[Federal Register: May 12, 2009 (Volume 74, Number 90)]
[Proposed Rules]
[Page 22123-22125]
[DOCID:fr12my09-12]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0436; Directorate Identifier 2009-NM-005-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model CL-600-2C10 (Regional
Jet Series 700 and 701) Airplanes and CL-600-2D24 (Regional Jet Series
900) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. 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: Frost, snow, slush or ice on the wing leading edges and
upper wing surfaces may change the stall speeds, stall characteristics
and the protection provided by the stall protection system, which could
result in reduced controllability of the aircraft. The proposed AD
would require actions that are intended to address the unsafe condition
described in the MCAI.

DATES: We must receive comments on this proposed AD by June 11, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Bruce Valentine, Aerospace Engineer,
Systems and Flight Test Branch, ANE-172, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0436;
Directorate Identifier 2009-NM-005-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2005-02, dated February 2, 2005 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Frost, snow, slush or ice on the wing leading edges and upper
wing surfaces may change the stall speeds, stall characteristics and
the protection provided by the stall protection system, which could
result in reduced controllability of the aircraft.
    Transport Canada has * * * approved temporary revisions to the
Aircraft Flight Manuals (AFM), which emphasize the cold weather
operational requirements to ensure that the wing leading edges and
upper wing surfaces are free from frost, snow, slush or ice.

    The corrective action is revising the AFMs to introduce procedures
for cold weather operations. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Bombardier has issued Temporary Revision RJ 900/48-3, dated August
19, 2008, to the Canadair Regional Jet Series 900 Airplane Flight
Manual (AFM), CSP C-012; and Temporary Revision RJ 700/87-3, dated
August 19, 2008, to the Canadair Regional Jet Series 700 and 701 AFM,
CSP B-012. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

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

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 336 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $26,880, or $80 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Bombardier, Inc. (Formerly Canadair): Docket No. FAA-2009-0436;
Directorate Identifier 2009-NM-005-AD.

Comments Due Date

    (a) We must receive comments by June 11, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Bombardier Model CL-600-2C10
(Regional Jet Series 700 and 701) airplanes and CL-600-2D24
(Regional Jet Series 900) airplanes, certificated in any category.

Subject

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

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
Frost, snow, slush or ice on the wing leading edges and upper wing
surfaces may change the stall speeds, stall characteristics and the
protection provided by the stall protection system, which could
result in reduced controllability of the aircraft.
    Transport Canada has * * * approved temporary revisions to the
Aircraft Flight Manuals (AFM), which emphasize the cold weather
operational requirements to ensure that the wing leading edges and
upper wing surfaces are free from frost, snow, slush or ice.
    The corrective action is revising the AFMs to introduce
procedures for cold weather operations.

Actions and Compliance

    (f) Unless already done, within 14 days after the effective date
of this AD, revise the Limitations--Operating Limitations sections

of the Canadair Regional Jet Series 900 Airplane Flight Manual
(AFM), CSP C-012, and the Canadair Regional Jet Series 700 and 701
AFM, CSP B-012, to include the information in Bombardier Temporary
Revision (TR) RJ 900/48-3, dated August 19, 2008, and TR RJ 700/87-
3, dated August 19, 2008, as specified in the TRs, as applicable.
These TRs introduce procedures for cold weather operations to ensure
that the wing leading edges and upper wing surfaces are free from
frost, snow, slush or ice. Operate the airplane according to the
limitations and procedures in the TRs.

    Note 1: This may be done by inserting copies of Bombardier TR RJ
700/87-3 and TR RJ 900/48-3 into the applicable AFM. When these TRs
have been included in general revisions of the applicable AFM, the
general revisions may be inserted into the AFM, provided the
relevant information in the general revision is identical to the
applicable AFM.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification 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: Bruce Valentine,
Aerospace Engineer, Systems and Flight Test Branch, ANE-172, FAA,
New York Aircraft Certification Office, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax (516)
794-5531. Before using any approved AMOC on any airplane to which
the AMOC applies, notify your principal maintenance inspector (PMI)
or principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2005-02
dated February 2, 2005; Bombardier TR RJ 700/87-3, dated August 19,
2008; and Bombardier TR RJ 900/48-3, dated August 19, 2008; for
related information.

    Issued in Renton, Washington, on May 1, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-10992 Filed 5-11-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Rules and Regulations]
[Pages 57816-57818]
[FR Doc No: 2019-23471]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2019-N-2484]

Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Continuous Glucose Monitor Data
Management System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the continuous glucose monitor data management system into class I
(general controls). We are taking this action because we have
determined that classifying the device into class I (general 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, in part by reducing regulatory burdens.

DATES: This order is effective October 29, 2019. The classification was
applicable on August 19, 2014.

FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the continuous glucose monitor
data management system as class I (general 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, in part by reducing
regulatory burdens 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 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 shall
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 within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. 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 in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On April 22, 2014, DEXCOM, Inc., submitted a request for De Novo
classification of the STUDIO on the Cloud Data Management Software. 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 I if general controls are sufficient
to 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 I. FDA has determined that general
controls will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on August 19, 2014, FDA issued an order to the requestor
classifying the device into class I. FDA is codifying the
classification of the device by adding 21 CFR 862.2120. We have named
the generic type of device continuous glucose monitor data management
system, and it is identified as an electronic device intended to
acquire, process, and correlate retrospective data from a continuous
glucose monitoring device. This device is intended to be used by
patients or their healthcare providers when determining therapeutic
strategies. A continuous glucose monitor data management system is not
a drug dose calculator and does not provide treatment recommendations.
    FDA has identified the following risks to health associated
specifically with this type of device in table 1.

            Table 1--Continuous Glucose Monitor Data Management System Risks and Mitigation Measures
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              Identified risks                                       Mitigation measures
----------------------------------------------------------------------------------------------------------------
Device malfunction (e.g., incorrect data     General controls, including design controls.
 analysis, etc.).
----------------------------------------------------------------------------------------------------------------

    Section 510(l)(1) of the FD&C Act provides that a device within a
type that has been classified into class I under section 513 of the
FD&C Act is exempt from premarket notification under section 510(k),
unless the device is of substantial importance in preventing impairment
of human health or presents a potentially unreasonable risk of illness
or injury (21 U.S.C. 360(l)(1)). Devices within this type are exempt
from the premarket notification requirements under section 510(k),
subject to the limitations of exemptions in 21 CFR 862.9.

