[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Page 15384]
[FR Doc No: 2023-05014]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: CP23-77-000.
    Applicants: Columbia Gas of Virginia, Inc.
    Description: Columbia Gas of Virginia submits Application for a
Certificate of Public Convenience and Necessity to transport and sell
natural gas in interstate commerce as though it were an intrastate
pipeline.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5200.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: RP23-561-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20230303 Negotiated Rate to be
effective 3/4/2023.
    Filed Date: 3/3/23.
    Accession Number: 20230303-5220.
    Comment Date: 5 p.m. ET 3/15/23.

    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.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: March 6, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-05014 Filed 3-10-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32140-32157]
[FR Doc No: 2015-13699]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0126]

Authorizations of Emergency Use of In Vitro Diagnostic Devices
for Detection of Ebola Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations), one of which was amended after initial issuance, for
in vitro diagnostic devices for detection of the Ebola virus in
response to the Ebola virus outbreak in West Africa. FDA

issued these Authorizations under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as requested by Corgenix, Inc. (Corgenix), and
Cepheid. The Authorizations contain, among other things, conditions on
the emergency use of the authorized in vitro diagnostic devices. The
Authorizations follow the September 22, 2006, determination by then-
Secretary of the Department of Homeland Security (DHS), Michael
Chertoff, that the Ebola virus presents a material threat against the
U.S. population sufficient to affect national security. On the basis of
such determination, the Secretary of Health and Human Services (HHS)
declared on August 5, 2014, that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection of
Ebola virus subject to the terms of any authorization issued under the
FD&C Act. The Authorizations, which include an explanation of the
reasons for issuance, are reprinted in this document.

DATES: The Authorization for the Corgenix ReEBOVTM Antigen
Rapid Test is effective as of February 24, 2015, and was amended and
reissued on March 16, 2015. The Authorization for the Cepheid
Xpert[supreg] Ebola Assay is effective as of March 23, 2015.

ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Acting Assistant
Commissioner for Counterterrorism Policy and Acting Director, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
or (4) the identification of a material threat by the Secretary of
Homeland Security under section 319F-2 of the Public Health Service Act
(PHS Act) (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \1\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Requests for In Vitro Diagnostic Devices for Detection of the
Ebola Virus

    On September 22, 2006, then-Secretary of Homeland Security, Michael
Chertoff, determined that the

Ebola virus presents a material threat against the U.S. population
sufficient to affect national security.\2\ On August 5, 2014, under
section 564(b)(1) of the FD&C Act, and on the basis of such
determination, the Secretary of HHS declared that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics
for detection of Ebola virus, subject to the terms of any authorization
issued under section 564 of the FD&C Act. Notice of the declaration of
the Secretary was published in the Federal Register on August 12, 2014
(79 FR 47141). On February 22, 2015, Corgenix submitted a complete
request for, and on February 24, 2015, FDA issued, an EUA for the
ReEBOVTM Antigen Rapid Test, subject to the terms of the
Authorization. On March 16, 2015, in response to a request from
Corgenix on March 10, 2015, FDA amended and reissued in its entirety
the EUA to allow, in addition to Corgenix, distributors that are
authorized by Corgenix to distribute the ReEBOVTM Antigen
Rapid Test, with certain conditions applicable to such authorized
distributor(s), subject to the terms of this Authorization. This EUA,
as amended and reissued on March 16, 2015, which includes an
explanation for its reissuance, is reprinted in this document. Because
the March 16, 2015, Authorization for Corgenix's assay replaces in its
entirety the EUA issued on February 24, 2015, the original
Authorization issued on February 24, 2015, is not reprinted in this
document. On February 26, 2015, Cepheid submitted a complete request
for, and on March 23, 2015, FDA issued, an EUA for the Xpert[supreg]
Ebola Assay, subject to the terms of this Authorization.
---------------------------------------------------------------------------

    \2\ Under section 564(b)(1) of the FD&C Act, the HHS Secretary's
declaration that supports EUA issuance must be based on one of four
determinations, including the identification by the DHS Secretary of
a material threat under section 319F-2 of the PHS Act sufficient to
affect national security or the health and security of U.S. citizens
living abroad (section 564(b)(1)(D) of the FD&C Act).
---------------------------------------------------------------------------

III. Electronic Access

    Electronic versions of these documents and the full text of the
Authorizations are available on the Internet at http://www.regulations.gov.

IV. The Authorizations

    Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of in vitro diagnostic devices for
detection of the Ebola virus subject to the terms of the
Authorizations. The Authorization for the Corgenix ReEBOVTM
Antigen Rapid Test issued on March 16, 2015, in its entirety (not
including the authorized versions of the fact sheets and other written
materials) follows and provides an explanation of the reasons for its
issuance, as required by section 564(h)(1) of the FD&C Act:

BILLING CODE 4164-01-P

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[GRAPHIC] [TIFF OMITTED] TN05JN15.007

    The Authorization for the Cepheid Xpert[supreg] Ebola Assay issued
on March 23, 2015, in its entirety (not including the authorized
versions of the fact sheets and other written materials) follows and
provides an explanation of the reasons for its issuance, as required by
section 564(h)(1) of the FD&C Act:

