5590 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

part 404 of chapter III of title 20 of the 

Code of Federal Regulations as set forth 

below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950–) 

Subpart P—Determining Disability and 

Blindness 

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows: 

Authority: 42 U.S.C. 402, 405(a)–(b) and 

(d)–(h), 416(i), 421(a) and (h)–(j), 422(c), 423, 

425, and 902(a)(5)); sec. 211(b), Pub. L. 104– 

193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 

108–203, 118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. In appendix 1 to subpart P of part 

404: 

■ a. In part A, amend section 1.00C7 by 

revising paragraphs a and c; and 

■ b. In part B, amend section 101.00C7 

by revising paragraphs a and c. 

The revisions read as follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

Part A 

* * * * * 

1.00 Musculoskeletal Disorders 

* * * * * 

C. * * * 

7. * * * 

a. The term pandemic period as used in 

1.00C7c means the period beginning on April 

2, 2021, and ending on May 11, 2025. The 

term post-pandemic evaluation period as 

used in 1.00C7c means the period beginning 

on May 12, 2025, and ending on May 11, 

2029. 

* * * * * 

c. For 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 

1.22, and 1.23, all of the required criteria 

must be present simultaneously, or within a 

close proximity of time, to satisfy the level 

of severity needed to meet the listing. The 

phrase ‘‘within a close proximity of time’’ 

means that all of the relevant criteria must 

appear in the medical record within a 

consecutive 4-month period, except for 

claims determined or decided during the 

pandemic period or post-pandemic 

evaluation period. For claims determined or 

decided during the pandemic period or postpandemic evaluation period, all of the 

relevant criteria must appear in the medical 

record within a consecutive 12-month 

period. When the criterion is imaging, we 

mean that we could reasonably expect the 

findings on imaging to have been present at 

the date of impairment or date of onset. For 

listings that use the word ‘‘and’’ to link the 

elements of the required criteria, the medical 

record must establish the simultaneous 

presence, or presence within a close 

proximity of time, of all the required medical 

criteria. Once this level of severity is 

established, the medical record must also 

show that this level of severity has 

continued, or is expected to continue, for a 

continuous period of at least 12 months. 

* * * * * 

Part B 

* * * * * 

101.00 Musculoskeletal Disorders. 

* * * * * 

C. * * * 

7. * * * 

a. The term pandemic period as used in 

101.00C7c means the period beginning on 

April 2, 2021, and ending on May 11, 2025. 

The term post-pandemic evaluation period as 

used in 101.00C7c means the period 

beginning on May 12, 2025, and ending on 

May 11, 2029. 

* * * * * 

c. For 101.15, 101.16, 101.17, 101.18, 

101.20C, 101.20D, 101.22, and 101.23, all of 

the required criteria must be present 

simultaneously, or within a close proximity 

of time, to satisfy the level of severity needed 

to meet the listing. The phrase ‘‘within a 

close proximity of time’’ means that all of the 

relevant criteria must appear in the medical 

record within a consecutive 4-month period, 

except for claims determined or decided 

during the pandemic period or postpandemic evaluation period. For claims 

determined or decided during the pandemic 

period or post-pandemic evaluation period, 

all of the relevant criteria must appear in the 

medical record within a consecutive 12- 

month period. When the criterion is imaging, 

we mean that we could reasonably expect the 

findings on imaging to have been present at 

the date of impairment or date of onset. For 

listings that use the word ‘‘and’’ to link the 

elements of the required criteria, the medical 

record must establish the simultaneous 

presence, or presence within a close 

proximity of time, of all the required medical 

criteria. Once this level of severity is 

established, the medical record must also 

show that this level of severity has 

continued, or is expected to continue, for a 

continuous period of at least 12 months. 

* * * * * 

[FR Doc. 2025–01283 Filed 1–16–25; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 16 

[Docket No. FDA–2024–N–3654] 

RIN 0910–AI97 

Regulatory Hearing Before the Food 

and Drug Administration; General 

Provisions; Amendments; Withdrawal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

published in the Federal Register of 

September 20, 2024, a direct final rule 

amending the Scope section of our 

regulation that provides for a regulatory 

hearing before the Agency. The 

comment period closed December 4, 

2024. FDA is withdrawing the direct 

final rule because the Agency received 

significant adverse comment. 

DATES: The direct final rule published at 

September 20, 2024, 89 FR 77019, is 

withdrawn effective January 17, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Robert Schwartz, Center for Tobacco 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 1– 

877–287–1373, CTPRegulations@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Therefore, 

under the Federal Food, Drug, and 

Cosmetic Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, the direct final rule 

published on September 20, 2024, 89 FR 

77019 is withdrawn. 

Dated: January 13, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01145 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2022–C–0098] 

Listing of Color Additives Exempt 

From Certification; Myoglobin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the color additive regulations 

to provide for the safe use of myoglobin 

as a color additive in ground meat and 

ground poultry analogue products. We 

are taking this action in response to a 

color additive petition (CAP) submitted 

by Motif FoodWorks, Inc. (Motif 

FoodWorks or petitioner). 

DATES: This order is effective February 

19, 2025. See section X for further 

information on the filing of objections. 

Either electronic or written objections 

and requests for a hearing on the order 

must be submitted by February 18, 

2025. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 


KHAMMOND on DSK9W7S144PROD with RULES