[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46935-46936]
[FR Doc No: 2018-20083]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP18-1146-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Annual Cash-Out Report of Colombia Gulf Transmission,
LLC under RP18-1146.
    Filed Date: 8/31/18.
    Accession Number: 20180831-5248.
    Comments Due: 5 p.m. ET 9/14/18.

    Docket Numbers: RP18-1147-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Operational Purchase and Sales Report of Colorado
Interstate Gas Company L.L.C under RP18-1147.
    Filed Date: 8/31/18.
    Accession Number: 20180831-5248.
    Comments Due: 5 p.m. ET 9/14/18.

    Docket Numbers: RP18-1148-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2018-09-04 BP, CP,
and Encana to be effective 9/1/2018.
    Filed Date: 9/5/18.
    Accession Number: 20180905-5080.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1151-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090518 Negotiated Rates--Mieco
Inc. R-7080-02 to be effective 11/1/2018.
    Filed Date: 9/5/18.
    Accession Number: 20180905-5138.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1152-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090518 Negotiated Rates--Mieco
Inc. R-7080-03 to be effective 11/1/2018.
    Filed Date: 9/5/18.
    Accession Number: 20180905-5140.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1153-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090518 Negotiated Rates--Mieco
Inc. R-7080-04 to be effective 11/1/2018.
    Filed Date: 9/5/18.
    Accession Number: 20180905-5141.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1154-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090518 Negotiated Rates--Mieco
Inc. R-7080-05 to be effective 11/1/2018.
    Filed Date: 9/5/18.
    Accession Number: 20180905-5143.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1155-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 090518 Negotiated Rates--Mieco
Inc. R-7080-06 to be effective 11/1/2018.
    Filed Date: 9/5/18.
    Accession Number: 20180905-5144.
    Comments Due: 5 p.m. ET 9/17/18.

    Docket Numbers: RP18-1156-000.
    Applicants: Black Marlin Pipeline Company.
    Description: Black Marlin Pipeline Company submits tariff filing
per 260.402: Black Marlin Pipeline Company: Petition for Waiver from
Filing Form No. 501-G to be effective N/A under RP18-1156.
    Filed Date: 09/06/2018.
    Accession Number: 20180906-5030.
    Comment Date: 5:00 p.m. ET 9/18/18.

    Docket Numbers: RP18-1157-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Eastern Shore Natural Gas Company submits tariff
filing per 260.402: Waiver to file FERC Form No. 501-G to be effective
N/A under RP18-1157.
    Filed Date: 09/06/2018.
    Accession Number: 20180906-5081.
    Comment Date: 5:00 p.m. ET 9/18/18.

    Docket Numbers: RP18-1158-000.
    Applicants: CNE Gas Supply, LLC,Exelon Generation Company, LLC.
    Description: Petition for Temporary Waivers of Capacity Regulations
and Policies, et al. of CNE Gas Supply, LLC, et al. under RP18-1158.
    Filed Date: 09/06/2018.
    Accession Number: 20180906-5132.
    Comment Date: 5:00 p.m. ET 9/18/18.

    Docket Numbers: RP18-1159-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: eTariff filing per 1430: Request for Waiver of Form
No. 501-G to be effective N/A.
    Filed Date: 9/7/18.
    Accession Number: 20180907-5030.
    Comments Due: 5 p.m. ET 9/19/18.

    Docket Numbers: RP18-1160-000.
    Applicants: Paiute Pipeline Company.
    Description: Compliance filing Compliance Filing--CP17-471 to be
effective 11/1/2018.
    Filed Date: 9/10/18.
    Accession Number: 20180910-5000.
    Comments Due: 5 p.m. ET 9/24/18.

    Docket Numbers: RP18-1161-000.
    Applicants: Iroquois Gas Transmission System, L.P.

    Description: Sec.  4(d) Rate Filing: 091018 Negotiated Rates--
Equinor Natural Gas LLC R-7120-07 to be effective 11/1/2018.
    Filed Date: 9/10/18.
    Accession Number: 20180910-5031.
    Comments Due: 5 p.m. ET 9/24/18.

    Docket Numbers: RP18-1162-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 091018 Negotiated Rates--
Equinor Natural Gas LLC R-7120-08 to be effective 11/1/2018.
    Filed Date: 9/10/18.
    Accession Number: 20180910-5041.
    Comments Due: 5 p.m. ET 9/24/18.

    Docket Numbers: RP18-1163-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 091018 Negotiated Rates--
Equinor Natural Gas LLC R-7120-09 to be effective 11/1/2018.
    Filed Date: 9/10/18.
    Accession Number: 20180910-5046.
    Comments Due: 5 p.m. ET 9/24/18.

    Docket Numbers: RP18-1164-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 091018 Negotiated Rates--
Equinor Natural Gas LLC R-7120-10 to be effective 11/1/2018.
    Filed Date: 9/10/18.
    Accession Number: 20180910-5047.
    Comments Due: 5 p.m. ET 9/24/18.

