[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60403-60405]
[FR Doc No: 2017-27157]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6580]

Drug Products Labeled as Homeopathic; Draft Guidance for Food and
Drug Administration Staff and Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for FDA staff and industry
entitled ``Drug Products Labeled as Homeopathic.'' This draft guidance
describes how FDA intends to prioritize enforcement and regulatory
action with regard to drug products, including biological products,
labeled as homeopathic and marketed in the United States without the
required FDA approval.

DATES: Submit either electronic or written comments on the draft
guidance by March 20, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6580 for ``Drug Products Labeled as Homeopathic.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796-
3600; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for FDA
staff and industry entitled ``Drug Products Labeled as Homeopathic.''
This draft guidance describes how FDA intends to prioritize enforcement
and regulatory action with regard to drug products, including
biological products, labeled as homeopathic and marketed in the United
States without the required FDA approval. Simultaneous with the
issuance of the final guidance, FDA will withdraw Compliance Policy
Guide (CPG) 400.400, ``Conditions Under Which Homeopathic Drugs May be
Marketed'', issued on May 31, 1988.
    Homeopathy is an alternative medical practice that has an
historical basis in theory and practice first systematized in the late
1700s. Homeopathy is generally based on two main principles: (1) A
substance that causes symptoms in a healthy person can be used in
diluted form to treat symptoms and illnesses (known as ``like-cures-
like'') and (2) the more diluted the substance, the more potent it is
(known as the ``law of infinitesimals'').
    The definition of ``drug'' in section 201(g)(1) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1))
includes articles recognized in the Homeopathic Pharmacopoeia of the
United States (HPUS) or any supplement to it. As such, homeopathic
drugs are subject to the same regulatory requirements as other drugs.
Generally, a drug, including a homeopathic drug, is considered a ``new
drug'' if it is not generally recognized by qualified experts as safe
and effective (GRAS/E) for its labeled uses (section 201(p) of the FD&C
Act). FDA makes GRAS/E determinations for over-the-counter (OTC) drugs
marketed under the OTC Drug Review (see 21 CFR part 330). FDA has not
reviewed any drug products labeled as homeopathic under the OTC Drug
Review because the Agency categorized these products as a separate
category and deferred consideration of them (37 FR 9464 at 9466 (May
11, 1972)). Under section 505(a) of the FD&C Act (21 U.S.C. 355(a)),
before any ``new drug'' is marketed, it must be the subject of an
approved application submitted pursuant to section 505(b) or section
505(j) of the FD&C Act; however, a biological product with an approved
license under section 351(a) of the Public Health Service Act (PHS Act)
(42 U.S.C. 262(a)) is not required to have an approved application
under section 505 of the FD&C Act. Accordingly, absent a determination
that a drug product labeled as homeopathic is not a ``new drug'' under
section 201(p), all drug products labeled as homeopathic are subject to
the premarket approval requirements in section 505 of the FD&C Act or
section 351 of the PHS Act. There are no drug products labeled as
homeopathic that are approved by FDA.
    In May 1988, FDA's Center for Drug Evaluation and Research issued
CPG 400.400 entitled ``Conditions Under Which Homeopathic Drugs May be
Marketed.'' As stated in the 1988 CPG, it delineates the conditions,
including conditions related to ingredients, labeling, prescription
status, and current good manufacturing practice, under which
homeopathic drug products may ordinarily be marketed.
    In light of the growth of the industry and passage of more than 2
decades since the 1988 CPG's issuance, FDA announced on March 27, 2015,
that it was evaluating its regulatory framework for these products. In
April 2015, FDA held a public hearing to obtain information and
comments from stakeholders about the current use of drug products
labeled as homeopathic, as well as the Agency's regulatory

framework for such products (Docket No. FDA-2015-N-0540; available at
https://www.regulations.gov/docket?D=FDA-2015-N-0540). FDA sought broad
public input on its enforcement policies related to drug products
labeled as homeopathic in an effort to better promote and protect the
public health.
    As a result of the Agency's evaluation, including consideration of
the public input received on this issue, FDA has determined that it is
in the best interest of public health to issue a new guidance that
applies a risk-based enforcement approach to drug products labeled as
homeopathic and marketed in the United States without the required FDA
approval, consistent with FDA's risk-based regulatory approaches
generally. The Agency generally intends to apply a risk-based
enforcement approach to the manufacturing, distribution, and marketing
of drug products labeled as homeopathic, as described in the draft
guidance, when finalized. However, the Agency has limited enforcement
resources and recognizes that many such products likely will fall
outside the risk-based categories described in the draft guidance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on drug products
labeled as homeopathic. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27157 Filed 12-18-17; 11:15 am]
 BILLING CODE 4164-01-P


