[Federal Register Volume 89, Number 159 (Friday, August 16, 2024)]
[Proposed Rules]
[Pages 66647-66655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2024-N-1111]
RIN 0910-AI64


Submission of Food and Drug Administration Import Data in the 
Automated Commercial Environment for Certain Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration, with the Department of the 
Treasury's concurrence, proposes amending its regulations to require 
that the Submission Tracking Number for Electronic Nicotine Delivery 
System tobacco products that are being imported or offered for import 
be submitted in the Automated Commercial Environment or any other 
electronic data interchange system authorized by U.S. Customs and 
Border Protection, at the time of entry.

DATES: Either electronic or written comments on the proposed rule must 
be submitted by October 15, 2024. Submit written comments (including 
recommendations) on the collection of information under the Paperwork 
Reduction Act of 1995 by October 15, 2024.

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 October 15, 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.

[[Page 66648]]

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-1111 for ``Submission of Food and Drug Administration Import 
Data in the Automated Commercial Environment for Certain Tobacco 
Products.'' 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, the 
plain language summary of the proposed rule of not more than 100 words 
as required by the ``Providing Accountability Through Transparency 
Act,'' 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.
    Submit comments on information collection under the Paperwork 
Reduction Act of 1995 to the Office of Management and Budget (OMB) at 
https://www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently Under Review--Open for 
Public Comments'' or by using the search function. The title of this 
proposed collection is ``Importer's Entry Notice--OMB Control Number 
0910-0046--Revision.''

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Ann 
M. Metayer, Office of Regulatory Affairs, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 4375, Silver Spring, MD 20993-
0002, 301-796-3324.
    With regard to the information collection: JonnaLynn Capezzuto, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction/History of This Rulemaking
    B. Need for the Regulation
    C. FDA's Current Regulatory Framework
IV. Legal Authority
V. Description of the Proposed Rule
VI. Proposed Effective Date
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    The proposed rule would require that the Submission Tracking Number 
(STN) for tobacco products, as defined in 21 CFR 1114.3, be submitted 
for any entry containing an Electronic Nicotine Delivery System (ENDS) 
tobacco product(s) at the time of entry in the Automated Commercial 
Environment (ACE) or any other electronic data interchange (EDI) system 
authorized by U.S. Customs and Border Protection (CBP). The purpose of 
the rulemaking is to assist the Food and Drug Administration (FDA, the 
Agency, or we) in making decisions on admissibility for ENDS products 
by facilitating FDA's automated review process. The proposed rule, if 
finalized, would result in a more effective and efficient import 
admissibility review process by lowering instances of manual review by 
FDA of entries containing ENDS products, which will protect the public 
health by conserving Agency resources and more quickly identifying ENDS 
products that do not have marketing authorization and which may be 
associated with a greater public health risk. The automated review 
compares the STN submitted by the ACE filer, as defined in 21 CFR 1.71, 
to information in FDA's internal databases to determine if a ``May 
Proceed'' is appropriate. An automated ``May Proceed'' does not 
constitute a determination by FDA about the

[[Page 66649]]

article's compliance status, and it does not preclude FDA action at a 
later time.

B. Summary of the Major Provisions of the Proposed Rule

    FDA proposes to revise part 1, subpart D of 21 CFR chapter I (21 
CFR part 1, subpart D), added by a final rule issued by the Agency on 
November 29, 2016 (81 FR 85854), which established requirements for the 
electronic filing of certain data elements for FDA-regulated products 
in ACE, or any other EDI system authorized by CBP, at the time of 
entry. That final rule took effect on December 29, 2016.
    The proposed rule would require an ACE filer to submit in ACE at 
the time of entry the Affirmation of Compliance for Tobacco Submission 
Tracking (code TST) for ENDS products. Specifically, TST requires the 
STN for the premarket application for an entry containing an ENDS 
product to be submitted in ACE at the time of entry. The STN is 
assigned by the Agency to the application for premarket review for an 
ENDS product under section 910 of the Federal Food, Drug and Cosmetic 
Act (FD&C Act) (21 U.S.C. 387j). Currently, the submission of the STN 
in ACE is optional. Requiring submission of the STN in ACE at the time 
of entry would help FDA to more effectively and efficiently make 
admissibility decisions for ENDS products being imported or offered for 
import into the United States by increasing the opportunity for 
automated admissibility review of these entries by FDA's import 
systems.

