[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Page 31870]
[FR Doc No: 2022-11246]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 4428-011]

Walden Hydro, LLC; Notice of Availability of Environmental
Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for license for the Walden Hydroelectric
Project, located on the Wallkill River in the Village of Walden, in
Orange County, New York, and has prepared an Environmental Assessment
(EA) for the project. The project does not occupy federal land.
    The EA contains staff's analysis of the potential environmental
impacts of the project and concludes that licensing the project, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    The Commission provides all interested persons with an opportunity
to view and/or print the EA via the internet through the Commission's
Home Page (http://www.ferc.gov) using the ``eLibrary'' link. Enter the
docket number, excluding the last three digits in the docket number
field, to access the document. For assistance, contact FERC Online
Support at [email protected] or toll-free at<PHONE_NUMBER>,
or for TTY,<PHONE_NUMBER>.
    You may also register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Any comments should be filed within 45 days from the date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments using the Commission's eFiling system at https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support. In lieu of
electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
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.
The first page of any filing should include docket number P-4428-011.
    For further information, contact Samantha Pollak at<PHONE_NUMBER>
or [email protected].

    Dated: May 19, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-11246 Filed 5-24-22; 8:45 am]
BILLING CODE 6717-01-P


INTERSTATE AIR QUALITY RULE DOCKETING FORM NAME OF GROUP: Congressional Staffers Jim Reilly and Sharon Segner MEETING__ X___ SPEECH_____ PHONE CALL_____

DATE: January 16, 2004 LOCATION OF MEETING/ SPEECH/ PHONE CALL: EPA Facility, Research Triangle Park, NC PURPOSE OF MEETING/ SPEECH/ PHONE CALL:

The purpose of the meeting was to discuss technological innovations for reducing NOx, SO2 and mercury from power plants. EPA staff presented the latest findings in PM research and the timing for the PM NAAQS review. In addition, EPA staff answered questions about the recently proposed Interstate Air Quality Rule and the Utility MACT.

ATTENDEES:

COMMENTS:

ATTACHMENTS ( HANDOUTS): See attached Attendees:

Sharon Segner, Jim Reilly Bob Hetes, Dan Costa, Deborah Janes, Frank Princiotta, Gregory Green, Jeffrey Clark, John Bachmann, Karen Martin, Lester Grant, Lydia Wegman, Mary Ross, Peter Tsirigotis, Ravi Srivastava, Bill Maxwell, Jenny Noonan, Steve Page, Sikander Khan, Sarah Dunham ( via phone), Robert Fegley, Don McKinnon, Bill Russo, Jim Vickery, Wojciech Jozewicz ( Acardis)


[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Page 3929]
[FR Doc No: 2011-1295]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on January 25, 2011
at 10:00 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:
    Item 1: The Commission will consider whether to adopt rules to
implement Section 951 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act, which requires shareholder advisory votes to approve
the compensation of executives, or say-on-pay votes, and the frequency
of shareholder say-on-pay votes. Section 951 also requires shareholder
advisory votes to approve certain agreements and understandings
concerning executive compensation that is based on or otherwise relates
to the acquisition, merger, consolidation, sale or other disposition of
all or substantially all of the assets of an issuer, and requires
enhanced disclosure of these golden parachute arrangements.
    Item 2: The Commission will consider whether to propose rule
amendments that would implement Section 413(a) of the Dodd-Frank Wall
Street Reform and Consumer Protection Act regarding the definition of
``accredited investor.''
    Item 3: The Commission will consider whether to propose a rule
under the Advisers Act establishing reporting obligations for advisers
to private funds to implement the requirements of Sections 404 and 406
of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: January 18, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-1295 Filed 1-19-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 17 (Monday, January 27, 2014)]
[Proposed Rules]
[Pages 4300-4302]
[FR Doc No: 2014-01470]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0031; Directorate Identifier 2013-CE-054-AD]
RIN 2120-AA64

Airworthiness Directives; SOCATA Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
SOCATA Model TBM 700 airplanes that would supersede AD 99-07-11. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as cracks on the outboard hinge
fittings. We are issuing this proposed AD to require actions to address
the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by March 13, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
SOCATA, Direction des Services, 65921 Tarbes Cedex 9, France; telephone
+33 (0) 5 62 41 73 00; fax +33 (0) 5 62 41 76 54, or for North America:
SOCATA NORTH AMERICA, North Perry Airport, 7501 South Airport Road,
Pembroke Pines, Florida 33023; telephone:<PHONE_NUMBER>; fax: (954)
964-4141; email<EMAIL_ADDRESS>Internet: www.mysocata.com.
You may review copies of the referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City,

Missouri 64106. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-
2014-0031; or in person at the Docket Management Facility between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this proposed AD, the regulatory evaluation, any
comments received, and other information. The street address for the
Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

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

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0031;
Directorate Identifier 2013-CE-054-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On March 18, 1999, we issued AD 99-07-11, Amendment 39-11096 (64 FR
14820, March 29, 1999) (``AD 99-07-11''). That AD required actions
intended to address an unsafe condition on the products listed above.
    Since we issued AD 99-07-11, SOCATA determined that the cause of
the cracks in the horizontal stabilizer outboard hinge fitting was due
to the incorrect installation of the fittings during production, which
induced stress. SOCATA has issued new mandatory service information to
require a modification to the outboard hinge fittings of the horizontal
stabilizer to eliminate the stress.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2013-0035, dated February 22, 2013 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:
During the 1990s, several occurrences were reported of finding
cracks in the outboard hinge fittings of the horizontal stabiliser
on TBM 700 aeroplanes.
This condition, if not detected and corrected, could result in
rupture of the outboard hinge fittings, which would adversely affect
the structural integrity of the horizontal stabiliser. The in-flight
loss of the horizontal stabiliser would result in reduced control of
the aeroplane,
To address this unsafe condition, DGAC France issued AD 1999-060(A),
requiring repetitive inspections of the fittings and, depending on
findings, corrective action.
After that AD was issued, SOCATA determined that the cause of the
cracks was a wrong installation of the fittings during production,
inducing stress. Consequently, DGAC France issued AD 2000-307(A),
partially retaining the requirements of DGAC France AD 1999-060(A),
which was superseded, and required, depending on findings, that the
installation of the fittings of in-service aeroplanes be rectified
by introduction of adjusting shims, a modification which was
introduced as standard on the production line from MSN 162. The
periodical inspection of the fittings for cracks was still required,
pending a better understanding of the cause of the cracks.
Since DCAG France AD 2000-307(A) was issued, the results of the
further analysis revealed that the final design (installation of
shims on the outboard hinge fittings of the horizontal stabiliser)
guarantees a service fatigue life which exceeds the one established
for the TBM 700 during certification. Consequently, for aeroplanes
with this modification, the repetitive inspections of the fittings
can be discontinued. However, as the installation of the fittings
was only required depending on findings, this modification may not
have been accomplished on all affected aeroplanes.
For the reasons described above, this AD supersedes (and thereby
cancels the requirements of) DGAC France AD 2000-307(A) and requires
installation of shims on the outboard hinge fittings of the
horizontal stabiliser.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-
2014-0031.

Relevant Service Information

    DAHER-SOCATA has issued TBM Aircraft Mandatory Service Bulletin SB
70-080, Amendment 2, dated August 2012. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

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

Costs of Compliance

    We estimate that this proposed AD will affect 159 products of U.S.
registry. We also estimate that it would take about 6.5 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts would cost
about $500 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $167,347.50, or $1,052.50 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-11096 (64 FR
14820, March 29, 1999), and adding the following new AD:

SOCATA: Docket No. FAA-2014-0031; Directorate Identifier 2013-CE-
054-AD.

