SR-NYSE-2009-91]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC
Amending NYSE Rules 103B and 104 To Increase the Amount of Time That a
Designated Market Maker Unit Must Maintain a Bid and an Offer at the
National Best Bid and National Best Offer for an Aggregate Average
Period of Time Monthly

August 31, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on August 31, 2009, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 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 NYSE Rules 103B and 104 to increase
the amount of time that a Designated Market Maker unit must maintain a
bid and an offer at the National Best Bid and National Best Offer for
an aggregate average period of time monthly. The text of the proposed
rule change is available at the Exchange, the Commission's Public
Reference Room, and www.nyse.com.

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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    Exchange market participants want a trading venue that encourages
participants to add liquidity and facilitate their ability to trade
larger orders more efficiently. The Exchange believes that essential to
meeting the demands of its market participants and maintaining market
quality is the availability of liquidity at the National Best Bid
(``NBB'') and National Best Offer (``NBO'') (collectively herein
``NBBO'').\4\ The Exchange therefore proposes to amend NYSE Rules 103B
and 104 to increase the amount of time that a Designated Market Makers
(``DMM'') unit must maintain a bid and an offer at the NBBO for an
aggregate average period of time monthly.
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    \4\ In addition, through a separate filing the Exchange proposes
to adjust DMM units' rebate payments to be based on (i) an increased
amount of time that DMM units must maintain a bid and an offer at
the NBBO on a stock by stock basis during a month; and (ii) a
requirement that the DMM units be 25% of the quoted volume during
the trading day on a stock by stock basis. See SR-NYSE-2009-90.
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Background
    The NYSE implemented sweeping changes to its market rules and
execution technology designed to improve execution quality on the
Exchange.\5\ Among the elements of the enhanced Exchange market model,
the NYSE eliminated the function of specialists on the Exchange
creating a new category of market participant, the Designated Market
Maker or DMM. The DMM, like specialists, have affirmative obligations
to make an orderly market, including continuous quoting requirements
and obligations to re-enter the market when reaching across to execute
against trading interest.
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    \5\ See Securities Exchange Act Release No. 58845 (October 24,
2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46) (approving
certain rules to operate as a pilot scheduled to end October 1,
2009). The NYSE also recognized that in view of the NYSE's
electronic execution functionality, the DMM, unlike the specialist,
would no longer be deemed the agent for every incoming order. The
NYSE also responded to customer demand to create additional
undisplayed reserve interest.
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    Moreover, the Exchange's market model was designed to encourage
DMMs to add liquidity at the NBBO. Specifically, the Exchange
implemented quoting requirements pursuant to Exchange Rules 103B
(``Security Allocation and Reallocation'') and 104 (``Dealings and
Responsibilities of DMMs''). The quoting requirement pursuant to Rule
103B is the single objective standard to determine DMM unit eligibility
for participation in the allocation process. NYSE Rule 104 employs the
same numerical standards as it relates to a DMM unit's affirmative
obligations to maintain a continuous two-sided quote.
    Under current Rules 103B and 104, for listed securities that have a
consolidated average daily volume of less than one million shares per
calendar month (``Less Active'') a DMM unit must maintain a bid and an
offer at the NBBO for an aggregate average monthly time of 10% or more
during a calendar month. For listed securities that have a consolidated
average daily volume equal to or greater than one million shares per
calendar month (``More Active''), the DMM unit must maintain a bid and
an offer at the NBBO for an aggregate average monthly time of 5% or
more during a calendar month. DMM units are required to satisfy the
quoting requirement for both categories of their assigned
securities.\6\
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    \6\ Under NYSE Rule 103B, if a DMM unit fails to satisfy the
quoting requirements during a one-month period, the Exchange issues
an initial warning letter to the DMM unit, advising it of its
deficiency. The DMM unit must provide in writing an explanation and
articulation of corrective action. If the DMM unit fails to meet the
requirement for a second consecutive month, the DMM unit is
ineligible to participate in the allocation process for a minimum of
two months following the second consecutive month of its failure to
meet its quoting requirement (``Penalty Period''). The DMM unit must
satisfy the quoting requirement for the two consecutive months of
the Penalty Period. In the event a DMM unit fails to satisfy its
quoting requirements for the two consecutive months of the Penalty
Period, the DMM unit will remain ineligible to participate in the
allocation process until it has met the quoting requirement for a
consecutive two calendar month period. Under NYSE Rule 104, failure
to satisfy the quoting requirement is a violation of the DMM unit's
affirmative obligation and may subject the DMM unit to regulatory
action, including formal or informal discipline.
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    Time at the NBBO is calculated as the average of the percentage of
time the DMM unit has a bid or offer at the NBBO. For example, if a DMM
unit maintains a quote at the National Best Bid for 6% of the trading
day and a quote at the National Best Offer for 4% of the trading day,
then the average of these times is 5%. The Exchange determines whether
a DMM unit has met its quoting requirements on a month-by-month basis
by calculating:

