Proposed Rule2024-18343
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products
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Published
August 16, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 159 (Friday, August 16, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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, <a href="/cdn-cgi/l/email-protection#91c1c3d0c2e5f0f7f7d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="69393b283a1d080f0f290f0d084701011a470e061f">[email protected]</span></a>.
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
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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.
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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 <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> (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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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