[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Notices]
[Page 73381]
[DOCID:fr02de08-121]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to title 49 Code of Federal Regulations (CFR) part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of a signal system, or relief from the requirements of
49 CFR part 236 as detailed below.

Docket Number FRA-2008-0134

    Applicant: Southern California Regional Rail Authority, Mr. Darrell
J. Maxey, P. E., Director, Engineering and Construction, 700 S. Flower
Street, 26th Floor, Los Angeles, California 90017.
    The Southern California Regional Rail Authority (SCRRA) seeks
relief from the requirements of the Rules, Standards, and Instructions,
title 49 CFR part 236, section 236.504, Operation interconnected with
automatic block-signal system; and Section 236.566, Locomotive of each
train operating in train stop, train control, or cab signal territory
equipped.
    The application seeks approval to expand the locations of the
intermittent inert ATS inductor territory both within the Orange
Subdivision and beyond the Orange and River Subdivision to SCRRA's four
other Subdivisions with passenger operations. SCRRA is proposing to
modify the previous ATS/BNSF criteria for installing inert ATS
inductors on the approach to 4 degree or greater curves. The new
criteria would be to install inert inductors in approach of 20 miles
per hour (mph) or greater permanent speed reductions. Freight train
locomotives would not be equipped per the current operating convention.
    The new criteria would result in the following additional 43 inert
ATS inductor installations for eastward and westward movements:
    Valley Subdivision--14 (7 West and 7 East).
    Ventura Subdivision--4 (2 West and 2 East).
    Olive Subdivision--1 (1 East).
    San Gabriel Subdivision--12 (7 West and 5 East).
    Orange Subdivision--12 (7 West and 5 East).
    Applicant's justification for relief: SCRRA feels that the
justification for installing additional inert inductors is as follows:
    1. Provides increased situational awareness for passenger train
engine men approaching (20 mph or greater) civil speed reductions.
    2. Compatible with existing SCRRA and Amtrak passenger train ATS
equipped fleet.
    3. Wayside inert ATS inductors can be designed, procured, and
installed in 9 months or less.
    4. Minimal changes required to existing SCRRA operating practices.
    5. Simplified design, procurement and installation process allows
SCRRA resources to be devoted to deploying Positive Train Control
(PTC).
    6. Inert inductors can be easily removed when PTC with active civil
speed enforcement is deployed.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    Any interested party desiring to protest the granting of an
application shall set forth specifically the grounds upon which the
protest is made, and it shall contain a concise statement of the
interest of the party in the proceeding. Additionally, one copy of the
protest shall be furnished to the applicant at the address listed
above.
    All communications concerning these proceedings should be
identified by Docket Number FRA-2008-0134 and may be submitted by any
of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received within 30 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on November 25, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E8-28568 Filed 12-1-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 198 (Thursday, October 13, 2011)]
[Rules and Regulations]
[Pages 63547-63549]
[FR Doc No: 2011-26413]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0939]
RIN 1625-AA87

Security Zone; Columbia and Willamette Rivers, Dredge Vessels
Patriot and Liberty

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary security zone
within 200 yards of the Dredge Vessels Patriot and Liberty while the
vessels are underway, anchored, or conducting dredging operations in
the vicinity of Willamette River Mile 2 and Columbia River Mile 105.
Entry into this zone is prohibited unless authorized by the Captain of
the Port, Columbia River or his designated representative. The Coast
Guard is establishing this temporary security zone around the vessels
to provide security during operations and this will be done so by
prohibiting all persons or vessels from operating within 200 yards of
the vessel.

DATES: This rule is effective from October 13, 2011, through October
31, 2011. The security zone has been enforced with actual notice since
from 7 a.m. on October 1, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0939 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0939 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, 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 FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail BM1 Silvestre Suga III, Waterways
Management Division, Coast Guard MSU Portland; telephone<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because to do so would be contrary to public
interest due to insufficient time in which to publish an NPRM since the
Dredge Vessels Patriot and Liberty would have started their operations
on the Columbia and Willamette Rivers by the time the notice could be
published and comments taken.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Publishing a NPRM would be
contrary to public interest since immediate action is necessary to
safeguard the Dredge Vessels Patriot and Liberty from sabotage, other
subversive acts, or accidents, and otherwise protect these vessels.

Background and Purpose

    The Dredge Vessels Patriot and Liberty will be conducting
operations at Columbia River Mile 105 and Willamette River Mile 2. This
temporary security zone is necessary to help ensure the security of
these vessels while conducting dredging operations. This will be done
by prohibiting all persons or vessels from operating near the vessels
while they are located in the Columbia or Willamette Rivers.