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 refers 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. 3501-3520). 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; and the collections of
information in 21 CFR part 820, regarding the quality system
regulation, including recordkeeping for design controls, have been
approved under OMB control number 0910-0073.

List of Subjects in 21 CFR Part 862

    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
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

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

0
2. Add Sec.  862.2120 to subpart C to read as follows:

Sec.  862.2120  Continuous glucose monitor data management system.

    (a) Identification. A continuous glucose monitor data management
system is an electronic device intended to acquire, process, and
correlate retrospective data from a continuous glucose monitoring
device. This device is intended to be used by patients or their
healthcare providers when determining therapeutic strategies. A
continuous glucose monitor data management system is not a drug dose
calculator and does not provide treatment recommendations.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec.  862.9.

    Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23471 Filed 10-28-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Page 69060]
[FR Doc No: 2016-24103]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0009 and EPA-HQ-OPP-2014-0011; FRL-9951-70]

Pesticide Product Registration; Receipt of Applications for New
Uses and New Active Ingredients; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; correction.

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SUMMARY: EPA issued a notice in the Federal Register of August 18,
2016, concerning its receipt of applications to add new food uses on
previously registered pesticide products and to register new pesticide
products containing active ingredients not included in any currently
registered pesticide products. This document corrects omissions within
the referenced notice.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    The Agency included in the August 18, 2016 notice a list of those
who may be potentially affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) numbers EPA-HQ-OPP-2014-0009 and HQ-OPP-2014-0011, are available
at http://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. What does this correction do?

    FR Doc. 2016-19758 published in the Federal Register of August 18,
2016 (81 FR 55192) (FRL-9950-20) is corrected as follows:
    1. On page 55192, first column, under the heading SUMMARY,
paragraph 1, line 1, correct ``EPA has received applications to
register pesticide products containing active ingredients not included
in any currently registered pesticide products.'' to read ``EPA has
received applications to add new food uses on previously registered
pesticide products and to register new pesticide products containing
active ingredients not included in any currently registered pesticide
products.''
    2. On page 55192, second column, under the heading ``II.
Registration Applications,'' paragraph 4, line 1, correct ``EPA has
received applications to register pesticide products containing active
ingredients not included in any currently registered pesticide
products.'' to read ``EPA has received applications to add new food
uses on previously registered pesticide products and to register new
pesticide products containing active ingredients not included in any
currently registered pesticide products.''

    Authority: 7 U.S.C. 136 et seq.

    Dated: September 16, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2016-24103 Filed 10-4-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Rules and Regulations]
[Pages 46880-46882]
[FR Doc No: 2018-20041]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2017-0542; FRL-9983-75--Region 4]

Air Plan Approval; Tennessee: Knox County NSR Reform

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is finalizing
approval of several Tennessee State Implementation Plan (SIP) revisions
submitted by the Tennessee Department of Environment & Conservation
(TDEC), on behalf of Knox County's Air Quality Management Division,
through letters dated March 7, 2017, and April 17, 2017. The SIP
revisions modify the Prevention of Significant Deterioration (PSD) and
Nonattainment New Source Review (NNSR) regulations in the Knox County
portion of the Tennessee SIP to address changes to the federal new
source review (NSR) regulations in recent years for the implementation
of the national ambient air quality standards (NAAQS). Additionally,
the SIP revisions include updates to Knox County's minor source
permitting regulations. This action is being approved pursuant to the
Clean Air Act (CAA or Act).

DATES: This rule will be effective October 17, 2018.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2017-0542. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Andres Febres of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Mr. Febres can also
be reached via electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?

    EPA is finalizing approval of changes to the Knox County portion of
the Tennessee SIP regarding PSD and NNSR permitting, as well as updates
to minor NSR, submitted by TDEC on behalf of Knox County's Air Quality
Management Division.
    On March 7, 2017, Tennessee submitted two SIP revisions updating
Knox County's Air Quality Management Regulations, Section 41.0 entitled
``Regulations for the Review of New Sources,'' and Section 45.0
entitled ``Prevention of Significant Deterioration.'' \1\ On April 17,
2017, Tennessee submitted two additional SIP revisions, including
additional changes to Section 41, and updates to Section 25.0 entitled
``Permits.'' \2\ These SIP revisions are meant to address changes to
the federal NSR regulations, as

promulgated by EPA in various rules. EPA is finalizing approval of the
aforementioned SIP submittals in their entirety. Additional detail on
these submittals, as well as the analysis of the changes and our
rationale for approving them is presented in EPA's June 20, 2018,
proposed rulemaking. See 83 FR 28568.
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    \1\ EPA notes that the Agency may not have received the
submittal on this date, which is the date of the State submittal's
cover letter.
    \2\ EPA notes that the Agency may not have received the
submittal on this date, which is the date of the State submittal's
cover letter.
---------------------------------------------------------------------------

II. Background

    Tennessee's March 7, 2017, SIP revisions make changes to Knox
County's Air Quality Regulations, Section 41.0--``Regulations for the
Review of New Sources'' and Section 45.0--``Prevention of Significant
Deterioration'' to address changes to the federal NSR regulations, as
promulgated by EPA in the 2002 NSR Reform Rules, and subsequent changes
in other relevant rulemakings.
    As part of the changes to Section 41 and Section 45, Knox County
adopted all the necessary provisions of the federal NNSR rules (found
in 40 CFR 51.165) and the federal PSD rules (found in 40 CFR 51.166) to
make them consistent with, and in some cases more stringent than, the
federal rules. These changes included the adoption of several
definitions in the federal PSD and NNSR rules, such as the definition
of ``regulated NSR pollutant,'' as well as provisions regarding major
NSR applicability procedures, actual-to-projected-actual applicability
tests, plantwide applicability limits (PALs), and recordkeeping.
Additionally, in the changes included in the March 7, 2017, SIP
submittal, Knox County adopted the provisions of EPA's Ozone Phase 2
Rule.
    The April 17, 2017, SIP revision included two changes to the Knox
County portion of the Tennessee SIP, one making additional changes to
Section 41, and another updating Section 25.0--``Permits.'' The
revisions to Section 41 include additional changes to address several
updates to the federal PSD rules regarding the PM2.5 NAAQS.
As part of the revisions to Section 25, Knox County amends subsections
25.1--``Construction Permit,'' and 25.3--``Operating Permit,'' to
included changes to its NSR construction and operating permit
regulations, as well as its minor NSR program.
    As mentioned above, EPA published a notice of proposed rulemaking
on June 20, 2018 (83 FR 28568), proposing to approve the changes from
Tennessee's March 7, 2017, and April 17, 2017, SIP revisions. The
proposed rulemaking contains more detailed information regarding the
Tennessee SIP revisions being approved and explains the rationale for
this action. Comments on the proposed rulemaking were due on or before
July 20, 2018. EPA received no relevant comments.

III. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Knox County's
Air Quality Management Regulations, Section 25.1--``Construction
Permit,'' which is state effective January 18, 2017; Section 25.3--
``Operating Permits,'' which is state effective January 18, 2017; \3\
Section 41.0--``Regulations for the Review of New Sources,'' which is
state effective January 18, 2017; and Section 45.0--``Prevention of
Significant Deterioration,'' which is state effective July 20, 2016.
These revisions amend Knox County's NSR rules to address several
changes to the federal NSR regulations, as promulgated by EPA in the
2002 NSR Reform Rules and subsequent actions. EPA has made, and will
continue to make, these materials generally available through
www.regulations.gov and at the EPA Region 4 Office (please contact the
person identified in the For Further Information Contact section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the SIP, have been incorporated
by reference by EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of EPA's approval, and will be incorporated by
reference in the next update to the SIP compilation.\4\
---------------------------------------------------------------------------

    \3\ EPA is also reformatting the identification of the SIP-
approved portions of Section 25.0--``Permits'' in 40 CFR 52.2220(c)
for ease of reference.
    \4\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

IV. Final Action

    EPA is finalizing approval of the revisions presented in
Tennessee's March 7, 2017, and April 17, 2017, SIP submittals
consisting of changes to Knox County's Air Quality Management
Regulations, Section 41.0 entitled ``Regulations for the Review of New
Sources,'' Section 45.0 entitled ``Prevention of Significant
Deterioration,'' and Section 25.0 entitled ``Permits.''

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. These actions merely
approve state law as meeting Federal requirements and do not impose
additional requirements beyond those imposed by state law. For that
reason, these actions:
     Are not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Are not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do 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);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not an economically significant regulatory action
based on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial

direct costs on tribal governments or preempt tribal law.
    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 action 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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 16, 2018. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action 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, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: September 4, 2018.
Onis ``Trey'' Glenn, III,
Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart RR--Tennessee

0
2. Section 52.2220(c) is amended in Table 3 by:
0
a. Removing the entry for ``25.0;''
0
b. Adding the heading ``Section 25.0--Permits'' and entries for
``25.1,'' ``25.3,'' and ``25.2; 25.4; 25.5; 25.6; 25.7; 25. 10; 25.11''
in numerical order; and
0
c. Revising the entries for ``41.0'' and ``45.0''.
    The additions and revisions read as follows:

Sec.  52.2220   Identification of plan.

* * * * *
    (c) * * *
* * * * *

                                 Table 3--EPA Approved Knox County, Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State        EPA approval
        State section              Title/subject     effective date        date               Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                              Section 25.0--Permits
----------------------------------------------------------------------------------------------------------------
25.1.........................  Construction Permit.       1/18/2017  9/17/2018,
                                                                      [Insert
                                                                      citation of
                                                                      publication].
25.3.........................  Operating Permit....       1/18/2017  9/17/2018,
                                                                      [Insert
                                                                      citation of
                                                                      publication].
25.2; 25.4; 25.5; 25.6; 25.7;  Application for            3/12/2014  4/22/2016, 81
 25.10; 25.11.                  Permit; Compliance                    FR 23640.
                                Schedule; Reporting
                                of Information;
                                Exemptions; Payment
                                of Fees; Permit by
                                Rule; Limiting a
                                Source's Potential
                                to Emit of VOC by
                                Recordkeeping.

                                                  * * * * * * *
41.0.........................  Regulation for the         1/18/2017  9/17/2018,
                                Review of New                         [Insert
                                Sources.                              citation of
                                                                      publication].
45.0.........................  Prevention of              7/20/2016  9/17/2018,
                                Significant                           [Insert
                                Deterioration.                        citation of
                                                                      publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-20041 Filed 9-14-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 108 (Tuesday, June 8, 2021)]
[Notices]
[Pages 30458-30459]
[FR Doc No: 2021-11955]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12611-014]

