[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Notices]
[Pages 32402-32403]
[FR Doc No: 2015-13965]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket No. FEMA-2015-0001; Internal Agency Docket No. FEMA-B-1436]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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SUMMARY: On November 3, 2014, FEMA published in the Federal Register a
proposed flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table, to be used in
lieu of the information published at 79 FR 65231. The table provided
here represents the proposed flood hazard determinations and
communities affected for Kenai Peninsula Borough, Alaska, and
Incorporated Areas.

DATES: Comments are to be submitted on or before September 8, 2015.

ADDRESSES: The Preliminary Flood Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study (FIS) report for each community
are available for inspection at both the online location and the
respective Community Map Repository address listed in the table below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1436, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain

management requirements of the NFIP and are also used to calculate the
appropriate flood insurance premium rates for new buildings built after
the FIRM and FIS report become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.

Correction

    In the proposed flood hazard determination notice published at 79
FR 65231 in the November 3, 2014, issue of the Federal Register, FEMA
published a table titled Kenai Peninsula Borough, Alaska, and
Incorporated Areas. This table contained inaccurate information as the
community map repository for the City of Kenai, City of Seward and
Kenai Peninsula Borough featured in the table.
    In this document, FEMA is publishing a table containing the
accurate information for the City of Kenai, City of Seward and Kenai
Peninsula Borough. The information for the City of Homer published
correctly and is not included in the table below. The information
provided below should be used in lieu of that previously published for
the City of Kenai, City of Seward and Kenai Peninsula Borough.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: May 21, 2015.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.

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                                             Community map repository
               Community                             address
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         Kenai Peninsula Borough, Alaska, and Incorporated Areas
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Maps available for inspection online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
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City of Kenai..........................  Donald E. Gilman River Center,
                                          514 Funny River Road,
                                          Soldotna, AK 99669.
City of Seward.........................  City Hall Annex, 238 Fifth
                                          Avenue, Seward, AK 99664.
Kenai Peninsula Borough................  Donald E. Gilman River Center,
                                          514 Funny River Road,
                                          Soldotna, AK 99669.
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[FR Doc. 2015-13965 Filed 6-5-15; 8:45 am]
 BILLING CODE 9110-12-P


promotional message.''); R. Stafford article (Ref. 13) (Encouraging
unapproved uses ``undermines the incentives for manufacturers to
perform rigorous studies--and instead subtly encourages them to game
the system by seeking approval for secondary indications for which
clinical trials are less complicated and less expensive. And off-
label use may discourage evidence-based practice.'').
    \21\ See, e.g., S. Kesselheim and J. Avorn article (Ref. 5)
(``In the pharmaceutical market, determining whether a drug is safe
and effective for an intended use can involve dozens of FDA
scientists poring over extensive databases of studies in animals,
toxicologic evaluations, and clinical trials. In essence, the agency
acts as a learned intermediary on behalf of prescribing
physicians.''); C. Good and W. Gellad article (Ref. 6) (``Even in
situations where an off-label indication has been studied,
pharmacokinetics, drug-disease interactions, and other safety
considerations are unlikely to have been studied systematically to
the level required during the FDA drug approval process. Likewise,
few clinicians have the time or the motivation to review evidence
for those off-label indications to arrive at a balanced assessment
of the risks and benefits to support the appropriate use of that
drug''); T. Eguale et al. article (Ref. 7) (summarizing study across
cohort of 46,000 patients, and concluding that unapproved use of
prescription drugs is associated with adverse drug events,
particularly where those uses lack strong scientific evidence in the
form of at least one randomized controlled trial).
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    At the same time, health care providers also prescribe and use
approved/cleared medical products for unapproved uses when they judge
that the unapproved use is medically appropriate for their individual
patients. Scientific or medical information regarding unapproved uses
of products may in some cases help health care providers make better
decisions regarding patients, such as where the patient has a disease
for which there is no approved/cleared treatment, where the patient is
part of a population that has not been studied, or where all approved/
cleared treatments have been exhausted. However, in other cases, the
use of approved/cleared medical products for unapproved uses has also
been associated with significant harm to patients, fraud, and waste of
health care resources.\22\
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    \22\ See J. Avorn et al. article (Ref. 8) (``Considerable
research shows that marketing can drive prescribing practices, which
in turn can lead to adverse patient outcomes if those decisions are
not evidence-based.''); A. Kapczynski article (Ref. 9) (``To be
effective, a company's marketing must also influence the prescribing
patterns of physicians. . . . [T]here is a strong and specific
association between pharmaceutical marketing and physician behavior,
independent of the evidence supporting the products.''); R.
Cardarelli et al. article (Ref. 10) (pharmaceutical industry
marketing to prescribing physician creates the potential for
prescribing practices that may not benefit the patient, which
contribute to escalating health care costs); T. Eguale et al.
article (Ref. 7).
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    FDA's current implementation approach seeks to integrate the
complex mix of numerous and sometimes competing interests at play while
also taking into account First Amendment issues. For example, FDA has
issued guidance documents to describe some of the circumstances when it
would not consider a firm's distribution of reprints, clinical practice
guidelines, or reference texts regarding unapproved uses of approved/
cleared medical products to be evidence of intended use; and issued a
draft guidance on unsolicited requests, confirming FDA's longstanding
position that it would not consider a firm's providing truthful,
balanced, non-misleading, and non-promotional scientific or medical
information (including information about an unapproved use) that is
responsive to unsolicited requests for information about FDA-regulated
medical products to be evidence of intended use. FDA takes the same
view of firms' presenting truthful and non-misleading scientific
information about unapproved uses at medical or scientific conferences
when done in non-promotional settings and not accompanied by
promotional materials.
    There are several points worth noting regarding the Central Hudson
evaluation conducted by Second Circuit panel majority in United States
v. Caronia. First, the panel majority's analysis was limited to
addressing the constitutionality of a specific ``construction of the
FDCA's misbranding provisions to prohibit and criminalize off-label
promotion'' (see 703 F.3d 149, 161-64, 166-69 (2d Cir. 2012)). The
Caronia majority did not conduct a Central Hudson evaluation of FDA's
actual approach to manufacturer communications regarding unapproved
uses of approved medical products, as described in the preceding
paragraph. Second, the panel majority did not consider the multiple
facets of public health advanced by FDA's statutory authorities,
regulations, and implementation policies, which include motivating the
development of reliable scientific evidence that enables the evaluation
of the safety and effectiveness of each intended use of a medical
product; maintaining the premarket review process for safety and
efficacy of each intended use in order to prevent harm, protect against
fraud, misrepresentation, and bias, and prevent the diversion of
healthcare resources toward ineffective treatments; ensuring required
labeling is accurate and informative; protecting the integrity and
reliability of promotional information regarding medical product uses;
protecting human subjects receiving experimental treatments; ensuring
informed consent; maintaining incentives for clinical trial
participation; protecting innovation incentives, including statutory
grants of exclusivity; and promoting the development of products for
underserved patients. The court's limited review of the interests at
stake necessarily affected the rest of its Central Hudson analysis.
Furthermore, the results of an exceptionally large Canadian study
showing an association between unapproved uses and adverse drug events
\23\ were released more than three years after the Caronia decision.
Accordingly, the Caronia court, in conducting its Central Hudson
evaluation, did not have the benefit of considering the significant
findings of this study.
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    \23\ T. Eguale et al. article (Ref. 7) (as noted above,
summarizing study across cohort of 46,000 patients, and concluding
that unapproved use of prescription drugs is associated with adverse
drug events, particularly where those uses lack strong scientific
evidence in the form of at least one randomized controlled trial).
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    (Comment 20) Several comments asserted that FDA should take this
opportunity to bring other related regulations and guidance documents
into conformance with modern First Amendment case law. These comments
suggested, for example, that FDA reconsider its approach to substantial
evidence to support manufacturer communications to health care
professionals about approved drugs, reconsider its interpretation of
the term