C. Legal Authority

    The legal authority for this proposed rule includes sections 301, 
701, 801, and 910 of the FD&C Act (21 U.S.C. 331, 371, 381 and 387j, 
respectively).

D. Costs and Benefits

    This proposed rule, if finalized, would require an ACE filer to 
submit the STN for tobacco products for any entry containing ENDS 
tobacco product(s) at the time of entry in ACE or any other EDI system 
authorized by CBP. Benefits of the rule would be cost savings for the 
Federal Government and industry from reducing FDA's time spent on 
obtaining the STN of each ENDS product contained in the entry. We 
discuss these benefits qualitatively. We quantify costs to ACE filers 
of import entries containing ENDS products from reading and 
understanding the rule as well as obtaining and submitting the STN for 
these ENDS product(s). We estimate that the present value of costs of 
the rule over 10 years would range from $0.021 million to $0.061 
million at a 2 percent discount rate, with a primary estimate of $0.041 
million. The annualized costs would range from $0.002 million to $0.007 
million, with a primary estimate of $0.005 million.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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                Abbreviation/acronym                                         What it means
----------------------------------------------------------------------------------------------------------------
ACE.................................................  Automated Commercial Environment or any other CBP-
                                                       authorized EDI system.
ACE filer...........................................  The person who is authorized by CBP to submit an
                                                       electronic import entry for an FDA-regulated product in
                                                       ACE, as defined in 21 CFR 1.71.
APPH................................................  Appropriate for the protection of the public health.
CBP.................................................  U.S. Customs and Border Protection.
EDI.................................................  Electronic Data Interchange.
ENDS................................................  Electronic Nicotine Delivery System. FDA generally
                                                       considers ``ENDS'' to be electronic nicotine delivery
                                                       systems that deliver aerosolized e-liquid when inhaled,
                                                       including components and/or parts of ENDS (e.g., e-
                                                       liquids, cartridges/pods, tanks).
FDA.................................................  U.S. Food and Drug Administration.
FD&C Act............................................  Federal Food, Drug and Cosmetic Act.
ITDS................................................  International Trade Data System.
MGO.................................................  A marketing granted order is the order described in
                                                       section 910(c)(1)(A)(i) of the FD&C Act stating that the
                                                       new tobacco product may be introduced or delivered for
                                                       introduction into interstate commerce.
PMTA................................................  Premarket Tobacco Product Application.
PRIA................................................  Preliminary Regulatory Impact Analysis.
PRA.................................................  Paperwork Reduction Act of 1995.
STN.................................................  Submission Tracking Number for ENDS tobacco products (the
                                                       application number that FDA assigns to submissions such
                                                       as a PMTA, supplemental PMTA, Substantial Equivalence
                                                       (SE) report, or Exemption from substantial Equivalence
                                                       Request (EX REQ) for ENDS tobacco products), as defined
                                                       in 21 CFR 1114.3.
TST.................................................  Tobacco Submission Tracking. Affirmation of Compliance
                                                       Code in ACE for the Submission Tracking Number for
                                                       tobacco products.
Unique ENDS product.................................  A particular combination of manufacturer, product code,
                                                       and ACE filer for an ENDS product.
----------------------------------------------------------------------------------------------------------------