(a) Comments Due Date

    We must receive comments by March 13, 2014.

(b) Affected ADs

    This AD supersedes AD 99-07-11, Amendment 39-11096 (64 FR 14820,
March 29, 1999).

(c) Applicability

    This AD applies to SOCATA TBM 700 airplanes, manufacturer serial
numbers (MSN) 1 through 98, 100 through 156, and 158 through 161,
certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 55: Stabilizers.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as cracks on the
outboard hinge fittings. We are issuing this AD to require the use
of new service information issued by DAHER-SOCATA to eliminate the
stress on the outboard hinge fittings, which is causing the cracks.
If this condition is not prevented, the outboard hinge fittings
could fail causing reduced structural integrity of the horizontal
stabilizer, which could result in reduced control.

(f) Actions and Compliance

    Unless already done, within the next 100 hours time-in-service
after the effective date of this AD or within the next 12 months
after the effective date of this AD, whichever occurs first, install
shims on the outboard hinge fittings of the horizontal stabilizer.
Do the modification following the Accomplishment Instructions in
DAHER-SOCATA TBM Aircraft Mandatory Service Bulletin SB 70-080,
Amendment 2, dated August 2012.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Albert Mercado, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2013-0035, dated February 22, 2013, for related information. You may
examine the MCAI on the Internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2014-0031. For
service information related to this AD, contact SOCATA, Direction
des Services, 65921 Tarbes Cedex 9, France; telephone +33 (0) 5 62
41 73 00; fax +33 (0) 5 62 41 76 54, or for North America: SOCATA
NORTH AMERICA, North Perry Airport, 7501 South Airport Road,
Pembroke Pines, Florida 33023; telephone: (954) 8-9893-1400; fax:
(954) 964-4141; email<EMAIL_ADDRESS>Internet:
www.mysocata.com. You may review copies of the referenced service
information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on January 17, 2014.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-01470 Filed 1-24-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Notices]
[Pages 65596-65598]
[FR Doc No: 2022-23575]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2396]

Chemistry, Manufacturing, and Controls Development and Readiness
Pilot Program; Program Announcement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the opportunity for a limited number of applicants to participate in a
Chemistry, Manufacturing, and Controls (CMC) Development and Readiness
Pilot (CDRP) program, to facilitate the expedited CMC development of
products under an investigational new drug (IND) application, where
warranted, based upon the anticipated clinical benefit of earlier
patient access to the products. FDA is implementing this pilot program
to facilitate CMC readiness for selected Center for Biologics
Evaluation and Research (CBER)- and Center for Drug Evaluation and
Research (CDER)-regulated products with accelerated clinical
development timelines. To accelerate CMC development and facilitate CMC
readiness, the pilot features increased communication between FDA and
sponsors and explores the use of science- and risk-based regulatory
approaches, such as those described in FDA guidance, as applicable.
This notice outlines the eligibility criteria and process for
submitting a request to participate in the pilot.

DATES: Starting April 1, 2023, FDA will accept requests to participate
in the CDRP program. See the ``Participation'' section of this document
for eligibility criteria, instructions on how to submit a request to
participate, and selection criteria and process.

FOR FURTHER INFORMATION CONTACT: Tanya Clayton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4506, Silver Spring, MD 20903-0002, 301-
796-0871; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    For general questions about the CDRP Program for CBER:
[email protected].
    For general questions about the CDRP Program for CDER: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Development programs for CBER- and CDER-regulated drugs and
biologics intended to diagnose, treat, or prevent a serious disease or
condition where there is an unmet medical need may have accelerated
clinical development timelines. Yet marketing applications for products
in expedited development programs still need to meet FDA's approval
standards, including manufacturing facility compliance with current
good manufacturing practice (CGMP). Products with accelerated clinical
development activities may face challenges in expediting CMC
development activities to align with the accelerated clinical
timelines. Successfully expediting CMC readiness may require additional
interactions with FDA during product development and, if applicable,
warrant the use of science- and risk-based regulatory approaches
allowing streamlining of CMC development activities, so that clinical
benefits of earlier patient access to these products can be realized.
    As described in the FDA Prescription Drug User Fee Act (PDUFA) VII
Commitment Letter for fiscal years (FYs) 2023 through 2027 (Ref. 1),
FDA is implementing the CDRP program to facilitate CMC readiness for
selected CBER- and CDER-regulated products with accelerated clinical
development timelines. To accelerate CMC development and facilitate CMC
readiness, the pilot features increased communication between FDA and
sponsors and explores the use of science- and risk-based regulatory
approaches, such as those described in the FDA guidance for industry
entitled ``Expedited Programs for Serious Conditions--Drugs and
Biologics'' (May 2014) (Ref. 2), as applicable.
    Starting in FY 2023, FDA (CBER and CDER) will conduct a CDRP to
facilitate the CMC development of selected products under INDs which
have expedited clinical development timeframes, based upon the
anticipated clinical benefits of earlier patient access to the
products. This includes products with Breakthrough Therapy (BT), Fast
Track (FT), and Regenerative Medicine Advance Therapy (RMAT)
designations. For sponsors participating in the pilot, FDA will provide
product-specific CMC advice during product development, to include two
additional CMC-focused Type B meetings, as well as a limited number of
additional CMC-focused discussions, based on readiness and defined CMC
milestones. The increased communication between FDA review staff and
sponsors is intended to ensure a mutual understanding of approaches to
completing CMC activities, including what information should be
provided at the appropriate timepoint (i.e., at the time of new drug
application (NDA) or biologics license application (BLA) submission,
prior to the end of the review cycle, or post-approval), to ensure CMC
readiness for a marketing application.

II. Participation

    Starting April 1, 2023, FDA will accept requests to participate in
the CDRP program and select no more than nine proposals, with
approximately two thirds being CBER-regulated products and one third
CDER-regulated products. Taking into consideration lessons from the
prior year, FDA will publish in the Federal Register a notice to
announce pilot programs for each of the 3 following fiscal years.
Sponsors who are interested in participating in the pilot program
should submit a request to participate in the pilot as an amendment to
their IND. The cover letter should state ``Request to participate in
the CMC Development and Readiness Pilot.''
    To promote innovation and understanding in this area, lessons
learned through the pilot may be presented by FDA (e.g., in a public
workshop) as case studies, including when the product studied in the
pilot has not yet been approved by FDA. FDA intends to conduct a public
workshop and issue a strategy document focused on CMC aspects of
expedited development incorporating lessons from the CDRP.
Participation in the pilot program is voluntary and at the discretion
of the sponsor. To be eligible for the pilot, the sponsor's written
request should include the following statement:

    ``We, , acknowledge that certain information
relevant to the CDRP may be publicly disclosed.''

    The general nature and extent of information that could be publicly
shared will be discussed and agreed upon between the sponsor and FDA
during the course of the pilot program, and, where feasible, FDA will
notify a sponsor in advance when it plans to include some aspect of
their program's experience in a public discussion (e.g., a slide
presentation, a white paper).

