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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations Body system listings
Current expiration date
Neurological Disorders 11.00 and 111.00

September 29, 2021

We continue to revise and update the listings on a regular basis, including those body systems not affected by this final rule.2 We intend to update the listings affected by this final rule as necessary based on medical advances as quickly as possible, but may not be able to publish final rules revising these listings by the current expiration date.
Therefore, we are extending the expiration date listed above.
Regulatory Procedures
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Justification for Final Rule We follow the Administrative Procedure Act APA rulemaking procedures specified in 5 U.S.C. 553 in promulgating regulations. Section 702a5 of the Social Security Act, 42
U.S.C. 902a5. Generally, the APA
requires that an agency provides prior notice and opportunity for public comment before issuing a final regulation. The APA provides exceptions to the notice-and-comment requirements when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest.
We determined that good cause exists for dispensing with the notice and public comment procedures. 5 U.S.C.
553bB. This final rule only extends the date on which the Neurological Disorders body system listings will no longer be effective. It makes no substantive changes to our rules. Our current regulations 3 provide that we may extend, revise, or promulgate the body system listings again. Therefore, we determined that opportunity for prior comment is unnecessary, and we are issuing this regulation as a final rule.
In addition, for the reasons cited above, we find good cause for dispensing with the 30-day delay in the effective date of this final rule. 5 U.S.C.
553d3. We are not making any substantive changes to the Neurological Disorders body system listing. Without an extension of the expiration date for this listing, we will not have the criteria we need to assess medical impairments in the body system at step three of the sequential evaluation processes. We 2 We last revised the expiration date for the Neurological Disorders body system listings when we updated the body system on July 1, 2016 81 FR
43038, 43052.
3 See the first sentence of appendix 1 to subpart P of part 404 of 20 CFR.

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therefore find it is unnecessary to delay the effective date of this final rule.
Executive Order 12866, as Supplemented by Executive Order 13563
We consulted with the Office of Management and Budget OMB and determined that this final rule does not meet the requirements for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB did not review it. We also determined that this final rule meets the plain language requirement of Executive Order 12866.
Regulatory Flexibility Act We certify that this final rule does not have a significant economic impact on a substantial number of small entities because it affects only individuals.
Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.
Paperwork Reduction Act These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.
Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security Disability Insurance; 96.002, Social SecurityRetirement Insurance; 96.004, Social SecuritySurvivors Insurance;
96.006, Supplemental Security Income
List of Subjects in 20 CFR Part 404
Administrative practice and procedure, Blind, Disability benefits, Old-Age, Survivors and Disability Insurance, Reporting and recordkeeping requirements, Social Security.
The Acting Commissioner of the Social Security Administration, Kilolo Kijakazi, having reviewed and approved this document, is delegating the authority to electronically sign this document to Faye I. Lipsky, who is the primary Federal Register Liaison for SSA, for purposes of publication in the Federal Register.
Faye I. Lipsky, Federal Register Liaison, Office of Legislative and Congressional Affairs, Social Security Administration.

For the reasons set out in the preamble, we are amending subpart P of part 404 of chapter III of title 20 of the Code of Federal Regulations as set forth below.

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Extended expiration date September 29, 2025.

PART 404FEDERAL OLD-AGE, SURVIVORS AND DISABILITY
INSURANCE 1950
Subpart PAmended 1. The authority citation for subpart P
of part 404 continues to read as follows:

Authority: Secs. 202, 205ab and d h, 216i, 221a and hj, 222c, 223, 225, and 702a5 of the Social Security Act 42 U.S.C. 402, 405ab and dh, 416i, 421a and hj, 422c, 423, 425, and 902a5; sec. 211b, Pub. L. 104193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108203, 118 Stat. 509 42 U.S.C. 902 note.

2. Amend appendix 1 to subpart P of part 404 by revising item 12 of the introductory text before Part A to read as follows:

Appendix 1 to Subpart P of Part 404
Listing of Impairments

12. Neurological Disorders 11.00 and 111.00: September 29, 2025.

FR Doc. 202116417 Filed 73021; 8:45 am BILLING CODE 419102P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Parts 201 and 801
Docket No. FDA2015N2002
RIN 0910AI47

Regulations Regarding Intended Uses AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final rule.

The Food and Drug Administration FDA, the Agency, or we is issuing a final rule to amend its medical product intended use regulations. This final rule amends FDAs regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act FD&C
Act, the Public Health Service Act PHS
Act, and FDAs implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from
SUMMARY:

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