[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Rules and Regulations]
[Pages 40963-40966]
[FR Doc No: 2013-16248]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 177

[Docket No. USCG-2013-0216]
RIN 1625-AC01

Regulated Navigation Areas; Bars Along the Coasts of Oregon and
Washington

AGENCY: Coast Guard, DHS.

ACTION: Interim rule with request for comments.

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SUMMARY: The Coast Guard is amending its regulations by removing the
wave height and surface current provisions and regulated boating areas
for bar crossing locations along the coasts of Oregon and Washington
because they conflict with more recently promulgated wave height
provisions and regulated boating areas for the same bar crossings. This
amendment is necessary in order to remove confusion as to which safety
requirements apply to recreational vessels, uninspected passenger
vessels, small passenger vessels, and commercial fishing vessels when
operating within the regulated navigation areas.

DATES: This interim rule is effective August 8, 2013. Comments and
related material must reach the Docket Management Facility on or before
September 9, 2013.

ADDRESSES: You may submit comments identified by docket number USCG-
2013-0216 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
email or call Mr. Burt Lahn, U.S. Coast Guard Office of Navigation
Standards (CG-NAV-3), email<EMAIL_ADDRESS>telephone 202-372-
1526. If you have questions on viewing or submitting material to the
docket, call Barbara Hairston, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Public Participation and Request for Comments
    A. Submitting comments
    B. Viewing comments and documents
    C. Privacy Act
    D. Public meeting
II. Abbreviations
III. Regulatory History and Information
IV. Basis and Purpose
V. Discussion of the Interim Rule
VI. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates Reform Act
    G. Taking of Private Property
    H. Civil Justice Reform
    I. Protection of Children
    J. Indian Tribal Governments
    K. Energy Effects
    L. Technical Standards
    M. Environment

I. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

A. Submitting comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2013-0216), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comments online, go to http://www.regulations.gov
and insert ``USCG-2013-0216'' in the ``Search'' box. Locate this
document in the search results, click on ``Submit a Comment,'' and
follow the instructions to submit your comments. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit them by mail and would like to know that they
reached the Facility, please enclose a stamped, self-addressed postcard
or envelope.
    We will consider all comments and material received during the
comment period and may change this rule based on your comments.

B. Viewing comments and documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov and
insert ``USCG-2013-0216'' in the ``Search'' box and locate this
document in the search results. Open the docket folder and use the
filters on the left side of the page to view public comments or other
types of documents. If you do not have access to the internet, you may
view the docket online by visiting the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. We have an agreement with the Department of Transportation to
use the Docket Management Facility.

C. Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

D. Public meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the methods specified under ADDRESSES. In
your request, explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

II. Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
NTSB National Transportation Safety Board
RNA Regulated Navigation Area
U.S.C. United States Code
Sec.  Section

III. Regulatory History & Information

    The bars along the coasts of Oregon and Washington are a maritime
operating environment unique to the Pacific Northwest. The bars can and
very often do become extremely hazardous for maritime traffic. On
February 12, 2009, the Coast Guard published a Notice of Proposed
Rulemaking (NPRM) in the Federal Register (74 FR 7022) that proposed to
establish Regulated Navigation Areas (RNAs) in 33 CFR 165.1325 for bars
along the coasts of Oregon and Washington. The proposals in the NPRM
were designed to help ensure the safety of persons and vessels
operating on or in the vicinity of the bars. The Coast Guard
subsequently published a final rule in the Federal Register on November
17, 2009 (74 FR 59098), adopting most of the NPRM's proposals.
    Certain provisions in the final rule superseded other existing
regulatory provisions. Specifically, 33 CFR 165.1325(a) sets forth the
specific locations for the RNAs that cover the bars along the Oregon
and Washington coasts, and supersedes the regulated boating areas in 33
CFR 177.08. Additionally, 33 CFR 165.1325(b)(13) defines the term
unsafe condition to include certain wave height conditions, and
supersedes the unsafe wave height formula and surface current
provisions in 33 CFR 177.07(f). The purpose of this interim rule is to
remove those superseded provisions from the CFR.
    The Coast Guard is issuing this interim rule without prior notice
and opportunity to comment pursuant to 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 an NPRM with respect to this rule because
that procedure would be contrary to the public interest. Failure to
amend 33 CFR part 177 will result in confusion as to which safety
requirements apply to recreational and small commercial vessels when
operating in certain bar crossing locations along the coasts of Oregon
and Washington. This rulemaking is necessary to remove the conflicting
provisions under 33 CFR 177.07(f) and 177.08 that have been superseded
by 33 CFR 165.1325 and to eliminate confusion regarding which
requirements apply specific to the bars along the coasts of Oregon and
Washington. Delaying this action in order to publish an NPRM would be
contrary to the public interest, as further delay would perpetuate
confusion.
    In addition, as discussed in the aforementioned 2009 NPRM, the
Coast Guard determined that the wave height and surface current
provisions in 33 CFR 177.07(f), and the regulated boating areas in 33
CFR 177.08, did not provide a sufficient measure of safety for persons
and vessels operating in those areas. In addition, multiple Coast Guard
and National Transportation Safety Board (NTSB) casualty investigations
indicated a need for additional regulations to mitigate the risks
associated with the bars and to enhance the safety of the persons and
vessels operating on and in the bars' vicinity. Thus, continuing to
keep these regulations in effect while publishing an NPRM would also be
contrary to the public interest in making boating operations as safe as
possible.

IV. Basis and Purpose

    Under 46 U.S.C. 4302, the Coast Guard is authorized to establish
regulations to promulgate minimum safety standards and procedures for
recreational vessels. Under 46 U.S.C. 4105(a), uninspected passenger
vessels are also subject to Chapter 43 of Title 46, U.S. Code.
    This rulemaking is necessary in order to remove the wave height and
surface current provisions under 33 CFR 177.07(f) and the geographic
coordinates in 33 CFR 177.08 that have been superseded by 33 CFR
165.1325, to eliminate confusion regarding which provisions apply
specific to the bars along the coasts of Oregon and Washington. The
regulations in 33 CFR 165.1325 establish clear procedures for
restricting and/or closing the bars as well as mandating additional
safety requirements for recreational and uninspected commercial vessels
operating on or in the vicinity of the bars, when certain conditions
exist. The RNAs established in 33 CFR 165.1325 help to expedite bar
restrictions and closures and include a mariner notification process
that helps keep vessels away from hazardous bars. The RNAs also require
the use and/or making ready of safety equipment, as well as additional
reporting requirements when certain conditions exist, which help
safeguard the persons and vessels that operate on or in the vicinity of
hazardous bars.

