[Federal Register Volume 88, Number 32 (Thursday, February 16, 2023)]
[Rules and Regulations]
[Pages 10024-10032]
[FR Doc No: 2023-01938]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 5, 70, 80, 101, 104, 105, 106, 115, 117, 162, 165, and
174

46 CFR Parts 1, 96, 160, 161, 162, 163, 173, and 178

[Docket No. USCG-2022-0323]

Navigation and Navigable Waters, and Shipping; Technical,
Organizational, and Conforming Amendments

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Final rule.

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SUMMARY: This final rule makes non-substantive technical,
organizational, and conforming amendments to existing Coast Guard
regulations. This rule is a continuation of our practice of
periodically issuing rules to keep our regulations up-to-date and
accurate. This rule will have no substantive effect on the regulated
public.

DATES: This final rule is effective February 16, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0323 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Ms. Victoria Phoenix, Coast

Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I. Abbreviations
II. Regulatory History
III. Basis and Purpose
IV. Discussion of the Rule
V. Regulatory Analyses
    A. Regulatory Planning and Review
    B. Small Entities
    C. Assistance for Small Entities
    D. Collection of Information
    E. Federalism
    F. Unfunded Mandates
    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. Abbreviations

CFR Code of Federal Regulations
CG-ENG Coast Guard Office of Design and Engineering Standards
DHS Department of Homeland Security
FR Federal Register
NVIC Navigation and Vessel Inspection Circular
OMB Office of Management and Budget
OMR Organization Modification Request
Sec.  Section
URL Uniform Resource Locator
U.S.C. United States Code

II. Regulatory History

    We did not publish a notice of proposed rulemaking for this rule.
Under Title 5 of the United States Code (U.S.C.), Section 553(b)(A),
the Coast Guard finds that this final rule is exempt from notice and
public comment rulemaking requirements because these changes involve
rules of agency organization, procedure, or practice. In addition, the
Coast Guard finds that notice and comment procedures are unnecessary
for this final rule under 5 U.S.C. 553(b)(B), as this rule consists of
only technical and editorial corrections and these changes will have no
substantive effect on the public. Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that, for the same reasons, good cause exists for making
this final rule effective upon publication in the Federal Register.

III. Basis and Purpose

    This final rule, which becomes effective on February 16, 2023,
makes technical and editorial corrections throughout titles 33 and 46
of the Code of Federal Regulations (CFR). These changes are necessary
to update authority citations, correct errors, update contact
information, and make other non-substantive amendments that improve the
clarity of the CFR. This rule does not create or change any substantive
requirements.
    This final rule is issued under the authority of 5 U.S.C. 552(a)
and 553; 14 U.S.C. 102 and 503; Department of Homeland Security (DHS)
Delegation No. 00170.1, Revision No. 01.3; and authorities listed at
the end of this rule for each CFR part this rule amends.

IV. Discussion of the Rule

    The Coast Guard periodically issues technical, organizational, and
conforming amendments to existing regulations in titles 33 and 46 of
the CFR. These technical amendments provide the public with accurate
and current regulatory information, but do not change the effect of any
Coast Guard regulations on the public.

A. Authority Citation Updates

    This rule updates the authority citations in 33 CFR parts 101, 104,
105, 106, 117, 162, and 174 and 46 CFR parts 1, 96, 160, 161, 162, 163,
173, and 178. Specifically, this rule implements the updates to DHS
Delegation No. 00170.1, Revision No. 01.3 in 33 CFR parts 101, 104,
105, 106, 117, 162, and 174 and 46 CFR parts 1, 96, 160, 161, 162, 163,
173, and 178. It also reflects the repeal of 46 U.S.C. 5115 by removing
that section from the authority citation for 46 CFR part 163. And this
rule removes the repealed 46 U.S.C. 4104 from the authority citation
for 46 CFR part 162.

B. Technical Amendments to Title 33 of the CFR

    In Sec.  5.9, this rule updates the website at which the public may
obtain copies of the Auxiliary Manual (Commandant Instruction
M16790.1(series)) and the Auxiliary Operations Policy Manual
(Commandant Instruction M16798.3(series)). This rule revises the web
address in this section to ``https://www.dcms.uscg.mil/directives.''
    In Sec. Sec.  70.01-1 and 70.05-20, this rule updates an outdated
cross-reference from 33 CFR part 68 to 33 CFR part 118. This reflects
the redesignation of 33 CFR part 68 (governing bridge lighting and
other signals). On June 11, 1975, the Coast Guard determined that all
bridge regulations be grouped in 33 CFR chapter I, subchapter J,
``Bridges,'' so 33 CFR part 68 was redesignated as 33 CFR part 118.
    In Sec.  80.135, this rule updates a reference to ``Canal
Breakwater Light 4'' in the demarcation lines set by the Convention on
the International Regulations for Preventing Collisions at Sea, 1972
for the Atlantic Coast from Hull, MA, to Race Point, MA. The reference
now reads as ``Canal Breakwater Light 6'' to match the marker that was
redesignated by the project to realign the Aids to Navigation channel.
    In Sec. Sec.  101.105 and 101.510, this rule updates references to
Navigation and Vessel Inspection Circular (NVIC) 09-02. This rule
replaces ``change 2'' in Sec.  101.105 and ``change 3'' in Sec.
101.510 with ``series'' to ensure that the public will always be
directed to the most current version of this circular (which is
currently on change 5). This rule also updates the link for the website
that the public can use to obtain this or other NVICs.
    In Sec. Sec.  104.267, 105.257, and 106.262, this rule replaces the
outdated link provided for the Coast Guard's Homeport website, ``http://homeport.uscg.mil'' with the new link, ``https://homeport.uscg.mil.''
    In Sec.  105.400, this rule removes irrelevant language that
contained a broken website link for submitting facility security plans
electronically. The link provided did not direct the user to a
functioning web page, so both the link and the sentence containing it
were removed.
    In Sec.  115.60(b)(2), this rule modernizes the language to include
email addresses and more closely align regulations with the
requirements for public meetings in 40 CFR 1506.6(b)(3). This rule also
clarifies the Coast Guard's options for publishing and posting notices
of public meetings.
    In Sec.  117.237(b)(2), this rule updates the phone number of the
Harrisburg, PA Dispatcher's Office to ``470-463-1102.''
    In Sec.  117.664, this rule corrects the misspelled ``Rainer'' to
``Ranier.''
    In Sec.  162.75(b)(5)(vi), this rule updates the phone number for
the Captain of the Port, New Orleans to ``504-365-2200 or 504-365-
2545.''
    In Table 5 to Sec.  165.801, this rule replaces ``Riverfront
Marketing Group'' in line 3 with ``Go 4th New Orleans'' to maintain
consistency with a sponsor's submission on form CG-4423, Application
for Approval of Marine Event.
    In Sec.  165.1334, this rule corrects ``BSU'' to ``Base'' in the
section heading to reflect the proper name of the listed Coast Guard
base.
    In Sec.  174.31(c), this rule removes the words ``The payment'' and
adds the words ``Proof of payment'' to clarify and align with the
wording in 46 U.S.C. 12307(2).