Discussion of Rule

    This rule establishes a temporary security zone around the Dredge
Vessels Patriot and Liberty while they are anchored, underway, or
conducting dredging operations. The security zone encompasses all
waters within 200 yards around the vessels. No person or vessel may
enter or remain in the security zone unless authorized by the Captain
of the Port, Columbia River or his designated representative.
    The security zone will be in effect while the Dredge Vessels are
operating in the Columbia and Willamette Rivers between approximately 7
a.m. on October 1, 2011 through October 31, 2011.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. The Coast Guard has made this
determination based on the fact that the security zone is limited in
duration and maritime traffic will be able to transit around the zones.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities some of which may
be small entities: The owners and operators of vessels intending to
operate in the area covered by the security zone created by this rule.
The security zone will not have a significant economic impact on a
substantial number of small entities because maritime traffic will be
able to transit around the zone and therefore any interruption to
navigation is minimal.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a security
zone. An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T13-197 to read as follows:

Sec.  165.T13-197  Security Zone; Columbia and Willamette Rivers, M/V
PATRIOT AND M/V LIBERTY.

    (a) Location. The following area is a security zone: All waters
within 200 yards in all directions of Dredge vessels Patriot and
Liberty while these vessels are operating at Willamette River Mile 2
and Columbia River Mile 105.
    (b) Regulations. In accordance with the general regulations in 33
CFR part 165, subpart D, no person may enter or remain in the security
zone created in this section or bring, cause to be brought, or allow to
remain in the security zone created in this section any vehicle,
vessel, or object unless authorized by the Captain of the Port or his
designated representative. Designated representatives are Coast Guard
personnel authorized by the Captain of the Port to grant persons or
vessels permission to enter or remain in the security zone created by
this section. See 33 CFR part 165, subpart D, for additional
information and requirements.
    (c) Enforcement period. The security zone created by this section
will be in effect from 7 a.m. on October 1, 2011, through October 31,
2011.

    Dated: September 28, 2011.
B.C. Jones,
Captain, U.S. Coast Guard, Captain of the Port, Columbia River.
[FR Doc. 2011-26413 Filed 10-12-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17157-17159]
[FR Doc No: 2021-06693]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-1314]

Determination of Regulatory Review Period for Purposes of Patent
Extension; IBSRELA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for IBSRELA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by June 1, 2021.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by September 28, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 1, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 1, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand d89.pelivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2020-E-1314 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; IBSRELA.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, IBSRELA
(tenapanor hydrochloride). IBSRELA is indicated for treatment of
irritable bowel syndrome with constipation in adults. Subsequent to
this approval, the USPTO received a patent term restoration application
for IBSRELA (U.S. Patent No. 8,541,448) from Ardelyx, Inc., and the
USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated May 26,
2020, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of IBSRELA represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
IBSRELA is 3,219 days. Of this time, 2,853 days occurred during the
testing phase of the regulatory review period, while 366 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
November 21, 2010. The applicant claims November 20, 2010, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was November
21, 2010, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act or section
351 of the Public Health Service Act: September 12, 2018. FDA has
verified the applicant's claim that the new drug application (NDA) for
IBSRELA (NDA 211801) was initially submitted on September 12, 2018.
    3. The date the application was approved: September 12, 2019. FDA
has verified the applicant's claim that NDA 211801 was approved on
September 12, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,272 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket

No. FDA-2013-S-0610. Submit written petitions (two copies are required)
to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: March 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06693 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Rules and Regulations]
[Pages 10831-10832]
[FR Doc No: 2021-02618]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0316; FRL-10018-14-Region 3]

Air Plan Approval; Pennsylvania; 1997 8-Hour Ozone National
Ambient Air Quality Standards Second Maintenance Plan for the Scranton-
Wilkes-Barre Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the Commonwealth of
Pennsylvania. This revision pertains to the Commonwealth's plan,
submitted by the Pennsylvania Department of Environmental Protection
(PADEP), for maintaining the 1997 8-hour ozone national ambient air
quality standard (NAAQS) (referred to as the ``1997 ozone NAAQS'') in
the Scranton-Wilkes-Barre, Pennsylvania area (Scranton-Wilkes-Barre
Area). This action is being taken under the Clean Air Act (CAA).