[GRAPHIC] [TIFF OMITTED] TN05JN15.008

[GRAPHIC] [TIFF OMITTED] TN05JN15.009

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[GRAPHIC] [TIFF OMITTED] TN05JN15.014

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13699 Filed 6-4-15; 8:45 am]
 BILLING CODE 4164-01-C


[Federal Register Volume 79, Number 67 (Tuesday, April 8, 2014)]
[Notices]
[Page 19327]
[FR Doc No: 2014-07792]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-653-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Negotiated Rates Trenton Woodbury to be effective 4/1/
2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5070.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-654-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Negotiated Rates--Cherokee AGL--Replacement Shippers--
Apr 2014 to be effective 4/1/2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5083.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-655-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Non-Conforming Agreement Filing (Conoco FT276) to be
effective 5/1/2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5095.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-656-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Incidental Purchases and Sales Report.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5130.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-657-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Integrys Energy Negotiated Rate to be effective 4/1/
2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5211.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-658-000.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Negotiated Rates Marketlink to be effective 4/1/2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5246.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-659-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 03/28/14 Negotiated Rates--United Energy Trading, LLC
(RTS) 5095-23 to be effective 4/1/2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5249.
    Comments Due: 5 p.m. ET 4/9/14.
    Docket Numbers: RP14-660-000.
    Applicants: Tallgrass Interstate Gas Transmission, L.
    Description: Neg Rate 2014-03-28 Valero/Aventine/Misc to be
effective 4/1/2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5258.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-661-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Neg Rate 2014-03-28 EOG, Encana NC NRA to be effective
4/1/2014.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5268.
    Comments Due: 5 p.m. ET 4/9/14.

    Docket Numbers: RP14-662-000.
    Applicants: Northern Border Pipeline Company.
    Description: Compressor Usage Surcharge 2014 to be effective 5/1/
2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5072.
    Comments Due: 5 p.m. ET 4/14/14.

    Docket Numbers: RP14-663-000.
    Applicants: Northern Border Pipeline Company.
    Description: BP Canada Energy to be effective 4/1/2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5073.
    Comments Due: 5 p.m. ET 4/14/14.

    Docket Numbers: RP14-664-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Cap Rel Neg Rate Agmts (Vanguard 598, 597 to Tenaska
1350, 1351) to be effective 4/1/2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5078.
    Comments Due: 5 p.m. ET 4/14/14.

    Docket Numbers: RP14-665-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Neg Rate Agmt Filing (Anadarko 21939) to be effective
4/1/2014.
    Filed Date: 3/31/14.
    Accession Number: 20140331-5079.
    Comments Due: 5 p.m. ET 4/14/14.

    Docket Numbers: RP14-666-000.
    Applicants: Bison Pipeline LLC.
    Description: Bison Pipeline LLC Company Use Gas Annual Report..
    Filed Date: 3/31/14.
    Accession Number: 20140331-5085.
    Comments Due: 5 p.m. ET 4/14/14.

    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.

Filings in Existing Proceedings

    Docket Numbers: RP08-350-007.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Southern Star Central Gas Pipeline, Inc. Annual
Report--Non-HCA Pipeline and Storage Lateral Integrity Expenses.
    Filed Date: 3/28/14.
    Accession Number: 20140328-5054.
    Comments Due: 5 p.m. ET 4/9/14.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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: March 31, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-07792 Filed 4-7-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70371-70373]
[FR Doc No: 2021-26738]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0585]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Ingested, Transient, Space Occupying Device for Weight
Management and/or Weight Loss

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the ingested, transient, space occupying device for weight management
and/or weight loss into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for the ingested, transient,
space occupying device for weight management and/or weight loss's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective December 10, 2021. The classification
was applicable on April 12, 2019.

FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the ingested, transient, space
occupying device for weight management and/or weight loss as class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness. In addition, we believe this
action will enhance patients' access to beneficial innovation by
placing the device into a lower device class than the automatic class
III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On November 15, 2018, Gelesis, Inc. submitted a request for De Novo
classification of the ingested, transient, space occupying device for
weight management and/or weight loss. FDA reviewed the request in order
to classify the device under the criteria for classification set forth
in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the

establishment of special controls. FDA has determined that these
special controls, in addition to the general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on April 12, 2019, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
876.5982.\1\ We have named the generic type of device ingested,
transient, space occupying device for weight management and/or weight
loss, and it is identified as an ingested material that transiently
occupies space in the stomach. The device passes from the body via the
natural gastrointestinal tract.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

     Table 1--Ingested, Transient, Space Occupying Device for Weight
       Management and/or Weight Loss Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Device related gastrointestinal adverse  Clinical performance testing,
 events, including:                       Non-clinical performance
 Obstruction...................   testing, Labeling, and Shelf
 Dilation......................   life testing.
     Diarrhea
     Constipation
     Dehydration
Weight gain............................  Clinical performance testing,
                                          and Labeling.
Interaction with medication............  Clinical performance testing,
                                          Non-clinical performance
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Non-clinical performance
                                          testing, and Shelf life
                                          testing.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k).
    At the time of classification, ingested, transient, space occupying
devices for weight management and/or weight loss are for prescription
use only. Prescription devices are exempt from the requirement for
adequate directions for use for the layperson under section 502(f)(1)
of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801 regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.5982 to subpart F to read as follows:

Sec.  876.5982  Ingested, transient, space occupying device for weight
management and/or weight loss.