    Docket Numbers: RP18-1165-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits tariff filing per
154.204: Errata to Administrative Cleanup to Tariff to be effective 10/
1/2018 under RP18-1165.
    Filed Date: 09/10/2018.
    Accession Number: 20180910-5134.
    Comment Date: 5:00 p.m. ET 9/24/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 11, 2018.
 Nathaniel J. Davis, Sr.
 Deputy Secretary.
[FR Doc. 2018-20083 Filed 9-14-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12950-12951]
[FR Doc No: 2021-04520]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0033]

Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval
of Seven Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of seven abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 5, 2021.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                 Drug               Applicant
------------------------------------------------------------------------
ANDA 065428..................  Cefprozil Tablets,    Morton Grove
                                250 milligrams (mg)   Pharmaceuticals
                                and 500 mg.           Inc./Wockhardt USA
                                                      LLC., 6451 Main
                                                      St., Morton Grove,
                                                      IL 60053.
ANDA 077699..................  Mefloquine            Hikma
                                Hydrochloride (HCl)   Pharmaceuticals
                                Tablets, 250 mg.      USA Inc., 1809
                                                      Wilson Rd.,
                                                      Columbus, OH
                                                      43228.
ANDA 078383..................  Pioglitazone HCl      Neopharma Inc., 211
                                Tablets, Equivalent   College Road East,
                                to (EQ) 15 mg base;   Suite 101,
                                EQ 30 mg base; EQ     Princeton, NJ
                                45 mg base.           08540.
ANDA 078953..................  Irinotecan HCl         Do.
                                Injection, 40 mg/2
                                milliliters (mL)
                                (20 mg/mL) and 100
                                mg/5 mL (20 mg/mL).
ANDA 079049..................  Alendronate Sodium     Do.
                                Tablets, EQ 5 mg
                                base; EQ 10 mg
                                base; EQ 35 mg
                                base; EQ 70 mg base.

ANDA 090732..................  Anastrozole Tablets,   Do.
                                1 mg.
ANDA 203161..................  Irbesartan Tablets,    Do.
                                75 mg, 150 mg, and
                                300 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
5, 2021. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on April 5, 2021 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04520 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 14, 2006 (Volume 71, Number 178)]
[Notices]
[Page 54278-54279]
[DOCID:fr14se06-37]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0041; FRL-8218-9]

Agency Information Collection Activities; Proposed Collection;
Comment Request; RadNet (Previously Known as ERAMS); EPA ICR No.
0877.09, OMB Control No. 2060-0015

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on February 28, 2007. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before November 13, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2003-0041, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: National Air and Radiation Environmental Laboratory,
540 South Morris Avenue, Montgomery, Alabama 36115-2601.
     Hand Delivery: Office of Air and Radiation Docket in the
EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution
Ave., NW., Washington, DC. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2003-0041. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
http://www.epa.gov/epahome/dockets.htm for current information on

docket operations, locations and telephone numbers. The Docket
Center's mailing address for U.S. mail and the procedure for
submitting comments to http://www.regulations.gov are not affected by the

flooding and will remain the same.

FOR FURTHER INFORMATION CONTACT: Charles M. Petko, Office of Radiation
and Indoor Air (ORIA), National Air and Radiation Environmental
Laboratory (NAREL), 540 South Morris Avenue, Montgomery, Alabama 36115-
2601. Tel:<PHONE_NUMBER>; Fax:<PHONE_NUMBER>; E-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2003-0041, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Office of Air and

Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room
B102, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public
Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Reading Room is
202-566-1744, and the telephone number for the Office of Air and
Radiation Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft collection of

information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;

    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

Docket ID No. EPA-HQ-OAR-2003-0041

    Affected entities: Entities potentially affected by this action are
sample collectors.
    Title: RadNet.
    ICR numbers: EPA ICR No. 0877.09, OMB Control No. 2060-0015.
    ICR status: This ICR is currently scheduled to expire on February
28, 2007. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: RadNet is a national network of stations collecting
sampling media that include air, precipitation, drinking water, and
milk. Samples are sent to EPA National Air and Radiation Environmental
Laboratory (NAREL) in Montgomery, Alabama, where they are analyzed for
radioactivity. RadNet provides emergency response/homeland security and
ambient monitoring information on levels of environmental radiation
across the nation. All stations, usually operated by state and local
personnel, participate in RadNet voluntarily. Station operators
complete information forms that accompany the samples. The forms
request descriptive information pertaining to sample location, e.g.,
sample type, sample location, length of sampling period, and volume
represented.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.3
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 249.
    Frequency of response: From twice weekly to four times annually,
depending upon type of medium being sampled.
    Estimated total average number of responses for each respondent:
34.
    Estimated total annual burden hours: 8,363 hours.
    Estimated total annual costs: $254,890. This cost refers to
respondent burden. The costs of capital investment, maintenance and
operational costs are assumed by the Agency.

Are There Changes in the Estimates From the Last Approval?

    There will be an increase in the total estimated respondent burden
compared with that identified in the ICR currently approved by OMB.
This increase reflects EPA's decision to upgrade and expand the air
monitoring network of RadNet. Over the years covered by this ICR
renewal, the air network will expand from existing 64 monitors to
approximately 130 monitors, which will result in the addition of 66
respondents.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: September 6, 2006.
Michael Clark,
Acting Director, National Air and Radiation Environmental Laboratory
(NAREL).
 [FR Doc. E6-15250 Filed 9-13-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72894-72895]
[FR Doc No: 2013-29010]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0795]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Third-Party Review Under the Food and Drug Administration Modernization
Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
3, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0375.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Devices; Third-Party Review Under the Food and Drug
Administration Modernization Act--(OMB Control Number 0910-0375)--
Extension

    Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360m), directing FDA to accredit persons in the private
sector to review certain premarket notifications (510(k)s).
Participation in this third-party review program by accredited persons
is entirely voluntary. A third party wishing to participate will submit
a request for accreditation to FDA. Accredited third-party reviewers
have the ability to review a manufacturer's 510(k) submission for
selected devices. After reviewing a submission, the reviewer will
forward a copy of the 510(k) submission, along with the reviewer's
documented review and recommendation to FDA. Third-party reviewers
should maintain records of their 510(k) reviews and a copy of the
510(k) for a reasonable period of time, usually a period of 3 years.
    This information collection will allow FDA to continue to implement
the accredited person review program established by FDAMA and improve
the efficiency of 510(k) review for low- to moderate-risk devices.
    Respondents to this information collection are businesses or other
for-profit organizations.
    In the Federal Register of July 9, 2013 (78 FR 41065), FDA
published a 60-day notice requesting public comment on the proposed
collection of information to which one comment was received but was
unrelated to the information collection.
    FDA estimates the burden of this collection of information as
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                         Activity                              Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for Accreditation...............................                  1                  1                  1                 24                 24
510(k) Reviews Conducted by Accredited Third Parties.....                 10                 26                260                 40             10,400
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................             10,424
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

510(k) Reviews Conducted by Accredited Third Parties
    According to FDA's data, the number of 510(k)s submitted for third-
party review is approximately 260 annually, which is 26 annual reviews
per each of the 10 accredited reviewers.

                                                     Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of       Number of records     Total annual     Average burden per
                      Activity                           recordkeepers     per recordkeeper         records          recordkeeping        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews......................................                 10                  26                 260                  10               2,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Third-party reviewers are required to keep records of their review
of each submission. According to FDA's data, the Agency anticipates
approximately 260 submissions of 510(k)s for third-party review per
year.

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29010 Filed 12-3-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Proposed Rules]
[Pages 72130-72132]
[FR Doc No: 2011-30062]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-27023; Directorate Identifier 98-ANE-47-AD]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney JT9D Series Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede an existing airworthiness directive
(AD) that applies to all Pratt & Whitney (PW) JT9D series turbofan
engines. The existing AD currently requires revisions to the
Airworthiness Limitations Section (ALS) of the manufacturer's
Instructions for Continued Airworthiness (ICA) to include required
enhanced inspection of selected critical life-limited parts at each
piece-part opportunity. Since we issued that AD, PW has added mandatory
inspections for certain critical life-limited parts. This proposed AD
would require additional revisions to the JT9D series engines ALS
sections of the manufacturer's ICA. This proposed AD results from the
need to require enhanced inspection of selected critical life-limited
parts of JT9D series engines. We are proposing this AD to prevent
critical life-limited rotating engine part failure, which could result
in an uncontained engine failure and damage to the airplane.

DATES: We must receive comments on this proposed AD by January 23,
2012.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Stephen Sheely, Aerospace Engineer,
Engine & Propeller Directorate, FAA, 12 New England Executive Park,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-
27023; Directorate Identifier 98-ANE-47-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On March 1, 2007, we issued AD 2007-05-17, Amendment 39-14978 (72
FR 10350, March 8, 2007), for all PW JT9D series turbofan engines. That
AD requires revisions to the ALS of the manufacturer's ICA to include
required enhanced inspection of selected critical life-limited parts at
each piece-part opportunity. We issued that AD to prevent critical
life-limited rotating engine part failure, which could result in an
uncontained engine failure and damage to the airplane.

Actions Since Existing AD (72 FR 10350, March 8, 2007) Was Issued

    Since we issued AD 2007-05-17, an FAA study of in-service events
involving uncontained failures of critical rotating engine parts has
indicated the need for additional mandatory inspections. The mandatory
inspections are needed to identify those critical rotating parts with
conditions which, if allowed to continue in service, could result in
uncontained engine failures. This proposal would require revisions to
the JT9D series engines ALS sections of the manufacturer's manuals and
an air carrier's approved continuous airworthiness maintenance program
to incorporate additional inspection requirements.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would retain all of the requirements of AD 2007-
05-17 (72 FR 10350, March 8, 2007). This proposed AD would supersede AD
2007-05-17 to require the following additional inspections:
     Adding eddy current inspections (ECIs) for web cooling
holes in high-pressure turbine (HPT) stage 1 disks installed in engine
models JT9D-3A, -7, -7A, -7AH, -7F, -7H, -7J, -20, and -20J engines;
     Adding ECIs for web cooling holes and tierod holes in HPT
stage 2 disks installed in JT9D-59A and -70A engines;
     Adding ECIs for web cooling holes and tierod holes in HPT
stage 2 disks installed in JT9D-7Q and -7Q3 engines;
     Adding ECIs for web cooling holes in HPT stage 2 disks,
and for fan hub

slots, installed in JT9D-7R4 engines; and
     Adding ECIs for web cooling holes and tierod holes in HPT
stage 2 disks installed in JT9D-7R4D, -7R4D1, -7R4E, and -7R4E1
engines.
    This proposed AD would also add the Engine Manual Inspection Task
and Sub Task Number references for these inspections.

Identifying the Part Nomenclatures and Inspections Added

    For reference, the part nomenclatures and inspections added to the
table in the compliance section of this proposed AD are identified by
two asterisks (**) that precede the part nomenclature.

