[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Proposed Rules]
[Pages 8235-8236]
[FR Doc No: 2018-03843]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2011-0941; FRL-9974-60]
RIN 2070-AB27

Modification of Significant New Use of a Certain Chemical
Substance; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: EPA issued a proposed rule in the Federal Register of February
8, 2018, proposing to amend the significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for
oxazolidine, 3,3'-methylenebis[5-methyl-, which was the subject of a
premanufacture notice (PMN) and a significant new use notice (SNUN).
This document extends the comment period for 17 days and provides
notice that EPA has added two documents to the docket.

DATES: The comment period for the proposed rule published February 8,
2018 (83 FR 5598) is extended. This document extends the comment period
for 17 days, from February 23, 2018, to March 12, 2018. Comments,
identified by docket identification (ID) number EPA-HQ-OPPT-2011-0941,
must be received on or before March 12, 2018.

ADDRESSES: Follow the detailed instructions provided under ADDRESSES in
the Federal Register document of February 8, 2018 (83 FR 5598) (FRL-
9973-02).

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, Chemical Control
Division, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register document of February 8, 2018
(83 FR 5598) (FRL-9973-02), which proposed amendments to the SNUR for
the chemical substance in 40 CFR 721.10461. EPA has added two documents
to the docket: the redacted (to mask information claimed as
confidential business information) Significant New Use Notice for
oxazolidine, 3,3'-methylenebis[5-methyl-,; and a revised redacted
version of the Structure Activity Team report. In order to give all
interested persons the opportunity to comment fully, EPA is hereby
extending the comment period, which was set to end on February 23,
2018, to March 12, 2018.
    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES in the Federal Register
document of February 8, 2018. If you have questions, consult the
technical person listed

under FOR FURTHER INFORMATION CONTACT.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous Substances,
Reporting and recordkeeping requirements.

    Dated: February 15, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2018-03843 Filed 2-23-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Page 7999]
[FR Doc No: 2020-02139]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2019-0706; FRL-10004-79-OAR]

Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2018

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability and request for comments.

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SUMMARY: The Draft Inventory of U.S. Greenhouse Gas Emissions and
Sinks: 1990-2018 is available for public review. EPA requests
recommendations for improving the overall quality of the inventory
report to be finalized in April 2020, as well as subsequent inventory
reports.

DATES: To ensure your comments are considered for the final version of
the document, please submit your comments by March 13, 2020. However,
comments received after that date will still be welcomed and considered
for the next edition of this report.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2019-0706, to the Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. Do
not submit electronically any information you consider to be
Confidential Business Information (CBI). Comments can also be submitted
in hardcopy to GHG Inventory at: Environmental Protection Agency,
Climate Change Division (6207A), 1200 Pennsylvania Ave. NW, Washington,
DC 20460, Fax:<PHONE_NUMBER>. You are welcome and encouraged to send
an email with your comments to<EMAIL_ADDRESS>EPA may publish
any comment received to its public docket, submitted in hardcopy or
sent via email. For additional submission methods, the full EPA public
comment policy, information about CBI, and general guidance on making
effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Ms. Mausami Desai, Environmental
Protection Agency, Office of Air and Radiation, Office of Atmospheric
Programs, Climate Change Division,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Annual U.S. emissions for the period of time
from 1990 through 2018 are summarized and presented by sector,
including source and sink categories. The inventory contains estimates
of carbon dioxide (CO2), methane (CH4), nitrous
oxide (N2O), hydrofluorocarbons (HFC), perfluorocarbons
(PFC), sulfur hexafluoride (SF6), and nitrogen trifluoride
(NF3) emissions. The technical approach used in this report
to estimate emissions and sinks for greenhouse gases is consistent with
the methodologies recommended by the Intergovernmental Panel on Climate
Change (IPCC), and reported in a format consistent with the United
Nations Framework Convention on Climate Change (UNFCCC) reporting
guidelines. The Inventory of U.S. Greenhouse Gas Emissions and Sinks:
1990-2018 is the latest in a series of annual, policy-neutral U.S.
submissions to the Secretariat of the UNFCCC. EPA requests
recommendations for improving the overall quality of the inventory
report to be finalized in April 2020, as well as subsequent inventory
reports. The draft report is available at https://www.epa.gov/ghgemissions/inventory-us-greenhouse-gas-emissions-and-sinks.

Christopher Grundler,
Director, Office of Atmospheric Programs.
[FR Doc. 2020-02139 Filed 2-11-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Notices]
[Pages 31590-31591]
[FR Doc No: 2023-10503]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2023-0002-N-6]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, this notice announces that FRA is forwarding
the Information Collection Request (ICR) abstracted below to the Office
of Management and Budget (OMB) for review and comment. The ICR
describes the information collection and its expected burden. On March
2, 2023, FRA published a notice providing a 60-day period for public
comment on the ICR.

DATES: Interested persons are invited to submit comments on or before
June 16, 2023.

ADDRESSES: Written comments and recommendations for the proposed ICR
should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find the particular ICR by selecting
``Currently under 30-day Review--Open