A. Eligibility Criteria

    To be considered for the pilot program, participants must meet the
following eligibility criteria:
1. Joint CBER and CDER Eligibility Criteria
     Participant must have an active commercial IND (See the
definitions of commercial INDs at: https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/research-investigational-new-drug-applications-what-you-need-know).
     IND has been submitted in, or converted to Electronic
Common Technical Document (eCTD) format, unless the IND is of a type
granted a waiver from eCTD format as per FDA's guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related
Submissions using the eCTD Specifications'' (February 2020) (Ref. 3).
     INDs for combination products (21 CFR 3.2 (e)(1)) are
eligible; products that require significant cross-Center interactions
(e.g., complex combination products) may be less likely to be selected
for the pilot.
     In general, at the time of application to the pilot, the
IND clinical program has not yet reached the end of Phase 2, to allow
the pilot to have sufficient time to have an impact on CMC readiness
(e.g., 2 years from anticipated marketing application submission).
However, in extenuating circumstances, requests for exceptions may be
considered, where the development programs would still benefit from the
pilot--examples of what could constitute such circumstances include:
    [cir] Cases where the clinical development is following an
innovative trial design,
    [cir] The product is intended to treat a rare disease.
     CMC-related information is provided to demonstrate a
commitment to pursue a CMC development plan that aligns with the
expedited clinical development program (see ``CMC Development Plan''
under What to Submit in a Request to Participate in the Pilot for
details).
    Due to the differences in product complexity between CBER- and
CDER-regulated products, the following eligibility and selection
criteria differ between the Centers.
2. CBER-Specific Eligibility Criteria
     IND is an existing, CBER-regulated IND intended for
submission as an application for licensure of a biological product
under section 351(a) of the Public Health Service Act (PHS Act) (42
U.S.C. 262(a)) for cellular therapies, gene therapies, and other
products regulated by the Office of Tissues and Advanced Therapies/CBER
or vaccines regulated by the Office of Vaccines Research and Review/
CBER.
     IND has a BT or RMAT designation.
3. CDER-Specific Eligibility Criteria
     IND is an existing, CDER-regulated IND for a product
intended for submission as an application for (1) approval of a new
drug submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)), or (2) licensure of a biological
product under section 351(a) of the PHS Act.
     IND has an expedited clinical timeframe warranted based
upon the anticipated clinical benefits of earlier patient access. This
would include INDs for products with a BT or FT designation; IND
sponsors of other products that meet this criterion may also apply to
the pilot, with their eligibility to be determined by FDA.

B. What To Submit in a Request To Participate in the Pilot

    To participate in the CDRP, sponsors should submit a written
request as an amendment to the IND. In addition to providing a point of
contact, and noting any expedited program designations the IND has
received to date, the request should include the following information.
1. CMC Development Plan
    To focus pilot resources where they should be most useful and have
an impact on the timeliness with which CMC readiness is achieved,
prospective applicants to the pilot program should include in their
Request to Participate a description of their CMC development plan that
includes a timeline for CMC development aligned with when the clinical
development program is expected to be complete:
    (1) The plan should describe the current state of CMC development,
including any ongoing activities not already included in the IND.
    (2) The plan should include a projected timeline for product
development that aligns with the anticipated clinical development
timeline, showing the CMC tasks and activities intended to yield
complete CMC data and information to be included in the marketing
application. This part of the plan should cover the following CMC-
related areas:
     Available product characterization and preliminary
identification of critical quality attributes.
     Description of the current drug substance and drug product
manufacturing process and control strategy (including identification
and development of assays), and a description of and plan for the
proposed commercial scale manufacturing and control strategy, including
any necessary microbial control strategy.
     Identification of manufacturing facilities, including any
contract facilities, along with the facilities' recent inspection
history (including foreign regulatory inspections, where applicable).
     Plans for ensuring product availability for commercial
launch.
     Drug substance and drug product stability assessment plan.
     Overall plan for process validation (e.g., stage 1 and
stage 2 as described in FDA's guidance for industry entitled ``Process
Validation: General Principles and Practices'' (Ref. 4)).
    (3) Given the expedited clinical timeframe, mapping out a plan for
manufacturing readiness within the same overall timespan may reveal
potential challenges in accomplishing CMC activities within the
allotted time that is typically needed during CMC development to
prepare a marketing application that can support approval. The plan
should highlight these areas (exemplified in the bulleted list above,
and any additional CMC challenges that may require FDA input), to
facilitate FDA engagement regarding the types of supportive data and
information that might be used to address these challenges.
Participants in the pilot should plan to discuss these challenges with
FDA during the pilot (for CDER-regulated products, see MAPP 5015.13,
Quality Assessment for Products in Expedited Programs (Ref. 5)).
2. Proposed Plan and Timing for Meetings With FDA
    The CMC Development Plan should include proposed timing (i.e.,
month and year), for the two additional CMC-specific Type B meetings
afforded by the pilot, as well as any other meetings and discussions
foreseen.

C. Selection Criteria and Process

    FDA intends to select participant CBER and CDER INDs based on the
criteria outlined below. Review of requests is planned to occur
quarterly, or as needed, depending upon the requests to participate in
the pilot that are received during the period. FDA intends to issue a
letter to notify each sponsor of FDA's decision on their request to
participate within 180 days of receipt.
    In selecting INDs for the pilot program, FDA intends to consider
factors such as (1) anticipated clinical benefits of facilitating
earlier patient access to the product, (2) novelty of the product, (3)
complexity of the product or its manufacturing process, including
technology, (4) sponsor's overall manufacturing experience, as well as
(5) sponsor's experience with the particular product type, class, or
the type of manufacturing process. FDA may give additional
consideration to less experienced sponsors. Overall, FDA intends to
seek balance and diversity in product types, sponsors, and therapeutic
indications to obtain a variety of relevant experience and learnings
from the pilot.

D. FDA-Sponsor Interactions During the Pilot

    During this CDRP program, sponsors will have the ability to discuss
their product development strategies and goals with FDA review staff
during predesignated Type B meetings and a limited number of additional
CMC-focused discussions. As part of the CMC readiness pilot, two
dedicated CMC meetings will be granted, and sponsors will have an
opportunity for followup discussions to address questions arising from
the meeting or meeting minutes, or if additional clarifications are
needed.
    In preparation for a meeting, sponsors should submit written
questions along with a background information package clearly marked as
a ``PDUFA VII CDRP meeting'' as part of the cover letter to enable FDA
review staff to address the questions. The briefing package should be
submitted to the corresponding IND. Meetings associated with the pilot
should be requested by sponsors. For additional information on meetings
and other communications between the sponsors and FDA, see the FDA
guidance for industry entitled ``Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA Products'' (December 2017) (Ref. 6),
CDER MAPP 6025.6: Good Review Practice: Management of Breakthrough
Therapy-Designated Drugs and Biologics (July 29, 2014) (Ref. 7), CBER
SOPP 8101: Regulatory Meetings with Sponsors and Applicants for Drugs
and Biological Products (February 27, 2022) (Ref. 8), and CBER SOPP
8212.3: Management of Breakthrough Therapy-Designated Products: Sponsor
Interactions and Status Assessment Including Rescinding (February 3,
2022) (Ref. 9).