MEMORANDUM

Tetra Tech, Inc.

400 Red Brook Blvd., Suite 200

Owings Mills, MD 21117

phone<PHONE_NUMBER>

fax<PHONE_NUMBER>

DATE: 		March 20, 2008

TO:			Paul Shriner, EPA

FROM:		Henry Latimer, Blaine Snyder, and Chris Millard

SUBJECT:		Taxonomically-based fish species grouping scheme

As part of a larger effort to interpret potential impingement mortality
and entrainment (IM&E) effects, it is desirable to organize fish species
into groups with similar IM&E vulnerabilities.  Ideally, these groups
would comprise fish species with similar characteristics (e.g., swim
speed, schooling behavior, reproductive and life history
characteristics) as well as habitat preferences (e.g., benthic vs.
pelagic, river vs. lake, freshwater vs. estuarine).  However, given the
number of fish species potentially exposed to IM&E and the effort
required to summarize relevant information to be used in grouping these
species, a first effort based simply on taxonomy has been undertaken.
The goals of this effort are to 1) help define the scope of the species
grouping effort and 2) better understand the types of information
required to successfully assemble species into meaningful groups.

There are currently 3,694 fish species in North America (Nelson et al.
2004).  Functionally, many of these species are not likely to be exposed
to cooling water intake structures (CWIS) in the U.S., either because
they occur only in Mexico or Canada or are pelagic marine species that
are unlikely to occur in near-shore waters.  The list of North American
fish species was screened to eliminate those that do not occur in the
U.S. and those that are unlikely to occur in near-shore waters.
Following this screening, 1,279 species remain that could reasonably be
expected to occur in the U.S. in the vicinity of CWISs and be exposed to
IM&E related to those CWISs.  This list includes all freshwater and most
(if not all) estuarine fish.  Future, comprehensive species grouping
efforts will require that marine species be reviewed in greater depth to
determine which species should be considered to be reasonably vulnerable
to IM&E.

To minimize the number of fish species groups, the taxonomic level
selected for use as a basis for groupings must be fairly general, but
specific enough to capture meaningful morphological and habitat-specific
differences among the various species.  For this exercise, we selected
Family as the appropriate level for use as the basis in establishing
groups.  Dividing the groups based on Class was determined to result in
species groupings that lumped clearly dissimilar species together.
Groups based on Genera would be preferable in terms of lumping more
similar species together, however such an approach yields so many groups
(278) as to limit the utility of a grouping approach.

The family-level evaluation yields 72 different groups (see attached
spreadsheet).  It is likely that in refining this approach, similarities
among some Families will be identified that will allow for several of
these distinct groups to be combined.  However, it is also known that
variations in morphology and preferred habitat within some Families will
require that those groupings be further sub-divided.

Based on a brief analysis, it is possible that some species from
differing families could be combined.  For example, some members of the
sculpin Family (Cottidae) would be able to be combined with some members
of the Perch Family (e.g., darters), in that some species within each
group exhibit similar, benthic habitat preferences.  However, further
investigation into habitat preferences, geographic ranges, and swim
speed analyses is required before such groupings can be made.  It is
also likely that some, more diverse Families would require further
division to more accurately represent the IM&E vulnerabilities of these
groups.  For instance, the minnow family (Cyprinidae) which contains
carp, minnows, and pike minnows would likely have to be divided into at
least three groups that are reflective of the diverse body sizes,
habitats, and swim speeds of fish within this family.