for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Ms. Arlette Mussington, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER> or Ms. Joanne Swafford, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. On March 2, 2023, FRA
published a 60-day notice in the Federal Register soliciting public
comment on the ICR for which it is now seeking OMB approval. See 88 FR
13224. FRA has received no comments related to the proposed collection
of information.
    Before OMB decides whether to approve this proposed collection of
information, it must provide 30-days' notice for public comment.
Federal law requires OMB to approve or disapprove paperwork packages
between 30 and 60 days after the 30-day notice is published. 44 U.S.C.
3507(b)-(c); 5 CFR 1320.10(b); see also 60 FR 44978, 44983, Aug. 29,
1995. OMB believes the 30-day notice informs the regulated community to
file relevant comments and affords the agency adequate time to digest
public comments before it renders a decision. 60 FR 44983, Aug. 29,
1995. Therefore, respondents should submit their respective comments to
OMB within 30 days of publication to best ensure having their full
effect.
    Comments are invited on the following ICR regarding: (1) Whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service.
    OMB Control Number: 2130-0593.
    Abstract: This collection of information is necessary to enable FRA
to garner customer and stakeholder feedback in an efficient, timely
manner, consistent with its commitment to improving service delivery.
The information collected from FRA's customers and stakeholders will
help ensure users have an effective, efficient, and satisfying
experience with FRA's programs. This feedback will provide insights
into customer and stakeholder perceptions, experiences, and
expectations, provide an early indicator of issues with service, and
focus attention on areas where communication, training or changes in
operations might improve delivery of products or services. This
collection will allow ongoing, collaborative, and actionable
communications between FRA and its customers and stakeholders. It also
allows feedback to contribute directly to the improvement of program
management. If this information is not collected, vital feedback from
customers and stakeholders on FRA's services will be unavailable.
    Improving FRA's programs requires ongoing assessment of service
delivery. FRA will collect, analyze, and interpret information gathered
through this generic clearance to identify strengths and weaknesses of
current services and make improvements to service delivery based on
feedback. The solicitation of feedback will target areas such as:
timeliness, appropriateness, information accuracy, courtesy, service
delivery efficiency, and issue resolution. FRA will assess responses in
order to plan and inform efforts seeking to improve the quality of
service offered to the public.
    FRA will only submit a collection for approval under this generic
clearance under the following conditions:
     The information gathered is only used internally for
general service improvement and program management purposes and is not
intended for public release;
     The information gathered is not used to substantially
inform significant policy decisions;
     The information gathered will yield qualitative
information; FRA will not design the collection or expect it to yield
statistically reliable results or use it as though the results are
generalizable to the study population;
     Participation in the collection is voluntary;
     The collection is low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and is low-cost for both the respondents
and the Federal Government;
     The collection is non-controversial and does not raise
issues of concern to other Federal agencies;
     The collection is directed to the solicitation of opinions
from respondents who have experience with the OMB program or may have
experience with the OMB program soon after receiving the collection;
and
     With the exception of information needed to provide
remuneration for focus group participants and cognitive laboratory
studies, personally identifiable information (PII) is collected only to
the extent necessary and is not retained by FRA.
    Type of Request: Extension without change (revised estimates) of a
currently approved collection.
    Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Governments.
    Form(s): N/A.
    Respondent Universe: 5,750.
    Frequency of Submission: Once per request.
    Total Estimated Annual Responses: 5,750.
    Total Estimated Annual Burden: 475 hours.
    FRA informs all interested parties that it may not conduct or
sponsor, and a respondent is not required to respond to, a collection
of information that does not display a currently valid OMB control
number.
    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Deputy Chief Counsel.
[FR Doc. 2023-10503 Filed 5-16-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 231 (Monday, December 4, 2023)]
[Notices]
[Pages 84137-84138]
[FR Doc No: 2023-26542]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-466-000]

Great Basin Gas Transmission Company; Notice of Availability of
the Environmental Assessment for the Proposed 2024 Great Basin
Expansion Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the 2024
Great Basin Expansion Project (Project), proposed by Great Basin Gas
Transmission Company (Great Basin) in the above-referenced docket.
Great Basin requests authorization to construct, operate, and abandon
certain natural gas pipeline facilities. The expansion would provide
5,674 dekatherms per day of incremental firm transportation service for
two existing firm transportation shippers and would require
construction of approximately 3.4 miles of upsized or looped pipeline
in three segments across Douglas, Lyon, and Storey Counties, Nevada.
    The EA assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed project, with appropriate
mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    The Bureau of Land Management (BLM) participated as a cooperating
agency in the preparation of the EA. Cooperating agencies have
jurisdiction by law or special expertise with respect to resources
potentially affected by the proposal and participate in the NEPA
analysis. The BLM will adopt and use the EA to consider the issuance of
a right-of-way grant for the portion of the project on federal lands.
    The proposed Project includes the following facilities:
     construction of approximately 0.3 mile of 20-inch-diameter
pipeline loop along the Carson Lateral in Storey County, Nevada,
referred to as the Truckee Canal segment;
     abandonment and replacement of approximately 2.9 miles of
existing 10-inch-diameter pipeline with new 20-inch-diameter pipeline
along the Carson Lateral in Lyon County, Nevada, referred to as the
Silver Springs segment; and
     construction of approximately 0.3 mile of 12-inch-diameter
pipeline loop paralleling its South Tahoe Lateral in Douglas County,
Nevada, referred to as the Kingsbury segment.
    The Commission mailed a copy of the Notice of Availability of the
EA to federal, state, and local government representatives and
agencies; elected officials; environmental and public interest groups;
Native American tribes; potentially affected landowners; environmental
justice stakeholders adjacent to the Project area that include legal
aid providers, rural cooperatives, community social services
organizations, senior citizens centers, public health agencies;
newspapers and libraries in the project area; and other interested
individuals and groups. The EA is only available in electronic format.
It may be viewed and downloaded from the FERC's website (www.ferc.gov),
on the natural gas environmental documents page (https://www.ferc.gov/
industries-data/natural-gas/environment/environmental-

documents). In addition, the EA may be accessed by using the eLibrary
link on the FERC's website. Click on the eLibrary link (https://elibrary.ferc.gov/eLibrary/search), select ``General Search'' and enter
the docket number in the ``Docket Number'' field, excluding the last
three digits (i.e. CP23-466). Be sure you have selected an appropriate
date range. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    The EA is not a decision document. It presents Commission staff's
independent analysis of the environmental issues for the Commission to
consider when addressing the merits of all issues in this proceeding.
Any person wishing to comment on the EA may do so. Your comments should
focus on the EA's disclosure and discussion of potential environmental
effects, reasonable alternatives, and measures to avoid or lessen
environmental impacts. The more specific your comments, the more useful
they will be. To ensure that the Commission has the opportunity to
consider your comments prior to making its decision on this project, it
is important that we receive your comments in Washington, DC on or
before 5:00pm Eastern Time on December 28, 2023.
    For your convenience, there are three methods you can use to file
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or [email protected]. Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. This is an easy method for submitting brief, text-only
comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to FERC Online. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP23-
466-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, 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.
    Filing environmental comments will not give you intervenor status,
but you do not need intervenor status to have your comments considered.
Only intervenors have the right to seek rehearing or judicial review of
the Commission's decision. At this point in this proceeding, the
timeframe for filing timely intervention requests has expired. Any
person seeking to become a party to the proceeding must file a motion
to intervene out-of-time pursuant to Rule 214(b)(3) and (d) of the
Commission's Rules of Practice and Procedures (18 CFR 385.214(b)(3) and
(d)) and show good cause why the time limitation should be waived.
Motions to intervene are more fully described at https://www.ferc.gov/how-intervene.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: November 28, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-26542 Filed 12-1-23; 8:45 am]
BILLING CODE 6717-01-P


