It further asserts that regardless of whether dual modality requires
simultaneous presentation of the major statement in both audio and
text, a visual presentation of the major statement would need to appear
on screen for a significant portion of many ads to allow consumers of
all abilities sufficient time to read and absorb the risk information,
which in turn might overemphasize risk information and thus result in
the non-neutral presentation of that risk information. That comment
also suggests that to meet a dual modality requirement, TV ads would
necessarily grow in length to accommodate required additional text.
However, another comment says that fulfilling a dual modality
requirement would not require more ad time, and in fact, requiring
audio and visual presentation of the major statement to occur at the
same time might even reduce ad length. A third comment expresses the
view that, to improve consumer risk awareness, the regulation should
require that the major statement be presented in dual modality, using
text that is either identical to the audio track or an abbreviated,
easily processed bullet point type of text, using only words that occur
in the audio track.
    (Response 21) To reinforce the presented risk information and
consequently help improve its comprehension, the final rule requires
the concurrent presentation of the major statement in the audio and in
text. This is consistent with the proposed rule, which reflected the
expectation that where text was used, it would appear ``concurrently
with any directly related audio information'' (75 FR 15376 at 15379) as
well as with the research cited in the proposed rule (75 FR 15376 at
15383). This is also consistent with the FTC standard, cited in the
proposed rule, for determining whether an affirmative disclosure in a
television commercial is clear and conspicuous, which states that for
disclosures in a television advertisement to be clear and conspicuous,
they should be presented simultaneously in both the audio and video
(Ref. 65) (75 FR 15376 at 15377 and 15380). Further, the final rule
provides additional clarity on how to achieve a dual modality
presentation of the major statement regarding what text must appear,
when the text must appear in relation to the audio, and for what
duration--consistent with research cited in the proposed rule (75 FR
15376 at 15383) and the approach used in the Distraction Study, the
report of which was placed in the docket and the comment period
reopened expressly to solicit comment on the results of that study in
relation to the proposed standards (77 FR 4273-74; Ref. 27). The
provisions in the final rule collectively provide considerable
flexibility to firms and do not necessitate that the textual
presentation of the major statement remain on screen throughout the ad.
    We agree with the comment noting that the text used to achieve dual
modality should present words that the corresponding audio uses, rather
than synonyms, and also agree that dual modality can be achieved using
text in an abbreviated form. This is consistent with the approaches
used in research that was cited in the proposed rule and that supported
dual modality (75 FR 15376 at 15383), as well as the approach used in
the Distraction Study (Ref. 27). Accordingly, the final rule specifies
that dual modality can be achieved either by displaying the verbatim
key words or phrases from the corresponding audio or by displaying the
verbatim complete transcript of the corresponding audio. This provides
firms flexibility to choose from various presentation options. For
example, if the audio states, ``The most common side effects of DRUGX
are dry mouth, headache, and heartburn,'' instead of presenting a
complete verbatim transcript of that statement, the accompanying text
could present bullets stating `` dry mouth  headache
 heartburn.''
    The final rule also addresses the duration of text display. Like
proposed standard #3 (which alone would not have required text, but
addressed how to present text if it were used in addition to the
already-required audio to present the major statement), the final rule
requires that text used to present the major statement be displayed for
a duration that allows it to be read easily. Discussion of proposed
standard #3 also indicated our intention to require that visually-
presented text information from the major statement appear
``concurrently with any directly related audio information'' (75 FR
15376 at 15379). These elements of proposed standard #3 regarding the
display of text are now picked up as part of the dual modality
requirement (final standard #3). Final standard #3 clarifies their
relationship to each other and to the audio presentation requirements
of the rule, stating that the duration of display of text is sufficient
if it starts at the same time and ends at approximately the same time
as the corresponding audio. This approach is similar to that required
for the presentation of closed captioning under Federal Communication
Commission regulations. See 47 CFR 79.1(j)(2)(ii). In turn, the pace of
the audio component of the major statement is determined by the
requirement that the audio information be at least as understandable as
the audio information presented in the rest of the ad--something that
the firm chooses. (See final standard #2 (Sec.  202.1(e)(1)(ii)(B)) and
section V.H of this document.) With this flexibility, we believe the
presentation of risk information will not be overemphasized. None of
the standards of the final rule that impact duration of text display,
including the dual modality standard, either separately or together,
require that the textual presentation of the major statement remain on
screen throughout the ad or generally require increasing the length of
ads in order to present the major statement. At the same time, we think
the methods of achieving dual modality described by the rule will
contribute to presenting the major statement in a clear, conspicuous,
and neutral manner.

L. First Amendment Freedom of Speech--Comments and FDA Response

    Two comments question whether the proposed rule is consistent with
First Amendment protections for freedom of speech. One addresses the
major statement's requirement to disclose side effects generally; the
other focuses on the proposal for presenting the major statement using
dual modality.
    (Comment 22) One comment asserts that the overall requirement for
the major statement to disclose side effects is unconstitutional under
the Supreme Court's decision in Central Hudson Gas & Elec. Corp. v.
Pub. Serv. Comm'n, 447 U.S. 557 (1980), regarding commercial