    (a) Identification. This device is an ingested material that
transiently occupies space in the stomach. The device passes from the
body via the natural gastrointestinal tract.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible for its intended use.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions for use, as
follows:
    (i) Performance bench testing in a simulated use model must
evaluate device disintegration and device

hydration state throughout the gastrointestinal tract;
    (ii) Bioburden and moisture content assessments must evaluate
device infection risk throughout the labeled shelf life; and
    (iii) Performance data must support the shelf life of the device by
demonstrating continued package integrity and device functionality over
the labeled shelf life.
    (3) Clinical performance testing must demonstrate the device
performs as intended and evaluate the following:
    (i) Weight change;
    (ii) All adverse events, including obstruction, dilation, diarrhea,
constipation, and dehydration; and
    (iii) Interaction with representative medications.
    (4) Physician and patient device labeling must state:
    (i) The clinical benefit of the device as assessed by using percent
total body weight loss;
    (ii) Treatment must be offered in combination with diet and
exercise;
    (iii) Instructions on how to use the device as intended including
how to avoid interaction with medication; and
    (iv) The shelf life of the device.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26738 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Page 53506]
[FR Doc No: 2019-21733]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87184; File No. SR-NYSEAMER-2019-35]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Withdrawal of Proposed Rule Change To Amend the NYSE American Options
Fee Schedule To Revise the Options Regulatory Fee

October 1, 2019.
    On August 30, 2019, NYSE American LLC (``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 amend the
Exchange's fee schedule to revise the Options Regulatory Fee charged
for August 30, 2019. The proposed rule change was immediately effective
upon filing with the Commission pursuant to Section 19(b)(3)(A) of the
Act.\3\ The proposed rule change was published for comment in the
Federal Register on September 19, 2019.\4\ The Commission received one
comment letter on the proposal from the Exchange noting that it planned
to withdraw File No. SR-NYSEAMER-2019-35.\5\ On September 18, 2019, the
Exchange withdrew the proposed rule change (SR-NYSEAMER-2019-35).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ See Securities Exchange Act Release No. 86960 (September 13,
2019), 84 FR 49359.
    \5\ See Letter to Vanessa Countryman, Secretary, Commission,
from Martha Redding, Associate General Counsel and Assistant
Secretary, Exchange, dated September 17, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-21733 Filed 10-4-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Proposed Rules]
[Pages 35099-35101]
[FR Doc No: 2014-14324]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 118 / Thursday, June 19, 2014 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0390; Directorate Identifier 2014-CE-013-AD]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Embraer S.A. Model EMB-505 airplanes that would supersede AD 2013-22-
20. This proposed AD results from mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as cracks beyond
acceptable limits in the carbon discs of the left hand (LH) and right
hand (RH) brake assemblies. We are issuing this proposed AD to require
actions to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by August 4, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
EMBRAER S.A., Phenom Maintenance Support, Avenida Brigadeiro Faria
Lima, 2170, S[atilde]o Jos[eacute] dos Campos--SP, CEP: 12227-901--PO
Box: 36/2, Brasil; telephone: (+55 12) 3927-1000; fax: (+55 12) 3927-
6600, ext. 1448; email<EMAIL_ADDRESS>Internet:
http://www.embraerexecutivejets.com/en-US/customer-support/Pages/Service-Center-Network.aspx.
    You may review copies of the referenced service information at the
FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0390; 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 proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0390;
Directorate Identifier 2014-CE-013-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On October 30, 2013, we issued AD 2013-22-20, Amendment 39-17652
(78 FR 67018; November 8, 2013). That AD required actions intended to
address an unsafe condition on Embraer S.A. Model EMB-505 airplanes and
was based on mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country.
    Since we issued AD 2013-22-20, Amendment 39-17652 (78 FR 67018;
November 8, 2013), new service information was published that revised
inspection and repair procedures.
    The Ag[ecirc]ncia Nacional De Avia[ccedil][atilde]o Civil (ANAC),
which is the aviation authority for Brazil, issued AD No.: 2014-04-01,
dated April 16, 2014 (referred to after this as ``the MCAI''), to
correct an unsafe condition for the specified products. The MCAI
states:

    This AD was prompted by reports that identified additional
locations where inspections and corrective actions on the Left Hand
(LH) and Right Hand (RH) brake assemblies are needed. We are issuing
this AD to detect cracks beyond acceptable limit in the carbon discs
of the brake assembly, which may result in reduced brake capability
and loss of brake parts in the runway.
    Since this condition may occur in other airplanes of the same
type and affects flight safety, a corrective action is required.
Thus, sufficient reason exists to request compliance with this AD in
the indicated time limit without prior notice.

The MCAI requires an inspection to determine if the airplane has the
affected part number brake assembly installed and an inspection for
cracks of the affected brake assembly with repair or replacement as
necessary. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0390.