III. Background

A. Introduction/History of This Rulemaking

    ACE is a commercial trade processing system operated by CBP that is 
designed to implement the International Trade Data System (ITDS), 
automate import and export processing, eliminate redundant information 
requirements, and allow the effective enforcement of laws and 
regulations related to international trade. FDA is a Partner Government 
Agency for purposes of import data submitted in ACE. As of July 23, 
2016, ACE became the sole EDI system authorized by CBP for entry of 
FDA-regulated products into the United States (see 81 FR 32339).
    FDA issued a final rule effective December 29, 2016, entitled 
``Submission of Food and Drug Administration Import Data in the 
Automated Commercial Environment'' which added subpart D to part 1 of 
21 CFR chapter I to require that certain data elements important to our 
import admissibility review be submitted in ACE at the time of entry. 
This proposed rule would add a requirement to submit in ACE, at the 
time of entry, the STN for an ENDS product to Sec.  1.79.
    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) enacted on June 22, 2009, provided FDA 
with the authority to regulate tobacco products by recognizing the 
Agency as the primary Federal regulatory authority with respect to the 
manufacture, marketing, and distribution of cigarettes, cigarette 
tobacco, roll-your-own tobacco, and smokeless tobacco, and any other 
tobacco products that the Agency by regulation deems to be subject to 
the law. Section 201(rr)(1) of the FD&C Act (21 U.S.C. 321(rr)(1)), 
defines ``tobacco product'' as ``any product made or derived from 
tobacco, or containing nicotine from any source, that is intended for 
human consumption,

[[Page 66650]]

including any component, part, or accessory of a tobacco product 
(except for raw materials other than tobacco used in manufacturing a 
component, part, or accessory of a tobacco product).'' The term 
``tobacco product'' does not mean an article that is: a drug (section 
201(g)(1)), a device (section 201(h)), a combination product (section 
503(g) of the FD&C Act (21 U.S.C. 353(g))). It also does not mean an 
article that is a food (section 201(f)), if such article contains no 
nicotine, or no more than trace amounts of naturally occurring 
nicotine.
    Component or part means any software or assembly of materials 
intended or reasonably expected: (1) to alter or affect the tobacco 
product's performance, composition, constituents, or characteristics or 
(2) to be used with or for the human consumption of a tobacco product. 
Component or part excludes anything that is an accessory of a tobacco 
product (21 CFR parts 1100, 1140, and 1143).
    The FD&C Act requires manufacturers of new tobacco products to 
receive marketing authorization before entering the market. Section 
910(a) of the FD&C Act defines a ``new tobacco product'' as any tobacco 
product (including those products in test markets) that was not 
commercially marketed in the United States as of February 15, 2007, or 
any modification (including a change in design, any component, any 
part, or any constituent, including a smoke constituent, or in the 
content, delivery, or form of nicotine, or any other additive or 
ingredient) of a tobacco product where the modified product was 
commercially marketed in the United States after February 15, 2007.
    The Deeming rule (81 FR 28973), which published in the Federal 
Register on May 10, 2016, and took effect on August 8, 2016, extended 
FDA's authority to regulate products that meet the statutory definition 
of ``tobacco product'' in the FD&C Act (including components and parts 
but excluding accessories of such newly deemed tobacco products). 
Deemed products include ENDS, and their components and parts, but not 
their accessories. Examples of ENDS products that were deemed include 
vapes or vape pens, e-liquids, e-cigarettes, cigalikes, e-pens, e-
hookahs, e-cigars, and e-pipes.
    The Consolidated Appropriations Act of 2022 (the Appropriations 
Act) (Pub. L. 117-103), enacted on March 15, 2022, expanded the 
definition of the term ``tobacco product'' in section 201(rr) of the 
FD&C Act to include products that contain nicotine from any source. The 
Appropriations Act also amended section 901(b) of the FD&C Act to apply 
chapter IX of the FD&C Act to any tobacco product containing nicotine 
that is not made or derived from tobacco. As a result, ENDS products 
that contain non-tobacco nicotine, including synthetic nicotine, are 
now subject to the provisions in chapter IX of the FD&C Act (21 U.S.C. 
387 to 387t).
    To legally market and distribute a new tobacco product in the 
United States, an applicant may seek authorization under the following 
three pathways: Premarket Tobacco Product Application (PMTA), 
Substantial Equivalence (SE), and Exemption from Substantial 
Equivalence (EX REQ). Generally, for a new tobacco product, a marketing 
granted order (MGO) under section 910(c)(1)(A)(i) of the FD&C Act is 
required unless: (1) the manufacturer of the product submits a report 
under section 905(j) of the FD&C Act (21 U.S.C. 387e(j)) and FDA issues 
an order finding the product substantially equivalent to a predicate 
tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the 
manufacturer submits a report under section 905(j)(1)(A)(ii) of the 
FD&C Act and all modifications are covered by exemptions from the 
requirements of substantial equivalence granted by FDA under section 
905(j)(3) of the FD&C Act. A tobacco product manufacturer includes any 
person, including any repacker or relabeler, who imports a finished 
tobacco product for sale or distribution in the United States. See 
section 900(20) (21 U.S.C. 387(20)) of the FD&C Act. We expect the vast 
majority of premarket applications for ENDS products to be submitted 
through the PMTA pathway.
    A new tobacco product that does not have an MGO in effect under 
section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt 
from the premarket review requirement is adulterated pursuant to 
section 902(6)(A) of the FD&C Act (21 U.S.C. 387b(6)(A)). In addition, 
a new tobacco product is misbranded under section 903(a)(6) of the FD&C 
Act (21 U.S.C. 387c(a)(6)) if a notice or other information respecting 
the product was not provided as required by section 905(j) of the FD&C 
Act. The premarket review requirements of chapter IX of the FD&C Act 
apply to all new tobacco products, including ENDS products (e.g., 
electronic cigarettes and e-liquids).

