This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

8173 

Vol. 90, No. 16 

Monday, January 27, 2025 

CONSUMER FINANCIAL PROTECTION 

BUREAU 

12 CFR Part 1022 

[Docket No. CFPB–2024–0023] 

RIN 3170–AA54 

Prohibition on Creditors and 

Consumer Reporting Agencies 

Concerning Medical Information 

(Regulation V) 

Correction 

In rule document 2024–30824, 

appearing on pages 3276–3374 in the 

issue of Tuesday, January 14, 2025, 

make the following correction: 

On page 3276, in the first column, in 

the DATES section, ‘‘March 17, 2024’’ 

should read ‘‘March 17, 2025’’. 

[FR Doc. C1–2024–30824 Filed 1–24–25; 8:45 am] 

BILLING CODE 0099–10–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 201 and 314 

[Docket No. FDA–2021–N–0862] 

RIN 0910–AH62 

Nonprescription Drug Product With an 

Additional Condition for 

Nonprescription Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; delay of effective 

date. 

SUMMARY: In accordance with the 

memorandum of January 20, 2025, from 

the President, entitled ‘‘Regulatory 

Freeze Pending Review,’’ the effective 

date of the final rule, entitled 

‘‘Nonprescription Drug Product With an 

Additional Condition for 

Nonprescription Use,’’ (ACNU) is 

delayed until March 21, 2025. 

DATES: The effective date for the final 

rule published December 26, 2024, (89 

FR 105288), is delayed until March 21, 

2025. 

FOR FURTHER INFORMATION CONTACT: 

Myla Dellupac, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Silver Spring, 

MD 20993–0002, 301–837–7461. 

SUPPLEMENTARY INFORMATION: 

I. Electronic Access and Filing 

A copy of the notice of proposed 

rulemaking (87 FR 38313, June 28, 

2022), all comments received, the final 

rule (89 FR 105288, December 26, 2024), 

and all background material may be 

viewed online at http://

www.regulations.gov using the docket 

number listed above. A copy of this 

document will be placed in the docket. 

Electronic retrieval help and guidelines 

are available on the website. It is 

available 24 hours each day, 365 days 

each year. An electronic copy of this 

document may also be downloaded 

from the Office of the Federal Register’s 

website at http://www.ofr.gov and the 

Government Publishing Office’s website 

at http://www.gpo.gov. 

II. Background 

FDA published a final rule, titled 

‘‘Nonprescription Drug Product With an 

Additional Condition for 

Nonprescription Use,’’ in the Federal 

Register on December 26, 2024 (89 FR 

105288). That rule was published with 

an effective date of January 27, 2025. On 

January 20, 2025, the President issued a 

memorandum titled, ‘‘Regulatory Freeze 

Pending Review.’’ With respect to rules 

that have been published in the Federal 

Register, but have not taken effect, the 

memorandum orders agencies consider 

postponing the rules’ effective dates for 

60 days from the date of the 

memorandum (i.e., until March 21, 

2025) for the purpose of reviewing any 

questions of fact, law, and policy the 

rules may raise. 

In accordance with this direction, 

FDA has decided to delay the effective 

date of the final rule, ‘‘Nonprescription 

Drug Product With an Additional 

Condition for Nonprescription Use’’ (89 

FR 105288), until March 21, 2025. The 

final rule establishes requirements for a 

nonprescription drug product with an 

ACNU, including application, labeling, 

and postmarketing reporting 

requirements. In addition to applicable 

existing application requirements, the 

final rule establishes the specific 

requirements for a new drug application 

(NDA) or abbreviated new drug 

application (ANDA) for a 

nonprescription drug product with an 

ACNU. In circumstances where a 

prescription drug product is already 

approved, the rule requires an applicant 

to submit a separate application for the 

approval of a nonprescription drug 

product with an ACNU, rather than a 

supplement to the existing application 

for the approved prescription drug 

product. The final rule establishes 

specific labeling requirements, 

including the content and format of 

specific labeling statements. 