III. Paperwork Reduction Act of 1995

    Collections of information from fewer than 10 respondents within
any 12-month period are not subject to the Paperwork Reduction Act of
1995 (PRA) (5 CFR 1320.3(c)(4)). To the extent this information
collection involves 10 or more respondents, this notice refers to
previously approved collections of information. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the PRA (44 U.S.C. 3501-3521). The collections of
information for NDAs, formal meetings with sponsors and applicants for
PDUFA products, and PDUFA VII Commitment Letter have been approved
under OMB control number 0910-0001. The collections of information for
INDs have been approved under OMB control number 0910-0014. The
collections of information for BLAs have been approved under OMB
control number 0910-0338. The collections of information pertaining to
CGMP requirements have been approved under OMB control number 0910-
0139. The collections of information pertaining to expedited programs
for serious conditions for drugs and biologics and breakthrough
therapy-designation for drugs and biologics have been approved under
OMB control number 0910-0765.

IV. References

    The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER>, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at https://www.regulations.gov.
FDA has verified the website addresses, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

1. PDUFA Reauthorization Performance Goals and Procedures--Fiscal
Years 2023 through 2027 at https://www.fda.gov/media/151712/download.
2. FDA guidance for industry ``Expedited Programs for Serious
Conditions--Drugs and Biologics'' (May 2014): https://www.fda.gov/media/86377/download.
3. FDA guidance for industry ``Providing Regulatory Submissions in
Electronic Format--Certain Human Pharmaceutical Product Applications
and Related Submissions using the eCTD Specifications'' (February
2020): https://www.fda.gov/media/135373/download.
4. FDA guidance for industry ``Process Validation: General
Principles and Practices'' (January 2011): https://www.fda.gov/
files/drugs/published/Process-Validation_General-Principles-and-
Practices.pdf.
5. CDER MAPP 5015.13: Quality Assessment for Products in Expedited
Programs (in clearance).
6. FDA guidance for industry ``Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA Products'' (December 2017): https://www.fda.gov/media/109951/download.
7. CDER MAPP 6025.6: Good Review Practice: Management of
Breakthrough Therapy-Designated Drugs and Biologics (July 2014).
8. CBER SOPP 8101: Regulatory Meetings with Sponsors and Applicants
for Drugs and Biological Products (February 2022).
9. CBER SOPP 8212.3: Management of Breakthrough Therapy-Designated
Products: Sponsor Interactions and Status Assessment Including
Rescinding (February 2022).

    Dated: October 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23575 Filed 10-28-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55686-55687]
[FR Doc No: 2023-17613]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-521-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on July 28, 2023, Columbia Gas Transmission, LLC
(Columbia) filed a prior notice request for authorization, in
accordance with Sections 157.205 and 157.216, of the Federal Energy
Regulatory Commission's (Commission) regulations under the Natural Gas
Act and Columbia's blanket certificate issued in Docket No. CP83-76-
000,\1\ to abandon one injection/withdrawal storage well, connecting
pipeline, and appurtenant facilities located in the Weaver Storage
Field in Richland County, Ohio (2023 Weaver Well 8889 Abandonment
Project). Columbia has determined that plugging and abandoning the
Weaver Well is the best course of action to maintain Weaver Field's
integrity and efficiency and aligns with the Pipeline and Hazardous
Materials Safety Administration Storage Final Rule. The estimated cost
of the project is approximately $624,800, all as more fully set forth
in its request which is on file with the Commission and open to public
inspection.
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    \1\ Columbia Gas Transmission Corporation (predecessor to
Columbia Gas Transmission, LLC), 22 FERC ] 62,029 (1983).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (www.ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room. For assistance, contact the Federal Energy Regulatory
Commission at [email protected] or call toll-free, (886) 208-
3676 or TTY<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
David A. Alonzo, Manager, Project Authorizations, Columbia Gas
Transmission, LLC, 700 Louisiana Street, Suite 1300, Houston, Texas,
77002, by telephone<PHONE_NUMBER>, or by email
[email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on October 9, 2023.
How to file protests, motions to intervene, and comments is explained
below.
    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
(202) 502-6595 or [email protected].

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is October 9, 2023. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
---------------------------------------------------------------------------

    \4\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is October 9, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before October 9, 2023. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-521-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select ``General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \7\
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    \7\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP23-521-000.

To file via USPS: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426
To file via any other method: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852

    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected].
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: David A.
Alonzo, Manager, Project Authorizations, Columbia Gas Transmission,
LLC, 700 Louisiana Street, Suite 1300, Houston, Texas, 77002, by
telephone<PHONE_NUMBER>, or by email [email protected]. Any
subsequent submissions by an intervenor must be served on the applicant
and all other parties to the proceeding. Contact information for
parties can be downloaded from the service list at the eService link on
FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    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. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: August 10, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-17613 Filed 8-15-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 10, 2006 (Volume 71, Number 28)]
[Notices]
[Page 7101-7103]
[DOCID:fr10fe06-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53224; File No. SR-NASD-2005-112]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Order Approving Proposed Rule Change Relating to
Amendments to Rule 3360 To Expand Short Interest Reporting to OTC
Equity Securities

February 3, 2006.

I. Introduction

    On September 20, 2005, the National Association of Securities
Dealers, Inc. (``NASD'') filed with the Securities and Exchange
Commission (``Commission'' or ``SEC''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend NASD Rule 3360 to expand
short interest reporting requirements to over-the-counter (``OTC'')
equity securities.\3\ The proposed rule change was published for
comment in the Federal Register on November 3, 2005.\4\ The Commission
received seven comment letters on the proposal.\5\ The NASD filed a
response to the comment letters on January 20, 2006.\6\ This order
approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The term ``OTC equity securities'' means any equity
securities that are neither included in the Nasdaq Stock Market nor
traded on a national securities exchange.
    \4\ See Securities Exchange Act Release No. 52679 (Oct. 26,
2005), 70 FR 66875 (Nov. 3, 2005) (the ``Proposing Release'').
    \5\ See e-mail from Greg Hogberg to<EMAIL_ADDRESS>dated
December 30, 2005 (attaching letter from Dr. Jim DeCosta to Jonathan
G. Katz, Secretary, SEC, dated November 24, 2005); e-mail from
Donald L. Smith to<EMAIL_ADDRESS>dated December 16, 2005;
letter from Dr. Jim DeCosta to Jonathan G. Katz, Secretary, SEC,
dated November 24, 2005 (``DeCosta''); e-mail from Paul Vuksich to
<EMAIL_ADDRESS>dated November 22, 2005 (``Vuksich''); e-mail

from David Patch to<EMAIL_ADDRESS>dated November 17, 2005
(``Patch''); e-mail from Daniel Opdyke to<EMAIL_ADDRESS>
dated November 10, 2005; e-mail from Chris Meredith to
<EMAIL_ADDRESS>dated November 1, 2005 (``Meredith'').

