[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Rules and Regulations]
[Pages 62977-62984]
[FR Doc No: 2022-22532]

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Rules and Regulations
                                                Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
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under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 87, No. 200 / Tuesday, October 18, 2022 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2018-N-4268]
RIN 0910-AH66

Submission of Food and Drug Administration Import Data in the
Automated Commercial Environment for Veterinary Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we),
with the Department of the Treasury's concurrence, is amending its
regulations to require that certain data elements be submitted for
veterinary devices that are being imported or offered for import in the
Automated Commercial Environment (ACE) or any other electronic data
interchange (EDI) system authorized by U.S. Customs and Border
Protection (CBP), in order for CBP to process the filing and to help
FDA in determining the admissibility of those veterinary devices. This
final rule will make the submission of the general data elements
currently required to be submitted in ACE for other FDA-regulated
products at the time of entry also required in ACE for veterinary
devices being imported or offered for import into the United States.
This final rule will increase effective and efficient admissibility
review by FDA of those entry lines containing a veterinary device,
which will protect public health by allowing the Agency to focus its
limited resources on FDA-regulated products that may be associated with
a greater public health risk.

DATES: This rule is effective November 17, 2022.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    With regard to the final rule: Brittani Everson-Riley, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, [email protected].
    With regard to the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
VI. Effective Date
VII. 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. References

I. Executive Summary

A. Purpose of the Final Rule

    For veterinary devices being imported or offered for import into
the United States via ACE or any other EDI system authorized by the
CBP, this rule requires the submission of certain data elements
material to FDA's process of making decisions on admissibility. This
action facilitates automated ``May Proceed'' determinations by FDA for
those veterinary devices that present a low risk to public health
which, in turn, allows the Agency to focus our limited resources on
those FDA-regulated products that may be associated with a greater
public health risk.

B. Summary of the Major Provisions of the Final Rule

    This rule revises subpart D of part 1 of 21 CFR chapter I (21 CFR
part 1), added by a final rule issued by the Agency on November 29,
2016 (81 FR 85854), to establish requirements for the electronic filing
of certain data elements for FDA-regulated products in ACE or any other
EDI system authorized by CBP. That final rule took effect on December
29, 2016.
    This rule makes the data elements that are required to be submitted
for other FDA-regulated products in Sec.  1.72 (21 CFR 1.72) also
mandatory for the electronic filing of entries containing a veterinary
device: (1) FDA Country of Production; (2) complete FDA Product Code;
(3) full intended use code; (4) and telephone number and email address
of the importer of record. Submission of these data elements in ACE
helps FDA to more effectively and efficiently make admissibility
determinations for veterinary devices by increasing the opportunity for
automated ``May Proceed'' of these entries by FDA's import systems.
These data elements are currently required to be submitted for the
electronic filing of entries containing food contact substances, drugs,
biological products, human cells, tissues or cellular or tissue-based
products (HCT/Ps), medical devices for human use, radiation-emitting
electronic products, cosmetics, and tobacco products.

C. Legal Authority

    The legal authority for this final rule includes sections 701 and
801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
371 and 381).

D. Costs and Benefits

    Cost savings result from increased efficiency in, and streamlining
of, FDA's imports admissibility process. These cost savings to the
industry and FDA cannot be quantified because FDA currently lacks data
to do so. Potential benefits to consumers, that we are similarly unable
to quantify, will result from a reduction in the number of non-
compliant veterinary device imports reaching U.S. consumers and from

compliant imported veterinary devices reaching U.S. consumers faster.
    The annualized costs of complying with this regulation are
estimated to be between $0.056 million and $0.140 million per year (in
2020 dollars annualized over 20 years using 7 percent discount rate).
These costs were already previously inadvertently included and the
benefits discussed in the regulatory impact analysis (RIA) for the
``Submission of Food and Drug Administration Import Data in the
Automated Commercial Environment'' 2016 final rule. Because we do not
want to double count these costs to the industry, we have concluded
that this final rule will have no additional costs beyond the costs
that were included in that RIA.