DATES: This final rule is effective on March 25, 2021.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2020-0316. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available through
https://www.regulations.gov, or please contact the person identified in
the For Further Information Contact section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Maria A. Pino, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2181. Ms. Pino can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On September 3, 2020 (85 FR 54961), EPA published a notice of
proposed rulemaking (NPRM) for the Commonwealth of Pennsylvania. In the
NPRM, EPA proposed approval of Pennsylvania's plan for maintaining the
1997 ozone NAAQS in the Scranton-Wilkes-Barre Area through December 19,
2027, in accordance with CAA section 175A. The formal SIP revision was
submitted by PADEP on March 10, 2020.

II. Summary of SIP Revision and EPA Analysis

    On November 19, 2007 (72 FR 64948, effective December 19, 2007),
EPA approved a redesignation request (and maintenance plan) from PADEP
for the Scranton-Wilkes-Barre Area. In accordance with section 175A(b),
at the end of the eighth year after the effective date of the
redesignation, the state must also submit a second maintenance plan to
ensure ongoing maintenance of the standard for an additional 10 years,
and in South Coast Air Quality Management District v. EPA,\1\ the D.C.
Circuit held that this requirement cannot be waived for areas, like the
Scranton-Wilkes-Barre Area, that had been redesignated to attainment
for the 1997 8-hour ozone NAAQS prior to revocation and that were
designated attainment for the 2008 ozone NAAQS. CAA section 175A sets
forth the criteria for adequate maintenance plans. In addition, EPA has
published longstanding guidance that provides further insight on the
content of an approvable maintenance plan, explaining that a
maintenance plan should address five elements: (1) An attainment
emissions inventory; (2) a maintenance demonstration; (3) a commitment
for continued air quality monitoring; (4) a process for verification of
continued attainment; and (5) a contingency plan.\2\ PADEP's March 10,
2020 submittal fulfills Pennsylvania's obligation to submit a second
maintenance plan and addresses each of the five necessary elements.
---------------------------------------------------------------------------

    \1\ 882 F.3d 1138 (D.C. Cir. 2018).
    \2\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (Calcagni Memo).
---------------------------------------------------------------------------

    As discussed in the September 3, 2020 NPRM, EPA allows the
submittal of a less rigorous, limited maintenance plan (LMP) to meet
the CAA section 175A requirements by demonstrating that the area's
design value \3\ is well below the NAAQS and that the historical
stability of the area's air quality levels shows that the area is
unlikely to violate the NAAQS in the future. EPA evaluated PADEP's
March 10, 2020 submittal for consistency with all applicable EPA
guidance and CAA requirements. EPA found that the submittal met CAA
section 175A and all CAA requirements, and proposed approval of the LMP
for the Scranton-Wilkes-Barre Area as a revision to the Pennsylvania
SIP. The effect of this action makes certain commitments related to the
maintenance of the 1997 ozone NAAQS Federally enforceable as part of
the Pennsylvania SIP.
---------------------------------------------------------------------------

    \3\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ozone concentrations. The design value for an ozone nonattainment
area is the highest design value of any monitoring site in the area.
---------------------------------------------------------------------------

    Other specific requirements of PADEP's March 10, 2020 submittal and
the rationale for EPA's proposed action are explained in the NPRM and
will not be restated here.

III. EPA's Response to Comments Received

    EPA received one comment in support of its proposed approval of
PADEP's March 10, 2020 submittal. EPA received no adverse comments on
the September 3, 2020 NPRM. Therefore, no response to comments is
required.

IV. Final Action

    EPA is approving PADEP's second maintenance plan for the Scranton-

Wilkes-Barre Area for the 1997 ozone NAAQS as a revision to the
Pennsylvania SIP.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 26, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    This action, approving PADEP's second maintenance plan for the
Scranton-Wilkes-Barre Area for the 1997 ozone NAAQS, may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: February 3, 2021.
Diana Esher,
Acting Regional Administrator, Region III.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
the entry ``Second Maintenance Plan for the Scranton-Wilkes-Barre 1997
8-Hour Ozone Nonattainment Area'' at the end of the table to read as
follows:

Sec.  52.2020   Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                                             State
  Name of non-regulatory SIP     Applicable  geographic    submittal       EPA approval date        Additional
           revision                       area                date                                 explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Second Maintenance Plan for    Scranton-Wilkes-Barre          3/10/20  2/23/21, [insert Federal  Scranton/Wilkes-
 the Scranton-Wilke-Barre       Area.                                   Register citation].       Barre Area:
 1997 8-Hour Ozone                                                                                Lackawanna,
 Nonattainment Area.                                                                              Luzerne,
                                                                                Monroe and
                                                                                Wyoming
                                                                                Counties.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-02618 Filed 2-22-21; 8:45 am]
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[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Rules and Regulations]
[Pages 1883-1884]
[FR Doc No: 2012-489]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2011-0020; Internal Agency Docket No. FEMA-8093]