V. Discussion of the Interim Rule

    Certain provisions of 33 CFR part 177, governing maritime traffic
operating on and in the vicinity of the bars along the coasts of Oregon
and Washington, provide insufficient safety measures for the persons
and vessels that operate in those areas. As discussed in the February
12, 2009 NPRM (74 FR 7022), multiple Coast Guard and NTSB casualty
investigations indicated a need for additional regulations to mitigate
the risks associated with the bars and to enhance the safety of the
persons and vessels operating on and in the bars' vicinity. To fulfill
this need, in 2009, the Coast Guard established the RNAs in 33 CFR
165.1325.
    The provisions in 33 CFR 165.1325 establish an increased measure of
safety and supersede the existing provisions in 33 CFR 177.07(f) and
177.08. Accordingly, the Coast Guard, through this interim rule,
removes the wave height provisions in 33 CFR 177.07(f)(1) and (2), the
surface current provision in 33 CFR 177.07(f)(3), and the regulated
boating areas in 33 CFR 177.08.

VI. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 (``Regulatory Planning and Review'') and
13563 (``Improving Regulation and Regulatory Review'') direct agencies
to assess the costs and benefits of available regulatory alternatives
and, if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety effects, distributive impacts, and equity).
Executive Order 13563 emphasizes the importance of quantifying both
costs and benefits, of reducing costs, of harmonizing rules, and of
promoting flexibility. This interim rule has not been designated a
``significant regulatory action'' under section 3(f) of Executive Order
12866. Accordingly, the interim rule has not been reviewed by the
Office of Management and Budget.
    The Coast Guard does not expect any economic impact as a result of
this interim rule because the rule is only removing two criteria for
unsafe conditions in 33 CFR part 177 that have been superseded by 33
CFR 165.1325.

B. 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.
This rule does not require a general notice of proposed rulemaking and,
therefore, is exempt from the requirements of the Regulatory
Flexibility Act. Although this rule is exempt, we have reviewed it for
potential economic impact on small entities.
    The Coast Guard does not expect any economic impact as a result of
this interim rule because the rule is only removing certain provisions
of 33 CFR part 177 that have been superseded by 33 CFR 165.1325. The
Coast Guard anticipates this interim rule will have no impacts, hence,
no costs to the affected population, including any small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule will have a
significant economic impact on it, please submit a comment to the
Docket Management Facility at the address under ADDRESSES. In your
comment, explain why you think it qualifies and how and to what degree
this rule would economically affect it.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule so that they can better evaluate
its effects on them and participate in the rulemaking. If the rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please consult Burt Lahn, U.S. Coast Guard
Office of Navigation Standards (CG-NAV-3), email<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>. 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.

D. 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).

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132. Our analysis is explained below.
    Under 46 U.S.C. 4306, Federal regulations promulgated under the
authority of 46 U.S.C. 4302 preempt State law unless the State law is
identical to a Federal regulation or a State is specifically provided
an exemption to those regulations, or permitted to regulate marine
safety articles carried or used to address a hazardous condition or
circumstance unique to that State. As noted above, this interim rule
simply removes superseded regulations regarding wave height and surface
current provisions, and certain regulated boating areas from 33 CFR
part 177. Additionally, there are no existing State laws that are
identical to these Federal regulations, nor have the States been
provided an exemption to those regulations or permitted to regulate
marine safety articles. Therefore, the rule is consistent with the
principles of federalism and preemption requirements in Executive Order
13132.
    While it is well settled that States may not regulate in categories
in which Congress intended the Coast Guard to be the sole source of a
vessel's obligations, the Coast Guard recognizes the key role that
State and local governments may have in making regulatory
determinations. Additionally, for rules with implications and
preemptive effect, Executive Order 13132 specifically directs agencies
to consult with State and local governments during the rulemaking
process.
    Therefore, the Coast Guard invites affected State and local
governments and their representative national organizations to indicate
their desire for participation and consultation in this rulemaking
process by submitting comments to this interim rule. In accordance with
Executive Order 13132, the Coast Guard will provide a federalism impact
statement to document: (1) The extent of the Coast Guard's consultation
with State and local officials who submit comments to this proposed
rule; (2) a summary of the nature of any concerns raised by State or
local governments and the Coast Guard's position thereon; and (3) a
statement of the extent to which the concerns of State and local
officials have been met. We will also report to the Office of
Management and Budget any written communications with the States.

F. 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. This rule will not result in such
expenditure.

G. 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.

H. 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.

I. 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.

J. 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.

K. 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.

L. 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.

M. 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
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under section 2.B.2,
Figure 2-1, paragraph 34(g), of the Instruction because it involves
regulations establishing, disestablishing, or changing RNAs. 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 177

    Marine safety.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 177 as follows:

Title 33--Navigation and Navigable Waters

PART 177--CORRECTION OF ESPECIALLY HAZARDOUS CONDITIONS

0
1. The authority citation for part 177 continues to read as follows:

    Authority: 46 U.S.C. 4302, 4311; Pub. L. 103-206, 107 Stat.
2439.

Sec.  177.04  [Amended]

0
2. In Sec.  177.04(a), remove the text ``Sec.  177.07(g)'' and add, in
its place, the text ``Sec.  177.07(f)''.

Sec.  177.07  [Amended]

0
3. In Sec.  177.07, remove paragraph (f) and redesignate paragraph (g)
as new paragraph (f).

Sec.  177.08  [Removed]

0
4. Remove Sec.  177.08.

Sec.  177.09  [Redesignated as Sec.  177.08]

0
5. Redesignate Sec.  177.09 as Sec.  177.08.