    (1) The ``Daily NBB Quoting Percentage'' by determining the
percentage of time a DMM unit has at least one round lot of
displayed interest in an Exchange bid at the National Best Bid
during each Trading Day for a calendar month;
    (2) The ``Daily NBO Quoting Percentage'' by determining the
percentage of time a DMM unit has at least one round lot of
displayed interest in an Exchange offer at the

National Best Offer during each Trading Day for a calendar month;
    (3) The ``Average Daily NBBO Quoting Percentage'' for each
Trading Day by summing the ``Daily NBB Quoting Percentage'' and the
``Daily NBO Quoting Percentage'' then dividing such sum by two;
    (4) The ``Monthly Average NBBO Quoting Percentage'' for each
security by summing the security's ``Average Daily NBBO Quoting
Percentages'' for each Trading Day in a calendar month then dividing
the resulting sum by the total number of Trading Days in such
calendar month; and
    (5) For the total Less Active Securities (More Active
Securities) assigned to a DMM unit, the Exchange will determine the
``Aggregate Monthly Average NBBO Quoting Percentage'' by summing the
Monthly Average NBBO Quoting Percentages for each Less Active
Security (More Active Security) assigned to a DMM unit, then
dividing such sum by the total number of Less Active Securities
(More Active Securities) assigned to such DMM unit.

    Below is an example of a quoting requirement calculation. For
purposes of this example, it is assumed that DMM Unit 1 has two
assigned securities, A and B and that there were 5 trading days in the
selected calendar month.
    The Average Daily NBBO for DMM Unit 1 is calculated for each
security by summing the daily NBB and NBO of each security for that day
and dividing that number by two:

------------------------------------------------------------------------
                                              Calculation
                     NBB          NBO        average daily     Average
  Trading days    (percent)    (percent)     NBBO for DMM     daily NBBO
                                                Unit 1        (percent)
------------------------------------------------------------------------
                               Security A
------------------------------------------------------------------------
T1.............            4            6  4% + 6% = 10%               5
                                            divided by 2 =
                                            5%.
T2.............            3            5  3% + 5% = 8%                4
                                            divided by 2 =
                                            4%.
T3.............            4            4  4% + 4% = 8%                4
                                            divided by 2 =
                                            4%.
T4.............            6            8  6% + 8% = 14%               7
                                            divided by 2 =
                                            7%.
T5.............            5            5  5% + 5% = 10%               5
                                            divided by 2 =
                                            5%.
------------------------------------------------------------------------
                               Security B
------------------------------------------------------------------------
T1.............            5            7  5% + 7% = 12%               6
                                            divided by 2 =
                                            6%.
T2.............            4            6  4% + 6% = 10%               5
                                            divided by 2 =
                                            5%.
T3.............            6            8  6% + 8% = 14%               7
                                            divided by 2 =
                                            7%.
T4.............            7            9  7% + 9% = 16%               8
                                            divided by 2 =
                                            8%.
T5.............            9            9  9% + 9% = 18%               9
                                            divided by 2 =
                                            9%.
------------------------------------------------------------------------

    The monthly average NBBO quoting percentage for DMM Unit 1 for each
security is then calculated by summing the security's average Daily
NBBO Quoting Percentages for all the Trading Days of the calendar month
and then dividing the resulting total by the number of Trading Days in
the calendar month (in this instance 5).

----------------------------------------------------------------------------------------------------------------
                            Average daily NBBO                                Calculation monthly      Monthly
---------------------------------------------------------------------------   average NBBO for DMM     average
          T1                 T2           T3           T4           T5               Unit 1              NBBO
----------------------------------------------------------------------------------------------------------------
                                                   Security A
----------------------------------------------------------------------------------------------------------------
5%....................           4%           4%           7%           5%  5% + 4% + 4% + 7% + 5%            5%
                                                                             = 25% divided by 5 =
                                                                             5%.
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                                                   Security B
----------------------------------------------------------------------------------------------------------------
6%....................           5%           7%           8%           9%  6% + 5% + 7% + 8% + 9%            7%
                                                                             = 35% divided by 5 =
                                                                             7%.
----------------------------------------------------------------------------------------------------------------

    The Aggregate Monthly Average NBBO Quoting Percentage for DMM Unit
1 is determined by summing the Monthly Average NBBO for each security
and then dividing such sum by the total number of securities.

