Designation of Authority, 66458-66459 [2021-25455]

Download as PDF 66458 Federal Register / Vol. 86, No. 223 / Tuesday, November 23, 2021 / Rules and Regulations At the time of classification, general laparoscopic power morcellation containment systems are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met. 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. lotter on DSK11XQN23PROD with RULES1 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 the guidance document ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ have been approved under OMB control number 0910–0844; the collections of information in 21 CFR 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 regulations, have been approved under OMB control number 0910–0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910–0485. List of Subjects in 21 CFR Part 878 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 878 is amended as follows: PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for part 878 continues to read as follows: ■ VerDate Sep<11>2014 16:32 Nov 22, 2021 Jkt 256001 Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 878.4825 to subpart E to read as follows: ■ § 878.4825 General laparoscopic power morcellation containment system. (a) Identification. A general laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate the sterility of patientcontacting components of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Demonstration of the device impermeability to tissue, cells, and fluids; (ii) Demonstration that the device allows for the insertion/withdrawal of laparoscopic instruments while maintaining pneumoperitoneum; (iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera; (iv) Demonstration that compatible laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and (v) Demonstration that users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents. (5) Training must be developed and validated to ensure users can follow the instructions for use. (6) Labeling must include: (i) A contraindication for use in gynecological procedures; PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 (ii) A contraindication against use of tissue that is known or suspected to contain malignancy; (iii) The following boxed warning: ‘‘Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. The use of laparoscopic power morcellators may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk;’’ (iv) A statement limiting use of device to physicians who have completed the training program; and (v) A shelf life. Dated: November 17, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–25585 Filed 11–22–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF JUSTICE 28 CFR Part 0 [Directive No. 2021–001] Designation of Authority Office of the Assistant Attorney General, Criminal Division, Department of Justice. ACTION: Final rule. AGENCY: The Attorney General has authorized the Assistant Attorney General for the Criminal Division to perform the functions of the ‘‘Designated Authority’’ under executive agreements between the United States and other countries on access to data by foreign governments and to delegate that authority to certain officials in the Office of International Affairs (‘‘OIA’’). Consistent with that authorization, the Assistant Attorney General for the Criminal Division delegates authority to perform the functions of the Designated Authority pursuant to such agreements to the Deputy Assistant Attorneys General, Criminal Division, and the Director, Deputy Directors and the Associate Director supervising the implementation of such agreements in OIA. SUMMARY: DATES: Effective November 23, 2021. FOR FURTHER INFORMATION CONTACT: Vaughn Ary, Director, Office of International Affairs, Criminal Division, U.S. Department of Justice, Washington, DC 20005; Telephone (202) 514–0000. SUPPLEMENTARY INFORMATION: Congress authorized the United States to enter into executive agreements with foreign governments under which the parties afford each other reciprocal rights of E:\FR\FM\23NOR1.SGM 23NOR1 Federal Register / Vol. 86, No. 223 / Tuesday, November 23, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 access to data covered by such agreements in response to qualifying, lawful orders. See Clarifying Lawful Overseas Use of Data Act, Public Law 115–141, Div. V, Section 105(a) (March 23, 2018), 18 U.S.C. 2523 (‘‘CLOUD Act’’). The first such executive agreement was concluded between the Government of the United States of America and the Government of the United Kingdom of Great Britain and Northern Ireland. See Agreement between the Government of the United States of America and the Government of the United Kingdom of Great Britain and Northern Ireland on Access to Electronic Data for the Purpose of Countering Serious Crime (October 3, 2019), available at https:// www.justice.gov/dag/cloudact (the ‘‘U.S.—U.K. Agreement’’). The U.S.— U.K. Agreement provides that a ‘‘Designated Authority’’ for each country shall perform certain, specified functions necessary to implement the agreement. As applied to the United States, ‘‘Designated Authority’’ is defined under the agreement as ‘‘the governmental entity designated . . . by the Attorney General.’’ Id. at Article 1.8. To address the requirements of this executive agreement, the Attorney General has designated the Criminal Division as the ‘‘Designated Authority’’ in a Federal Register notice published on October 23, 2020. The Attorney General has authorized the Assistant Attorney General in charge of the Criminal Division to perform the functions of the Designated Authority and also to delegate this authority. 28 CFR 0.64–6. This final rule delegates that authority to officials in the Criminal Division and OIA. To address future agreements of this nature, this final rule applies to any executive agreement under 18 U.S.C. 2523 that either designates the Attorney General or the Department of Justice as the Designated Authority or authorizes the Attorney General to designate a Designated Authority (or like designation), and for which the Attorney General has designated the Criminal Division as such authority. Administrative Procedure Act—5 U.S.C. 553 This rule is a rule of agency organization and relates to a matter relating to agency management and is therefore exempt from the requirements of prior notice and comment and a 30day delay in the effective date. See 5 U.S.C. 553(a)(2), 553(b)(3)(A), 553(d). Regulatory Flexibility Act Further, a Regulatory Flexibility Analysis is not required to be prepared VerDate Sep<11>2014 16:32 Nov 22, 2021 Jkt 256001 for this final rule because the Department was not required to publish a general notice of proposed rulemaking for this matter. 5 U.S.C. 604(a). Executive Orders 12866 and 13563— Regulatory Review This action has been drafted and reviewed in accordance with section 1(b) of Executive Order 12866, ‘‘Regulatory Planning and Review,’’ and section 1(b) of Executive Order 13563, ‘‘Improving Regulation and Regulatory Review.’’ This rule is limited to agency organization, management, and personnel as described in section 3(d)(3) of Executive Order 12866 and, therefore, is not a ‘‘regulation’’ or ‘‘rule’’ as defined by the order. Accordingly, this action has not been reviewed by the Office of Management and Budget. Executive Order 13132—Federalism This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. Executive Order 12988—Civil Justice Reform This rule was drafted in accordance with the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988. Unfunded Mandates Reform Act of 1955 This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector of $100,000,000 or more in any one year (adjusted annually for inflation), and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act Frm 00057 Fmt 4700 Sfmt 4700 List of Subjects in 28 CFR Part 0 International agreements, Treaties. For the reasons stated in the preamble, part 0 of title 28 of the Code of Federal Regulations is amended as follows: PART 0—ORGANIZATION OF THE DEPARTMENT OF JUSTICE 1. The authority citation for part 0 continues to read as follows: ■ Authority: 5 U.S.C. 301; 28 U.S.C. 509, 510, 515–519. 2. Add Directive No. 2021–001 at the end of Appendix to Subpart K to read as follows: ■ Appendix to Subpart K of Part 0 Criminal Division * * * * * Directive No. 2021–001 Designated Authority under executive agreements on access to data by foreign governments. By virtue of the authority vested in me by § 0.64–6 of Title 28 of the Code of Federal Regulations, I hereby delegate the authority to perform the functions of the Designated Authority under executive agreements between the United States of America and other countries regarding access to data by foreign governments, negotiated pursuant to the authority in 18 U.S.C. 2523, to the Deputy Assistant Attorneys General, Criminal Division, and the Director, the Deputy Directors and the Associate Director supervising implementation of such agreements in the Office of International Affairs. This delegation applies to executive agreements that either designate the Attorney General or the Department of Justice as the Designated Authority (or like designation) or authorize the Attorney General to designate a Designated Authority (or like designation), and for which the Attorney General has designated the Criminal Division as such authority. Dated: October 7, 2021. Kenneth A. Polite, Jr., Assistant Attorney General. [FR Doc. 2021–25455 Filed 11–22–21; 8:45 am] BILLING CODE 4410–14–P LIBRARY OF CONGRESS Copyright Royalty Board This action pertains to agency management, personnel, and organization and does not substantially affect the rights or obligations of nonagency parties and, accordingly, is not a ‘‘rule’’ as that term is used by the Congressional Review Act, 5 U.S.C. 804(3)(B), (C). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply. PO 00000 66459 37 CFR Part 381 [Docket No. 21–CRB–0011–PBR (2018– 2022) COLA (2022)] Cost of Living Adjustment to Public Broadcasters Compulsory License Royalty Rate Copyright Royalty Board, Library of Congress. AGENCY: E:\FR\FM\23NOR1.SGM 23NOR1