Verdant Power, LLC; Notice of Application Ready for Environmental
Analysis and Soliciting Comments, Recommendations, Terms and
Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent Minor License.
    b. Project No.: P-12611-014.
    c. Date filed: December 30, 2019.
    d. Applicant: Verdant Power, LLC (Verdant Power).
    e. Name of Project: Roosevelt Island Tidal Energy Project (RITE
Project).
    f. Location: On the East River in New York County, New York. The
project does not occupy federal land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Ronald F. Smith, President and Chief
Operating Officer, Verdant Power, LLC, P.O. Box 282, Roosevelt Island,
New York, New York 10044. Phone:<PHONE_NUMBER>. Email:
<EMAIL_ADDRESS>    i. FERC Contact: Andy Bernick at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
https://ferconline.ferc.gov/QuickComment.aspx. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Submissions sent via any other
carrier must be addressed to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852. The first page of any filing should include docket number P-
12611-014.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted and is now ready for
environmental analysis.
    The Council on Environmental Quality (CEQ) issued a final rule on
July 15, 2020, revising the regulations under 40 CFR parts 1500-1518
that federal agencies use to implement NEPA (see Update to the
Regulations Implementing the Procedural Provisions of the National
Environmental Policy Act, 85 FR 43304). The Final Rule became effective
on and applies to any NEPA process begun after September 14, 2020. An
agency may also apply the regulations to ongoing activities and
environmental documents begun before September 14, 2020, which includes
the RITE Project. Commission staff intends to conduct its NEPA review
in accordance with CEQ's new regulations.
    l. The existing pilot project license, which expires on December
31, 2021, authorizes the following project facilities: (a) Thirty 35-
kilowatt, 5-meter-diameter axial flow turbine-generator units; (b) ten
triframe mounts, each supporting three turbine-generator units; (c)
480-volt underwater cables from each triframe mount to five shoreline
switchgear vaults that interconnect to a control room and
interconnection points; and (d) appurtenant facilities for navigation
safety and operation.
    On October 22, 2020, Verdant installed three turbine-generator
units attached to one tri-frame mount under the existing pilot project
license. Between October 2020 and January 2021, the pilot project
generated about 90 megawatt-hours. Under the current pilot project
license, Verdant is required to remove all project facilities,
including triframe mounts and turbines, prior to the expiration of its
pilot project license.
    The proposed project would consist of a maximum of fifteen 35-
kilowatt, 5-meter-diameter axial flow turbine-generator units with a
total installed capacity of 0.525 megawatt, with underwater cables
connecting five triframe mounts to two shoreline switchgear vaults. The
project would operate using the natural tidal currents of the East
River, during both ebb and flood tidal periods. As the direction of
tidal flow changes, each turbine-generator unit would rotate (or yaw)
to align the rotor to the direction of flow, through a passive system
caused by hydrodynamic forces on the turbine-generator unit. The annual
generation is expected to be from 840 to 1,200 megawatt-hours.
    m. A copy of the application can be viewed on the Commission's
website at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support.
    All filings must (1) bear in all capital letters the title
``COMMENTS,'' ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via

email of new filings and issuances related to this or other pending
projects. For assistance, contact FERC Online Support.
    n. The applicant must file no later than 60 days following the date
of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification. Please note
that the certification request must comply with 40 CFR 121.5(b),
including documentation that a pre-filing meeting request was submitted
to the certifying authority at least 30 days prior to submitting the
certification request. Please also note that the certification request
must be sent to the certifying authority and to the Commission
concurrently.
    o. Procedural schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Deadline for Filing Comments,            August 2021.
 Recommendations, and Agency Terms and
 Conditions/Prescriptions.
Deadline for Filing Reply Comments.....  September 2021.
------------------------------------------------------------------------

    Dated: June 2, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-11955 Filed 6-7-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 200 (Wednesday, October 16, 2019)]
[Notices]
[Page 55321]
[FR Doc No: 2019-22468]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0001]

Notice of Adjustment of Countywide Per Capita Impact Indicator

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: FEMA gives notice that the countywide per capita impact
indicator under the Public Assistance program for disasters declared on
or after October 1, 2019, will be increased.

DATES: This adjustment applies to major disasters declared on or after
October 1, 2019.

FOR FURTHER INFORMATION CONTACT: Tod Wells, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street SW, Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In assessing damages for area designations
under 44 CFR 206.40(b), FEMA uses a countywide per capita indicator to
evaluate the impact of the disaster at the county level. FEMA will
adjust the countywide per capita impact indicator under the Public
Assistance program to reflect annual changes in the Consumer Price
Index for All Urban Consumers published by the Department of Labor.
    FEMA gives notice of an increase in the countywide per capita
impact indicator to $3.84 for all disasters declared on or after
October 1, 2019.
    FEMA bases the adjustment on an increase in the Consumer Price
Index for All Urban Consumers of 1.7 percent for the 12-month period
that ended in August 2019. The Bureau of Labor Statistics of the U.S.
Department of Labor released the information on September 12, 2019.

Catalog of Federal Domestic Assistance No. 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters).

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-22468 Filed 10-15-19; 8:45 am]
 BILLING CODE 9111-11-P


 Forwarded by Vivian Prunier/ DC/ USEPA/ US on 08/ 07/ 2003 01: 08 PM

Vivian Prunier 08/ 04/ 2003 04: 28 PM To: Vivian Prunier/ DC/ USEPA cc: ajames@ pestfacts. org, alan@ petnet. buffalo. edu, allen. jennings@ usda. gov, apolansky@ kda. state. ks. us beth. carroll@ syngenta. com, Betty Shackleford/ DC/ USEPA/ US@ EPA, bgoldburg@ environmentaldefense. org, Blacco@ ix. netcom. com, boddisb@ em. agr. ca, Britt@ cetos. org, Bruce Sidwell/ DC/ USEPA/ US@ EPA, brutala@ unch. unc. edu, cbaker@ gowanco. com, ccqc1946@ pacbell. net, Claire_ franklin@ hc sc. gc. ca, clarkc@ doacs. state. fl. us, cliff@ lodiwine. com, clough. kerry@ epa. gov, csantos@ mail. ssa. gob. mx, cwbrickey@ aol. com, dan@ ffva. com, djg2@ cdc. gov, Douglas Parsons/ DC/ USEPA/ US@ EPA, edsnets@ tvutel. com, enicholson@ ufwmail. com, eolson@ nrdc. org, eortman@ reeusda. gov, ephi@ manainc. com, glibman@ att. net, goldad@ consumer. org, has_ shah@ americanchemistry. com, holm@ aesop. rutgers. edu, J Amador@ TAMU. edu, janis. mcfarland@ syngenta. co Jay Ellenberger/ DC/ USEPA/ US@ EPA, jsass@ nrdc. org, julie. spagnoli. b@ bayer jvickery@ mcg. net, jvroom@ croplifeamerica. org, jwzellers@ aol. com, Kate Bouve/ DC/ USEPA/ US@ EPA, kthayer@ ewg. org, Kugelzur@ migrantclinician. org kwzell@ sssnet. com, lelworth@ agcenter. org, llove78@ aol. com, lori@ minorcrop lori@ yurok. com, Luis Suguiyama/ DC/ USEPA/ US@ EPA, Margie Fehrenbach/ DC/ USEPA/ US, markm@ fb. org, mmiller@ oehha. ca. gov, mmk2@ cdc. gov, nefcon@ aol. com, nfoster@ usapple. org, nlewis2@ unl. edu, pbright@ abcbirds. org, perreault. peg@ epa. gov, phelliker@ cdpr. ca. gov, Phil@ AGR. State. VT. US, Philip Ross/ DC/ USEPA/ US@ EPA, pquinn@ theaccordgroup. com, Richard Dumas/ DC/ USEPA/ US@ EPA, Richard Keigwin/ DC/ USEPA/ US@ EPA, rich. liroff@ wwfus. org, rjjackson@ cdc. gov, rkiefer@ cspa. org, robhedberg@ erols. com, Rodman. joanne@ epa. gov, rosenberg@ pestworld. org, rutzs@ doacs. state. fl. us, rywang@ cdc. gov, sarah. lynch@ wwfus. org, sauers. lj@ pg. com, screscenzi@ steptoe. com, sdavis@ nclr. org, skellner@ cspa. org, Skellner@ cpsa. org, Steve. Balling@ delmonte. com, Ted. Head@ us. nufarm. com, Teresa Downs/ DC/ USEPA/ US@ EPA, terry. troxell@ cfsan. fda. gov, therese. murtaugh@ usda. gov, troys@ peta. org, Tslaton@ cdc. gov, ttroxell@ cfsan. fda. gov, warren@ cpda. com, Whalon@ pilot. msu. edu, wichterman@ lcmcd. org, William. McCormick@ Clorox. com, wkh1@ psu. edu Subject: PPDC registration review  Draft paper on scheduling criteria Dear Workgroup members,