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

------------------------------------------------------------------------
     Abbreviation/acronym                    What it means
------------------------------------------------------------------------
ACE..........................  Automated Commercial Environment or any
                                other CBP-authorized EDI system.
ACE filer....................  The person who is authorized to submit an
                                electronic import entry for an FDA-
                                regulated product in ACE.
ACS..........................  Automated Commercial System--the
                                predecessor CBP-authorized EDI system to
                                ACE.
Agency.......................  U.S. Food and Drug Administration.
CBP..........................  U.S. Customs and Border Protection.
EDI..........................  Electronic Data Interchange.
FDA..........................  U.S. Food and Drug Administration.
FD&C Act.....................  Federal Food, Drug and Cosmetic Act.
HCT/P........................  Human cells, tissues, or cellular or
                                tissue-based products.
ITDS.........................  International Trade Data System.
RIA..........................  Regulatory Impact Analysis.
PRA..........................  Paperwork Reduction Act of 1995.
We, Our, Us..................  U.S. Food and Drug Administration.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation/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, enhance border security, and
foster U.S. economic security through lawful international trade and
policy. FDA is a Partner Government Agency for purposes of submission
of import data in ACE. As of July 23, 2016 (81 FR 32339), ACE became
the sole EDI system authorized by CBP for entry of FDA-regulated
articles into the United States.
    On November 29, 2016, FDA issued a final rule entitled ``Submission
of Food and Drug Administration Import Data in the Automated Commercial
Environment'' (the ACE final rule), which added subpart D to part 1 to
require that certain data elements material to our import admissibility
review be submitted in ACE at the time of entry. This rule adds
veterinary devices to the list of other FDA-regulated products being
imported or offered for import for which the data elements required
under Sec.  1.72 must be submitted in ACE at the time of entry. The
data elements in Sec.  1.72 are FDA Country of Production, complete FDA
Product Code, full intended use code, and telephone number and email
address of the importer of record.
    A veterinary device is a ``device'' as defined in section 201(h) of
the FD&C Act (21 U.S.C. 321(h)) that is intended for use in animals.
Section 201(h) of the FD&C Act defines ``device'' as an instrument,
apparatus, implement, machine, contrivance, implant, in vitro reagent,
or other similar or related article, including any component, part, or
accessory, which is: (1) recognized in the official National Formulary,
or the U.S. Pharmacopeia, or any supplement to them; (2) intended for
use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other
animals; or (3) intended to affect the structure or any function of the
body of man or other animals. Further, such device does not achieve its
primary intended purposes through chemical action within or on the body
of man or other animals and is not dependent upon being metabolized for
the achievement of its primary intended purposes.
    Manufacturers and distributors of veterinary devices are
responsible for ensuring that these devices are safe, effective, and
properly labeled. Under section 801(a) of the FD&C Act (21 U.S.C.
381(a)), FDA may refuse admission of veterinary devices being imported
or offered for import that appear to be adulterated or misbranded.
Devices, including veterinary devices, are subject to the adulteration
provisions of section 501 of the FD&C Act (21 U.S.C. 351) and the
misbranding provisions of section 502 of the FD&C Act (21 U.S.C. 352).
We have determined that the data elements required to be submitted in
ACE at the time of entry under Sec.  1.72 are material to our import
admissibility review of veterinary devices. Receipt of this information
increases the opportunity for automated ``May Proceed'' determinations
by us for those veterinary devices that present a low public health
risk which, in turn, allows the Agency to focus our limited resources
on those FDA-regulated products that may be associated with a greater
public health risk.
    ACE electronically transmits the entry data submitted by a filer at
the time of entry to FDA via an electronic interface. The entry is then
initially screened by FDA using FDA's Predictive Risk-based Evaluation
for Dynamic Import Compliance Targeting (PREDICT), a risk-based
electronic screening tool, to determine if automated or manual review
of the entry is appropriate. An automated ``May Proceed'' determination
is much faster and less resource intensive for FDA and the importer
than a manual ``May Proceed'' determination. An automated ``May
Proceed'' does not constitute a determination by FDA about the
article's compliance status, and it does not preclude FDA action later.
If the initial electronic review indicates that manual review is
appropriate, FDA personnel will review the entry information submitted
by the entry filer and may request additional information to make an
admissibility determination and/or may examine or sample the FDA-
regulated article.
    ACE also allows importers to submit optional information relevant
to FDA's admissibility determination on veterinary devices. We strongly
encourage the submission of the optional data elements in ACE at the
time of entry if the importer of an FDA-regulated product is interested
in an expedited admissibility review on its