Thus, while a taxonomically-based species grouping effort is a
reasonable initial step in grouping fish species in terms of IM&E
vulnerability, there are clear shortcomings of this approach.  To
assemble larger and more inclusive species groups, the scientific
literature must be evaluated to gather data on species-specific habitat
preferences, geographic range, and swim speeds.  Such information is
required to determine whether the groupings based on potential IM&E
vulnerability are similar to existing taxonomic groupings and, if not,
how such groupings could be refined.  Further, information should be
assembled for more than one life-stage to ensure that the IM&E
vulnerability of potentially more sensitive (but less well-studied) life
stages (e.g., egg) are adequately addressed.  It is likely that the
scientific literature does not contain complete, relevant information
for the majority (possibly the vast majority) of species.  It is
expected that this more in depth approach would be able to propose IM&E
vulnerability values for a subset of all fish species.  These values
would then be extrapolated and applied to all taxonomically similar
species within each group.  The scientific validity of the final
proposed grouping schemes would be directly dependent upon the amount of
available species-specific data available in the literature.

An alternative approach would be to refine the species list (currently
1,279 for freshwater and estuarine in the U.S. and 3,694 if all North
American fish are included) based upon those fish that can reasonably be
expected to be subject to IM&E.  A judgment as to which species can
reasonably be expected to be subject to IM&E could be made based upon an
analysis of those fish species actually impinged and entrained through
CWISs at representative facilities (e.g., encompassing intake types,
sizes, and locations) throughout the U.S.  Such data from facilities
located in all geographic (e.g., Northeast, Southwest, Midwest) areas
and water body types (e.g., river, lake, Great Lakes, estuary, marine)
have already been collected and are available in state and/or EPA
records.  Evaluation of assembled impingement and entrainment (I&E) data
would be expected to yield a much more limited list of species which are
demonstrably subject to IM&E in the U.S.

A list of species that are actually subject to IM&E would be useful for
a variety of reasons.  This list would be expected to represent a small
percentage of all species in the U.S., thus enabling species grouping
efforts to be streamlined, more relevant, and likely more scientifically
defensible.  Such a list would also reveal real-world data that is
directly relevant to species specific IM&E vulnerability which may be
more useful that literature-derived data that may have questionable
application in determining IM&E vulnerability.  The resulting list would
also allow alternative approaches to be explored to evaluate and
regulate IM&E.  Further, this list would allow EPA to make more informed
decisions as to how IM&E regulations should be applied to various water
body types and how the various water body types could reasonably be
combined (e.g., address whether separation of lakes and rivers is
appropriate or necessary).

We are optimistic that some type of species grouping scheme is possible.
 However, we believe that inclusion of actual I&E data is a necessary
step to screen the list of all possible fish species to assemble a list
of fish species that can reasonably be expected to be subject to IM&E.
Using this revised list, a more appropriate and defensible IM&E
vulnerability assessment could be made of each species, and reasonable
species groupings could then be assembled with a fairly high degree of
confidence.

Literature Cited

Nelson, J.S., E.J. Crossman, H. Espinosa-Perez, L.T. Findley, C.R.
Gilbert, R.N. Lea, and J.D. Williams.  2004.  Common and scientific
names of fishes from the Unites States, Canada, and Mexico.  American
Fisheries Society, Special Publication 29, Bethesda, Maryland.


[Federal Register: May 27, 2010 (Volume 75, Number 102)]
[Notices]
[Page 29779-29780]
[DOCID:fr27my10-84]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2010-0030]

Agency Information Collection Activities: Proposed Collection;
Comment Request, 1660-0102; Federal Emergency Management Agency Housing
Inspection Services Customer Satisfaction Survey

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; revision of a
currently approved information collection; OMB No. 1660-0102; FEMA Form
007-0-1, Federal Emergency Management Agency Housing Inspection
Services Customer Satisfaction Survey.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this Notice seeks comments concerning FEMA conducting surveys to
determine the level of satisfaction of applicants for FEMA disaster
assistance with contracted inspectors and the process in their housing
inspections.

