[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Rules and Regulations]
[Pages 95863-95869]
[FR Doc No: 2016-31370]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]

Refuse To Accept Procedures for Premarket Tobacco Product
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
describing when FDA will refuse to accept a tobacco product submission
(or application) because the application has not met a minimum
threshold for acceptability for FDA review. Under the rule, FDA will
refuse to accept a tobacco product submission, for example, that is not
in English, does not pertain to a tobacco product, or does not identify
the type of submission. By refusing to accept submissions that have the
deficiencies identified in the proposed rule, FDA will be able to focus
our review resources on submissions that meet a threshold of
acceptability and encourage quality submissions.

DATES: This rule is effective January 30, 2017.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Paul Hart, Office
of Regulations, Center for Tobacco Products (CTP), Food and Drug
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of the Rule

    FDA is issuing this refuse to accept rule to identify deficiencies
that will result in FDA's refusal to accept certain tobacco product
submissions under sections 905, 910, and 911 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act), as amended by the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (21 U.S.C.
387e, 387j, and 387k).\1\ Because these submissions will be refused
before they enter FDA's review queue, more resources will be available
for submissions that are ready for further review. This rule
establishes a refuse to accept process for premarket tobacco product
submissions, including premarket tobacco product applications (PMTAs),
modified risk tobacco product applications (MRTPAs), substantial
equivalence (SE) applications (also called SE reports), and exemption
requests (including subsequent abbreviated reports).
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    \1\ FDA has published a final rule extending the Agency's
``tobacco product'' authorities in the FD&C Act to all categories of
products that meet the statutory definition of ``tobacco product''
in the FD&C Act, except accessories of such newly deemed tobacco
products (Final Rule Deeming Tobacco Products To Be Subject to the
Federal Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act; Restrictions on the Sale
and Distribution of Tobacco Products and Required Warning Statements
for Tobacco Products (81 FR 28974, May 10, 2016) (the Deeming
rule)). This rule will apply to all tobacco products FDA regulates
under Chapter IX of the FD&C Act.
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B. Summary of the Major Provisions of the Regulatory Action

    The rule explains when FDA will refuse to accept a premarket
submission, including PMTAs, MRTPAs, SE applications, and exemption
requests (including subsequent abbreviated reports). The rule is based
on FDA's experience in reviewing these submissions. Under the rule, FDA
will refuse to accept a premarket submission that: (1) Does not pertain
to a tobacco product; (2) is not in English (or does not include a
complete translation); (3) is submitted in an electronic format that
FDA cannot process, read, review, or archive; (4) does not include the
applicant's contact information; (5) is from a foreign applicant and
does not include the name and contact information of an authorized U.S.
agent (authorized to act on behalf of the applicant for the
submission); (6) does not include a required form(s); (7) does not
identify the tobacco product; (8) does not identify the type of
submission; (9) does not include the signature of a responsible
official authorized to represent the applicant; or (10) does not
include an environmental assessment or claim of a categorical
exclusion, if applicable. Under the rule, if FDA refuses to accept the
submission, FDA will send the contact (if available) a notification. If
the submission is accepted for further review, FDA will send an
acknowledgement letter.

II. Background

    FDA published two rulemaking documents concerning refuse to accept
procedures in the Federal Register of August 8, 2016: A direct final
rule (81 FR 52329) and a companion proposed rule (81 FR 52371). We
published the direct final rule because we believed that the rule was
noncontroversial, and we did not anticipate that it would receive any
significant adverse comments. As a companion to the direct final rule,
we published a proposed rule with the same codified language published
in the proposed rules section of the Federal Register. The companion
proposed rule provides a procedural framework to finalize the rule in
the event that the direct final rule receives any adverse comment and
is withdrawn. We received adverse comment on the direct final rule and
withdrew the direct final rule by issuing a notice in the Federal
Register of November 16, 2016 (81 FR 80567). We are now finalizing the
proposed rule and responding to the comments we received.

III. Purpose and Legal Authority

A. Purpose

    FDA is issuing this refuse to accept rule to efficiently handle
submissions that do not meet a threshold of acceptability for FDA
review (e.g., the submission lacks certain information FDA needs for
substantive review of the submission). Currently, FDA often expends
extensive time and resources in attempts to obtain information and
resolve the deficiencies identified in the rule simply to begin
substantively processing the submission. FDA expects that this rule
will enhance the quality of the submissions and that submissions will
move expeditiously through the review process. In addition, this rule
will help submitters better understand the common hurdles FDA
encounters in conducting a substantive review of submissions.
    The rule identifies deficiencies that FDA has seen across types of
premarket submissions and will result in FDA refusing to accept the
submission. This rule applies to all tobacco product applications; we
note that there are additional deficiencies that are not covered in
this rule that may arise for specific types of premarket submissions
that would also result in FDA's refusal to accept that specific type of
premarket submission (e.g., omission of labeling for a PMTA that is
required under section 910(b)(1)(F) of the FD&C Act).
    FDA's refusal to accept a tobacco product submission does not
preclude an applicant from resubmitting a new submission that addresses
the deficiencies. In addition, acceptance of a submission does not mean
that FDA has determined that the submission is complete, rather only
that the submission meets the basic, minimum threshold for acceptance.
Substantive review of the submission will begin once FDA accepts the
submission, and for submissions with filing requirements (i.e., PMTAs
and MRPTAs), once filed. This rule establishes a general process for
refusing to accept submissions for premarket tobacco review, including
PMTAs, MRTPAs, SE applications, and exemption requests (including
subsequent abbreviated reports). Because administratively incomplete
submissions will be refused before FDA begins substantive review, we
will be able to use our resources on submissions that are more complete
and better prepared for further review. In addition, FDA intends to
determine, as soon as practicable, whether the submission will be
accepted. We intend to determine whether we will refuse to accept most
premarket submissions under this rule by 21 to 60 days of receipt, with
less lengthy submissions, such as some exemption requests, taking
closer to 21 days or fewer and other more lengthy submissions taking
closer to 60 days or fewer; however, this range is an initial estimate
and the actual time required may vary depending on the volume of
submissions received at any one time. FDA remains committed to an
efficient product review process and intends to establish and implement
performance goals for this action once it has experience with the
volume of submissions it will receive for newly deemed tobacco
products. FDA expects the performance goals to be generally similar to
other Agency performance goals, i.e. a certain percentage of refuse to
accept determinations made within a defined period of time, and with
the percentage rising over time.