Johnd Bachmann 12/ 10/ 2003 06: 56 PM To: Amy_ L._ Farrell@ omb. eop. gov cc: Jeff Holmstead/ DC/ USEPA/ US@ EPA, Bill Wehrum/ DC/ USEPA/ US@ EPA, Stephanie Daigle/ DC/ USEPA/ US@ EPA, Don Zinger/ DC/ USEPA/ US@ EPA, Peter Tsirigotis/ RTP/ USEPA/ US@ EPA, Lisaa Jones/ DC/ USEPA/ US@ EPA, Sarah Dunham, Sam Napolitano, Lydia Wegman/ RTP/ USEPA/ US@ EPA Subject: IAQR Economic and Energy Analyses This is the draft memorandum containing the economic and energy analyses done for the Interstate Air Quality Rule. We will send the benefit cost comparison analyses and an updated section XI of the preamble inserting the completed analytical results under separate cover later tonight. The additional supporting analytical material write ups ( SBREFA and UMRA) will come tommorrow morning.

John Bachmann U. S. EPA C404 04 Research Triangle Park, NC27711 Voice 919 541 5359 Fax 919 541 2464 email Bachmann. JohnD@ epa. gov


[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Rules and Regulations]
[Pages 26567-26569]
[FR Doc No: 2019-11962]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0334]
RIN 1625-AA00

Safety Zone; Upper Mississippi River, Miles 109.9-184, St. Louis,
MO

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Upper Mississippi River from mile marker (MM)
109.9 to MM 184 in St. Louis, MO. This action is necessary to provide
for the safety of persons and vessels, on these navigable waters as a
result of increasing flow and high water conditions on the river. Entry
of vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Sector Upper Mississippi River or
a designated representative.

DATES: This rule is effective without actual notice from June 7, 2019
through July 3, 2019. For the purposes of enforcement, actual notice
will be used from May 31, 2019, through June 7, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0334 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Christian Barger, Sector Upper
Mississippi River Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Upper Mississippi River
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. It is
impracticable because we must establish this safety zone immediately
and lack sufficient time to provide a reasonable comment period and
then consider those comments before issuing this rule. The NPRM process
would delay the establishment of the safety zone and compromise public
safety.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying this rule would be
contrary to public interest because immediate action is necessary to
respond to the potential safety hazards associated with floodwaters and
high flow of the river.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper
Mississippi River (COTP) has determined that potential hazards
associated with flood waters exist on the Upper Mississippi River
between St. Louis, MO and Chester, IL. Increased flow rates and river
height make navigating this area extremely difficult due to a high
number of highway and railroad bridges in the area, and vessel traffic
poses a risk to overtopping or damaging flood control levees. This rule
is necessary to ensure the safety of persons and vessels on these
navigable waters.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from June 1, 2019
through July 3, 2019, or until terminated by the Captain of the Port
Sector Upper Mississippi River (COTP), whichever occurs. The safety
zone covers all navigable waters of the Upper Mississippi River from MM
109.9 to MM 184, unless reduced in scope by the COTP, as flood
conditions warrant.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard (USCG) assigned to units under
the operational control of USCG Sector Upper Mississippi River. To seek
permission to enter, contact the COTP or a designated representative
via VHF-FM channel 16, or through USCG Sector Upper Mississippi River
at<PHONE_NUMBER>. Persons and vessels permitted to enter the safety zone
must comply with all lawful orders or directions issued by the COTP or
designated representative. The COTP or a designated representative will
inform the public of the effective period for the

safety zone as well as any changes in the dates and times of
enforcement, as well as reductions in size of the safety zone as flood
conditions improve, through Local Notice to Mariners (LNMs), Broadcast
Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins
(MSIBs), as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the emergency
nature of the action and the increasing flow rates and river height.
When the Upper Mississippi River gauge in St. Louis, MO reaches 38 feet
above zero, increased flow rates and vertical clearances associated
with bridges in the St. Louis area between MM 179 and MM 184 result in
difficulty with making safe approaches to the bridges and increase the
potential for bridge strikes. When the Upper Mississippi River gauge at
St. Louis, MO reaches 45 feet above zero, increased flow rates and
river heights coupled with passing vessels will threaten overtopping or
failure of levees between MM 109.9 and MM 179. Moreover, the Coast
Guard will issue a Local Notice to Mariners (LNMs), Marine Safety
Information Bulletins (MSIBs), andBNM via VHF-FM marine channel 16
about the zones, and the rule allows vessels to seek permission to
enter the zone on a case-by-case basis.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a temporary safety zone prohibiting
entry to vessels and persons on a 74 mile stretch of the Upper
Mississippi River that is experiencing significant flooding. It is
categorically excluded from further review under paragraph L60(d) in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures 5090.1. A Record of Environmental Consideration supporting
this determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0334 to read as follows:

Sec.  165.T08-0334  Safety Zone; Upper Mississippi River, Miles 109.9-
184, St. Louis, MO.