Additionally, the rule requires that an 

applicant submit a postmarketing report 

of an ACNU failure. The final rule 

clarifies that an ACNU constitutes a 

meaningful difference between a 

prescription drug product and a 

nonprescription drug product that 

makes the nonprescription drug product 

safe and effective for use without the 

supervision of a practitioner licensed by 

law to administer such drug; therefore, 

a prescription drug product and a 

nonprescription drug product with an 

ACNU with the same active ingredient 

may be simultaneously marketed even if 

they do not have meaningful differences 

other than the ACNU, such as different 

indications or strengths. The final rule 

specifies that FDA will refuse to 

approve an application for a 

nonprescription drug product with an 

ACNU if the application fails to meet 

applicable requirements. The final rule 

exempts a nonprescription drug product 

with an ACNU from the requirement to 

be labeled with adequate directions for 

use, provided that certain labeling 

conditions are met and the ACNU is 

implemented by the applicant as 

approved by FDA. Finally, the final rule 

explains certain circumstances in which 

a nonprescription drug product with an 

ACNU would be misbranded. 

To the extent that 5 U.S.C. 553 applies 

to this action, it is exempt from notice 

and comment because it constitutes a 

rule of procedure under 5 U.S.C. 

553(b)(A). Alternatively, FDA’s 

implementation of this action without 

opportunity for public comment, 

effective immediately, is based on the 

good cause exceptions in 5 U.S.C. 

553(b)(B) and (d)(3). Seeking public 


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8174 Federal Register / Vol. 90, No. 16 / Monday, January 27, 2025 / Rules and Regulations 

1 In the event that this rule does not publish on 

or before January 27, 2025, good cause similarly 

exists to stay the effectiveness of the rule published 

December 26, 2024, and revise its effective date 

until March 21, 2025. 

1See Department of Transportation, Pipeline and 

Hazardous Materials Safety Administration, 

Hazardous Materials: Harmonization With 

International Standards, 89 FR 25434, 25490 (Apr. 

10, 2024). 

comment is impracticable, unnecessary, 

and contrary to the public interest. The 

temporary delay in the effective date 

until March 21, 2025, is necessary to 

give Agency officials the opportunity for 

further review and consideration of the 

new regulation, consistent with the 

memorandum described previously. 

Given the imminence of the effective 

date and the brief length of the 

extension of the effective date, seeking 

prior public comment on this temporary 

delay would have been impracticable, as 

well as contrary to the public interest in 

the orderly promulgation and 

implementation of regulations.1 FDA 

also believes that affected entities need 

to be informed as soon as possible of the 

extension and its length in order to plan 

and adjust their implementation process 

accordingly. 

Dorothy A. Fink, 

Acting Secretary. 

[FR Doc. 2025–01840 Filed 1–24–25; 8:45 am] 

BILLING CODE 4164–01–P 

POSTAL SERVICE 

39 CFR Parts 111 and 211 

New Mailing Standards for Hazardous 

Materials Outer Packaging and 

Nonregulated Toxic Materials 

AGENCY: Postal ServiceTM. 

ACTION: Final rule. 

SUMMARY: The Postal Service is 

amending Publication 52, Hazardous, 

Restricted, and Perishable Mail (Pub 52 

or Publication 52) by adding new 

section 131 to require specific outer 

packaging when mailing most 

hazardous materials (HAZMAT) or 

dangerous goods (DG), to remove 

quantity restrictions for nonregulated 

toxic materials, and to remove the 

telephone number requirement from the 

lithium battery mark. 

DATES: Effective January 27, 2025. 

Applicable beginning January 19, 2025. 

FOR FURTHER INFORMATION CONTACT: Dale 

Kennedy, (202) 268–6592, or Jennifer 

Cox, (202) 268–2108. 

SUPPLEMENTARY INFORMATION: The Postal 

Service amends Publication 52, 

Hazardous, Restricted, and Perishable 

Mail (Pub 52 or Publication 52), with 

the provisions set forth herein. While 

not codified in title 39 of the Code of 

Federal Regulations (CFR), Publication 

52 is a regulation of the Postal Service, 

and changes to it may be published in 

the Federal Register. 39 CFR 211.2(a)(2). 