Suspension of Community Eligibility for Repealing Its Floodplain
Management Regulations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: FEMA is suspending one community because it repealed its
floodplain management regulations under the National Flood Insurance
Program (NFIP). If documentation is received from the community before
the effective suspension date, indicating it has amended its floodplain
management regulations in compliance with the NFIP requirements, FEMA
will withdraw the suspension by publication in the Federal Register on
a subsequent date.

DATES: Effective Dates: The effective date of the community's scheduled
suspension is the date listed in the fourth column of the following
table.

FOR FURTHER INFORMATION CONTACT: David Stearrett, Mitigation
Directorate, 1800 South Bell Street Arlington, VA 20598-3072, (202)
646-2953.

SUPPLEMENTARY INFORMATION: The National Flood Insurance Program (NFIP)
enables property owners to purchase flood insurance that is generally
not otherwise available. In return, communities agree to adopt and
implement local floodplain management regulations that contribute to
protecting lives and reducing the risk of property damage from future
flooding. Section 1315 of the National Flood Insurance Act of 1968, as
amended (42 U.S.C. 4022), prohibits flood insurance coverage authorized
under the National Flood Insurance Program (42 U.S.C. 4001-4128) unless
an appropriate public body adopts adequate floodplain management
measures with effective administration and enforcement processes.
    The community listed in this notice no longer complies with the
NFIP requirements set forth at 44 CFR part 59 et seq. Under 44 CFR
59.24(d), communities will be suspended from the NFIP for repealing its
floodplain management regulations. Accordingly, FEMA is suspending
Graham County, North Carolina (``the County'') on the effective date in
the fourth column of the table. As of that date, the purchase of new
flood insurance policies or the renewal of existing flood insurance
policies under the NFIP will no longer be available.
    FEMA will not suspend Graham County, however, if the community
submits the documentation required under 44 CFR 59.24(d) to show that
it has amended its floodplain management regulations to adopt the
current effective Flood Insurance Study and Flood Insurance Rate Map
dated April 19, 2010. This documentation must be received by FEMA
before the actual suspension date. If Graham County successfully
demonstrates its compliance with NFIP regulations, FEMA will continue
its eligibility for the sale of NFIP insurance. FEMA will then publish
in the Federal Register a notice withdrawing the suspension of the
community. In the interim, if you wish to determine whether FEMA has
suspended the County on the suspension date, please contact the FEMA
Region IV office at<PHONE_NUMBER>. Additional information may also be
found at http://www.fema.gov/plan/prevent/floodplain/nfipkeywords/suspension.shtm.
    FEMA identified the special flood hazard areas (SFHAs) in this
community by publishing a Flood Insurance Rate Map. The effective date
of this map is indicated in the last column of the table. By law, no
Federally regulated entity may provide financial assistance for
acquisition or construction purposes for property located in a SFHA
unless the community in which the property is located is participating
in the NFIP (42 U.S.C. 4106(a)). The prohibition against certain types
of Federal disaster assistance also becomes effective for Graham
County, North Carolina, on the date shown in the fourth column (42
U.S.C. 4106(b)).
    The Administrator finds that notice and public comment procedure
under 5 U.S.C. 553(b) are impracticable and unnecessary because the
community listed in this final rule has been adequately notified. The
community received a letter dated August 3, 2011, and a subsequent
Suspension Letter. FEMA addressed these notifications to the Chairman
of the Graham County Board of Commissioners indicating that we will
suspend the County unless the County takes the required corrective
actions and remedial measures before the effective suspension date.
Because we have made these notifications, this final rule may take
effect within less than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR Part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The community listed no longer complies
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the community unless remedial
action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the

Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR Part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq., Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Date certain Federal assistance no
                                                                                longer available in special flood
                State                          Location           Community No.    hazard area and the sale of flood      Current effective map date
                                                                                insurance no longer available in
                                                                                the community
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Region IV

North Carolina.......................  Graham, County of......            370105  February 1, 2012..................  April 19, 2010.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 83.100, ``Flood
Insurance.'')

    Dated: January 4, 2012.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Federal Emergency Management Agency, Department of
Homeland Security.
[FR Doc. 2012-489 Filed 1-11-12; 8:45 am]
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