products by the Agency (see the FDA Supplemental Guide which includes
the optional data elements published at: https://www.cbp.gov/sites/default/files/assets/documents/2021-Sep/FDASupplementalGuideVersion2.5.5_508c%28003%29%281%29.pdf. Accurate and
complete information submitted by a filer increases the likelihood that
an entry line will receive an automated ``May Proceed'' determination
from FDA.

B. Summary of Comments to the Proposed Rule

    We received four comments on the proposed rule by the close of the
comment period, all from individuals. One comment is unintelligible.
The remaining three comments from individuals made general remarks
supportive of the proposed rule. All suggested extending the beneficial
aspects of the proposed electronic submission of the general data
elements for veterinary devices to other FDA-regulated products. A
requirement for this specific process in the ACE environment for other
FDA-regulated products was established under the ACE final rule, which
was effective in December 2016. We are finalizing the proposed rule
without revision.

C. General Overview of the Final Rule

    FDA is amending Sec.  1.72 to make that section applicable to
veterinary devices, as defined in proposed Sec.  1.71. In addition, we
are amending Sec.  1.75 to include the requirement that the information
in Sec.  1.72 must be submitted in ACE at the time of entry for
veterinary devices being imported or offered for import into the United
States.
    As explained in the Notice of Proposed Rulemaking entitled
``Submission of Food and Drug Administration Import Data in the
Automated Commercial Environment'' published in the Federal Register of
July 1, 2016 (81 FR 43155), CBP collected the data elements FDA Country
of Production and the complete FDA Product Code, prior to ACE, in the
Automated Commercial System (ACS), operated by CBP for the submission
of electronic entries, to assist FDA in making admissibility decisions
for FDA-regulated products. The FDA Country of Production data element
identifies the country where an FDA-regulated article last underwent
any manufacturing or processing but only if such manufacturing or
processing was of more than a minor, negligible, or insignificant
nature. The complete FDA Product Code data element is an alphanumeric
code that we use for classification and analysis of regulated products.
The FDA Product Code builder application allows ACE filers to locate or
build the appropriate FDA Product Code. The complete FDA Product Code
must be consistent with the invoice description submitted in ACE at the
time of entry (Sec.  1.72(a)(2)). The FDA Product Code builder
application is currently available on FDA's website at https://www.accessdata.fda.gov/scripts/ora/pcb/.
    A full intended use code consists of a base code that designates
the general use intended for the article and a subcode, if applicable,
that designates the specific use intended for the article. Filers may
submit the intended use code ``UNK,'' representing ``unknown,'' at the
time of entry. entry filers need to be aware that submitting ``UNK'' as
the intended use code will, in most cases, subject the entry to a
manual review for admissibility provided the entry filing is not
rejected by FDA (81 FR 85854 at 85859 to 85860).
    The email address and telephone number for the importer of record
is also being required. This information will enable us to contact that
person with any questions about the import entry as well as send
notices of FDA actions, such as detention or refusal, electronically to
that person (81 FR 43155 at 43161).
    Section 1.75 codifies additional information that is required at
the time of filing an entry in ACE for animal drugs being imported or
offered for import beyond that listed in Sec.  1.72. The final rule
amends Sec.  1.75 to include veterinary devices by: (1) revising the
section title to ``Animal drugs and veterinary devices''; (2)
redesignating current Sec.  1.75(a), (b), (c), and (d) to Sec.
1.75(a)(1), (2), (3), and (4); and (3) adding Sec.  1.75(b) Veterinary
devices. Section 1.75(b) states that no additional information is
required beyond that listed in Sec.  1.72 for veterinary devices.
Current Sec.  1.75(d), redesignated to Sec.  1.75(a)(4) by the final
rule, is being amended by adding the word ``file'' where the section
refers to the ``investigational new animal drug number'' and by
replacing the word ``application'' with ``file'' where the section
refers to ``investigational new animal drug application.'' This is a
technical amendment for the purpose of using the more appropriate
terminology ``investigational new animal drug file number'' and
``investigational new animal drug file'' in that section, which is
consistent with the terminology used in other FDA regulations.