DATES: Comments must be submitted on or before July 26, 2010.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http://www.regulations.gov under
Docket ID FEMA-2010-0030. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Office of Chief Counsel,
Regulation and Policy Team, DHS/FEMA, 500 C Street, SW., Room 835,
Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2010-0030 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Contact Dawson Riggleman, Contract
Officer Technical Representative,<PHONE_NUMBER> for additional
information. You may contact the Office of Records Management for
copies of the proposed collection of information at facsimile number
(202) 646-3347 or e-mail address: FEMA-Information-Collections-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This collection is in accordance with
Executive Order 12862 (September 11, 1993), that requires all Federal
agencies to survey customers to determine the kind and quality of
services they want and their level of satisfaction with existing
services. In addition, the Government Performance and Results Act
(GPRA) requires agencies to set missions and goals and measure
performance against them. FEMA will fulfill these requirements, in
part, by collecting customer service information through a survey of
the FEMA Recovery Division's external customers.

Collection of Information

    Title: Federal Emergency Management Agency Housing Inspection
Services Customer Satisfaction Survey.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0102.
    Form Titles and Numbers: FEMA Form 007-0-1, Federal Emergency
Management Agency Housing Inspection Services Customer Satisfaction
Survey.
    Abstract: FEMA Housing Inspection Services contracts inspectors to
assess dwelling damage and verify personal information of applicants
for FEMA disaster assistance in federally declared disasters areas.
Because FEMA needs to evaluate the inspectors' performance, FEMA
conducts surveys to measure the satisfaction level of the applicants
with their inspection experience. FEMA Inspection Services Managers and
Task Monitors generally use the survey results to gauge and make
improvements to disaster services that increase customer satisfaction
and program effectiveness. The information is shared with Regional
staff specific to the federal declaration for which the survey is
conducted.
    Affected Public: Individuals or households.
    Estimated Total Annual Burden Hours: 2,541 burden hours.

                                                       Estimated Annualized Burden Hours and Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                Avg. burden     Total                     Total
                                                                Number of    responses      Total         per         annual    Avg. hourly     annual
         Type of respondent              Form name/Form No.    respondents      per       number of     response   burden  (in   wage rate    respondent
                                                                             respondent   responses    (in hours)     hours)                     cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individuals in Households...........  Federal Emergency             10,164            1       10,164      .25 (15        2,541       $28.45   $72,291.45
                                       Management Agency                                                 minutes)
                                       Housing Inspection
                                       Services Customer
                                       Satisfaction Survey/
                                       FEMA Form 007-0-1.
                                                              ------------------------------------------------------------------------------------------
    Total...........................  .......................       10,164  ...........       10,164  ...........        2,541  ...........    72,291.45
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Capital or Start-up Cost: There are no record keeping,
capital, start-up or maintenance costs associated with this information
collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: May 20, 2010.
Tammi Hines,
Acting Director, Records Management Division, Mission Support Bureau,
Federal Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2010-12733 Filed 5-26-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Rules and Regulations]
[Pages 69372-69373]
[FR Doc No: 2014-26860]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0309; Airspace Docket No. 14-AWP-3]

Amendment of Class E Airspace; Lakeport, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Lakeport, CA.
Controlled airspace is necessary to accommodate Area Navigation (RNAV)
Global Positioning System (GPS) standard instrument approach procedures
at Lampson Field. The FAA is taking this action to enhance the safety
and management of instrument flight rules (IFR) operations at the
airport.

DATES: Effective date, 0901 UTC, January 8, 2015. 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.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call
(202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and Regulations Group,
Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC, 20591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA, 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On July 23, 2014 the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to amend controlled airspace at Lakeport,
CA (79 FR 42723). Interested parties were invited to participate in
this rulemaking effort by submitting written comments on the proposal
to the FAA. One comment from Martin Breunig was received in favor of
the proposal.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9Y, dated August 6, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR Part 71.1. The E
airspace designations listed in this document will be published
subsequently in this Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by creating Class E airspace extending upward from 700 feet
above the surface within a 4-mile radius of Lampson Field, Lakeport,
CA. Controlled airspace is needed for RNAV (GPS) standard instrument
approaches and departures. This action enhances the safety and
management of IFR operations at the airport.
    The FAA has determined 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
only affects air traffic procedures and air navigation, it is certified
this rule, when promulgated, does 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 discusses 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 modifies
controlled airspace at Lampson Field, Lakeport, CA.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion

under the National Environmental Policy Act in accordance with FAA
Order 1050.1E, ``Environmental Impacts: Policies and Procedures,''
paragraph 311a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    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 7400.9Y, Airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP CA E5 Lakeport, CA [Amended]

