Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 77019 

Issued in Washington, DC, on September 

16, 2024. 

Frank Lias, 

Manager, Rules and Regulations Group. 

[FR Doc. 2024–21465 Filed 9–19–24; 8:45 am] 

BILLING CODE 4910–13–C 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

issuing a direct final rule amending the 

Scope section of our regulation that 

provides for a regulatory hearing before 

the Agency in order to clarify when 

such hearings are available. We are 

revising the list of statutory provisions 

enumerated in the Scope section of the 

regulation by adding one statutory 

reference and removing a different 

statutory reference. The Agency is 

issuing these amendments directly as a 

final rule because we believe they are 

noncontroversial and FDA anticipates 

no significant adverse comments. 

DATES: This rule is effective February 3, 

2025. Either electronic or written 

comments on the direct final rule or its 

companion proposed rule must be 

submitted by December 4, 2024. If FDA 

receives no significant adverse 

comments within the specified 

comment period, the Agency intends to 

publish a document confirming the 

effective date of the final rule in the 


ddrumheller on DSK120RN23PROD with RULES1ER20SE24.009</GPH>
77020 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 

Federal Register within 30 days after 

the comment period on this direct final 

rule ends. If timely significant adverse 

comments are received, the Agency will 

publish a document in the Federal 

Register withdrawing this direct final 

rule within 30 days after the comment 

period on this direct final rule ends. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

December 4, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–3654 for ‘‘Regulatory Hearing 

Before the Food and Drug 

Administration; General Provisions; 

Amendments.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

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: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Direct Final Rule 

B. Summary of the Major Provisions of the 

Direct Final Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Direct Final Rulemaking Procedures 

III. Background 

IV. Legal Authority 

V. Description of the Direct Final Rule 

VI. Economic Analysis of Impacts 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. Consultation and Coordination With 

Indian Tribal Governments 

I. Executive Summary 

A. Purpose of the Direct Final Rule 

FDA is issuing this direct final rule to 

amend § 16.1 (21 CFR 16.1) to revise the 

list of statutory provisions enumerated 

in the Scope section of the regulation 

and thus clarify the circumstances 

under which the Agency intends to use 

the procedures in part 16 (21 CFR part 

16) for regulatory hearings. This rule 

revises the list in § 16.1 by removing 

one statutory reference and adding a 

different statutory reference under the 

same section of the same statute. 

Because we believe the rule contains 

noncontroversial changes and we do not 

expect significant adverse comment on 

the rulemaking, we are using direct final 

rulemaking procedures, as described in 

this document. 

B. Summary of the Major Provisions of 

the Direct Final Rule 

The direct final rule revises § 16.1, 

Scope, in order to clarify the 

circumstances under which the Agency 

intends to use the procedures in part 16 

for regulatory hearings. The rule amends 

the list of statutory provisions 

enumerated in § 16.1. Specifically, the 

rule removes the reference to section 

906(e)(1)(B) of the Federal Food, Drug, 

& Cosmetic Act (FD&C Act) (21 U.S.C. 

387f(e)(1)(B)) (the statutory provision 

that requires FDA to afford an 

opportunity for an oral hearing prior to 

promulgating a tobacco product 

manufacturing practice (TPMP) 

requirements regulation) and adds a 

reference to section 906(e)(2)(E) of the 

FD&C Act (the statutory provision that 

provides a petitioner an opportunity for 

an informal hearing on an order issued 

on the petitioner’s request for temporary 

or permanent exemption or variance 

from TPMP requirements). 

C. Legal Authority 

FDA is issuing this rule under 

provisions of the FD&C Act related to 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 77021 

1 ‘‘Further Amendments to General Regulations of 

the Food and Drug Administration to Incorporate 

Tobacco Products,’’ Food and Drug Administration, 

77 FR 5171, February 2, 2012. 

regulations and hearings (21 U.S.C. 

371), and general provisions respecting 

control of tobacco products, (21 U.S.C. 

387f(e)). 