speech restrictions, but the comment does not address any specific
elements of the proposed manner of presentation that are the subject of
this rulemaking. This comment asserts that, for the Government to
restrict advertising, among other things, the advertising must be
misleading, and the comment states without elaboration that ``lack of
disclosure or lack of clarity'' of side effects does not make
advertising misleading. The comment also asserts that the Government
has no substantial interest in mandating disclosure of risk information
in DTC ads in TV/radio format and, consequently, that no requirements
for a major statement in a DTC ad could satisfy the First Amendment.
The comment states that the Government interest implicated by requiring
disclosure of side effects in DTC prescription drug advertising is one
intended to protect consumer safety but that this interest ``cannot be
proven as substantial'' because it is already addressed by the
requirement to obtain a prescription to access a prescription drug. The
comment further suggests that the information is unnecessary in ads
because all prescription orders explain drug side effects.
    Another comment raises concerns that a dual modality requirement
would violate the First Amendment. The comment suggests that the
proposed dual modality requirement is subject to First Amendment
analysis under Central Hudson and under Thompson v. Western States
Medical Center, 535 U.S. 357 (2002), and also suggests that ``a
regulatory scheme that formats the style and content of advertising in
advance of its presentation to the public'' might impose an unlawful
prior restraint on advertising. In addition, the comment asserts that
to hold a firm liable for failing to use dual modality, FDA would have
to prove that absent dual modality, the ad would be false or misleading
to the consumer, noting that a consumer cannot obtain a prescription
for an advertised drug without consulting a physician. The comment
suggests that, unless FDA can establish in advance that all ads that
lack dual modality would be false or misleading, the dual modality
requirement is not constitutional.
    (Response 22) We disagree that the major statement requirement as a
whole, the dual modality requirement in particular, or any other aspect
of this rule's standards for presenting the major statement in a clear,
conspicuous, and neutral manner violates the First Amendment.
    As the Supreme Court has explained, Government mandates for
``health and safety warnings'' have been ``long considered
permissible,'' and these warnings as well as ``purely factual and
uncontroversial disclosures about commercial products'' are legal under
the First Amendment (Nat'l Inst. of Family and Life Advocates v.
Becerra, 138 S. Ct. 2361, 2376 (2018)). The presentation of the major
statement addressed in this rule, as well as the underlying requirement
to provide the important side effects and contraindications of the
drug, fall squarely within these categories.
    Specifically, the major statement is quintessential health and
safety warning information, reflecting the contraindications and side
effects of a prescription drug as described in the prescription drug's
approved labeling. The content of the major statement is not changed by
this rulemaking. As explained in section III of this document, there is
a long history of requirements to provide health and safety warnings
about a prescription drug's risks, including in its advertising, and to
ensure that understanding of required disclosures about these products
is not undermined by an inadequate manner of presentation of the
information.
    More generally, the major statement is a factual disclosure about a
commercial product to be included in its advertising. The Supreme Court
examines factual disclosures about products and services in commercial
speech under the analysis in Zauderer v. Office of Disciplinary
Counsel, 471 U.S. 626 (1985). See Nat'l Inst. of Family and Life
Advocates, 138 S. Ct. 2361, 2377-2378; Milavetz, Gallop & Milavetz,
P.A. v. United States 559 U.S. 229, 250, 252-253 (2010). Under the
approach articulated in Zauderer, courts have upheld required
disclosures of factual and uncontroversial information about a product
or service in commercial speech about that product or service. See,
e.g., American Hosp. Ass'n, 983 F.3d 528, 540 (posting negotiated rates
for hospital services); American Meat Inst. v. Dept. of Agric., 760
F.3d 18 (D.C. Cir. 2014) (en banc) (country of origin labeling for
meat); N.Y. State Restaurant Ass'n v. N.Y.C. City Bd. of Health, 556
F.3d 114 (2d Cir. 2009) (calorie information on menus); Nat'l Elec.
Mfrs. Ass'n, 272 F.3d 104 (labeling identifying presence of mercury in
light bulbs). Where such disclosures are not unjustified or unduly
burdensome, their imposition does not offend the First Amendment. See,
e.g., Nat'l Inst. of Family and Life Advocates, 138 S. Ct. 2361, 2377-
2378; American Hosp. Ass'n, 983 F.3d 528, 541 (required publication of
standard charges is not unduly burdensome in a way that chills
commercial speech as it ``neither requires hospitals to endorse a
particular viewpoint nor prevents them from adding their own message on
the same website or even in the same file''; alleged financial burden
of compliance with the disclosure requirement not established to be
burden on speech); Spirit Airlines, Inc. v. United States Dep't of
Transp., 687 F.3d 403, 414 (D.C. Cir. 2012) (requirement for airlines
to make total price the most prominent cost figure does not
significantly burden airlines' ability to advertise); Discount Tobacco
City & Lottery, Inc., 674 F.3d 509, 524 (size of required tobacco
warnings is not unduly burdensome where remaining portions of their
packaging are available for other information).
    The provisions of this rule likewise satisfy the requirements of
Zauderer and subsequent cases. First, the required information about
the drug's side effects and contraindications presented in the major
statement is factual and uncontroversial. As already noted, it is
derived from the drug's FDA-approved labeling, which is based on data
and information about the product submitted by the drug's sponsor and
evaluated by FDA.
    Second, requiring that this information be presented in DTC TV/
radio ads in a clear, conspicuous, and neutral manner is justified by
the interests described in section III of this document. Contrary to
the implications of both comments, the substantial Government interests
supporting these measures are not limited to preventing consumers from
being misled or protecting consumer safety. Rather, the substantial
Government interests underlying this rule also include helping to
ensure consumers are better informed when they participate in
healthcare decision making, including when no HCP is present (see
discussion in section III.A). Communicating risk information in a
manner that improves the likelihood that consumers notice, attend to,
and comprehend that information is instrumental to advancing this
purpose of including risk information in the first place. See Discount
Tobacco City & Lottery, Inc., 674 F.3d 509, 561-564 (enhanced warnings
on tobacco products advance the interests in promoting greater public
understanding of the risks of those products; ``A warning that is not
noticed, read, or understood by consumers does not serve its
function'').
    Third, this rule is not unduly burdensome. The final rule's
requirements for the manner of presenting the major statement--
including the requirement for dual