    \6\ See letter from Andrea D. Orr, Assistant General Counsel,
NASD, to Nancy M. Morris, Secretary, SEC, dated January 20, 2006.
---------------------------------------------------------------------------

II. Description of the Proposal

    The proposal would amend Rule 3360, Short-Interest Reporting, to
require that members maintain and report on a monthly basis total short
positions in OTC equity securities in all customer and proprietary firm
accounts.\7\ Currently, Rule 3360(a) requires members to maintain a
record of total short positions \8\ in all customer and proprietary
firm accounts in Nasdaq securities (and listed securities if not
reported to another self-regulatory organization (``SRO'')) and
requires members to report such information to the NASD on a monthly
basis. The NASD believes that expanding the monthly short interest
reporting requirements to OTC equity securities will increase the
information available to public investors and other interested parties
related to trading in OTC equity securities. Accordingly, the NASD

proposes to amend Rule 3360(a) to require that members maintain and
report to the NASD short sale positions for OTC equity securities. For
purposes of the proposed rule change, OTC equity securities would be
defined as any equity security that is not listed on The Nasdaq Stock
Market or a national securities exchange.
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    \7\ Non-self-clearing broker-dealers generally are considered to
have satisfied their reporting requirement by making appropriate
arrangements with their respective clearing organizations. See NASD
Notice to Members 03-08 (Jan. 2003).
    \8\ Rule 3360(b) provides that short positions required to be
reported under the rule are those resulting from short sales as the
term is defined in Rule 200 of Regulation SHO under the Act
(``Regulation SHO''), with limited exceptions. Rule 200 of
Regulation SHO provides, in part, the following: ``The term `short
sale' shall mean any sale of a security which the seller does not
own or any sale which is consummated by the delivery of a security
borrowed by, or for the account of, the seller.'' 17 CFR 242.200(a).
---------------------------------------------------------------------------

    The NASD will announce the effective date of the proposed rule
change in a Notice to Members to be published no later than 60 days
following Commission approval. In the proposed rule change, the NASD
stated that in recognition of the technological and systems changes the
proposed rule change may require, the effective date for the proposed
rule change will be 90 days following publication of the NASD's Notice
to Members announcing Commission approval.\9\
---------------------------------------------------------------------------

    \9\ See 70 FR at 66876.
---------------------------------------------------------------------------

    In the Proposing Release,\10\ the Commission specifically requested
comment regarding whether the implementation period for the proposed
rule change could be shorter.\11\ The Commission did not receive any
comments regarding this specific request for comment. Thus, the
Commission has determined not to request that the NASD shorten the
implementation period.
---------------------------------------------------------------------------

    \10\ See supra note 4.
    \11\ 70 FR at 66876.
---------------------------------------------------------------------------

III. Summary of Comments

    The Commission received seven comment letters on the proposal.\12\
The commenters generally supported the proposal. Some commenters,
however, recommended additional changes to the proposed rule and to
other rules relating to short selling. The following is a summary of
the major concerns the commenters raised.
---------------------------------------------------------------------------

    \12\ See supra note 5.
---------------------------------------------------------------------------

    Two commenters questioned the exceptions to the short interest
reporting requirements contained in current Rule 3360 and in the
proposed rule change.\13\ Both current Rule 3360 and the proposed rule
change provide that NASD members must report short interest positions
that result from ``short sales,'' as that term is defined in Rule 200
of Regulation SHO,\14\ with the exception of positions that meet the
requirements of subsections (e)(1), (6), (7), (8) and (10) of Rule 10a-
1 under the Act.\15\
---------------------------------------------------------------------------

    \13\ See Patch at 1; Meredith at 1.
    \14\ See 17 CFR 242.200(a).
    \15\ See NASD Rule 3360(b); supra note 4. Rule 10a-1 provides
that, subject to certain exceptions, a short sale in an exchange-
registered security may be effected only pursuant to the price test
restrictions contained in Rule 10a-1. Subsection (e) of Rule 10a-1
contains exceptions to the price test restrictions. The exceptions
in Rule 10a-1(e) were designed to permit certain types of trading
activities that were intended to benefit the markets or that were
believed to carry little risk of the kind of manipulative or
destabilizing trading that the rule was designed to address. See
Securities Exchange Act Release No. 48709 (Oct. 28, 2003), 68 FR
62972 (Nov. 6, 2003). Subsection (e)(1) of Rule 10a-1 permits short
sales to be effected without regard to the price test restrictions
in the rule if the seller owns the security sold and intends to
deliver such security as soon as possible without undue
inconvenience or expense. See 17 CFR 240.10a-1(e)(1). Subsection
(e)(6) of Rule 10a-1 contains an exception for certain sales of a
security effected with the approval of an exchange which are
necessary to equalize the price of such security with the current
price of such security on another national securities exchange,
which is the principal exchange market. See 17 CFR 240.10a-1(e)(6).
Subsection (e)(7) of Rule 10a-1 contains an exception for certain
bona fide domestic arbitrage transactions. See 17 CFR 240.10a-
1(e)(7). Subsection (e)(8) of Rule 10a-1 contains an exception for
certain international domestic arbitrage transactions. See 17 CFR
240.10a-1(e)(8). Subsection (e)(10) of Rule 10a-1 generally excepts
sales of securities by underwriters or syndicate members
participating in a distribution in connection with an over-
allotment, and any lay-off sales by such a person in connection with
a distribution of securities through rights or a standby
underwriting commitment. See 17 CFR 240.10a-1(e)(10).
---------------------------------------------------------------------------

    The commenters recommended that the exceptions be eliminated from
the proposed rule change and all short interest positions be reported
and publicly disseminated.\16\ One commenter argued that all short
interest positions should be disclosed to the investing public so that
investors have an understanding of exactly how much supply is actually
in the system because the short interest position affects the overall
valuation of a security.\17\
---------------------------------------------------------------------------

    \16\ See Patch at 1; Meredith at 1.
    \17\ See Patch at 1.
---------------------------------------------------------------------------

    One commenter proposed amendments to Rule 3360 that would require
issuers to cause their transfer agents to report long and short
interest positions to the NASD at the close of each trading day.\18\
This commenter's recommendation would also require transfer agents on
behalf of issuers to report certain share information to the NASD at
the close of each trading day, such as authorized shares, total shares
outstanding, and shares held in street name.\19\
---------------------------------------------------------------------------

    \18\ See Vuksich at 1.
    \19\ See id.
---------------------------------------------------------------------------

    Some commenters asserted that further action in the short selling
area is necessary, in particular to address naked short selling abuses
and what they believe to be certain loopholes in Regulation SHO.\20\
Other commenters raised concerns regarding hedge fund regulation, the
National Securities Clearing Corporation's Continuous Net Settlement
System and the Depository Trust & Clearing Corporation's stock loan
program.\21\
---------------------------------------------------------------------------

    \20\ See e.g., DeCosta.
    \21\ See e.g., Meredith at 1; DeCosta at 2-8.
---------------------------------------------------------------------------

IV. NASD's Response

    In its response letter,\22\ the NASD stated that it believed that
all the comments were outside the scope of its rule filing because the
proposed rule change is limited to expanding the current short interest
reporting requirements to OTC equity securities.\23\ The NASD stated in
its letter that because the changes recommended by the commenters were
not germane to the proposal, were beyond the purview of the NASD, or
related to amendments to another SRO's rules or SEC rules, the NASD was
not responding to those recommendations specifically in its response
letter.\24\ In addition, the NASD stated that it would review and
analyze these recommendations in the same manner in which it would
consider any requests for rulemaking, and, based on such review and
analysis, would determine whether further action on these
recommendations is appropriate.\25\
---------------------------------------------------------------------------

    \22\ See supra note 6.
    \23\ Id. at 3.
    \24\ Id.
    \25\ Id.
---------------------------------------------------------------------------

    With respect to comments regarding the exceptions to short interest
reporting contained in current NASD Rule 3360 and the proposed rule
change, the Commission urges the NASD to conduct an in-depth review of
the exceptions to short interest reporting to determine whether future
rulemaking regarding the exceptions is appropriate.

V. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange and, in
particular, the requirements of Section 15A of the Act \26\ and the
rules and regulations thereunder. Specifically, the Commission finds
that the proposed rule change is consistent with the provisions of
Section 15A(b)(6) of the Act,\27\ which requires, among other things,
that the NASD's rules be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, remove impediments to a free and open market and a
national market system, and, in general, to protect investors and the
public interest.\28\
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78o-3.
    \27\ 15 U.S.C. 78o-3(b)(6).
    \28\ In approving this proposed rule change the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).