Lampson Field, CA
    (Lat. 38[deg]59'26'' N., long. 122[deg]54'03'' W.)
Sutter Lakeside Hospital Heliport, CA Point in Space Coordinates
    (Lat. 39[deg]06'09'' N., long. 122[deg]53'19'' W.)

    That airspace extending upward from 700 feet above the surface
within a 4-mile radius of Lampson Field, and within a 5-mile radius
of the Point in Space serving the Sutter Lakeside Hospital Heliport.

    Issued in Seattle, Washington, on November 6, 2014.
Christopher Ramirez,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2014-26860 Filed 11-20-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 70 (Thursday, April 11, 2019)]
[Notices]
[Pages 14666-14668]
[FR Doc No: 2019-07163]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1918]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before July 10, 2019.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://www.fema.gov/preliminaryfloodhazarddata and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1918, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed 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 used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information 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 also will be considered before 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 only may 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 https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://www.fema.gov/preliminaryfloodhazarddata and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

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

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Carroll County, Kentucky and Incorporated Areas
        Project: 12-04-8528S Preliminary Date: September 20, 2018
------------------------------------------------------------------------
City of Prestonville...................  Carroll County Emergency
                                          Operations Center, 829 Polk
                                          Street, Carrollton, KY 41008.
------------------------------------------------------------------------
Unincorporated Areas of Carroll County.  Carroll County Emergency
                                          Operations Center, 829 Polk
                                          Street, Carrollton, KY 41008.
------------------------------------------------------------------------
              Henry County, Kentucky and Incorporated Areas
        Project: 12-04-8528S Preliminary Date: September 20, 2018
------------------------------------------------------------------------
Unincorporated Areas of Henry County...  Henry County Planning and
                                          Zoning Department, 19 South
                                          Property Road, New Castle, KY
                                          40050.
------------------------------------------------------------------------
             Oldham County, Kentucky and Incorporated Areas
        Project: 12-04-8528S Preliminary Date: September 20, 2018
------------------------------------------------------------------------
City of Crestwood......................  Oldham County Planning and
                                          Zoning Department, 100 West
                                          Jefferson Street, La Grange,
                                          KY 40031.
City of La Grange......................  Oldham County Planning and
                                          Zoning Department, 100 West
                                          Jefferson Street, La Grange,
                                          KY 40031.
City of Orchard Grass Hills............  Oldham County Planning and
                                          Zoning Department, 100 West
                                          Jefferson Street, La Grange,
                                          KY 40031.
Unincorporated Areas of Oldham County..  Oldham County Planning and
                                          Zoning Department, 100 West
                                          Jefferson Street, La Grange,
                                          KY 40031.
------------------------------------------------------------------------
             Spencer County, Kentucky and Incorporated Areas
        Project: 18-04-0034S Preliminary Date: September 28, 2018
------------------------------------------------------------------------
City of Taylorsville...................  Spencer County Planning and
                                          Zoning, 220 Main Cross,
                                          Taylorsville, KY 40071.
Unincorporated Areas of Spencer County.  Spencer County Planning and
                                          Zoning, 220 Main Cross,
                                          Taylorsville, KY 40071.
------------------------------------------------------------------------
             Trimble County, Kentucky and Incorporated Areas
        Project: 12-04-8528S Preliminary Date: September 20, 2018
------------------------------------------------------------------------
City of Milton.........................  City Hall, 10179 Highway 421
                                          North, Milton, KY 40045.
Unincorporated Areas of Trimble County.  Office of Executive County
                                          Judge, 123 Church Street,
                                          Bedford, KY 40006.
------------------------------------------------------------------------
            Bradford County, Pennsylvania (All Jurisdictions)
         Project: 16-03-0615S Preliminary Date: August 30, 2018
------------------------------------------------------------------------
Borough of Athens......................  Municipal Building, 2 South
                                          River Street, Athens, PA
                                          18810.
Borough of Sayre.......................  Borough Hall, 110 West Packer
                                          Avenue, Sayre, PA 18840.
Borough of Towanda.....................  Municipal Building, 724 Main
                                          Street, Towanda, PA 18848.
Borough of Wyalusing...................  Borough Hall, 50 Senate Street,
                                          Wyalusing, PA 18853.
Township of Asylum.....................  Asylum Township Building, 19981
                                          Route 187, Towanda, PA 18848.
Township of Athens.....................  Athens Township Building, 45
                                          Herrick Avenue, Sayre, PA
                                          18840.
Township of Litchfield.................  Litchfield Township Building,
                                          1391 Hill Road, Sayre, PA
                                          18840.
Township of North Towanda..............  North Towanda Township Office,
                                          292 Old Mills Road, Towanda,
                                          PA 18848.
Township of Sheshequin.................  Sheshequin Township Office,
                                          1774 North Middle Road,
                                          Ulster, PA 18850.
Township of Standing Stone.............  Standing Stone Township
                                          Building, 35165 Route 6,
                                          Wysox, PA 18854.
Township of Terry......................  Terry Township Building, 1876
                                          Rienze Road, Wyalusing, PA
                                          18853.
Township of Towanda....................  Township Office, 44 Chapel
                                          Street, Towanda, PA 18848.
Township of Tuscarora..................  Tuscarora Township Building,
                                          2298 Underhill Road,
                                          Laceyville, PA 18623.

