Crabmeat; Amendment of Common or Usual Name Regulation, 19429-19431 [2018-09371]

Download as PDF Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations previously issued. It is unlikely that prior public comment would result in a significant change from the subject contained herein. Therefore, notice and opportunity for prior public comment hereon are unnecessary and the FAA finds good cause, in accordance with 5 U.S.C. 553(b)(3)(B) and 553(d)(3), making these special conditions effective upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above. List of Subjects in 14 CFR Part 23 Aircraft, Aviation safety, Signs and symbols. Citation The authority citation for these special conditions is as follows: ■ Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701–44702, 44704; Pub. L. 113–53, 127 Stat 584 (49 U.S.C. 44704) note; 14 CFR 21.16 and 21.101; and 14 CFR 11.38 and 11.19. The Special Conditions Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Textron Aviation B300, B300C, B300C (MC–12W), and B300C (UC– 12W) airplanes modified by St. Louis Helicopter, LLC. ■ sradovich on DSK3GMQ082PROD with RULES 1. Installation of Lithium Battery The FAA adopts that the following special conditions be applied to lithium battery installations on the Textron Aviation models B300, B300C, B300C (MC–12W), and B300C (UC–12W) airplanes in lieu of the requirements § 23.1353 (a), (b), (c), (d), and (e), amendment 23–49. Lithium battery installations on the models B300, B300C, B300C (MC–12W), and B300C (UC–12W) airplanes must be designed and installed as follows: (1) Safe cell temperatures and pressures must be maintained during— i. Normal operations; ii. Any probable failure conditions of charging or discharging or battery monitoring system; and iii. Any failure of the charging or battery monitoring system not shown to be extremely remote. (2) The rechargeable lithium battery installation must be designed to preclude explosion or fire in the event of 1(1)ii and 1(1)iii failures. (3) Design of the rechargeable lithium batteries must preclude the occurrence of self-sustaining, uncontrolled increases in temperature or pressure. VerDate Sep<11>2014 15:59 May 02, 2018 Jkt 244001 (4) No explosive or toxic gasses emitted by any rechargeable lithium battery in normal operation or as the result of any failure of the battery charging system, monitoring system, or battery installation, which is not shown to be extremely remote, may accumulate in hazardous quantities within the airplane. (5) Installations of rechargeable lithium batteries must meet the requirements of § 23.863(a) through (d), amendment 23–34. (6) No corrosive fluids or gases that may escape from any rechargeable lithium battery, may damage surrounding structure or any adjacent systems, equipment, electrical wiring, or the airplane in such a way as to cause a major or more severe failure condition, in accordance with § 23.1309, amendment 23–49, and applicable regulatory guidance. (7) Each rechargeable lithium battery installation must have provisions to prevent any hazardous effect on structure or essential systems that may be caused by the maximum amount of heat the battery can generate during a short circuit of the battery or of its individual cells. (8) Rechargeable lithium battery installations must have— i. A system to automatically control the charging rate of the battery to prevent battery overheating and overcharging; and either ii. A battery temperature sensing and over-temperature warning system with a means for automatically disconnecting the battery from its charging source in the event of an over-temperature condition; or iii. A battery failure sensing and warning system with a means for automatically disconnecting the battery from its charging source in the event of battery failure. (9) Any rechargeable lithium battery installation, the function of which is required for safe operation of the aircraft, must incorporate a monitoring and warning feature that will provide an indication to the appropriate flight crewmembers whenever the state of charge of the batteries has fallen below levels considered acceptable for dispatch (see note 1) of the aircraft. 19429 contain the rechargeable lithium battery or rechargeable lithium battery system. The lithium rechargeable batteries and lithium rechargeable battery systems must not degrade below specified ampere-hour levels sufficient to power the aircraft system. The ICA must also contain procedures for the maintenance of replacement batteries (see note 4) to prevent the installation of batteries that have degraded charge retention ability or other damage due to prolonged storage at a low state of charge. Replacement batteries must be of the same manufacturer and part number as approved by the FAA. Note 2: Maintenance requirements include procedures that— (a) Check battery capacity, charge degradation at manufacturers recommended inspection intervals; and (b) Replace batteries at manufacturers recommended replacement schedule/time to prevent age related degradation. Note 3: The term ‘‘sufficiently charged’’ means that the battery must retain enough charge, expressed in ampere-hours, to ensure that the battery cells will not be damaged. A battery cell may be damaged by low charge (i.e., below certain level), resulting in a reduction in the ability to charge and retain a full charge. This reduction would be greater than the reduction that may result from normal operational degradation. Note 4: Replacement battery in spares storage may be subject to prolonged storage at a low state of charge. Issued in Kansas City, Missouri on April 23, 2018. Pat Mullen, Manager, Small Airplane Standards Branch, Aircraft Certification Service. [FR Doc. 2018–09350 Filed 5–2–18; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 102 [Docket No. FDA–2018–N–1438] RIN 0910–AI04 Note 1: Reference § 23.1353(h) for dispatch consideration. Crabmeat; Amendment of Common or Usual Name Regulation (10) The Instructions for Continued Airworthiness (ICA) required by § 23.1529 must contain maintenance requirements (see note 2) to assure that the battery has been sufficiently charged (see note 3) at appropriate intervals specified by the battery manufacturer and the equipment manufacturer that AGENCY: PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA or we) is amending the common or usual name SUMMARY: E:\FR\FM\03MYR1.SGM 03MYR1 19430 Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations regulation for crabmeat by replacing ‘‘brown king crabmeat’’ with ‘‘golden king crabmeat’’ as the common or usual name for crabmeat derived from the species Lithodes aequispinus. We are taking this action due to a recently enacted law. We are also correcting an error in the placement of a scientific term, which is editorial in nature. DATES: This rule is effective May 3, 2018. The compliance date for this rule is January 1, 2020. ADDRESSES: For access to the docket, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the ‘‘Search’’ box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–5316, Steven.Bloodgood@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. General Overview of Final Rule II. Background and Legal Authority III. Compliance Date IV. Economic Analysis of Impacts V. Analysis of Environmental Impact VI. Paperwork Reduction Act of 1995 VII. Federalism VIII. Consultation and Coordination With Indian Tribal Governments IX. References sradovich on DSK3GMQ082PROD with RULES I. General Overview of Final Rule This rule amends § 102.50 (21 CFR 102.50) to designate ‘‘golden king crabmeat’’ as the sole common or usual name of crabmeat derived from the species Lithodes aequispinus. The regulation at § 102.50 currently lists ‘‘brown king crabmeat’’ as the common or usual name of crabmeat derived from the species Lithodes aequispina. In addition to replacing the common or usual name, we are revising the scientific name to read as Lithodes aequispinus, in accordance with a recently enacted law designating the acceptable market name of the species as ‘‘golden king crab.’’ We are also correcting § 102.50 so that Paralithodes platypus appears under the ‘‘Scientific name of crab’’ column for King crabmeat. II. Background and Legal Authority In the Federal Register of July 3, 1995 (60 FR 34459), we published a final rule amending the common or usual name provisions for crabmeat, to provide that the common or usual name of crabmeat VerDate Sep<11>2014 15:59 May 02, 2018 Jkt 244001 derived from the species Lithodes aequispina is ‘‘brown king crabmeat.’’ On May 5, 2017, the Consolidated Appropriations Act, 2017 (Pub. L. 115– 31), was signed into law. Section 774 of the Consolidated Appropriations Act, 2017, provides that, for purposes of applying the Federal Food, Drug, and Cosmetic Act (FD&C Act), the acceptable market name of Lithodes aequispinus is ‘‘golden king crab.’’ The final rule amends § 102.50 to reflect the common or usual name of crabmeat derived from Lithodes aequispinus as provided by the Consolidated Appropriations Act, 2017, and to revise the scientific name of the species. The final rule also corrects § 102.50 to move the scientific name for King crabmeat, Paralithodes platypus, from the ‘‘Common or usual name of crabmeat’’ column to the ‘‘Scientific name of crab’’ column. FDA finds good cause for issuing this amendment as a final rule without notice and comment because this amendment only updates the regulation to align with the law enacted by the Consolidated Appropriations Act, 2017 (5 U.S.C. 553(b)(B)). (‘‘[W]hen regulations merely restate the statute they implement, notice-and-comment procedures are unnecessary.’’ Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d 1284, 1291 (DC Cir. 1991); see also Komjathy v. Nat. Trans. Safety Bd., 832 F.2d 1294, 1296 (DC Cir. 1987), cert. denied, 486 U.S. 1057 (1988) (when a rule ‘‘does no more than repeat, virtually verbatim, the statutory grant of authority,’’ notice-and-comment procedures are not required)).) Therefore, we are issuing this amendment as a final rule, and publication of this document constitutes final action under the Administrative Procedure Act (APA) (5 U.S.C. 553). In addition, we find good cause for this amendment to become effective on the date of publication of this action. The APA allows an effective date less than 30 days after publication as ‘‘provided by the agency for good cause found and published with the rule’’ (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in this case because the new requirements regarding golden king crab are already effective as a matter of law and because moving the scientific name for King crabmeat is a ministerial action. Therefore, we find good cause for this amendment to become effective on the date of publication of this action. III. Compliance Date With respect to a compliance date, we intend that any adjustments to a product’s labeling occur in a manner PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 consistent with our uniform compliance date (see 81 FR 85156, November 25, 2016). Thus, the compliance date is January 1, 2020. IV. Economic Analysis of Impacts We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations ‘‘shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.’’ We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866 and is not a deregulatory action for purposes of Executive Order 13771. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We estimate that the mean cost per crab covered by the final rule is $0.23 (2016$). We estimate that the revenue per crab covered by the final rule ranges from $17.65 to $99.42 (2016$). Because the cost per crab covered by the final rule as a percentage of the revenue per crab covered by the final rule is small, ranging from 0.2 percent to 1.3 percent, we certify that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount. We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. E:\FR\FM\03MYR1.SGM 03MYR1 Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations The full analysis of economic impacts is available in the docket for this final rule (Ref. 1). V. Analysis of Environmental Impact We have determined under 21 CFR 25.30(k) 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. VI. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. VII. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. VIII. Consultation and Coordination With Indian Tribal Governments We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required. in the Federal Register, but websites are subject to change over time. 1. FDA, ‘‘Crabmeat; Amendment of Common or Usual Name Regulation: Final Regulatory Impact Analysis,’’ 2017. Also available at https://www.fda.gov/ AboutFDA/ReportsManualsForms/ Reports/EconomicAnalyses/default.htm. List of Subjects in 21 CFR Part 102 Beverages, Food grades and standards, Food labeling, Frozen foods, Oils and fats, Onions, Potatoes, Seafood. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 102 is amended as follows: PART 102—COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 1. The authority citation for part 102 continues to read as follows: ■ Authority: 21 U.S.C. 321, 343, 371. 2. In § 102.50 revise the table to read as follows: ■ § 102.50 * * Crabmeat. * * Scientific name of crab Chionoecetes opilio, Chionoecetes tanneri, Chionoecetes bairdii, and Chionoecetes angulatus. Erimacrus isenbeckii ....... Lithodes aequispinus ...... Paralithodes brevipes ..... Paralithodes camtschaticus and Paralithodes platypus. * Snow crabmeat. Korean variety crabmeat or Kegani crabmeat. Golden King crabmeat. King crabmeat or Hanasaki crabmeat. King crabmeat. Dated: April 27, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–09371 Filed 5–2–18; 8:45 am] sradovich on DSK3GMQ082PROD with RULES IX. References The following reference is on display in the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the website addresses, as of the date this document publishes VerDate Sep<11>2014 15:59 May 02, 2018 Jkt 244001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 54 [TD 9744] RIN 1545–BJ45, 1545–BJ50, 1545–BJ62, 1545–BJ57 DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Part 2590 RIN 1210–AB72 DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 144, 146, and 147 [CMS–9993–N] RIN 0938–AS56 Clarification of Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; and Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Final rule; clarification. AGENCY: Common or usual name of crabmeat BILLING CODE 4164–01–P 19431 On November 18, 2015, the Departments of Labor, Health and Human Services, and the Treasury (the Departments) published a final rule in the Federal Register titled ‘‘Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act’’ (the November 2015 final rule), regarding, in part, the coverage of emergency services by nongrandfathered group health plans and health insurance issuers offering nongrandfathered group or individual health insurance coverage, including the requirement that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage limit cost-sharing for out-ofnetwork emergency services and, as part of that rule, pay at least a minimum amount for out-of-network emergency services. The American College of SUMMARY: E:\FR\FM\03MYR1.SGM 03MYR1