    Dated: June 28, 2013.
Dana A. Goward,
Director, Marine Transportation Systems, U.S. Coast Guard.
[FR Doc. 2013-16248 Filed 7-8-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Pages 53823-53824]
[FR Doc No: 2020-19036]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-2091 and FDA-2019-E-2092]

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

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

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for POTELIGEO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications 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
biological 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 October 30, 2020.
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 March 1, 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 October 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 30, 2020. 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 Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-2091 and FDA-2019-E-2092 For ``Determination of Regulatory
Review Period for Purposes of Patent Extension; POTELIGEO.'' 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product POTELIGEO
(mogamulizumab-kpkc). POTELIGEO is indicated for the treatment of adult
patients with relapsed or refractory mycosis fungoides or S[eacute]zary
syndrome after at least one prior systemic therapy. Subsequent to this
approval, the USPTO received patent term restoration applications for
POTELIGEO (U.S. Patent Nos. 6,989,145 and 7,504,104) from Kyowa Hakko
Kirin, and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
June 21, 2019, FDA advised the USPTO that this human biological product
had undergone a regulatory review period and that the approval of
POTELIGEO 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
POTELIGEO is 3,536 days. Of this time, 3,227 days occurred during the
testing phase of the regulatory review period, while 309 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 (21 U.S.C. 355(i)) became effective: December 4,
2008. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on December
4, 2008.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): October 4, 2017. FDA has verified the
applicant's claim that the biologics license application (BLA) for
POTELIGEO (BLA 761051) was initially submitted on October 4, 2017.
    3. The date the application was approved: August 8, 2018. FDA has
verified the applicant's claim that BLA 761051 was approved on August
8, 2018.
    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 applications for patent extension,
this applicant seeks 1,826 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: August 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19036 Filed 8-28-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Notices]
[Pages 64949-64950]
[FR Doc No: 2019-25484]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

NextGen Advisory Committee (NAC); Notice of Public Meeting

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

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the NextGen Advisory
Committee (NAC).

DATES: The meeting will be held on December 12, 2019, from 9:00 a.m.-
12:30 p.m. EST.
    Requests to attend the meeting in person must be received by
December 3, 2019.
    Requests to listen-only by telephone must be received by December
3, 2019.
    Requests for accommodations to a disability must be received by
December 3, 2019.
    Anyone who wishes to speak during the meeting must be received by
December 3, 2019, along with a written copy of the remarks to be
delivered.
    Requests to submit written materials to be reviewed by the NAC must
be received no later than December 6, 2019, along with a copy of such
written materials.

ADDRESSES: The meeting will be held at The MITRE Corporation, MITRE 1
Building Conference Center: 7525 Colshire Drive, McLean, VA 22102.
Emails related to registration for attending the meeting should be sent
to<EMAIL_ADDRESS>Information on the committee,
including copies of the meeting minutes, will be available on the NAC
internet website at https://www.faa.gov/about/office_org/headquarters_offices/ang/nac/.

FOR FURTHER INFORMATION CONTACT: Greg Schwab, NAC Coordinator, U.S.
Department of Transportation, at<EMAIL_ADDRESS>or 202-267-
1201. Any requests or questions not regarding attendance registration
should be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The NAC was created under the Federal Advisory Committee Act
(FACA), in accordance with the provisions of the FACA as amended (Pub.
L. 92-463, 5 U.S.C. App 2), to provide independent advice and
recommendations to the FAA and to respond to specific taskings received
directly from the FAA. The NAC recommends consensus-driven advice for
FAA consideration relating to Air Traffic Management System
modernization.

II. Agenda

    At the December 12, 2019 meeting, the agenda will cover the
following topics:

 NAC Chairman's Report
 FAA Report
 NAC Subcommittee Chairman's Report:
    [cir] Multiple Runway Operations, Data Communications, Performance
Based Navigation, Surface and Data Sharing, and Northeast Corridor
 NAC Chairman Closing Comments

III. Public Participation

    The meeting will be open to the public on a first come, first
served basis, as space is limited. Members of the public who wish to
attend in-person are asked to register via email by submitting your
full legal name, country of citizenship, and name of your industry
association, or applicable affiliation, to<EMAIL_ADDRESS>For Foreign National attendees, please also
provide your company/organization country.
    Individuals requiring accessibility accommodations, such as sign
language, interpretation, or other ancillary aids, may request by
contacting the person listed under the heading FOR FURTHER INFORMATION
CONTACT.
    For members of the public who wish to listen-only by telephone,
provide your full name, company/organization you are representing,
title/position, and contact information (telephone number

and email address) to<EMAIL_ADDRESS>and you will be
provided the teleconference call-in number and passcode. Callers are
responsible for paying associated long-distance charges.
    With prior approval of the NAC Chair, members of the public may
present oral statements at the meeting. To accommodate as many speakers
as possible, the time for each is limited to two minutes. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration. Speakers are required to submit a
copy of their prepared remarks for inclusion in the meeting records and
for circulation to NAC members to the person listed under the heading
FOR FURTHER INFORMATION CONTACT. All prepared remarks submitted on time
will be considered as part of the record.
    Persons who wish to only submit written comments to the NAC may do
so. All written comments submitted to the person listed under the
heading FOR FURTHER INFORMATION CONTACT in time will be reviewed and
considered for inclusion as part of the record. Comments received after
the due date will be distributed to the members but may not be reviewed
prior to the meeting.

    Dated: November 20, 2019.
Tiffany Ottilia McCoy,
General Engineer, NextGen Office of Collaboration and Messaging, ANG-M,
Office of the Assistant Administrator for NextGen, Federal Aviation
Administration.
[FR Doc. 2019-25484 Filed 11-22-19; 8:45 am]
BILLING CODE P


[Federal Register Volume 84, Number 159 (Friday, August 16, 2019)]
[Proposed Rules]
[Pages 41942-41944]
[FR Doc No: 2019-17667]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2019-0362; FRL-9998-32-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
District of Columbia; Infrastructure Requirements for the 2015 Ozone
National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision from the District of
Columbia (the District). This SIP revision addresses certain
infrastructure requirements to implement, maintain, and enforce the
2015 ozone national ambient air quality standards (NAAQS), including
the requirements for interstate transport. This action is being taken
under the Clean Air Act (CAA).

DATES: Written comments must be received on or before September 16,
2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2019-0362 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Emlyn V[eacute]lez-Rosa, 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-
2038. Ms. V[eacute]lez-Rosa can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 24, 2018, the District Department
of Environment and Energy (DOEE) submitted a revision to its SIP
addressing infrastructure requirements for the 2015 ozone NAAQS.