    (a) Location. The following area is a safety zone: All navigable
waters of the Upper Mississippi River from mile marker (MM) 109.9 to MM
184. This section will be enforced on all navigable waters of the Upper
Mississippi River from MM 109.9 to MM 184, unless reduced in scope by
the Captain of the Port Sector Upper Mississippi River (COTP) as flood
conditions warrant.
    (b) Effective period. This section is effective without actual
notice from June 7, 2019 until July 3, 2019, or until cancelled by the
COTP, whichever occurs first. For the purposes of enforcement, actual
notice will be provided on June 1, 2019 until June 7, 2019.
    (c) Period of enforcement. This section will be enforced from June
1, 2019 through July 3, 2019, or until terminated by the Captain of the
COTP, whichever occurs first.
    (d) Regulations. (1) In accordance with the general safety zone
regulations in Sec.  165.23, entry of persons or vessels into this
safety zone described in paragraph (a) of this section is prohibited
unless authorized by the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard (USCG) assigned to units under the operational
control of USCG Sector Upper Mississippi River.
    (2) To seek permission to enter, contact the COTP or a designated
representative via VHF-FM channel 16, or through USCG Sector Upper
Mississippi River at<PHONE_NUMBER>. Persons and vessels permitted to
enter the safety zone must comply with all lawful orders or directions
issued by the COTP or designated representative.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the effective period for the
safety zone as well as any changes in the dates and times of
enforcement, as well as reductions in size of the safety zone as flood
conditions improve, through Local Notice to Mariners (LNMs), Broadcast
Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins
(MSIBs) as appropriate.

    Dated: May 31, 2019.
S.A. Stoermer,
Captain, U.S. Coast Guard, Captain of the Port Sector Upper Mississippi
River.
[FR Doc. 2019-11962 Filed 6-6-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)]
[Proposed Rules]
[Pages 48942-48944]
[FR Doc No: 2017-22365]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2017-0340; FRL-9969-72-Region 2]

Approval and Revision of Air Quality Implementation Plans; State
of New York; Regional Haze State and Federal Implementation Plans

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
a source-specific revision to the New York State Implementation Plan
(SIP). The SIP revision establishes Best Available Retrofit Technology
(BART) emission limits for sulfur dioxide that are identical to those
set by the EPA's Federal Implementation Plan (FIP) for the Roseton
Generating Station, Units 1 and 2, which was promulgated in an action
taken on August 28, 2012. The EPA proposes to find that the SIP
revision fulfills the requirements of the Clean Air Act and the EPA's
Regional Haze Rule for the Roseton Generating Station, Units 1 and 2.
In conjunction with this proposed approval, we propose to withdraw
those portions of the FIP that address BART for the Roseton Generating
Station, Units 1 and 2.

DATES: Comment must be received on or before November 22, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R02-
OAR-2017-0340), to http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed 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, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Irene B. Nielson, Environmental
Protection Agency, Air Programs Branch, 290 Broadway, New York, New
York 10007-1866 at<PHONE_NUMBER> or by email at [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What action is the EPA proposing?
II. What is the background information for this proposal?
    A. SIP and FIP Background
    B. Regional Haze Background
    C. EPA Action on New York's Regional Haze Submittals
III. What is included in the NYSDEC SIP proposal?
IV. What is the EPA analysis of NYSDEC's submittal?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

    Throughout this document whenever ``Agency,'' ``we,'' ``us,'' or
``our'' is used, we mean the EPA.

I. What action is the EPA proposing?

    The EPA is proposing to approve a source-specific State
Implementation Plan (SIP) revision for Units 1 and 2 at the Roseton
Generating Station submitted by the New York State Department of
Environmental Conservation (NYSDEC) on April 18, 2017. The EPA is
proposing to approve emission limits for sulfur dioxide
(SO2) for Units 1 and 2 at the Roseton Generating Station
that are equivalent to the emission limits established by the EPA's
Federal Implementation Plan (FIP), as promulgated on August 28, 2012
(77 FR 51915).

II. What is the background information for this proposal?

    This section provides a brief overview of the requirements of the
Clean Air Act (CAA) and Regional Haze Rule, as they apply to this
particular action. Please refer to our previous rulemakings on the New
York Regional Haze SIP for additional background regarding the
visibility protection provisions of the CAA and the Regional Haze
Rule.\1\
---------------------------------------------------------------------------

    \1\ 77 FR 24794 (April 25, 2012) (proposed rule); 77 FR 27162
(May 9, 2012) (Notice of Data Availability); 77 FR 51915 (Aug. 28,
2012) (final rule).
---------------------------------------------------------------------------

A. SIP and FIP Background

    The CAA requires each state to develop plans to meet various air
quality requirements, including protection of visibility. (CAA sections
110(a), 169A, and 169B). The plans developed by a state are referred to
as SIPs. A state must submit its SIPs and SIP revisions to EPA for
approval. Once approved, a SIP is federally enforceable, that is
enforceable by the EPA and subject to citizen suits under the CAA. If a
state fails to make a required SIP submittal, or if we find that a
state's required submittal is incomplete, or if we disapprove the
submittal, then EPA must promulgate a FIP to fill this regulatory gap.
(CAA section 110(c)(1)).

B. Regional Haze Background

    In the 1977 Amendments to the CAA, Congress initiated a program for
protecting visibility in the nation's national parks and wilderness
areas. Section 169A(a)(1) of the CAA establishes as a national goal the
``prevention of any future, and the remedying of any existing,
impairment of visibility in mandatory Class I Federal areas which
impairment results from manmade air pollution.'' In 1990 Congress added
section 169B to the CAA to address regional haze issues. On July 1,
1999, the EPA promulgated the Regional Haze Rule (RHR) (64 FR 35714).
The requirement to submit a Regional Haze SIP applies to New York and
all 50 states, the District of Columbia and the Virgin Islands. The RHR
required states to submit the first implementation plan addressing
regional haze visibility impairment no later than December 17, 2007. 40
CFR 51.308(b).

