[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Rules and Regulations]
[Pages 39970-39974]
[FR Doc No: 2019-17234]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 138

[Docket No. USCG-2019-0392]
RIN 1625-AC53

Consumer Price Index Adjustments of Oil Pollution Act of 1990
Limits of Liability--Vessels, Deepwater Ports and Onshore Facilities

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is issuing this final rule to adjust the
limits of liability for vessels, deepwater ports, and onshore
facilities under the Oil Pollution Act of 1990 (OPA 90), as amended, to
reflect the increase in the Consumer Price Index since 2015. These
regulatory inflation increases to the limits of liability are required
by OPA 90 and are necessary to preserve the deterrent effect and
``polluter pays'' principle embodied in the Act. This update promotes
the Coast Guard's missions of maritime safety and stewardship.

DATES: This final rule is effective on November 12, 2019.

ADDRESSES: Documents mentioned in this rule are available in our online

docket at http://www.regulations.gov and can be viewed by entering
``USCG-2019-0392'' in the search field and following the website's
instructions.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Benjamin White, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents for Preamble

I.Abbreviations
II. Basis and Purpose, and Regulatory History
III. Background and Justification for Final Rule
IV. Calculation for the Adjustment
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 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. Abbreviations

BLS Bureau of Labor Statistics
BOEM Bureau of Ocean Energy Management
CPI Consumer Price Index
CPI-U Consumer Price Index--All Urban Consumers, Not Seasonally
Adjusted, U.S. City Average, All Items, 1982-84 = 100
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
OPA90 Oil Pollution Act of 1990
U.S.C. United States Code
Sec.  Section

II. Basis and Purpose, and Regulatory History

    Under the Oil Pollution Act of 1990 (OPA 90) (33 U.S.C. 2701, et
seq.), the responsible parties for any vessel (other than a public
vessel) or facility from which oil is discharged, or which poses a
substantial threat of discharge of oil, into or upon the navigable
waters or the adjoining shorelines or the exclusive economic zone of
the United States are strictly liable, jointly and severally, under 33
U.S.C. 2702 (a) and (b), for the removal costs and damages that result
from such incident. Under 33 U.S.C. 2704 (a), the responsible parties'
liability with respect to OPA 90 and any one incident is limited,
subject to certain exceptions specified in 33 U.S.C. 2704 (c).
    In the instances when a limit of liability applies, the Oil Spill
Liability Trust Fund (``the Fund'') is available to compensate the OPA
90 removal costs and damages incurred by the responsible parties and
third-party claimants in excess of the applicable limit of liability.
The statutory limits of liability for vessels and three types of
facilities are set forth in OPA 90: (1) Onshore facilities, (2)
deepwater ports, and (3) offshore facilities other than deepwater
ports. In addition, to prevent the real value of the OPA 90 statutory
limits of liability from depreciating over time as a result of
inflation, and to preserve the ``polluter pays'' principle, OPA 90
requires that the limits of liability be adjusted ``not less than every
3 years'' to reflect significant increases in the Consumer Price Index
(CPI).\1\
---------------------------------------------------------------------------

    \1\ 33 U.S.C. 2704(d)(4).
---------------------------------------------------------------------------

    The Coast Guard is responsible for adjusting the limits of
liability for vessels, deepwater ports, and onshore facilities. The
Department of the Interior's Bureau of Ocean Energy Management (BOEM)
is responsible for adjusting the limits of liability for offshore
facilities. Regarding vessels and deepwater ports, the Coast Guard
adjusted the limits of liability in 2009 (74 FR 31357) \2\ and in 2015
(80 FR 72342). Regarding onshore facilities, USCG adjusted the limits
of liability only once, in 2015 (80 FR 72342), after the President
issued Executive Order 13638, which restated and simplified the
delegations in Executive Order 12777, section 4, and vested the
authority to make CPI adjustments to the onshore facility statutory
limit of liability in ``the Secretary of the Department in which the
Coast Guard is operating.'' The Secretary of the Department of Homeland
Security (DHS) delegated that authority to the Coast Guard. Regarding
offshore facilities, BOEM published a final rule and adjusted the
limits of liability for offshore facilities in 2018 (83 FR 2540) from
$133,650,000 to $137,659,500.
---------------------------------------------------------------------------

    \2\ The 2009 interim rule was adopted without change as a final
rule in 2010 (75 FR 750).
---------------------------------------------------------------------------