I. Background

    On October 26, 2015, EPA issued a final rule strengthening both the
primary and secondary ozone NAAQS for ground-level ozone to 70 parts
per billion (ppb), based on the fourth-highest maximum daily 8-hour
ozone concentration per year (hereafter the 2015 ozone NAAQS). 80 FR
65292.
    Whenever EPA promulgates a new or revised NAAQS, CAA section
110(a)(1) requires states to make SIP submissions to provide for the
implementation, maintenance, and enforcement of the NAAQS. This
particular type of SIP revision is commonly referred to as an
``infrastructure SIP revision.'' Infrastructure SIP revisions must meet
the various requirements of CAA section 110(a)(2), as applicable.
Section 110(a)(2) includes a list of specific elements that each
infrastructure SIP revision must address. The infrastructure
requirements of section 110(a)(2) are designed to ensure that the
structural components of each state's air quality management program
are adequate to meet the state's responsibilities under the CAA for
implementation of a particular NAAQS.
    Due to ambiguity in some of the language of CAA section 110(a)(2),
EPA believes that it is appropriate to interpret these provisions in
the specific context of acting on infrastructure SIP revisions.\1\ EPA
has previously provided comprehensive guidance on the application of
these provisions through a guidance document for infrastructure SIP
submissions and through regional actions on infrastructure submissions.
Unless otherwise noted below, EPA is following that existing approach
in acting on the District's infrastructure SIP revision. In addition,
in the context of acting on such infrastructure SIP revision, EPA
evaluates the submitting state's overall SIP for facial compliance with
statutory and regulatory requirements, not for the state's
implementation of its SIP.\2\ EPA has other authority to address any
issues concerning a state's implementation of the rules, regulations,
consent orders, etc. that comprise its SIP.
---------------------------------------------------------------------------

    \1\ EPA explains and elaborates on these ambiguities and its
approach to address them in its September 13, 2013 guidance document
titled ``Guidance on Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2)''
(``the 2013 Infrastructure SIP Guidance''), as well as in numerous
agency actions, including EPA's prior action on the District's
infrastructure SIP revision to address the 2012 fine particulate
matter (PM2.5) NAAQS. See 81 FR 54504 (August 16, 2016).
A copy of the 2013 Infrastructure Guidance can be found in the
docket for this rulemaking action.
    \2\ See U.S. Court of Appeals for the Ninth Circuit decision in
Montana Environmental Information Center v. EPA, No. 16-71933
(August 30, 2018).
---------------------------------------------------------------------------

II. Summary of SIP Revision and EPA Analysis

    On August 24, 2018, DOEE submitted a formal SIP revision to EPA to
satisfy the infrastructure requirements of CAA section 110(a)(2) for
the 2015 ozone NAAQS. This SIP revision addresses the following
infrastructure elements, or portions thereof, for the 2015 ozone NAAQS:
CAA section 110(a)(2)(A), (B), (C), (D)(i)(I), D(i)(II), D(ii), (E),
(F), (G), (H), (J), (K), (L), and (M). The August 24, 2018 SIP revision
addresses the interstate transport requirements of CAA section
110(a)(2)(D)(i)(I) for the 2015 ozone NAAQS (also known as good
neighbor provisions). The SIP revision provides technical information
supporting the conclusion that the emissions from the District do not
significantly contribute to nonattainment or interfere with maintenance
of the 2015 ozone NAAQS in any other state.
    The August 24, 2018 SIP revision did not address the portion of
element (C) or element (I) referring to the nonattainment requirements
of part D, title I of the CAA. Part D, title I of the CAA addresses SIP
requirements and submission deadlines for designated nonattainment
areas for each NAAQS. Such nonattainment SIP revisions are required if
an area is designated nonattainment and would be due to EPA by the
dates statutorily prescribed in subparts 1 through 5 under part D,
title I of the CAA. EPA believes that because the CAA directs states to
submit these nonattainment SIP requirements on a separate schedule, it
is not necessary for states to include neither element (I) nor the
portion of element (C) referring to part D as part of the
infrastructure SIP revisions due three years after adoption or revision
of any NAAQS.\3\
---------------------------------------------------------------------------

    \3\ See EPA's 2013 Infrastructure SIP Guidance.

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

    Upon receipt, EPA evaluated the District's August 24, 2018 SIP
revision submittal for technical and administrative completeness, in
accordance with 40 CFR part 51, appendix V. EPA determined that the
submittal was technically incomplete with respect to the portions of
the infrastructure elements in CAA section 110(a)(2)(C), (D)(i)(II),
(D)(ii), and (J) relating to the Prevention of Significant
Deterioration (PSD) permitting program under part C, title I of the
CAA, because the District has not adequately addressed its part C
requirement of having a SIP-approved PSD program. By contrast, EPA
found the remainder of the August 24, 2018 SIP revision submittal to be
administratively and technically complete in accordance with 40 CFR
part 51, appendix V.
    On February 27, 2019, EPA sent a letter to DOEE notifying the
District of this completeness determination. As a result of this
finding, EPA can only proceed in taking rulemaking action on the
complete portions of the District's August 24, 2018 submittal, and
cannot take rulemaking action on the PSD-related portions of CAA
section 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J) for the 2015 ozone
NAAQS, until DOEE submits a SIP revision to address the PSD permit
requirements of part C, title I of the CAA.
    EPA recognizes, however, that the District is already subject to a
Federal implementation plan (FIP) containing the Federal PSD
program,\4\ which EPA issued to correct the District's PSD SIP
deficiency, and that DOEE does not have to take further action for the
FIP-based permitting program to be implemented. Notably, EPA does not
anticipate any adverse consequences to DOEE from the February 27, 2019
incompleteness finding for the PSD-related portions of the elements
listed above for the District's 2015 ozone NAAQS submission. Mandatory
sanctions would not apply to the District under CAA section 179,
because the failure to submit a PSD SIP revision is neither with
respect to a submission that is required under CAA title I part D, nor
in response to a SIP call under CAA section 110(k)(5). In addition, EPA
is not subject to any further FIP duties from this incompleteness
finding, because there is already a PSD FIP for the District, which
addresses the District's SIP deficiency. This rulemaking action is only
addressing the complete portions of the District's August 24, 2018
infrastructure SIP revision submittal for the 2015 ozone NAAQS.
---------------------------------------------------------------------------