Aggregate Monthly Average for Specialist Unit 1

Monthly Average NBBO Security A + Monthly Average NBBO Security B
divided by 2
    5% + 7% = 12% divided by 2 = 6% Aggregate Monthly Average

    The Exchange reviews each DMM unit's trading, as illustrated in the
example above, on a monthly basis to determine whether the DMM unit has
satisfied its quoting requirement.\7\ In the example above, assuming
that Securities A and B were Less Active Securities, then the DMM Unit
1 would not have met that component of its quoting obligation for the
month because the 6% aggregate monthly average is 4% less than the
required 10% monthly average time at the NBBO for its Less Active
Securities. If however, Securities A and B were More Active Securities,
then DMM Unit 1 would have met that component of its quoting obligation
for the month because the 6% aggregate monthly average is 1% higher
than the 5% monthly average time at the NBBO for More Active
Securities.
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    \7\ See NYSE Rule 103B, Section II(J)(4).
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Proposed Amendment to NYSE Rules 103B and 104
    The Exchange proposes to increase DMM units' quoting requirement
for both Less Active and More Active securities in both NYSE Rules 103B
and 104. For Less Active securities the Exchange seeks to amend NYSE
Rule 103B Section II(D) and NYSE Rule 104(a)(1)(A) to increase the
current requirement that DMM units be 10% of the time at the NBBO to
15%. For More Active securities, the Exchange proposes to amend NYSE
Rule 103B Section II(E) and NYSE Rule 104(a)(1)(A) to increase the
current 5% of the time at the NBBO to 10%. Time at the NBBO will
continue to be calculated on a month-by-month basis as the average of
the percentage of time DMM units have a bid or offer at the NBBO.
    As proposed, assuming again that DMM Unit 1 has two assigned
securities, A and B and that there were

5 trading days in the selected calendar month, then DMM Unit 1 must
increase its quoting such that for Less Active Securities, it is 10% of
the time at the NBBO and for More Active Securities it is 15% of time
at the NBBO as illustrated in the example below.

------------------------------------------------------------------------
                                              Calculation
                     NBB          NBO        average daily     Average
  Trading days    (percent)    (percent)     NBBO for DMM     daily NBBO
                                                Unit 1        (percent)
------------------------------------------------------------------------
                               Security A
------------------------------------------------------------------------
T1.............            8           12  8% + 12% = 20%             10
                                            divided by 2 =
                                            10%.
T2.............            6           10  6% + 10% = 16%              8
                                            divided by 2 =
                                            8%.
T3.............            8            8  8% + 8% =16%                8
                                            divided by 2 =
                                            8%.
T4.............           12           16  12% + 16% = 28%            14
                                            divided by 2 =
                                            14%.
T5.............           10           10  10% + 10% = 20%            10
                                            divided by 2 =
                                            10%.
------------------------------------------------------------------------
                               Security B
------------------------------------------------------------------------
T1.............           10           14  10% + 14% = 24%            12
                                            divided by 2 =
                                            12%.
T2.............            8           12  8% + 12% = 20%             10
                                            divided by 2 =
                                            10%.
T3.............           12           16  12% + 16% = 28%            14
                                            divided by 2 =
                                            14%.
T4.............           14           18  14% + 18% = 32%            16
                                            divided by 2 =
                                            16%.
T5.............           18           18  18% + 18% = 36%            18
                                            divided by 2 =
                                            18%.
------------------------------------------------------------------------

    The monthly average NBBO quoting percentage for DMM Unit 1 for each
security is then calculated by summing the security's average Daily
NBBO Quoting Percentages for all the Trading Days of the calendar month
and then dividing the resulting total by the number of Trading Days in
the calendar month (in this instance 5).