B. Need for the Regulation

    Manufacturers, importers, retailers, and distributors of ENDS 
products are responsible for ensuring that these tobacco products are 
compliant with the FD&C Act requirements and implementing regulations, 
including premarket authorization requirements.
    Any tobacco product imported or offered for import into the United 
States that appears to be adulterated and/or misbranded is subject to 
refusal under section 801(a)(3) of the FD&C Act. We have determined 
that the STN for an ENDS product contained in an entry is a data 
element that is important for our import admissibility review of that 
ENDS product. Currently, this information is an optional submission in 
ACE for ENDS products and is not currently being submitted by ACE 
filers at the time of entry. Submission of a complete and accurate STN 
in ACE at the time of entry will facilitate FDA's review process by 
electronically comparing the STN to information in FDA's internal 
databases. This will help to expedite FDA's import review process and 
increase the likelihood of an entry of an ENDS product with a currently 
effective marketing authorization receiving an automated ``May 
Proceed.'' Facilitating the use of automated review for admissibility 
of ENDS products would allow the Agency to conserve our resources by 
reducing the instances of manual admissibility review and to more 
effectively and efficiently make admissibility decisions.
    FDA generally considers ENDS to be electronic nicotine delivery 
systems that deliver aerosolized e-liquid when inhaled, to include 
components, and/or parts (e.g., e-liquids, cartridges/pods, tanks) of 
ENDS. FDA conducts a science-based evaluation to determine whether a 
new tobacco product meets the applicable statutory standard for 
marketing authorization--such as, whether the product would be 
appropriate for the protection of the public health (APPH) with respect 
to the risks and benefits to the population as a whole, including both 
users and nonusers, and taking into account the increased or decreased 
likelihood that existing users of tobacco products will stop using such 
products; and the increased or decreased likelihood that those who do 
not use tobacco products will start using them.
    Public health risks can include, for example, ENDS batteries that 
overheat, cause fires, or explode; ENDS packaging that allows for young 
children to be accidentally exposed to the product and poisoned; and 
youth initiation and use of ENDS products. In making the APPH 
assessment for a tobacco product such as an ENDS product, for example, 
FDA weighs, among other things, the negative public health impact 
stemming from youth initiation and use of the product against the 
potential positive public health impact stemming from

[[Page 66651]]

adult cigarette smokers transitioning away from combusted cigarettes to 
the ENDS product.

