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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations 11 After a De Novo request is accepted for review under 860.230b, the requester makes significant unsolicited changes to the devices:
i Indications for use; or ii Technological characteristics.
d An order declining a De Novo request will inform the requester of the deficiencies in the De Novo request, including each applicable ground for declining the De Novo request.
e FDA will use the criteria specified in 860.7 to determine the safety and effectiveness of a device in deciding whether to grant or decline a De Novo request. FDA may use information other than that submitted by the requester in making such determination.
Dated: September 30, 2021.
Janet Woodcock, Acting Commissioner of Food and Drugs.
FR Doc. 202121677 Filed 10421; 8:45 am BILLING CODE 416401P

FEDERAL MEDIATION AND
CONCILIATION SERVICE
29 CFR Part 1400
RIN 3076AA19

Outside Employment, Business Activities, or Interests Regulation Federal Mediation and Conciliation Service.
ACTION: Final rule; rescission of regulation.
AGENCY:

On August 7, 1992, the Office of Government Ethics OGE published a final rule entitled Supplemental Agency Regulations requiring Federal agencies creating supplemental ethics regulations to submit such regulations to OGE for concurrence and joint issuance within their regulations. In accordance with Supplemental Agency Regulations, this final rule rescinds the current Federal Mediation and Conciliation Service FMCS
supplemental ethics regulation Outside employment, business activities, or interests.
DATES: This final rule is effective October 5, 2021.
FOR FURTHER INFORMATION CONTACT:
Alisa Silverman, Attorney-Advisor, Office of General Counsel, Federal Mediation and Conciliation Service, 250
E St. SW, Washington, DC 20427;
Office/Fax/Mobile 2026065488;
asilverman@fmcs.gov.
SUPPLEMENTARY INFORMATION:

lotter on DSK11XQN23PROD with RULES1

SUMMARY:

I. Discussion On April 13, 1968, at 33 FR 5765, the Federal Mediation and Conciliation
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17:01 Oct 04, 2021

Jkt 256001

54851

Service FMCS published a final rule entitled Outside employment, business activities, and interests. This final rule implemented ethics regulations concerning outside activities.
On August 7, 1992, at 57 FR 35042, the Office of Government Ethics OGE
published a rule Supplemental Agency Regulations requiring Federal agencies creating supplemental ethics regulations to submit such regulations to OGE for concurrence and joint issuance within title 5 of the Code of Federal Regulations.
In accordance with 5 CFR 2635.105, FMCS is working jointly with OGE to develop new supplemental agency regulations to be published by OGE
within title 5 of the Code of Federal Regulations. Therefore, FMCS is issuing this final rule, which rescinds the current rule on outside employment, business activities, and interests within title 29 of the Code of Federal Regulations.

Authority: E.O. 11222, 30 FR 6469, 3 CFR, 1965 Supp.; 5 CFR 735.104.

II. Final Rule
AGENCY:

FMCS has determined that this rule is suitable for final rulemaking. The revisions to FMCS policies and requirements surrounding outside activities are purely internal matters of agency management, as well as the agencys procedure, and practice.
Accordingly, FMCS is not required to engage in a notice and comment process to issue this rule under the Administrative Procedures Act, See U.S.C. 553a2, 553bA.
Furthermore, because this rule is procedural rather than substantive, the normal requirement of 5 U.S.C. 553d that a rule not be effective until at least 30 days after publication in the Federal Register is inapplicable. FMCS also finds good cause to provide an immediate effective date for this rule because it imposes no obligations on parties outside the Federal Government and therefore no advance notice is required to enable employers or other private parties to come into compliance.
List of Subjects in 29 CFR Part 1400
Administrative practice and procedure.
For the reasons discussed in the preamble, and under the authority 29
U.S.C. 172 of Taft Harley Act of 1947, and 5 U.S.C. 7301, FMCS amends 29
CFR chapter XII as follows:
PART 1400STANDARDS OF
CONDUCT, RESPONSIBILITIES, AND
DISCIPLINE
1. The authority citation for part 1400
continues to read as follows:

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1400.73512

Removed
2. Remove 1400.73512.

Issued in Washington, DC.
Sarah Cudahy, General Counsel.
FR Doc. 202121716 Filed 10421; 8:45 am BILLING CODE 673201P

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard 33 CFR Part 117
Docket No. USCG20200647
RIN 1625AA09

Drawbridge Operation Regulation; New Jersey Intracoastal Waterway, Point Pleasant, NJ; Correction Coast Guard, Department of Homeland Security DHS.
ACTION: Correcting amendments.
The Coast Guard published a final rule in the Federal Register on August 23, 2021, which was effective on September 22, 2021, announcing changes to the Route 88 Veterans Memorial Bridge and Route 13
Lovelandtown Bridge across the NJICW at Point Pleasant Canal, mile 3.0
and 3.9, respectively at Point Pleasant, NJ. The amendatory instruction within that final rule was incorrect and the changes could not be incorporated into the CFR. This correcting amendment incorporates those changes into the CFR.
DATES: The correction is effective on October 5, 2021.
ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https
www.regulations.gov, type USCG2020
0647. In the SEARCH box and click SEARCH. Click on Open Docket Folder on the line associated with this rulemaking.
FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Mr. Mickey Sanders, Bridge Administration Branch, Fifth District, U.S. Coast Guard, telephone 757 398
6587, email Mickey.D.Sanders2@
uscg.mil.
SUMMARY:

SUPPLEMENTARY INFORMATION:

Correction On August 23, 2021, the Coast Guard published a final rule titled Drawbridge Operation Regulation; New
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