----------------------------------------------------------------------------------------------------------------
                            Average daily NBBO                                Calculation monthly      Monthly
---------------------------------------------------------------------------   average NBBO for DMM     average
          T1                 T2           T3           T4           T5               Unit 1              NBBO
----------------------------------------------------------------------------------------------------------------
                                                   Security A
----------------------------------------------------------------------------------------------------------------
10%...................           8%           8%          14%          10%  10% + 8% + 8% + 14% +            10%
                                                                             10% = 50% divided by 5
                                                                             = 10%.
----------------------------------------------------------------------------------------------------------------
                                                   Security B
----------------------------------------------------------------------------------------------------------------
12%...................          10%          14%          16%          18%  12% + 10% + 14% + 16% +          14%
                                                                             18% = 70% divided by 5
                                                                             = 14%.
----------------------------------------------------------------------------------------------------------------

    The Aggregate Monthly Average NBBO Quoting Percentage for DMM Unit
1 is determined by summing the Monthly Average NBBO for each security
and then dividing such sum by the total number of securities.

Aggregate Monthly Average for Specialist Unit 1

Monthly Average NBBO Security A + Monthly Average NBBO Security B
divided by 2
    10% + 14% = 24% divided by 2 = 12% Aggregate Monthly Average

    In the example above, assuming Securities A and B were Less Active
Securities, then DMM Unit 1 would not have met that component of the
proposed quoting obligation for the month because the 12% aggregate
monthly average is 3% less than the required 15% monthly average time
at the NBBO for its Less Active Securities. If, however, Securities A
and B were More Active Securities, then the DMM Unit 1 would have met
that component of the proposed quoting obligation for that month
because the 12% aggregate monthly average is 2% higher than the
required 10% monthly average time at the NBBO for More Active
Securities.
    The Exchange will continue to review each DMM unit's trading on a
monthly basis to determine whether the DMM unit has satisfied its
quoting requirement for both Less Active and More Active Securities.
The Exchange's current review of DMM units' trading on a monthly basis
suggests that the proposed increase would not place an undue burden on
DMM units. All DMM units currently exceed their quoting requirements on
a monthly basis. Based on past performance, the Exchange anticipates
that the changes proposed herein combined with the above referenced
rebate changes will establish a new baseline for quoting by DMM units
that will incentivize the DMM units to provide additional liquidity
above the new proposed minimum standards. Accordingly, the Exchange
believes that the proposed quoting requirements increase is reasonable,
since it is anticipated to improve market quality by increasing
liquidity at the NBBO, without adversely impacting the DMM units'
ability to meet their market making obligations.
    Moreover, the Exchange believes that increasing the quoting
requirements pursuant to both NYSE Rules 103B and 104 is consistent
with the Exchange's commitment to providing its customers with a
trading venue that has deep liquidity at the NBBO and transparency, the
hallmark of a fair and efficient market.
2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (the ``Act'')
\8\ for these proposed rule changes is the requirement under Section
6(b)(5) \9\ that an Exchange have rules that are

designed 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. The proposed rule change supports these principles in
that it serves to increase the liquidity available at the NBBO. The
Exchange believes that increased liquidity at the NBBO will lead to
enhanced market quality which ultimately serves to protect investors
and the public interest.
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    \8\ 15 U.S.C. 78a.
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \12\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) \13\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has
requested that the Commission waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The
Commission believes that waiving the 30-day operative delay \14\ is
consistent with the protection of investors and the public interest
because such waiver will permit the Exchange to immediately apply the
new enhanced quoting requirements.
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ Id.
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2009-91 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2009-91. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office 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 publicly available. All
submissions should refer to File Number SR-NYSE-2009-91 and should be
submitted on or before September 29, 2009.
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    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-21586 Filed 9-4-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39033-39035]
[FR Doc No: 2021-15648]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0363]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
Advertising

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 written comments (including recommendations) on the
collection of information by August 23, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0686. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St. North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Prescription Drug Advertising--21 CFR Part 202

OMB Control Number 0910-0686--Extension

    This information collection supports Agency regulations and
associated guidance. FDA protects the public health by assuring the
safety, effectiveness, and security of a wide range of products. We
also help consumers get accurate, science-based information they need
to use medicines appropriately and improve their health.

Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 331) prohibits the misbranding of FDA-regulated products,
including prescription drugs. Section 502 of the FD&C Act (21 U.S.C.
352) requires that manufacturers, packers, and distributors, or anyone
acting on their behalf (firms) include certain information in human
prescription drug promotional labeling and advertisements.
    Our prescription drug advertising regulations in part 202 (21 CFR
part 202) describe requirements and standards for print and broadcast
advertisements. Section 202.1 applies to advertisements published in
journals, magazines, other periodicals, and newspapers, and
advertisements broadcast through media such as radio, television, and
telephone communication systems. Print advertisements must include a
brief summary of each of the risk concepts from the product's approved
package labeling (Sec.  202.1(e)(1)). Advertisements that are broadcast
through media such as television, radio, or telephone communications
systems must disclose the major risks from the product's package
labeling in either the audio or audio and visual parts of the
presentation (Sec.  202.1(e)(1)); this disclosure is known as the
``major statement.'' If a broadcast advertisement omits the major
statement, or if the major statement minimizes the risks associated
with the use of the drug, the advertisement could render the drug
misbranded in violation of the FD&C Act (21 U.S.C. 352(n) and section
201 of the FD&C Act (21 U.S.C. 321(n)), and FDA's implementing
regulations at Sec.  202.1(e).
    Section 202.1(e)(6) provides for certain waivers. The waiver
request must set forth clearly and concisely the petitioner's interest
in the advertisement, the specific provision of Sec.  202.1(e)(6) from
which a waiver is sought, a complete copy of the advertisement, and a
showing that the advertisement is not false, lacking in fair balance or
otherwise misleading, or otherwise violative of section 502(n) of the
FD&C Act.
    Under Sec.  202.1(j)(1), a sponsor must submit advertisements to
FDA for prior approval before dissemination if: (1) The sponsor or FDA
has received information that has not been widely publicized in medical
literature that the use of the drug may cause fatalities or serious
damage; (2) FDA has notified the sponsor that the information must be
part of the advertisements for the drug; and (3) the sponsor has failed
to present to FDA a program for assuring that such information will be
publicized promptly and adequately to the medical profession in
subsequent advertisements, or if such a program has been presented to
FDA but is not being followed by the sponsor.
    Under Sec.  202.1(j)(1)(iii), a sponsor must provide to FDA a
program for assuring that significant new adverse information about the
drug that becomes known (i.e., use of drug may cause fatalities or
serious damage) will be publicized promptly and adequately to the
medical profession in any subsequent advertisements. Under Sec.
202.1(j)(4), a sponsor may voluntarily submit advertisements to FDA for
comment prior to publication.
    While the regulations establish requirements for prescription drug
advertisements, we have developed the guidance document entitled,
``Product Name Placement, Size, and Prominence in Promotional Labeling
and Advertisements; Guidance for Industry'' to clarify requirements for
product name placement, size, prominence, and frequency in promotional
labeling and advertisements for human and animal prescription drugs and
prescription biological products. The guidance includes recommendations
that pertain to traditional print promotional labeling and
advertisements (e.g., journal ads, detail aids, brochures), audiovisual
promotional labeling (e.g., videos shown in a healthcare provider's
office), broadcast advertisements (e.g., television advertisements,
radio advertisements), and electronic and computer-based promotions
(e.g., internet, social media, emails, CD-ROMs, DVDs). The guidance
document was issued consistent with our Good Guidance Practice
regulations in part 10.115 which provide for public comment at any
time, and is available from our website at: https://www.fda.gov/media/87202/download.
    In the Federal Register of April 29, 2021 (86 FR 22686), we
published a 60-day notice requesting public comment on the proposed
collection of information. Three comments were received, all generally
supportive of FDA's drug advertising regulations; however, some
commenters suggested FDA might do more to promote truthful advertising
with regard to prescription drug products. We appreciate all comments.
No comment suggested a revision to our current estimate for the
information collection.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   21 CFR section; activity        Number of     responses per    Total annual      Hours per       Total hours
                                  respondents      respondent       responses        response
----------------------------------------------------------------------------------------------------------------
CDER Regulated Products:
    202.1(e)(6); waiver                      1                1               1               12              12
     request..................
    202.1(j)(1); submission of               1                1               1                2               2
     advertisement............
    202.1(j)(1)(iii); assuring               1                1               1               12              12
     that adverse information
     be publicized............
    202.1(j)(4); voluntary                  59             1.85             109               20           2,180
     submission of ad to FDA..
CBER Regulated Products:
    202.1(e)(6); waiver                      1                1               1               12              12
     request..................
    202.1(j)(1); submission of               1                1               1                2               2
     advertisement............
    202.1(j)(1)(iii); assuring               1                1               1               12              12
     that adverse information
     be publicized............
    202.1(j)(4); voluntary                   7             2.57              18               20             360
     submission of ad to FDA..
CVM Regulated Products:
    202.1(e)(6); waiver                      1                1               1               12              12
     request..................
    202.1(j)(1); submission of               1                1               1                2               2
     advertisement............
    202.1(j)(1)(iii); assuring               1                1               1               12              12
     that adverse information
     be publicized............
    202.1(j)(4); voluntary                   7                1               7               20             140
     submission of ad to FDA..
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ...............             143  ...............           2,758
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    Our estimate of burden we attribute to the reporting provisions in
part 202 is based on our experience with the collection and a review of
Agency data.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                     21 CFR section; activity                         Number of      disclosures per    Total annual      Burden per       Total hours
                                                                     respondents       respondent       disclosures       disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1; ad prepared in accordance with part 202...................             670            111.08           74,425               400       29,770,000
202.1(j)(1); info. included re. fatalities or serious damage.....               1                 1                1                40               40
                                                                  --------------------------------------------------------------------------------------
    Total........................................................  ...............  ................          74,426   ................      29,770,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
\2\ Numbers rounded to the nearest one/one-hundredth.