C. Technical Amendments to Title 46 of the CFR

    In Sec.  1.01-10(e)(1), this rule replaces the text to reflect
changes brought on by the 2018 Organization Modification Request (OMR).
The 2018 OMR resulted

in changes in which offices are responsible for specific functions,
created the Coast Guard's Flag State Control Division (CG-CVC-4), and
eliminated the Coast Guard's Human Element and Ship Design Division
(CG-ENG-1). This rule's revision of Sec.  1.01-10(e)(1) better defines
the Coast Guard Office of Design and Engineering Standards (CG-ENG) and
align the functional statement with CG-ENG's Strategic Business Plan.
    In Sec.  96.07-5(a), this rule replaces ``shall'' with ``must'' to
fix a grammatical inaccuracy and to follow Federal plain language
guidelines.
    In Sec. Sec.  160.051-5(a), 160.076-11(a), 160.077-5(a), 160.115-
5(a), 160.132-5(a), 160.133-5(a), 160.135-5(a), 160.151-5(a), 160.156-
5(a), 160.170-5(a), and 160.176-4(a), this rule removes outdated
instructions and replaces it with updated locations, websites, and
email addresses. These changes conform to the Office of the Federal
Register's requirements for writing ``incorporation by reference''
sections.
    In Sec. Sec.  161.010-4(a), 162.017-6(a), 162.018-8(a), and
162.050-7(a), this rule corrects a mistake from a previous rulemaking
and replaces ``submitting the VSP electronically'' with ``electronic
submittals.'' ``VSP'' means ``vessel security plan,'' which is
unrelated to approving floating electric water light, safety relief
valve, pressure-vacuum valve, or pollution prevention equipment. In
these same sections, this rule also updates the Uniform Resource
Locator (URL) for submitting vessel security plans electronically to
read as ``https://www.uscg.mil/HQ/MSC.''
    In Sec.  173.095(b) and (d), this rule updates the equation. The
way that the equation is written in the CFR, it is unclear whether the
quantity ``(PxD)'' is to be multiplied by \2/3\ or raised to the power
of \2/3\, so this rule corrects ``\2/3\'' to ``[supcaret]\2/3\''. The
public regularly contacted the Marine Safety Center requesting
clarification on how to calculate the equation. This rule clarifies
that the quantity (PxD) is to be raised to the power of \2/3\.
    In Sec.  178.450(a), this rule corrects the typo ``Basis Drainage''
to ``Basic Drainage'' to help clear confusion for readers and to match
the rest of the text, which uses ``Basic Drainage.''

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or 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.
    One additional Executive order was published to promote the goals
of Executive Order 13610 (Identifying and Reducing Regulatory Burdens).
Executive Order 13610 aims to modernize the regulatory systems and to
reduce unjustified regulatory burdens and costs on the public.
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. A regulatory analysis follows.
    This rule involves non-substantive technical amendments and
internal agency practices and procedures; it will not impose any
additional costs. The technical amendments in this rule fit into
categories that involve (1) correcting inadvertent typographical errors
in the CFR; (2) modifying existing language in the CFR by addition or
subtraction to improve the readability or clarity of regulations; (3)
removing irrelevant information, such as expired regulatory provisions
or cancelled reference material, and replacing outdated regulatory
information with current information where applicable; and (4) revising
office contact information and mailing addresses. The Coast Guard does
not expect that there will be any additional costs conferred on the
public or the Federal Government because none of the technical and
editorial changes included in this rule will change existing regulatory
requirements. A summary of these amendments by category and by CFR
title and section are presented below in table 1.
    The unquantified benefits of the non-substantive technical
amendments are increased accuracy of regulatory information by
correcting erroneous information, and improved readability and clarity
of regulations by removing redundant or confusing language and by
removing expired or cancelled provisions that are no longer relevant.
In addition, correcting technical items such as office contact details
and location coordinates will improve the ability to reference and
contact the correct entities.

     Table 1--Summary of Regulatory Changes by CFR Title and Section
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                                     Description of
   CFR title       CFR section           changes        Economic impact
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33............  Sec.  Sec.         Adds clarifying     Improves
                 70.01-1, 70.05-    language and        readability and
                 20, 80.135(b),     removes             clarity of
                 115.60(b)(2).      redundant,          regulations.
                                    confusing, or
                                    incorrect
                                    language.
46............  Sec.  Sec.         Adds clarifying     Improves
                 96.07-5(a),        language and        readability and
                 161.010-4(a).      removes             clarity of
                                    redundant,          regulations.
                                    confusing, or
                                    incorrect
                                    language.
46............  Sec.  Sec.         Removes outdated    Conforms to the
                 160.051-5(a),      instructions and    Office of the
                 160.076-11(a),     replaces it with    Federal
                 160.077-5(a),      updated             Register's
                 160.115-5(a),      locations,          requirements for
                 160.132-5(a),      websites, and       wording
                 160.133-5(a),      email addresses.    centralized
                 160.135-5(a),                          sections for
                 160.151-5(a),                          incorporation by
                 160.156-5(a),                          reference.
                 160.170-5(a),
                 160.176-4(a).
33............  Sec.  Sec.         Improves the        Corrects various
                 117.664,           accuracy of         typographical
                 165.1334,          regulatory          errors.
                 174.31(c).         information by
                                    correcting
                                    erroneous
                                    information.