labeling, and revise its regulations to confirm that FDA will abide by
restrictions on FDA authority imposed by federal courts in United
States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and similar First
Amendment decisions. At least one comment asserted, citing United
States v. Caronia, that FDA's interpretation and implementation of the
FD&C Act restricts speech based on the identity of the speaker. The
comment further asserted that any restrictions on truthful and non-
misleading speech are subject to ``heightened judicial scrutiny'' and
are ``presumptively invalid'' under Sorrell v. IMS Health Inc., 564
U.S. 552, 565, 571 (2011), Reed v. Town of Gilbert, 135 S. Ct. 2218,
2226 (2015), and Rosenberger v. Rector & Visitors of the Univ. of Va.,
515 U.S. 819, 828 (1995). Another comment, quoting Bolger v. Youngs
Drug Prods., 463 U.S. 60, 66 (1983), asserted that FDA should recognize
that commercial speech is limited to speech that ``does no more than
propose a commercial transaction.'' Another comment urged FDA to open a
separate docket related to free speech issues regarding medical
products.
    (Response) To the extent these comments propose that FDA consider,
in this rulemaking, issues that are beyond the scope of this
rulemaking, FDA declines the suggestion. FDA agrees with the comment
that suggests that broader First Amendment issues should be considered
in the context of separate proceedings. FDA notes that there are
separate proceedings that are currently ongoing (see, e.g., 81 FR
60299, Sept 1, 2016, announcing a public hearing and request for
comments on Manufacturer Communications Regarding Unapproved Uses of
Approved or Cleared Medical Products, available at: http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm489499.htm).
    In addition, FDA notes its disagreement with certain
characterizations of the existing case law. First, as discussed
earlier, the court in Caronia based its analysis on a legal theory that
is more proscriptive than the one FDA actually holds. Second, the cited
Supreme Court cases did not overrule the Central Hudson test for
commercial speech. The Supreme Court in Sorrell confirmed that, where,
as here, the speech in question is commercial, the Court applies the
``commercial speech inquiry'' as outlined in Central Hudson (Sorrell v.
IMS Health Inc., 564 U.S. 552, 571-72 (2011); see also 1-800-411-Pain
Referral Service, LLC v. Otto, 744 F.3d 1045, 1055 (8th Cir. 2014)
(observing that Sorrell held that content- or speaker-based
restrictions on commercial speech are subject to ``heightened
scrutiny,'' and using the Central Hudson test to determine the
constitutionality of such restrictions)). The Sorrell Court also
confirmed that ``content-based restrictions on protected expression are
sometimes permissible, and that principle applies to commercial
speech'' (Sorrell, 564 U.S. at 579).
    In Reed v. Town of Gilbert, the Court applied strict scrutiny to
content-based restrictions on non-commercial speech in public fora.
That holding has no bearing on the commercial speech at issue here
(see, e.g., Sarver v. Chartier, 813 F.3d 891, 903 n.5 (9th Cir. 2016)
(stating that Reed does not apply to laws governing commercial speech);
Mass. Ass'n of Private Career Sch. v. Healey, 159 F. Supp. 3d 173, 192-
93 (D. Mass. 2016) (same); San Francisco Apt. Ass'n v. City & Cnty. of
San Francisco, 142 F. Supp. 3d 910, 922 (N.D. Cal. 2015) (same), appeal
docketed, No. 15-17381 (9th Cir. Dec. 3, 2015). The Supreme Court's
1995 decision, Rosenberger v. Rector & Visitors of the Univ. of Va.,
515 U.S. 819, likewise did not involve commercial speech.
    Third, we disagree with the one comment that asserts, quoting
Bolger v. Youngs Drug Prods., 463 U.S. 60, 66 (1983), that the Supreme
Court limited the application of the Central Hudson test to speech that
literally ``does no more than propose a commercial transaction.''
Although the Court in Bolger referred to speech that proposes a
commercial transaction as ``the core notion of commercial speech,'' the
Court then explained that ``informational pamphlets'' that ``cannot be
characterized merely as proposals to engage in commercial
transactions'' were nevertheless commercial speech based on a
combination of relevant circumstances, such as mentioning the seller's
product in the pamphlet and the economic motivation of the seller (see
Bolger, 463 U.S. at 66-68 (emphasis added); see also Conn. Bar Ass'n v.
United States, 620 F.3d 81, 93-94 (2d Cir. 2010)).
    (Comment 21) Several comments suggested that FDA replace the phrase
``is intended for use'' in the first sentence of Sec.  1100.5 with
other phrases, such as ``is commonly used'' or ``is primarily used.''
    (Response) FDA declines this suggestion. The phrase ``is intended
for use'' is necessary because it reflects the fact that FDA's
regulatory authority over a product made or derived from tobacco is, in
the context of regulating them as medical products, dependent upon the
product's intended use.
    (Comment 22) Several comments urged FDA not to consider a
manufacturer's knowledge when determining a manufacturer's intent with
respect to the regulation of human cells, tissues, and cellular and
tissue-based products (HCT/Ps). The comments also request that the
Agency use notice and comment rulemaking instead of guidance to make
changes regarding manufacturer intent related to HCT/Ps.
    (Response) These comments concern regulations and guidance
documents relating specifically to HCT/Ps and are outside the scope of
this rulemaking.

D. Comments and Responses Regarding Marketing Concerns

    (Comment 23) At least one comment suggested that FDA amend Sec.
1100.5(a) to incorporate the following points: (1) Products intended
for use in the cure and treatment of smoking or any other tobacco
product use are subject to regulation as medical products; (2) products
intended for use for the prevention of relapse into any smoking,
tobacco product, or nicotine relapse are subject to regulation as
medical products; and (3) relief from nicotine withdrawal symptoms also
includes relief from smoking or tobacco use withdrawal symptoms.
    (Response) FDA agrees that the three uses identified in the comment
appear to be intended uses that would render the products subject to
regulation as medical products. Section 1100.5(a) explains that a
product made or derived from tobacco is subject to regulation as a
medical product if it is intended for use in the diagnosis of disease
or other conditions, or in the cure, mitigation, treatment, or
prevention of disease. For illustrative purposes, the section also
provides several examples of intended uses that will subject a product
to regulation as a medical product. We believe the list of examples,
which is not intended to be exhaustive, adequately illustrates the
types of intended uses that will subject a product made or derived from
tobacco to regulation as a medical product. Thus, while we agree that
the three identified uses appear to be intended uses that would render
the products subject to regulation as medical products, we decline to
amend the list to incorporate the uses identified by the comment.
    (Comment 24) At least one comment objected that the rule would
limit e-cigarettes to marketing claims of ``smoking pleasure'' and
``smoking satisfaction'' since that is how traditional tobacco products
were ``customarily marketed'' prior to March