B. Legal Authority

    Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) provides FDA with
the authority to issue regulations for the efficient enforcement of the
FD&C Act. This rule will allow FDA to more efficiently use our
resources to review premarket submissions under sections 905, 910, and
911 of the FD&C Act. FDA has processed and reviewed many submissions
since the enactment of the Tobacco Control Act, and submissions with
the deficiencies identified in the rule have been repeatedly identified
by FDA as reflecting submissions that are incomplete and not prepared
for further review.

IV. Overview of the Final Rule

    We are finalizing the proposed rule with only editorial changes.
The rule adds part 1105 (21 CFR part 1105) to title 21, specifically
Sec.  1105.10. Section 1105.10 provides that FDA will refuse to accept,
as soon as practicable, PMTAs, MRTPAs, SE applications, and exemption
requests (including subsequent abbreviated reports) for the reasons
listed in paragraphs (a)(1) through (a)(10), if applicable.

V. Comments on the Proposed Rule

    We consider any comments that were submitted on the direct final
rule to have been submitted on the proposed rule. We received two sets
of comments on the proposed rule, one from a tobacco product
manufacturer and another from a public health group. In general, one of
the commenters expressed strong support for this rule, asking that it
be applied to a broader set of applications, while the other commenter
identified concerns with the rulemaking, including that ``promulgating
a direct final rule was procedurally improper.'' This commenter
suggested that FDA withdraw the rule in its entirety and issue any
future rule only after engaging in notice and comment rulemaking. This
rulemaking, however, did provide both notice and an opportunity for
comments. As previously noted, FDA withdrew the direct final rule and
is proceeding with the rulemaking under the procedural framework of the
proposed rule. FDA has considered the comments submitted to the docket
for the rulemaking and responds to the comments in the following
paragraphs.
    To make it easier to identify comments and our responses, the word
``Comment,'' in parentheses, will appear before each comment, and the
word ``Response,'' in parentheses, will appear before each response. We
have numbered the comments to make it easier to distinguish between
comments; the numbers are for organizational purposes only and do not
reflect the order in which we received the comments or any value
associated with the comment. We have combined similar comments under
one numbered comment.
    (Comment 1) One commenter suggested that FDA apply the rule to
provisional substantial equivalence applications submitted by
manufacturers under section 910(a)(2)(B) of the FD&C Act for new
tobacco products that were first introduced or delivered for
introduction into interstate commerce between February 15, 2007, and
March 22, 2011.
    (Response) FDA disagrees with this comment. We do not believe that
this rule should be applied retroactively to refuse to accept
submissions submitted before the rule is effective. While the refuse to
accept criteria represent a minimum threshold that applications should
be able to meet, we believe that applying this rule retroactively would
be unfair to applicants because they had no notice that they would be
subject to the rule's requirements.
    (Comment 2) One commenter suggested that FDA apply this
``commonsense regulation'' to premarket submissions for newly deemed
tobacco products submitted during the compliance period announced in
the Deeming rule.
    (Response) FDA notes that, as explained in the proposed rule, the
rule once effective, will apply to premarket submissions for all
tobacco products, including those that are for products covered by the
Deeming rule.
    (Comment 3) One commenter requested that FDA revise and expand the
requirements of the rule to allow FDA to refuse to accept substantial
equivalence applications that fail to

comply with certain criteria that relate to the substantial equivalence
pathway, such as creating product-identifying information requirements
for predicate products.
    (Response) FDA disagrees with this comment. The rule creates a
minimum threshold of acceptability for all premarket submissions,
regardless of the type of submission, and is not intended to address
content specific to only one type of premarket submission. FDA plans to
consider including refuse to accept criteria that are specific to a
particular premarket pathway as part of future rulemakings. For
example, FDA has already issued one such rule, ``Tobacco Products,
Exemptions From Substantial Equivalence Requirements,'' which contains
refuse to accept criteria relating specifically to exemption requests
(July 5, 2011, 76 FR 38961).
    (Comment 4) One commenter argued that FDA lacks the legal authority
to implement the rule. The commenter stated that because the Tobacco
Control Act does not set forth content requirements for substantial
equivalence applications or exemption requests, FDA has no statutory
justification for pre-review of those submissions. The commenter
further stated that while the Tobacco Control Act does set forth
content requirements for premarket tobacco product applications and
modified risk tobacco product applications that grant FDA authority to
conduct filing reviews of those submissions, FDA lacks the statutory
authority to conduct a separate acceptance review as part of the pre-
review of an application. In sum, the commenter argued that FDA does
not have the statutory authority, either explicit or implicit, to
refuse to accept tobacco product submissions.
    (Response) FDA disagrees with this comment. As described in section
III.B of the rule, section 701(a) grants FDA the authority to issue
regulations for the efficient enforcement of the FD&C Act. As also
discussed in the proposed rule, this rule will allow FDA to efficiently
enforce the premarket review requirements of sections 905, 910, and 911
of the FD&C Act by allowing FDA to refuse to accept submissions that do
not meet basic criteria and focus its resources on those submissions
that are ready for review.
    (Comment 5) One commenter argued that unless FDA establishes a time
by which FDA will refuse to accept a premarket submission, the rule is
legally problematic for a number of reasons. While two of the specific
reasons are discussed in this document in separate comments and
responses, overall, the commenter suggested that FDA should, similar to
its approach for new drug applications and premarket approval
applications for medical devices, create a limit of 15 days in which to
determine whether it will refuse to accept a premarket submission.
    (Response) FDA declines the suggestion that FDA adopt a 15-day time
limit similar to the refuse to accept review periods for refuse to
accept notifications for 510(k) and premarket approval applications
established by the Center for Devices and Radiological Health (CDRH).
CDRH has had a significantly longer time reviewing such applications
and has gained extensive experience doing so. CTP currently lacks
sufficient experience reviewing tobacco product submissions to develop
specific timeframes. Moreover, there is some uncertainty regarding the
types and number of applications that manufacturers will choose to
submit for products covered by the Deeming rule and regarding the
precise timing of such submissions. Given the size of the industry and
the number of newly deemed products on the market, FDA anticipates a
large influx of applications, many of which could be at the end of the
initial compliance periods for each premarket pathway. It is likely
that many applicants will have no experience with the FDA premarket
review process, so the quality of the submissions is likewise very
difficult to predict. Due to this uncertainty and the difficulty
predicting the level of resources FDA will have to expend as a result,
FDA is not prepared at this time to commit to a single time limit for
all submissions. Instead, FDA is providing an estimated timeframe in
which it intends to determine whether to accept submissions: FDA
intends to make the determination of whether it will accept an
application for review based upon the requirements in the rule by 21 to
60 days of receipt. Further, we intend to establish performance goals
or other timeframes once we gain sufficient experience.
    (Comment 6) One commenter argues that the absence of a time limit
in the rule poses a problem under the First Amendment. Specifically,
the commenter alleges that FDA's premarket review of tobacco product
submissions, particularly with regard to MRTPAs, are prior restraints
on speech; thus, the lack of a time limit for FDA to make acceptance
determinations allows the Agency to delay the applicant's truthful and
non-misleading speech indefinitely.
    (Response) FDA disagrees with the commenter's assertion that the
rule's provisions are problematic under the First Amendment. First, as
the commenter acknowledges in a footnote, members of the tobacco
industry challenged the MRTP provisions, including the absence of a
time limit, on First Amendment grounds, and the Sixth Circuit rejected
that challenge and upheld the MRTP provisions (Discount Tobacco v.
United States, 674 F.3d 509, 537 (6th Cir. 2012)). Second, the
premarket review process is not unique to FDA's regulation of tobacco
and in fact is employed widely across most of FDA's product areas. The
commenter singles out the MRTP review process as particularly
problematic, but they misapprehend the structure of the provision,
which imposes no direct restriction on speech. Rather, it requires
premarket review before a product may be introduced into interstate
commerce and defines such product in part by reference to its
promotional claims. Courts have upheld FDA premarket reviews in other
product areas based on a similar scheme. See, e.g., United States v.
LeBeau, 2016 U.S. App. LEXIS 12375 (7th Cir. 2016); Whitaker v.
Thompson, 353 F.3d 947 (D.C. Cir. 2004); United States v. Cole, 84 F.
Supp. 3d 1159, 1166 (D. Or. 2015). Third, there is a split in authority
regarding whether the prior restraint doctrine applies to commercial
speech; the Sixth Circuit in Discount Tobacco found that the doctrine
did not apply to evaluation of the MRTP provisions (674 F.3d at 532-
33). Fourth, even assuming that the marketing of a tobacco product is
speech to which the prior restraint doctrine could possibly apply, the
process established here would satify the requirements of that
doctrine. First, prior restraints are not acceptable where they place
``unbridled discretion in the hands of a government official or
agency.'' (FW/PBS, Inc. v. Dallas, 493 U.S. 215, 225-226 (1990)
(plurality opinion).) Here, however, the rule lays out 10 basic
requirements for tobacco product applications which, if not met, will
cause FDA to refuse to accept the submission. Further, when assessing
whether a submission meets that minimum threshold of acceptability, FDA
will look only to whether the submission is facially complete and it
will not conduct a substantive review. Second, the prior restraint
doctrine requires that decisions ``must be issued within a reasonable
period of time.'' (City of Littleton v. Z.J. Gifts D-4, L.L.C, 541 U.S.
774, 780 (2004).) For instance, in a case involving FDA premarket
review of health claims for dietary supplements, the Second Circuit
held that a 540-day period was permissible ``given the need to protect
consumers before any harm occurs,'' to ``evaluate the evidence in
support of labeling