Township of Ulster.....................  Municipal Building, 23849 Route
                                          220, Ulster, PA 18850.
Township of Wilmot.....................  Wilmot Township Municipal
                                          Building, 4861 Route 187,
                                          Sugar Run, PA 18846.
Township of Wyalusing..................  Township Hall, 41908 Route 6,
                                          Wyalusing, PA 18853.
Township of Wysox......................  Township Building, 1789
                                          Hillside Drive, Wysox, PA
                                          18854.
------------------------------------------------------------------------

[FR Doc. 2019-07163 Filed 4-10-19; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Notices]
[Pages 47624-47625]
[FR Doc No: 2012-19524]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-2374-000]

Tall Bear Group, 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 Tall Bear Group, LLC's application for market-based rate authority,
with an accompanying rate schedule, 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 August 24, 2012.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 3, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-19524 Filed 8-8-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Page 48478]
[FR Doc No: 2022-17081]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-10124-01-OA; EPA-HQ-OA-2022-0053]

National Environmental Justice Advisory Council; Notification of
Virtual Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification for a public meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), the
U.S. Environmental Protection Agency (EPA) hereby provides notice that
the National Environmental Justice Advisory Council (NEJAC) will meet
on the date and time described below. The meeting is open to the
public. Members of the public are encouraged to provide comments
relevant to EPA's pursuit in addressing Environmental Justice and any
related topics being considered by the NEJAC. For additional
information about registering to attend the meeting or to provide
public comment, please see ``Registration'' under SUPPLEMENTARY
INFORMATION. Pre-Registration is required.

DATES: The NEJAC will convene a virtual public meeting on Wednesday,
September 28, 2022, from approximately 12:00 p.m. to 6:00 p.m., Eastern
Time. The meeting discussions will focus on several topics including,
but not limited to, EPA administration priorities, recommendations on
EPA's 2021 PFAS (per- and polyfluoroalkyl substances) Strategic
Roadmap, and recommendations on community air quality monitoring that
provides greater protection, and clean and healthy air to environmental
justice communities. A public comment period relevant to the specific
issues will be considered by the NEJAC during the meeting (see
SUPPLEMENTARY INFORMATION). Members of the public who wish to register
to speak during the public comment period must register by 11:59 p.m.,
Eastern Time, September 21, 2022.

FOR FURTHER INFORMATION CONTACT: Paula Flores-Gregg, NEJAC Designated
Federal Officer, U.S. EPA; email: [email protected]; or by telephone at:
(214) 665-8123. Additional information about the NEJAC is available at
https://www.epa.gov/environmentaljustice/national-environmental-justice-advisory-council.