D. Costs and Benefits 

This direct final rule clarifies the 

circumstances under which the Agency 

intends to use the procedures in part 16 

for a regulatory hearing. Potentially 

affected entities would include 

manufacturers of finished and bulk 

tobacco products who choose to request 

an exemption or variance from TPMP 

requirements and are afforded an 

opportunity for a hearing on orders 

regarding such requests. Because this 

rule merely clarifies which of its 

existing procedures FDA intends to use 

when conducting certain types of 

hearings under the FD&C Act, costs and 

benefits of this rule are expected to be 

minimal. 

II. Direct Final Rulemaking Procedures 

In the document titled ‘‘Guidance for 

FDA and Industry: Direct Final Rule 

Procedures,’’ announced and provided 

in the Federal Register of November 21, 

1997 (62 FR 62466), FDA described its 

procedures on when and how we will 

employ direct final rulemaking. The 

guidance may be accessed at https://

www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125166.htm. We have 

determined that this rule is appropriate 

for direct final rulemaking because we 

believe that it includes only 

noncontroversial amendments and we 

anticipate no significant adverse 

comments. Consistent with our 

procedures on direct final rulemaking, 

FDA is also publishing elsewhere in this 

issue of the Federal Register a 

companion proposed rule to clarify 

when the Agency intends to use the 

procedures under the regulation for 

regulatory hearings before the Food and 

Drug Administration. The companion 

proposed rule provides a procedural 

framework within which the rule may 

be finalized in the event that the direct 

final rule is withdrawn because of any 

significant adverse comments. The 

comment period for the direct final rule 

runs concurrently with the comment 

period for the companion proposed rule. 

Any comments received in response to 

the companion proposed rule will be 

considered as comments regarding the 

direct final rule. 

We are providing a comment period 

on the direct final rule of 75 days after 

the date of publication in the Federal 

Register. If we receive any significant 

adverse comments, we intend to 

withdraw this direct final rule before its 

effective date by publication of a notice 

in the Federal Register. A significant 

adverse comment is defined as a 

comment that explains why the rule 

would be inappropriate, including 

challenges to the rule’s underlying 

premise or approach, or would be 

ineffective or unacceptable without a 

change. In determining whether an 

adverse comment is significant and 

warrants terminating a direct final 

rulemaking, we will consider whether 

the comment raises an issue serious 

enough to warrant a substantive 

response in a notice-and-comment 

process. Comments that are frivolous, 

insubstantial, or outside the scope of the 

rule will not be considered significant 

or adverse under this procedure. A 

comment recommending a regulation 

change in addition to those in this direct 

final rule would not be considered a 

significant adverse comment unless the 

comment states why the rule would be 

ineffective without the additional 

change. In addition, if a significant 

adverse comment applies to part of this 

rule and that part can be severed from 

the remainder of the rule, we may adopt 

as final those provisions of the rule that 

are not subject to the significant adverse 

comment. 

If any significant adverse comments 

are received during the comment 

period, FDA will publish, before the 

effective date of this direct final rule, a 

notice of significant adverse comment 

and withdraw the direct final rule. If we 

withdraw the direct final rule, any 

comments received will be applied to 

the proposed rule and will be 

considered in developing a final rule 

using the usual notice-and-comment 

procedures. 

If FDA receives no significant adverse 

comments during the specified 

comment period, FDA intends to 

publish a document confirming the 

effective date within 30 days after the 

comment period ends. 

III. Background 

Part 16 provides procedures for 

regulatory hearings held before FDA. 

The procedures in part 16 apply, among 

other circumstances, when a statute or 

regulation provides a person an 

opportunity for a hearing on a 

regulatory action. In 2012, FDA 

amended part 16 1 to add several 

statutory and regulatory provisions 

throughout 21 CFR parts 1, 7, and 16, 

to include reference to tobacco 

products, where appropriate, so that 

tobacco products would be subject to 

the same general requirements that 

apply to other FDA-regulated products. 