21, 2000. The comment asserted that the rule would either force e-
cigarettes off the market as unapproved medical products, or require e-
cigarettes to be marketed similar to how traditional tobacco products
were marketed prior to March 21, 2000, which would be deceptive because
e-cigarettes are not intended for smoking pleasure or tobacco
satisfaction. The comment argued that FDA should treat e-cigarettes
differently from products that both contain tobacco leaf and were
commercially available before March 21, 2000, when considering the
types of claims that will subject a product made or derived from
tobacco to regulation as a medical product.
    (Response) FDA disagrees. As explained elsewhere in this document,
we believe that the rule gives manufacturers and retailers ample
flexibility to market e-cigarettes in a manner that is distinct from
how cigarettes were marketed prior to March 21, 2000. The date of March
21, 2000, is relevant only to considering claims about a product's
effects related to nicotine on the structure or function of the body as
evidence of a product's intended use. E-cigarette manufacturers' and
retailers' claims related to customizability, number of puffs per
cartridge or charge, and various other differentiating features that do
not relate to nicotine structure/function effects, irrespective of
whether such claims were customarily and legally made in the marketing
of cigarettes and smokeless tobacco products before March 21, 2000,
should generally not affect the determination of a product's intended
use. A manufacturer's making a modified risk claim for a specific
tobacco product renders the product an MRTP, which can be marketed only
after the manufacturer substantiates any modified risk claims in an
MRTP application and after FDA determines that the product meets the
statutory standard. Additionally, if a manufacturer intends that its
product be used for cessation, it can submit an NDA, Abbreviated New
Drug Application (ANDA), Premarket Approval Application (PMA), or
premarket notification submission so that FDA can determine whether the
product meets the statutory standard and can approve the application or
clear the submission, if appropriate.
    (Comment 25) At least one comment questioned whether the marketing
for tobacco products that are not MRTPs may contain useful contextual
information (e.g., ingredient information).
    (Response) This comment is outside the scope of this rulemaking
because it does not relate to the circumstances in which a product that
is made or derived from tobacco will be regulated as a medical product
or a tobacco product.
    (Comment 26) Several comments stated that ENDS manufacturers need
to be able to inform and explain how to properly use vaping devices to
help novices to prevent them from having accidents. The comments stated
that vape shops need to be able to correctly educate consumers on how
to use the products they sell.
    (Response) FDA agrees. FDA recognizes that manufacturers may wish
to provide instructions to consumers on how to use novel tobacco
products, and instructions may be helpful in some cases in preventing
consumer injury, such as nicotine poisoning or injuries from exploding
batteries. Manufacturers may provide instructions to the consumer in
many ways, including verbal instruction. However, if the instructions
provided by the manufacturer convey that the product is to be used as a
cessation device, then the product will generally be regulated as a
medical product. Additionally, if the instructions make a modified risk
claim, then the manufacturer must submit an MRTP application so that
FDA can determine whether the product meets the statutory standard and
can issue an order authorizing it to be marketed as an MRTP.
    (Comment 27) Several commenters noted that tobacco products are
advertised in a variety of media, including traditional print or
mainstream media, blogs, social media, testimonials, and links to
studies or media reports on Web sites. One comment observed that
manufacturers of ENDS products often use online blogs as a way to make
implicit or explicit cessation claims, and in some cases such
assertions run counter to disclaimers posted on the same Web site that
hosts the blog. Another comment noted that manufacturers used consumer
testimonials that make cessation or MRTP claims on their company Web
sites. Commenters observed that conflicting claims in advertising
caused confusion among consumers regarding whether ENDS products are
FDA-approved smoking cessation aids.
    (Response) FDA agrees. Tobacco products are advertised in a variety
of media, and advertisements may include conflicting information
regarding whether the product is a recreational tobacco product or an
FDA-approved smoking cessation product. When conflicting claims are
made to the consumer, consumers can be confused by those claims. Thus,
FDA believes that manufacturers' making smoking cessation claims for
any product creates a strong suggestion of therapeutic benefit to the
user that would subject the product to regulation under FDA's medical
products authority. Such a suggestion generally will be difficult to
overcome absent clear context indicating that the product is not
intended for use to cure or treat nicotine addiction or its symptoms,
or for another therapeutic purpose. As discussed in response to Comment
12, where products making claims related to quitting smoking also
attempt to disclaim that use in some way, FDA intends to view such
disclaimers skeptically because of the likelihood of consumer
confusion. In most cases, FDA does not believe that disclaimers will
sufficiently mitigate consumer confusion related to the intended
therapeutic use of the product.
    (Comment 28) Several comments stated that adolescent smokers are
especially vulnerable to cessation and therapeutic claims in tobacco
product marketing. These comments believe that adolescents misperceive
the supposed benefits and underestimate the relative harms, risks, and
addictive properties of e-cigarettes and other non-cigarette products.
    (Response) FDA agrees that youth and young adults generally
``underestimate the tenacity of nicotine addiction and overestimate
their ability to stop smoking when they choose'' (Ref. 14). For
example, one survey found that ``nearly 60 percent of adolescents
believed that they could smoke for a few years and then quit'' (Ref.
15). FDA also believes that unsubstantiated cessation claims that reach
adolescents may confuse teens and lead teens to believe that these
products are FDA-approved smoking cessation products. For example, a
teenager in a recent qualitative study said, ``I heard that the only
reason they were made is to help people get off from cigarettes for
people that want to quit. You would use an e-cigarette to help you quit
supposedly. It was on the news'' (Ref. 16). FDA believes it is
important to avoid consumer confusion about which products are intended
for medical uses versus recreational or other tobacco product uses
among both adolescents and adults, and this rule will help consumers.
    (Comment 29) At least one comment stated that users consider ENDS
and smokeless tobacco products effective cessation interventions. The
comment believed that many people use these products to try to stop
smoking because they are influenced by manufacturers' and sellers'
marketing messages that

make cessation and therapeutic claims about ENDS and other non-
cigarette tobacco products.
    (Response) FDA agrees that marketing can influence how consumers
perceive tobacco products, and products advertised with cessation
claims can lead consumers to believe that the product is an FDA-
approved smoking cessation device. FDA also agrees that many consumers
are using ENDS products for therapeutic purposes. One study concluded
that, among State tobacco cessation quitline callers, the most common
reported reason for using e-cigarettes was to cut down on, or quit,
traditional tobacco use (Ref. 17). Another study concluded that some
smokers who were interested in quitting were using ENDS for cessation
purposes, possibly discouraging the use of proven smoking cessation
treatments, delaying cessation, and thus prolonging exposure to harmful
agents in combusted tobacco as an unintended consequence. Additionally,
FDA received a large number of comments from individuals using ENDS for
therapeutic purposes. One purpose of this regulation is to avoid
consumer confusion about which products made or derived from tobacco
are intended for a medical use versus for a recreational use.