IV. Legal Authority

    FDA has the legal authority under the FD&C Act to regulate the
importation of veterinary devices 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 final rule
is being jointly prescribed by FDA and the Department of the Treasury.

V. Comments on the Proposed Rule and FDA Response

    We received four comments on the proposed rule by the close of the
comment period, all from individuals. One comment is unintelligible.
The remaining three comments make brief general remarks supportive of
the proposed rule; all suggest extending the beneficial aspects of the
proposed electronic submission of general data elements for veterinary
devices to other FDA-regulated products. A requirement for this
specific process in the ACE environment for such other FDA-regulated
products was created under the ACE final rule in 2016. Because these
comments were outside the scope of this rule, further discussion of
them is not included here.
    We are finalizing the proposal without revision.

VI. Effective Date

    The rule is effective November 17, 2022.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, 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 and 13563 direct us to assess all costs
and benefits 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). We
believe that this final rule is not an economically significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. This final rule simply extends to veterinary devices the
submission of the data

elements that are currently required for other FDA-regulated imports
covered under the ACE final rule (Ref. 1). The RIA for the ACE final
rule estimates that: (1) small businesses will be affected by that
final rule in the same way as non-small businesses and that (2) small
businesses will bear the costs, but will also enjoy most of the
benefits (Ref. 2). According to FDA's internal data (Ref. 3), there are
no businesses that solely specialize on importing veterinary devices
into the United States. Because no additional businesses will be
impacted by this final rule, we certify that this final rule will not
have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    For veterinary devices being imported or offered for import into
the United States, and where entry is electronically filed in ACE or
any other EDI system authorized by CBP, this final rule requires the
submission of certain data elements material to FDA's process of making
decisions on admissibility. This final rule therefore simply extends to
veterinary devices the submission of the data elements that are
currently required for other FDA-regulated products by Sec.  1.72.
    The costs of this final rule were inadvertently included, and the
benefits discussed, in the RIA for the ACE final rule (Ref. 2). More
specifically, one data category that was used in the RIA of the ACE
final rule included both animal drug import lines and veterinary device
import lines and should have only included animal drug import lines. As
a result of inadvertently including veterinary device import lines in
the RIA of the ACE final rule, the costs of the ACE final rule were
overestimated by $0.028 million to $0.071 million per year (in 2015
dollars, annualized over 20 years using a 7 percent discount rate).
These costs to industry \1\ included the costs of preparing the
required information for each import entry, checking data quality, and
completing and submitting the electronic entry submission. Because we
do not want to double count these costs to the industry, we conclude
that this final rule has no additional costs beyond the costs that were
included in the RIA of the ACE final rule (Ref. 2). Updated to 2020
dollars and using actual import line counts for years since the
publication of the ACE final rule (2016 to 2020), the costs of
complying with this regulation are between $0.056 million and $0.140
million per year with the best estimate of $0.077 million per year at a
7 percent discount rate and are between $0.059 million and $0.147
million per year with the best estimate of $0.080 million per year at a
3 percent discount rate (table 1).
---------------------------------------------------------------------------

    \1\ We assume that the importer bears the actual burden of the
ACE final rule even if the importer, for example, hires a customs
broker to complete some of the tasks in order to comply with this
regulation.