III. Background and Justification for Final Rule

    The Coast Guard is promulgating this rule pursuant to the
provisions of Title I of OPA, Executive Order 12777, as amended, and
Coast Guard regulations in Title 33 of the Code of Federal Regulations
(CFR) part 138, subpart B--OPA 90 Limits of Liability (Vessels,
Deepwater Ports and Onshore Facilities). Under 5 U.S.C. 553(b)(B), the
Coast Guard has good cause for issuing this final rule without notice
or comment as providing notice and comment is unnecessary. Prior notice
and comment is ``unnecessary'' when the change is minor or merely
technical.\3\ Prior notice and comment is also unnecessary when there
is no need to allow ``affected parties an opportunity to participate in
agency decision making early in the process, when the agency is more
likely to consider alternative ideas,'' \4\ and where Congress requires
an agency to perform a non-discretionary act, and where no extent of
notice or commentary could have altered the obligation of the agency.
In this instance, a proposed rule is unnecessary because the adjustment
in the limit of liability is mandated by statute, and is therefore non-
discretionary for the Coast Guard. Furthermore, the methodology for
determining the amount is defined in the Coast Guard's regulations, and
the regulations in 33 CFR 138.240(a) provide that inflation adjustments
to the limits of liability for vessels, deepwater ports, and onshore
facilities will be implemented through final rulemaking.\5\ The full
legislative and regulatory history for the OPA 90 limit of liability
inflation adjustments can be found in the rulemaking preamble for the
last inflation adjustment in the final rule found at 80 FR 72342.
---------------------------------------------------------------------------

    \3\ Northern Arapahoe Tribe v. Hodel, 808 F.2d 741, 751 (10th
Cir. 1987).
    \4\ Id.
    \5\ In the NPRM for the 2015 adjustment, titled Consumer Price
Index Adjustments of Oil Pollution Act of 1990 Limits of Liability-
Vessels, Deepwater Ports and Onshore Facilities, the Coast Guard
proposed a simplified regulatory procedure for making future
inflation updates to the OPA 90 limits of liability. Under that
procedure in new 33 CFR 138.240(a), the Director of NPFC publishes
the inflation-adjusted limits of liability in the Federal Register
as final rule amendments to 33 CFR 138.230. Further, the preamble of
that NPRM stated that ``[b]ecause the adjustment methodology was
established by the CPI-1 Rule, and the simplified [regulatory]
procedure will be established by this rulemaking, publication of an
NPRM would not be necessary for these future mandated inflation
adjustments.'' 79 FR 49206 at 49211; August 19, 2014.
---------------------------------------------------------------------------

IV. Calculation for the Adjustment

    The Coast Guard is issuing this final rule to update the OPA 90
limits of liability for vessels, deepwater ports, and onshore
facilities, as set forth in 33 CFR part 138, subpart B, to reflect
significant increases in the CPI since the limits were last adjusted.
OPA 90 requires adjustments to the limits of liability not less than
every 3 years to reflect significant increases in the CPI. The method
for calculating these adjustments is set forth in 33 CFR 138.240.
    This final rule provides these periodic inflation adjustments to
the limits of liability to reflect changes in the CPI since the limits
were last adjusted for inflation in 2015 (80 FR 72342). As provided in
33 CFR 138.240, we

calculate limit of liability adjustments, using the Consumer Price
Index--All Urban Consumers, Not Seasonally Adjusted, U.S. City Average,
All Items, 1982-84=100 (CPI-U) values published by the Bureau of Labor
Statistics (BLS), as follows--
    1. Formula to calculate the percent change in the Annual CPI-U:
Percent change in the Annual CPI-U = [(Annual CPI-U for current period
- Annual CPI-U for previous period) / Annual CPI-U for previous period]
x 100, then rounded to one decimal place.
    2. Formula to derive the new limit of liability, applying the
percent change in the Annual CPI-U: New Limit of Liability = Previous
Limit of Liability + (Previous Limit of Liability x Percent Change in
CPI), then rounded to the closest $100.
    For this update, we used the 2018 Annual CPI-U value of 251.107 as
the ``current period'' value, which is the most recent Annual CPI-U
published by the BLS.\6\ The Coast Guard used the 2014 Annual CPI-U
value of 236.736 as the ``previous period'' value, which was the Annual
CPI-U used as the ``current period'' value when the limits of liability
were last adjusted in 2015. Applying the formula in Item 1 above, we
have determined that there was a 6.1 percent increase in the Annual
CPI-U since the OPA 90 limits of liability for vessels, deepwater
ports, and onshore facilities were last adjusted. Table 1 below shows
the previous and new limits of liability derived by applying the
percent increase using the formula in Item 2 above.
---------------------------------------------------------------------------

    \6\ https://www.bls.gov/cpi/tables/supplemental-files/historical-cpi-u-201905.pdf.