E. Other Comments and Responses

    (Comment 30) At least one comment expressed concern that since the
Sottera decision, FDA has not taken action against products made or
derived from tobacco and making claims that were ``clearly
therapeutic.'' In order to protect consumers from ``false, misleading,
and confusing tobacco industry claims,'' the comment asks that products
made or derived from tobacco making claims without an MRTP order be
regulated as drug/device products in the Center for Drug Evaluation and
Research.
    (Response) FDA disagrees with the comment to the extent that the
comment suggests that tobacco products properly regulated as MRTPs be
regulated as drugs or devices in the absence of an MRTP order. Tobacco
products making modified risk claims are regulated under the tobacco
product authorities in the FD&C Act, and an MRTP marketed without an
MRTP order would be subject to enforcement as a tobacco product, rather
than subject to regulation as a drug or medical device product. With
respect to enforcement generally, FDA notes that it is issuing this
rule to clarify its interpretation of the drug and device definitions
with respect to products made or derived from tobacco, and that it
expects this clarification to assist industry in determining the
applicable regulatory framework for particular products and help
consumers differentiate between products that are intended for medical
use and products intended for other uses.
    (Comment 31) At least one comment observed that researchers may
wish to study the effects that a product made or derived from tobacco
has on health outcomes (e.g., withdrawal symptoms, hypertension, etc.)
or on the structure and function of the body (e.g., blood pressure,
lung function), or the effects of substituting one product made or
derived from tobacco for another product. The comment asserted that the
methods and measures of such studies are not evidence that the product
being investigated is a drug and that FDA should not require an
investigational new drug application (IND) for these studies unless
they are sponsored by a manufacturer with the intention of supporting a
health or medical drug claim.
    (Response) The regulations in part 312 set forth the circumstances
in which an IND is required for clinical investigations in which a drug
is administered to human subjects. The IND requirement applies
irrespective of whether the investigation is sponsored by a
manufacturer or an academic institution. A study involving a product
made or derived from tobacco will generally require an IND if the
product, as used in the study, is subject to regulation as a drug.
Whether the product, as used in the study, is subject to regulation as
a drug depends on whether the product is being investigated for any of
the purposes described in Sec.  1100.5(a) or (b) of this rule. To
determine if a product made or derived from tobacco is being
investigated for one of these purposes, FDA generally would review the
protocol for the study, including the proposed methods and measures. In
the Agency's experience, the proposed methods and measures for a study
can provide insight into the purposes for which a product is being
investigated. Ultimately, however, whether a product is being
investigated for a therapeutic purpose, and thus whether the study
requires an IND, is a fact-specific, case-by-case inquiry. Additional
information about the IND requirement can be found in the FDA guidance
document entitled ``Investigational New Drug Applications (INDs)--
Determining Whether Human Research Studies Can Be Conducted Without an
IND.'' We encourage researchers to review this guidance document, which
is available on FDA's Web site at http://www.fda.gov/downloads/UCM229175.pdf.
    (Comment 32) At least one comment encouraged FDA to coordinate
between centers to promote development of safer tobacco products as
well as more effective medical products for the treatment of nicotine
addiction. This comment also argued that FDA should not allow similar
or identical products to be marketed as both tobacco products and
medical products, and should consider approving categories of products,
rather than individual products, for smoking cessation. This comment
also expressed concern about dual use between tobacco product
categories.
    (Response) FDA agrees with this comment to the extent the comment
considers the proposed rule to promote effective coordination between
centers by clarifying which center should take the lead in review of
premarket applications and postmarketing regulation of particular
products. We note that FDA currently interprets the standards in
various medical and tobacco product premarket review pathways to refer
to individual products rather than product categories, and the question
of whether a particular product could obtain marketing authorization as
both a tobacco product and as a medical product is beyond the scope of
this rule. By clarifying the jurisdictional lines between tobacco and
medical products, FDA believes that finalization of this rule will make
it less likely that manufacturers will attempt to market products made
or derived from tobacco both as tobacco products and as medical
products--for example, if a tobacco product manufacturer attempts to
add claims to a currently marketed tobacco product that would require
the product to be regulated as drug, device, or combination product.
    (Comment 33) Several comments recommended that the Center for
Tobacco Products (CTP) have sole regulatory jurisdiction over tobacco
and nicotine-containing products and provided suggestions for how CTP
should structurally reorganize itself to better regulate these
products.
    (Response) CTP oversees the regulation of products made or derived
from tobacco that are intended for human consumption. As stated in this
preamble, when a product made or derived from tobacco is marketed or
distributed for an intended use that falls within the drug/device
definitions, it would be regulated as a medical product unless it is
intended to affect the structure or any function of the body in any way
related to the effects of nicotine that were commonly and legally
claimed prior to March 21, 2000. In this situation, one of FDA's
medical product

centers would have regulatory oversight over these products because CTP
does not oversee the regulation of medical products. As these comments
relate to potentially undertaking a structural re-organization, CTP is
not considering a structural reorganization at this time.
    (Comment 34) At least one comment suggested that FDA create a
separate regulatory category for e-cigarettes that is based on the
Agency's medical product regulations, but with less stringent quality
standards.
    (Response) This recommendation is not consistent with the statutory
definitions in the FD&C Act. Under the FD&C Act, a product made or
derived from tobacco is subject to regulation as a tobacco product
unless it meets the definition of a drug or device or is a combination
product, in which case it is subject to regulation as a medical
product.
    (Comment 35) Several comments stated that the cost and resources
required to complete FDA's drug application process would be simply too
great and would shut down many small manufacturers.
    (Response) This regulation simply clarifies the circumstances under
which a product made or derived from tobacco would be regulated as a
drug, device, or combination product, and the circumstances under which
it would be regulated as a tobacco product; it does not create new
jurisdictional lines or impose new obligations on product
manufacturers. Because the jurisdictional lines already exist, tobacco
product manufacturers currently making claims that would render their
product subject to regulation as a medical product or who wish to make
such claims in the future are within FDA's drug and device
jurisdiction, absent limited exceptions, and they must follow the
applicable statutory and regulatory requirements.
    (Comment 36) Many comments believed that the regulation would make
e-cigarettes less available to consumers.
    (Response) FDA disagrees. This regulation simply clarifies the
circumstances under which a product made or derived from tobacco will
be regulated as a drug, device, or combination product, and the
circumstances under which it will be regulated as a tobacco product.
This regulation will not add any additional burden to manufacturers who
sell ENDS for recreational use. However, if a manufacturer is selling
ENDS and making medical product claims, then the product would be
subject to regulation as a drug, device, or combination product if
those claims are not structure/function claims related to the effects
of nicotine that were commonly and legally claimed prior to March 21,
2000.
    (Comment 37) At least one comment suggested that the final rule
should include a discussion of how the regulation will affect public
health.
    (Response) The preamble to the proposed rule contained some
discussion of this topic, and this preamble to the final rule further
expands on various public health protections.
    (Comment 38) FDA proposed that a product made or derived from
tobacco that is intended for use in smoking cessation be subject to
regulation as a medical product. Several comments objected that smoking
is not a disease, but a behavior, and that a product that claims to
help individuals quit smoking should not be regulated as a medical
product absent any assertions that it will prevent disease or treat
nicotine dependence. One comment asserted that promoting a product as
suitable for continued nicotine use after stopping smoking traditional
cigarettes is the functional equivalent of a ``smoking alternative''
claim, which FDA has said does not fall within the Agency's medical
product authority, and, therefore, should not subject the product to
regulation as a medical product.
    (Response) Over the past 50 years, smoking has been causally linked
to diseases of nearly all organs of the body, diminished health status,
and fetal harm. Most current adult smokers want to quit smoking
completely for health reasons (Ref. 18). Given these facts, we believe
that statements related to quitting smoking generally create a strong
suggestion that a product is intended for a therapeutic purpose. We
recognize, however, that public perception can change and evidence may
be developed showing that, in some situations, ``smoking cessation'' is
understood in context as referring to ending the use of traditional
cigarettes and switching to a non-combustible product made or derived
from tobacco. We have revised the codified language in Sec.  1100.5(a)
in the final rule, to reflect that ``smoking cessation'' is one type of
intended use related to ``the cure or treatment of nicotine
addiction.'' FDA intends to closely scrutinize ``smoking cessation''
claims to ensure that consumers are not misled about the intended use
of a product made or derived from tobacco.
    (Comment 39) One comment stated that this regulation should not
require companies that handle raw materials to determine whether those
raw materials would be used in tobacco products or whether those
materials would be used in medical products. The comment stated that
the intended use of the product is completely within the discretion of
the sellers and distributors of the finished products, and the Agency
should not extend regulations to cover companies that handle raw
materials.
    (Response) This comment is beyond the scope of this rule. This
regulation does not create new jurisdictional lines or impose new
obligations on product manufacturers or companies that handle raw
materials. Rather, this rulemaking simply clarifies the circumstances
under which a product made or derived from tobacco would be regulated
as a drug, device, or combination product, and the circumstances under
which it would be regulated as a tobacco product. If FDA were to
consider extending its authority in such a way that would place
additional requirements on companies handling raw materials, the Agency
would do so through a separate rulemaking.