C. EPA Action on New York's Regional Haze Submittals

    The EPA's final action on New York's Regional Haze SIP included
approving 17 source-specific SIP revisions containing permits for Best
Available Retrofit Technology (BART) and promulgating a FIP to address
two sources where EPA disapproved New York's BART determinations. These
two sources are the Roseton Generating Station (Units 1 and 2) and the
Danskammer Generating Station (Unit 4). 77 FR 51915 (August 28, 2012).
    In the 2012 FIP, the EPA ``encourage[d] New York at any time to
submit a SIP revision to incorporate provisions that match the terms of
our FIP, or relevant portion thereof,'' explaining that if EPA approved
the SIP revision, it would replace the FIP provisions (77 FR 51915). On
April 18, 2017, NYSDEC responded to this by submitting a request for a
source-specific SIP revision for the Roseton Generating Station, Units
1 and 2, that matches the terms of EPA's FIP. Because NYSDEC was not
required to update its BART determinations beyond incorporating the
BART emission limits from the 2012 FIP, the EPA has no basis to
disapprove the SIP revision and supplant it with another FIP.
Therefore, in this action, the EPA proposes to approve the SIP revision
and remove the Roseton Generating Station, Units 1 and 2, from the FIP.
This action follows EPA's proposed action to remove the Danskammer
Generation Station Unit 4 from the FIP. See 82 FR 21749 (May 10, 2017).

III. What is included in the NYSDEC SIP submittal?

    On April 18, 2017, NYSDEC submitted a request for a source-specific
SIP Revision for Roseton Generating Station, Units 1 and 2, intended to
replace the EPA's FIP BART emission limits and related requirements
that were promulgated on August 28, 2012 (77 FR 51915).
    NYSDEC submitted to the EPA the Title V permit conditions 32.1 and
32.2 (pages 30-31) of the permit renewed on December 5, 2016 for the
Roseton Generating Station, Units 1 and 2, and a copy of the NYSDEC ENB
notice of February 15, 2017 for the proposed Roseton Generating Station
SIP revision.\2\
---------------------------------------------------------------------------

    \2\ In the SIP submittal and in subsequent correspondence with
the EPA, NYSDEC notes the NOX and PM limits for Roseton
Generating Station Units 1 and 2, which were not subject to the FIP
and are not part of this SIP action, are consistent with BART limits
approved by EPA in in its August 28, 2012 Final Action on New York's
Regional Haze SIP (77 FR 51915).
---------------------------------------------------------------------------

IV. What is the EPA analysis of NYSDEC's submittal?

    NYSDEC's submittal includes BART emission limits for the Roseton
Generating Station, Units 1 and 2, that are identical to those
contained in the EPA FIP: 0.55 pounds of SO2 per million
British thermal unit (lb SO2/MMBtu) calculated on a 24 hour
average for each unit (Units 1 and 2).
    The EPA has evaluated and is proposing to approve NYSDEC's SIP
submittal for the Roseton Generating Station, Units 1 and 2, which
consists of emission limits for SO2 and other administrative
requirements (i.e., monitoring, recordkeeping and reporting
requirements). The SIP requirements are identical to those in the EPA's
FIP promulgated on August 28, 2012. Consequently, the EPA proposes to
withdraw those portions of the FIP that address BART for the Roseton
Generating Station, Units 1 and 2. The EPA will fully consider all
significant comments on this proposed revision to the NYSDEC SIP with
regard to Roseton Generating Station.

V. 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 a source-specific SIP revision dated April 18, 2017, which
includes BART emission limits for SO2. The summary of
emission limits and other enforceable requirements are included in
section IV of this rulemaking. The EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and/or at the EPA Region 2 Office (please contact the person identified
in the For Further Information Contact section of this preamble for
more information).

VI. Statutory and Executive Order Reviews

    In reviewing NYSDEC's SIP submittal, the EPA's role is to approve
state choices if they meet the requirements of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not

impose additional requirements beyond those imposed by state law. For
that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993)) and 13563 (76 FR 3821, January
21, 2011);
     is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is 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.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is 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
     does 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).

In addition, 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 and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Sulfur oxides, Reporting
recordkeeping requirements.

    Dated: September 29, 2017.
Catherine R. McCabe,
Acting Regional Administrator, Region 2.
[FR Doc. 2017-22365 Filed 10-20-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58806-58807]
[FR Doc No: 2022-20997]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Statement of Organization, Functions, and Delegations of
Authority

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

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA), Center for Biologics
Evaluation and Research (CBER), Office of Tissues and Advanced
Therapies (OTAT) has modified its organizational structures.

DATES: These new organizational structures were approved by the
Secretary of Health and Human Services on August 8, 2022, and effective
on September 16, 2022.

FOR FURTHER INFORMATION CONTACT: Yashika Rahaman, Director, Office of
Planning, Evaluation and Risk Management, Office of Finance, Budget,
Acquisitions and Planning, FDA, 4041 Powder Mill Road, Beltsville, MD,
20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Part D, Chapter D-B, (Food and Drug Administration), the Statement
of Organization, Functions and Delegations of Authority for the
Department of Health and Human Services (35 FR 3685, February 25, 1970,
60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August 18, 2009, 76 FR 45270, July 28,
2011, and 84 FR 22854, May 20, 2019) is revised to reflect the Food and
Drug Administration's reorganization of CBER, Office of Tissues and
Advanced Therapies (OTAT).
    CBER's mission is to protect and enhance public health through the
regulation of biological and related products including blood,
vaccines, allergenics, tissues, and cellular and gene therapies. With
substantial growth in innovative, novel products, as well as a need to
address an ever-changing landscape of potential public health threats,
CBER is currently facing scientific, medical, and regulatory challenges
that require changes to its structure.
    Utilizing key tenets of CBER's modernization efforts, CBER will
retitle OTAT to the Office of Therapeutic Products (OTP) and elevate
OTP to a Super Office to manage its program at a macro level and to
better position the Center to address an everchanging public health
landscape. With the current and anticipated increase in workloads, the
proposed structural changes will improve functional alignment, increase
review capabilities, and enhance expertise on new cell and gene
therapies. Additional supervisory positions will not only help to
address this increased workload but will also provide advancement
opportunities to facilitate recruitment and retention of highly
qualified staff. The proposal creates flexibility and capacity for
future growth in Full-Time Employees (FTEs) and workload, avoiding the
need for continual reorganizations. The reorganization will position
OTP to focus on commitments, including those negotiated with industry
in the prescription drug user fee agreement (PDUFA) for FY 2023-2027,
and other key priorities that protect public health. To advance the
field and support the next generation of cell and gene therapies, OTP
will continue to see growth in the Regenerative Medicine Advanced
Therapy (RMAT) program, established in the 21st Century Cures Act.
    The Food and Drug Administration's Center for Biologics Evaluation
and Research, Office of Tissues and Advanced Therapies, has been
restructured as follows:
    DCB. ORGANIZATION. The Center for Biologics Evaluation and Research
is headed by the Center Director, Center for Biologics Evaluation and
Research.