Agencies

Department of Justice

[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Rules and Regulations]
[Pages 66458-66459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25455]


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DEPARTMENT OF JUSTICE

28 CFR Part 0

[Directive No. 2021-001]


Designation of Authority

AGENCY: Office of the Assistant Attorney General, Criminal Division, 
Department of Justice.

ACTION: Final rule.

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

SUMMARY: The Attorney General has authorized the Assistant Attorney 
General for the Criminal Division to perform the functions of the 
``Designated Authority'' under executive agreements between the United 
States and other countries on access to data by foreign governments and 
to delegate that authority to certain officials in the Office of 
International Affairs (``OIA''). Consistent with that authorization, 
the Assistant Attorney General for the Criminal Division delegates 
authority to perform the functions of the Designated Authority pursuant 
to such agreements to the Deputy Assistant Attorneys General, Criminal 
Division, and the Director, Deputy Directors and the Associate Director 
supervising the implementation of such agreements in OIA.

DATES: Effective November 23, 2021.

FOR FURTHER INFORMATION CONTACT: Vaughn Ary, Director, Office of 
International Affairs, Criminal Division, U.S. Department of Justice, 
Washington, DC 20005; Telephone (202) 514-0000.

SUPPLEMENTARY INFORMATION: Congress authorized the United States to 
enter into executive agreements with foreign governments under which 
the parties afford each other reciprocal rights of

[[Page 66459]]

access to data covered by such agreements in response to qualifying, 
lawful orders. See Clarifying Lawful Overseas Use of Data Act, Public 
Law 115-141, Div. V, Section 105(a) (March 23, 2018), 18 U.S.C. 2523 
(``CLOUD Act''). The first such executive agreement was concluded 
between the Government of the United States of America and the 
Government of the United Kingdom of Great Britain and Northern Ireland. 
See Agreement between the Government of the United States of America 
and the Government of the United Kingdom of Great Britain and Northern 
Ireland on Access to Electronic Data for the Purpose of Countering 
Serious Crime (October 3, 2019), available at https://www.justice.gov/dag/cloudact (the ``U.S.--U.K. Agreement''). The U.S.--U.K. Agreement 
provides that a ``Designated Authority'' for each country shall perform 
certain, specified functions necessary to implement the agreement. As 
applied to the United States, ``Designated Authority'' is defined under 
the agreement as ``the governmental entity designated . . . by the 
Attorney General.'' Id. at Article 1.8. To address the requirements of 
this executive agreement, the Attorney General has designated the 
Criminal Division as the ``Designated Authority'' in a Federal Register 
notice published on October 23, 2020. The Attorney General has 
authorized the Assistant Attorney General in charge of the Criminal 
Division to perform the functions of the Designated Authority and also 
to delegate this authority. 28 CFR 0.64-6. This final rule delegates 
that authority to officials in the Criminal Division and OIA.
    To address future agreements of this nature, this final rule 
applies to any executive agreement under 18 U.S.C. 2523 that either 
designates the Attorney General or the Department of Justice as the 
Designated Authority or authorizes the Attorney General to designate a 
Designated Authority (or like designation), and for which the Attorney 
General has designated the Criminal Division as such authority.

Administrative Procedure Act--5 U.S.C. 553

    This rule is a rule of agency organization and relates to a matter 
relating to agency management and is therefore exempt from the 
requirements of prior notice and comment and a 30-day delay in the 
effective date. See 5 U.S.C. 553(a)(2), 553(b)(3)(A), 553(d).

Regulatory Flexibility Act

    Further, a Regulatory Flexibility Analysis is not required to be 
prepared for this final rule because the Department was not required to 
publish a general notice of proposed rulemaking for this matter. 5 
U.S.C. 604(a).

Executive Orders 12866 and 13563--Regulatory Review

    This action has been drafted and reviewed in accordance with 
section 1(b) of Executive Order 12866, ``Regulatory Planning and 
Review,'' and section 1(b) of Executive Order 13563, ``Improving 
Regulation and Regulatory Review.'' This rule is limited to agency 
organization, management, and personnel as described in section 3(d)(3) 
of Executive Order 12866 and, therefore, is not a ``regulation'' or 
``rule'' as defined by the order. Accordingly, this action has not been 
reviewed by the Office of Management and Budget.

Executive Order 13132--Federalism

    This rule will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on distribution of power and responsibilities among the various levels 
of government. Therefore, in accordance with Executive Order 13132, it 
is determined that this rule does not have sufficient federalism 
implications to warrant the preparation of a federalism summary impact 
statement.

Executive Order 12988--Civil Justice Reform

    This rule was drafted in accordance with the applicable standards 
set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

Unfunded Mandates Reform Act of 1955

    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector of 
$100,000,000 or more in any one year (adjusted annually for inflation), 
and it will not significantly or uniquely affect small governments. 
Therefore, no actions were deemed necessary under the provisions of the 
Unfunded Mandates Reform Act of 1995.

Congressional Review Act

    This action pertains to agency management, personnel, and 
organization and does not substantially affect the rights or 
obligations of non-agency parties and, accordingly, is not a ``rule'' 
as that term is used by the Congressional Review Act, 5 U.S.C. 
804(3)(B), (C).
    Therefore, the reporting requirement of 5 U.S.C. 801 does not 
apply.

List of Subjects in 28 CFR Part 0

    International agreements, Treaties.

    For the reasons stated in the preamble, part 0 of title 28 of the 
Code of Federal Regulations is amended as follows:

PART 0--ORGANIZATION OF THE DEPARTMENT OF JUSTICE

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

    Authority:  5 U.S.C. 301; 28 U.S.C. 509, 510, 515-519.

0
2. Add Directive No. 2021-001 at the end of Appendix to Subpart K to 
read as follows:

Appendix to Subpart K of Part 0

Criminal Division

* * * * *

Directive No. 2021-001

Designated Authority under executive agreements on access to data by 
foreign governments.

    By virtue of the authority vested in me by Sec.  0.64-6 of Title 
28 of the Code of Federal Regulations, I hereby delegate the 
authority to perform the functions of the Designated Authority under 
executive agreements between the United States of America and other 
countries regarding access to data by foreign governments, 
negotiated pursuant to the authority in 18 U.S.C. 2523, to the 
Deputy Assistant Attorneys General, Criminal Division, and the 
Director, the Deputy Directors and the Associate Director 
supervising implementation of such agreements in the Office of 
International Affairs. This delegation applies to executive 
agreements that either designate the Attorney General or the 
Department of Justice as the Designated Authority (or like 
designation) or authorize the Attorney General to designate a 
Designated Authority (or like designation), and for which the 
Attorney General has designated the Criminal Division as such 
authority.

    Dated: October 7, 2021.
Kenneth A. Polite, Jr.,
Assistant Attorney General.
[FR Doc. 2021-25455 Filed 11-22-21; 8:45 am]
BILLING CODE 4410-14-P

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