C. FDA's Current Regulatory Framework

    ACE electronically transmits the entry data submitted by an ACE 
filer at the time of entry to FDA via an electronic interface. The 
Affirmation of Compliance for STN in ACE for tobacco products is 
currently an optional submission. When FDA's import systems receive 
entry data from ACE, the data is initially screened using FDA's 
Predictive Risk-based Evaluation for Dynamic Import Compliance 
Targeting (PREDICT), a risk-based electronic screening tool, to 
determine if manual review of the entry is required. A manual review 
means that FDA personnel will review the entry information submitted by 
the ACE filer and may request additional information to make an 
admissibility determination and/or may direct that the FDA-regulated 
product be examined or sampled by FDA before admissibility is 
determined.
    By requiring the STN to be submitted in ACE at the time of entry 
for ENDS products being imported or offered for import into the United 
States, FDA would be able to more effectively and efficiently determine 
the marketing authorization status of these products. Accurate and 
complete information submitted by an ACE filer increases the likelihood 
that an entry line containing an ENDS product that has a currently 
effective MGO will be given an automated ``May Proceed'' by FDA. We 
have found that ACE filers are not submitting the STN for an ENDS 
product in ACE at the time of entry. The proposed rule would preserve 
Agency resources by decreasing the amount of manual reviews, which may 
involve document requests and communication with ACE filers or 
importers because the STN and marketing status of the ENDS product will 
be able to be verified electronically using FDA's internal databases. A 
``May Proceed'' does not constitute a determination by FDA that the 
product complies with all provisions of the FD&C Act and FDA 
regulations, and it does not preclude FDA action later. We believe that 
submission of the STN for all entries containing ENDS products would 
increase the opportunity for issuing a ``May Proceed'' without manual 
review of ENDS products that have a currently effective MGO. This would 
result in a much faster and effective admissibility review process for 
both FDA and trade than a manual review.

IV. Legal Authority

    FDA has the legal authority under the FD&C Act to regulate the 
importation of ENDS products into the United States (sections 701 and 
801 of the FD&C Act). Section 701(a) of the FD&C Act authorizes the 
Agency to issue regulations for the efficient enforcement of the FD&C 
Act, while section 701(b) of the FD&C Act authorizes FDA and the 
Department of the Treasury to jointly prescribe regulations for the 
efficient enforcement of section 801 of the FD&C Act. This proposed 
rule is being jointly prescribed by FDA and the Department of the 
Treasury.
    Section 801(a) of the FD&C Act provides authority for FDA to refuse 
admission to a tobacco product being imported or offered for import if 
such product appears adulterated or misbranded. A new tobacco product 
that does not have an FDA marketing order in effect pursuant to section 
910(c)(1)(A) is adulterated pursuant to section 902(6)(A) of the FD&C 
Act. In addition, a new tobacco product is misbranded under section 
903(a)(6) of the FD&C Act if a notice or other information respecting 
the product was not provided as required by section 905(j) of the FD&C 
Act. Under section 301(a) of the FD&C Act, it is a prohibited act to 
introduce or deliver for introduction into interstate commerce a 
tobacco product that is adulterated or misbranded.

V. Description of the Proposed Rule

    We propose to revise to part 1 of 21 CFR chapter I to require 
submission of the STN in ACE or any other CBP-authorized EDI system, at 
the time the electronic entry is filed. The STN is currently an 
optional submission in ACE for ENDS products. This information is 
important data for FDA to efficiently verify premarket authorization 
for the ENDS product in the entry. Under this proposed rule, if 
finalized, if an ACE filer fails to submit the STN as required in 
proposed Sec.  1.79(b), the ACE system would not process the entry. If 
the complete STN is submitted in ACE in the correct syntax and the 
provided entry information matches the information in FDA's databases 
for that STN, the entry of that ENDS product may be eligible for a 
``May Proceed'' using an automated admissibility review by FDA. If the 
STN submitted in ACE does not correspond with the information in FDA's 
data systems for that ENDS product, FDA would need to conduct a manual 
review to verify the STN. Conducting a manual review slows FDA's review 
by creating inefficiencies in the review process and could create 
delays for the importer and other parties to the shipment.
    As discussed earlier, FDA could issue an automated ``May Proceed'' 
if the ACE filer submits a complete STN, in the correct syntax, in ACE 
at the time of entry and the provided entry information matches the 
information in FDA's databases for that STN.
    Currently, due to FDA's import program's limited resources, the 
automated look up validation process (the part of FDA's import systems 
that matches the STN with information in our databases) is only 
programmed for STNs for ENDS products. Thus, this proposed rule is 
limited to ENDS products because, at this time, the FDA automated look 
up validation process can only perform electronic verification of the 
STN for ENDS products.