    \4\ EPA promulgated the PSD FIP in 1980, and later amended it in
2003. The PSD FIP for the District is incorporated by reference in
the District's SIP in 40 CFR 52.499, and it contains the provisions
of 40 CFR 52.21, with the exception of paragraph (a)(1). See 45 FR
52676, at 52741 (August 7, 1980), 68 FR 11316, at 11322 (March 10,
2003), and 68 FR 74483, at 74488 (December 24, 2003).
---------------------------------------------------------------------------

    Based upon EPA's review of the District's August 24, 2018 SIP
revision, EPA believes that the District has met its obligations under
CAA section 110(a)(2)(A), (B), (C), (D)(i)(I), D(i)(II), D(ii), (E),
(F), (G), (H), (J), (K), (L), and (M), with exception of the PSD-
related portions of section 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J),
for the reasons discussed earlier. Thus, EPA determines that the August
24, 2018 SIP revision adequately satisfies the District's applicable
infrastructure requirements, or portions thereof, listed above for the
2015 ozone NAAQS. A detailed summary of EPA's review and rationale for
taking rulemaking action on the District's infrastructure SIP revision
may be found in the technical support document (TSD) for this proposed
rulemaking action which is available online at www.regulations.gov,
docket number EPA-R03-OAR-2019-0362.

III. Proposed Action

    EPA is proposing to approve the District's August 24, 2018 SIP
revision as meeting the requirements of section 110(a)(2) of the CAA to
implement, maintain, and enforce the 2015 ozone NAAQS, including
specifically section 110(a)(2)(A), (B), (C), (D)(i)(I), (D)(i)(II),
(D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) for this NAAQS,
with exception of those portions addressing requirements related to the
PSD permitting program of part C, title I of the CAA in section
110(a)(2)(C), (D)(i)(II), (D)(ii), and (J), which EPA has deemed
incomplete pursuant to 40 CFR part 51, appendix V. This proposed
rulemaking action does not include action on section 110(a)(2)(I) or
portions of section 110(a)(2)(C) referring to the permit program under
part D, title I of the CAA. EPA is soliciting public comments on the
issues discussed in this document which will be considered before
taking final rulemaking action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed 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 proposed rule, pertaining to the District of
Columbia's infrastructure requirements for the 2015 ozone NAAQS under
CAA section 110(a)(2), 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations,

Nitrogen dioxide, Ozone, Volatile organic compounds.

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

    Dated: August 5, 2019.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2019-17667 Filed 8-15-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 9, 2010 (Volume 75, Number 131)]
[Notices]
[Page 39617]
[DOCID:fr09jy10-120]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with part 211 of title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Middletown & Hummelstown Railroad

[Waiver Petition Docket Number FRA-2010-0105]

    The Middletown & Hummelstown Railroad (MIDH) has petitioned FRA for
a waiver of compliance with the requirements of 49 CFR 215.203(a)(1)
``Restricted Cars'' (more than 50 years old) for 2 cars, RPCX 1987 and
CNJ91537. Both of these cars are cabooses built in 1956, and 1942,
respectively. MIDH is also requesting a waiver of compliance with 49
CFR 223.13, ``Glazing requirements for existing cabooses'' because of
the high costs of FRA Type I and Type II Glazing, as opposed to the
very low incidences of vandalism. MIDH operates its own rail line
between Middletown and Hummelstown, Pennsylvania, a distance of
approximately 7 miles. The maximum passenger train speed is 15 mph, and
these cabooses will be used on this trackage.
    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.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2010-0105) 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 45 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 document (or signing the
document, 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;
Page 19477) or at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on July 2, 2010.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2010-16722 Filed 7-8-10; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Page 7168]
[FR Doc No: 2022-02538]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-938-000]

New Market Solar ProjectCo 2, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
New Market Solar ProjectCo 2, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is February 22, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    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 (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: February 1, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-02538 Filed 2-7-22; 8:45 am]
BILLING CODE 6717-01-P


One commenter ( New York et al., @ 2555) stated that there was nothing in the WEPCO decision that implies an intention that physical changes must be of at least the same magnitude as those undertaken by WEPCO to trigger NSR requirements. The commenter argued that although the total cost of the activities at issue in WEPCO may have exceeded 20 percent of each unit's replacement cost, the Court upheld EPA's determination that each of the activities triggered NSR, including the air heater replacements that cost a fraction of the total cost. If the ERP had been applicable, at a minimum those reheater replacements would have been exempt from NSR review. In addition, the EPA compared the total cost of all renovation activities at all process units to the replacement costs of all units to find that the WEPCO replacements totaled 22 29 percent of replacement value. The EPA's analysis would have merit only if it disaggregated its analysis to individual components and individual units, as called for by the ERP. Indeed, it is to be expected that many of the individual projects at issue in WEPCO, taken alone, would have cost less than 20 percent of the replacement value of the particular unit. 80 Response:

We disagree with the commenters that the WEPCO case does not support our selection of a 20 percent replacement value threshold. As we set out in the final ERP rule preamble ( 68 FR 61256), and as discussed in more detail in previous comment responses, the 20 percent threshold is beneath the scope of the activities at issue ( as not constituting RMRR) in the WEPCO case and not inconsistent with the decision made by the Court in that case. Furthermore, we continue to believe that, under the ERP, the equipment replacements at issue in that case would not automatically qualify as being excluded from major NSR.

4.2.11Miscellaneous Objections To the Use of a 20 Percent Replacement Cost Threshold Comment:

One commenter ( New Jersey, @ 2671) believed that if the EPA's replacement value is used along with the 20 percent cost threshold, a 1,000 MW plant would be allowed to incrementally replace components of up to $ 240 million each without being subject to NSR review ( assuming a basis of $ 1,200/ kW). Thus, with 5 projects, a facility can replace an entire 40 year old 1,000 MW power plant without having to install any air pollution controls or undergo air quality impact reviews, regardless of the emission consequences of the replacement.

Response:

An important factor of the ERP is that related activities must be aggregated in the same way as they would have to be aggregated for other NSR applicability purposes. Under our current policy of aggregation, two or more replacement activities that occur at different times are not automatically considered separate activities solely because they happen at different times. In the case of replacing an entire facility, it is not feasible that an owner or operator could successfully argue that multiple projects occurring one after the other are not related to one another and should not be aggregated for applicability purposes. These other rule criteria play an important part in determining what replacements can qualify for the ERP.