Center for Biologics Evaluation and Research (DCB)

Office of Therapeutic Products (DCBG)
Administrative Staff (DCBG1)
Policy and Special Projects Staff (DCBG2)
Office of Gene Therapy CMC (DCBGF)
Division of Gene Therapy I (DCBGFA)
Gene Therapy Branch 1 (DCBGFA1)
Gene Therapy Branch 2 (DCBGFA2)
Gene Therapy Branch 3 (DCBGFA3)
Division of Gene Therapy II (DCBGFB)
Gene Transfer and Immunogenicity Branch (DCBGFB1)
Gene Therapy Branch 4 (DCBGFB2)
Gene Therapy Branch 5 (DCBGFB3)
Office of Cellular Therapy and Human Tissues CMC (DCBGG)
Division of Cell Therapy I (DCBGGA)
Cell Therapy Branch 1 (DCBGGA1)
Cell Therapy Branch 2 (DCBGGA2)
Cellular and Tissue Therapy Branch (DCBGGA3)
Division of Cell Therapy II (DCBGGB)
Tissue Engineering Branch 1 (DCBGGB1)
Tissue Engineering Branch 2 (DCBGGB2)
Tumor Vaccine and Biotechnology Branch (DCBGGB3)
Division of Human Tissues (DCBGGC)
Human Tissues and Reproduction Staff (DCBGGC1)
Office of Plasma Protein Therapeutics CMC (DCBGH)
Division of Hemostasis (DCBGHA)
Hemostasis Branch 1 (DCBGHA1)
Hemostasis Branch 2 (DCBGHA2)
Division of Plasma Derivatives (DCBGHB)
Plasma Derivatives Branch 1 (DCBGHB1)
Plasma Derivatives Branch 2 (DCBGHB2)
Office of Clinical Evaluation (DCBGI)
Division of Clinical Evaluation General Medicine (DCBGIA)
General Medicine Branch 1 (DCBGIA1)
General Medicine Branch 2 (DCBGIA2)
General Medicine Branch 3 (DCBGIA3)
General Medicine Branch 4 (DCBGIA4)
Division of Clinical Evaluation Oncology (DCBGIB)
Oncology Branch 1 (DCBGIB1)
Oncology Branch 2 (DCBGIB2)
Division of Clinical Evaluation Hematology (DCBGIC)
Benign Hematology Branch (DCBGIC1)
Malignant Hematology Branch (DCBGIC2)
Office of Pharmacology/Toxicology (DCBGJ)
Division of Pharmacology/Toxicology I (DCBGJA)
Pharmacology/Toxicology Branch 1 (DCBGJA1)
Pharmacology/Toxicology Branch 3 (DCBGJA2)
Division of Pharmacology/Toxicology II (DCBGJB)
Pharmacology/Toxicology Branch 2 (DCBGJB1)
Pharmacology/Toxicology Branch 4 (DCBGJB2)
Office of Review Management and Regulatory Review (DCBGK)
Division of Review Management and Regulatory Review I (DCBGKA)
Regulatory Review Branch 1 (DCBGKA1)
Review Management Support Branch 1 (DCBGKA2)
Division of Review Management and Regulatory Review II (DCBGKB)

Regulatory Review Branch 2 (DCBGKB1)
Review Management Support Branch 2 (DCBGKB2)

II. Delegations of Authority

    Pending further delegation, directives, or orders by the
Commissioner of Food and Drugs, all delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegations, provided they are consistent with this reorganization.

III. Electronic Access

    This reorganization is reflected in FDA's Staff Manual Guide (SMG).
Persons interested in seeing the complete Staff Manual Guide can find
it on FDA's website at: https://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.

(Authority: 44 U.S.C. 3101)

    Dated: September 23, 2022.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2022-20997 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24172-24174]
[FR Doc No: 2022-08564]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1137]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of an FDA guidance document related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidance identified in this
notice addresses issues related to the COVID-19 PHE and has been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidance has been implemented without prior comment, but it remains
subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidance is published in the Federal
Register on April 22, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR/2015/09/18/pdf/2015/-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of this guidance to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, the
Secretary of Health and Human Services (HHS), pursuant to the authority
under section 319 of the Public Health Service Act (42 U.S.C. 247d),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services, ``Determination that
a Public Health Emergency Exists Nationwide as the Result of the
2019 Novel Coronavirus'' (originally issued on January 31, 2020, and
subsequently renewed), available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ ``Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak'' (March 13,
2020), available at: https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February
24, 2021, there was a Presidential Declaration continuing the
national emergency concerning the COVID-19 pandemic beyond March 1,
2021. See ``Continuation of the National Emergency Concerning the
Coronavirus Disease 2019 (COVID-19) Pandemic'' (February 24, 2021),
available at https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR/2020/03/25/pdf/2020/06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)) and Sec.  10.115(g)(2)). The guidances are available on
FDA's web pages entitled ``COVID-19-Related Guidance Documents for
Industry, FDA Staff, and Other Stakeholders'' (available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders)
and ``Search for FDA Guidance Documents'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidance:

                        Table 1--Guidance Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
            Docket No.                       Center              Title of guidance        request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137...................  CBER...................  Emergency Use              Office of Communication,
                                                              Authorization for          Outreach and
                                                              Vaccines to Prevent        Development, 10903 New
                                                              COVID-19 (Updated March    Hampshire Ave., Bldg.
                                                              31, 2022).                 71, Rm. 3128, Silver
                                                                                Spring, MD 20993-0002,
                                                                                1-800-835-4709 or 240-
                                                                                402-8010; email
                                                                                [email protected].
----------------------------------------------------------------------------------------------------------------