Relevant Service Information

    Embraer S.A. has issued Phenom Service Bulletin No. 505-32-0011,

Revision No. 1, dated March 31, 2014. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

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

Costs of Compliance

    We estimate that this proposed AD will affect 117 products of U.S.
registry. We also estimate that it would take about 2 work-hours per
product to comply with Part 1 of the inspection and 3 work-hours per
product to comply with Part 2 of the inspection requirements of this
proposed AD. The average labor rate is $85 per work-hour. Based on
these figures, we estimate the cost of the proposed AD on U.S.
operators to be $19,890, or $170 per product for Part 1 of the
inspection, and $29,835, or $255 per product for Part 2 of the
inspection.
    In addition, we estimate that any necessary follow-on actions would
take 1.5 work-hours and require parts costing $2,405, for a cost of
$2532.50 per product per side for repair or 3 work-hours and require
parts costing $26,177, for a cost of $26,432 per product per side for
replacement.
    We have no way of determining the number of products that may need
these actions.
    According to the manufacturer, all of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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 Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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. Amend Sec.  39.13 by removing Amendment 39-17652 (78 FR 67018;
November 8, 2013), and adding the following new AD:

Embraer S.A.: Docket No. FAA-2014-0390; Directorate Identifier 2014-
CE-013-AD.

(a) Comments Due Date

    We must receive comments by August 4, 2014.

(b) Affected ADs

    This AD supersedes AD 2013-22-20, Amendment 39-17652 (78 FR
67018; November 8, 2013).

(c) Applicability

    This AD applies to Embraer S.A. Models EMB-505 airplanes, all
serial numbers, that are:
    (1) Equipped with a part number (P/N) DAP00097-01 or P/N
DAP00097-02 brake assembly; and
    (2) certificated in any category.

 (d) Subject

    Air Transport Association of America (ATA) Code 32: Landing
Gear.

 (e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as cracks beyond
acceptable limits in the carbon discs of the left hand (LH) and
right hand (RH) brake assemblies. We are issuing this AD to detect
and correct cracking of the stator pressure plate and possible loss
of brake parts on the runway, which could result in reduced brake
capability and a possible runway excursion.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) through (f)(14) of this AD, including all subparagraphs.
    (1) If the number of cycles is unknown, calculate the compliance
times of cycles in this AD by multiplying the number of hours time-
in-service (TIS) on the brake assembly by .71 to come up with the
number of cycles. For the purposes of this AD, some examples are
below:
    (i) 500 hours TIS equates to 355 cycles; and
    (ii) 12 hours equates to 9 cycles.
    (2) Do a general visual inspection (GVI) for cracks in the
stator pressure plate on both the LH and RH brake assemblies
following Part 1 of the Accomplishment Instructions in Embraer
Phenom Service Bulletin No. 505-32-0011, Revision 01, dated March
31, 2014. Use the compliance times in paragraphs (f)(2)(i) and
(f)(2)(ii) of this AD:
    (i) For brake assemblies with 300 flight cycles or less since
new or since the last overhaul: Before or upon accumulating 150
flight cycles after the effective date of this AD or within the next
30 flight cycles after the effective date of this AD, whichever
occurs later, and repetitively thereafter at intervals not to exceed
60 flight cycles or the next tire change, whichever occurs first.
    (ii) For brake assemblies with more than 300 flight cycles since
new or since the last overhaul: Within the next 10 flight cycles
after the effective date of this AD, and repetitively thereafter at
intervals not to exceed 60 flight cycles or the next tire change,
whichever occurs first.
    (3) If no cracks are found during any of the inspections
required in paragraph (f)(2) of

this AD, continue the repetitive inspection intervals required in
paragraph (f)(2) of this AD, including all subparagraphs.
    (4) If any crack is found in the stator pressure plate during
any of the inspections required in paragraph (f)(2) of this AD,
before further flight, do a detailed inspection (DET) following Part
1 of the Accomplishment Instructions in Embraer Phenom Service
Bulletin No. 505-32-0011, Revision 01, dated March 31, 2014.
    (5) If no cracks beyond the acceptable limits are found during
the DET required in paragraph (f)(4) of this AD, continue the
repetitive inspection intervals required in paragraph (f)(2) of this
AD, including all subparagraphs.
    (6) If cracks that exceed the acceptable limits are found during
the DET required in paragraph (f)(4) of this AD, before further
flight, repair the brake assembly following Appendix 2 of Embraer
Phenom Service Bulletin No. 505-32-0011, Revision 01, dated March
31, 2014; or replace the brake assembly with a brake assembly that
has been inspected and found free of cracks that exceed the
acceptable limits following the Accomplishment Instructions of
Embraer Phenom Service Bulletin No. 505-32-0011, Revision 01, dated
March 31, 2014.

    Note 1 to paragraph (f)(6) of this AD:  Appendix 2 of Embraer
Phenom Service Bulletin No. 505-32-0011, Revision 01, dated March
31, 2014, includes Meggitt Aircraft Braking System Service Bulletin
No. SB-32-1625, Revision A, dated October 17, 2013.