Moreover, Publication 52 is 

incorporated by reference into Mailing 

Standards of the United States Postal 

Service, Domestic Mail Manual (DMM) 

section 601.8.1, which is incorporated 

by reference, in turn, into the Code of 

Federal Regulations. 39 CFR 111.1 and 

111.3. Publication 52 is publicly 

available, in a read-only format, via the 

Postal Explorer® website at https://

pe.usps.com. In addition, links to Postal 

Explorer are provided on the landing 

page of USPS.com, the Postal Service’s 

primary customer-facing website, and 

on Postal Pro, an online informational 

source available to postal customers. 

Summary of New Measures 

The Postal Service is the sole 

regulatory authority for the mail but 

aligns with regulations within 49 CFR in 

some instances. Per the regulations in 

49 CFR 171.1(d)(7) the Postal Service is 

not subject to the regulations in the 

Hazardous Materials Regulations 

(HMR). Due to the increase of 

eCommerce shipping over the last 

several years, HAZMAT/Dangerous 

Goods (DG) incidents have increased 

significantly. Historic postal data from 

2020 through 2022, showed a significant 

increase in HAZMAT/DG incidents, 

which prompted the Postal Service to 

implement new policies requiring 

mailers to present HAZMAT/DG 

separately from non-HAZMAT/DG and 

to include HAZMAT Service Type 

Codes (STC) and Extra Service Codes 

(ESC) when packages contain 

HAZMAT/DG. These requirements, at 

least in part, resulted in a 20% 

reduction of overall HAZMAT/DG 

incidents in 2023. 

Except as otherwise specified below, 

the Postal Service will require mailers 

shipping HAZMAT or DG to utilize 

rigid outer packaging that meets a 

minimum edge crush test requirement 

of at least 32 or 200 lbs. burst test 

strength for packages weighing 20 

pounds or less and at least 44 edge 

crush test or 275 lbs. burst test strength 

for packages weighing more than 20 

pounds. By implementing these 

requirements, the capability of packages 

to withstand normal processing and 

handling from induction to delivery 

point will be increased, reducing the 

overall potential for HAZMAT or DG 

incidents. 

Previously, the uses of padded and 

poly bags as outer packaging were 

permitted only when the mailpiece 

contained button cell batteries installed 

in the equipment/device they operate. 

This change will now allow mailers to 

use padded or poly bags as outer 

packaging for shipments containing 

lithium batteries installed in the new or 

manufacturer refurbished equipment/ 

device they operate when placed within 

in a secondary container (i.e., the 

manufacturer’s box) that can withstand 

a 1.2-meter drop test, and only if they 

do not display and are not required to 

display HAZMAT text, marks or labels 

as provided in sections 349.221a6, 

622.51f, and 622.52g of Publication 52. 

The Postal Service will remove 

quantity restrictions for nonregulated 

liquid and solid toxic materials, for 

products such as pesticides, 

insecticides, and herbicides in section 

346.232 of Publication 52, but any such 

items must be contained within outer 

packaging meeting the requirements of 

section 131 of Publication 52. 

Lastly, the Postal Service will align 

with Pipeline and Hazardous Materials 

Safety Administration’s (PHMSA) 

decision to remove the telephone 

number requirement from the lithium 

battery mark.1 The Postal Service 

encourages mailers to switch to a mark 

that does not include a telephone 

number as soon as possible and be fully 

compliant by January 1, 2027. 

This new rule reduces complexity and 

provides consistency for all customers. 

Therefore, the Postal Service believes 

this rule will provide a continued 

reduction in incidents and enhance the 

safety of our employees, our networks, 

and our transportation partners. 

Response to Comments 

In response to the proposed rule (88 

FR 86868, December 15, 2023), the 

Postal Service received six formal 

responses to the proposed changes. 

The comments received are as 

follows: 

Comment: One commenter requested 

a 60-day extension to the public 

comment period. 

Response: The Postal Service was 

unable to grant this request. 

Comment: One commenter indicated 

they didn’t believe outer packaging 

requirements should be based on the 

weight of hazardous materials, but 

instead on the total package weight and 

provided alternate language for new 

section 131. 

Response: The Postal Service agrees 

with the alternate language and has 

incorporated it within new section 131. 

Comment: One commenter indicated 

that the last sentence of proposed 

section 131 was very obtuse and may be 

misconstrued that it is applicable to 


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