46............  Sec.   173.095(b)  Improves the        Corrects various
                 and (d).           accuracy of         typographical
                                    regulatory          errors. And,
                                    information by      reduces the
                                    correcting          public from
                                    erroneous           contacting the
                                    information         Marine Safety
                                    concerning an       Center
                                    equation.           requesting
                                                        clarification on
                                                        how to calculate
                                                        the equation.
33............  Sec.   165.801     Removes or          Improves
                 Table 5, Row 3.    replaces expired    readability by
                                    or cancelled        removing or
                                    references or       replacing
                                    provisions.         irrelevant and
                                                        outdated
                                                        information.
46............  Sec.   1.01-       Reflects changes    Improves
                 10(e)(1).          brought on by the   readability by
                                    2018 Organization   removing or
                                    Modification        replacing
                                    Request (OMR).      irrelevant and
                                                        outdated
                                                        information.
46............  Sec.  Sec.         Removes or          Improves
                 162.017-6(a),      replaces expired    readability by
                 162.018-8(a),      or cancelled        removing or
                 162.050-7(a).      references or       replacing
                                    provisions.         irrelevant and
                                                        outdated
                                                        information.
------------------------------------------------------------------------

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.
    Therefore, 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.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996, Public Law 104-121, we offer to assist small
entities in understanding this rule so that they can better evaluate
its effects on them and participate in the rulemaking. 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 or revised 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 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 Executive Order 13132 and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.

F. Unfunded Mandates

    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. Although this rule will not result
in such expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

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 will not create an
environmental risk to health or risk to safety that might
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 will 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.

L. Technical Standards

    The National Technology Transfer and Advancement Act, codified as a
note to 15 U.S.C. 272, directs agencies to use voluntary consensus
standards in their regulatory activities unless the agency provides
Congress, through OMB, 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 DHS Management Directive 023-01,
Rev. 1, associated implementing instructions, and Environmental
Planning COMDTINST 5090.1 (series),

which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a determination that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. A Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble. This
rule is categorically excluded under paragraph L54 of Appendix A, Table
1 of DHS Instruction Manual 023-01-001-01, Rev 1. Paragraph L54
pertains to regulations which are administrative or procedural, such as
those updating addresses or establishing application procedures. This
rule involves making non-substantive technical, organizational, and
conforming amendments to existing Coast Guard regulations to keep our
regulations up-to-date and accurate.

List of Subjects

33 CFR Part 5

    Volunteers.

33 CFR Part 70

    Navigation (water), Penalties.

33 CFR Part 80

    Navigation (water), Treaties, Waterways.

33 CFR Part 101

    Harbors, Maritime security, Reporting and recordkeeping
requirements, Security measures, Vessels, Waterways.

33 CFR Part 104

    Maritime security, Reporting and recordkeeping requirements,
Security measures, Vessels.

33 CFR Part 105

    Maritime security, Navigation (water), Reporting and recordkeeping
requirements, Security measures, Waterways.

33 CFR Part 106

    Continental shelf, Maritime security, Reporting and recordkeeping
requirements, Security measures.

33 CFR Part 115

    Administrative practice and procedure, Bridges, Reporting and
recordkeeping requirements.

33 CFR Part 117

    Bridges.

33 CFR Part 162

    Navigation (water), Waterways.

33 CFR Part 165

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

33 CFR Part 174

    Intergovernmental relations, Marine safety, Reporting and
recordkeeping requirements.

46 CFR Part 1

    Administrative practice and procedure, Organization and functions
(Government agencies), Reporting and recordkeeping requirements.

46 CFR Part 96

    Cargo vessels, Marine safety, Navigation (water).

46 CFR Part 160

    Incorporation by reference, Marine safety, Reporting and
recordkeeping requirements.

46 CFR Part 161

    Fire prevention, Marine safety, Reporting and recordkeeping
requirements.

46 CFR Part 162

    Fire prevention, Marine safety, Oil pollution, Reporting and
recordkeeping requirements.

46 CFR Part 163

    Marine safety.

46 CFR Part 173

    Marine safety, Vessels.

46 CFR Part 178

    Marine safety, Passenger vessels.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 5, 70, 80, 101, 104, 105, 106, 115, 117, 162, 165, and 174
and 46 CFR parts 1, 96, 160, 161, 162, 163, 173, and 178 as follows:

Title 33--Navigation and Navigable Waters

PART 5--COAST GUARD AUXILIARY

0
1. The authority citation for part 5 continues to read as follows:

    Authority: 14 U.S.C. 503, 3901, 3902, 3903, 3904, 3905, 3907,
3908, 3909, 3910, 3911, 3912, 3913, 4102.

Sec.  5.9   [Amended]

0
2. In Sec.  5.9, remove the text ``http://www.uscg.mil/auxiliary/publications/comdtinst/'' and add, in its place, the text ``https://www.dcms.uscg.mil/directives''.

PART 70--INTERFERENCE WITH OR DAMAGE TO AIDS TO NAVIGATION

0
3. The authority citation for part 70 continues to read as follows:

    Authority: 33 U.S.C. 408, 411, 412; 14 U.S.C. 501, 503, 543,
545, 546.

Sec.  70.01-1   [Amended]

0
4. In Sec.  70.01-1, remove the text ``67, or 68 of this subchapter''
and add, in its place, the text ``67, or 118 of this chapter''.

Sec.  70.05-20   [Amended]

0
5. In Sec.  70.05-20, remove the text ``Part 64, 66, 67, or 68 of this
subchapter'' and ``46 CFR 4'' and add, in their places, the text ``part
64, 66, 67, or 118 of this chapter'' and ``46 CFR part 4'',
respectively.

PART 80--COLREGS DEMARCATION LINES

0
6. The authority citation for part 80 continues to read as follows:

    Authority: 14 U.S.C. 102, 503; 33 U.S.C. 151(a).

Sec.  80.135  [Amended]

0
7. In Sec.  80.135(b), remove the text ``Light 4'' and add, in its
place, the text ``Light 6''.

PART 101--MARITIME SECURITY: GENERAL

0
8. The authority citation for part 101 is revised to read as follows:

    Authority: 46 U.S.C. 70034, 70051, 70052, Chapter 701; E.O.
12656, 53 FR 47491, 3 CFR, 1988 Comp., p. 585; 33 CFR 1.05-1, 6.04-
11, 6.14, 6.16, and 6.19; DHS Delegation No. 00170.1, Revision No.
01.3.

Sec.  101.105  [Amended]

0
9. In Sec.  101.105, amend the definition of ``Area Maritime Security
(AMS) Committee'' as follows:
0
a. Remove the text ``change 2'' and add, in its place, the text
``series''; and
0
b. Remove the text ``http://www.uscg.mil/hq/cg5/nvic/'' and add, in its
place, the text ``https://www.dco.uscg.mil/Our-Organization/NVIC/''.

Sec.  101.510  [Amended]

0
10. Amend Sec.  101.510 as follows:
0
a. In the introductory text, remove the text ``http://www.uscg.mil/hq/
g-m/nvic'' and add, in its place, the text ``https://www.dco.uscg.mil/
Our-Organization/NVIC/''; and
0
b. In paragraph (a), remove the text ``change 3'' and add, in its
place, the text ``series''.