                                    Table 1--CPI-Adjusted Limits of Liability
----------------------------------------------------------------------------------------------------------------
                                                                          Percent
                                                                        increase in
             Source category                  Previous limit  of        the annual    New CPI-adjusted  limit of
                                                   liability               CPI-U               liability
                                                                         (percent)
----------------------------------------------------------------------------------------------------------------
                                            Sec.   138.230(a) Vessels
----------------------------------------------------------------------------------------------------------------
(1) The OPA 90 limits of liability for    ..........................  ..............  ..........................
 tank vessels, other than edible oil
 tank vessels and oil spill response
 vessels, are--.
(i) For a single-hull tank vessel         The greater of $3,500 per              6.1  The greater of $3,700 per
 greater than 3,000 gross tons \7\.        gross ton or $25,845,600.                   gross ton or $27,422,200.
(ii) For a tank vessel greater than       The greater of $2,200 per              6.1  The greater of $2,300 per
 3,000 gross tons, other than a single-    gross ton or $18,796,800.                   gross ton or $19,943,400.
 hull tank vessel.
(iii) For a single-hull tank vessel less  The greater of $3,500 per              6.1  The greater of $3,700 per
 than or equal to 3,000 gross tons.        gross ton or $7,048,800.                    gross ton or $7,478,800.
(iv) For a tank vessel less than or       The greater of $2,200 per              6.1  The greater of $2,300 per
 equal to 3,000 gross tons, other than a   gross ton or $4,699,200.                    gross ton or $4,985,900.
 single-hull tank vessel.
(2) The OPA 90 limits of liability for    The greater of $1,100 per              6.1  The greater of $1,200 per
 any vessel other than a vessel listed     gross ton or $939,800.                      gross ton or $997,100.
 in subparagraph (a)(1) of Sec.
 138.230, including for any edible oil
 tank vessel and any oil spill response,
 vessel, are--.
----------------------------------------------------------------------------------------------------------------
                                        Sec.   138.230(b) Deepwater ports
----------------------------------------------------------------------------------------------------------------
(1) The OPA 90 limit of liability for     $633,850,000..............             6.1  $672,514,900.
 any deepwater port, including for any
 component pipelines, other than a
 deepwater port listed in subparagraph
 (b)(2) of Sec.   138.230, is--.
(2) The OPA 90 limits of liability for    ..........................  ..............  ..........................
 deepwater ports with limits of
 liability established by regulation
 under OPA 90 (33 U.S.C. 2704(d)(2)),
 including for any component pipelines,
 are--.
(i) For the Louisiana Offshore Oil Port   $96,366,600...............             6.1  $102,245,000.
 (LOOP).
(ii) [Reserved].........................  N/A.......................             N/A  N/A
----------------------------------------------------------------------------------------------------------------
                                      Sec.   138.230(c) Onshore facilities
----------------------------------------------------------------------------------------------------------------
The OPA 90 limit of liability for         $633,850,000..............             6.1  $672,514,900.
 onshore facilities, including, but not
 limited to, any motor vehicle, rolling
 stock or onshore pipeline, is--.
----------------------------------------------------------------------------------------------------------------

V. Regulatory Analyses
---------------------------------------------------------------------------

    \7\ As of January 1, 2015, tank vessels not equipped with a
double hull can no longer operate on waters subject to the
jurisdiction of the United States, including the Exclusive Economic
Zone, carrying oil in bulk as cargo or cargo residue; and there are
no waivers or extensions of the deadline. However, OPA 90 continues
to specify limits of liability for single-hull tank vessels. The
Coast Guard, therefore, continues to adjust those limits of
liability for inflation.
---------------------------------------------------------------------------

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. A summary of our analyses based
on these statutes or Executive orders follows.