F. Other Changes to the Codified Text

    To eliminate redundancy, we deleted ``or prevention or mitigation
of disease'' from the end of Sec.  1100.5(a), as the opening text
already includes similar language. Because of this deletion, we
inserted the word ``or'' in front of ``relief of nicotine withdrawal
symptoms.''

G. Effective Date

    This final rule will become effective 30 days after the date of its
publication in the Federal Register. During those 30 days,
manufacturers will continue to be under an obligation to comply with
all applicable provisions of the FD&C Act and applicable regulations.

V. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the final
rule does not contain policies that would 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,
the Agency concludes that the final 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.

VI. Executive Order 13175: Tribal Consultation

    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.

VII. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(h) and (k) 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.

VIII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits 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). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. We believe that this final rule
is not a significant regulatory action as defined by Executive Order
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because, as described in detail in the section entitled
``Final Small Entity Analysis'' in the full analysis of economic
impacts available in the docket for this final rule (Ref. 19) and at
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm, the clarifications in this final rule
will not significantly increase costs on manufacturers of products made
or derived from tobacco, we certify that the final rule will not 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 $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in expenditure
in any year that meets or exceeds this amount.
    The final rule will reduce ambiguity in the market for products
made or derived from tobacco and clarify FDA's interpretation and
application of its existing intended use regulations. The rule
clarifies the intended uses and supporting evidence that would result
in these products being regulated as drugs, devices, or combination
products rather than tobacco products. Products derived from tobacco
that are intended to: (1) Diagnose, cure, mitigate, treat or prevent
disease, including use in smoking cessation or (2) affect the structure
or any function of the body in any way that is different from effects
related to nicotine that were commonly and legally claimed in the
marketing of cigarettes and smokeless tobacco prior to March 21, 2000,
such as an intended use for improving respiratory function, will be
subject to regulation as drugs, devices, or combination products. We
estimate that there would be one-time costs for tobacco manufacturers
to evaluate current product communications such as labeling and
associated promotional materials in light of the clarifications in this
final rule, and to revise them if needed. We expect that only a small
number of product communications such as labeling and associated
materials will undergo a one-time change as a result of this rule.
    The final rule will provide greater clarity to producers regarding
the regulatory requirements for products made or derived from tobacco
and to consumers to distinguish products intended for medical uses from
those marketed for other uses. The reduction in ambiguity will enhance
consumers' understanding of the products they purchase and may increase
consumer welfare as a result.

                                                  Table 2--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                              Primary                                    ------------------------------------------------
                Category                     estimate      Low estimate    High estimate                   Discount rate  Period covered       Notes
                                                                                Year dollars         (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized..............................  ..............  ..............  ..............  ..............               7  ..............
Monetized ($millions/year)..............  ..............  ..............  ..............  ..............               3  ..............
Annualized..............................  ..............  ..............  ..............  ..............               7  ..............
Quantified                                ..............  ..............  ..............  ..............               3  ..............
                                         ---------------------------------------------------------------------------------------------------------------
Qualitative.............................            Reduce regulatory ambiguity

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized..............................          $0.246          $1.126          $0.365            2014               7              10
Monetized ($millions/year)..............           0.202           0.202           0.202  ..............  ..............  ..............
                                                   0.202           0.104           0.301            2014               3              10
Annualized                                ..............  ..............  ..............  ..............               7  ..............
Quantified..............................  ..............  ..............  ..............  ..............               3  ..............
Qualitative.............................  ..............  ..............  ..............  ..............  ..............  ..............

Transfers...............................  ..............  ..............  ..............  ..............  ..............  ..............
Federal.................................  ..............  ..............  ..............  ..............               7  ..............
Annualized..............................  ..............  ..............  ..............  ..............               3  ..............
Monetized ($millions/year)
                                         ---------------------------------------------------------------------------------------------------------------
From/To                                   From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other...................................  ..............  ..............  ..............  ..............               7  ..............
Annualized..............................  ..............  ..............  ..............  ..............               3  ..............
Monetized ($millions/year)
                                         ---------------------------------------------------------------------------------------------------------------
From/To                                   From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects
State, Local or Tribal Government: No Effect
Small Business: No effect
Wages: No estimated effect
Growth: No estimated effect
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The full analysis of economic impacts is available in the docket
for this final rule (Ref. 19) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IX. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

X. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. Defendants' Memorandum of Points and Authorities in Support of
Motion to Dismiss or for Summary Judgment. Allergan Inc. v. United
States of America, et al., 1:09-cv-01879-JDB (D.D.C. Jan. 11, 2010),
2010 WL 11211158.
2. Etter, J.-F., C. Bullen, ``Electronic Cigarette: Users Profile,
Utilization, Satisfaction and Perceived Efficacy,'' Addiction,
106(11):2017-2028, 2011.
3. Byron, M.J., S.A. Baig, K.E. Moracco, and N.T. Brewer,
``Adolescents' and Adults' Perceptions of `Natural', `Organic' and
`Additive-Free' Cigarettes, and the Required Disclaimers,'' Tobacco
Control, Dec 1:tobaccocontrol-2015, 2015.
4. Green, K.C. and J.S. Armstrong, ``Evidence on the Effects of
Mandatory Disclaimers in Advertising,'' Journal of Public Policy &
Marketing, 31(2):293-304, 2012.
5. Kesselheim, A.S. and J. Avorn, ``Pharmaceutical Promotion to
Physicians and First Amendment Rights,'' New England Journal of
Medicine, 358:1727-1732, 2008.
6. Good, C.B. and W.F. Gellad, ``Off-Label Drug Use and Adverse
Events: Turning up the Heat on Off-Label Prescribing,'' Journal of
American Medical Association Internal Medicine, 176(1):63-64, 2016.
7. Eguale, T., D.L. Buckeridge, A. Verma, et al., ``Association of
Off-Label Drug Use and Adverse Drug Events in an Adult Population,''
Journal of American Medical Association Internal Medicine,
176(1):55-63, 2016.
8. Avorn, J., A. Sarpatwari, and A.S. Kessleheim, ``Forbidden and
Permitted Statements About Medications--Loosening the Rules,'' New
England Journal of Medicine, 373:967-973, 2015.
9. Kapczynski, A., ``Free Speech and Pharmaceutical Regulation--
Fishy Business,'' Journal of American Medical Association Internal
Medicine, 176(3):295-296, 2016.
10. Cardarelli, R., J.C. Licciardone, and L.G. Taylor, ``A Cross-
Sectional Evidence-Based Review of Pharmaceutical Promotional
Marketing Brochures and Their Underlying Studies: Is What They Tell
Us Important and True?,'' BMC Family Practice, 7(1):13, 2006.
11. Eisenberg, R.S., ``The Role of the FDA in Innovation Policy,''
Michigan Telecommunications and Technology Law Review, 13:2:345,
370, 2007.
12. Kesselheim, A.S., and M.M. Mello, ``Healthcare Decisions in the
New Era of Healthcare Reform: Prospects for Regulation of Off-Label
Drug Promotion in an Era of Expanding Commercial Speech
Protection,'' North Carolina Law Review, 92:1539, 1585, 2014.
13. Stafford, R.S., ``Regulating Off-Label Drug Use--Rethinking the
Role of the FDA,'' New England Journal of Medicine, 358:1427-1429,
2008.
14. President's Cancer Panel, ``Promoting Healthy Lifestyles,''
2007, available at http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp07rpt/pcp07rpt.pdf.
15. Institute of Medicine of the National Academies, ``Ending the
Tobacco Problem: A Blueprint for the Nation,'' 2007, available at
https://www.nap.edu/read/11795/chapter/1.
16. Roditis, M.L., and B. Halpern-Felsher, ``Adolescents'
Perceptions of Risks and Benefits of Conventional Cigarettes, E-
Cigarettes and Marijuana: A Qualitative Analysis,'' Journal of
Adolescent Health, 57(2):179-185, 2015.
17. Vickerman, K.A., K.M. Carpenter, T. Altman, et al., ``Use of
Electronic Cigarettes Among State Tobacco Cessation Quitline
Callers,'' Nicotine & Tobacco Research, 15(10):1787-1791, 2013.
18. Gallup Consumption Habits poll, July 2013 (see http://www.gallup.com/poll/163763/smokers-quit-tried-multiple-times.aspx).
19. Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination; Amendments to
Regulations Regarding ``Intended Uses,'' Final Rule; Final
Regulatory Impact Analysis.
20. Janssen, W.F., ``Outline of the History of U.S. Drug Regulation
and Labeling,'' Food Drug Cosmetic Law Journal, 36: 420, 437-438,
1981.