                                    Table 1--Summary of Costs, Benefits, and Distributional Effects of the Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                              ------------------------------------
                 Category                    Primary       Low        High                               Period                    Notes
                                            estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized, $millions/year.
    Annualized Quantified................
                                          --------------------------------------------------------------------------------------------------------------
    Qualitative..........................  Potential time reduction for
                                           veterinary device import entry
                                           processing by FDA; more efficient
                                           use of FDA's internal resources;
                                           potential increase in
                                           predictability of the import
                                           process for veterinary devices;
                                           potentially fewer veterinary
                                           device imports being held;
                                           potentially shorter timeframes for
                                           imported veterinary devices being
                                           held pending a final admissibility
                                           decision; potentially fewer
                                           recalls of imported veterinary
                                           devices; potential reduction in
                                           the number of violative veterinary
                                           devices entering the United States
                                           and reaching U.S. consumers;
                                           compliant imported veterinary
                                           devices potentially reaching U.S.
                                           consumers faster.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized, $millions/year.      $0.077      $0.056      $0.140        2020           7          20
                                                0.080       0.059       0.147        2020           3          20
    Annualized Quantified................
                                          --------------------------------------------------------------------------------------------------------------
    Qualitative..........................

--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized,
     $millions/year.
                                          --------------------------------------------------------------------------------------------------------------
                                           From:
                                           To:
                                          --------------------------------------------------------------------------------------------------------------

    Other Annualized Monetized $millions/
     year.
                                          --------------------------------------------------------------------------------------------------------------
                                           From:
                                           To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No significant effect............................................................................................
    Small Business: Small businesses are affected by this final rule in the same way as non-small businesses. Businesses that are affected by this rule
     are the same businesses as some of the importers affected by the ACE final rule because there are no businesses that solely specialize on importing
     veterinary devices into the United States. Small businesses that import veterinary devices will bear the costs of this rule, but also will enjoy
     most of the benefits. We estimate that providing several additional data elements to FDA via ACE in exchange for a potentially more efficient
     import admissibility review process will not cause a significant impact on a substantial number of small entities. Benefits that we were not able
     to quantify arise from improved prevention of risks to public health from non-compliant veterinary device imports and increased efficiency and
     streamlining of the overall import process of veterinary devices; these benefits are presumed to be positive..
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Next, we qualitatively discuss the benefits and the costs of this
final rule that were previously discussed in the RIA of the ACE final
rule (Ref. 2) and will also apply to veterinary devices covered by this
final rule. The cost savings to both the industry and FDA that we are
unable to quantify arise from the reduced time of import entry
processing for veterinary devices, fewer veterinary device imports
being held, and a shorter timeframe between the time of veterinary
device import entry transmission and a final admissibility decision by
FDA. Such time savings will arise as a result of increased efficiency
in FDA's imports admissibility process.
    Without this final rule, the amount of information provided by
veterinary device import entry filers would be sub-optimal; the
information material to FDA's determination of admissibility on an
imported veterinary device would be collected only if and to the extent
it is voluntarily provided by filers. In order to operate more
efficiently and to make risk-based admissibility decisions potentially
faster for all veterinary device import entries, FDA needs certain data
elements. A manual review of a veterinary device entry line on average
takes about 24 hours (Ref. 3), whereas an automated ``May Proceed''
outcome may take only minutes. Therefore, increasing the number of
automated ``May Proceed'' outcomes results in time and cost savings to
both FDA and industry. By requiring import entry filers to submit data
elements mandated by this final rule into ACE, FDA will further
streamline review of import entry declarations for veterinary devices
and will facilitate a more efficient use of FDA's internal resources.
    Benefits to consumers from this final rule that we are similarly
unable to quantify will result from a reduction in the number of non-
compliant veterinary device imports reaching U.S. consumers and from
compliant imported veterinary devices reaching U.S. consumers faster.
There have been recalls of imported veterinary devices in the past. For
example, in 2016 there were three recalls of imported veterinary
devices (Ref. 3). The potential health risk could be avoided if non-
compliant veterinary devices are prevented from entering the U.S.
market in the first place. FDA anticipates that requiring the data
elements to be submitted in ACE for veterinary devices will reduce the
number of violative veterinary devices entering the United States and
consequently reaching American consumers. In some, but not in all
cases, defects or adulteration of veterinary devices that are being
imported or offered for import into the United States will be
discovered upon a manual review that will be triggered as a result of
information submitted in ACE.
    In the RIA of the ACE final rule, we estimate that the costs to
both domestic and foreign entities of complying with the rule as based
largely on the amount of additional time it will take firms to: (1)
have an administrative worker prepare the additional information
required for each import line; (2) have the owner or manager in charge
confirm the information is correct; and (3) have an administrative
worker complete the entry declarations using software that is connected
to ACE. We also projected that the annual number of FDA-regulated
import lines and the number of lines covered by the ACE final rule and
therefore by this final rule would continue to grow at a rate of
between 0 and 10 percent per year, with the most likely rate of 2.45
percent per year, resulting in increasing total annual costs to
industry. For years since the publication of the ACE final rule (2016
to 2020), we replaced this assumption with actual veterinary device
import line counts.
    The estimated costs of this final rule are summarized in table 2.
The lower and upper estimates are at the 5 and 95 percent confidence
interval, respectively. Updated to 2020 dollars, the present value of
total costs of this rule is $0.81 million at a 7 percent discount rate
and $1.19 million at a 3 percent discount rate.