The 2012 amendments revised § 16.1, 

which governs the scope of part 16, to 

include references to certain sections of 

the FD&C Act that provide an 

opportunity for a hearing. Among other 

changes, the 2012 amendments added a 

reference to section 906(e)(1)(B) of the 

FD&C Act to § 16.1. This rule further 

amends § 16.1, as described below. 

The Agency is amending the list of 

statutory provisions enumerated in 

§ 16.1(b)(1) by removing the reference to 

section 906(e)(1)(B) and adding a 

reference to section 906(e)(2)(E) of the 

FD&C Act. The list of statutory 

provisions enumerated in § 16.1(b)(1) 

included section 906(e)(1)(B) of the 

FD&C Act, which requires FDA to afford 

the public an opportunity for an oral 

hearing before issuing any TPMP 

requirements regulation. The purpose of 

an oral hearing under section 

906(e)(1)(B) of the FD&C Act is to allow 

the public to provide viewpoints, 

opinions, and information on proposed 

TPMP rules. The procedures under part 

16 are not in alignment with the 

purpose and goals of the oral hearing 

required under section 906(e)(1)(B) of 

the FD&C Act. For example, part 16 

includes procedures to resolve a 

‘‘genuine and substantial issue of fact’’ 

that is in dispute and the right to 

confront and cross-examine witnesses, 

which are not well suited for allowing 

the public to provide viewpoints, 

opinions, and information to FDA 

regarding TPMP rules. Accordingly, 

FDA is removing the reference to 

section 906(e)(1)(B) of the FD&C Act 

from part 16 as other available 

procedures are better suited to achieve 

its purposes. 

The Agency is also adding a reference 

to section 906(e)(2)(E) of the FD&C Act 

to § 16.1(b)(1). Section 906(e)(2)(E) of 

the FD&C Act provides an opportunity 

for an informal hearing after the 

issuance of an order related to a 

petitioner’s request for a temporary or 

permanent exemption or variance from 

TPMP requirements. The list of 

statutory provisions in § 16.1(b)(1) that 

specifies the statutory and regulatory 

provisions under which regulatory 

hearings under part 16 are available did 

not previously include section 

906(e)(2)(E) of the FD&C Act. FDA is 

adding this reference to clarify that it 

intends to use the procedures in part 16 

when conducting such hearings. 

FDA is amending § 16.1 to clarify 

when it intends to use the procedures in 

part 16 for regulatory hearings. The 

amended rule is more consistent with 

the statute as it aligns the purposes of 

the two hearings referenced above with 

more appropriate hearing procedures 


ddrumheller on DSK120RN23PROD with RULES1
77022 Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 

under FDA’s regulations. It also clarifies 

the availability of hearings under part 

16 to tobacco product manufacturers. 

IV. Legal Authority 

FDA is issuing this rule under 

provisions of the FD&C Act related to 

regulations and hearings (21 U.S.C. 

371), and general provisions respecting 

control of tobacco products (21 U.S.C. 

387f). Section 701 (21 U.S.C. 371) vests 

FDA with ‘‘the authority to promulgate 

regulations for the efficient enforcement 

of [the FD&C Act].’’ Section 906(e) of the 

FD&C Act includes provisions regarding 

TPMP requirements regulations and 

temporary and permanent exemptions 

and variances from TPMP requirements. 

V. Description of the Direct Final Rule 

We are revising § 16.1, Scope, to 

remove a reference to ‘‘Section 

906(e)(1)(B) of the FD&C Act relating to 

the establishment of good 

manufacturing practice requirements for 

tobacco products’’ and add a reference 

to ‘‘Section 906(e)(2)(E) of the FD&C Act 

relating to exemptions or variances from 

tobacco product manufacturing practice 

requirements.’’ The amended rule 

clarifies the availability of the 

procedures in part 16 for regulatory 

hearings to include situations when a 

petitioner has requested a temporary or 

permanent exemption or variance from 

TPMP requirements. 