claims,'' and to develop ``a record on the matter so that a court can
determine whether the regulated speech is, in fact, truthful and non-
misleading.'' (Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d
Cir. 1998).) Furthermore, as the district court in the Discount Tobacco
case noted, the Administrative Procedure Act (APA) ``imposes a general
but nondiscretionary duty upon an administrative agency to pass upon a
matter presented to it `within a reasonable time,' 5 U.S.C. 555(b), and
authorizes a reviewing court to `compel agency action unlawfully
withheld or unreasonably delayed,' 5 U.S.C. 706(1).'' (Commonwealth
Brands, Inc. v. United States, 678 F. Supp. 2d 512, 533 (W.D. Ky.
2010).) The APA requirement that the Agency act on matters before it
``within a reasonable time,'' in conjunction with FDA's estimated
timeframes and the performance goals for refuse to accept review that
FDA intends to establish, indicate that FDA will not leave applications
``in limbo,'' as claimed by the commenter, but will act on them in a
reasonable amount of time. For all of these reasons, the rule's
provisions do not constitute an unconstitutional prior restraint.
    (Comment 7) One commenter argued that implementing the rule would
allow FDA to deprive manufacturers of the valuable substantive right to
market their products during the compliance period for deemed products
with no hearing and no substantive review, which is contrary to
Congress' intent in the Tobacco Control Act. The commenter further
argued that the Tobacco Control Act allows FDA to require certain
tobacco products to be taken off of the market only upon making a
substantive determination that the action is warranted under statutory
standards, and thus FDA cannot require that products be removed from
the market without any such substantive review.
    (Response) FDA disagrees with this comment. Under the FD&C Act,
generally, a new tobacco product may not be introduced or delivered for
introduction into interstate commerce unless it is subject to a
marketing order under section 910(c)(1)(A)(i), FDA has issued an order
finding the new tobacco product substantially equivalent to a predicate
product, or FDA has issued an exemption from the requirements of
substantial equivalence. The final Deeming rule, issued with notice and
an opportunity for comment, extends this requirement to newly regulated
products that are not grandfathered (i.e., marketed as of February 15,
2007). Thus, as of August 8, 2016, marketing these products without FDA
authorization is prohibited by statute. However, FDA is affording
staggered compliance periods during which FDA does not intend to
enforce the premarket review requirements. These compliance periods are
general statements of policy that do not establish any rights for any
person, and are not binding on FDA or the public. (See e.g.,
Professionals and Patients for Customized Care v. Shalala, 56 F.3d 592
(5th Cir. 1995).) The commenter gives a vague reference to the rule
depriving manufacturers of a ``substantive right'' to market with no
hearing or substantive review, but without citing any authority for
such a right. Irrespective of the rule, a manufacturer does not have a
right to market a product that is in violation of the FD&C Act because
it does not have a required premarket authorization.
    (Comment 8) One commenter stated that FDA should allow
manufacturers to amend applications that FDA finds to be deficient and
consider the amended applications to be received as of their original
submission dates. The commenter explained that this approach would not
tie up Agency resources because FDA could simply notify an applicant of
any deficiencies and suspend substantive review until the applicant
resolves those issues and, as such, there is no valid reason for
requiring that applications be resubmitted rather than amended.
    (Response) FDA disagrees with this suggestion. Creating a queue of
deficient premarket submissions that FDA must track and manage is the
type of inefficient process that FDA seeks to eliminate from the
premarket submission review process with the rule. A queue for plainly
deficient submissions will require a redirection of FDA resources away
from more complete, quality submissions. Additionally, we disagree with
the suggestion that we should consider amended submissions to have been
received by the original submission date. This would allow
manufacturers to submit woefully deficient premarket submissions and
rely on FDA to identify deficiencies to be resolved.
    (Comment 9) One commenter argued that FDA should withdraw the rule
and instead issue rules specifying the content that must be contained
in each type of application because without such application-specific
rules, the rule is unconstitutionally vague. The commenter further
explained that without the promulgation of such content regulations, it
considers the rule to violate the Due Process Clause of the 5th
Amendment as well as the APA because it would allow FDA to deny
applications without fully explaining application content requirements
to applicants. Additionally, the comment asserts that the rule is
unduly vague under the Due Process Clause and the APA on the basis that
some of the criteria are either ``ill-defined or entirely undefined.''
    (Response) FDA disagrees with this comment. The rule is not
impermissibly vague as it provides applicants with fair notice of 10
criteria by which FDA will refuse to accept a premarket submission.
These criteria are not specific to the requirements of any one
premarket pathway but instead include basic parameters that apply to
all premarket submissions. Detailed criteria that are specific to each
premarket pathway are not necessary to implementing a rule that applies
to all types of premarket submissions generally without any
consideration of content specific to each premarket pathway. Any
additional grounds for which FDA may refuse a premarket submission
exist independently from this rulemaking; therefore, the vagueness of
such grounds, if any, is not attributable to the rule and does not
cause it to violate the Due Process clause of the 5th Amendment or the
APA. Further, the comment incorrectly asserts that some of the criteria
required by the rule are unduly vague under the Due Process Clause and
the APA. A law is impermissibly vague if it does not give ``a person of
ordinary intelligence a reasonable opportunity to know what is
prohibited.'' Grayned v. City of Rockford, 408 U.S. 104, 108 (1972). To
the extent that the commenter identifies concerns with specific
requirements of the rule, we address them in the responses to comments
10-14; however, FDA believes that the requirements of this rule are
sufficiently clear to give submitters a reasonable opportunity to be
aware of what information must be included with a tobacco product
application.
    (Comment 10) One commenter argued that FDA must edit the rule so
that it comprehensively states all potential refuse to accept criteria
for each premarket pathway and commit to accepting all submissions that
meet those specific criteria because granting FDA discretion to refuse
to accept submissions on the basis of criteria not specified in this
rule violates the principles of fair notice embodied in the
Constitution and the APA.
    (Response) FDA disagrees. Under Sec.  1105.10(b), FDA ``may accept
the submission'' if it ``finds that none of the reasons in paragraph
(a) of this section exists for refusing to accept a premarket
submission.'' The use of the word