SUPPLEMENTARY INFORMATION: The Charter of the NEJAC states that the
advisory committee ``will provide independent advice and
recommendations to the Administrator about broad, crosscutting issues
related to environmental justice. The NEJAC's efforts will include
evaluation of a broad range of strategic, scientific, technological,
regulatory, community engagement and economic issues related to
environmental justice.''
    Registration: Individual registration is required for the virtual
public meeting. No two individuals can share the same registration
link. Information on how to register is located at https://www.epa.gov/environmentaljustice/national-environmental-justice-advisory-council-
meetings. Registration to attend the meetings is available through the
scheduled end time of the meeting day. Registration to speak during the
virtual public comment period will close at 11:59 p.m., Eastern Time,
September 21, 2022. When registering, please provide your name,
organization, city and state, and email address for follow up. Please
indicate if you would like to provide oral public comment during the
meeting, and if you are submitting written comments at time of
registration.

A. Public Comment

    The NEJAC is interested in receiving public comments on several
topics including, but not limited to, EPA administration priorities and
recommendations on EPA's 2021 PFAS (per- and polyfluoroalkyl
substances) Strategic Roadmap, and recommendations on community air
quality monitoring that provides greater protection, and clean and
healthy air to environmental justice communities. Every effort will be
made to hear from as many registered public commenters during the time
specified on the agenda. Individuals or groups making remarks during
the oral public comment period will be limited to three (3) minutes.
Please be prepared to briefly describe your comments; including what
you want the NEJAC to advise the EPA to do. Submitting written comments
for the record are strongly encouraged. You can submit your written
comments in three different ways, (1) by using the webform at https://www.epa.gov/environmentaljustice/forms/national-environmental-justice-advisory-council-nejac-public-comment, (2) by sending comments via
email to [email protected] and (3) by creating comments in the Docket ID
No. EPA-HQ-OA-2022-0053 at http://www.regulations.gov. Written comments
can be submitted through October 12, 2022.

B. Information About Services for Individuals With Disabilities or
Requiring English Language Translation Assistance

    For information about access or services for individuals requiring
assistance, please contact Paula Flores-Gregg, via email at
[email protected], or contact by phone at<PHONE_NUMBER>. To request
special accommodations for a disability or other assistance, please
submit your request at least seven (7) working days prior to the
meeting, to give EPA sufficient time to process your request. All
requests should be sent to the address or email listed in the FOR
FURTHER INFORMATION CONTACT section.

Matthew Tejada,
Director for the Office of Environmental Justice.
[FR Doc. 2022-17081 Filed 8-8-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Rules and Regulations]
[Pages 87336-87338]
[FR Doc No: 2023-27678]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1807; Project Identifier MCAI-2023-00394-T;
Amendment 39-22618; AD 2023-24-02]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. (Type Certificate
Previously Held by Yabor[atilde] Ind[uacute]stria Aeron[aacute]utica
S.A.; Embraer S.A.; Empresa Brasileira de Aeron[aacute]utica S.A.
(EMBRAER)) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Embraer S.A. Model EMB-135BJ airplanes. This AD was prompted by
reports of missing sealant on the rivets installed in the interface
between rib 3 and the wing skin. This AD requires applying sealant on
the rivets installed in the interface between rib 3 and wing skin, as
specified in an Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil
(ANAC) AD, which is incorporated by reference. The FAA is issuing this
AD to address the unsafe condition on these products.

DATES: This AD is effective January 22, 2024.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 22,
2024.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1807; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For material incorporated by reference in this AD, contact
ANAC, Aeronautical Products Certification Branch (GGCP), Rua Dr.
Orlando Feirabend Filho, 230--Centro Empresarial Aquarius--Torre B--
Andares 14 a 18, Parque Residencial Aquarius, CEP 12.246-190--
S[atilde]o Jos[eacute] dos Campos--SP, Brazil; telephone 55 (12) 3203-
6600; email<EMAIL_ADDRESS>website anac.gov.br/en/. You may find this
material on the ANAC website at sistemas.anac.gov.br/certificacao/DA/
DAE.asp.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2023-1807.