modality--do not threaten to drown out or chill the firm's other
messages. Indeed, the firm not only remains free to present other
messages in the ad; under this rule, it retains substantial ability to
choose how to present the major statement.
    For example, the major statement has long been required to be
presented in audio. This rule provides more direction on how to do so
but leaves many implementation details up to the firm. With regard to
this audio presentation, the final standard requires that the volume,
articulation, and pacing make the audio presentation of the major
statement ``at least as understandable as the audio presented in the
rest of the advertisement'' (Sec.  202.1(e)(1)(ii)(B))--leaving it
substantially up to the firm how it wants to use audio for all the
content in the ad. To fulfill the dual modality requirement for ads in
TV format, the display of text is sufficient if it begins at the same
time and ends at approximately the same time as the corresponding audio
and displays the verbatim key terms or phrases from the corresponding
audio (Sec.  202.1(e)(1)(ii)(C)). Ultimately, then, this final rule,
including dual modality, retains the firm's substantial control of the
overall presentation and duration of the major statement and preserves
the firm's opportunity to present the advertised drug's benefits or any
other messages in other parts of the ad. And, as discussed in section
V.K of this document, the use of dual modality does not decrease the
recall or comprehension of benefit information even while it improves
consumer comprehension and recall of the risk information, advancing
the Government interests discussed in section III.A.1 of this document.
    While we conclude that Zauderer provides the relevant framework for
analysis of the mandatory risk disclosure provisions of this rule and
that its requirements are satisfied, we also conclude that this
rulemaking is consistent with the First Amendment if analyzed under
more exacting scrutiny, including Central Hudson, a case mentioned by
both comments. Contrary to the implication of both comments, FDA's
authority to regulate prescription drug advertising is not limited to
cases in which that speech is misleading (or false). Rather, under the
Central Hudson framework, even if commercial speech is truthful, is not
inherently or actually misleading, and relates to lawful activity, the
Government may impose restrictions that directly advance a
``substantial'' Government interest and are no ``more extensive than is
necessary to serve that interest'' (Central Hudson Gas & Elec. Corp.,
447 U.S. 557, 566).
    In cases examining limitations on commercial speech, the Supreme
Court has endorsed ``the principle that disclosure of truthful,
relevant information is more likely to make a positive contribution to
decisionmaking than is concealment of such information'' (Peel v.
Attorney Registration and Disciplinary Comm'n of Illinois, 496 U.S. 91,
108 (1990)). As a result, the Court has favored use of disclosures over
restrictions on speech to advance the substantial interests in
preventing consumers from being misled and in making a positive
contribution to informed decision making (id. at 109-110); Shapero v.
Kentucky Bar Ass'n, 486 U.S. 466, 477-478 (1988); In re R.M.J., 455
U.S. 191, 203 (1982); Bates v. State Bar of Arizona, 433 U.S. 350, 375
(1977); Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer
Council, 425 U.S. 748, 770 (1976).
    Similarly, the FD&C Act and FDA implementing regulations require
disclosures of risk information where prescription drug ads promote the
product's benefits to directly advance the substantial Government
interests previously described in section III of this document. The
requirements in this rule to ensure that important facts about the
risks of an advertised drug are presented in a clear, conspicuous, and
neutral manner in its DTC TV/radio ads are reasonable in proportion to
these interests and thus present no constitutional infirmity under any
potentially applicable First Amendment standard.
    Three of the standards for presenting the major statement address
basic techniques for any communication targeting a broad consumer
audience: that it uses consumer-friendly language and terminology,
rather than technical language; that its audio be at least as
understandable as other audio in the same ad; and that the visual
aspects of text used to present the major statement allow that text to
be read easily. (See Sec.  202.1(e)(1)(ii)(A), (B), and (D).) The two
remaining standards likewise are appropriately tailored to the
interests behind the rule and do not unreasonably burden speech. Dual
modality has already been discussed, and as noted, research indicates
that using this technique to present risk information improves consumer
risk comprehension and recall--advancing the Government interest--
without decreasing the recall or comprehension of benefit information,
thus reinforcing the reasonableness of this requirement. (See Sec.
202.1(e)(1)(ii)(C).)
    The last standard, in Sec.  202.1(e)(1)(ii)(E), is a common-sense
measure that adds to the others to help ensure that consumers notice,
attend to, and understand the major statement by prohibiting the
simultaneous presentation of other audio or visual elements, alone or
in combination, that are likely to interfere with comprehension of the
major statement. This requirement applies only during the limited part
of the ad that presents the major statement, placing no restrictions on
any other part of the ad. Even during the presentation of the major
statement, it does not categorically prohibit other audio or visual
elements. In sum, these measures to advance the substantial Government
interests in communicating the major side effects and contraindications
of a prescription drug advertised to consumers satisfy the framework
for analysis described in Central Hudson and are consistent with the
First Amendment.
    FDA has considered and rejects the suggestion in the comments that
the Government interests that justify this rule are adequately advanced
by the requirement to obtain a prescription from an HCP to access a
prescription drug. The comments do not recognize consumers as active
participants in their own healthcare, and do not address the Government
interest in helping to ensure that consumers are better informed when
they participate in healthcare decision making. This Government
interest is not completely or sufficiently addressed by the requirement
to obtain a prescription or visit an HCP before accessing a
prescription drug. Both before and after contact with an HCP, consumers
are frequently exposed to DTC TV/radio ads describing the drug's
benefits. Requiring that such ads also convey the advertised product's
risks better advances the substantial Government interests than
reliance on the HCP alone. For example, for a patient already taking a
prescribed drug, certain side effects may occur at any time, and
presenting information about that drug's risks in DTC ads provides the
patient with information about the side effects each time they
encounter the ad. Providing this information helps ensure that
consumers are better informed about side effects that they may
experience in connection with their use of the drug. Furthermore, the
assumption in comments that HCPs or ``prescription orders'' will
communicate prescription drug risks to consumers does not dispute that
consumers should be informed of those risks. Rather, it