Comment:

One commenter ( New Jersey, @ 2671) stated that despite settlements in other NSR violation cases, other companies have been unwilling to settle, or have not followed through on agreements in principle, since the ERP was adopted. The commenter believed that these actions occurred because the type of projects that led to the Consent Decrees fall into the types of activities that may qualify for the equipment replacement exclusion, if applied retroactively. Hence, the commenter argued that significant emission reductions that can be achieved with enforcement of NSR have been slowed with the ERP rule. 81 Response:

As discussed in the final ERP preamble ( 68 FR 61263), as recognized by the U. S. Supreme Court, an agency may not promulgate retroactive rules absent express congressional authority. See Bowen v. Georgetown Univ. Hosp., 488 U. S. 204, 208, 102 L. Ed. 2d 493, 109 S. Ct. 468 ( 1988). The CAA contains no such expressed grant of authority, and we do not intend by our actions today to create retroactive applicability to the ERP. The promulgated ERP applies only to the conduct that occurs after the rule's effective date.

Comment:

One commenter ( New Jersey, @ 2671) pointed out that the EPA stated in the preamble to the final rule that an " additional safeguard is that an excluded replacement activity cannot cause the process unit to exceed any emission limitation or operational limitation ( that has the effect of constraining emissions) that applies to the process unit and that is legally enforceable." In other words, the EPA indicated that under the ERP, facilities will be allowed to make equipment replacements as long as the resulting emissions are not larger than what the permit allows. The commenter compared allowable emission levels of approved Title V permits for 20 industrial facilities, power plants, and refineries in New Jersey with actual emissions for the year 2002 and found that the emission levels allowed by the Title V permits are dramatically higher than the actual emission levels. Thus, allowing facilities to modify equipment to emit at the level specified in a permit, as opposed to the level at which they have actually been emitting, means that there will be a real and potentially enormous increase in actual emissions. By allowing modifications to increase actual emissions to allowable levels, the commenter argued that the ERP could result in significant emission increases and could have significant adverse air quality impacts.

Response:

As discussed more thoroughly in the TSD for the final rule and elsewhere in this TSD, we have analyzed the likelihood of an overall " enormous increase in actual emissions" and found it unlikely, in part due to other CAA programs that require overall reductions in emissions. The commenter's assumption that all sources will emit up to current permit levels is impracticable given the nature of the affected facilities and ignores these programs. Also implicit is the assumption there is sufficient demand to make it economical for all sources to simultaneously maximize operation levels. Neither assumption is sound. To the extent that maintaining a unit's actual emissions at levels far below its permit is necessary for the State's attainment strategy, nothing in the ERP prevents the State from doing so pursuant to its SIP. 82 4.3 Support for the simplified procedure for incorporating a FIP into State plans to accommodate changes to the NSR rules Comment:

Four commenters ( Dominion, @ 2562; Edison Electric Institute, @ 2567; Cinergy Corp., @ 2672; CAA Services Steering Committee, @ 2522) supported EPA's streamlined updates of State plans through a simple cross referencing of the relevant Federal provisions required for States with unapproved PSD programs. This new, straightforward format allows for automatic updates of affected state plans whenever new sections are added to the PSD FIP. The automatic update will eliminate paperwork delays and typographical errors associated with future updates to Federal PSD requirements. One commenter ( CAA Services Steering Committee, @ 2522) believed that it will reduce the potential for confusion when the PSD rules are updated.

Response:

We cross referenced the relevant Federal provisions required for States with unapproved PSD programs to ensure that the relevant Federal provisions were included in updated PSD FIPs in a consistent and efficient manner. United States Office of Air Quality Planning and Standards Publication No. EPA 456/ R 05 003 Environmental Protection Air Quality Strategies and Standards Division June 2005 Agency Research Triangle Park, NC


[Federal Register: October 19, 2009 (Volume 74, Number 200)]
[Notices]
[Page 53492]
[DOCID:fr19oc09-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13301-002-WY]

Town of Afton, Notice of Availability of Environmental Assessment

October 9, 2009.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR Part
380 (Order No. 486, 52 FR 47,897), the Office of Energy Projects has
reviewed the application for a minor license for the Culinary Water
System Hydroelectric Project, and has prepared an Environmental
Assessment (EA). The proposed project would be built on the Culinary
Water Supply System, in the Town of Afton, Lincoln County, Wyoming. The
project would occupy approximately 8 acres of U.S. Forest Service land
in the Bridger-Teton National Forest.
    The EA contains the staff's analysis of the potential environmental
impacts of the project and concludes that licensing the project would
not constitute a major Federal action that would significantly affect
the quality of the human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY,
(202) 502-8659.
    You may also register online at http://www.ferc.gov/
esubscribenow.htm to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support at<EMAIL_ADDRESS>or toll-free
at 1-866-208-3676, or for TTY,<PHONE_NUMBER>.
    Please contact Ryan Hansen by telephone at<PHONE_NUMBER> or by e-
mail at<EMAIL_ADDRESS>if you have any questions.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-25019 Filed 10-16-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Notices]
[Pages 73471-73472]
[FR Doc No: 2012-29650]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 10, 2013, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Caleb Briggs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
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should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss new drug application (NDA)
204042, canagliflozin tablets, proposed trade name INVOCANA, submitted
by Janssen Research and Development, LLC. Canagliflozin is a member of
the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was
developed as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
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posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
December 27, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
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make their presentation on or before December 20, 2012. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by December 21, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the

Agency is not responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at its advisory committee
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    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 4, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-29650 Filed 12-7-12; 8:45 am]
BILLING CODE 4160-01-P


MEMORANDUM

TO:	EPA Docket No. EPA-HQ-OAR-2018-0417

FROM:	Larry Sorrels, Economist
            U.S. EPA/OAQPS/HEID/AEG (C439-02)
Date:		March, 2020
Subject:	Economic and Small Business Impact Analysis for the HCl Production Risk and Technology Review (RTR) NESHAP Final

	This report is the economic impact analysis for the hydrochloric acid (HCl) production risk and technology review (RTR) rule.  This rule is intended as a review of the existing Maximum Achievable Control Technology (MACT) standard promulgated in 2004.  This rule is under a court-ordered schedule for promulgation by March 13, 2020.  The final hazardous air pollutant (HAP) risk assessment for this rule determined that the residual risk from this industry was adequate, thus no additional control is necessary to reduce risk.  The final technology review determined that no new control technologies had become available for HAP reductions since the promulgation of the MACT in 2004. Thus, no new technologies are available to apply for additional HAP control for this RTR.