PART 104--MARITIME SECURITY: VESSELS

0
11. The authority citation for part 104 is revised to read as follows:

    Authority: 46 U.S.C. 70051, 70116, Chapter 701; 33 CFR 1.05-1,
6.04-11, 6.14, 6.16, and 6.19; DHS Delegation No. 00170.1, Revision
No. 01.3.

Sec.  104.267   [Amended]

0
12. In Sec.  104.267(b)(2) introductory text, remove the text ``http://homeport.uscg.mil'' and add, in its place, the text ``https://homeport.uscg.mil''.

PART 105--MARITIME SECURITY: FACILITIES

0
13. The authority citation for part 105 is revised to read as follows:

    Authority:  46 U.S.C. 70034, 70103, 70116; sec. 811, Pub. L.
111-281, 124 Stat. 2905 (46 U.S.C. 70103 note); 33 CFR 1.05-1, 6.04-
11, 6.14, 6.16, and 6.19; DHS Delegation No. 00170.1, Revision No.
01.3.

Sec.  105.257   [Amended]

0
14. In Sec.  105.257(b)(2) introductory text, remove the text ``http://homeport.uscg.mil'' and add, in its place, the text ``https://homeport.uscg.mil''.

Sec.  105.400  [Amended]

0
15. In Sec.  105.400(b), remove the second sentence.

PART 106--MARINE SECURITY: OUTER CONTINENTAL SHELF (OC) FACILITIES

0
16. The authority citation for part 106 is revised to read as follows:

    Authority: 46 U.S.C. 70051, 70116, Chapter 701; 33 CFR 1.05-1,
6.04-11, 6.14, 6.16, and 6.19; DHS Delegation No. 00170.1, Revision
No. 01.3.

Sec.  106.262  [Amended]

0
17. In Sec.  106.262(b)(2) introductory text, remove the text ``http://homeport.uscg.mil'' and add, in its place, the text ``https://homeport.uscg.mil''.

PART 115--BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE
PROCEDURES

0
18. The authority citation for part 115 continues to read as follows:

    Authority: c. 425, sec. 9, 30 Stat. 1151 (33 U.S.C. 401); c.
1130, sec. 1, 34 Stat. 84 (33 U.S.C. 491); sec. 5, 28 Stat. 362, as
amended (33 U.S.C. 499); sec. 11, 54 Stat. 501, as amended (33
U.S.C. 521); c. 753, title V, sec. 502, 60 Stat. 847, as amended (33
U.S.C. 525); 86 Stat. 732 (33 U.S.C. 535); 14 U.S.C. 503.

0
19. In Sec.  115.60, revise paragraph (b)(2) to read as follows:

Sec.  115.60  Procedures for handling applications for bridge permits.

* * * * *
    (b) * * *
    (2) Notice of the public meeting will be published in the Federal
Register. Notice of the meeting is also emailed or mailed to State,
county, municipal authorities, and all other known interested parties.
It may also be posted in public places in the vicinity of the project
or published in local publications and through local media channels, or
both.
* * * * *

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
20. The authority citation for part 117 is revised to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No.
00170.1, Revision No. 01.3.

Sec.  117.237  [Amended]

0
21. In Sec.  117.237(b)(2), remove the text ``(717) 541-2140'' and add,
in its place, the text ``470-463-1102''.

Sec.  117.664  [Amended]

0
22. In Sec.  117.664, remove the word ``Rainer'' and add, in its place,
the word ``Ranier''.

PART 162--INLAND WATERWAYS NAVIGATION REGULATIONS

0
23. The authority citation for part 162 is revised to read as follows:

    Authority: 46 U.S.C. 70034; DHS Delegation No. 00170.1, Revision
No. 01.3.

Sec.  162.75  [Amended]

0
24. In Sec.  162.75(b)(5)(vi), remove the text ``504-846-5923'' and
add, in its place, the text ``504-365-2200 or<PHONE_NUMBER>''.

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
26. In Sec.  165.801, revise row 3 in table 5 to read as follows:

Sec.  165.801  Annual fireworks displays and other events in the Eighth
Coast Guard District requiring safety zones.

* * * * *

   Table 5 of Sec.   165.801--Sector New Orleans Annual and Recurring
                              Safety Zones
------------------------------------------------------------------------
                                          Sector New
        Date           Sponsor/name    Orleans location    Safety zone
------------------------------------------------------------------------

                              * * * * * * *
3. July 4th........  Go 4th New        Mississippi       Mississippi
                      Orleans/          River, New        River mile
                      Independence      Orleans, LA.      marker 94.3 to
                      Day Celebration.                    95.3, New
                                                          Orleans, LA.

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

* * * * *

Sec.  165.1334   [Amended]

0
27. In Sec.  165.1334, the heading is amended by removing the text
``BSU'' and adding, in its place, the text ``Base''.

PART 174--STATE NUMBERING AND CASUALTY REPORTING SYSTEMS

0
28. The authority citation for part 174 is revised to read as follows:

    Authority: 46 U.S.C. 6101 and 12302; DHS Delegation No. 00170.1,
Revision No. 01.3.

Sec.  174.31   [Amended]

0
29. In Sec.  174.31(c), remove the words ``The payment'' and add, in
its place, the words ``Proof of payment''.

Title 46--Shipping

PART 1--ORGANIZATION, GENERAL COURSE AND METHODS GOVERNING MARINE
SAFETY FUNCTIONS

0
30. The authority citation for part 1 is revised to read as follows:

    Authority: 5 U.S.C. 552; 6 U.S.C. 111, 468, 552; 14 U.S.C. 503;
46 U.S.C. 7701; 46 U.S.C. Chapter 93; DHS Delegation No. 00170.1,
Revision No. 01.3; Sec.  1.01-35 also issued under the authority of
44 U.S.C. 3507; and Sec.  1.03-55 also issued under the authority of
46 U.S.C. 3306(j).

0
31. In Sec.  1.01-10, revise paragraph (e)(1) to read as follows:

Sec.  1.01-10   Organization.