appears to suggest that it is appropriate for a pharmaceutical firm to
benefit from advertising its prescription drug's positive attributes
directly to consumers while placing the entire burden of informing
consumers about that advertised drug's risks on other members of the
healthcare system. The First Amendment does not compel us to adopt that
policy.
    One of the comments also cited Western States, in which the Court
applied the Central Hudson test to evaluate the advertising restriction
at issue (535 U.S. 375 at 368-77). In an analysis that broke no ``new
ground'' (id. at 368), the Court explained that, in general, the
Government should not restrict the communication of truthful and non-
misleading information for the sole purpose of preventing members of
the public from making bad decisions with the information (id. at 374).
That holding and rationale has no application to this rule, where
formatting and presentation requirements help ensure the effective
disclosure of information to the public.
    Finally, with regard to the mention of prior restraint in the
context of the comment on dual modality, we disagree that this rule
presents any constitutional infirmity under that analysis. The
fundamental concern of the prior restraint doctrine is with Government
censorship in advance of publication. See Southeastern Promotions, Ltd.
v. Conrad, 420 U.S. 546, 553 (1975). Here, however, neither the dual
modality requirement nor any other aspect of this rule requires a firm
to seek any permission from FDA before running an ad or otherwise
enjoins speech before it occurs, and therefore the regulation does not
impose a prior restraint. See, e.g., Alexander v. United States, 509
U.S. 544, 549-553 (1993).

M. Role of Healthcare Professional--Comments and FDA Response

    (Comment 23) One comment asserted that too much information in the
major statement can make it difficult for the audience to comprehend
the information and that the role of the prescribing HCP as a learned
intermediary is an important consideration in determining the relevancy
of risk information to be included in a DTC broadcast ad.
    Another comment says that because doctors are responsible for their
patient's care and well-being, prescription drug ads should be required
to include--``instead of a clear, conspicuous, and neutral statement of
effects and contraindications''--a statement ``that only a patient's
doctor can fully provide this vital information.''
    (Response 23) This rulemaking does not change the content of the
major statement, but focuses on the manner of presenting it in DTC TV/
radio ads. Further, FDA acknowledges the role of HCPs regarding
prescription drugs; however, as discussed in section III.A of this
document, that role does not completely address the reasons to require
prescription drug firms to communicate risk information about their
products in a clear, conspicuous, and neutral manner in DTC TV/radio
ads that communicate the benefits of such products.

N. Costs--Comments and FDA Response

    (Comment 24) One comment states that the specific dollar estimates
to revise any ad with a life cycle extending beyond the compliance date
of the final rule were optimistically low and questions how FDA or its
industry sources arrived at these estimates. Furthermore, the comment
requests that FDA revisit the cost estimates (and publish a more
detailed analysis) to make certain that they accurately reflect the
costs that firms will incur in bringing their existing campaigns into
compliance. As part of addressing costs, the comment requests that FDA
consider a longer effective date.
    (Response 24) No comments included quantified costs that firms will
incur in bringing their existing campaigns into compliance. With regard
to the request for an updated estimate of costs, we direct readers to
the Regulatory Impact Analysis (Ref. 66), which evaluates the
anticipated costs to firms for complying with this rule. In light of
concerns regarding costs, FDA has agreed to a compliance date of 365
days after the date of the final rule publication for all ads. (See
section VI of this document.)

O. Enforcement--Comments and FDA Response

    (Comment 25) One comment suggests that FDA should enforce these
standards through civil monetary penalties (CMPs) for misleading DTC
advertising, as authorized under 21 U.S.C. 333(g)(1).
    (Response 25) Failure to follow this rule will render a drug
misbranded under 21 U.S.C. 352(n). The Agency will have all compliance
tools associated with its authority available to enforce these
provisions; see generally the FD&C Act sections 301 (prohibited acts),
302 (21 U.S.C. 332) (injunction proceedings), and 303 (penalties),
including, as applicable, CMPs for false or misleading DTC ads
authorized under section 303(g)(1) of the FD&C Act (21 U.S.C.
333(g)(1)).