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 costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 13771 (Reducing Regulation and Controlling

Regulatory Costs) directs agencies to reduce regulation and control
regulatory costs and provides that ``for every one new regulation
issued, at least two prior regulations be identified for elimination,
and that the cost of planned regulations be prudently managed and
controlled through a budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, OMB has not reviewed it. Because this rule is
not a significant regulatory action, this rule is exempt from the
requirements of Executive Order 13771. See the OMB Memorandum titled
``Guidance Implementing Executive Order 13771, titled `Reducing
Regulation and Controlling Regulatory Costs' '' (April 5, 2017). A
regulatory analysis (RA) follows.
    As was the case with the BOEM rulemaking increasing the limits of
liability for offshore facilities, this final rule is an update to the
limit of liability for vessels, deepwater ports, and onshore facilities
under OPA 90.\8\ This rule does not increase the regulatory burden on
regulated entities when measured in constant or real dollars. This
final rule simply maintains the value of the limit of liability set by
OPA 90 by updating the limit of liability for inflation, as required by
OPA 90 in 33 U.S.C. 2704(d)(4).
---------------------------------------------------------------------------

    \8\ Documents from the BOEM rulemaking are available at https://www.regulations.gov by entering ``BOEM-2017-0048'' in the search
field and following the website's instructions.
---------------------------------------------------------------------------

Regulatory Cost
    This final rule increases the limits of liability under OPA 90 for
vessels, deepwater ports, and onshore facilities by 6.1 percent. The
Coast Guard does not expect Certificate of Financial Responsibility
guarantor insurance premiums for vessels to increase as a result of
this rule. This final rule will only affect vessels, deepwater ports,
and onshore facilities that have an OPA 90 incident that exceeds their
existing limit of liability. The Coast Guard estimates that this final
rule will affect, at most, three vessels per year. We estimate that the
rule could also affect one deepwater port and one onshore facility over
a 10-year period. In such a case, the maximum amount of additional
liability will represent a maintenance of the value of the limits of
liability set by OPA 90.
Regulatory Benefit
    This rulemaking ensures that the OPA 90 limits of liability keep
pace with inflation as required by OPA 90 (33 U.S.C. 2704(d)(4)). This
final rule requires responsible parties to internalize inflation,
thereby benefitting the public, because the appropriate amount of
removal costs and damages are borne by the responsible party. The
liability risk will not shift from the responsible party to the public
and the Fund. This helps preserve the ``polluter pays'' principle as
intended by Congress and preserves the Fund for its other authorized
uses. Absent CPI adjustments, a responsible party gains an advantage
not intended by OPA 90. Without inflation incorporated into the
determination of the applicable limit of liability, the responsible
party ultimately pays a reduced percentage of the total incident costs.
Hence, this final rule ensures that the limits of liability are
adjusted according to inflation and remain constant over time.

B. Small Entities

    Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have
considered whether this rule will have a significant economic impact on
a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Regulatory Flexibility Act does not apply when notice and
comment rulemaking is not required. This rule is not preceded by a
notice of proposed rulemaking (NPRM). Therefore, it is exempt from the
requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612).
Furthermore, this rulemaking is statutorily mandated. Pursuant to
established procedure in 33 CFR 138.240(a), an NPRM is unnecessary.
Therefore, the Coast Guard has determined that a Regulatory Flexibility
Analysis does not apply to this rulemaking.

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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247).

D. Collection of Information

    The Paperwork Reduction Act of 1995, (44 U.S.C. 3501-3520) requires
that the Coast Guard consider the impact of paperwork and other
information collection burdens imposed on the public. The Coast Guard
had determined that there is no new requirement for information
collection associated with this final rule.

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.
    This final rule makes necessary adjustments to the OPA 90 limits of
liability to reflect significant increases in the CPI. Nothing in this
final rule affects the preservation of State authorities under 33
U.S.C. 2718, including the authority of any State to impose additional
liability or financial responsibility requirements with respect to
discharges of oil within such State. Therefore, this final rule has no
implications for federalism.
    The Coast Guard recognizes the key role that State and local
governments may have in making regulatory determinations. Additionally,
for rules with federalism implications and preemptive effect, Executive
Order 13132 specifically directs agencies to consult with State and
local governments during the rulemaking process. The Coast Guard
invites anyone who believes this rule has implications for federalism
under Executive Order 13132 to contact the person listed in the FOR
FURTHER INFORMATION section of this preamble.