	This proposal is estimated to yield $10,899 (2016 dollars) in annual cost savings in most years in the course of this analysis due to a reduction in monitoring, recordkeeping, and reporting requirements.   These cost savings are, in present value (PV) terms, equal to $53,690 at a discount rate of 3% and $41,973 at a discount rate of 7%, discounted to 2020.   The equivalent annualized value, which is consistent with the PV estimate, is equal to $7,649 at a discount rate of 3% and $7,029 at a discount rate of 7% (2016 dollars).

	Given the cost savings that are expected with this proposal, no adverse economic impact to the industry is expected.  No small businesses will be impacted, so there is no adverse impact to small businesses.

	Below is a brief profile of the HCl production industry. This industry profile describes the hydrochloric acid production industry, the processes included in production of this chemical and a list of HCl production facilities affected by this proposal. The ultimate parent company for each facility is listed, along with revenues and employment for each company.

1. Hydrochloric Acid Production Industry

1.1 Product and Manufacturing Overview

	Hydrochloric acid is produced largely as an intermediate chemical used in the manufacturing of other chemicals. A gaseous stream enters an absorption tower in which the HCl is absorbed into water or dilute HCl to produce concentrated HCl. Concentrated aqueous HCl is then used on-site for other processes or transported off-site.

2.0 Hydrochloric Acid Production Manufacturing Process

2.1 Overview of Process

	The HCl production process involves the absorption of gaseous HCl into water or aqueous HCl, associated material transfer and loading operations, HCl storage tanks, and other equipment to move the HCl between these points in the process. The process covered by the HCl production NESHAP begins at the point that gaseous HCl enters and absorber and ends at the point where the liquid HCl product produced in the HCl production unit is loaded into a tank truck, rail car, ship, or barge, at the point the HCl product enters another process on the plant site, or at the point the HCl product leaves the plant site via pipeline.

2.2 Process Description: This section describes each of the principal processing steps in the hydrochloric acid production process.

2.2.1 HCl Absorber. The source category begins at the point that a gaseous HCl stream enters an absorber. There are numerous types of processes that produce a gaseous stream containing HCl that is the starting point for an HCl facility (including fume silica production). However, the NESHAP is blind to the type of process that generates the HCl, as the HCl production facility begins at the point where the stream containing HCl enters the absorber. The gaseous HCl stream enters the absorption tower and is absorbed into water or aqueous HCl. The gaseous stream leaving the absorption column contains HCl that was not absorbed into the liquid in the tower and any Cl2 present in the inlet stream. This outlet stream may be routed (or recycled) to another process, in which case it is no longer part of the HCl production affected source. However, if the outlet stream is directly discharged to the atmosphere or if it is routed through other recovery/control devices before being discharged to the atmosphere, it is considered an HCl process vent from an HCl production facility.

2.2.2 HCl Storage, Transfer, and Loading. If the liquid HCl leaving the absorption tower is routed to an HCl storage tank, there is the potential for HCl emissions from the tank. There is also the potential for emissions when HCl is loaded from a storage tank to a tank truck, rail car, ship, or barge. Plants often reduce HCl emissions from HCl storage tanks and HCl transfer operations by using a scrubber.

3.0 Economic Profile of the Hydrochloric Acid Production Industry

      The HCl acid production industry is found in NAICS 325180 (Other Basis Inorganic Chemical Manufacturing) and NAICS 325199 (All Other Basic Organic Chemical Manufacturing).   Most of the affected facilities are in NAICS 325199, which was determined to be unconcentrated with regards to firm concentration as calculated by the Herfindahl-Hirschmann Index (HHI) in a 2013 EPA memo.  The HCl acid production source category includes 19 facilities, a substantial decline (more than 65%) since the 2004 final rule was promulgated. At that time, there were over sixty facilities in the source category. These 19 facilities are owned by 14 different ultimate parent companies, with one facility operating as a joint venture between two parent companies.  No growth in the number of HCl acid production facilities is expected in the next several years.  The EPA collected facility and emissions data for this rulemaking from EPA databases such as the 2014 National Emissions Inventory (NEI), Enforcement and Compliance History Online (ECHO), and state title V permit databases.  Thus, the facility names are consistent with the facility identifications in these EPA databases.  The EPA collected ultimate parent company data from a variety of sources, with the companies' annual reports being the most common.  Most of the affected companies are large, U.S.-owned firms that operate globally.  All revenue and employment data is for 2016.  We note that using updated revenue data will not lead to any difference in impacts as a result of this final rule.

                  Table 1: HCl Production Facility List

Facility Name
Address
Ultimate Parent Company
Revenues (2016 dollars)
Employment (2016)
Arkema Inc.
4444 Industrial Pkwy, Calvert City, KY 42029
Arkema Inc.
$8,314,000,000
19,637
BASF Corp.
2525 S. Kensington Rd., Kankakee, IL 60901
BASF
67,770,550,000
113,830
BASF Corp.  -  Geismar Site
8404 River Rd. (Highway 75), Geismar, LA 70734
BASF

BASF Corporation
1379 Ciba Road, Mcintosh, AL, 36553
BASF

Cabot Corp
700 E. US Highway 36, Tuscola, IL, 61953
Cabot
2,411,000,000
4,500
Dow Chemical Company
901 Loveridge Road, Pittsburg, CA, 94565
DowDuPont
62,484,000,000
98,000
Dow Texas Operations Freeport
2301 N. Brazosport Blvd., Clute, TX 77541
DowDuPont

The Dow Chemical Co.  -  Louisiana Operations
21255 Hwy 1, Plaquemine, LA 70765
Olin Corp.
5,550,600,000
6,400
The Dow Chemical Company U.S.A., Midland
1790 Building, Midland, MI 48674
DowDuPont

Dupont Washington Works
Route 892, Washington, WV 26181
Chemours
5,400,000,000
7,000
E.I. du Pont de Nemours & Co.
4200 Camp Ground Rd., Louisville, KY 40216
Chemours

Evonik Corporation
4201 Evonik Road, Theodore, AL 36582
Evonik Industries AG
14,133,000,000
34,351
Hexion Inc.  -  Norco Facility
16122 River Rd. Lot 3, Norco, LA 70079
Hexion Inc. (controlled by Apollo Global Management, LLC)
3,400,000,000
4,300
Honeywell International Inc.  -  Baton Rouge Plant
Lupine & Ontario, Baton Rouge, LA 70821
Honeywell Inc.
39,302,000,000
131,000
Honeywell International Inc.  -  Geismar Plant
5525 Hwy 3115, Geismar, LA 70734
Honeywell Inc.