    (7) At the next tire change or 30 days after the effective date
of this AD, whichever occurs later, do a DET for cracks on the
external visible surface of the thrust stator, double stator, and
rotors following Part 2 of the Accomplishment Instructions in
Embraer Phenom Service Bulletin No. 505-32-0011, Revision 01, dated
March 31, 2014.
    (8) If no crack is detected or if any crack within the
acceptable limits shown in Figure 4 Detail G of Embraer Phenom
Service Bulletin No. 505-32-0011, Revision 01, dated March 31, 2014,
is detected in the inspection required in paragraph (f)(7) of this
AD, repeat the inspection required by paragraph (f)(7) of this AD at
each tire change or at each maintenance action that requires wheel
removal, whichever occurs first.
    (9) If any crack within the acceptable limits shown in Figure 4
Detail H of Embraer Phenom Service Bulletin No. 505-32-0011,
Revision 01, dated March 31, 2014, is detected in the inspection
required in paragraph (f)(7) of this AD, the affected brake assembly
must be replaced within 40 flight cycles.
    (10) If any crack beyond the acceptable limits shown in Figure 4
Detail H of Embraer Phenom Service Bulletin No. 505-32-0011,
Revision 01, dated March 31, 2014, is detected, the affected brake
assembly must be replaced before the next flight.
    (11) After any repair or replacement of the brake assembly, the
brake assembly P/N DAP00097-01 or P/N DAP00097-02 is subject to the
inspections required in paragraphs (f)(2) through (f)(10), including
all subparagraphs, of this AD.
    (12) For the purposes of this AD, a GVI is a visual examination
of an interior or exterior area, installation or assembly, to detect
obvious damage, failure, or irregularity. This level of inspection
is made from within touching distance, unless otherwise specified. A
mirror may be necessary to enhance visual access to all exposed
surfaces in the inspection area. This level of inspection is made
under normally available lighting conditions such as daylight,
hangar lighting, flashlight, or drop-light. It may require removal
or opening of access panels or doors. Stands, ladders, or platforms
may be required to gain proximity to the area being checked.
    (13) For the purposes of this AD, a DET is an intensive
examination of a specific item, installation or assembly, to detect
damage, failure, or irregularity. Available lighting is normally
supplemented with a direct source of good lighting at an intensity
deemed appropriate. Inspection aids such as mirrors, magnifying
lenses, etc., may be necessary. Surface cleaning and elaborate
access procedures may be required.
    (14) As of November 8, 2013 (the effective the date of AD 2013-
22-20) and to the effective date of this AD, do not install on any
airplane a brake assembly P/N DAP00097-01 or P/N DAP00097-02 unless
it is inspected per the requirements of AD 2013-22-20 and continues
to be crack free or the cracks do not exceed the allowable limits;
and as of the effective date of this AD, do not install on any
airplane a brake assembly P/N DAP00097-01 or P/N DAP00097-02 unless
it is inspected per the requirements of this AD and continues to be
crack free or the cracks do not exceed the allowable limits.

(g) Credit for Actions Done Following Previous Service Information

    This AD provides credit for the inspections required in
paragraphs (f)(2) and (f)(6) of this AD, if those actions were
performed before the effective date of this AD, using Embraer Alert
Service Bulletin (ASB) 505-32-A011, original issue, dated September
13, 2013; Embraer Alert Service Bulletin (ASB) 505-32-A011, Revision
01, dated November 01, 2013; Embraer Alert Service Bulletin (ASB)
505-32-A011, Revision 02, dated December 19, 2013; or Embraer Phenom
Service Bulletin No. 505-32-0011, original issue, dated February 11,
2014.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>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.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(i) Related Information

    Refer to MCAI Ag[ecirc]ncia Nacional De Avia[ccedil][atilde]o
Civil (ANAC) AD No.: 2014-04-01, dated April 16, 2014, for related
information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2014-0390. For service information related to this AD, contact
EMBRAER S.A., Phenom Maintenance Support, Avenida Brigadeiro Faria
Lima, 2170, S[atilde]o Jos[eacute] dos Campos--SP, CEP: 12227-901--
PO Box: 36/2, Brasil; telephone: (+55 12) 3927-1000; fax: (+55 12)
3927-6600, ext. 1448; email<EMAIL_ADDRESS>
Internet: http://www.embraerexecutivejets.com/en-US/customer-support/Pages/Service-Center-Network.aspx. You may review copies of
the referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on June 12, 2014.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2014-14324 Filed 6-18-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Notices]
[Page 60304]
[DOCID:fr10oc08-92]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1795-DR]

Indiana; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Indiana (FEMA-1792-DR), dated September 23, 2008, and
related determinations.

DATES: Effective Date: October 3, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of September 23, 2008.

    Clark, Crawford, Dearborn, Jackson, Knox, Lawrence, Martin,
Pike, Spencer, and Switzerland Counties for Individual Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-24071 Filed 10-9-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 88 (Monday, May 8, 2023)]
[Notices]
[Pages 29802-29803]
[FR Doc No: 2023-09656]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2023-0029]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on March 21, 2023, Indiana
Northeastern Railroad Company, in partnership with Little River
Railroad, Inc. (Petitioners), petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR part 240
(Qualification and Certification of Locomotive Engineers). FRA assigned
the petition Docket Number FRA-2023-0029.
    Specifically, Petitioners request relief from Sec.  240.201(d),
which requires that only certified persons operate locomotives and
trains. The relief would allow noncertified persons to pay a fee and
operate a locomotive as part of a ``throttle time'' program. In support
of its petition, Petitioners note that the relief would only apply to
persons participating in the program, and that participants would be 18
years of age or older and under the direct supervision of a certified
and qualified locomotive