VI. Economic Analysis of Impacts 

We have examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, Executive Order 

14094, the Regulatory Flexibility Act (5 

U.S.C. 601–612), the Congressional 

Review Act/Small Business Regulatory 

Enforcement Fairness Act (5 U.S.C. 801, 

Pub. L. 104–121), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). 

Executive Orders 12866, 13563, and 

14094 direct us to assess all benefits, 

costs, and transfers of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Rules 

are ‘‘significant’’ under Executive Order 

12866 Section 3(f)(1) (as amended by 

Executive Order 14094) if they ‘‘have an 

annual effect on the economy of $200 

million or more (adjusted every 3 years 

by the Administrator of [the Office of 

Information and Regulatory Affairs 

(OIRA)] for changes in gross domestic 

product); or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, territorial, or tribal 

governments or communities.’’ OIRA 

has determined that this final rule is not 

a significant regulatory action under 

Executive Order 12866 Section 3(f)(1). 

Because this rule is not likely to result 

in an annual effect on the economy of 

$100 million or more or meets other 

criteria specified in the Congressional 

Review Act/Small Business Regulatory 

Enforcement Fairness Act, OIRA has 

determined that this rule does not fall 

within the scope of 5 U.S.C. 804(2). 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because this rule merely clarifies which 

of its existing procedures FDA intends 

to use when conducting certain types of 

hearings under the FD&C Act, we certify 

that the final rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes estimates of anticipated 

impacts, before issuing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $183 

million, using the most current (2023) 

Implicit Price Deflator for the Gross 

Domestic Product. This final rule will 

not result in an expenditure in any year 

that meets or exceeds this amount. 

This rule clarifies the procedures FDA 

intends to use when conducting certain 

types of hearings under the FD&C Act. 

When the TPMP rule becomes final and 

effective, potentially affected entities, 

including manufacturers of finished and 

bulk tobacco products, who choose to 

request an exemption or variance from 

TPMP requirements would be afforded 

an opportunity for a hearing on orders 

regarding such requests. 

We do not know how many 

manufacturers would pursue petitioning 

for an exemption or variance from 

TPMP requirements, once the Agency 

has published a final TPMP rule to 

establish such requirements and that 

rule is in effect, nor do we know how 

many requirements may be included in 

each petition. We reason that a 

manufacturer would petition for an 

exemption or variance from a TPMP 

requirement only if compliance with 

said requirement is not a financially 

viable choice compared to the cost of a 

filing a petition. Because this rule 

merely clarifies which of its existing 

procedures FDA intends to use when 

conducting certain types of hearings 

under the FD&C Act, costs and benefits 

of this rule are expected to be minimal. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VIII. Paperwork Reduction Act of 1995 

This direct final rule contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

IX. Federalism 

We have analyzed this direct final 

rule in accordance with the principles 

set forth in Executive Order 13132. We 

have determined that this direct final 

rule does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

Order and, consequently, a federalism 

summary impact statement is not 

required. 

X. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this direct final 

rule in accordance with the principles 

set forth in Executive Order 13175. We 

have determined that the rule does not 

contain policies that have substantial 

direct effects on one or more Indian 

Tribes, on the relationship between the 

Federal Government and Indian Tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

Accordingly, we conclude that the rule 

does not contain policies that have 

tribal implications as defined in the 

Executive Order and, consequently, a 

tribal summary impact statement is not 

required. 

List of Subjects in 21 CFR Part 16 

Administrative practice and 

procedure. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 16 is 

amended as follows: 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 183 / Friday, September 20, 2024 / Rules and Regulations 77023 

PART 16—REGULATORY HEARING 

BEFORE THE FOOD AND DRUG 

ADMINISTRATION 

■ 1. The authority citation for part 16 

continues to read as follows: 

Authority: 15 U.S.C. 1451–1461; 21 U.S.C. 

141–149, 321–394, 467f, 679, 821, 1034; 28 

U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. 

■ 2. Amend § 16.1 by revising paragraph 

(b)(1) to read as follows: 

§ 16.1 Scope. 