* * * * *
    (e) * * *
    (1) The Chief, Office of Design and Engineering Standards (CG-ENG),
at Headquarters, under the direction of the Assistant Commandant for
Prevention Policy (CG-5P) and the Director of Commercial Regulations
and Standards (CG-5PS), develops and maintains national regulations and
standards that govern the safe design, engineering, and construction of
ships and shipboard equipment; establishes policy, provides technical
clarifications, and resolves appeals; and represents the United States
at the International Maritime Organization (IMO) and is actively
engaged in standards committees and classification society rules
committees in support of marine safety, security and environmental
stewardship.
* * * * *

PART 96--VESSEL CONTROL AND MISCELLANEOUS SYSTEMS AND EQUIPMENT

0
32. The authority citation for part 96 is revised to read as follows:

    Authority:  46 U.S.C. 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980
Comp., p. 277; DHS Delegation No. 00170.1, Revision No. 01.3.

Sec.  96.07-5   [Amended]

0
33. In Sec.  96.07-5(a), remove the text ``shall'' and ``Subpart 90.35
of this subchapter'' and add, in their places, the text ``must'' and
``46 CFR part 90, subpart 90.35'', respectively.

PART 160--LIFESAVING EQUIPMENT

0
34. The authority citation for part 160 is revised to read as follows:

    Authority: 46 U.S.C. 2103, 3103, 3306, 3703, 4102, 4302, and
4502; and DHS Delegation No. 00170.1, Revision No. 01.3.

0
35. In Sec.  160.051-5, revise paragraph (a) to read as follows:

Sec.  160.051-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the source in the following paragraph of this
section.
* * * * *

0
36. In Sec.  160.076-11, revise paragraph (a) to read as follows:

Sec.  160.076-11  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the source in the following paragraph of this
section.
* * * * *

0
37. In Sec.  160.077-5, revise paragraph (a) to read as follows:

Sec.  160.077-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the sources in the following paragraphs of this
section.
* * * * *

0
38. In Sec.  160.115-5, revise paragraph (a) to read as follows:

Sec.  160.115-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the source in the following paragraph of this
section.
* * * * *

0
39. In Sec.  160.132-5, revise paragraph (a) to read as follows:

Sec.  160.132-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the

sources in the following paragraphs of this section.
* * * * *

0
40. In Sec.  160.133-5, revise paragraph (a) to read as follows:

Sec.  160.133-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the sources in the following paragraphs of this
section.
* * * * *

0
41. In Sec.  160.135-5, revise paragraph (a) to read as follows:

Sec.  160.135-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the sources in the following paragraphs of this
section.
* * * * *

0
42. In Sec.  160.151-5, revise paragraph (a) to read as follows:

Sec.  160.151-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the sources in the following paragraphs of this
section.
* * * * *

0
43. In Sec.  160.156-5, revise paragraph (a) to read as follows:

Sec.  160.156-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the sources in the following paragraphs of this
section.
* * * * *

0
44. In Sec.  160.170-5, revise paragraph (a) to read as follows:

Sec.  160.170-5  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the sources in the following paragraphs of this
section.
* * * * *

0
45. In Sec.  160.176-4, revise paragraph (a) to read as follows:

Sec.  160.176-4  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at Coast Guard
Headquarters and at the National Archives and Records Administration
(NARA). Contact the Coast Guard at: Commandant (CG-ENG-4), U.S. Coast
Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC
20593-7509; or email [email protected] or visit https://www.dco.uscg.mil/CG-ENG-4/. For information on the availability of this
material at NARA, email: [email protected], or go to:
www.archives.gov/federal-register/cfr/ibr-locations.html. The material
may be obtained from the sources in the following paragraphs of this
section.
* * * * *

PART 161--ELECTRICAL EQUIPMENT

0
46. The authority citation for part 161 is revised to read as follows:

    Authority: 46 U.S.C. 3306, 3703, 4302; E.O. 12234, 45 FR 58801,
3 CFR, 1980 Comp., p. 277; DHS Delegation No. 00170.1, Revision No.
01.3.

Sec.  161.010-4  [Amended]

0
47. In Sec.  161.010-4(a), remove the text ``submitting the VSP
electronically'' and ``http://www.uscg.mil/HQ/MSC'' and add, in their
places, the text ``electronic submittals'' and ``https://www.uscg.mil/HQ/MSC'', respectively.

PART 162--ENGINEERING EQUIPMENT

0
48. The authority citation for part 162 is revised to read as follows:

    Authority: 33 U.S.C. 1321(j), 1903; 46 U.S.C. 3306, 3703, 4302;
E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56
FR 54757, 3 CFR, 1991 Comp., p. 351; DHS Delegation No. 00170.1,
Revision No. 01.3.

Sec.  162.017-6  [Amended]

0
49. In Sec.  162.017-6(a), remove the text ``submitting the VSP
electronically'' and ``http://www.uscg.mil/HQ/MSC'' and

add, in their places, the text ``electronic submittals'' and ``https://www.uscg.mil/HQ/MSC'', respectively.

Sec.  162.018-8  [Amended]

0
50. In Sec.  162.018-8(a), remove the text ``submitting the VSP
electronically'' and ``http://www.uscg.mil/HQ/MSC'' and add, in their
places, the text ``electronic submittals'' and ``https://www.uscg.mil/HQ/MSC'', respectively.

Sec.  162.050-7  [Amended]

0
51. In Sec.  162.050-7(a), remove the text ``submitting the VSP
electronically'' and ``http://www.uscg.mil/HQ/MSC'' and add, in their
places, the text ``electronic submittals'' and ``https://www.uscg.mil/HQ/MSC'', respectively.

PART 163--CONSTRUCTION

0
52. The authority citation for part 163 is revised to read as follows:

    Authority: 46 U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR,
1980 Comp., p. 277; DHS Delegation No. 00170.1, Revision No. 01.3.

PART 173--SPECIAL RULES PERTAINING TO VESSEL USE

0
53. The authority citation for part 173 is revised to read as follows:

    Authority: 43 U.S.C. 1333; 46 U.S.C. 2113, 3306, 5115; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; DHS Delegation No.
00170.1, Revision No. 01.3.

0
54. In Sec.  173.095, revise the equations in paragraphs (b) and (d) to
read as follows:

Sec.  173.095  Towline pull criterion.

* * * * *
    (b) * * *
    [GRAPHIC] [TIFF OMITTED] TR16FE23.015

* * * * *

PART 178--INTACT STABILITY AND SEAWORTHINESS

0
55. The authority citation for part 178 is revised to read as follows:

    Authority: 43 U.S.C. 1333; 46 U.S.C. 2103, 3306, 3703; E.O.
12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; DHS Delegation No.
00170.1, Revision No. 01.3.

Sec.  178.450   [Amended]

0
56. In Sec.  178.450(a), remove the text ``Basis Drainage'' and add, in
its place, the text ``Basic Drainage''.

