Federal Register - December 8, 2021

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Source: Federal Register

Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Rules and Regulations reorganization of its fuel-related regulations.
These rule revisions are effective on December 8, 2021.
FOR FURTHER INFORMATION CONTACT:
Hampton Newsome 2023262889, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, Room CC9528, 600
Pennsylvania Avenue NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION:
DATES:

I. Conforming Amendment Recently, EPA issued amendments streamlining its fuel quality regulations 85 FR 78412 Dec. 4, 2020. As part of this process, EPA transferred regulations that are cross-referenced in the FTCs Fuel Rating Rule from 40 CFR part 80
to a new 40 CFR part 1090. To conform to these changes, the FTC amends 306.10 of its Fuel Rating Rule to update a reference to EPAs ethanol labeling requirements in paragraph a.
Specifically, in 16 CFR 306.10a, the amendment removes the reference to 40
CFR 80.1501 and adds, in its place, a reference to 40 CFR 1090.1510 the new location of those same EPA
requirements.

jspears on DSK121TN23PROD with RULES1

II. Procedural Requirements There is good cause for adopting this final rule without advance public notice or an opportunity for public comment.1
The amendment published in this document merely updates a cross reference to an EPA fuel quality rule referenced in the Commissions Rule.
This minor technical revision does not change any substantive obligations under the Rule or create new requirements. In addition, under the Administrative Procedure Act, a final rule may be made effective without 30
days advance publication in the Federal Register if an agency finds good cause.
Prompt adoption of this amendment is necessary to avoid confusion by updating the Rules reference to EPAs ethanol labeling requirement. Therefore, this final rule is effective upon publication in the Federal Register.
The Office of Management and Budget OMB has approved the information collections contained in the Rule through September 30, 2023 OMB
Control No. 30840068. Since this amendment only updates a crossreference to existing EPA requirements, 1 Notice and comment are not required when the agency for good cause finds and incorporates the finding and a brief statement of reasons therefore in the rules issued that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C.
553b3B.

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it does not change the Rules information collection requirements and does not require further OMB clearance.
The requirements of the Regulatory Flexibility Act also do not apply.2
Pursuant to the Congressional Review Act 5 U.S.C. 801 et seq., the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 8042.
List of Subjects in 16 CFR Part 306
Fuel, Fuel ratings, Gasoline, Trade practices.
For the reasons discussed in the preamble, the Federal Trade Commission amends part 306 of Title 16
of the Code of Federal Regulations as follows:
PART 306AUTOMOTIVE FUEL
RATINGS, CERTIFICATION AND
POSTING
1. The authority citation for part 306
continues to read as follows:

Authority: 15 U.S.C. 2801 et seq.; 42 U.S.C.
17021.
306.10

Amended
2. In 306.10, in paragraph a, remove 40 CFR 80.1501 and add in its place 40 CFR 1090.1510.

April J. Tabor, Secretary.
FR Doc. 202126558 Filed 12721; 8:45 am BILLING CODE 675001P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 890
Docket No. FDA2021P0424

Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final amendment; final order.

The Food and Drug Administration FDA or Agency is publishing an order setting forth the final determination of a petition requesting exemption from premarket notification 510k requirements for the generic device type, powered patient transport, all other powered patient
SUMMARY:

2 A regulatory flexibility analysis under the RFA
is required only when an agency must publish a notice of proposed rulemaking for comment. See 5
U.S.C. 603.

PO 00000

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transport product code ILK, classified as class II devices. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. These devices do not include motorized threewheeled vehicles or wheelchairs, and are distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation product code PCD. FDA is publishing this order in accordance with procedures established in the Federal Food, Drug, and Cosmetic Act FD&C Act.
DATES: This order is effective December 8, 2021.
FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1526, Silver Spring, MD 209930002, 2404024717.
SUPPLEMENTARY INFORMATION:
I. Statutory Background Section 510k of the FD&C Act 21
U.S.C. 360k and its implementing regulations in part 807, subpart E 21
CFR part 807, subpart E require persons who propose to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use to submit a 510k to FDA.
The device may not be marketed until FDA finds it substantially equivalent within the meaning of section 513i of the FD&C Act 21 U.S.C. 360ci to a legally marketed device that does not require premarket approval.
On November 21, 1997, the President signed into law the Food and Drug Administration Modernization Act of 1997 FDAMA Pub. L. 105115, section 206 of which added section 510m to the FD&C Act, which was amended on December 13, 2016, by the 21st Century Cures Act Cures Act Pub. L. 114255. Section 510m1 of the FD&C Act, requires FDA to publish in the Federal Register a list of each type of class II device that does not require a report under section 510k of the FD&C Act to provide reasonable assurance of safety and effectiveness.
Section 510m of the FD&C Act further provides that a 510k will no longer be required for these devices upon the date of publication of the list in the Federal Register. FDA published the required lists in accordance with FDAMA and the Cures Act, in the Federal Register of January 21, 1998 63 FR 3142, and July 11, 2017 82 FR 31976, respectively.

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Federal Register - December 8, 2021

TitoloFederal Register

PaeseStati Uniti

Data08/12/2021

Conteggio pagine406

Numero di edizioni7792

Prima edizione14/03/1936

Ultima edizione10/06/2026

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