engineer. Further, all movements would take place during daylight hours
and at restricted speed.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by July 7, 2023 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT)
solicits comments from the public to better inform its processes. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2023-09656 Filed 5-5-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Notices]
[Pages 12916-12917]
[FR Doc No: 2020-04467]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2013-0437; FRL-10004-24-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Emission Control System Performance Warranty
Regulations and Voluntary Aftermarket Part Certification Program
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Emission Control System
Performance Warranty Regulations and Voluntary Aftermarket Part
Certification Program (EPA ICR Number 0116.12, OMB Control Number 2060-
0060) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through May
30, 2020. Public comments were previously requested via the Federal
Register on October 10, 2019 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 6, 2020.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2013-0437, to (1) EPA online using www.regulations.gov (our
preferred method), or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Lynn Sohacki, Compliance Division,

Office of Transportation and Air Quality, U.S. Environmental Protection
Agency, 2000 Traverwood, Ann Arbor, Michigan 48105; telephone number:
734-214-4851; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Under Section 206(a) of the Clean Air Act (42 U.S.C.
7521), on-highway engine and vehicle manufacturers may not legally
introduce their products into U.S. commerce unless EPA has certified
that their production complies with applicable emission standards. Per
section 207(a), original vehicle manufacturers must warrant that
vehicles are free from defects in materials and workmanship that would
cause the vehicle not to comply with emission regulations during its
useful life. Section 207(a) directs EPA to provide certification to
those manufacturers or builders of automotive aftermarket parts that
demonstrate that the installation and use of their products will not
cause failure of the engine or vehicle to comply with emission
standards. An aftermarket part is any part offered for sale for
installation in or on a motor vehicle after such vehicle has left the
vehicle manufacturer's production line (40 CFR 85.2113(b)).
Participation in the aftermarket certification program is voluntary.
Aftermarket part manufacturers or builders (manufacturers) electing to
participate conduct emission and durability testing as described in 40
CFR part 85, subpart V, and submit data about their products and
testing procedures. Any information submitted to the Agency for which a
claim of confidentiality is made is safeguarded according to policies
set forth in CFR title 40, chapter 1, part 2, subpart B--
Confidentiality of Business Information (see 40 CFR part 2).
    Form Numbers: None.
    Respondents/affected entities: Manufacturers or builders of
automotive aftermarket parts.
    Respondent's obligation to respond: Required to obtain or retain a
benefit.
    Estimated number of respondents: 1 (total).
    Frequency of response: On occasion.
    Total estimated burden: 547 hours (per year). Burden is defined at
5 CFR 1320.3(b).
    Total estimated cost: $19,063 (per year), which includes $1,955
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the total estimated
respondent burden compared with the ICR currently approved by OMB.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-04467 Filed 3-4-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Proposed Rules]
[Pages 50021-50022]
[FR Doc No: 2022-17176]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0903; Airspace Docket No. 22-ANE-8]
RIN 2120-AA66

Proposed Establishment of Class E Airspace; Norway, ME, and
Proposed Amendment of Class E Airspace; Oxford, ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace extending
upward from 700 feet above the surface at Stephens Memorial Hospital
Heliport, Norway, ME, to accommodate area navigation (RNAV) global
positioning system (GPS) standard instrument approach procedures
(SIAPs) serving this heliport. Also, this action proposes to amend
Class E airspace extending upward from 700 feet above the surface for
Oxford County Regional Airport, Oxford, ME, by updating the airport's
geographic coordinates, and removing unnecessary verbiage from the
airport description. Controlled airspace is necessary for the safety
and management of instrument flight rules (IFR) operations in the area.

DATES: Comments must be received on or before September 29, 2022.

ADDRESSES: Send comments on this proposal to: the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2022-0903; Airspace Docket No. 22-ANE-8 at the beginning
of your comments. You may also submit comments through the internet at
www.regulations.gov.
    FAA Order JO 7400.11F Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT:  John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. 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 would establish airspace in Norway, ME, and amend airspace in
Oxford, ME, to support IFR operations in the area.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,

environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2022-0903 and Airspace Docket No. 22-ANE-8) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2022-0903; Airspace Docket No. 22-ANE-8.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays, at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA proposes an amendment to 14 CFR part 71 to establish Class
E airspace extending upward from 700 feet above the surface at Stephens
Memorial Hospital Heliport, Norway, ME, to accommodate RNAV GPS
standard instrument approach procedures (SIAPs) serving this heliport.
This action would also amend Class E airspace extending upward from 700
feet above the surface at Oxford County Regional Airport, Oxford, ME,
by updating the airport's geographic coordinates to coincide with the
FAA's database, and removing `excluding that airspace within the
Auburn, ME Class E airspace area' from the airport description, as it
is unnecessary verbiage, as per Order 7400.2N.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order JO 7400.11F, dated August 10, 2021, and effective September
15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (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 proposed 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.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'', prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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 part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 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 71.1 of Federal Aviation
Administration Order JO 7400.11F, Airspace Designations and Reporting
Points, dated August 10, 2021, and effective September 15, 2021, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANE ME E5 Norway, ME [Established]

Stephens Memorial Hospital Heliport, ME
    (Lat. 44[deg]12'34'' N, long. 70[deg]31'54'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.0-mile radius of Stephens Memorial Hospital Heliport.