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 million
(adjusted for inflation) or more in any one year. Although this rule
will not result in such an 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 final 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 Department of Homeland Security
Management Directive 023-01 and Environmental Planning COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary 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. This final rule is categorically
excluded under paragraph L53 of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 01. Paragraph L53 pertains to
congressionally mandated regulations designed to improve or protect the
environment. This rule adjusts the limits of liability for vessels,
deepwater ports, and onshore facilities to reflect significant
increases in the CPI using the methodology established in 33 CFR
138.40(a) and mandated by statute. The Coast Guard certifies this rule
will not have significant environmental impacts.

List of Subjects in 33 CFR Part 138

    Hazardous materials transportation, Insurance, Oil pollution,
Reporting and recordkeeping requirements, Surety bonds, Vessels, Water
pollution control.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 138 as follows:

PART 138--FINANCIAL RESPONSIBILITY FOR WATER POLLUTION (VESSELS)
AND OPA 90 LIMITS OF LIABILITY (VESSELS, DEEPWATER PORTS AND
ONSHORE FACILITIES)

0
1. The authority citation for part 138 continues to read as follows:

    Authority: 33 U.S.C. 2704, 2716, 2716a; 42 U.S.C. 9608, 9609; 6
U.S.C. 552; E.O. 12580, Sec. 7(b), 3 CFR, 1987 Comp., p. 193; E.O.
12777, Secs. 4 and 5, 3 CFR, 1991 Comp., p. 351, as amended by E.O.
13286, Sec. 89, 3 CFR, 2004 Comp., p. 166, and by E.O. 13638, Sec.
1, 3 CFR, 2014 Comp., p.227; Department of Homeland Security
Delegation Nos. 0170.1 and 5110, Revision 01. Section 138.30 also
issued under the authority of 46 U.S.C. 2103 and 14302.

Subpart B--OPA 90 Limits of Liability (Vessels, Deepwater Ports and
Onshore Facilities)

Sec.  138.230  [Amended]

0
2. Amend Sec.  138.230 as follows:
0
a. In paragraph (a)(1)(i), remove the text ``$3,500 per gross ton or
$25,845,600'' and add, in its place, the text ``$3,700 per gross ton or
$27,422,200'';
0
b. In paragraph (a)(1)(ii), remove the text ``$2,200 per gross ton or
$18,796,800'' and add, in its place, the text ``$2,300 per gross ton or
$19,943,400'';
0
c. In paragraph (a)(1)(iii), remove the text ``$3,500 per gross ton or
$7,048,800'' and add, in its place, the text ``$3,700 per gross ton or
$7,478,800'';
0
d. In paragraph (a)(1)(iv), remove the text ``$2,200 per gross ton or
$4,699,200'' and add, in its place, the text ``$2,300 per gross ton or
$4,985,900'';
0
e. In paragraph (a)(2), remove the text ``$1,100 per gross ton or
$939,800'' and add, in its place, the text ``$1,200 per gross ton or
$997,100'';
0
f. In paragraph (b)(1) remove the text ``$633,850,000'' and add, in its
place, the text ``$672,514,900'';
0
g. In paragraph (b)(2)(i), remove the text ``$96,366,000'' and add, in
its place, the text ``$102,245,000''; and
0
h. In paragraph (c), remove the text ``$633,850,000'' and add, in its
place, the text ``$672,514,900''.

    Dated: July 22, 2019.
Thomas G. Allan,
Assistant Commandant for Resources, United States Coast Guard.
[FR Doc. 2019-17234 Filed 8-12-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 249 (Thursday, December 29, 2022)]
[Rules and Regulations]
[Pages 80038-80040]
[FR Doc No: 2022-28168]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2022-N-3186]

Medical Devices; Cardiovascular Devices; Classification of the
Extracorporeal System for Carbon Dioxide Removal

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the extracorporeal system for carbon dioxide removal into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the extracorporeal system for carbon dioxide
removal's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.

DATES: This order is effective December 29, 2022. The classification
was applicable on November 13, 2021.