``may'' in this section reflects the fact that this rule addresses the
basic threshold of acceptability that all premarket submissions must
meet; however it does not address other grounds on which FDA could
refuse to accept a specific type of premarket submission, such as the
omission of labeling from a PMTA that is required by section
910(b)(1)(F) of the FD&C Act. Any additional grounds on which FDA may
refuse to accept a premarket submission exist independently from this
rulemaking and are outside of its scope.
    (Comment 11) One commenter argues that FDA's discussion in the
preamble of the proposed rule regarding ``other information'' that FDA
recommends be included as part of the product-identifying information
submitted under Sec.  1105.10(a)(7) should either be deleted or
modified to provide a full and complete description of what ``other
information'' applicants should provide. The commenter also suggests
that FDA must state whether failure to provide such information would
be grounds for FDA to refuse to accept a submission.
    (Response) FDA disagrees with this comment. Section 1105.10(a)(7)
specifically lists the product-identifying information that is required
under the rule: The manufacturer of the tobacco product; the product
name, including the brand and subbrand; the product category and
subcategory; package type and package quantity; and characterizing
flavor. The preamble of the proposed rule notes that other information
may be needed to identify the product, such as product descriptors that
are not a part of the product name (e.g., premium), but it merely
requests such information be submitted to facilitate FDA's review.
Failure to include additional product-identifying information beyond
those specifically listed in Sec.  1105.10(a)(7) is not grounds for FDA
to refuse to accept a submission under the rule.
    (Comment 12) One commenter argued that FDA must either remove the
requirement in Sec.  1105.10(a)(7) that applicants specify the category
and subcategory of the tobacco product or provide a list of all
potential categories and subcategories. The commenter further noted
that FDA could require a uniform system of product identification under
21 U.S.C. 387e(e) (section 905(e) of the FD&C Act), but it has not yet
issued a regulation doing so.
    (Response) FDA disagrees with this comment. The rule requires
applicants to describe the category and subcategory of the tobacco
product that is the subject of the premarket submission. This is a
requirement to provide basic product-identifying information, such as
describing the product category as ``Smokeless Tobacco Product'' and
the subcategory as ``Dissolvable,'' which in no way creates a rigid
system of product identification with which an applicant must
comply.\2\ Creating an exhaustive product categorization system is not
necessary for applicants to describe the product's category and
subcategory and in some cases may not allow applicants to accurately
describe new tobacco products that fall into novel categories or
subcategories. Table 1 in the preamble of the proposed rule provides
some recommendations on how an applicant may satisfy this requirement,
but it is not intended to be an exhaustive list (for example, although
recommendations for waterpipes were not included in table 1,
submissions on waterpipes should include similar information). While
the table is not an exhaustive list of every tobacco product category
and subcategory that exists, manufacturers have enough information to
reasonably understand how to comply with the requirement and can
provide information based on internal classifications. Applicants
unable to identify the category or subcategory of the tobacco product
that will be the subject of a premarket submission are encouraged to
contact FDA prior to submission.
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    \2\ Applicants should note that some categories are defined in
section 900 of the FD&C Act (e.g., cigarette (900(3)), cigarette
tobacco (900(4)), roll-your-own tobacco (900(15)), smokeless tobacco
(900(18))).
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    (Comment 13) One commenter argued that FDA should not require an
applicant to identify the submission type as part of a premarket
submission because the list of submission types provided to implement
Sec.  1105.10(a)(8) is incomplete. To support this statement, the
commenter notes that the list in the preamble of the proposed rule does
not mention Product Quantity Change SE Reports as a potential premarket
submission type.
    (Response) FDA disagrees with the suggestion that manufacturers
should not be required to identify the type of application they are
submitting and that the list of submission types described in the
preamble of the proposed rule is incomplete. Identifying the type of
submission is necessary for FDA to review a premarket submission
because it enables FDA to determine the appropriate decisional standard
to apply to a submission (e.g., whether it is a PMTA subject to the
requirements of section 910 of the FD&C Act or an MRTPA subject to the
requirements of section 911 of the FD&C Act). The commenter is also
incorrect in its assertion that the proposed rule's discussion of the
types of premarket submissions is incomplete. The only example the
commenter provides to support this assertion is the Product Quantity
Change SE Reports, which are SE applications. The preamble of the
proposed rule described the types of premarket submissions, which are
PMTAs, MRTPAs, SE applications, and exemption requests (and subsequent
abbreviated reports). Applicants are welcome to provide additional
information regarding their submission type, such as specifying that
their SE application is being submitted for a product quantity change,
provided that the basic submission type remains clear. Applicants
unsure of how to identify the type of application that they are
submitting are encouraged to contact FDA prior to submission.
    (Comment 14) One commenter argued that FDA should remove the
requirement that a premarket submission be accompanied by required
forms because FDA has yet to require any forms and it is unclear what
those forms may eventually require. The commenter stated that if and
when FDA creates required forms, it can issue regulations providing how
and when the forms must be submitted.
    (Response) We disagree with the suggestion that this requirement
should be removed from the rule. As described in section IV of the
proposed rule, if and when FDA issues any forms it would need to do so
in accordance with applicable requirements, e.g., notice and
opportunity to comment on such forms in accordance with rulemaking
procedures and the Paperwork Reduction Act of 1995 and rulemaking under
the APA. We have chosen to include the form submission requirement in
this rule to provide notice that the failure to submit any required
forms, if and whenever they are issued, will be grounds for refusing to
accept a premarket submission.
    (Comment 15) One commenter argued that FDA should not require
applicants to identify whether a product has a characterizing flavor
until FDA has issued a full explanation of what it considers to be a
characterizing flavor and how it expects manufacturers to determine
what the characterizing flavor of a tobacco product is. The commenter
also argued that the requirement to identify a characterizing flavor
has no statutory basis and is not necessary to identify a product in
light of all other information FDA is requiring, such as the product
name, brand, subbrand, category, and subcategory.
    (Response) FDA disagrees with this comment. This requirement, along
with