Momentive Performance Materials
260 Hudson River Rd., Waterford, NY 12188
MPM Holdings, Inc.
2,200,000,000
4,900
Polymer Additives Inc.
US Rt 130 South, Bridgeport, NJ 08014
Metals and Additives Group

PPG  -  South Plant
PPG Industries, Inc., Barberton, OH 44203
PPG
14,751,000,000
47,000
Rubicon LLC  -  Geismar Plant
9156 Hwy 75, Geismar, LA 70734
Joint venture between Huntsman and Laxness

	None of the ultimate parent companies affected by this final RTR is small according to the Small Business Administration (SBA) size standards applicable to companies in this industry.  The relevant small business size standards are listed in Table 2 below. The vast majority of affected ultimate parent companies are classified in NAICS 325199.

Table 2.  Small Business Size Standards for Companies in HCl Production Industry*

            NAICS Code
NAICS Code Definition
Small Business Size Standards (employees or gross annual revenues)
325180
Other Basic Inorganic Chemical Manufacturing
1,000
325199
All Other Basic Organic Chemical Manufacturing
1,250
*Small Business Size Standards are found at Table of Small Business Size Standards, U.S. SBA, updated October 1, 2017.   Available at https://www.sba.gov/sites/default/files/files/Size_Standards_Table_2017.pdf.

	The references for the data in Table 1 is available in the spreadsheet, "HClProdcutionFinalRTREconomicData.xls."  This spreadsheet is in the docket for this rulemaking.

4.0 Impact Results

	According to the HCl Production RTR cost memo, annualized cost savings are estimated to be $10,899 for most years of compliance (all except years 1 and 2, which will have an estimated cost of less than $4,000 at most).  Therefore, no business will be adversely affected by this final rule over the course of this analysis.  With no small businesses impacted, there are no adverse impacts to small businesses.  There will also be no adverse impacts to consumers of HCl as an intermediate or end-use chemical product, as well.

      In implementing Executive Order 13771, the U.S. Office of Management and Budget has requested agencies calculate the present value (PV) in 2016 of the costs or cost savings of an action using both 7 percent and 3 percent end-of-period discount rates for those actions, including those not economically significant according to Executive Order 12866, subject to the Exec. Order such as this one.  OMB directs this PV be calculated over the full duration of the expected effects of the action.
      For this final rule, an eight-year time period was selected as section 112 of the Clean Air Act requires standards such as this one be reviewed every 8 years.   Given a compliance period of three years from promulgation, compliance costs are calculated with the expectation that costs will be incurred (or savings experienced) beginning in 2020 as this rule is expected to be finalized under court-order by March 13, 2020.  With a 2020 promulgation date early in this year, the 8 years over which these calculations are made cover the years 2020-2027.
      Table 3 below shows the undiscounted stream of costs and costs savings per year, as well as their present values discounted to 2020.  All costs are in 2016 dollars. Costs with a negative sign are cost savings.  There are no changes in capital costs resulting from this final rule.  As shown below, the PV for 2020 at a discount rate of 3% is -$55,301 and -$44,911 at a discount rate of 7%.   Thus, the PV of costs for this proposal is negative under each discount rate (and therefore positive for affected entities).  Thus, the proposal yields a cost savings under a present value calculation in the course of this analysis.
      The cost estimate for this proposal include changes due to the removal of startup, shutdown, and maintenance (SSM) recordkeeping and reporting requirements, introduction of electronic reporting, and a one-time initial cost from review of the proposal requirements by staff at affected facilities.  The impact of these changes is a cost savings each year except for the first year of compliance.
Table 3. Undiscounted Costs, Discounted Costs, and Present Value Analysis for the HCl Production RTR. (2016$)
Year

Undiscounted  (Annual) Cost
Total Discounted Costs

                                   Capital
                                   O&M
                                      3%
                                      7%
2020
                                      $0
                                    $3,965
                                    $3,706
                                      $3,
2021
                                      $0
                                    -$3,711
                                    -$3,498
                                    -$3,241
2022
                                      $0
                                   -$10,899
                                    -$9,974
                                    -$8,897
2023
                                       0
                                   -$10,899
                                    -$9,684
                                    -$8,315
2024
                                       0
                                   -$10,899
                                    -$9,402
                                    -$7,771
2025
                                       0
                                   -$10,899
                                    -$9,128
                                    -$7,262
2026
                                       0
                                   -$10,899
                                    -$8,862
                                    -$6,787
2027
                                       0
                                   -$10,899
                                    -$8,604
                                    -$6,343
2020 Present Value

                                   -$55,341
                                   -$44,911

      Table 4 summarizes the present value of the costs in 2020, accounting for the additional compliance costs to industry, as well as the equivalent annualized values (EAV) over the chosen 8-year time frame. The EAV is the annualized present value of the costs, and is a calculation consistent with the estimate for the PV discounted to 2020. As seen below, the EAV at a discount rate of 3% is -$7,649 and -$7,029 at a discount rate of 7%.   Thus, the EAV of costs for this proposal is negative under each discount rate, and the annualized costs calculated in this way show cost savings.
      All calculations of PV and EAV are documented in the spreadsheet "EO13771 (2020)_HClProductionRTRfinal.xls."   This spreadsheet is found in the docket for this rulemaking.

Table 4.  2020 Present Value of Costs (Savings) and Equivalent Annualized Values for the HCl Production RTR. (2016$)

2020 Present Value of
 Costs
Equivalent Annualized Value of
 Costs
7% Discount Rate
                                   -$44,911
                                    -$7,029
3% Discount Rate
                                   -$55,341
                                    -$7,649