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

    The Commission believes that expanding short interest reporting to
OTC equity securities will protect investors and the public interest by
requiring NASD members to increase the information available to
investors and other interested parties related to trading in OTC equity
securities.

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\29\ that the proposed rule change (SR-NASD-2005-112) be, and it
hereby is, approved.
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    \29\ 15 U.S.C. 78s(b)(2).
    \30\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\30\
Nancy M. Morris,
Secretary.
[FR Doc. E6-1842 Filed 2-9-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 30 (Wednesday, February 17, 2021)]
[Rules and Regulations]
[Pages 9879-9883]
[FR Doc No: 2021-03168]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 281

[EPA-R05-UST-2020-0685; FRL-10020-05-Region 5]

Indiana: Final Approval of State Underground Storage Tank Program
Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: Pursuant to the Resource Conservation and Recovery Act (RCRA
or Act), the Environmental Protection Agency (EPA) is taking direct
final action to approve revisions to the State of Indiana's Underground
Storage Tank (UST) program submitted by the State. EPA has determined
that these revisions satisfy all requirements needed for program
approval. The State's federally-authorized program, as revised pursuant
to this action, will remain subject to EPA's inspection and enforcement
authorities under sections 9005 and 9006 of RCRA subtitle I and other
applicable statutory and regulatory provisions.

DATES: This rule is effective April 19, 2021, unless EPA receives
adverse comment by March 19, 2021. If EPA receives adverse comment, it
will publish a timely withdrawal in the

Federal Register informing the public that the rule will not take
effect.

ADDRESSES: Submit your comments, identified by EPA-R05-UST-2020-0685 by
one of the following methods:
    1. Federal eRulemaking Portal: https://www.regulations.gov. Follow
the online instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    Instructions: Direct your comments to Docket ID No. EPA-R05-UST-
2020-0685. EPA's policy is that all comments received will be included
in the public docket without change and may be available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov, or email. The federal https://www.regulations.gov
website is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to EPA
without going through https://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties, and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    EPA encourages electronic submittals, but if you are unable to
submit electronically, please reach out to EPA contact person listed in
the notice for assistance with additional submission methods.
    You can view and copy the documents that form the basis for this
action and associated publicly available materials through
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Sherry Kamke, Environmental Engineer,
Corrective Action Section #3, Remediation Branch (LR-17J), EPA Region
5, 77 West Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Out of an abundance of caution for members of the
public and our staff, EPA's Region 5 office will be closed to the
public to reduce the risk of transmitting COVID-19. We encourage the
public to submit comments via https://www.regulations.gov or via email.
Please call or email the contact listed above if you need alternative
means to access the material provided in the docket.

SUPPLEMENTARY INFORMATION:

I. Approval of Revisions to Indiana's Underground Storage Tank Program

A. Why are revisions to state programs necessary?

    States which have received final approval from EPA under RCRA
section 9004(b) of RCRA, 42 U.S.C. 6991c(b), must maintain an
underground storage tank program that is equivalent to, consistent
with, and no less stringent than the federal underground storage tank
program. When EPA makes revisions to the regulations that govern the
UST program, states must revise their programs to comply with the
updated regulations and submit these revisions to EPA for approval.
Most commonly, states must change their programs because of changes to
EPA's regulations in 40 Code of Federal Regulations (CFR) part 280.
States can also initiate changes on their own to their underground
storage tank program and these changes must then be approved by EPA.

B. What decisions has EPA made in this rule?

    On October 11, 2018, in accordance with 40 CFR 281.51(a), Indiana
submitted a complete program revision application seeking EPA approval
for its UST program revisions (State Application). Indiana's revisions
correspond to EPA's final rule published on July 15, 2015 (80 FR
41566), which revised the 1988 UST regulations and the 1988 state
program approval (SPA) regulations (2015 Federal Revisions). As
required by 40 CFR 281.20, the State Application contains the
following: A transmittal letter from the Governor requesting approval,
a description of the program and operating procedures, a demonstration
of the state's procedures to ensure adequate enforcement, a Memorandum
of Agreement outlining the roles and responsibilities of EPA and the
implementing agency, a statement of certification from the Attorney
General, and copies of all relevant state statutes and regulations. We
have reviewed the State Application and determined that the revisions
to Indiana's UST program are equivalent to, consistent with, and no
less stringent than the corresponding federal requirements in subpart C
of 40 CFR part 281, and that the Indiana program provides for adequate
enforcement of compliance (40 CFR 281.11(b)). Therefore, EPA grants
Indiana final approval to operate its UST program with the changes
described in the program revision application and as outlined below in
Section I.G of this document.

C. What is the effect of this action on the regulated community?

    This action does not impose additional requirements on the
regulated community because the regulations being approved by this rule
are already in effect in the State of Indiana, and are not changed by
this action. This action merely approves the existing state regulations
as meeting the federal requirements and renders them federally
enforceable.

D. Why is EPA using a direct final rule?

    EPA is publishing this direct final rule without a prior proposed
rule because we view this as a noncontroversial action and we
anticipate no adverse comment. Indiana did not receive any comments
during its comment period when the rules and regulations being
considered today were proposed at the state level.

E. What happens if EPA receives comments that oppose this action?

    Along with this direct final rule, EPA is publishing a separate
document in the ``Proposed Rules'' section of this Federal Register
that serves as the proposal to approve the State's UST program
revisions, and provides an opportunity for public comment. If EPA
receives comments that oppose this approval, EPA will withdraw this
direct final rule by publishing a document in the Federal Register
before it becomes effective. EPA will base any further decision on
approval of the State Application after considering all comments
received during the comment period. EPA will then address all public
comments in a later final rule. You may not have another opportunity to
comment. If you want to comment on this approval, you must do so at
this time.

F. For what has Indiana previously been approved?

    On August 11, 2006, EPA finalized a rule approving the UST program
that Indiana proposed to administer in lieu of the federal UST program.
The State's

program has not previously been codified.