Costs of Compliance

    We estimate that 438 JT9D series engines are installed on airplanes
of U.S. registry and would be affected by this proposed AD. We also
estimate that about 4 work hours per engine are needed to perform the
proposed actions, and that the average labor rate is $85 per work hour.
Since this is an added inspection requirement that will be part of the
normal maintenance cycle, no additional parts costs are involved. Based
on these figures, we estimate the total cost of the proposed AD to U.S.
operators to be $148,920.

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 have 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 that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing airworthiness directive
(AD) 2007-05-17, Amendment 39-14978 (72 FR 10350, March 8, 2007), and
adding the following new AD:

Pratt & Whitney: Docket No. FAA-2007-27023; Directorate Identifier
98-ANE-47-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by January 23,
2012.

(b) Affected ADs

    This AD supersedes AD 2007-05-17, Amendment 39-14978 (72 FR
10350, March 8, 2007).

(c) Applicability

    This AD applies to Pratt & Whitney (PW) JT9D-3A, -7, -7A, -7H, -
7AH, -7F, -7J, -20J, -59A, -70A, -7Q, -7Q3, -7R4D, -7R4D1, -7R4E, -
7R4E1, -7R4E4, -7R4G2, and -7R4H1 series turbofan engines.

(d) Unsafe Condition

    This AD results from the need to require enhanced inspection of
selected critical life-limited parts of JT9D series turbofan
engines. We are issuing this AD to prevent critical life-limited
rotating engine part failure, which could result in an uncontained
engine failure and damage to the airplane.

(e) Compliance

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

(f) Inspections

    Within the next 30 days after the effective date of this AD, add
the following section to the Airworthiness Limitations Section (ALS)
of your copy of the manufacturer's Instructions for Continued
Airworthiness (ICA) and, for air carrier operations, to your
continuous airworthiness air carrier maintenance program:

``MANDATORY INSPECTIONS''

    (1) Inspect the following life-limited parts at each piece-part
opportunity in accordance with the instructions provided in the
applicable manual provisions:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Engine manual part No. (P/                                    Inspect per
             Engine model                           N)                    Part nomenclature         manual section             Inspection/check
--------------------------------------------------------------------------------------------------------------------------------------------------------
3A/7/7A/7AH/7F/7H/7J/20/20J...........  *646028 (or the            All Fan Hubs..................          72-31-04  Inspection-02.
                                         equivalent customized
                                         versions, 770407 and
                                         770408).
                                                                   All HPC Stage 5-15 Disks and            72-35-00  Inspection-03.
                                                                    Rear Compressor Drive Turbine
                                                                    Shafts.
                                                                   All HPT Stage 1-2 Disks and             72-51-00  Inspection-03.
                                                                    Hubs.
                                                                   **All HPT Stage 1 Disk Web              72-51-02  Inspection-06.
                                                                    Cooling Holes.
                                                                   All HPT Stage 2 Disk Web                72-51-02  Inspection-05.
                                                                    Tierod Holes.
                                                                   All LPT Stage 3-6 Disks and             72-52-00  Inspection-03.
                                                                    Hubs.
--------------------------------------------------------------------------------------------------------------------------------------------------------
59A/70A...............................  754459...................  All Fan Hubs..................          72-31-00  Check-00.
                                                                   All HPC Stage 5-15 Disks and            72-35-00  Check-00.
                                                                    Rear Compressor Drive Turbine
                                                                    Shafts.
                                                                   All HPT Stage 1-2 Disks and             72-51-00  Check-03.
                                                                    Hubs.

                                        .........................  All HPT Stage 1 Disk Web                72-51-02  Check-03.
                                                                    Cooling Holes.
                                                                   **All HPT Stage 2 Disk Tierod           72-51-02  Check-04.
                                                                    and Web Cooling Holes.
                                                                   All LPT Stage 3-6 Disks and             72-52-00  Check-03.
                                                                    Hubs.
--------------------------------------------------------------------------------------------------------------------------------------------------------
7Q/7Q3................................  777210...................  All Fan Hubs..................          72-31-00  Inspection-03.
                                                                   All HPC Stage 5-15 Disks and            72-35-00  Inspection-03.
                                                                    Rear Compressor Drive Turbine
                                                                    Shafts.
                                                                   All HPT Stage 1-2 Disks and             72-51-00  Inspection-03.
                                                                    Hubs All HPT Stage 1 Disk Web          72-51-06  Inspection-03.
                                                                    Cooling Holes.
                                                                   **All HPT Stage 2 Disk Tierod           72-51-07  Inspection-03.
                                                                    and Web Cooling Holes.
                                                                   All LPT Stage 3-6 Disks and             72-52-00  Inspection-03.
                                                                    Hubs.
--------------------------------------------------------------------------------------------------------------------------------------------------------
7R4 ALL...............................  785058, 785059, and        All Fan Hubs..................          72-31-00  Inspection/Check-03.
                                         789328.
                                                                   **All Fan Hub Slots...........          72-31-01  Inspection/Check-02.
                                                                   All HPC Stage 5-15 Disks and            72-35-00  Inspection/Check 03.
                                                                    Rear Compressor Drive Turbine
                                                                    Shafts.
                                                                   All HPT Stage 1-2 Disks and             72-51-00  Inspection/Check 03.
                                                                    Hubs.
                                                                   All LPT Stage 3-6 Disks and             72-52-00  Inspection/Check 03
                                                                    Hubs.
                                                                   **All HPT Stage 2 Disk Tierod           72-51-07  Inspection/Check-02.
                                                                    and Web Cooling Holes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
7R4D/D1/E/E1..........................  785058 and 785059........  All HPT Stage 1 Disk Web                72-51-06  Inspection/Check-02.
                                                                    Cooling Holes.
                                                                   **All HPT Stage 2 Disk Tierod           72-51-07  Inspection/Check-02.
                                                                    and Web Cooling Holes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* P/N 770407 and 770408 are customized versions of P/N 646028 engine manual.
** Two asterisks identify the part nomenclatures and inspections added to the table.