Sue Crescenzi reminded me that she had provided a draft paper on scheduling registration reviews, as she had promised at the July 16.

I apologize for omitting this item from the note I sent earlier today.

Vivian Prunier


[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Page 4900]
[FR Doc No: 2014-01867]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14559-000]

ECOsponsible, Inc.; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On October 24, 2013, ECOsponsible, Inc. filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Setting Pole Rapids
Dam Hydro Project (project) to be located on the Raquette River, in
Franklin County, New York, near the Town of Tupper Lake, New York. The
sole purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project would consist of the following: (1) Installing
three RivGen\TM\ Turbine Generator Units with a total installed
capacity of 1,487 kilowatts below Setting Pole Rapids Dam in the
Raquette River; (2) a shore power station housing two inverters to
convert direct current to alternating current; (3) an overhead 1,450-
foot-long, 46.1-kilovolt (kV) transmission line extending from the
project to the interconnection with National Grid; and (4) appurtenant
facilities. The estimated annual generation of the Setting Pole Rapids
Dam Hydro Project would be 10,420 megawatt-hours.
    Applicant Contact: Mr. Dennis Ryan, ECOsponsible, Inc., 120
Mitchell Road, Suite 100, East Aurora, NY 14052; phone:<PHONE_NUMBER>.
    FERC Contact: Tim Looney; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14559-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14559) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: January 23, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-01867 Filed 1-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Proposed Rules]
[Pages 44895-44896]
[FR Doc No: 2015-18339]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-1835; Airspace Docket No. 14-AGL-7]

Proposed Establishment of Class E Airspace; Hart/Shelby, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E airspace at Hart/
Shelby, MI. Controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures at Oceana County Airport. The
FAA is proposing this action to enhance the safety and management of
Instrument Flight Rules (IFR) operations at the airport.

DATES: Comments must be received on or before September 11, 2015.

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. You
must identify the docket number FAA-2015-1835/Airspace Docket No. 14-
AGL-7, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.
    FAA Order 7400.9Y, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and Regulations Group,
Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Central Service
Center, Operations Support Group, Federal Aviation Administration,
Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone:
817-321-7740.

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 Class E airspace at Oceana County
Airport, Hart/Shelby, MI.

Comments Invited

    Interested parties are invited to participate in 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 and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2015-1835/
Airspace Docket No. 14-AGL-7.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/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 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 during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.9Y, Airspace
Designations and Reporting Points, dated August 6, 2014, and effective
September 15, 2014. FAA Order 7400.9Y is publicly available as listed
in the ADDRESSES section of this proposed rule. FAA Order 7400.9Y lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by establishing Class E airspace extending upward
from 700 feet above the surface within a 6.0-mile radius of Oceana
County Airport, Hart/Shelby, MI, to accommodate new standard instrument
approach procedures. Controlled airspace is needed for the safety and
management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9Y, dated August 6, 2014, and effective September 15, 2014, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document will be published subsequently in
the Order.

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 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 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

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

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

* * * * *

AGL MI E5 Hart/Shelby, MI [New]

Oceana County Airport, MI
    (Lat. 43[deg]38'30'' N., long. 086[deg]19'45'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.0-mile radius of Oceana County Airport.

    Issued in Fort Worth, TX, on June 14, 2015.
Humberto Melendez,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-18339 Filed 7-27-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45331-45334]
[FR Doc No: 2022-16169]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1591]

Food Safety Modernization Act Domestic and Foreign Facility
Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal
Year 2023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fiscal year (FY) 2023 fee rates for certain domestic and foreign
facility reinspections, failures to comply with a recall order, and
importer reinspections that are authorized by the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety
Modernization Act (FSMA).

DATES: These fees are effective on October 1, 2022, and will remain in
effect through September 30, 2023.