    Dated: January 25, 2023.
Michael Cunningham,
Chief, Office of Regulations and Administrative Law.
[FR Doc. 2023-01938 Filed 2-15-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Proposed Rules]
[Pages 48780-48781]
[FR Doc No: 2017-22706]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2017-0157; FRL-9969-86-Region 5]

Air Plan Approval; Wisconsin; Regional Haze Progress Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the regional haze progress report under the Clean Air Act as a
revision to the Wisconsin State Implementation Plan (SIP). Wisconsin
has satisfied the progress report requirements of the Regional Haze
Rule. Wisconsin has also met the requirements for a determination of
the adequacy of its regional haze plan with its negative declaration
submitted with the progress report.

DATES: Comments must be received on or before November 20, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2017-0157 at http://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: Gilberto Alvarez, Environmental
Scientist, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West
Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the

remainder of the rule, EPA may adopt as final those provisions of the
rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the Rules
section of this Federal Register.

     Dated: October 10, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-22706 Filed 10-19-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Rules and Regulations]
[Pages 17369-17372]
[FR Doc No: 2023-05632]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0999; Airspace Docket No. 22-AWA-2]
RIN 2120-AA66

Amendment of Class C Airspace; Chicago, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Chicago, IL, Class C airspace area
surrounding the Chicago Midway International Airport, IL (MDW), by
extending the existing Class C airspace shelf within 10 nautical miles
(NM) of MDW from the southeast counterclockwise to the northeast. The
FAA is taking this action to reduce the risk of midair collisions and
enhance the efficient management of air traffic operations in the MDW
terminal area.

DATES: Effective date 0901 UTC, June 15, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: A copy of the NPRM, all comments received, this final rule,
and all background material may be viewed online at www.regulations.gov
using the FAA Docket number. Electronic retrieval help and guidelines
are available on the website. It is available 24 hours each day, 365
days each year. An electronic copy of this document may also be
downloaded from the Office of the Federal Register's website at
www.federalregister.gov.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the Class C airspace surrounding MDW to reduce
the potential for midair collisions and enhance the management of air
traffic in the terminal area as necessary to preserve the safe and
efficient flow of air traffic within the National Airspace System
(NAS).

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2022-0999 in the Federal Register (87 FR 64737; October 26, 2022)
proposing to modify the Class C airspace area surrounding MDW.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal. Two comments
were received.

Discussion of Comments

    The first commenter, the Airline Pilots Association (ALPA),
affirmed their support for the new MDW Class C airspace design. They
also commented against any proposals the FAA may receive aiming to
raise the proposed Class C airspace floor over Lake Michigan above
2,300 feet mean sea level (MSL). In their concern, they cited such a
proposed action may result in increased Traffic Collision Avoidance
System (TCAS) Resolution Advisory (RA) events, unstable and/or missed
approaches, near midair collisions (NMAC), or midair collisions between
commercial and general aviation aircraft.
    The FAA appreciates ALPA's support for the new MDW Class C airspace
design. To their comment associated with any proposals submitted to the
FAA aiming to raise the Class C airspace floor over Lake Michigan, no
comments or proposals addressing that concern were received. Further,
the FAA is not considering any amendment to the Class C airspace design
that was proposed in the NPRM published in the Federal Register of
October 26, 2022.
    The second commenter, the Aircraft Owners and Pilots Association
(AOPA), was supportive of the proposed change. In addition, AOPA
commented that changes were needed to the Letter of Agreement (LOA)
between Chicago Terminal Radar Approach Control (TRACON) and Midway
Airport Traffic Control Tower (ATCT) regarding visual approaches to
Runway 22L. They referenced the FAA's response to a pre-NPRM Ad Hoc
Committee recommendation which stated the aforementioned LOA currently
required that IFR aircraft conducting visual approaches to Runway 22L
must only maintain 2,500 feet MSL until contacting the MDW ATCT. AOPA's
concern was that the altitude constraint could easily lead to IFR
aircraft crossing the Chicago lakefront VFR flyway only 200 feet above
the proposed 2,300-foot Class C floor and result in possible wake
turbulence issues, loss of separation, or more frequent TCAS RAs. AOPA
acknowledged Runway 22L visual approaches are rarely used but believed
the FAA should alter the LOA to require IFR aircraft conducting Runway
22L visual approaches to remain at or above 3,000 feet AGL until
reaching the Chicago lakefront (or until reaching the DXXON waypoint).
    The FAA appreciates AOPA's support and offers the following to
their comment. In response to AOPA's comment with respect to requiring
IFR aircraft conducting Runway 22L visual approaches to remain at or
above 3,000 feet MSL until reaching the Chicago lakefront or the DXXON
waypoint, the FAA revisited the Ad Hoc Committee's recommendation on
the same requirement for aircraft flying visual approaches to Runway
22L from the east. The FAA reconsidered the Ad Hoc Committee's
recommendation and AOPA's request for IFR aircraft conducting Runway
22L visual approaches to remain at or above 3,000 feet MSL until the
Chicago lakefront or DXXON waypoint. After reconsideration of the
recommendation and the request, the FAA agrees and will support the
requested altitude requirement, to the maximum extent possible, for
visual approaches flown to Runway 22L from the east.
    The transfer of communications and control point from the Chicago
TRACON to the MDW ATCT for IFR aircraft inbound to MDW Runway 22L from
the east, whether on an instrument or visual approach, is over land
beyond the Chicago lakefront VFR flyway and the DXXON waypoint. As
such, IFR aircraft inbound to MDW Runway 22L remain under Chicago
TRACON's control until after they pass the Chicago lakefront VFR flyway
or DXXON waypoint. As an alternative to AOPA's request to update the
LOA between Chicago TRACON and MDW ATCT, the

FAA determined that documenting the operational guidance for keeping
IFR aircraft flying visual approaches to MDW Runway 22L from the east
at or above 3,000 feet MSL would be better located in Chicago TRACON's
operating procedures. Therefore, the existing LOA between Chicago
TRACON and MDW ATCT will not be amended as requested.
    Additionally, visual approaches are never advertised as the
approach in use at MDW and all IFR aircraft arriving from the east are
sequenced on the final approach course for the Area Navigation (RNAV)
approaches when Runway 22L is the active runway. Should an IFR pilot
established on the Runway 22L final approach course from the east
report visual contact with MDW and request a visual approach, Chicago
TRACON controllers would issue an altitude restriction of 3,000 feet
MSL until reaching the DXXON waypoint, then clear the aircraft for the
visual approach as a routine practice. However, in the event of
emergency situations or safety of flight requirements, the Chicago
TRACON may require IFR aircraft to operate at other Class C airspace
altitudes as the situation requires.