VI. Effective/Compliance Dates

    This rule is effective May 20, 2024. The compliance date is
November 20, 2024.
    As described in the proposed rule, in accordance with FDAAA, the
statutory requirement that the major statement in human prescription
drug advertisements presented directly to consumers in television or
radio format and stating the name of the drug and its conditions of use
be presented in a clear, conspicuous, and neutral manner has been in
effect since March 25, 2008 (75 FR 15376 at 15380). In the proposed
rule, FDA proposed that the standards in the final rule would become
effective 90 days after the publication of the final rule in the
Federal Register.
    (Comment 26) One comment supports the 90-day proposal. Two comments
request the earliest possible implementation of the proposed standards.
Another comment agrees that 90 days is reasonable for DTC ads that have
not already begun production. However, the comment suggests 180 days
for ads that are already in production or circulation because it allows
time for modifications if required.
    (Response 26) Based on comments, FDA agrees that it is appropriate
to provide a longer period for implementation than originally proposed.
We therefore make the effective date 180 days after publication.
Affected firms are encouraged to comply as soon as possible after the
effective date. However, we recognize that this rule could impact
existing ads, ads in production, and distribution agreements.
Accordingly, we now conclude that a compliance date of 365 days after
the date of publication of the final rule is appropriate to enable
firms to bring all ads subject to this rule into compliance without
undue burden. One schedule of 365 days after publication of the final
rule for compliance is clearer and easier to administer than having two
different schedules depending on where the ad is in production or on
other factors. While we did not receive data to support an alternative
estimate of costs, given the complexities of distribution agreements
and concerns raised with costs, we have also determined that a longer
time for implementation is appropriate.

VII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional

Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C.
801, Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094, direct us to assess all
benefits, costs and transfers of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866,
section 3(f)(1) (as amended by Executive Order 14094), if they ``have
an annual effect on the economy of $200 million or more (adjusted every
3 years by the Administrator of the Office of Information and
Regulatory Affairs (OIRA) for changes in gross domestic product); or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, territorial, or tribal governments
or communities.'' OIRA has determined that this final rule is not a
significant regulatory action under Executive Order 12866, section
3(f)(1).
    Because this rule is likely to result in an annual effect on the
economy of $100 million or more or meets other criteria specified in
the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does fall within the
scope of 5 U.S.C. 804(2).
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the estimated costs of compliance in the first year
could exceed 1 percent of sales revenues for the smallest affected
entities, we find that the final rule will have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $177
million, using the most current (2022) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    Under section 502(n) of the FD&C Act, as amended by section
901(d)(3)(A) of FDAAA, Congress has mandated that the disclosure of the
major side effects and contraindications of the advertised product
(known as the ``major statement'') in human prescription drug ads
presented directly to consumers in TV or radio format stating the name
of the drug and its conditions of use be presented in a ``clear,
conspicuous, and neutral manner.'' Section 901(d)(3)(B) of FDAAA
mandates that FDA issue regulations that establish standards for
determining whether a major statement is presented in such a manner. In
accordance with this legislation, this final rule requires that the
major statement in such ads be presented in a clear, conspicuous, and
neutral manner and provides standards for determining whether this is
the case.

B. Summary of Costs and Benefits

    The costs of this final rule include the cost to read and
understand the rule, to revise a firm's standard operating procedures,
and to revise DTC TV/radio ads during the transition period leading up
to the compliance date. These activities and their associated costs
will occur during the first year. We also expect there to be modest
ongoing costs for industry to review future DTC TV/radio ads to ensure
that these ads comply with this final rule and an ongoing opportunity
cost related to a potential change in the relative allocation of time
within the ad between the presentation of the major statement and the
presentation of other content. The total present value of costs over a
10-year time horizon ranges from $104.8 million to $331.8 million, with
a primary estimate of $218.3 million, at a 7 percent discount rate; the
present value ranges from $123.8 million to $393.0 million, with a
primary estimate of $258.4 million, at a 3 percent discount rate.
Annualized costs over a 10-year time horizon range from $14.9 million
to $47.2 million, with a primary estimate of $31.1 million at a 7
percent discount rate; annualized costs over a 10-year time horizon
range from $14.5 million to $46.1 million, with a primary estimate of
$30.3 million at a 3 percent discount rate.
    The benefits of this final rule stem from and include helping
consumers notice, attend to, and understand the major statement in DTC
TV/radio ads. The standards in the final rule help to ensure that DTC
TV/radio ads convey a truthful and non-misleading net impression about
the advertised drug and help ensure that consumers are better informed
when they participate in healthcare decisionmaking.
    Table 1 summarizes the annualized costs and describes the benefits
of this final rule.

                                      Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ------------------------------------
                    Category                       Primary       Low        High                               Period                 Notes
                                                  estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year........  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
    Annualized Quantified......................  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    Qualitative................................  Helping consumers notice, attend to, and understand the
                                                 major statement in DTC TV/radio ads
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year........        31.1        14.9        47.2        2020           7          10
                                                       30.3        14.5        46.1        2020           3          10
    Annualized Quantified......................  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    Qualitative................................

--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:

    Federal Annualized Monetized $millions/year  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    From/To....................................  From:
                                                 To:
                                                --------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/year..  ..........  ..........  ..........  ..........           7  ..........
                                                 ..........  ..........  ..........  ..........           3  ..........
                                                --------------------------------------------------------------------------------------------------------
    From/To....................................  From:
                                                 To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.............................................................................................................
    Small Business: Compliance costs in the first year may exceed 1 percent of revenues for the smallest affected entities..............................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (docket number
FDA-2009-N-0582) (Ref. 66) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual third-party disclosure burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    Title: Prescription Drug Advertisements.
    Description: Under Sec.  202.1, FDA has established requirements
for ads for human prescription drug and biological products and ads for
animal prescription drugs. The regulations apply to ads including those
published in journals, magazines, other periodicals, and newspapers and
those broadcast through media, such as radio, TV, and telephone
communication systems. Under Sec.  202.1(e)(1), FDA's regulations
describe when a true statement of information in brief summary relating
to side effects, contraindications, and effectiveness is required. In
this final rule, the Agency amends these regulations. Specifically,
under Sec.  202.1(e)(1)(ii), FDA implements section 502(n) as amended,
which requires that in human prescription drug advertisements presented
directly to consumers in television or radio format and stating the
name of the drug and its conditions of use, the major statement
relating to side effects and contraindications must be presented in a
clear, conspicuous, and neutral manner. The rule also includes
standards for determining whether the major statement is presented in a
clear, conspicuous, and neutral manner.
    General requirements for prescription drug ads to include a true
statement of information in brief summary relating to side effects,
contraindications, and effectiveness are located in the opening
paragraph of Sec.  202.1(e), and specific provisions for prescription
drug ads broadcast through media such as radio, TV, or telephone
communications systems addressing inclusion of the major statement and
adequate provision of the approved labeling are located in Sec.
202.1(e)(1)(i). These provisions were already in effect and approved
under OMB control number 0910-0686. The requirements of Sec.
202.1(e)(1), including these existing requirements and new requirements
imposed by this final rule in Sec.  202.1(e)(1)(ii)--which address only
the manner of presentation of the major statement in certain ads while
retaining the pre-existing content requirements--collectively mandate
that ads disclose information to the public and thus are subject to the
Paperwork Reduction Act of 1995.
    Description of Respondents: Respondents to the collection of
information are manufacturers, packers, and distributors; application
holders and their representatives with approved new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and biologics
licensing applications (BLAs) for human prescription drugs; and those
that market prescription drugs for human use without an approved
application.
    Based on a recent review of data collected via FDA Form 2253
advertisement submissions, we revised our previously estimated burden
of this information collection. Specifically, relying on data from
calendar year 2020 Form 2253 submissions, we increased the number of
corresponding disclosures and recalculated the burden as an increase to
the existing burden, using the most recent numbers for that burden
estimate, under the approved OMB control number 0910-0686 collection
covering the regulations under Sec.  202.1. The collections of
information pertaining to FDA Form 2253 (``Transmittal of
Advertisements and Promotional Labeling for Drugs and Biologics for
Human Use,'' located on the FDA website at https://www.fda.gov/about-fda/reports-manuals-forms/forms) are approved under OMB control numbers
0910-0001 and 0910-0338.
    FDA estimates the burden of the collections of information as
follows:

        Table 2--Estimated Burden Resulting From Revising TV/Radio Ads To Comply With 21 CFR 202.1(e)(1)
----------------------------------------------------------------------------------------------------------------
                                                           Number of                         Hourly
   21 CFR 202.1--Prescription drug        Number of     disclosures per    Total annual    burden per    Total
              marketing                  respondents       respondent       disclosures    disclosure    hours
----------------------------------------------------------------------------------------------------------------
One-time activities: reading and                   57                  3             171          2.5      427.5
 understanding rule, revising company
 SOPs, modifying existing ads (if
 necessary)..........................
202.1(e)(1)(ii): Ongoing                           57              11.02             628            5      3,140
 implementation of revised
 requirements for future TV and radio
 ads.................................
                                      --------------------------------------------------------------------------
    Total............................  ..............  .................             799  ...........    3,567.5
----------------------------------------------------------------------------------------------------------------

    According to this 2020 submission data from the Center for Drug
Evaluation and Research (CDER), we estimate 564 DTC TV ads for
prescription drugs will be prepared by 37 firms under Sec.
202.1(e)(1)(ii) annually. Likewise, based on data from the Center for
Biologics Evaluation and Research (CBER), we estimate that six DTC TV
ads will be prepared by three firms annually. Our total estimated
number of DTC TV ads under Sec.  202.1(e)(1)(ii), then, is 570. Based
on our experience with reviewing DTC TV ads, we believe an expenditure
of approximately 5 hours per disclosure should be sufficient to ensure
that the major statement in DTC TV ads is presented in a clear,
conspicuous, and neutral manner in accordance with the requirements of
this final rule.
    Also based on data from CDER, we estimate 56 DTC radio ads for
prescription drugs will be prepared by 16 firms under Sec.
202.1(e)(1)(ii) annually. Based on data from CBER, we estimate two DTC
radio ads will be prepared by one firm annually. The total estimated
number of DTC radio ads subject to disclosures under Sec.
202.1(e)(1)(ii), then, is 58. Based on our experience reviewing DTC
radio ads, we believe an expenditure of approximately 5 hours per
disclosure should satisfy the requirements in Sec.  202.1(e)(1)(ii).
    In sum, as shown in table 2, FDA estimates that, annually, 57
respondents will submit DTC TV or radio ads, resulting in 628
disclosures. FDA estimates 5 hours per disclosure will satisfy the
requirements, resulting in an estimated annual expenditure of 3,140
hours. In addition, as noted in the table, FDA estimates that, for
those 57 respondents, there will be a one-time burden of 427.5 hours.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive order and, consequently, a
tribal summary impact statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display
at 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. 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.

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List of Subjects in 21 CFR Part 202

    Advertising, Prescription drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
202 is amended as follows:

PART 202--PRESCRIPTION DRUG ADVERTISING

0
1. The authority citation for part 202 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 352, 355, 360b, 371.

0
2. In Sec.  202.1, add introductory text and revise paragraph (e)(1) to
read as follows:

Sec.  202.1  Prescription-drug advertisements.