    (2) For the purposes of these mandatory inspections, piece-part
opportunity means:
    (i) The part is considered completely disassembled when
disassembly is in accordance with the disassembly instructions in
the manufacturer's engine shop manual; and
    (ii) The part has accumulated more than 100 cycles-in-service
since the last piece-part opportunity inspection, provided that the
part was not damaged or related to the cause for its removal from
the engine.''
    (g) Except as provided in paragraph (h) of this AD, and
notwithstanding contrary provisions in section 43.16 of the Federal
Aviation Regulations (14 CFR 43.16), these mandatory inspections
shall be performed only in accordance with the ALS of the
manufacturer's ICA.

(g) Alternative Methods of Compliance (AMOC)

    (1) You must perform these mandatory inspections using the ALS
of the ICA and the applicable Engine Manual, unless you receive
approval to use an AMOC under paragraph (h)(2) of this AD. Section
43.16 of the Federal Aviation Regulations (14 CFR 43.16) may not be
used to approve alternative methods of compliance or adjustments to
the times in which these inspections must be performed.
    (2) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD, if
requested using the procedures found in 14 CFR 39.19.

(h) Maintaining Records of the Mandatory Inspections

    (1) You have met the requirements of this AD when you revise
your copy of the ALS of the manufacturer's ICA as specified in
paragraph (f) of this AD. For air carriers operating under part 121
of the Federal Aviation Regulations (14 CFR part 121), you have met
the requirements of this AD when you modify your continuous
airworthiness air carrier maintenance program as specified in
paragraph (f) of this AD. You do not need to record each piece-part
inspection as compliance to this AD, but you must maintain records
of those inspections according to the regulations governing your
operation. For air carriers operating under part 121, you may use
either the system established to comply with section 121.369 or an
alternative accepted by your principal maintenance inspector if that
alternative:
    (i) Includes a method for preserving and retrieving the records
of the inspections resulting from this AD;
    (ii) Meets the requirements of section 121.369(c); and
    (iii) Maintains the records either indefinitely or until the
work is repeated.
    (2) These record keeping requirements apply only to the records
used to document the mandatory inspections required as a result of
revising the ALS of the manufacturer's ICA as specified in paragraph
(f) of this AD. These record keeping requirements do not alter or
amend the record keeping requirements for any other AD or regulatory
requirement.

(i) Related Information

    For more information about this AD, contact Stephen Sheely,
Aerospace Engineer, Engine & Propeller Directorate, FAA, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued in Burlington, Massachusetts, on November 15, 2011.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2011-30062 Filed 11-21-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76188-76189]
[FR Doc No: 2022-26997]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.220(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may 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, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

------------------------------------------------------------------------
          Docket Nos.               File date     Presenter or requester
------------------------------------------------------------------------
Prohibited:
    1. EL20-42-000.............       12-1-2022  FERC Staff.\1\
Exempt:
    1. P-14803-001, P-2082-063.       11-1-2022  U.S. Congress.\2\
    2. CP16-22-000.............      11-23-2022  U.S. Senator Sherrod
                                                  Brown.
    3. CP16-22-000.............      11-28-2022  U.S. Senator Sherrod
                                                  Brown.
    4. CP16-22-000.............      11-28-2022  U.S. Senator Sherrod
                                                  Brown.
    5. CP16-22-000.............      11-28-2022  U.S. Senator Sherrod
                                                  Brown.
    6. CP16-22-000.............      11-29-2022  U.S. Senator Sherrod
                                                  Brown.
    7. CP16-22-000.............      11-29-2022  U.S. Senator Sherrod
                                                  Brown.
    8. CP19-502-000, CP19-502-        12-1-2022  FERC Staff.\3\
     001.
    9. ER21-1111-000...........       12-2-2022  U.S. Representative
                                                  Nathan Ballentine.
------------------------------------------------------------------------
\1\ Email dated 6/3/2020 from Janet Ward.
\2\ Congressmen Cliff Bentz and Doug LaMalfa.
\3\ Memo dated 12/1/2022 regarding telephone communication with the U.S.
  Army Corps of Engineers.

    Dated: December 7, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-26997 Filed 12-12-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Proposed Rules]
[Pages 7046-7049]
[FR Doc No: 2023-02134]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2020-0239; FRL-10597-01-R9]

Air Plan Actions; Nevada; Clark County--Department of Environment
and Sustainability; Stationary Source Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing an
approval, a partial approval and partial disapproval, and a limited
approval and limited disapproval of certain revisions to the Clark
County portion of the Nevada State Implementation Plan (SIP). These
revisions primarily concern the Clark County Department of Environment
and Sustainability's (``DES'' or ``Department'') general definitions
rule and New Source Review (NSR) permitting program for new and
modified sources of air pollution under the Clean Air Act (CAA or
``Act''). We are taking comments on this proposal and plan to follow
with a final action.