* * * * * 

(b) * * * 

(1) The statutory provisions are as 

follows: 

TABLE 1 TO PARAGRAPH (b)(1) 

Section 304(g) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of devices and drugs (see §§ 800.55(g) and 

1.980(g) of this chapter). 

Section 304(h) of the Federal Food, Drug, and Cosmetic Act relating to the administrative detention of food for human or animal consumption 

(see part 1, subpart k of this chapter). 

Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to the modification or revocation of a variance from the requirements 

of section 419 (see part 112, subpart P of this chapter). 

Section 515(e)(1) of the Federal Food, Drug, and Cosmetic Act relating to the proposed withdrawal of approval of a device premarket approval 

application. 

Section 515(e)(3) of the Federal Food, Drug, and Cosmetic Act relating to the temporary suspension of approval of a premarket approval application. 

Section 515(f)(6) of the Federal Food, Drug, and Cosmetic Act relating to a proposed order revoking a device product development protocol or 

declaring a protocol not completed. 

Section 515(f)(7) of the Federal Food, Drug, and Cosmetic Act relating to revocation of a notice of completion of a product development protocol. 

Section 516(b) of the Federal Food, Drug, and Cosmetic Act regarding a proposed regulation to ban a medical device with a special effective 

date. 

Section 518(b) of the Federal Food, Drug, and Cosmetic Act relating to a determination that a device is subject to a repair, replacement, or refund order or that a correction plan, or revised correction plan, submitted by a manufacturer, importer, or distributor is inadequate. 

Section 518(e) of the Federal Food, Drug, and Cosmetic Act relating to a cease distribution and notification order or mandatory recall order concerning a medical device for human use. 

Section 520(f)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to exemptions or variances from device current good manufacturing 

practice requirements (see § 820.1(d)). 

Section 520(g)(4) and (g)(5) of the Federal Food, Drug, and Cosmetic Act relating to disapproval and withdrawal of approval of an application 

from an investigational device exemption (see §§ 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of this chapter). 

Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products. 

Section 906(e)(2)(E) of the Federal Food, Drug, and Cosmetic Act relating to exemptions or variances from tobacco product manufacturing 

practice requirements. 

Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a new tobacco product to be introduced or delivered for introduction into interstate commerce. 

Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a modified risk tobacco product to be 

introduced or delivered for introduction into interstate commerce. 

* * * * * 

§ 16.1 [Amended] 

■ 3. Effective December 18, 2025, in 

§ 16.1, amend paragraph (b)(2) by 

redesignating table 1 to paragraph (b)(2) 

as table 2 to paragraph (b)(2). 

Dated: September 6, 2024. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2024–21231 Filed 9–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2024–0032; FRL–11685– 

02–R9] 

Air Plan Revisions; California; San 

Diego County Air Pollution Control 

District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking final action to 

approve a revision to the San Diego 

County Air Pollution Control District 

(SDCAPCD) portion of the California 

State Implementation Plan (SIP). This 

revision concerns a rule submitted to 

address section 185 of the Clean Air Act 

(CAA or ‘‘Act’’). 

DATES: This rule is effective October 21, 

2024. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R09–OAR–2024–0032. All 

documents in the docket are listed on 

the https://www.regulations.gov 

website. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available through https://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. If 

you need assistance in a language other 

than English or if you are a person with 

a disability who needs a reasonable 

accommodation at no cost to you, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: Kira 

Wiesinger, EPA Region IX, 75 

Hawthorne St., San Francisco, CA 

94105; phone: (415) 972–3827; email: 

wiesinger.kira@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. Proposed Action 

II. Public Comments and EPA Responses 

III. EPA Action 

IV. Incorporation by Reference 

V. Statutory and Executive Order Reviews 

I. Proposed Action 

On April 2, 2024 (89 FR 22648), the 

EPA proposed to approve the following 

rule into the California SIP. 


ddrumheller on DSK120RN23PROD with RULES1