Prescription drug as used in this section means any drug defined in
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or Sec.
201.105 of this chapter, applicable to drugs intended for use by humans
and to veterinary drugs, respectively.
* * * * *
(e) * * *
(1) When required. All advertisements for any prescription drug, except
advertisements described in paragraph (e)(2) of this section, must
present a true statement of information in brief summary relating to
side effects, contraindications (when used in this section, ``side
effects, contraindications'' include side effects, warnings,
precautions, and contraindications and include any such information
under such headings as cautions, special considerations, important
notes, etc.), and effectiveness.
(i) Broadcast advertisements. Advertisements broadcast through media
such as radio, television, or telephone communications systems must:
(A) Include information relating to the major side effects and
contraindications (``major statement'') of the advertised drugs in the
audio or audio and visual parts of the presentation, unless required by
paragraph (e)(1)(ii)(C) of this section to present the major statement
using audio and text; and
(B) Contain a brief summary of all necessary information related to
side effects and contraindications, unless adequate provision is made
for dissemination of the approved or permitted product labeling in
connection with the broadcast presentation.
(ii) Human drug advertisements in television or radio format--Clear,
conspicuous, and neutral manner. For advertisements for prescription
drugs intended for use by humans presented directly to consumers in
television or radio format, the major statement must be presented in a
clear, conspicuous, and neutral manner. The major statement is
presented in a clear, conspicuous, and neutral manner if the following
are met:
(A) It is presented in consumer-friendly language and terminology that
is readily understandable.

(B) Its audio information, in terms of the volume, articulation, and
pacing used, is at least as understandable as the audio information
presented in the rest of the advertisement.
(C) In advertisements in television format, it is presented
concurrently using both audio and text (dual modality). To achieve dual
modality:
(1) Either the text displays the verbatim key terms or phrases from the
corresponding audio, or the text displays the verbatim complete
transcript of the corresponding audio; and
(2) The text is displayed for a sufficient duration to allow it to be
read easily. For purposes of the standard in this paragraph
(e)(1)(ii)(C)(2), the duration is considered sufficient if the text
display begins at the same time and ends at approximately the same time
as the corresponding audio.
(D) In advertisements in television format, for the text portion of the
major statement, the size and style of font, the contrast with the
background, and the placement on the screen allow the information to be
read easily.
(E) During the presentation of the major statement, the advertisement
does not include audio or visual elements, alone or in combination,
that are likely to interfere with comprehension of the major statement.
* * * * *

    Dated: November 8, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-25428 Filed 11-20-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 230 (Wednesday, November 30, 2011)]
[Notices]
[Pages 74105-74107]
[FR Doc No: 2011-30814]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65819; File No. SR-FINRA-2011-068]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Amend FINRA Rule 6121.01 (Trading Pauses) To
Exclude Rights and Warrants From the Trading Pause Pilot

November 23, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 21, 2011, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as constituting a ``non-controversial'' rule
change under paragraph (f)(6) of Rule 19b-4 under the Act,\3\ which
renders the proposal effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend Supplementary Material .01 (Trading
Pauses) to FINRA Rule 6121 (Trading Halts Due to Extraordinary Market
Volatility) to exclude all rights and warrants from the trading pause
pilot.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    FINRA proposes to amend FINRA Rule 6121.01 (Trading Pauses) to
exclude all rights and warrants from the trading pause pilot. The
Commission approved FINRA Rule 6121.01 on a pilot basis on June 10,
2010 to provide for trading pauses in individual securities due to
extraordinary market volatility (``Trading Pause Pilot'').\4\ The pilot
was developed and implemented as a market-wide initiative by FINRA and
other self-regulatory organizations (``SROs'') in consultation with
Commission staff. Initially, the pilot covered only the securities
included in the S&P 500 [supreg] Index (``S&P 500'') (``Phase I
securities''). FINRA and the other SROs subsequently expanded the
Trading Pause Pilot to add the securities included in the Russell 1000
[supreg] Index and a specified list of exchange traded products
(``Phase II securities'').\5\ FINRA and the other SROs have stated in
previous filings that they would continue to review whether and when to
add securities to the pilot and whether the parameters of the pilot
should be adjusted for different securities.\6\
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    \4\ See Securities Exchange Act Release No. 62251 (June 10,
2010), 75 FR 34183 (June 16, 2010) (Order Approving File No. SR-
FINRA-2010-025).
    \5\ See Securities Exchange Act Release No. 62883 (September 10,
2010), 75 FR 56608 (September 16, 2010) (Order Approving File No.
SR-FINRA-2010-033).
    \6\ See e.g., Securities Exchange Act Release No. 62416 (June
30, 2010), 75 FR 39069 (July 7, 2010) (Notice of Filing of File No.
SR-FINRA-2010-033).
---------------------------------------------------------------------------

    On June 23, 2011, the Commission approved proposed amendments by
FINRA and the other SROs to expand the Trading Pause Pilot to include
all remaining NMS stocks (``Phase III securities''), which included
rights and warrants.\7\ With respect to the Phase III securities, the
SRO rules \8\ apply wider percentage price moves for triggering a
trading pause than apply to the Phase I or Phase II securities.\9\
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    \7\ See Securities Exchange Act Release No. 64735 (June 23,
2011), 76 FR 38243 (June 29, 2011) (Order Approving File No. SR-
FINRA-2011-023). This amendment became effective on August 8, 2011.
    \8\ FINRA's trading pause rule does not include specific trigger
percentages, but rather provides that FINRA will halt trading
otherwise than on an exchange in a security if a primary listing
market has issued an individual stock trading pause under its rules.
    \9\ For example, under amended NASDAQ Rule 4120(a)(11), a pause
is triggered by a 30% or more price move in a Phase III Security
priced at $1.00 or higher, and by a 50% or more price move to such a
security priced less than $1.00. The price of a security is based on
the closing price on the previous trading day or, if no closing
price exists, the last sale reported to the consolidated tape on the
previous trading day.
---------------------------------------------------------------------------