G. What changes are we approving with this action and what standards do
we use for review?

    In order to be approved, each state program application must meet
the general requirements in 40 CFR 281.11, and specific requirements in
40 CFR Subpart B (Components of a Program Application); Subpart C
(Criteria for No Less Stringent); and Subpart D (Adequate Enforcement
of Compliance). This also is true for proposed revisions to approved
state programs.
    As more fully described below, the State has made the changes to
its approved UST program to reflect the 2015 Federal Revisions. EPA is
approving the State's changes because they are equivalent to,
consistent with, and no less stringent than the federal UST program and
because EPA has confirmed that the Indiana UST program will continue to
provide for adequate enforcement of compliance as described in 40 CFR
281.11(b) and part 281, Subpart D after this approval.
    The Indiana Department of Environmental Management (IDEM or
Department) is the lead implementing agency for the UST program in
Indiana, except in Indian country.
    IDEM continues to have broad statutory authority to regulate the
installation, operation, maintenance, and closure of USTs, as well as
UST releases under Indiana Code Title 4 State Offices and
Administration, Article 22 Administrative Rules and Procedures, Chapter
2, Adoption of Administrative Rules; and selected provisions from Title
13 Environment, Article 23 Underground Storage Tanks. The Indiana UST
Program gets its enforcement authority from the powers of the
Department found in IC Sections 4-21.5-4, 13-14-2-6. 13-14-2-7, 13-23-
1-4, 13-23-14-3, and 13-30-3. Under IC 13-14-2-2, an employee or agent
of the Department has the authority to enter and inspect any property
premises or place where regulated substances are stored at any
reasonable time. In the case of a release, IC Sections 13-23-13-2, 13-
23-13-4, and 13-23-13-12 provide employees or agents of the Department
the authority to take such action as necessary, including the authority
to enter any property, premises or place where an UST is located for
inspection, in order to conduct sampling, and to have access to
records. IC Section 13-23-13-1 provides the Department with rulemaking
authority for corrective action. Notice of violation may be issued, and
penalties for non-compliance with Indiana's UST Act may be assessed
under IC 13-30-3-3. The State also includes requirements for delivery
prohibitions in the event of non-compliance as described in 329 Indiana
Administrative Code (IAC) Section 9-1-15.1.
    Specific authorities to regulate the installation, operation,
maintenance, and closure of USTs, as well as UST releases are found
under IC 13-23, in addition to the regulatory provisions in 329 IAC
Article 9 Underground Storage, as amended effective June 28, 2018;
Reporting and recordkeeping requirements are found under 329 IAC 9-3-1.
The aforementioned statutory and regulatory sections satisfy the
requirements of 40 CFR 281.40 and 281.41.
    Through a Memorandum of Agreement between the State of Indiana and
EPA, signed by EPA Region 5 Regional Administrator November 27, 2018,
the State maintains procedures for receiving and ensuring proper
consideration of information about violations submitted by the public.
The State agrees to comply with public participation provisions
contained in 40 CFR 281.42 including the provision that the State will
not oppose intervention under Rule 24 of the Indiana Rules of Court,
Rules of Trial Procedure, in the same manner as the Federal rules at 40
CFR 281.42.
    To qualify for final approval, revisions to a state's program must
be ``equivalent to, consistent with, and no less stringent'' than the
2015 Federal Revisions. In the 2015 Federal Revisions, EPA addressed
UST systems deferred in the 1988 UST regulations, and added, among
other things, new operation and maintenance requirements; secondary
containment requirements for new and replaced tanks and piping;
operator training requirements; and a requirement to ensure UST system
compatibility before storing certain biofuel blends. In addition, EPA
removed past deferrals for emergency generator tanks, field constructed
tanks, and airport hydrant systems. EPA analyzes revisions to approved
state programs pursuant to the criteria found in 40 CFR 281.30 through
281.39.
    The Department has revised its regulations to help ensure that the
state's UST program revisions are equivalent to, consistent with, and
no less stringent than the 2015 Federal Revisions. In particular, the
Department has amended Indiana Administrative Code to incorporate the
revised requirements of 40 CFR part 280, including the requirements
added by the 2015 Federal Revisions. The State, therefore, has ensured
that the criteria found in 40 CFR 281.30 through 281.38 are met.
    Title 40 CFR 281.39 describes the state operator training
requirements that must be met in order to be considered equivalent to,
consistent with, and no less stringent than federal requirements.
Indiana has elected to incorporate by reference the Federal Rules at
329 IAC 9-1-1(b) and (c); therefore, Indiana's operator training
requirements are equivalent to, consistent with, and no less stringent
than federal requirements.
    As part of the State Application, the Chief Counsel in the Advisory
Division of the State of Indiana--Office of the Attorney General
certified that the laws of Indiana provide adequate authority to carry
out the ``no less stringent'' technical requirements submitted by the
State in order to meet the criteria in 40 CFR 281.30 through 281.39.
EPA is relying on this certification in addition to the analysis
submitted by the State in making our determination.
    For further information on EPA's analysis of the State's
application, see the supporting documentation for both the statutory
and regulatory programs contained in the docket for this rulemaking.

H. Where are the revised rules different from the federal rules?

Broader in Scope Provisions
    Where an approved state program has a greater scope of coverage
than required by federal law, the additional coverage is not part of
the federally-approved program and are not federally enforceable (40
CFR 281.12(a)(3)(ii)). The following regulatory requirements are
considered broader in coverage than the federal program as these state-
only regulations are not required by federal regulation and are
implemented by the state in addition to the federally approved program:
    Indiana Code Title 13, Article 23 Underground Storage Tanks:
    Chapter 6 Underground Storage Petroleum Tank Trust Fund, Sections
13-23-6-1 through 13-23-6-5; Chapter 7 Underground Petroleum Storage
Tank Excess Liability Fund, Sections 13-23-7-1 through 13-23-7-7;
Chapter 8 Use of Money in Excess Liability Fund, Sections 13-23-8-4
through 13-23-8-6; Chapter 9 Payment from Excess Liability Fund,
Sections 13-23-9-1.3 through 13-23-9-6; and Chapter 13 Corrective
Actions, Sections 13-23-13-6 and 13-23-13-7, because funds of this type
are state specific and are broader in scope than the federal program.
    Chapter 12 Fees, Sections 13-23-12-1 through 13-23-12-4 because
fees are