FOR FURTHER INFORMATION CONTACT: Jimmy Carlton, Office of Management,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 107 of the FSMA (Pub. L. 111-353) added section 743 to the
FD&C Act (21 U.S.C. 379j-31) to provide FDA with the authority to
assess and collect fees from, in part: (1) the responsible party for
each domestic facility and the U.S. agent for each foreign facility
subject to a reinspection to cover reinspection-related costs; (2) the
responsible party for a domestic facility and an importer who does not
comply with a recall order to cover food \1\ recall activities
associated with such order; and (3) each importer subject to a
reinspection to cover reinspection-related costs (sections
743(a)(1)(A), (B), and (D) of the FD&C Act). Section 743 of the FD&C
Act directs FDA to establish fees for each of these activities based on
an estimate of 100 percent of the costs of each activity for each year
(sections 743(b)(2)(A)(i), (ii), and (iv)), and these fees must be made
available solely to pay for the costs of each activity for which the
fee was incurred (section 743(b)(3)). These fees are effective on
October 1, 2022, and will remain in effect through September 30, 2023.
Section 743(b)(2)(B)(iii) of the FD&C Act directs FDA to develop a
proposed set of guidelines in consideration of the burden of fee
amounts on small businesses. As a first step in developing these
guidelines, FDA invited public comment on the potential impact of the
fees authorized by section 743 of the FD&C Act on small businesses (76
FR 45818, August 1, 2011). The comment period for this request ended
November 30, 2011. As stated in FDA's September 2011 ``Guidance for
Industry: Implementation of the Fee Provisions of Section 107 of the
FDA Food Safety Modernization Act,'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-implementation-fee-provisions-section-107-fda-food-safety-modernization-act), because FDA recognizes that for small businesses
the full cost recovery of FDA reinspection or recall oversight could
impose severe economic hardship, FDA intends to consider reducing
certain fees for those firms. FDA does not intend to issue invoices for
reinspection or recall order fees until FDA publishes a guidance
document outlining the process through which firms may request a
reduction in fees.
---------------------------------------------------------------------------

    \1\ The term ``food'' for purposes of this document has the same
meaning as such term in section 201(f) of the FD&C Act (21 U.S.C.
321(f)).
---------------------------------------------------------------------------

    In addition, as stated in the September 2011 Guidance, FDA is in
the process of considering various issues associated with the
assessment and collection of importer reinspection fees. The fee rates
set forth in this notice will be used to determine any importer
reinspection fees assessed in FY 2023.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2023

    FDA is required to estimate 100 percent of its costs for each
activity in order to establish fee rates for FY 2023. In each year, the
costs of salary (or

personnel compensation) and benefits for FDA employees account for
between 50 and 60 percent of the funds available to, and used by, FDA.
Almost all the remaining funds (operating funds) available to FDA are
used to support FDA employees for paying rent, travel, utility,
information technology (IT), and other operating costs.

A. Estimating the Full Cost per Direct Work Hour in FY 2023

    Full-time Equivalent (FTE) reflects the total number of regular
straight-time hours--not including overtime or holiday hours--worked by
employees, divided by the number of compensable hours applicable to
each fiscal year. Annual leave, sick leave, compensatory time off, and
other approved leave categories are considered ``hours worked'' for
purposes of defining FTE employment.
    In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of an FTE or paid staff year.
Calculating an Agency-wide total cost per FTE requires three primary
cost elements: payroll, nonpayroll, and rent.
    We have used an average of past year cost elements to predict the
FY 2023 cost. The FY 2023 FDA-wide average cost for payroll (salaries
and benefits) is $173,393; nonpayroll (including equipment, supplies,
IT, and general and administrative overhead) is $103,078; and rent,
including cost allocation analysis and adjustments for other rent and
rent-related costs, is $23,944 per paid staff year, excluding travel
costs.
    Summing the average cost of an FTE for payroll, nonpayroll, and
rent, brings the FY 2023 average fully supported cost to $300,416 \2\
per FTE, excluding travel costs. FDA will use this base unit fee in
determining the hourly fee rate for reinspection and recall order fees
for FY 2023 prior to including domestic or foreign travel costs as
applicable for the activity.
---------------------------------------------------------------------------

    \2\ Total includes rounding.
---------------------------------------------------------------------------

    To calculate an hourly rate, FDA must divide the FY 2023 average
fully supported cost of $300,416 per FTE by the average number of
supported direct FDA work hours in FY 2021 (the last fiscal year for
which data are available). See table 1.

Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2021
------------------------------------------------------------------------

------------------------------------------------------------------------
Total number of hours in a paid staff year......................   2,080
Less:
  11 paid holidays..............................................     -88
  20 days of annual leave.......................................    -160
  10 days of sick leave.........................................     -80
  12.5 days of training.........................................    -100
  22 days of general administration.............................    -176
  26.5 days of travel...........................................    -212
  2 hours of meetings per week..................................    -104
                                                                 -------
  Net Supported Direct FDA Work Hours Available for Assignments.   1,160
------------------------------------------------------------------------

    Dividing the average fully supported FTE cost in FY 2023 ($300,416)
by the total number of supported direct work hours available for
assignment in FY 2023 (1,160) results in an average fully supported
cost of $259 (rounded to the nearest dollar), excluding inspection
travel costs, per supported direct work hour in FY 2023.