the other product-identifying information in Sec.  1105.10(a)(7), will
identify to FDA the specific tobacco product that is the intended
subject of the application. As explained in the preamble to the
proposed rule, FDA is requiring this product-identifying information
under section 701 of the FD&C Act to efficiently enforce premarket
review requirements for tobacco requirements. For example, FDA needs to
be able to distinguish between products that have the same brand and
subbrand, but different flavors (e.g., brand X menthol or brand X
cinnamon). This also helps ensure that FDA ultimately issues an order
that addresses the intended tobacco product. For the purposes of the
refuse to accept process and to appropriately identify the specific
product that is the subject of the submission, FDA is solely looking to
see how the applicant identifies the tobacco product as having no
characterizing flavor or having a particular characterizing flavor.
Thus, for example, a firm would give ``menthol'' as the characterizing
flavor a tobacco product it identifies as ``Brand A menthol''. At the
acceptance stage, FDA would not review beyond how the product is
identified, such as to determine whether the product contains a
different or additional characterizing flavor. Applicants that have
questions regarding how to describe their product's characterizing
flavor are encouraged to contact FDA prior to submission.
    (Comment 16) One commenter argued that FDA should either modify the
rule so that it contains procedures to resolve disputes regarding
whether FDA should have refused to accept an application, or it should
specify whether the procedures for internal Agency review of decisions
specified in Sec.  10.75 (21 CFR 10.75) applies.
    (Response) The procedures for internal Agency review of decisions
in Sec.  10.75 apply to a decision of an FDA employee, other than
commissioner, on a matter. Applicants seeking review of a refuse to
accept decision may use this mechanism or consider other mechanisms set
out in part 10. FDA expects, however, that most applicants will find
that addressing any deficiencies in the application will quickly
resolve issues.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this 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.

VII. Federalism

    We have analyzed this 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.

VIII. 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 would 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;
consequently, a tribal summary impact statement is not required.

IX. 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.

X. Economic Analysis of Impacts

    We have examined the impacts of the 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 believe
that this 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 this rule establishes a procedure that FDA is
responsible for implementing and has the effect of providing all
entities useful feedback on the readiness of a submission, we certify
that the 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 proposing ``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 rule does not
result in expenditure in any year that meets or exceeds this amount.
    This rule identifies 10 significant and common deficiencies in
premarket tobacco submissions that will cause FDA to refuse to accept
them. Encouraging submissions that are free of the deficiencies listed
in this rule does not represent a change in Agency expectations. One of
the 10 deficiencies is required by statute (i.e., must be a tobacco
product). One of the deficiencies is required by another regulation
(i.e., must comply with requirements related to environmental
assessments or exclusions from such assessments). The remaining eight
deficiencies are basic expectations for an application to enter the
review process. Therefore, this rule clarifies these expectations. This
clarification will result in cost savings for both the applicant and
FDA as less time is spent by FDA working with applicants to address
these significant deficiencies. Applicants have clarity about basic
expectations regarding requirements for acceptance of premarket
applications. In addition, refusing to accept submissions with these
deficiencies will allow Agency staff to more efficiently process
submissions and quickly move those submissions without these
deficiencies into review of substantial scientific issues.

List of Subjects in 21 CFR Part 1105

    Administrative practices and procedures, Tobacco, Tobacco products.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner

of Food and Drugs, 21 CFR chapter I is amended by adding part 1105,
consisting of Sec.  1105.10, to read as follows:

PART 1105--GENERAL

    Authority: 21 U.S.C. 371(a), 387e, 387j, and 387k.

Subpart A--General Submission Requirements

Sec.  1105.10  Refusal to accept a premarket submission.