FOR FURTHER INFORMATION CONTACT: Hassan Ibrahim, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Embraer S.A.
Model EMB-135BJ airplanes. The NPRM published in the Federal Register
on August 30, 2023 (88 FR 59813). The NPRM was prompted by AD 2023-03-
01, effective March 6, 2023, issued by ANAC, which is the aviation
authority for Brazil (ANAC AD 2023-03-01) (also referred to as the
MCAI). The MCAI states that missing sealant was identified on the
rivets installed in the interface between rib 3 and the wing skin in
some Embraer Model EMB-135BJ airplanes. The lack of sealant when a
failure on the rivet installation exists may result in a potential
ignition source inside the fuel tank during a lightning strike, which,
combined with flammable fuel vapors, could result in a

fuel tank explosion and consequent loss of the airplane.
    In the NPRM, the FAA proposed to require applying sealant on the
rivets installed in the interface between rib 3 and wing skin, as
specified in ANAC AD 2023-03-01. The FAA is issuing this AD to address
the unsafe condition on these products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-1807.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    ANAC AD 2023-03-01 specifies procedures for applying sealant on the
rivets installed in the interface between rib 3 and wing skin.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 10 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
             Labor cost                Parts cost       Cost per product           Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 7 work-hours x $85 per hour =              $0  Up to $595...........  Up to $5,950.
 $595.
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Amendment

    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 airworthiness
directive:

2023-24-02 Embraer S.A. (Type Certificate Previously Held by
Yabor[atilde] Ind[uacute]stria Aeron[aacute]utica S.A.; Embraer
S.A.; Empresa Brasileira de Aeron[aacute]utica S.A. (EMBRAER)):
Amendment 39-22618; Docket No. FAA-2023-1807; Project Identifier
MCAI-2023-00394-T.

(a) Effective Date

    This airworthiness directive (AD) is effective January 22, 2024.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Embraer S.A. Model EMB-135BJ airplanes,
certificated in any category, having serial numbers 14501119 through
14501165 inclusive, 14501167 through 14501215 inclusive, and
14501217 through 14501236 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by reports of missing sealant on the rivets
installed in the interface between rib 3 and the wing skin. The FAA
is issuing this AD to address the lack of sealant on the rivets,
which may result in a potential ignition source inside the fuel tank
during a lightning strike when a failure on the rivet installation
exists, which, combined with flammable fuel vapors, could result in
a fuel tank explosion and consequent loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o
Civil (ANAC) AD 2023-03-01,

effective March 6, 2023 (ANAC AD 2023-03-01).

(h) Exceptions to ANAC AD 2023-03-01

    (1) Where ANAC AD 2023-03-01 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) This AD does not adopt paragraph (c)(1) of ANAC AD 2023-03-
01.

(i) No Reporting Requirement

    Although the service information referenced in ANAC AD 2023-03-
01 specifies to submit certain information to the manufacturer, this
AD does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (k) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or ANAC; or ANAC's authorized Designee. If
approved by the ANAC Designee, the approval must include the
Designee's authorized signature.

(k) Additional Information

    For more information about this AD, contact Hassan Ibrahim,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email
[email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC)
AD 2023-03-01, effective March 6, 2023.
    (ii) [Reserved]
    (3) For ANAC AD 2023-03-01, contact ANAC, Aeronautical Products
Certification Branch (GGCP), Rua Dr. Orlando Feirabend Filho, 230--
Centro Empresarial Aquarius--Torre B--Andares 14 a 18, Parque
Residencial Aquarius, CEP 12.246-190--S[atilde]o Jos[eacute] dos
Campos--SP, Brazil; telephone 55 (12) 3203-6600; email
<EMAIL_ADDRESS>website anac.gov.br/en/. You may find this ANAC AD
on the ANAC website at sistemas.anac.gov.br/certificacao/DA/DAE.asp.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations.html or email [email protected].

    Issued on November 29, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-27678 Filed 12-15-23; 8:45 am]
BILLING CODE 4910-13-P