Agencies

[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Rules and Regulations]
[Pages 19429-19431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09371]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 102

[Docket No. FDA-2018-N-1438]
RIN 0910-AI04


Crabmeat; Amendment of Common or Usual Name Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
common or usual name

[[Page 19430]]

regulation for crabmeat by replacing ``brown king crabmeat'' with 
``golden king crabmeat'' as the common or usual name for crabmeat 
derived from the species Lithodes aequispinus. We are taking this 
action due to a recently enacted law. We are also correcting an error 
in the placement of a scientific term, which is editorial in nature.

DATES: This rule is effective May 3, 2018. The compliance date for this 
rule is January 1, 2020.

ADDRESSES: For access to the docket, go to https://www.regulations.gov 
and insert the docket number found in brackets in the heading of this 
final rule into the ``Search'' box and follow the prompts, and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-5316, 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Overview of Final Rule
II. Background and Legal Authority
III. Compliance Date
IV. Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Consultation and Coordination With Indian Tribal Governments
IX. References

I. General Overview of Final Rule

    This rule amends Sec.  102.50 (21 CFR 102.50) to designate ``golden 
king crabmeat'' as the sole common or usual name of crabmeat derived 
from the species Lithodes aequispinus. The regulation at Sec.  102.50 
currently lists ``brown king crabmeat'' as the common or usual name of 
crabmeat derived from the species Lithodes aequispina. In addition to 
replacing the common or usual name, we are revising the scientific name 
to read as Lithodes aequispinus, in accordance with a recently enacted 
law designating the acceptable market name of the species as ``golden 
king crab.'' We are also correcting Sec.  102.50 so that Paralithodes 
platypus appears under the ``Scientific name of crab'' column for King 
crabmeat.