Incorporation by Reference

    Class C airspace designations are published in paragraph 4000 of
FAA Order JO 7400.11, Airspace Designations and Reporting Points, which
is incorporated by reference in 14 CFR 71.1 on an annual basis. This
document amends the current version of that order, FAA Order JO
7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA
Order JO 7400.11G is publicly available as listed in the ADDRESSES
section of this document. This amendment will be published in the next
update to FAA Order JO 7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by modifying the Chicago, IL,
Class C airspace surrounding MDW by extending the airspace shelf
further around the airport on the east side to end northeast of the
airport. This amendment enhances flight safety in the MDW terminal area
(see the attached chart).
    The current Chicago, IL, Class C airspace consists of two
concentric circles, a surface area and an airspace shelf, centered on
the MDW airport reference point: (1) that airspace extending upward
from the surface to 3,600 feet MSL within a 5 NM radius of the airport;
and (2) that airspace extending upward from 1,900 feet MSL to 3,600
feet MSL between 5 NM and 10 NM from 2-miles northeast of and parallel
to the MDW RWY 31C localizer course southeast of the airport, clockwise
to the Chicago O'Hare Class B airspace area northwest of the airport.
The Class C airspace area excludes the airspace within the adjacent
Chicago, IL, Class B airspace area.
    This action modifies the Chicago, IL, Class C airspace area by
extending the existing airspace shelf between 5 NM and 10 NM further
around MDW on the east side from the existing boundary located 2 NM
northeast of and parallel to the MDW RWY 31C localizer course to a new
boundary defined by the 090[deg] bearing of the intersection of the 10-
mile radius around the Chicago O'Hare International Airport and the 5-
mile radius around MDW. The new Class C airspace shelf extends from the
Chicago Class B airspace located northwest of MDW counterclockwise
around MDW to a boundary slightly south of Interstate 290 located
northeast of MDW and includes the airspace over Chicago and Lake
Michigan between 5 NM and 10 NM of MDW. The portion of the Class C
airspace shelf over land retains the existing airspace shelf altitudes
extending upward from 1,900 feet MSL to 3,600 feet MSL and the portion
of the Class C airspace shelf over Lake Michigan extends upward from
2,300 feet MSL to 3,600 feet MSL. The exclusion of the airspace within
the Chicago, IL, Class B airspace area is retained.
    This modified Class C airspace shelf enhances flight safety in the
MDW terminal area by encompassing the MDW RNAV RWY 22L approaches for
IFR aircraft, retaining the VFR flyway along the Lake Michigan
shoreline outside Class C airspace for VFR pilots that elect not to
communicate with ATC and fly within the Class C airspace, and
preserving the VFR sightseeing operations north of Interstate 290
without impact.

Regulatory Notices and Analyses

    Federal agencies consider impacts of regulatory actions under a
variety of executive orders and other requirements. First, Executive
Order 12866 and Executive Order 13563 direct that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). The current threshold after adjustment for inflation is
$165,000,000, using the most current (2021) Implicit Price Deflator for
the Gross Domestic Product. This portion of the preamble summarizes the
FAA's analysis of the economic impacts of this final rule.
    In conducting these analyses, the FAA determined that this final
rule: will result in minimal cost; is not an economically ``significant
regulatory action'' as defined in section 3(f) of Executive Order
12866; will not have a significant economic impact on a substantial
number of small entities; will not create unnecessary obstacles to the
foreign commerce of the United States; and will not impose an unfunded
mandate on State, local, or tribal governments, or on the private
sector. These analyses are summarized below.
    As discussed above, the FAA determined that changes put forth in
this rule will increase airspace safety with minimal cost impact. The
final rule extends the Class C airspace area surrounding MDW Airport to
reduce the risk of midair collisions and enhance the efficient
management of air traffic operations in the MDW terminal area. The
costs of the rule are the value of resources needed to comply with the
airspace changes. In this case, VFR pilots desiring to fly at their
current altitudes within the proposed Class C airspace are required to
establish two-way communications with ATC. VFR pilots flying in the
vicinity of MDW are likely equipped for this communication and as such
this change would involve only minimal time for awareness and planning.
The FAA also does not anticipate increased staffing needs. Therefore,
costs are likely minimal.

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that

agencies shall endeavor, consistent with the objectives of the rule and
of applicable statutes, to fit regulatory and informational
requirements to the scale of the businesses, organizations, and
governmental jurisdictions subject to regulation.'' To achieve this
principle, agencies are required to solicit and consider flexible
regulatory proposals and to explain the rationale for their actions to
assure that such proposals are given serious consideration.'' The RFA
covers a wide range of small entities, including small businesses, not-
for-profit organizations, and small governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
However, if an agency determines that a rule is not expected to have a
significant economic impact on a substantial number of small entities,
section 605(b) of the RFA provides that the head of the agency may so
certify and a regulatory flexibility analysis is not required. The
certification must include a statement providing the factual basis for
this determination, and the reasoning should be clear.
    The final rule amends 14 CFR part 71 by modifying the Chicago, IL,
Class C airspace area to extend the airspace shelf around MDW further
around the airport on the east side to end northeast of the airport.
The FAA is taking this action to reduce the risk of midair collisions
and enhance the efficient management of air traffic operations in the
MDW terminal area. The rule will affect VFR pilots desiring to fly at
their current altitudes within the proposed Class C airspace. These
pilots will need to establish two-way communications with ATC; however,
they are likely equipped for this communication and as such this change
would involve only minimal time for awareness and planning. The final
rule results in a minimal economic impact on small entities. Therefore,
as provided in section 605(b), the head of the FAA certifies that this
rulemaking does not result in a significant economic impact on a
substantial number of small entities.

International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such as the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this final rule and determined that it
should improve safety and is consistent with the Trade Agreements Act.

Unfunded Mandates Assessment

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
governs the issuance of Federal regulations that require unfunded
mandates. An unfunded mandate is a regulation that requires a state,
local, or tribal government or the private sector to incur direct costs
without the Federal government having first provided the funds to pay
those costs. The FAA determined that the proposed rule will not result
in the expenditure of $165,000,000 or more by State, local, or tribal
governments, in the aggregate, or the private sector, in any one year.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA determined that there
is no new information collection requirement associated with this
proposed rule.