    (a) FDA will refuse to accept for review, as soon as practicable, a
premarket tobacco product application, modified risk tobacco product
application, substantial equivalence application, or exemption request
or subsequent abbreviated report for the following reasons, if
applicable:
    (1) The submission does not pertain to a tobacco product as defined
in 21 U.S.C. 321(rr).
    (2) The submission is not in English or does not contain complete
English translations of any information submitted within.
    (3) If submitted in an electronic format, the submission is in a
format that FDA cannot process, read, review, and archive.
    (4) The submission does not contain contact information, including
the applicant's name and address.
    (5) The submission is from a foreign applicant and does not
identify an authorized U.S. agent, including the agent's name and
address, for the submission.
    (6) The submission does not contain a required FDA form(s).
    (7) The submission does not contain the following product-
identifying information: The manufacturer of the tobacco product; the
product name, including the brand and subbrand; the product category
and subcategory; package type and package quantity; and characterizing
flavor.
    (8) The type of submission is not specified.
    (9) The submission does not contain a signature of a responsible
official, authorized to represent the applicant, who either resides in
or has a place of business in the United States.
    (10) For premarket tobacco applications, modified risk tobacco
product applications, substantial equivalence applications, and
exemption requests only: The submission does not include a valid claim
of categorical exclusion in accordance with part 25 of this chapter, or
an environmental assessment.
    (b) If FDA finds that none of the reasons in paragraph (a) of this
section exists for refusing to accept a premarket submission, FDA may
accept the submission for processing and further review. FDA will send
to the submitter an acknowledgement letter stating the submission has
been accepted for processing and further review and will provide the
premarket submission tracking number.
    (c) If FDA finds that any of the reasons in paragraph (a) of this
section exist for refusing to accept the submission, FDA will notify
the submitter in writing of the reason(s) and that the submission has
not been accepted, unless insufficient contact information was
provided.

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31370 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Notices]
[Page 45332]
[FR Doc No: 2016-16481]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78240; File No. SR-NYSEArca-2016-64]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proposed Rule
Change, as Modified by Amendment Nos. 1 and 2, To List and Trade Shares
of the AdvisorShares KIM Korea Equity ETF

July 7, 2016.
    On May 2, 2016, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares (``Shares'') of the AdvisorShares KIM Korea Equity ETF
(``Fund'') under NYSE Arca Equities Rule 8.600. On May 13, 2016, the
Exchange submitted Amendment No. 1 to the proposed rule change. The
Commission published notice of the proposed rule change, as modified by
Amendment No. 1, in the Federal Register on May 23, 2016.\3\ On May 23,
2016, the Exchange submitted Amendment No. 2 to the proposed rule
change.\4\ The Commission received no comments on the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 77847 (May 17,
2016), 81 FR 32364 (NYSEArca-2016-64).
    \4\ Amendment No. 2 is available at https://www.sec.gov/comments/sr-nysearca-2016-64/nysearca201664-2.pdf.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
Commission is extending this 45-day time period. The Commission finds
that it is appropriate to designate a longer period within which to
take action on the proposed rule change so that it has sufficient time
to consider the proposed rule change.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    Accordingly, the Commission, pursuant to section 19(b)(2) of the
Act,\6\ designates August 21, 2016 as the date by which the Commission
shall either approve or disapprove or institute proceedings to
determine whether to disapprove the proposed rule change (File Number
SR-NYSEArca-2016-64).
---------------------------------------------------------------------------

    \6\ Id.
    \7\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
Brent J. Fields,
Secretary.
[FR Doc. 2016-16481 Filed 7-12-16; 8:45 am]
 BILLING CODE 8011-01-P


                      Department of Environmental Quality

                                 Amanda Smith
Executive Director

                            DIVISION OF AIR QUALITY
                                 Cheryl Heying
Director

                      Department of Environmental Quality

                                 Amanda Smith
Executive Director

                            DIVISION OF AIR QUALITY
                                 Cheryl Heying
Director

                                State of Utah

                                GARY R. HERBERT
Governor

                                   GREG BELL
Lieutenant Governor

                                State of Utah

                                GARY R. HERBERT
Governor

                                   GREG BELL
Lieutenant Governor

150 North 1950 West :: Salt Lake City, UT                                                                                Mailing Address:  P.O. Box 144820 :: Salt Lake City, UT  84114-4820                                                                                Telephone<PHONE_NUMBER> :: Fax<PHONE_NUMBER> :: T.D.D.<PHONE_NUMBER>                                                                                www.deq.utah.gov
Printed on 100% recycled paper

                                                                    DAQE-026-09

December 14, 2009

Irene Heng
PacifiCorp, Inc.
1407 W. North Temple
Salt Lake City, Utah 84116

Dear Ms. Heng:

RE:	PacifiCorp, Inc Emission Credit Order

This Order confirms the transfer of 190 tons/year of NOx, 35 tons/year of SO2, and 150 tons/year PM10 banked emissions from Staker Parson Companies to PacifiCorp, Inc.  The transfer results in the following emissions balance for PacifiCorp, Inc. in the Utah County Emissions Credit Registry.

                     Utah County Emissions Credit Registry
                                   Pollutant
                         Previous Credits (tons/year)
                              Credit Transferred
                           By this Order (tons/year)
                      Total Emissions Credit (tons/year)
                                     PM10
                                     71.54
                                    150.00
                                    221.54
                                      SO2
                                     6.60
                                     35.00
                                     41.60
                                      NOx
                                    476.30
                                    190.00
                                    666.30

Should you have any questions, please feel free to call Camron Harry at<PHONE_NUMBER>, or Email<EMAIL_ADDRESS>

Sincerely,

M. Cheryl Heying, Executive Secretary
Utah Air Quality Board

MCH:CAH:sa


[Federal Register: November 27, 2007 (Volume 72, Number 227)]
[Notices]
[Page 66203]
[DOCID:fr27no07-120]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 206(4)-4; SEC File No. 270-304; OMB Control No. 3235-0345

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collections
of information summarized below. The Commission plans to submit these
existing collections of information to the Office of Management and
Budget for extension and approval.
    The title for the collection of information is ``Rule 206(4)-4''
(17 CFR 275.206(4)-4) under the Investment Advisers Act of 1940 (15
U.S.C. 80b-1 et seq.). Rule 206(4)-4 requires advisers to disclose
certain financial and disciplinary information to clients. The
disclosure requirements in rule 206(4)-4 are designed so that a client
will have information about an adviser's financial condition and
disciplinary events that may be material to an evaluation of the
adviser's integrity or ability to meet contractual commitments to
clients. Respondents are registered investment advisers with certain
disciplinary history or a financial condition that is reasonably likely
to affect contractual commitments. We estimate that approximately 1,839
advisers are subject to this rule. The rule requires approximately 7.5
burden hours per year per adviser and amounts to approximately 13,793
total burden hours (7.5 x 1,839) for all advisers.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312; or
send an e-mail to<EMAIL_ADDRESS>
    Dated: November 19, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-23004 Filed 11-26-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: July 2, 2008 (Volume 73, Number 128)]
[Rules and Regulations]
[Page 37786-37789]
[DOCID:fr02jy08-6]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0225; Directorate Identifier 2007-NM-210-AD;
Amendment 39-15583; AD 2008-13-20]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 757 Airplanes Equipped
With Rolls Royce RB211-535E Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 757 airplanes equipped with Rolls Royce RB211-535E
engines. This AD requires repetitive inspections for signs of damage of
the aft hinge fittings and attachment bolts of the thrust reversers,
and related investigative and corrective actions if necessary. This AD
results from reports of several incidents of bolt failure at the aft
hinge fittings of the thrust reversers due to, among other things, high
operational loads. We are issuing this AD to prevent failure of the
attachment bolts and consequent separation of a thrust reverser from
the airplane during flight, which could result in structural damage to
the airplane.