    Although this guidance has been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidance as appropriate (see Sec.  10.115(g)(3)).
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115). The guidance represents the
current thinking of FDA. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

    While this CBER guidance contains no collection of information, it
does refer to previously approved FDA collections of information
(listed in table 2). Therefore, clearance by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44
U.S.C. 3501-3521) is not required for this guidance. The previously
approved collections of information are subject to review by OMB under
the PRA. The collections of information in the following FDA
regulations and guidance have been approved by OMB as listed in the
following table:

                                     Table 2--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                                        Another guidance title
         COVID-19 guidance title            CFR cite referenced in      referenced in COVID-19      OMB control
                                               COVID-19 guidance               guidance               No(s).
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for Vaccines  21 CFR 314.420............  ..........................
 to Prevent COVID-19 (Updated March 31,   21 CFR part 312...........  ..........................
 2022).                                   21 CFR parts 210, 211, and  0910-0001.................
                                           610.                       0910-0014.................
                                                                      0910-0139.................

                                          21 CFR part 600...........  ..........................       0910-0308
                                          21 CFR part 601...........  0910-0338.................
                                                                      Emergency Use                    0910-0595
                                                                       Authorization of Medical
                                                                       Products and Related
                                                                       Authorities.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or https://www.regulations.gov.

    Dated: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08564 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Pages 59899-59901]
[FR Doc No: 2011-24790]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-1024; FRL-9471-9]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Prevention of Significant Deterioration Greenhouse Gas
Tailoring Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving revisions to the Indiana State Implementation
Plan (SIP), submitted by the Indiana Department of Environmental
Management (IDEM) to EPA on July 7, 2011. The SIP revision modifies
Indiana's Prevention of Significant Deterioration (PSD) program to
establish appropriate emission thresholds for determining which new
stationary sources and modification projects become subject to
Indiana's PSD permitting requirements for their greenhouse gas (GHG)
emissions. EPA proposed approval of these regulatory revisions on June
17, 2011, and received no comments. This action affects major
stationary sources in Indiana that have GHG emissions above the
thresholds established in the PSD regulations.

DATES: This final rule is effective on October 28, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2010-1024. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, i.e., Confidential Business
Information (CBI) 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 http://www.regulations.gov or in hard copy at
the Environmental Protection Agency, Region 5, Air and Radiation
Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This
facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. We recommend that you telephone Sam
Portanova, Environmental Engineer, at<PHONE_NUMBER> before visiting
the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Sam Portanova, Environmental Engineer,
Air Permits Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background for this action?
II. What comments did EPA receive?
III. What is the effect of this action?
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

I. What is the background for this action?

    EPA has recently undertaken a series of actions pertaining to the
regulation of GHGs that, although for the most part distinct from one
another, establish the overall framework for today's final action on
the Indiana SIP. Four of these actions include, as they are commonly
called, the ``Endangerment Finding'' and ``Cause or Contribute
Finding,'' which EPA issued in a single final action,\1\ the ``Johnson
Memo Reconsideration,'' \2\ the ``Light-Duty Vehicle Rule,'' \3\ and
the ``Tailoring Rule.'' \4\ Taken together and in conjunction with the
Clean Air Act (CAA), these actions established regulatory requirements
for GHGs emitted from new motor vehicles and new motor vehicle engines;
determined that such regulations, when they took effect on January 2,
2011, subjected GHGs emitted from stationary sources to PSD
requirements; and limited the applicability of PSD requirements to GHG
sources on a phased-in basis.
---------------------------------------------------------------------------

    \1\ ``Endangerment and Cause or Contribute Findings for
Greenhouse Gases Under Section 202(a) of the Clean Air Act.'' 74 FR
66496 (December 15, 2009).
    \2\ ``Interpretation of Regulations that Determine Pollutants
Covered by Clean Air Act Permitting Programs.'' 75 FR 17004 (April
2, 2010).
    \3\ ``Light-Duty Vehicle Greenhouse Gas Emission Standards and
Corporate Average Fuel Economy Standards; Final Rule.'' 75 FR 25324
(May 7, 2010).
    \4\ ``Prevention of Significant Deterioration and Title V
Greenhouse Gas Tailoring Rule; Final Rule.'' 75 FR 31514 (June 3,
2010).
---------------------------------------------------------------------------

    Recognizing that some states had approved SIP PSD programs that do
apply PSD to GHGs, but that do so for sources that emit as little as
100 or 250 tons per year of GHG, and that do not limit PSD
applicability to GHGs to the higher thresholds in the Tailoring Rule,
EPA published a final rule on December 30, 2010, narrowing its previous
approval of PSD programs as applicable to GHG-emitting sources in SIPs
for 24 states, including Indiana (PSD Narrowing Rule).\5\ In the PSD
Narrowing Rule, EPA withdrew its approval of Indiana's SIP, among other
SIPs, to the extent that SIP applies PSD permitting requirements to GHG
emissions from sources emitting at levels below those set in the
Tailoring Rule. Subsequently, Indiana's approved SIP provided the state
with authority to regulate GHGs, but only at and above the Tailoring
Rule thresholds; and Federally required new and modified sources to
receive a PSD permit based on GHG emissions only if they emitted at or
above the Tailoring Rule thresholds.
---------------------------------------------------------------------------

    \5\ ``Limitation of Approval of Prevention of Significant
Deterioration Provisions Concerning Greenhouse Gas Emitting-Sources
in State Implementation Plans.'' 75 FR 82536 (December 30, 2010).
---------------------------------------------------------------------------

    On December 3, 2010, in response to the Tailoring Rule and earlier
GHG-related EPA rules, IDEM submitted a draft revision to EPA for
parallel processing approval into the Indiana SIP to establish
appropriate emission thresholds for determining which new

or modified stationary sources become subject to PSD permitting
requirements for GHG emissions. Subsequently, on June 17, 2011, EPA
published a proposed approval of this parallel processing SIP
submittal. See 76 FR 35380. Specifically, EPA proposed to approve
revisions to 326 IAC 2-2-1 and 326 IAC 2-2-4 of Indiana's PSD rules to
add GHG permitting requirements. Detailed background information and
EPA's rationale for the proposed approval are provided in EPA's June
17, 2011, Federal Register action.
    EPA's June 17, 2011, proposed approval was contingent upon Indiana
providing a final SIP revision that was substantively the same as the
December 3, 2010, submittal for parallel processing. Indiana provided
its final SIP submittal on July 7, 2011, which included rules adopted
final by IDEM on March 16, 2011. There were no differences between the
December 3, 2010, draft SIP revision, and the July 7, 2011, final SIP
revision.