VI. Proposed Effective Date

    We propose that any final rule based on this proposal become 
effective 30 days after the date of publication of the final rule in 
the Federal Register.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), 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 OIRA [the Office of Information and 
Regulatory Affairs] 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 proposed rule is not a 
significant regulatory action under Executive Order 12866 Section 
3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Small

[[Page 66652]]

businesses would be affected by the rule in the same way as non-small 
businesses. Small businesses would bear the costs of the rule, if 
finalized, but would also enjoy most of the benefits. Because small 
entities would face minor one-time costs relative to firm revenue to 
read the rule and to submit the required data, we propose to certify 
that the proposed 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 an assessment of 
anticipated costs and benefits, before proposing ``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 proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    This proposed rule, if finalized, would require an ACE filer to 
submit the STN for tobacco products submitted for any import entry 
containing ENDS tobacco product(s) at the time of entry in ACE or any 
other EDI system authorized by CBP. This information is important data 
for FDA to efficiently verify premarket authorization for the ENDS 
product in the entry.
    If the STN is not voluntarily submitted in ACE at the time of 
entry, FDA needs to conduct a manual review, which includes contacting 
the ACE filer or importer to obtain the STN of each ENDS product 
contained in the entry. The manual admissibility review slows FDA 
import admissibility decisions. Thus, by reducing FDA's time spent on 
obtaining the STN of each ENDS product contained in the entry, we 
expect this rulemaking to generate benefits in the form of cost savings 
for the Federal Government and industry. The proposed rule, if 
finalized, would result in a more effective and efficient admissibility 
review by FDA of those entry lines containing an ENDS product. Industry 
may benefit from the reduced time spent by FDA in making admissibility 
determinations on ENDS products contained in an entry.
    ACE filers of import entries containing ENDS products would face 
costs to read and understand the rule as well as to obtain and submit 
the STN for ENDS product(s) imported or offered for import. These costs 
would occur only once for each unique entity and ENDS product 
combination as a requirement upon initial submission of the STN, as 
explained in the Preliminary Regulatory Impact Analysis (PRIA).
    Table 1 summarizes the estimated benefits and costs of this 
proposed rule, if finalized. Because we lack information to quantify 
expected benefits of the rule, table 1 presents them qualitatively. We 
expect that the rule would result in cost savings to both industry and 
FDA from more efficient and effective import admissibility review. We 
estimate that the present value of costs of the rule over 10 years 
would range from $0.021 million to $0.061 million at a 2 percent 
discount rate, with a primary estimate of $0.041 million. The estimated 
annualized costs of this rulemaking over a 10-year period would range 
from $0.002 million to $0.007 million at a 2 percent discount rate, 
with a primary estimate of $0.005 million.

                                     Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
                                                               [Millions of 2022 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    Notes (e.g., risk
                                                                                                                                   assumptions; source
                                                                                                                                    citations; whether
            Category                 Primary      Low estimate    High estimate    Dollar year    Discount rate   Time horizon     inclusion of capital
                                    estimate                                                                                      effects differs across
                                                                                                                                    low, primary, high
                                                                                                                                     estimates; etc.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized monetized         ..............  ..............  ..............  ..............              2%  ..............  .......................
     benefits.
    Annualized quantified, but   ..............  ..............  ..............  ..............  ..............  ..............  .......................
     non-monetized, benefits.
                                ------------------------------------------------
    Unquantified benefits......      Cost savings to Federal Government and      ..............  ..............  ..............  Cost savings.
                                   industry from more efficient and effective
                                                 import review.
                                ------------------------------------------------
Costs:
    Annualized monetized costs.          $0.005          $0.002          $0.007            2022              2%              10  .......................
    Annualized quantified, but   ..............  ..............  ..............  ..............  ..............  ..............  .......................
     non-monetized, costs.
    Unquantified costs.........  ..............  ..............  ..............  ..............  ..............  ..............  .......................
Transfers:

[[Page 66653]]

 
    Annualized monetized         ..............  ..............  ..............  ..............              2%  ..............  .......................
     Federal budgetary
     transfers.
    Bearers of transfer gain     ..............  ..............  ..............  ..............  ..............  ..............  .......................
     and loss?
    Other annualized monetized   ..............  ..............  ..............  ..............              2%  ..............  .......................
     transfers.
    Bearers of transfer gain     ..............  ..............  ..............  ..............  ..............  ..............  .......................
     and loss?
Net Benefits:
    Annualized monetized net     ..............  ..............  ..............  ..............              2%  ..............  .......................
     benefits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Category                         Effects
                                 Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Effects on State, local, or  None.
     Tribal governments.
 