DATES: Comments must be received by March 6, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2020-0239 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be removed or edited from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets. If you need assistance in
a language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, Air-3-
1, 75 Hawthorne St., San Francisco, CA 94105,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. What are the rule deficiencies?
    D. EPA Recommendations To Further Improve the Rule
    E. Proposed Action and Public Comment
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules \1\ addressed by this proposal, including
the dates they were adopted by the Clark County Board of County
Commissioners, and the dates they were submitted by the Nevada Division
of Environmental Protection (NDEP) to the EPA.
---------------------------------------------------------------------------

    \1\ These rules are referred to by the Clark County DES as
``Sections.''

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                                                                Cover letter
                Section                       Section title           Adopted          date       Submittal date
----------------------------------------------------------------------------------------------------------------
0.....................................  Definitions.............         7/20/21         1/31/22         1/31/22
10....................................  Compliance Schedules            12/18/18          6/6/19         6/10/19
                                         (Request to rescind).
12.0..................................  Applicability and                1/21/20         3/13/20         3/16/20
                                         General Requirements.
12.1..................................  Permit Requirements For         12/18/18         4/12/19         4/12/19
                                         Minor Sources.
12.11.................................  General Permits for             12/18/18         4/12/19         4/12/19
                                         Minor Stationary
                                         Sources.
----------------------------------------------------------------------------------------------------------------

    Six months after the submittal of each rule, the EPA determined
that the SIP submittals were deemed complete by the operation of law to
meet the completeness criteria, in 40 CFR part 51, appendix V, which
must be met before formal EPA review.

B. Are there other versions of these rules?

    There are previous versions of some of these rules approved in the
SIP. The current SIP-approved rules are listed in Table 2.

                                           Table 2--SIP-Approved Rules
----------------------------------------------------------------------------------------------------------------
                                                                     SIP approval
                  Rule                           Rule title              date         Federal Register citation
----------------------------------------------------------------------------------------------------------------
0......................................  Definitions..............        10/17/14  79 FR 62350.
1......................................  Definition: Subsection            4/14/81  46 FR 21758.
                                          1.1, Affected Facility.
1......................................  Definition: Subsection            4/14/81  46 FR 21758.
                                          1.26, Dust.
1......................................  Definition: Subsection            4/14/81  46 FR 21758.
                                          1.29, Existing Gasoline
                                          Station.
1......................................  Definition: Subsection            4/14/81  46 FR 21758.
                                          1.36, Fumes.
1......................................  Definition: Subsection            4/14/81  46 FR 21758.
                                          1.51, Mist.
1......................................  Definition: Subsection            6/21/82  47 FR 26620.
                                          1.57, New Gasoline
                                          Station.
1......................................  Definition: Subsection            4/14/81  46 FR 21758.
                                          1.95, Uncombined Water.
10.....................................  Compliance Schedules.....         8/27/81  46 FR 43141.
12.0...................................  Applicability and General        10/17/14  79 FR 62350.
                                          Requirements.
12.1...................................  Permit Requirements For          10/17/14  79 FR 62350.
                                          Minor Sources.
----------------------------------------------------------------------------------------------------------------

C. What is the purpose of the submitted rules?

    The submitted rules are intended to update the Nevada SIP with
recent revisions to the Department's Air Quality Regulations.\2\ The
revisions to Section 0, ``Definitions,'' would add, revise or remove
certain definitions, and move six definitions currently found in SIP-
approved Section 1, ``Definition,'' into Section 0. Section 10,
``Compliance Schedules,'' was repealed locally because it had become
obsolete. The SIP submittal requests that the EPA remove Section 10
from the SIP.
---------------------------------------------------------------------------

    \2\ We are not taking action on earlier revised versions of
Section 0 that were adopted on December 18, 2018, December 17, 2019,
and January 21, 2020, which have been superseded by the more recent
version of Section 0 that was adopted on July 20, 2021, and
submitted to the EPA on January 31, 2022. However, we have
considered relevant information relating to the revisions made in
those older versions of Section 0 in evaluating the July 20, 2021,
version of Section 0. Similarly, we are not taking action on an
earlier revised version of Section 12.0 that was adopted on December
18, 2018, which has been superseded by the more recent version of
Section 12.0 that was adopted on January 21, 2020, and submitted to
the EPA on March 16, 2020. However, we have considered relevant
information relating to the revisions made in that older version of
the rule in evaluating the January 21, 2020, version of Section
12.0.
---------------------------------------------------------------------------

    The revisions to Section 12.0, ``Applicability and General
Requirements,'' remove a portion of the rule entitled ``Transition
Procedures,'' that had been included for the sole purpose of aiding in
the transition from the 2004 version of Section 12 to the new Sections
12.1, 12.2, 12.3 and 12.4 that replaced it in 2011. This transition was
completed in 2015. Other minor editorial changes were also made, such
as capitalizing defined terms and replacing the term ``Department of
Air Quality'' with the term ``Department''.
    The revisions to Section 12.1, ``Permit Requirements for Minor
Sources,'' include numerous updates and minor revisions including edits
to provide clarity to rule provisions, as well as the addition of
several new or clarified permit exemptions for insignificant
activities.
    Section 12.11 is a new SIP submittal of a rule to regulate the
issuance of General Permits for minor stationary sources.
    Additional information concerning these submittals can be found in
our Technical Support Document (TSD) for this action, which can be
found in the docket for this rulemaking.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rules?