DATES: This AD is effective August 6, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 6,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jason Deutschman, Aerospace Engineer,
Airframe Branch, ANM-120S, Seattle Aircraft Certification Office, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6449; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 757 airplanes equipped with Rolls Royce RB211-535E
engines. That NPRM was published in

the Federal Register on November 26, 2007 (72 FR 65903). That NPRM
proposed to require repetitive inspections for signs of damage of the
aft hinge fittings and attachment bolts of the thrust reversers, and
related investigative and corrective actions if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Request to Include Terminating Action

    Continental Airlines (CAL) and Federal Express (FedEx) ask that the
preventive modification specified in Boeing Special Attention Service
Bulletins 757-54-0049 and 757-54-0050, both dated July 16, 2007, be
included in the AD as follows:
    CAL asks that a new paragraph be added to clarify that
accomplishing the preventive modification provided in Part III of the
above referenced service bulletins constitutes terminating action for
the repetitive inspections required by paragraph (f) of the NPRM.
    FedEx states that the referenced service bulletins specify that the
repetitive inspections are no longer necessary once the preventive
modification is accomplished. FedEx would like to confirm that
accomplishing the preventive modification will terminate any further
inspections in the NPRM, and asks that we include the terminating
action in the AD.
    We agree that clarification is necessary for the reasons provided;
therefore, we have added a new paragraph (h) to this AD (and re-
identified subsequent paragraphs) to include optional terminating
action for paragraph (f) of this AD.

Request To Clarify Applicability

    FedEx asks that Model 757-200SF (special freighter) airplanes be
added to the applicability specified in paragraph (c) of the NPRM.
FedEx states that the NPRM applies to Model 757-200, -200CB, -200PF,
and -300 series airplanes equipped with Rolls Royce RB211-535E engines.
FedEx states that its airplanes will be modified from the Model 757-200
passenger configuration to a special freighter configuration. FedEx
adds that it will submit a supplemental type certificate (STC) to the
FAA to confirm the new certification of the airplane after release of
this AD.
    We do not agree that Model 757-200SF airplanes should be added to
the applicability in this AD. The airplanes cited by the commenter are
legally known as ``Model 757-200 airplanes'' as identified on the
airplane data plate. Even though they might be modified by STC and
commonly known as ``special freighters,'' these airplanes continue to
be identified by the type certificated model designation. We have made
no change to the AD in this regard.
    FedEx also asks for clarification of the difference between the
effectivity specified in the concurrent service information referenced
in paragraph (h) of the NPRM and the applicability in the NPRM. FedEx
states that the concurrent service bulletin (Boeing Service Bulletin
757-54-0015, Revision 3, dated September 19, 1996) addresses the
replacement of older hinge fittings for airplanes having line numbers 2
through 241.
    We provide the following clarification. Paragraph (h) of the NPRM
(changed to paragraph (i) in the final rule) requires accomplishing the
actions in Boeing Service Bulletin 757-54-0015 prior to or concurrently
with accomplishing the actions specified in Boeing Special Attention
Service Bulletin 757-54-0049, dated July 16, 2007. Airplanes having
line number 242 and subsequent have the production change installed and
are covered by paragraph (e) of this AD. The NPRM is applicable to
airplanes equipped with Rolls Royce RB211-535E engines; no line numbers
are identified. Therefore, we have made no change to the AD in this
regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the change described previously. We also determined that
this change will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    There are about 606 airplanes of the affected design in the
worldwide fleet. This AD affects about 295 airplanes of U.S. registry.
The inspections take about 2 work hours per airplane, at an average
labor rate of $80 per work hour. Based on these figures, the estimated
cost of the AD for U.S. operators is $47,200, or $160 per airplane, per
inspection cycle.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-13-20 Boeing: Amendment 39-15583. Docket No. FAA-2007-0225;
Directorate Identifier 2007-NM-210-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective August 6,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 757-200, -200CB, -200PF, and
-300 series airplanes, certificated in any category; equipped with
Rolls Royce RB211-535E engines.

Unsafe Condition

    (d) This AD results from reports of several incidents of bolt
failure at the aft hinge fittings of the thrust reversers due to,
among other things, high operational loads. We are issuing this AD
to prevent failure of the attachment bolts and consequent separation
of a thrust reverser from the airplane during flight, which could
result in structural damage to the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Repetitive Inspections/Investigative and Corrective Actions

    (f) At the time specified in paragraph 1.E. ``Compliance,'' of
Boeing Special Attention Service Bulletin 757-54-0049 or 757-54-
0050, both dated July 16, 2007, as applicable, except as provided by
paragraph (g) of this AD: Do a detailed inspection for signs of
damage of the aft hinge fittings and attachment bolts of the thrust
reversers by doing all the actions, including all applicable related
investigative and corrective actions, as specified in the
Accomplishment Instructions of the applicable service bulletin. Do
all applicable related investigative and corrective actions at the
time specified in paragraph 1.E., ``Compliance,'' of the applicable
service bulletin. If any damage is found and the service bulletins
specify to contact Boeing for appropriate action: Before further
flight, repair using a method approved in accordance with the
procedures specified in paragraph (k) of this AD.
    (g) Where Boeing Special Attention Service Bulletins 757-54-0049
and 757-54-0050, both dated July 16, 2007, specify compliance times
relative to the date on the service bulletin, this AD requires
compliance within the specified compliance time after the effective
date of this AD.

Optional Terminating Action

    (h) Accomplishing the preventive modification specified in
Boeing Special Attention Service Bulletin 757-54-0049 or 757-54-
0050, both dated July 16, 2007, terminates the repetitive
inspections required by paragraph (f) of this AD.

Concurrent Actions

    (i) Prior to or concurrently with accomplishing the actions
specified in Boeing Special Attention Service Bulletin 757-54-0049,
dated July 16, 2007, accomplish the replacement specified in Boeing
Service Bulletin 757-54-0015, Revision 3, dated September 19, 1996.
    (j) Actions accomplished before the effective date of this AD in
accordance with Boeing Service Bulletin 757-54-0015, dated February
16, 1989; Revision 1, dated December 20, 1990; or Revision 2, dated
April 21, 1994 are considered acceptable for compliance with the
corresponding actions specified in paragraph (i) of this AD.