    The trading pauses triggered since the adoption of the Trading
Pause Pilot have been analyzed and over 25% of trading pauses have
occurred in rights and warrants. Further, the SROs have experienced a
significant increase in trading pauses involving rights and warrants
since the inclusion of the Phase III securities, with such pauses
representing as much as 52% of all trading pauses occurring through the
end of August 2011 on one exchange. Rights and warrants trade on equity
exchanges, but are closely related to call options.\10\ Like options,
the price of rights and warrants are affected by the price of the
underlying stock as well as other factors, particularly the volatility
of the stock. Consequently, the price of rights and warrants may move
more dramatically than the price of the underlying stock, even when the
rights and warrants (and the underlying stock)

are trading in an orderly manner. This difference in trading behavior
may result in a scenario whereby the rights and warrants trigger, and
are subject to, a trading pause, even while the underlying stock
continues to trade. This can be particularly true of lower-priced
rights and warrants. Accordingly, FINRA, in consultation with the other
SROs, is proposing to exclude rights and warrants from the trading
pause pilot of Rule 6121.01.
---------------------------------------------------------------------------

    \10\ Rights and warrants entitle owners to purchase shares of
stock at predetermined prices subject to timing and various other
conditions.
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness and has requested that the Commission waive the
requirement that the proposed rule change not become operative for 30
days after the date of filing to avoid further triggers of trading
pauses in rights and warrants, thereby avoiding the potential confusion
caused by such pauses.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\11\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change meets
these requirements because it is consistent with the trading pause
rules of the primary listing markets and refines the trading pause
pilot to exclude certain securities that are prone to triggering pauses
because of their unique characteristics. Given the fact that the price
of rights and warrants may move more dramatically than the prices of
the underlying stocks to which they are related, even when both are
trading in an orderly manner, FINRA questions the benefit of applying
the trading pause pilot to such securities. FINRA also believes that
the proposed rule change promotes uniformity across markets concerning
decisions to pause trading in a security when there are significant
price movements.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    FINRA has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
Because the 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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \14\ and Rule 19b-
4(f)(6)(iii) thereunder.\15\
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires FINRA to give the Commission written notice of the FINRA's
intent to file the proposed rule change along with a brief
description and text of 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. FINRA
has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \17\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. FINRA has asked the
Commission to waive the 30-day operative delay so that the proposal may
become operative immediately upon filing.
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
Including rights and warrants in the pilot program which may trigger a
circuit breaker and be subject to a trading pause, even while the
underlying security continues to trade, provides little benefit and has
the potential to create confusion among investors. Excluding rights and
warrants from the pilot program should minimize investor confusion that
could result from temporary trading pauses in these securities. For
this reason, the Commission designates the proposed rule change as
operative upon the date of this Notice.\18\
---------------------------------------------------------------------------

    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-FINRA-2011-068 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 No. SR-FINRA-2011-068. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing

also will be available for inspection and copying at the principal
office of FINRA. All comments received will be posted without change;
the Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File No. SR-FINRA-
2011-068 and should be submitted on or before December 21, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-30814 Filed 11-29-11; 8:45 am]
BILLING CODE 8011-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, DC

Issued by the Department of Transportation on February 4, 2003

NOTICE OF ACTION TAKEN --DOCKET OST-2002-11985

__________________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of Atlas Air, Inc.  filed 1/29/03 for:

XX  Waiver of the dormancy condition applicable to certain of its
US-Brazil all-cargo frequencies.

Atlas requests a three-month extension through May 9, 2003, of its
current waiver of the 90-day dormancy condition applicable to two of its
ten US-Brazil all-cargo frequencies.  By Notice of Action Taken, dated
September 24, 2002, in this docket, the Department granted Atlas a
dormancy waiver for four of its ten US-Brazil frequencies through
November 9, 2002.  Subsequently, by Notice of Action Taken, dated
November 7, 2002, in this docket, the Department granted Atlas a further
dormancy waiver for two of the ten US-Brazil frequencies through
February 9, 2003.

In support of its further waiver request here, Atlas states that it
seeks additional time to respond to economic circumstances and operate
the full ten frequencies.

Applicant rep:  Russell E. Pommer,<PHONE_NUMBER>      DOT analyst:
Michael D. Bodman<PHONE_NUMBER>

DISPOSITION

XX  Granted. (See below).

The above action was effective when taken: February 4, 2003, through May
9, 2003.

Action taken by:  Paul L. Gretch, Director

		    Office of International Aviation

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, limitations indicated:  XX Holder’s certificate
of public convenience and necessity

________________________________________________________________________
____________

Remarks:  We acted on this application prior to the expiration date for
answers with the consent of all parties served.

As we have previously done, we reserve the right to reexamine whether
grant of this waiver continues to be in the public interest should
another carrier seek to use the frequencies at issue.  Any future
request to extend the dormancy waiver for these frequencies at issue
here will have to be considered in light of the specific arguments
offered and responses thereto.

________________________________________________________________________
____________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; and (2) grant of the authority was consistent with the public
interest.  To the extent not granted, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the action taken in
this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

Atlas’ waiver from the dormancy condition is effective through May 9,
2003.   As to any frequency with which Atlas does not begin service by
May 9, 2003, its allocation with respect to that frequency will expire
automatically.