    Under Sec.  202.1, advertisements for human and animal prescription
drug and biological products must comply with the standards described
in that section. Under Sec.  202.1(j)(1), if information that the use
of a prescription drug may cause fatalities or serious damage has not
been widely publicized in the medical literature, a sponsor must
include such information in the advertisements for that drug. Based on
a review of Agency data we estimate an average of 29,770,040 hours is
incurred annually by respondents in complying with third-party
disclosure requirements for prescription drug advertising. We assume a
placeholder of 1 for disclosures under Sec.  202.1(j)(1).

                                        Table 3--Estimated Annual Disclosure Burden Discussed in Agency Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
              Information collection recommendations                  Number of      disclosures per    Total annual    per disclosure     Total hours
                                                                     respondents       respondent       disclosures       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product name placement, size, and prominence in promotional                   715             190.3          136,069                 3          408,207
 labeling and advertisements' disclosures........................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The placement, size, prominence, and frequency of the proprietary
and established names for human prescription drugs, including
prescription biological products, and animal prescription drugs are
specified in labeling and advertising regulations (Sec. Sec.  201.10(g)
and (h); 202.1(b)-(d)). Based on Agency data, we estimate that, for
human and animal prescription drugs and prescription biological
products, an average of 715 firms disseminate approximately 136,069
advertisements and promotional pieces each year. We assume that the
burden associated with complying with the regulatory requirements
discussed in the guidance would be approximately 3 hours per response.
    We have adjusted our estimate upward to reflect increases in
prescription drug advertisements and associated disclosures.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15648 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 58985-58986]
[FR Doc No: 2012-23526]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER12-2310-001.
    Applicants: Zephyr Wind, LLC.
    Description: Amendment to Pending 1 to be effective 9/25/2012.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5125.
    Comments Due: 5 p.m. ET 10/5/12.

    Docket Numbers: ER12-2629-000.
    Applicants: Northern States Power Company, a Wisconsin corporation.
    Description: 2012-9-14 DPC Const Agrmt NOC--290-NSPW to be
effective 11/14/2012.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5123.
    Comments Due: 5 p.m. ET 10/5/12.

    Docket Numbers: ER12-2630-000.
    Applicants: Noble Americas Energy Solutions LLC.
    Description: Errata to MBR tariff re Seller Category to be
effective 11/1/2010.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5129.
    Comments Due: 5 p.m. ET 10/5/12.

    Docket Numbers: ER12-2631-000.
    Applicants: Pacific Wind Lessee, LLC, Catalina Solar, LLC.
    Description: Shared Transmission Facilities Agreement of Pacific
Wind Lessee LLC & Catalina Solar LLC to be effective 11/15/2012.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5130.
    Comments Due: 5 p.m. ET 10/5/12.

    Docket Numbers: ER12-2632-000.
    Applicants: Pacific Gas and Electric Company.
    Description: E&P Agreement for SKIC Solar, LLC to be effective 9/
17/2012.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5131.
    Comments Due: 5 p.m. ET 10/5/12.

    Docket Numbers: ER12-2633-000.
    Applicants: Catalina Solar, LLC.
    Description: Catalina Solar Concurrence to Shared Transmission
Facilities Agreement to be effective 11/15/2012.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5133.
    Comments Due: 5 p.m. ET 10/5/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing

requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 17, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-23526 Filed 9-24-12; 8:45 am]
BILLING CODE 6717-01-P