    The EPA reviewed Clark County's revisions for compliance with the
applicable requirements of section 110(a)(2) and associated regulations
at 40 CFR 51.160 through 51.164. We also reviewed the rules for
consistency with other CAA general requirements for SIP submittals,
including requirements at section 110(a)(2)(A) regarding rule
enforceability, and requirements at sections 110(l) and 193 for SIP
revisions.
    Section 110(a)(2)(C) of the CAA requires each SIP to include a
program to regulate the modification and construction of any stationary
source within the areas covered by the SIP as necessary to assure
attainment and maintenance of the National Ambient Air Quality
Standards (NAAQS). The EPA's regulations at 40 CFR 51.160 through
51.164 provide specific programmatic requirements to implement this
statutory mandate. These requirements, commonly referred to as the
``minor NSR'' or ``general NSR'' program, apply generally to both major
and non-major stationary sources and modifications and in both
attainment and nonattainment areas, in contrast to the specific
statutory and regulatory requirements for permitting programs under
parts C and D of title I of the CAA that apply to major sources in
attainment and nonattainment areas, respectively.
    Section 110(a)(2)(A) of the CAA requires that regulations submitted
to the EPA for SIP approval be clear and legally enforceable. Section
110(l) of the CAA prohibits the EPA from approving any SIP revisions
that would interfere with any applicable requirement concerning
attainment and reasonable further progress (RFP) or any other
applicable requirement of the CAA. Section 193 of the CAA prohibits the
modification of a SIP-approved control requirement in effect before
November 15, 1990, in a nonattainment area, unless the modification
ensures equivalent or greater emission reductions of the relevant
pollutant(s). With respect to procedural requirements, CAA sections
110(a)(2) and 110(l) require that revisions to a SIP be adopted by the
state after reasonable notice and public hearing.

B. Do the rules meet the evaluation criteria?

    Based on our review of the public process documentation included in
Clark County's submittals, which include Affidavits of Publications and
Records of Publications, we find that

Clark County has provided sufficient evidence of public notice,
opportunity for comment and a public hearing prior to adoption and
submittal of these rules to the EPA, consistent with CAA sections
110(a)(2) and 110(l). With respect to the substantive requirements
found in CAA sections 110(a)(2)(A) and (C), and 40 CFR 51.160 through
51.164, we evaluated Clark County's submittal in accordance with the
applicable CAA and regulatory requirements, primarily focusing on those
that apply to new source review permit programs, and find that the
revisions to the SIP as reflected in our action on the revised rules,
as well as new Section 12.11, and the removal of Section 10 from the
SIP, satisfy these requirements, except for a few relatively minor
deficiencies, discussed in Section II.C. of this proposal.
    With respect to the substantive requirements found in CAA sections
110(l) and 193, we find that our approval of this SIP submittal would
not interfere with any applicable requirement concerning attainment and
RFP or any other applicable requirement of the CAA. In addition, we
find that the revisions to the SIP as reflected in our action on the
submitted rules listed in Table 1 of this proposal will not relax any
pre-November 15, 1990 control requirement in the SIP. Accordingly, we
have concluded that our action is consistent with the requirements of
CAA sections 110(l) and 193.
    Our TSD contains a more detailed discussion of our analysis.

C. What are the rule deficiencies?

    For Section 0, we find that the removal of the definition of
``Clearing and Grubbing'' is not approvable as the term is still used
in the Section 94 Handbook that is part of the SIP.
    For Section 12.1, we identified the following four deficiencies.
First and second, the provisions in Sections 12.1.2(c)(7) and (8),
which exempt ancillary parts washers and degreasers that use only
certified clean air solvents from permitting requirements, are
deficient because the term ``certified clean air solvents'' is not
defined in any Section 12 series rule, which makes the provision
unenforceable. Third, the provision in Section 12.1.2(c)(10) allowing
the Control Officer to deem any other emission unit or activity to be
insignificant on a case-by-case basis with no specific criteria for
making this determination is deficient because it contains
impermissible Director's discretion. Fourth, the provision in Section
<IP_ADDRESS>(z) contains impermissible Control Officer discretion to decide
whether certain conditions should be added to portable minor source
permits.
    For Section 12.11, the rule contains an unenforceable cross-
reference relating to certain emissions inventory report requirements,
and does not satisfy the requirement in 40 CFR 51.160(f) that the
screening model used pursuant to Section 12.11.1(f) be based on the
applicable models, databases, and other requirements specified in 40
CFR part 51, appendix W.
    Our TSD contains a more detailed discussion of these deficiencies.

D. EPA Recommendations To Further Improve the Rule

    The TSD also includes recommendations for additional clarifying
revisions to consider for the rules evaluated in this SIP submittal.