II. What comments did EPA receive?

    The public comment period on the proposed approval of Indiana's SIP
revision ended on July 18, 2011. EPA did not receive any comments on
the proposed approval of this SIP revision.

III. What is the effect of this action?

    Final approval of Indiana's July 7, 2011, SIP revision incorporates
changes to 326 IAC 2-2-1 and 326 IAC 2-2-4 of the state's rules to
establish the GHG emission thresholds for PSD applicability set forth
in EPA's Tailoring Rule, confirming that smaller GHG sources emitting
less than these thresholds will not be subject to PSD permitting
requirements under the approved Indiana SIP. EPA has determined that
the SIP revision approved by today's action is consistent with EPA's
regulations, including the Tailoring Rule. Furthermore, EPA has
determined that this SIP revision is consistent with section 110 of the
CAA. Pursuant to section 110 of the CAA, EPA approves this revision
into Indiana's SIP.
    As result of today's action approving Indiana's incorporation of
the appropriate GHG permitting thresholds into its SIP, paragraph (k)
in 40 CFR 52.773, as included in EPA's PSD Narrowing Rule, is no longer
necessary.\6\ Thus, today's action also amends 40 CFR 52.773 to remove
this unnecessary regulatory language.
---------------------------------------------------------------------------

    \6\ 40 CFR 52.773(k) codifies EPA's limiting its approval of
Indiana's PSD SIP to not cover the applicability of PSD to GHG-
emitting sources below the Tailoring Rule thresholds.
---------------------------------------------------------------------------

IV. What action is EPA taking?

    EPA is approving the revisions to 326 IAC 2-2-1 and 326 IAC 2-2-4
of Indiana's PSD regulations which were submitted by IDEM on July 7,
2011. These revisions establish appropriate emissions thresholds for
determining PSD applicability with respect to new or modified GHG-
emitting stationary sources in accordance with EPA's June 3, 2010,
Tailoring Rule.
    With this approval, EPA also amends 40 CFR 52.773 to remove
paragraph (k).

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 CAA and applicable
Federal regulations. 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. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is 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.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is 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
     Does 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).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not 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 28, 2011. 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, Incorporation by
reference, Intergovernmental relations, and Reporting and recordkeeping
requirements.

    Dated: September 15, 2011.
Susan Hedman,
Regional Administrator, Region 5.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart P--Indiana

0
2. In Sec.  52.770 the table in paragraph (c) is amended by revising
the entries for ``2-2-1'' and ``2-2-4'' to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                                            EPA-Approved Indiana Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Indiana
         Indiana citation                  Subject         effective date             EPA approval date                            Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
2-2-1.............................  Definitions..........      03/16/2011  9/28/2011, [Insert page number where    .....................................
                                                                            the document begins].

                                                                      * * * * * * *
2-2-4.............................  Air quality analysis;      03/16/2011  9/28/2011, [Insert page number where    .....................................
                                     requirements.                          the document begins].

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

* * * * *

0
3. In Sec.  52.773, paragraph (k) is removed.
[FR Doc. 2011-24790 Filed 9-27-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 27 (Monday, February 10, 2020)]
[Proposed Rules]
[Pages 7472-7474]
[FR Doc No: 2020-02492]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0110; Airspace Docket No. 20-AGL-5]
RIN 2120-AA66

Proposed Establishment of Class E Airspace; Killdeer and New
Town, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E airspace extending
upward from 700 feet above the surface at Dunn County Weydahl Field,
Killdeer, ND, and New Town Municipal Airport, New Town, ND. The FAA is
proposing this action due to the establishment of new public instrument
procedures at these airports. Airspace design is necessary for the
safety and management of instrument flight rules (IFR) operations at
these airports.

DATES: Comments must be received on or before March 26, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0110/Airspace Docket No. 20-AGL-5, at the beginning of your
comments. You may also submit comments through the internet at https://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.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://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. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that

section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would establish Class E airspace extending upward from
700 feet above the surface at Dunn County Weydahl Field, Killdeer, ND,
and New Town Municipal Airport, New Town, ND, to support IFR operations
at these airports.

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-2020-0110/
Airspace Docket No. 20-AGL-5.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the 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 Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to 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 6.4-mile radius Dunn County Weydahl Field,
Killdeer, ND, with an extension 1.1 miles each side of the 293[deg]
bearing from the airport extending from the 6.4-mile radius to 7.9
miles west of the airport;
    And establishing Class E airspace extending upward from 700 feet
above the surface within a 6.5-mile radius of New Town Municipal
Airport, New Town, ND.
    These actions are the result of new public instrument procedures
being established at these airports.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, 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.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this 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

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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 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 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

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

* * * * *

AGL ND E5 Killdeer, ND [Establish]

Dunn County Weydahl Field, ND
    (Lat. 47[deg]23'29'' N, long. 102[deg]46'19'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Dunn County Weydahl Field, and within
1.1 miles each side of the 293[deg] bearing from the airport
extending from the 6.4-mile radius to 7.9 miles west of the airport.
* * * * *

AGL ND E5 New Town, ND [Establish]

New Town Municipal Airport, ND
    (Lat. 47[deg]58'04'' N, long. 102[deg]28'41'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the airport.

    Issued in Fort Worth, Texas, on February 3, 2020.
Marty Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-02492 Filed 2-7-20; 8:45 am]
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