Environmental Review

    The FAA determined that this action of amending the Chicago, IL,
Class C airspace area by extending the airspace shelf between 5 NM and
10 NM further around MDW on the east side from the existing boundary
located southeast of MDW to a new boundary slightly south of Interstate
290 located northeast of MDW qualifies for categorical exclusion under
the National Environmental Policy Act (42 U.S.C. 4321 et seq.) and its
implementing regulations at 40 CFR part 1500, and in accordance with
FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points). As such, this action
is not expected to result in any potentially significant environmental
impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding
Extraordinary Circumstances, the FAA reviewed this action for factors
and circumstances in which a normally categorically excluded action may
have a significant environmental impact requiring further analysis.
Accordingly, the FAA determined that no extraordinary circumstances
exist that warrant preparation of an environmental assessment or
environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 4000 Class C Airspace.

* * * * *

AGL IL C Chicago, IL [Amended]

Chicago Midway International Airport, IL
    (Lat. 41[deg]47'10'' N, long. 087[deg]45'09'' W)

    That airspace extending upward from the surface to 3,600 feet
MSL within a 5-mile radius of the Chicago Midway International
Airport; that airspace extending upward from 1,900 feet MSL to 3,600
feet MSL within an area beginning at a point north of Chicago Midway
International Airport at the intersection of the 10-mile radius
around a point centered at lat. 41[deg]59'16'' N, long.
087[deg]54'17'' W and the 5-mile radius of the Chicago Midway
International Airport, thence extending on a 090[deg] bearing to the
Lake Michigan shoreline at lat. 41[deg]52'09'' N, long.
087[deg]36'59'' W, thence southward following the shoreline to the
10-mile radius of the Chicago Midway International Airport at lat.
41[deg]44'59'' N, long. 087[deg]32'06'' W, thence clockwise along
that 10-mile radius to the intersection with the 10.5-mile radius
around a point centered at lat. 41[deg]59'16'' N,

long. 087[deg]54'17'' W, thence counterclockwise along that 10.5-
mile radius to the intersection with the 5-mile radius of the
Chicago Midway International Airport, thence counterclockwise along
that 5-mile radius to the intersection with the 10-mile radius
around a point centered at lat. 41[deg]59'16'' N, long.
087[deg]54'17'' W; and that airspace extending upward from 2,300
feet MSL to 3,600 feet MSL within an area beginning at a point on
the Lake Michigan shoreline at lat. 41[deg]52'09'' N, long.
087[deg]36'59'' W, thence extending on a 090[deg] bearing to the 10-
mile radius of the Chicago Midway International Airport, thence
clockwise along that 10-mile radius to the Lake Michigan shoreline
at lat. 41[deg]44'59'' N, long. 087[deg]32'06'' W, thence northward
following the shoreline to lat. 41[deg]52'09'' N, long.
087[deg]36'59'' W. This Class C airspace area excludes the airspace
within the Chicago, IL, Class B airspace area.
* * * * *

MODIFICATION OF THE CHICAGO MIDWAY INTERNATIONAL AIRPORT CLASS C
AIRSPACE AREA (Docket Number 22-AWA-2)
[GRAPHIC] [TIFF OMITTED] TR23MR23.002

    Issued in Washington, DC, on March 15, 2023.
Brian Konie,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-05632 Filed 3-22-23; 8:45 am]
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[Federal Register: August 3, 2010 (Volume 75, Number 148)]
[Notices]
[Page 45640-45641]
[DOCID:fr03au10-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0246]

Draft Guidance for Industry on Residual Drug in Transdermal and
Related Drug Delivery Systems; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Residual Drug
in Transdermal and Related Drug Delivery Systems.'' This draft guidance
provides recommendations to developers and manufacturers of transdermal
drug delivery systems (TDDS), transmucosal drug delivery systems
(TMDS), and topical patch products regarding use of an appropriate
scientific approach during product design and development--as well as
during manufacturing and product lifecycle management--to ensure that
the amount of residual drug substance at the end of the labeled use
period is minimized. The draft guidance is applicable to
investigational new drug applications (INDs), new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and supplemental new
drug applications (sNDAs) for TDDS, TMDS, and topical patch products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance, including comments regarding the proposed collection of
information, by November 1, 2010.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Terrance Ocheltree, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 21, rm.
1609, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
1988.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Residual Drug in Transdermal and Related Drug Delivery
Systems.'' This draft guidance provides recommendations to developers
and manufacturers of TDDS, TMDS, and topical patch products regarding
use of an appropriate scientific approach during product design and
development--as well as during manufacturing and product lifecycle
management--to ensure that the amount of residual drug substance at the
end of the labeled use period is minimized.
    Existing TDDS, TMDS, and topical patches contain a larger amount of
the drug substance than what is intended to be delivered to the
patient. This excess amount of drug substance is needed to facilitate
delivery of the intended amount of the drug to the patient and remains
as residual drug in the used system. The amount of residual drug
substance in TDDS, TMDS, and topical patches has a significant
potential to impact the products' quality, safety, and efficacy.
Consequently, it is necessary to ensure that an appropriate scientific
approach is used to design and develop these products. The approach
should ensure that the amount of residual drug substance is minimized
consistent with the current state of technology.
    Currently marketed TDDS, TMDS, and topical patches may retain 10 to
95 percent of the initial total amount of drug after the intended use
period. This raises a potential safety issue not only to the patient,
but also to others including family members, caregivers, children, and
pets. For example, adverse events due to a patient's failure to remove
TDDS at the end of the intended use period have been reported and are
generally related to an increased or prolonged pharmacological effect
of the drug. Some children have died from inadvertent exposure to
discarded TDDS. Reported adverse events resulting from various quality
problems pertaining to TDDS have lead to product recalls, withdrawals,
and public health advisories.
    To reduce some of these risks, we recommend that an enhanced design
and development approach--specifically Quality by Design (QbD), as
described in the International Conference on Harmonization (ICH)
guidance for industry Q8(R2) Pharmaceutical Development--be used when
developing and manufacturing TDDS, TMDS, and topical patches. We also
recommend that sufficient scientific justification to support the
amount of residual drug in TDDS, TMDS, or topical patches be included
in an application. The level of information in the justification should
be sufficient to demonstrate product and process understanding and
ensure that a scientific, risk-based approach has been taken to
minimize the amount of residual drug in a system after use to the
lowest possible level. Furthermore, it is expected that the amount of
residual drug in a newly developed system will not exceed that of
similar FDA-approved products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on residual
drug in transdermal and related drug delivery systems. It does not
create or confer any rights for or on

any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
Information in an application on the product and process development
and justification for the final formulation and system design is
approved by OMB under control numbers 0910-0001 and 0910-0014.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19041 Filed 8-2-10; 8:45 am]
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