B. Adjusting FY 2021 Travel Costs for Inflation To Estimate FY 2023
Travel Costs

    To adjust the hourly rate for FY 2023, FDA must estimate the cost
of inflation in each year for FY 2022 and FY 2023. FDA uses the method
prescribed for estimating inflationary costs under the Prescription
Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1)
(21 U.S.C. 379h(c)(1)), the statutory method for inflation adjustment
in the FD&C Act that FDA has used consistently. FDA previously
determined the FY 2022 inflation rate to be 2.2013 percent; this rate
was published in the FY 2022 PDUFA user fee rates notice in the Federal
Register (August 16, 2021, 86 FR 45732). Utilizing the method set forth
in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation
rate of 2.2013 percent for FY 2022 and 1.6404 percent for FY 2023, and
FDA intends to use these inflation rates to make inflation adjustments
for FY 2023 for several of its user fee programs; the derivation of
this rate will be published in the Federal Register in the FY 2023
notice for the PDUFA user fee rates.
    The average fully supported cost per supported direct FDA work
hour, excluding travel costs, of $259 already takes into account
inflation as the calculation above is based on FY 2023 predicted costs.
FDA will use this base unit fee in determining the hourly fee rate for
reinspection and recall order fees for FY 2023 prior to including
domestic or foreign travel costs as applicable for the activity. In FY
2021, FDA's Office of Regulatory Affairs (ORA) spent a total of
$4,920,033 for domestic regulatory inspection travel costs and General
Services Administration Vehicle costs related to FDA's Center for Food
Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine
(CVM) field activities programs. The total ORA domestic travel costs
spent is then divided by the 4,965 CFSAN and CVM domestic inspections,
which averages a total of $991 per inspection. These inspections
average 46.43 hours per inspection. Dividing $991 per inspection by
46.43 hours per inspection results in a total and an additional cost of
$21 (rounded to the nearest dollar) per hour spent for domestic
inspection travel costs in FY 2021. To adjust for the $21 per hour
additional domestic cost inflation increases for FY 2022 and FY 2023,
FDA must multiply the FY 2022 PDUFA inflation rate adjustor (1.022013)
times the FY 2023 PDUFA inflation rate adjustor (1.016404) times the
$21 additional domestic cost, which results in an estimated cost of $22
(rounded to the nearest dollar) per paid hour in addition to $259 for a
total of $281 per paid hour ($259 plus $22) for each direct hour of
work requiring domestic inspection travel. FDA will use these rates in
charging fees in FY 2023 when domestic travel is required.
    In FY 2020,\3\ ORA spent a total of $1,449,058 on 171 foreign
inspection trips related to FDA's CFSAN and CVM field activities
programs, which averaged a total of $8,474 per foreign inspection trip.
These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing
$8,474 per trip by 120 hours per trip results in a total and an
additional cost of $71 (rounded to the nearest dollar) per paid hour
spent for foreign inspection travel costs in FY 2020. To adjust $71 for
inflationary increases in FY 2021, FY 2022, and FY 2023, FDA must
multiply it by the same inflation factors mentioned previously in this
document (1.022013 and 1.016404) and the inflation factor for FY 2021
\4\ (1.013493), which results in an estimated cost of $75 (rounded to
the nearest dollar) per paid hour in addition to $259 for a total of
$334 per paid hour ($259 plus $75) for each direct hour of work
requiring foreign inspection travel. FDA will use these rates in
charging fees in FY 2023 when foreign travel is required.
---------------------------------------------------------------------------

    \3\ We use FY 2020 numbers for the foreign inspection travel
costs due to the limited number of inspections done in FY 2021 due
to travel restrictions caused by the COVID-19 Pandemic.
    \4\ FDA previously determined the FY 2021 inflation rate to be
1.3493 percent; this rate was published in the FY 2021 PDUFA user
fee rates notice in the Federal Register (August 3, 2020, 85 FR
46651).

                 Table 2--FSMA Fee Schedule for FY 2023
------------------------------------------------------------------------
                                                               Fee rates
                        Fee category                            for FY
                                                                 2023
------------------------------------------------------------------------
Hourly rate if domestic travel is required..................        $281
Hourly rate if foreign travel is required...................         334
------------------------------------------------------------------------

III. Fees for Reinspections of Domestic or Foreign Facilities Under
Section 743(a)(1)(A)

A. What will cause this fee to be assessed?

    The fee will be assessed for a reinspection conducted under section
704 of the FD&C Act (21 U.S.C. 374) to determine whether corrective
actions have been implemented and are effective and compliance has been
achieved to the Secretary of Health and Human Services' (the Secretary)
(and, by delegation, FDA's) satisfaction at a facility that
manufactures, processes, packs, or holds food for consumption
necessitated as a result of a previous inspection (also conducted under
section 704) of this facility, which had a final classification of
Official Action Indicated (OAI) conducted by or on behalf of FDA, when
FDA determined the noncompliance was materially related to food safety
requirements of the FD&C Act. FDA considers such noncompliance to
include noncompliance with a statutory or regulatory requirement under
section 402 of the FD&C Act (21 U.S.C. 342) and section 403(w) of the
FD&C Act (21 U.S.C. 343(w)). However, FDA does not consider
noncompliance that is materially related to a food safety requirement
to include circumstances where the noncompliance is of a technical
nature and not food safety related (e.g., failure to comply with a food
standard or incorrect font size on a food label). Determining when
noncompliance, other than under sections 402 and 403(w) of the FD&C
Act, is materially related to a food safety requirement of the FD&C Act
may depend on the facts of a particular situation. FDA intends to issue
guidance to provide additional information about the circumstances
under which FDA would consider noncompliance to be materially related
to a food safety requirement of the FD&C Act.
    Under section 743(a)(1)(A) of the FD&C Act, FDA is directed to
assess and collect fees from ``the responsible party for each domestic
facility (as defined in section 415(b) (21 U.S.C. 350d(b))) and the
U.S. agent for each foreign facility subject to a reinspection'' to
cover reinspection-related costs.
    Section 743(a)(2)(A)(i) of the FD&C Act defines the term
``reinspection'' with respect to domestic facilities as ``1 or more
inspections conducted under section 704 subsequent to an inspection
conducted under such provision which identified noncompliance
materially related to a food safety requirement of th[e] Act,
specifically to determine whether compliance has been achieved to the
Secretary's satisfaction.''
    The FD&C Act does not contain a definition of ``reinspection''
specific to foreign facilities. In order to give meaning to the
language in section 743(a)(1)(A) of the FD&C Act to collect fees from
the U.S. agent of a foreign facility subject to a reinspection, the
Agency is using the following definition of ``reinspection'' for
purposes of assessing and collecting fees under section 743(a)(1)(A),
with respect to a foreign facility: ``1 or more inspections conducted
by officers or employees duly designated by the Secretary subsequent to
such an inspection which identified noncompliance materially related to
a food safety requirement of the FD&C Act, specifically to determine
whether compliance has been achieved to the Secretary's (and, by
delegation, FDA's) satisfaction.''
    This definition allows FDA to fulfill the mandate to assess and
collect fees from the U.S. agent of a foreign facility in the event
that an inspection reveals noncompliance materially related to a food
safety requirement of the FD&C Act, causing one or more subsequent
inspections to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction. By requiring the
initial inspection to be conducted by officers or employees duly
designated by the Secretary, the definition ensures that a foreign
facility would be subject to fees only in the event that FDA, or an
entity designated to act on its behalf, has made the requisite
identification at an initial inspection of noncompliance materially
related to a food safety requirement of the FD&C Act. The definition of
``reinspection-related costs'' in section 743(a)(2)(B) of the FD&C Act
relates to both a domestic facility reinspection and a foreign facility
reinspection, as described in section 743(a)(1)(A).