ANE ME E5 Oxford, ME [Amended]

Oxford County Regional Airport, ME
    (Lat. 44[deg]09'27'' N, long. 70[deg]28'53'' W)

    That airspace extending upward from 700 feet above the surface
within a 9.6-mile radius of Oxford County Regional Airport.

    Issued in College Park, Georgia, on August 5, 2022.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2022-17176 Filed 8-12-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Proposed Rules]
[Pages 16825-16826]
[FR Doc No: 2013-06196]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 49

[EPA-R09-OAR-2013-0009; FRL-9791-8]

Approval of Air Quality Implementation Plans; Navajo Nation;
Regional Haze Requirements for Navajo Generating Station; Extension of
Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: On February 5, 2013, the Environmental Protection Agency (EPA)
proposed a source-specific federal implementation plan (FIP) requiring
the Navajo Generating Station (NGS), located on the Navajo Nation, to
reduce emissions of oxides of nitrogen (NOX) under the Best
Available Retrofit Technology (BART) provision of the Clean Air Act
(CAA or Act) in order to reduce visibility impairment resulting from
NGS at 11 National Parks and Wilderness Areas. EPA provided a 90-day
public comment period for the proposed rule that is scheduled to close
on May 6, 2013. The Navajo Nation and other stakeholders have submitted
requests to extend the comment period an additional 90 days to allow
time for interested parties to explore alternatives to BART that
provide additional flexibility and also ensure greater reasonable
progress than would be achieved under BART. In today's action, EPA is
extending the comment period an additional 90 days.

DATES: Comments on the proposed rulemaking published on February 5,
2013 (78 FR 8274) must be submitted no later than August 5, 2013.

ADDRESSES: Submit comments identified by docket number EPA-R09-OAR-
2013-0009, by one of the following methods:
    Federal eRulemaking Portal: www.regulations.gov. Follow the on-line
instructions.
    Email<EMAIL_ADDRESS>    Mail or deliver: Anita Lee (Air-2), U.S. Environmental Protection
Agency Region 9, 75 Hawthorne Street, San Francisco, CA 94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Hearings: EPA intends to hold public hearings, at least 30 days
prior to the close of the comment period, to accept oral and written
comments on the proposed rulemaking. EPA will provide notice and
additional details related to the hearings in the Federal Register, on
our Web site, and in the docket for this proposed rulemaking.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 9,
75 Hawthorne Street, San Francisco, California. While documents in the
docket are listed in the index, some information may be publicly
available only at EPA Region 9 (e.g., maps, voluminous reports,
copyrighted material), and some may not be publicly available in either
location (e.g., CBI). To inspect the hard copy materials, please
schedule an appointment during normal business hours with the contact
listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Anita Lee, EPA Region 9, (415) 972-
3958<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we'', ``us'',
and ``our'' refer to EPA.

Table of Contents

I. Background
II. Today's Action

I. Background

    NGS is a coal-fired power plant located on the Navajo Nation Indian
Reservation, just east of Page, Arizona, approximately 135 miles north
of Flagstaff, Arizona. Emissions of NOX from NGS affect
visibility at 11 National Parks and Wilderness Areas that are

designated as Class I federal areas, mandated by Congress to receive
heightened protection. NGS is subject to the BART requirement of the
CAA and the Regional Haze Rule based on its age and its effects on
visibility in Class I areas.\1\
---------------------------------------------------------------------------

    \1\ Please refer to 78 FR 8274 (February 5, 2013) for additional
background information related to NGS, regional haze and the
protection of visibility at mandatory Class I federal areas, and the
statutory and regulatory framework for addressing visibility
impairment from sources located in Indian country.
---------------------------------------------------------------------------

    On February 5, 2013, EPA proposed a BART determination to require
NGS to achieve a nearly 80 percent reduction of its current overall
NOX emission rate. EPA also proposed an alternative to BART
that would provide flexibility to NGS in the schedule for the
installation of new post-combustion control equipment. EPA's proposed
alternative to BART credits NGS for its early and voluntary
installation of new combustion controls to reduce NOX
emissions beginning in 2009 and therefore achieves greater reasonable
progress than BART.
    In recognition that there may be other approaches that could result
in equivalent or better visibility benefits than BART, as well as the
singular importance of NGS to the Navajo Nation, Hopi Tribe, and other
numerous tribes located in Arizona, EPA also outlined a framework for
evaluating other alternatives to provide greater flexibility than EPA's
proposed alternative to BART. EPA requested comment on Alternatives 2
and 3 that provide until 2025 or 2026 for compliance but would require
the owners of NGS to implement additional emission reductions in order
to assure greater reasonable progress than would otherwise be achieved
under BART.
    EPA encouraged a robust public discussion of our proposed BART
determination and alternative, as well as Alternatives 2 and 3, and
recognized the potential need for a supplemental proposal if
Alternatives 2 or 3, or other approaches developed by other parties,
are identified as meeting the needs of stakeholders and meeting the
requirements of the CAA.
    On February 15, 2013, Salt River Project (SRP), co-owner and
operator of NGS, requested a 90-day extension of the public comment
period. SRP stated that identifying and analyzing alternatives and
discussing options with interested parties would require a significant
amount of time. On February 21, 2013, the Central Arizona Water
Conservation District (CAWCD) submitted a similar request for a 90-day
extension of the comment period.\2\ On March 1, 2013, the Navajo Nation
also requested a 90-day extension of the comment period in order to
allow the Navajo Nation the time and opportunity to participate with
NGS owners and other stakeholders in examining the feasibility of
additional alternatives, including Alternatives 2 and 3.
---------------------------------------------------------------------------