E. Proposed Action and Public Comment

    Pursuant to section 110(k)(3) of the Act, for Section 0, we are
proposing a partial approval and partial disapproval. We are proposing
approval of the rule with the exception of its removal of the
definition of ``Clearing and Grubbing.'' This definition is separable
from the other definitions and revisions in Section 0 and therefore the
disapproval issue related to this definition is suitable for a partial
disapproval.
    If this action is finalized as proposed, the July 20, 2021, version
of Section 0 would be approved into the SIP, and a separate entry for
the definition of ``Clearing and Grubbing'' from the current SIP-
approved version of Section 0, approved into the SIP on October 17,
2014, and referenced in Table 2 of this proposal, would be retained in
the SIP. Therefore, this partial disapproval action would require no
further action from the Department to remedy the identified deficiency.
More generally, the incorporation of the submitted version of Section 0
into the SIP would replace the older version of Section 0 that is
currently in the SIP, as referenced in Table 2, except for the
definition of ``Clearing and Grubbing''; that older version of Section
0 would be removed from the SIP (except for the specified definition).
In addition, our approval of certain definitions in the submitted
version of Section 0 would replace in the SIP the older versions of
those same definitions that are currently included in SIP-approved
Section 1, as referenced in Table 2 of this proposal; these older
versions of the definitions would be removed from the SIP.
    Pursuant to CAA section 110(k)(3), we are proposing to approve the
request to rescind Section 10 from the SIP, as we have determined that
its removal is consistent with the relevant CAA requirements. We are
also proposing to fully approve Section 12.0, adopted on January 21,
2020, based on our determination that the rule revisions satisfy the
applicable statutory and regulatory provisions governing regulation of
stationary sources under CAA section 110(a)(2)(C), including the
permitting requirements in 40 CFR 51.160 through 51.164. If our action
is finalized as proposed, the submitted version of Section 12.0 would
replace the older version of Section 12.0 that is currently in the SIP,
as referenced in Table 2 of this proposal, which would be removed from
the SIP.
    Pursuant to CAA sections 110(k)(3) and 301(a) of the Act, we are
proposing limited approval and limited disapproval of Sections 12.1 and
12.11, both adopted on December 18, 2018. We are proposing to approve
these rules based on our determination that the rules mostly satisfy
the applicable statutory and regulatory provisions governing regulation
of stationary sources under CAA section 110(a)(2)(A) and (C), including
the permitting requirements for stationary sources in 40 CFR 51.160
through 51.164. If our action is finalized as proposed, our limited
approval of Section 12.1 would replace the older version of Section
12.1 that is currently in the SIP, as referenced in Table 2, which
would be removed from the SIP. Our limited approval of Section 12.11
would approve it into the SIP in its entirety. We are also proposing a
limited disapproval of these same rules because they contain certain
deficiencies as discussed above and in Sections 5.5, 5.6, and 6 of the
TSD. The intended effect of this proposed limited approval and limited
disapproval action is to update the applicable SIP with current and
clarified, and, in some regards, strengthened, Department permitting
rules, while triggering the obligation to remedy the identified
deficiencies.
    In support of our proposed action, we have also concluded that our
approval and limited approval of the submitted rules would comply with
sections 110(l) and 193 of the Act, as explained above. If we finalize
this action as proposed, our action will be codified through revisions
to 40 CFR 52.1470 (Identification of plan).
    If we finalize the limited disapproval of Sections 12.1 and 12.11
as proposed, CAA section 110(c) would require the EPA to promulgate a
Federal Implementation Plan (FIP) within 24 months unless we approve a
subsequent SIP revision that corrects the deficiencies identified in
the final limited disapproval. A final limited

disapproval of Sections 12.1 and 12.11 will not start any CAA section
179 sanctions clocks as both rules address only minor source program
requirements.\3\
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    \3\ Our partial disapproval of Section 0 does not trigger any
FIP obligation, as the identified deficiency is remedied by the fact
that the provision necessary to address the deficiency is already
included in the SIP and will not be removed as part of this action.
For the same reason, this partial disapproval also would not
potentially trigger any offset or highway sanctions pursuant to CAA
section 179.
---------------------------------------------------------------------------

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the following Clark County DES rules: Sections 0, 12.0, 12.1
and 12.11, as described in Table 1 of this proposal concerning
definitions and New Source Review permit program requirements. The EPA
has made, and will continue to make, these materials available through
https://www.regulations.gov and at the EPA Region IX Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this proposal for more information).

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
state, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the National Government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because the SIP is not approved to apply on any
Indian reservation land or in any other area where the EPA or an Indian
tribe has demonstrated that a tribe has jurisdiction, and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    The state did not evaluate environmental justice considerations as
part of its SIP. There is no information in the record inconsistent
with the stated goals of Executive Order 12898 of achieving
environmental justice for people of color, low-income populations, and
indigenous peoples.

List of Subjects in 40 CFR Part 52

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: January 26, 2023.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2023-02134 Filed 2-1-23; 8:45 am]
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[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56768-56769]
[FR Doc No: 2013-22262]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2013-38]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and

must be received on or before October 3, 2013.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0743 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Andrea Copeland, ARM-208, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591; email<EMAIL_ADDRESS>(202) 267-
8081.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on September 9, 2013.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2013-0743
    Petitioner: Metropolitan State University of Denver.
    Section of 14 CFR Affected: 14 CFR 61.160(b)(3)(i).
    Description of Relief Sought: Metropolitan State University of
Denver (MSUD) seeks relief to enable graduates of MSUD Aviation
Technology program to qualify for the 1,000 hour restricted ATP
certificate by enabling its students to take part 141 cross-listed
ground school classes for the instrument rating and commercial ground
school certificate held by Colorado Northwest Community College (CNCC),
and require its students seeking the restricted certificate to conduct
flight training under CNCCs part 141 flight training program, under a
training agreement between MSUD and CNCC.

[FR Doc. 2013-22262 Filed 9-12-13; 8:45 am]
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