List of Subjects

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping
requirements.

21 CFR Part 1100

    Combination products, Devices, Drugs, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter 1 is amended as follows:

PART 201--LABELING

0
1. The authority citation for part 201 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Revise Sec.  201.128 to read as follows:

Sec.  201.128  Meaning of ``intended uses''.

    The words intended uses or words of similar import in Sec. Sec.
201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this
chapter refer to the objective intent of the persons legally
responsible for the labeling of drugs. The intent is determined by such
persons' expressions or may be shown by the circumstances surrounding
the distribution of the article. This objective intent may, for
example, be shown by labeling claims, advertising matter, or oral or
written statements by such persons or their representatives. It may be
shown, for example, by circumstances in which the article is, with the
knowledge of such persons or their representatives, offered and used
for a purpose for which it is neither labeled nor advertised. The
intended uses of an article may change after it has been introduced
into interstate commerce by its manufacturer. If, for example, a
packer, distributor, or seller intends an article for different uses
than those intended by the person from whom he received the drug, such
packer, distributor, or seller is required to supply adequate labeling
in accordance with the new intended uses. And if the totality of the
evidence establishes that a manufacturer objectively intends that a
drug introduced into interstate commerce by him is to be used for
conditions, purposes, or uses other than ones for which it is approved
(if any), he is required, in accordance with section 502(f) of the
Federal Food, Drug, and Cosmetic Act, or, as applicable, duly
promulgated regulations exempting the drug from the requirements of
section 502(f)(1), to provide for such drug adequate labeling that
accords with such other intended uses.

PART 801--LABELING

0
3. The authority citation for part 801 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371,
374.

0
4. Revise Sec.  801.4 to read as follows:

Sec.  801.4  Meaning of intended uses.

    The words intended uses or words of similar import in Sec. Sec.
801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the
objective intent of the persons legally responsible for the labeling of
devices. The intent is determined by such persons' expressions or may
be shown by the circumstances surrounding the distribution of the
article. This objective intent may, for example, be shown by labeling
claims, advertising matter, or oral or written statements by such
persons or their representatives. It may be shown, for example, by
circumstances in which the article is, with the knowledge of such
persons or their representatives, offered and used for a purpose for
which it is neither labeled nor advertised. The intended uses of an
article may change after it has been introduced into interstate
commerce by its manufacturer. If, for example, a packer, distributor,
or seller intends an article for different uses than those intended by
the person from whom he received the device, such packer, distributor,
or seller is required to supply adequate labeling in accordance with
the new intended uses. And if the totality of the evidence establishes
that a manufacturer objectively intends that a device introduced into
interstate commerce by him is to be used for conditions, purposes, or
uses other than ones for which it has been approved, cleared, granted
marketing authorization, or is exempt from premarket notification
requirements (if any), he is required, in accordance with section
502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable,
duly promulgated regulations exempting the device from the requirements
of section 502(f)(1), to provide for such device adequate labeling that
accords with such other intended uses.

PART 1100--TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY

0
5. The authority citation for part 1100 is revised to read as follows:

    Authority:  21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d),
Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55,
17.1, and 17.2. Section 1100.5 is issued under 21 U.S.C. 321,
353(g), and 371(a); 21 CFR 1.1.

0
6. Part 1100 is amended by adding Sec.  1100.5 to read as follows:

Sec.  1100.5  Exclusion from tobacco regulation.

    If a product made or derived from tobacco that is intended for
human consumption is intended for use for any of the purposes described
in paragraph (a) or (b) of this section, the product is not a tobacco
product as defined in section 201(rr) of the Federal Food, Drug, and
Cosmetic Act and will be subject to regulation as a drug, device, or
combination product.
    (a) The product is intended for use in the diagnosis of disease or
other conditions, or in the cure, mitigation, treatment or prevention
of disease, including use in the cure or treatment of nicotine
addiction (e.g., smoking cessation), relapse prevention, or relief of
nicotine withdrawal symptoms;
    (b) The product is intended to affect the structure or any function
of the body in any way that is different from effects related to
nicotine that were commonly and legally claimed in the marketing of
cigarettes and smokeless tobacco products prior to March 21, 2000.

    Dated: December 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31950 Filed 1-6-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Page 60773]
[FR Doc No: 2016-21083]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability for Final Environmental Impact Statement
(Final EIS), Department of Transportation Act of 1966 Section 4(f)
Evaluation, and Alaska National Interest Lands Conservation Act
Subsistence Evaluation for the Proposed Airport, Angoon, Alaska

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation.

ACTION: Notice of Availability (NOA).

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

SUMMARY: In accordance with the National Environmental Policy Act of
1969 and Council on Environmental Quality (CEQ) regulations, the FAA
issues this notice to advise the public that a Final EIS for the
proposed airport in Angoon, Alaska, has been prepared. Included in the
Final EIS are a subsistence evaluation consistent with Section 810 of
the Alaska National Interest Lands Conservation Act (ANILCA) and a
final evaluation pursuant to Section 4(f) of the Department of
Transportation Act of 1966. The FAA will not make a decision on the
proposed action for a minimum of 30 days following the publication of
this NOA in the Federal Register. The FAA will record their decision or
decisions in a Record of Decision.

ADDRESSES: Copies of the Final EIS and the evaluations are available at
the following locations. Paper copies may be viewed during regular
business hours.
    1. Online at www.angoonairporteis.com.
    2. Juneau Public Library:

 Downtown Branch, 292 Marine Way, Juneau, AK 99801
 Douglas Branch, 1016 3rd Street, Douglas, AK 99824
 Mendenhall Mall Branch, 9109 Mendenhall Mall Road, Juneau, AK
99801
    3. U.S. Forest Service, Admiralty Island National Monument Office,
8510 Mendenhall Loop Road, Juneau, AK 99801.
    4. Angoon Community Association Building, 315 Heendae Road, Angoon,
AK 99820.
    5. Angoon City Government Office, 700 Aan Deina Aat Street, Angoon,
AK 99820.
    6. Angoon Senior Center, 812 Xootz Road, Angoon, AK 99820.
    7. The FAA Airports Division in Anchorage, AK. Please contact
Leslie Grey at<PHONE_NUMBER> to schedule.