    \2\ The CAWCD manages the Central Arizona Project, a water
delivery system that relies on electricity from NGS to pump surface
water from the Colorado River for use by numerous tribes in Arizona,
as well as agricultural, municipal, and industrial water users.
Please refer to 78 FR 8274 (February 5, 2013) for additional
information about CAWCD and its relationship to NGS and tribes
located in Arizona.
---------------------------------------------------------------------------

II. Today's Action

    EPA recognizes that the stakeholder process, to develop viable
alternatives to BART that provide additional flexibility to the owners
of NGS while achieving more emission reductions to assure greater
reasonable progress than BART, will require a significant amount of
time. EPA also recognizes the critical importance of active
participation by the Navajo Nation, the Hopi Tribe, and other affected
tribes located in Arizona in the development of alternatives to BART.
Therefore, EPA is extending the comment period by an additional 90
days.

List of Subjects in 40 CFR Part 49

    Environmental protection, Administrative practice and procedure,
Air pollution control, Indians, Intergovernmental relations, Reporting
and recordkeeping requirements.

    Dated: March 8, 2013.
Jared Blumenfeld,
Regional Administrator, Region 9.
[FR Doc. 2013-06196 Filed 3-18-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 10, 2008 (Volume 73, Number 47)]
[Rules and Regulations]
[Page 12639-12640]
[DOCID:fr10mr08-7]

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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2007-0621; FRL-8530-7]

Revisions to the California State Implementation Plan, South
Coast Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing approval of revisions to the South Coast Air
Quality Management District (SCAQMD) portion of the California State
Implementation Plan (SIP). These revisions were proposed in the Federal
Register on November 20, 2007, and concern particulate matter (PM)
emissions from fugitive dust sources and cement manufacturing plants.
We are approving local rules that regulate these emission sources under
the Clean Air Act as amended in 1990 (CAA or the Act).

DATES: Effective Date: This rule is effective on April 9, 2008.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2007-0621 for
this action. The index to the docket is available electronically at
www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne
Street, San Francisco, California. While all documents in the docket
are listed in the index, some information may be publicly available
only at the hard copy location (e.g., copyrighted material), and some
may not be publicly available in either location (e.g., CBI). To
inspect the hard copy materials, please schedule an appointment during
normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Jerry Wamsley, EPA Region IX, at
either<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On November 20, 2007 (see 72 Federal Register (FR) 65285), EPA
proposed to approve the following rules into the California SIP.

                                            Table 1.--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                              Rule
               Local agency                   No.                Rule title               Adopted     Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD....................................      403  Fugitive Dust....................     06/03/05     10/20/05
SCAQMD....................................     1156  Further Reductions of Particulate     11/04/05     12/29/06
                                                      Emissions from Cement
                                                      Manufacturing Facilities.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve these rules because we determined that they
complied with the relevant CAA requirements. Our proposed action
contains more information on the rules and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received one comment from an unidentified person
on December 20, 2007. The comment and our response are summarized
below.
    Comment: The commenter is critical of EPA's action to deny
California's request for a waiver of Federal preemption of motor
vehicle greenhouse gas emission standards announced December 19, 2007.
Also, the commenter makes unsubstantiated allegations that unnamed EPA
officials took bribes from GM, Ford, and Cerberus Corporation in
deciding on the merits of this waiver.
    Response: We proposed to approve rules reducing particulate matter
emissions from local sources so that the South Coast air basin can meet
the national particulate matter health standard. Our proposal did not
concern California's waiver request; consequently, the comment is not
germane to our proposed action.

However, we thank the commenter for his interest.

III. EPA Action

    No comments were submitted that change our assessment that the
submitted rules comply with the relevant CAA requirements. Therefore,
as authorized in section 110(k)(3) of the Act, EPA is fully approving
these rules into the California SIP.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect 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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
    This action also does not have Federalism implications because it
does not 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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This action merely approves a state rule implementing a
Federal standard, and does not alter the relationship or the
distribution of power and responsibilities established in the Clean Air
Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it approves a state rule
implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission; to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 9, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: January 17, 2008.
Jane Diamond,
Acting Regional Administrator, Region IX.

0
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52 [AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(342)(i)(C)(4) and
(c)(348) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (342) * * *
    (i) * * *
    (C) * * *
    (4) Rule 403, adopted on May 7, 1976 and amended on June 3, 2005.
* * * * *
    (348) New and amended rules for the following APCDs were submitted
on December 29, 2006 by the Governor's designee.
    (i) Incorporation by reference.
    (A) San Joaquin Valley Air Pollution Control District.
    (1) Rule 4354, adopted on August 17, 2006.
    (B) South Coast Air Quality Management District.
    (1) Rule 1156, adopted on November 4, 2005.
* * * * *
 [FR Doc. E8-4147 Filed 3-7-08; 8:45 am]

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