broader in scope and not imposed by the federal program.
More Stringent Provisions
    Where an approved state program includes requirements that are
considered more stringent than required by federal law, the more
stringent requirements become part of the federally approved program
(40 CFR 281.12(a)(3)(i)).
    The following regulatory requirements are considered more stringent
than the federal program, and on approval, they become part of the
federally approved program and are federally enforceable:
    Under 329 Indiana Administrative Code (IAC):
    At Section 329 IAC 9-2-2(f) Indiana requires UST system owners and
operators to ensure that workers performing UST installations, testing,
upgrades, closures, removals, and change in service are certified by
the State Fire Marshall. The federal regulations do not require
certification making the state requirement more stringent.
    At Section 329 IAC 9-2-2(g) Indiana requires UST system owners and
operators to submit notice of temporary closure, upgrades, or release
detection installation within 30 days of completing such actions. The
federal regulations do not contain similar requirements.
    Indiana has state-only provisions related to reporting at 329 IAC
9-3-1(b)(4), and (b)(6)-(b)(15). These additional reporting
requirements are more stringent than the federal regulations because 40
CFR 280.34 does not require the submittal of the documentation
described in this state program requirement.
    At Section 329 IAC 9-3-1(c)(5)-(c)(10) the state has additional
recordkeeping requirements that require retention of additional items
not required by the federal regulations. These additional requirements
make the state program more stringent than the federal regulations.
    329 IAC 9-2-3 requires UST system owners or operators to certify
compliance with the release detection requirements of 40 CFR 280,
Subpart D and Indiana Article 9 within the state's notification forms.
The federal program requires certification, but does not require the
use of specific notification forms or that the person who performs the
work be certified by the state fire marshal, making this state-only
requirement more stringent.
    At Section 329 IAC 9-4-4(a)(1) the State requires owners and
operators to contain, cleanup a spill or overfill, and report the
incident in cases when a petroleum release to the environment equals or
exceeds 25 gallons at 329 IAC 9-4-4(a)(1)(A). This state provision is
more stringent than the federal regulations, because under the federal
regulations these actions are only required if the release of petroleum
exceeds 25 gallons.
    Section 329 IAC 9-5-5.1 is more stringent because Indiana has
additional and more detailed requirements for site characterization
after release than federal regulations. Specifically, at 329 IAC 9-5-
5.1(b), Indiana requires an investigation and submittal of a signed
report detailing specific information concerning site background,
release incident description, initial response and abatement, free
product recovery, investigation, sampling, results and conclusions, and
recommendations.
    At Section 329 IAC 9-5-4.2 the state provision is more stringent
because Indiana has a more detailed requirement for the safe handling
of flammable products. Specifically, at 329 IAC 9-5-4.2(3), Indiana
requires that flammable products be handled in in accordance with the
site health and safety plan which is required under the State's
corrective action plan at Section 329 IAC 9-5-7(e).
    329 IAC 9-5-6 addresses further site investigations for soil and
ground water cleanup. The state provisions are more stringent than the
federal regulations because Indiana has additional and more detailed
requirements for further site investigation in the event evidence
exists that a contaminant exceeds the cleanup objectives of IC 13-12-3-
2.
    At Section 329 IAC 9-5-7 the state provisions are more stringent
because Indiana has additional and more detailed requirements for the
corrective action plan than the federal regulations including
consideration of the proximity of potential contaminant receptors and
suitability of chosen remediation method when approving corrective
action plans and adherence to a written health and safety plan.
    At 329 IAC 9-6-5(d) the State requires owners and operators provide
certification of closure compliance pursuant to the notification form
requirements at 329 IAC 9-2-2 (see specifically 329 IAC 9-2-2(f) and
(g)). The federal program does not include a similar requirement making
the state provision potentially more stringent than the federal
regulations.
    At 329 IAC 9-6-2.1(a) the State requires owners and operators to
notify both the department and the office of the state fire marshal
before beginning permanent closure or a change-in-service where the
federal regulation requires notification only of the implementing
agency. The state provision is more stringent than federal regulations
because of this additional notification requirement.
    Section 329 IAC 9-6-3 requires that when previously closed UST
systems must be assessed and closed as directed by the State
Commissioner, the closures be performed by a person certified under the
rules of the fire prevention and building safety commission at 675 IAC
12-12. The State's requirement for certification is more stringent than
federal regulations.
    At Section 329 IAC 9-8-4(a) the state provision is more stringent
than the federal regulations as it requires all UST system owners and
operators to maintain financial responsibility for corrective action
and third-party claims in a per-occurrence amount of at least $1
million, without considering their monthly throughput or whether they
are located at petroleum marketing facilities. The federal regulations
allow owners or operators who do not meet the requirement of
280.93(a)(1) to maintain financial responsibility of $500,000.
    At Section 329 IAC 9-8-17(b) this state provision continues to
require that the local government fund be funded for ten times the full
amount of coverage required under 329 IAC 9-8-4 though EPA reduced the
required local government fund funding amount from ten times the full
amount of coverage required under Sec.  280.93 to five times the
coverage. The State's higher coverage requirement makes the state
provision more stringent than the federal regulations.
    At Section 329 IAC 9-8-25(a) and (b) the State requires owners or
operators to replenish guarantees, letters of credit and surety bonds
by the anniversary date or within 120 days after the reduction has
occurred, whichever is sooner. The State's inclusion of this other
option and subjecting owners or operators to whichever option is sooner
is more stringent than the federal program that does not contain these
requirements.

I. How does this action affect Indian country (18 U.S.C. 1151) in
Indiana?

    EPA's approval of Indiana's Program does not extend to Indian
country as defined in 18 U.S.C. 1151. Indian country generally includes
any land held in trust by the United States for an Indian tribe; and
any other areas that are ``Indian country'' within the meaning of 18
U.S.C. 1151. Any lands removed from an Indian reservation status by
federal court action are not considered reservation lands even if
located within

the exterior boundaries of an Indian reservation. EPA will retain
responsibilities under RCRA for underground storage tanks in Indian
country. Therefore, this action has no effect in Indian country. See 40
CFR 281.12(a)(2).

II. Statutory and Executive Order (E.O.) Reviews

    This action only applies to Indiana's UST Program requirements
pursuant to RCRA Section 9004 and imposes no requirements other than
those imposed by state law. It complies with applicable EOs and
statutory provisions as follows:

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

    The Office of Management and Budget (OMB) has exempted this action
from the requirements of Executive Order 12866 (58 FR 51735, Oct. 4,
1993) and 13563 (76 FR 3821, Jan. 21, 2011). This action approves state
requirements for the purpose of RCRA section 9004 and imposes no
additional requirements beyond those imposed by state law. Therefore,
this action is not subject to review by OMB.

B. Unfunded Mandates Reform Act and Executive Order 13175: Consultation
and Coordination With Indian Tribal Governments

    Because this action approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by state law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538). For the same
reason, this action also does not significantly or uniquely affect the
communities of tribal governments, as specified by Executive Order
13175 (65 FR 67249, November 9, 2000).

C. Executive Order 13132: Federalism

    This action will not have substantial direct effects on the states,
on the relationship between the national government and the states, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, Aug. 10, 1999), because it merely approves state requirements as
part of the state RCRA Underground Storage Tank Program without
altering the relationship or the distribution of power and
responsibilities established by RCRA.

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

    This action also is not subject to Executive Order 13045 (62 FR
19885, Apr. 23, 1997), because it is not economically significant and
it does not make decisions based on environmental health or safety
risks.

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

    This rule is not subject to Executive Order 13211 (66 FR 28355, May
22, 2001) because it is not a ``significant regulatory action'' as
defined under Executive Order 12866.

F. National Technology Transfer and Advancement Act

    Under RCRA section 9004(b), EPA grants a state's application for
approval as long as the state meets the criteria required by RCRA. It
would thus be inconsistent with applicable law for EPA, when it reviews
a state approval application, to require the use of any particular
voluntary consensus standard in place of another standard that
otherwise satisfies the requirements of RCRA. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.

G. Executive Order 12988: Civil Justice Reform

    As required by section 3 of Executive Order 12988 (61 FR 4729,
February 7, 1996), in issuing this rule, EPA has taken the necessary
steps to eliminate drafting errors and ambiguity, minimize potential
litigation, and provide a clear legal standard for affected conduct.

H. Executive Order 12630: Governmental Actions and Interference With
Constitutionally Protected Property Rights

    EPA has complied with Executive Order 12630 (53 FR 8859, Mar. 15,
1988) by examining the takings implications of the rule in accordance
with the ``Attorney General's Supplemental Guidelines for the
Evaluation of Risk and Avoidance of Unanticipated Takings'' issued
under the executive order.

I. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.). ``Burden'' is defined at 5 CFR 1320.3(b).

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

    Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. Because this rule approves pre-
existing state rules which are at least equivalent to, consistent with,
and no less stringent than existing federal requirements, and imposes
no additional requirements beyond those imposed by state law, and there
are no anticipated significant adverse human health or environmental
effects, the rule is not subject to Executive Order 12898.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801-808, 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 document 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 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). However,
this action will be effective April 19, 2021 because it is a direct
final rule.

    Authority: This rule is issued under the authority of Sections
2002(a), 7004(b), and 9004, 9005 and 9006 of the Solid Waste
Disposal Act, as amended, 42 U.S.C. 6912(a), 6974(b), and 6991c,
6991d, and 6991e.

List of Subjects in 40 CFR Parts 281 and 282

    Environmental protection, Administrative practice and procedure,
Hazardous substances, State program approval, and Underground storage
tanks.

    Dated: February 9, 2021.
Cheryl Newton,
Acting Regional Administrator, Region 5.
[FR Doc. 2021-03168 Filed 2-16-21; 8:45 am]
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