FOR FURTHER INFORMATION CONTACT: Leslie Grey, AAL-611, Federal Aviation
Administration, Alaskan Region, Airports Division, 222 W. 7th Avenue,
Box #14, Anchorage, AK 99513. Ms. Grey may be contacted by telephone
during business hours at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Alaska Department of Transportation and
Public Facilities (DOT&PF) has requested funding and approval from the
FAA for a new land-based airport and an access road to improve the
availability and reliability of transportation services to and from
Angoon. The DOT&PF's proposed action would be located in the Admiralty
Island National Monument and Kootznoowoo Wilderness Area (Monument-
Wilderness Area). The FAA has proposed alternatives to the proposed
action, including the no action alternative. The purpose and need for
the airport are discussed in detail in the Final EIS.
    The project would consist of a paved, 3,300-foot-long and 75-foot-
wide runway, with future expansion to 4,000 feet long.
    Construction of the proposed airport would be completed in two to
three construction seasons. Many of the impact categories considered in
the Final EIS are required by FAA Orders 1050.1E and 5050.4B. In
addition, subsistence activities, wilderness character, and impacts to
the Admiralty Island National Monument are evaluated. Because the
DOT&PF's proposed action is located in the Monument-Wilderness Area,
the DOT&PF has submitted an application to the FAA, the U.S. Forest
Service, and the U.S. Army Corps of Engineers under ANILCA Title XI to
use the lands. The federal agencies have drafted findings and a
notification of tentative disapproval of the application. At this time,
no notification will be sent to the President pending discussions with
the sponsor and the cooperating agencies on next steps.
    Additional details regarding the project can be found on the
project Web site at www.angoonairporteis.com.

    Issued in Anchorage, Alaska, on August 23, 2016.
Byron K. Huffman,
Manager, Airports Division, AAL-600.
[FR Doc. 2016-21083 Filed 9-1-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Proposed Rules]
[Pages 2281-2284]
[FR Doc No: 2011-585]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1308; Directorate Identifier 2009-NM-069-AD]
RIN 2120-AA64

Airworthiness Directives; BAE SYSTEMS (OPERATIONS) LIMITED Model
BAe 146 Airplanes, and Model Avro 146-RJ Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above that would supersede an existing AD. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as:

    During the period 2001/2002, skin cracking was found adjacent to
the butt joint forward of frame 19 * * *. The cracks emanated from
chemically-etched pockets on the internal surface of the skin. * * *
[C]racking in multiple adjacent bays * * * could compromise the
structural integrity of the fuselage in the event that the multiple
cracks joined into a single crack. * * *
    During 2008, a further report was received at BAE Systems of a
13.78 inch crack in an AVRO 146-RJ that occurred 514 flight cycles
(FC) short of the next 4 000-FC repetitive inspection interval. * *
*
* * * * ** *
    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by February 28,
2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact BAE
SYSTEMS (OPERATIONS) LIMITED, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; e-mail
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1175; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-1308;
Directorate Identifier 2009-NM-069-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any

personal information you provide. We will also post a report
summarizing each substantive verbal contact we receive about this
proposed AD.

Discussion

    On June 14, 2005, we issued AD 2005-13-19, Amendment 39-14156 (70
FR 37022, June 28, 2005). That AD required actions intended to address
an unsafe condition on the products listed above.
    Since we issued AD 2005-13-19, a further report of cracking has
been received at an interval shorter than the repetitive inspection
interval required by AD 2005-13-19. The European Aviation Safety Agency
(EASA), which is the Technical Agent for the Member States of the
European Community, has issued EASA Airworthiness Directive 2009-
0070R1, dated July 2, 2010 (referred to after this as ``the MCAI''), to
correct an unsafe condition for the specified products. The MCAI
states:

    During the period 2001/2002, skin cracking was found adjacent to
the butt joint forward of frame 19 when unrelated in-service
maintenance inspections of the forward fuselage structure were being
completed. The cracks emanated from chemically-etched pockets on the
internal surface of the skin. The then current MRB [maintenance
review board] inspection requirements were not adequate to address
cracking in multiple adjacent bays, which could compromise the
structural integrity of the fuselage in the event that the multiple
cracks joined into a single crack. Investigations resulted in the
publication of BAE Systems (Operations) Limited Inspection Service
Bulletin (ISB).53-167 in June [27,] 2003, which was made mandatory
by CAA UK AD 007-06-2003. The ISB was subsequently re-issued at
Revision 1 during 2004 [May 18, 2004] to clarify the inspection
requirements and provide an improved inspection procedure. CAA UK AD
G-2005-0002 [which corresponds to FAA AD 2005-13-19] (EASA approval
number 2005-313) was issued to require accomplishment of the
improved inspections.
    During 2008, a further report was received at BAE Systems of a
13.78 inch crack in an AVRO 146-RJ that occurred 514 flight cycles
(FC) short of the next 4 000-FC repetitive inspection interval. A
reassessment of ISB instructions and its supporting data concluded
that these original inspection periods were too long, and the method
for defining the areas requiring inspection could be open to
misinterpretation. In response, BAE Systems has updated the ISB to
Revision 2 [dated December 12, 2008] to reduce the inspection
intervals, introducing different inspection intervals associated
with specific areas of the forward fuselage skins and instructions
to inspect additional areas of the forward fuselage skin.
    For the reasons described above, this AD retains the
requirements of CAA UK AD G-2005-0002, which is superseded, and
requires the implementation of revised repetitive inspections,
including inspection of additional areas of the forward fuselage
skin panels for cracking and follow-on repair action(s), depending
on findings.
    This AD is [further] revised to acknowledge the issuance of BAE
Systems (Operations) Limited ISB.53-167 Revision 3, [dated June 17,
2009] which allows the repetitive inspection intervals to be
extended and introduces grace periods to carry out the initial
inspections. In addition, this AD at Revision 1 [EASA AD 2009-
0070R1, dated July 2, 2010] acknowledges the issuance of BAE Systems
ISB.53-167 Revision 4 [dated June 10, 2010] which corrects the grace
period for the initial inspections on BAe 146 aeroplane types.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    BAE SYSTEMS (OPERATIONS) LIMITED has issued Inspection Service
Bulletin ISB.53-167, Revision 4, dated June 10, 2010. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1 product of U.S. registry.
    The actions that are required by AD 2005-13-19 and retained in this
proposed AD take about 40 work-hours per product, at an average labor
rate of $85 per work hour. Based on these figures, the estimated cost
of the currently required actions is $3,400 per product.
    We estimate that it would take about 32 work-hours per product to
comply with the new basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of the proposed AD on U.S. operators to be $2,720, or $2,720
per product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-14156 (70 FR
37022, June 28, 2005) and adding the following new AD:

BAE SYSTEMS (OPERATIONS) LIMITED: Docket No. FAA-2010-1308;
Directorate Identifier 2009-NM-069-AD.

Comments Due Date

    (a) We must receive comments by February 28, 2011.

Affected ADs

    (b) This AD supersedes AD 2005-13-19, Amendment 39-14156.