    Effects on small businesses  None.
 
    Effects on wages...........  None.
 
    Effects on growth..........  None.
 
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis economic of impacts is available in the docket for 
this proposed rule (Ref. 1) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. 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.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). A 
description of these provisions is given in the Description of the 
Proposed Rule section of this document. Included in our estimate of the 
annual reporting and recordkeeping burden is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Importer's Entry Notice--OMB Control Number 0910-0046--
Revision.
    Description: This proposed rule would require the submission of the 
STN for tobacco products for ENDS products being imported or offered 
for import into the United States via ACE or any other electronic data 
interchange system authorized by CBP. The purpose of the rule is to 
facilitate FDA's review of imported ENDS products. This will allow the 
Agency to focus our resources on those FDA-regulated products that may 
be associated with a greater public health risk.
    Description of Respondents: Respondents to the information 
collection provisions of the proposed rule are importers, and licensed 
customs brokers hired by an importer to file the entry in ACE, who 
offer products for importation that are finished ENDS products, 
including components and parts of ENDS products, sealed in final 
packaging or in the final form in which

[[Page 66654]]

they are intended to be sold to consumers.
    The proposed rule would add the STN, assigned to the premarket 
application for an ENDS product under section 910 of the FD&C Act, to 
the data elements required for entries containing FDA-regulated tobacco 
products in Sec.  1.79 that must be submitted in ACE at the time of 
entry. Currently, this is an optional submission. Requiring the STN to 
be submitted in ACE at the time of entry for finished ENDS products 
would help facilitate FDA's import review.
    FDA's burden estimates are based on data discussed in the PRIA. For 
the analysis of the information collection, we calculate the submission 
of the STN in the ACE system as an initial first-year burden and 
subsequent recurring years. We anticipate these data retrieval and 
entry times to occur in the first year the rule becomes effective for 
all ENDS products imported or offered for import as a requirement upon 
initial submission of import information for unique entities and ENDS 
products combinations. In each subsequent year, any additional time 
spent on obtaining and submitting the required information would depend 
on the number of new Unique ENDS products imported or offered for 
import. As discussed in the PRIA, we assessed the baseline procedure 
for verifying marketing status. Currently, entries received without the 
optional STN data element trigger a manual admissibility review process 
by FDA to determine their premarket review status. From January 1, 
2021, through June 27, 2023, there were no entries containing ENDS 
products where a filer voluntarily submitted a STN in ACE at the time 
of entry. We therefore assume that no ACE filers are submitting this 
information at baseline. For each Unique ENDS product, we assume time 
would be spent by an administrative worker on locating the sources of 
the data; obtaining the required information for submission to ACE, 
including reaching out to manufacturers if necessary; logging into the 
system; entering the required information or updating the already 
existing information in that firm's internal database(s). Once this 
information is gathered and entered into a firm's internal database(s), 
we foresee that it does not need to be gathered again for a subsequent 
shipment of the same Unique ENDS product.
    As part of this proposed rulemaking, we are revising the currently 
approved collection of information for the ACE system under OMB control 
number 0910-0046.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 2--Estimated First-Year Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
          21 CFR 1.79(b); Activity               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gathering and Entering STN into an ACE                   177          60.825          10,766  0.033 (2 minutes).........................             355
 Filer's internal database(s).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2 displays the estimated first year reporting burden 
associated with gathering and entering the required STN for ENDS 
products into the ACE filer's software program. Our burden estimates 
are consistent with estimates from table 5 in the PRIA, which 
summarizes the number of import lines, ACE filers, and unique ENDS 
products expected to be affected by the rule. As we stated previously, 
we identify Unique ENDS products through a particular combination of 
manufacturer, product code, and ACE filer. Table 5 in the PRIA presents 
low and high estimates. For PRA purposes, we have utilized the midpoint 
of these low and high values. We estimate that 177 respondents (number 
of ACE filers) will submit 10,766 annual responses (number of unique 
ENDS products) in the first year that the proposed rule is finalized.
    The 2016 ACE final rule assumed that preparing data elements for 
the first time could range from a few seconds to several minutes, 
depending on the complexity and location of the information. We assume 
that ACE filers have the required information readily available and 
that they will not need to contact manufacturers or other entities to 
obtain this data element. Likewise, we assume that importers would 
provide the necessary information to any licensed customs brokers they 
hire to complete these tasks. Finally, we assume that this time 
includes quality checks to ensure the accuracy of the information 
submitted in ACE. Some of this verification may be manual verification 
by staff or messaging from ACE or FDA that identifies incorrect 
information. To calculate the average burden per response we utilized 
assumptions in the 2016 ACE final rule, and we assume the time needed 
to locate, prepare, enter, and quality check the required information 
would range from 1 to 3 minutes per Unique ENDS product. For PRA 
estimates we have used the midpoint of 2 minutes (0.033 hours) per 
response. Our total first year burden is estimated to be 355 hours.