FOR FURTHER INFORMATION CONTACT: Alejandra Cambonchi, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2253, Silver Spring, MD 20993-0002,
301-796-0552, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the extracorporeal system for
carbon dioxide removal as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On August 30, 2021, FDA received ALung Technologies, Inc.'s request
for De Novo classification of the Hemolung Respiratory Assist System.
FDA reviewed the request in order to classify the device under the
criteria for classification set forth in section 513(a)(1) of the FD&C
Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device
    Therefore, on November 13, 2021, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
870.4150.\1\ We have named the generic type of device extracorporeal
system for carbon dioxide removal, and

it is identified as a system of devices and accessories that provides
assisted extracorporeal carbon dioxide removal from the patient's blood
in patients with acute respiratory failure, where other available
treatment options have failed, and continued clinical deterioration is
expected or the risk of death is imminent. The main devices and
accessories of the system include, but are not limited to, the console
(hardware), software, and disposables, including, but not limited to, a
gas exchanger, blood pump, cannulae, tubing, filters, and other
accessories (e.g., monitors, detectors, sensors, connectors).
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Extracorporeal System for Carbon Dioxide Removal Risks and
                           Mitigation Measures
------------------------------------------------------------------------
       Identified risks                   Mitigation measures
------------------------------------------------------------------------
Bleeding, Thrombocytopenia,    In Vivo Evaluation, Non-clinical
 Hemolysis, Thrombosis.         performance testing, and Labeling.
Infection....................  In Vivo Evaluation, Sterility, Shelf-life
                                testing, and Labeling.
Adverse Tissue and/or          In Vivo Evaluation, Biocompatibility, and
 Hematologic Reaction.          Labeling.
Mechanical Failure...........  In Vivo Evaluation, Non-clinical
                                performance testing, Labeling, and
                                Software Validation, verification, and
                                hazard analysis.
Hemodynamic Instability......  In Vivo Evaluation, Non-clinical
                                performance testing, and Labeling.
Hypothermia..................  In Vivo Evaluation, Non-clinical
                                performance testing, and Labeling.
Mechanical Injury to Access    In Vivo Evaluation, Non-clinical
 Vessels.                       performance testing, and Labeling.
Inadequate gas exchange......  In Vivo Evaluation, Non-clinical
                                performance testing, and Labeling.
Hemodilution.................  In Vivo Evaluation, Non-clinical
                                performance testing, and Labeling.
Gas embolism.................  In Vivo Evaluation, Non-clinical
                                performance testing, and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. We encourage sponsors to consult with us if they wish to
use a non-animal testing method they believe is suitable, adequate,
validated, and feasible. We will consider if such an alternative method
could be assessed for equivalency to an animal test method. This device
is subject to premarket notification requirements under section 510(k)
of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in part 814, subparts A through E,
regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR parts 801, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.4150 to subpart E to read as follows:

Sec.  870.4150  Extracorporeal system for carbon dioxide removal.

    (a) Identification. An extracorporeal system for carbon dioxide
removal is a system of devices and accessories that provides assisted
extracorporeal carbon dioxide removal from the patient's blood in
patients with acute respiratory failure, where other available
treatment options have failed, and continued clinical deterioration is
expected or the risk of death is imminent. The main devices and
accessories of the system include, but are not limited to, the console
(hardware), software, and disposables, including, but not limited to, a
gas exchanger, blood pump, cannulae, tubing, filters, and other
accessories (e.g., monitors, detectors, sensors, connectors).
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) In vivo evaluation, which may include animal testing and
clinical data, of the devices and accessories in the circuit must
demonstrate their performance over the intended duration of use,
including a detailed summary of the in vivo evaluation pertinent to the
use of the devices and accessories to demonstrate their effectiveness.
    (2) The technological characteristics of the device must ensure
that the geometry and design parameters are consistent with the
intended use, and that the devices and accessories in the circuit are
compatible.
    (3) Non-clinical performance testing of the devices and accessories
in the circuit must demonstrate that the device performs as intended
under anticipated conditions of use. The following performance
characteristics must be tested:
    (i) Mechanical integrity;
    (ii) Durability; and

    (iii) Reliability.
    (4) All patient contacting components of the device must be
demonstrated to be biocompatible.
    (5) Performance testing must demonstrate the electrical safety and
electromagnetic compatibility (EMC) of any electrical components.
    (6) Software validation, verification, and hazard analysis must be
performed.
    (7) Performance testing must demonstrate the sterility of all
patient-contacting components.
    (8) Performance testing must support the shelf life of the device
by demonstrating continued sterility and device functionality over the
identified shelf life.
    (9) Labeling must include the following:
    (i) A detailed summary of the non-clinical and in vivo evaluations
pertinent to use of the device and accessories in the circuit;
    (ii) Adequate instructions with respect to circuit setup,
performance characteristics with respect to compatibility among
different devices and accessories in the circuit, and maintenance
during a procedure; and
    (iii) A shelf life.

    Dated: December 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28168 Filed 12-28-22; 8:45 am]
BILLING CODE 4164-01-P