Applicability

    (c) This AD applies to all BAE SYSTEMS (OPERATIONS) LIMITED
Model BAe 146-100A, -200A, and -300A airplanes; and Model Avro 146-
RJ70A, 146-RJ85A, and 146-RJ100A airplanes; certificated in any
category.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    During the period 2001/2002, skin cracking was found adjacent to
the butt joint forward of frame 19 * * *. The cracks emanated from
chemically-etched pockets on the internal surface of the skin. * * *
[C]racking in multiple adjacent bays * * * could compromise the
structural integrity of the fuselage in the event that the multiple
cracks joined into a single crack. * * *
    During 2008, a further report was received at BAE Systems of a
13.78 inch crack in an AVRO 146-RJ that occurred 514 flight cycles
(FC) short of the next 4 000-FC repetitive inspection interval. * *
*
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.
    RESTATEMENT OF REQUIREMENTS OF AD 2005-13-19:

Inspections and Repair

    (g) Within the applicable compliance time specified in paragraph
(g)(1) or (g)(2) of this AD, perform an external eddy current
inspection of the forward fuselage skin to detect cracking, in
accordance with the Accomplishment Instructions of BAE Systems
(Operations) Limited Modification Service Bulletin ISB.53-167,
including Appendix 2, Revision 1, dated May 18, 2004. Doing the
inspection required by paragraph (j) of this AD terminates the
requirements of this paragraph of this AD.
    (1) For Model BAe 146 series airplanes: Inspect before the
accumulation of 16,000 total landings, or within 4,000 landings
after the August 2, 2005 (the effective date of AD 2005-13-19),
whichever is later.
    (i) For areas where no crack is found, repeat the inspection at
intervals not to exceed 8,000 landings.
    (ii) For areas where any crack is found, before further flight,
perform repairs in accordance with a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
the Civil Aviation Authority (CAA) (or its delegated agent), or EASA
(or its delegated agent). No further inspection of any repaired area
is required by paragraph (g) of this AD.
    (2) For Model Avro 146-RJ series airplanes: Inspect before the
accumulation of 10,000 total landings, or within 2,000 landings
after August 2, 2005, whichever is later.
    (i) For areas where no crack is found, repeat the inspection at
intervals not to exceed 4,000 landings.
    (ii) For areas where any crack is found, before further flight,
perform repairs in accordance with a method approved by the Manager,
International Branch, ANM-116, the CAA (or its delegated agent), or
EASA (or its delegated agent). No further inspection of any repaired
area is required by paragraph (g) of this AD.

Inspections Accomplished According to Previous Issue of Service
Bulletin

    (h) Inspections accomplished before August 2, 2005, in
accordance with BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-167, including Appendices 2 and 3, all dated June
27, 2003, are considered acceptable for compliance with the
corresponding action specified in paragraph (g) of this AD.

No Reporting Requirement for AD 2005-13-19

    (i) Although BAE Systems (Operations) Limited Modification
Service Bulletin ISB.53-167, including Appendix 2, Revision 1, dated
May 18, 2004, specifies to submit Appendix 1 of that service
bulletin with certain information to the manufacturer, this AD does
not include that requirement.
    New Requirements of this AD:

Inspection and Repair--Expanded Area of Forward Fuselage Skin and
Reduced Inspection Intervals

    (j) For Model BAe 146 airplanes: At the later of the times
specified in paragraphs (j)(1), (j)(2), and (j)(3) of this AD, do an
external eddy current inspection of the forward fuselage skin to
detect cracking, in accordance with the Accomplishment Instructions
of BAE Systems (Operations) Limited Inspection Service Bulletin
ISB.53-167, including Appendix 2, Revision 4, dated June 10, 2010.
Repeat the inspection thereafter at intervals not to exceed 3,600
flight cycles for areas specified in Drawings 2, 3, 4, 5, and 7 of
BAE Systems (Operations) Limited Inspection Service Bulletin ISB.53-
167, including Appendix 2, Revision 4, dated June 10, 2010, and at
intervals not to exceed 4,600 flight cycles for areas specified in
Drawings 1, 6, 8, and 9 of BAE Systems (Operations) Limited
Inspection Service Bulletin ISB.53-167, including Appendix 2,
Revision 4, dated June 10, 2010. Doing the inspection required by
this paragraph terminates the requirements of paragraph (g) of this
AD for that airplane.
    (1) Before the accumulation of 16,000 total flight cycles.
    (2) Within 2,000 flight cycles after the effective date of this
AD.
    (3) Within the applicable times specified in paragraphs
(j)(3)(i) and (j)(3)(ii) of this AD.
    (i) For areas specified in Drawings 2, 3, 4, 5, and 7 of BAE
Systems (Operations) Limited Inspection Service Bulletin ISB.53-167,
including Appendix 2, Revision 4, dated June 10, 2010: Within 3,600
flight cycles after the last inspection done in accordance with
paragraph (g) of this AD.
    (ii) For areas specified in Drawings 1, 6, 8, and 9 of BAE
Systems (Operations) Limited Inspection Service Bulletin ISB.53-167,
including Appendix 2, Revision 4, dated June 10, 2010: Within 4,600
flight cycles after the last inspection done in accordance with
paragraph (g) of this AD.
    (k) For Model Avro 146-RJ airplanes: At the later of the times
specified in paragraph (k)(1), (k)(2), and (k)(3) of this AD, do an
external eddy current inspection of the forward fuselage skin to
detect cracking, in accordance with the Accomplishment Instructions
of BAE Systems (Operations) Limited Inspection Service Bulletin
ISB.53-167, including Appendix 2, Revision 4, dated June 10, 2010.
Repeat the inspection thereafter at intervals not to exceed 2,400
flight cycles for areas specified in Drawings 2, 3, 4, 5, and 7 of
BAE Systems (Operations) Limited Inspection Service Bulletin ISB.53-
167, including Appendix 2, Revision 4, dated June 10, 2010, and
3,000 flight cycles for areas specified in Drawings 1, 6, 8, and 9
of BAE Systems (Operations) Limited Inspection Service Bulletin
ISB.53-167, including Appendix 2, Revision 4, dated June 10, 2010.
Doing the inspection required by this paragraph terminates the
requirements of paragraph (g) of this AD for that airplane.
    (1) Before the accumulation of 10,000 total flight cycles.
    (2) Within 1,000 flight cycles after the effective date of this
AD.
    (3) Within the applicable times specified in paragraphs
(k)(3)(i) and (k)(3)(ii) of this AD.
    (i) For areas specified in Drawings 2, 3, 4, 5, and 7 of BAE
Systems (Operations) Limited Inspection Service Bulletin ISB.53-167,
including Appendix 2, Revision 4, dated June 10, 2010: Within 3,600
flight cycles after the last inspection done in accordance with
paragraph (g) of this AD.
    (ii) For areas specified in Drawings 1, 6, 8, and 9 of BAE
Systems (Operations) Limited

Inspection Service Bulletin ISB.53-167, including Appendix 2,
Revision 4, dated June 10, 2010: Within 4,600 flight cycles after
the last inspection done in accordance with paragraph (g) of this
AD.
    (l) If any cracking is found during any inspection required by
paragraph (j) or (k) of this AD, before further flight, accomplish
the repair in accordance with a method approved by the FAA or EASA
(or its delegated agent). Repair of an airplane in accordance with
the requirements of this paragraph of this AD does not constitute
terminating action for the inspection requirements of this AD.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (m) Inspections done before the effective date of this AD in
accordance with BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-167, including Appendix 2, Revision 2, dated
November 17, 2008; or Revision 3, dated June 17, 2009; are
acceptable for compliance with the corresponding requirements of
paragraphs (j) and (k) of this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (n) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-1175; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.,
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

Related Information

    (o) Refer to MCAI EASA Airworthiness Directive 2009-0070R1,
dated July 2, 2010; and BAE Systems (Operations) Limited
Modification Service Bulletin ISB.53-167, including Appendix 2,
Revision 1, dated May 18, 2004; and BAE Systems (Operations) Limited
Inspection Service Bulletin ISB.53-167, including Appendix 2,
Revision 4, dated June 10, 2010; for related information.

    Issued in Renton, Washington, on January 5, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-585 Filed 1-12-11; 8:45 am]
BILLING CODE 4910-13-P