                                                Table 3--Estimated Subsequent Years Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
          21 CFR 1.79(b); Activity               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gathering and Entering the Submission                      8            56.5             452  0.033 (2 minutes).........................              15
 Tracking Number into Filer's Internal
 Database.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 3 displays the estimated subsequent years burden associated 
with gathering and entering the required STN for ENDS products into the 
ACE filer's internal database. In each subsequent year after year one, 
any additional time spent preparing the required information would 
depend on the number of new Unique ENDS products imported or offered 
for import. As with the estimate for first year burden, our estimates 
for subsequent year burden are based on the midpoint of low and high 
estimates from table 5 in the PRIA. We estimate recurring

[[Page 66655]]

burden by averaging years 2-3 based on a 3-year OMB approval timeframe, 
which equaled to 8.25 respondents (number of ACE filers) and rounded to 
8. For the number of annual responses, we used the average of years 2-3 
which equaled to 452 annual responses (number of Unique ENDS products). 
We estimate the same estimate of 2 minutes (0.033 hours) per response 
as in table 2, and our total recurring burden is estimated to be a 
rounded 15 hours.
    If this proposed rule is finalized, we estimate that ENDS tobacco 
product importers submitting the required STN will increase the burden 
under OMB control number 0910-0046 by 370 hours (355 first year burden 
hours + 15 subsequent (years 2-3) recurring hours).
    To ensure that comments on information collection are received, OMB 
recommends that written comments be submitted through https://www.regulations.gov (see ADDRESSES). All comments should be identified 
with the title of the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), we have submitted the information collection provisions of 
this proposed rule to OMB for review. These information collection 
requirements will not be effective until FDA publishes a final rule, 
OMB approves the information collection requirements, and the rule goes 
into effect. FDA will announce OMB approval of these requirements in 
the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed 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 this proposed 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.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the proposed rule does not contain policies that would 
have a substantial direct effect 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.

XII. Reference

    The following reference is on display at the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. Although FDA 
verified the website addresses in this document, please note that 
websites are subject to change over time.
    1. FDA, Submission of Food and Drug Administration Import Data in 
the Automated Commercial Environment (Proposed Rule) Preliminary 
Regulatory Impact Analysis. Economic Impact Analyses of FDA 
Regulations.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend 21 CFR part 1 as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 
374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 
241, 243, 262, 264, 271.

0
2. In Sec.  1.79, add paragraph (b) to read as follows:


Sec.  1.79  Tobacco products.

* * * * *
    (b) Submission tracking number assigned to an application for 
market authorization submitted for an electronic nicotine delivery 
system product, such as a premarket tobacco product application (PMTA) 
or a supplemental PMTA.

    Dated: August 12, 2024.
Robert M. Califf,
Commissioner of Food and Drugs. In concurrence with FDA.
    Dated: August 12, 2024.
Aviva R. Aron-Dine, Acting Assistant Secretary of the Treasury for Tax 
Policy.
[FR Doc. 2024-18343 Filed 8-15-24; 8:45 am]
BILLING CODE 4164-01-P