Alternative Methods of Compliance (AMOCs)

    (k)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (l) You must use the Boeing service information contained in
Table 1 of this AD to do the actions required by this AD, unless the
AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (3) You may review copies of the service information that is
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

                                  Table 1.--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
          Service information                         Revision                               Date
----------------------------------------------------------------------------------------------------------------
Boeing Special Attention Service        3..................................  September 19, 1996.
 Bulletin 757-54-0015.
Boeing Special Attention Service        Original...........................  July 16, 2007.
 Bulletin 757-54-0049.
Boeing Service Bulletin 757-54-0050...  Original...........................  July 16, 2007.
----------------------------------------------------------------------------------------------------------------

    Issued in Renton, Washington, on June 8, 2008.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-14190 Filed 7-1-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15388-15389]
[FR Doc No: 2023-05098]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-1252-000]

Ortega Grid, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Ortega Grid, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 27, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: March 7, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-05098 Filed 3-10-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Rules and Regulations]
[Page 8483-8484]
[DOCID:fr25fe10-10]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0858; Airspace Docket No. 09-ASW-22]

Amendment of Class E Airspace; Llano, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace for Llano, TX, adding
additional controlled airspace to accommodate Area Navigation (RNAV)
Standard Instrument Approach Procedures (SIAPs) at Llano Municipal
Airport, Llano, TX, and updates the airport's geographic coordinates.
The FAA is taking this action to enhance the safety and management of
Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective 0901 UTC, June 3, 2010. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On October 14, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for Llano, TX,
reconfiguring controlled airspace at Llano Municipal Airport, Llano, TX
(74 FR 52702) Docket No. FAA-2009-0858. Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9T
signed August 27, 2009, and effective September 15, 2009, which is
incorporated by reference in 14 CFR Part 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace for the Llano, TX area, adding
additional controlled airspace extending upward from 700 feet above the
surface to accommodate SIAPs at Llano Municipal Airport, Llano, TX.
This action also updates the geographic coordinates of Llano Municipal
Airport to coincide with the FAA's National Aeronautical Charting
Office. This action is necessary for the safety and management of IFR
operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3)

does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Llano Municipal Airport, Llano, TX.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is amended as follows:
* * * * *
Paragraph 6005 Class E airspace areas extending upward from 700 feet
or more above the surface.
* * * * *

ASW TX E5 Llano, TX [Amended]

Llano Municipal Airport, TX
    (Lat. 30[deg]47'01'' N., long. 98[deg]39'43'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Llano Municipal Airport and within 4
miles each side of the 359[deg] bearing from the airport extending
from the 6.5-mile radius to 13.5 miles north of the airport.
* * * * *

    Issued in Fort Worth, Texas, on February 4, 2010.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-3738 Filed 2-24-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22875-22876]
[FR Doc No: 2022-08239]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC22-47-000.
    Applicants: Berkshire Hathaway Inc.
    Description: Supplement to March 21, 2022 Application for
Authorization Under Section 203 of the Federal Power Act of Berkshire
Hathaway Inc.
    Filed Date: 4/11/22.
    Accession Number: 20220411-5197.
    Comment Date: 5 p.m. ET 4/21/22.

    Docket Numbers: EC22-52-000.
    Applicants: Hallador Power Company, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act of Hallador Power Company, LLC.
    Filed Date: 4/11/22.
    Accession Number: 20220411-5199.
    Comment Date: 5 p.m. ET 5/2/22.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL22-51-000.
    Applicants: King Mountain Upton Wind, LLC.
    Description: Petition for Declaratory Order of [King Mountain Upton
Wind, LLC].
    Filed Date: 4/5/22.
    Accession Number: 20220405-5210.
    Comment Date: 5 p.m. ET 5/5/22.

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

    Docket Numbers: ER17-1821-004.
    Applicants: Panda Stonewall LLC.
    Description: Refund Report: Potomac Energy Center, LLC submits
tariff filing per 35.19a(b): Refund Report to be effective N/A.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5042.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER21-1005-003.
    Applicants: Montana-Dakota Utilities Co.
    Description: Compliance filing: Reactive Service Rate Schedule
Compliance Filing to be effective 4/1/2021.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5109.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1008-002.
    Applicants: AEP Texas Inc.
    Description: Tariff Amendment: AEPTX-ETT (Salvare) First Amended
and Restated Facilities Development Agreement to be effective 1/27/
2022.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5056.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1610-000.
    Applicants: Big River Solar, LLC.
    Description: Baseline eTariff Filing: Reactive Power Compensation
Filing to be effective 6/11/2022.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5023.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1611-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2022-04-12 Mosca to San Luis
115kV--678--Concurrence to be effective 2/25/2022.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5025.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1612-000.
    Applicants: Central Maine Power Company.
    Description: Sec.  205(d) Rate Filing: Second Amendment to Sappi
North America, Inc. Interconnection Agreement to be effective 12/31/
9998.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5037.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1613-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to Rate Schedule
FERC No. 72 to be effective 6/13/2022.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5104.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1614-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA, SA No.
5875; Queue No. AE2-129 (amend) to be effective 12/3/2020.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5125.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1615-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Notice of Cancellation of ICSA, SA
No. 5551; Queue No. AB2-047 re: complete to be effective 10/30/2020.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5153.
    Comment Date: 5 p.m. ET 5/3/22.

    Docket Numbers: ER22-1616-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 6423; Queue No. AG1-197 to be effective 3/14/2022.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5165.
    Comment Date: 5 p.m. ET 5/3/22

    Docket Numbers: ER22-1617-000.
    Applicants: American Electric Power Service Corporation, Ohio Power
Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: American Electric Power
Service Corporation submits tariff filing per 35.13(a)(2)(iii: AEP
submits four Facilities Agreements re: ILDSA, SA No. 1336 to be
effective 6/12/2022.
    Filed Date: 4/12/22.
    Accession Number: 20220412-5168.
    Comment Date: 5 p.m. ET 5/3/22.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH22-9-000.
    Applicants: New Jersey Resources Corporation.
    Description: New Jersey Resources Corporation submits FERC 65-A
Exemption Notification.
    Filed Date: 4/8/22.
    Accession Number: 20220408-5272.
    Comment Date: 5 p.m. ET 4/29/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing

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

    Dated: April 12, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-08239 Filed 4-15-22; 8:45 am]
BILLING CODE 6717-01-P