II. Background and Legal Authority

    In the Federal Register of July 3, 1995 (60 FR 34459), we published 
a final rule amending the common or usual name provisions for crabmeat, 
to provide that the common or usual name of crabmeat derived from the 
species Lithodes aequispina is ``brown king crabmeat.''
    On May 5, 2017, the Consolidated Appropriations Act, 2017 (Pub. L. 
115-31), was signed into law. Section 774 of the Consolidated 
Appropriations Act, 2017, provides that, for purposes of applying the 
Federal Food, Drug, and Cosmetic Act (FD&C Act), the acceptable market 
name of Lithodes aequispinus is ``golden king crab.''
    The final rule amends Sec.  102.50 to reflect the common or usual 
name of crabmeat derived from Lithodes aequispinus as provided by the 
Consolidated Appropriations Act, 2017, and to revise the scientific 
name of the species. The final rule also corrects Sec.  102.50 to move 
the scientific name for King crabmeat, Paralithodes platypus, from the 
``Common or usual name of crabmeat'' column to the ``Scientific name of 
crab'' column.
    FDA finds good cause for issuing this amendment as a final rule 
without notice and comment because this amendment only updates the 
regulation to align with the law enacted by the Consolidated 
Appropriations Act, 2017 (5 U.S.C. 553(b)(B)). (``[W]hen regulations 
merely restate the statute they implement, notice-and-comment 
procedures are unnecessary.'' Gray Panthers Advocacy Committee v. 
Sullivan, 936 F.2d 1284, 1291 (DC Cir. 1991); see also Komjathy v. Nat. 
Trans. Safety Bd., 832 F.2d 1294, 1296 (DC Cir. 1987), cert. denied, 
486 U.S. 1057 (1988) (when a rule ``does no more than repeat, virtually 
verbatim, the statutory grant of authority,'' notice-and-comment 
procedures are not required)).) Therefore, we are issuing this 
amendment as a final rule, and publication of this document constitutes 
final action under the Administrative Procedure Act (APA) (5 U.S.C. 
553).
    In addition, we find good cause for this amendment to become 
effective on the date of publication of this action. The APA allows an 
effective date less than 30 days after publication as ``provided by the 
agency for good cause found and published with the rule'' (5 U.S.C. 
553(d)(3)). A delayed effective date is unnecessary in this case 
because the new requirements regarding golden king crab are already 
effective as a matter of law and because moving the scientific name for 
King crabmeat is a ministerial action. Therefore, we find good cause 
for this amendment to become effective on the date of publication of 
this action.

III. Compliance Date

    With respect to a compliance date, we intend that any adjustments 
to a product's labeling occur in a manner consistent with our uniform 
compliance date (see 81 FR 85156, November 25, 2016). Thus, the 
compliance date is January 1, 2020.

IV. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this final rule is not a significant regulatory action as 
defined by Executive Order 12866 and is not a deregulatory action for 
purposes of Executive Order 13771.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. We estimate that the mean cost per crab covered by the final 
rule is $0.23 (2016$). We estimate that the revenue per crab covered by 
the final rule ranges from $17.65 to $99.42 (2016$). Because the cost 
per crab covered by the final rule as a percentage of the revenue per 
crab covered by the final rule is small, ranging from 0.2 percent to 
1.3 percent, we certify that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $148 
million, using the most current (2016) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule.

[[Page 19431]]

The full analysis of economic impacts is available in the docket for 
this final rule (Ref. 1).

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) 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.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VIII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects 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. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

IX. References

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. FDA, ``Crabmeat; Amendment of Common or Usual Name Regulation: 
Final Regulatory Impact Analysis,'' 2017. Also available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 102

    Beverages, Food grades and standards, Food labeling, Frozen foods, 
Oils and fats, Onions, Potatoes, Seafood.

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

PART 102--COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS

0
1. The authority citation for part 102 continues to read as follows:

    Authority: 21 U.S.C. 321, 343, 371.


0
2. In Sec.  102.50 revise the table to read as follows:


Sec.  102.50  Crabmeat.

* * * * *

------------------------------------------------------------------------
                                               Common or usual name of
          Scientific name of crab                     crabmeat
------------------------------------------------------------------------
Chionoecetes opilio, Chionoecetes tanneri,  Snow crabmeat.
 Chionoecetes bairdii, and Chionoecetes
 angulatus.
Erimacrus isenbeckii......................  Korean variety crabmeat or
                                             Kegani crabmeat.
Lithodes aequispinus......................  Golden King crabmeat.
Paralithodes brevipes.....................  King crabmeat or Hanasaki
                                             crabmeat.
Paralithodes camtschaticus and              King crabmeat.
 Paralithodes platypus.
------------------------------------------------------------------------


    Dated: April 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09371 Filed 5-2-18; 8:45 am]
BILLING CODE 4164-01-P


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