B. Who will be responsible for paying this fee?

    The FD&C Act states that this fee is to be paid by the responsible
party for each domestic facility (as defined in section 415(b) of the
FD&C Act) and by the U.S. agent for each foreign facility (section
743(a)(1)(A) of the FD&C Act). This is the party to whom FDA will send
the invoice for any fees that are assessed under this section.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on such
reinspections, including time spent conducting the physical
surveillance and/or compliance reinspection at the facility, or
whatever components of such an inspection are deemed necessary, making
preparations and arrangements for the reinspection, traveling to and
from the facility, preparing any reports, analyzing any samples or
examining any labels if required, and performing other activities as
part of the OAI reinspection until the facility is again determined to
be in compliance. The direct hours spent on each such reinspection will
be billed at the appropriate hourly rate shown in table 2 of this
document.

IV. Fees for Noncompliance With a Recall Order Under Section
743(a)(1)(B)

A. What will cause this fee to be assessed?

    The fee will be assessed for not complying with a recall order
under section 423(d) (21 U.S.C. 350l(d)) or section 412(f) of the FD&C
Act (21 U.S.C. 350a(f)) to cover food recall activities associated with
such order performed by the Secretary (and by delegation, FDA) (section
743(a)(1)(B) of the FD&C Act). Noncompliance may include the following:
(1) not initiating a recall as ordered by FDA; (2) not conducting the
recall in the manner specified by FDA in the recall order; or (3) not
providing FDA with requested information regarding the recall, as
ordered by FDA.

B. Who will be responsible for paying this fee?

    Section 743(a)(1)(B) of the FD&C Act states that the fee is to be
paid by the responsible party for a domestic facility (as defined in
section 415(b) of the FD&C Act) and an importer who does not comply
with a recall order under section 423 or under section 412(f) of the
FD&C Act. In other words, the party paying the fee would be the party
that received the recall order.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on taking
action in response to the firm's failure to comply with a recall order.
Types of activities could include conducting recall audit checks,
reviewing periodic status reports, analyzing the status reports and the
results of the audit checks, conducting inspections, traveling to and

from locations, and monitoring product disposition. The direct hours
spent on each such recall will be billed at the appropriate hourly rate
shown in table 2 of this document.

D. How must the fees be paid?

    An invoice will be sent to the responsible party for paying the fee
after FDA completes the work on which the invoice is based. Payment
must be made within 30 days of the invoice date in U.S. currency by
check, bank draft, or U.S. postal money order payable to the order of
the Food and Drug Administration. Detailed payment information will be
included with the invoice when it is issued.

V. What are the consequences of not paying these fees?

    Under section 743(e)(2) of the FD&C Act, any fee that is not paid
within 30 days after it is due shall be treated as a claim of the U.S.
Government subject to provisions of subchapter II of chapter 37 of
title 31, United States Code.

    Dated: July 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16169 Filed 7-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Rules and Regulations]
[Pages 59670-59671]
[FR Doc No: 2022-21346]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0578; Airspace Docket No. 21-AWP-60]
RIN 2120-AA66

Modification & Removal of Class E Airspace; Valle Airport, AZ

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

ACTION: Final rule.

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SUMMARY: This action modifies the Class E airspace extending upward
from 700 feet above the surface, and removes the Class E airspace
extending upward from 1,200 feet above the surface at Valle Airport,
Grand Canyon, AZ. Additionally, this action makes administrative
changes to the existing Class E legal description. These actions will
ensure the safety and management of instrument flight rules (IFR)
operations at the airport.

DATES: Effective 0901 UTC, December 29, 2022. The Director of the
Federal Register approves this incorporation by reference under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11,
Airspace Designations and Reporting Points, and publication of
conforming amendments.

ADDRESSES: FAA Order JO 7400.11G, 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: Gerald DeVore II, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; 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 modifes and removes Class E airspace at Valle Airport, Grand
Canyon, AZ, to support IFR operations at the airport.

History

    The FAA published a notice of proposed rulemaking (NPRM) in the
Federal Register for FAA-2021-0578 (87 FR 39023; June 30, 2022) that
proposed to modify the Class E airspace extending upward from 700 feet
above the surface, and remove the Class E airspace extending upward
from 1,200 feet above the surface at Valle Airport, Grand Canyon, AZ.
Additionally, the NPRM proposed to make administrative changes to the
existing Class E legal description. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designation listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11G, Airspace Designations
and Reporting Points, dated August 19, 2022, and effective September
15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11G lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending 14 CFR part 71 by modifying Class E airspace
extending upward from 700 feet above the surface at Valle Airport,
Grand Canyon, AZ. This airspace modification removes the extensions
north and south of the airport, as the extensions are no longer needed.
Furthermore, to properly contain departing IFR aircraft flying toward
or over rising terrain to 1,200 feet above the surface, the eastern
portion of the airspace radius is increased from 6.4 miles to 6.8
miles.
    Additionally, the FAA is removing the Class E airspace extending
upward from 1,200 feet above the surface. This area is contained within
the Los Angeles Class E airspace designated as a domestic en route
airspace area, and duplication is not necessary.
    Finally, the FAA is making several administrative modifications to
the legal description. The city, name, and geographic coordinates at
Valle Airport, Grand Canyon, AZ are updated to match the FAA's
database.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designation listed in this document will be published
subsequently in FAA Order JO 7400.11.
    FAA Order JO 7400.11 is published annually and becomes effective on
September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and

unlikely to result in adverse or negative comments. 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 rule,
when promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant the preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the FAA amends 14 CFR part 71 as
follows:

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

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

    Authority:  49 U.S.C. 106(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 FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

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

* * * * *

AWP AZ E5 Grand Canyon, AZ [Amended]

Valle Airport, AZ
    (Lat. 35[deg]39'02'' N, long. 112[deg]08'53'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of the airport beginning at the 020[deg]
bearing from the airport clockwise to the 190[deg] bearing from the
airport, and within a 6.4-mile radius of the airport beginning at
the 190[deg] bearing from the airport clockwise to the 020[deg]
bearing from the airport.

    Issued in Des Moines, Washington, on September 27, 2022.
B.G. Chew,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2022-21346 Filed 9-30-22; 8:45 am]
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