                Table 2--Summary of Estimated Costs, Cost Savings, and Benefits of the Final Rule
                                         [In thousands of 2020 dollars]
----------------------------------------------------------------------------------------------------------------
                                          Discount rate
                                               (%)         Lower estimate    Primary estimate    Upper estimate
----------------------------------------------------------------------------------------------------------------
Year 1 Costs...........................  ...............               $29                 $49               $73
Year 2 Costs...........................  ...............                39                  53                97
Year 3 Costs...........................  ...............                51                  69               127
Year 4 Costs...........................  ...............                52                  71               130
Year 5 Costs...........................  ...............                51                  69               127
Year 6 Costs...........................  ...............                53                  71               131

Year 7 Costs...........................  ...............                54                  74               136
Year 8 Costs...........................  ...............                56                  76               140
Year 9 Costs...........................  ...............                58                  78               145
Year 10 Costs..........................  ...............                60                  81               149
Year 11 Costs..........................  ...............                62                  84               154
Year 12 Costs..........................  ...............                64                  86               159
Year 13 Costs..........................  ...............                66                  89               165
Year 14 Costs..........................  ...............                68                  92               170
Year 15 Costs..........................  ...............                71                  95               176
Year 16 Costs..........................  ...............                73                  98               182
Year 17 Costs..........................  ...............                75                 102               188
Year 18 Costs..........................  ...............                78                 105               194
Year 19 Costs..........................  ...............                80                 109               200
Year 20 Costs..........................  ...............                83                 112               207
Total Costs............................  ...............             1,225               1,663             3,048
Present Value of Costs.................                7               596                 813             1,483
Present Value of Costs.................                3               878               1,194             2,185
Annualized Costs.......................                7                56                  77               140
Annualized Costs.......................                3                59                  80               147
                                                         -------------------------------------------------------
    Total Benefits.....................  ...............                      Not Quantified
                                                         -------------------------------------------------------
    Present Value of Benefits..........  ...............                      Not Quantified
                                                         -------------------------------------------------------
    Annualized Benefits................  ...............                      Not Quantified
----------------------------------------------------------------------------------------------------------------

Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Veterinary device importers that are impacted by
this final rule are included in the Final Regulatory Flexibility
Analysis for the ACE final rule (Ref. 2). As such, the impacts on these
small businesses are already discussed in the Regulatory Flexibility
Analysis for the ACE final rule (Ref. 2). This analysis serves as the
Final Regulatory Flexibility Analysis for this rule, as required under
the Regulatory Flexibility Act. Because no additional business will be
impacted by this final rule (Ref. 3), we certify that the final rule
will not have a significant economic impact on a substantial number of
small entities.

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 final 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 (PRA) (44 U.S.C. 3501-3521). A
description of these provisions is given in the Description section of
this document with an estimate of the one-time and recurring reporting
burdens. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    Title: Importer's Entry Notice--OMB Control Number 0910-0046--
Revision.
    Description: We are issuing a regulation that requires ACE filers
to submit certain data elements material to our import admissibility
review of veterinary devices in ACE, or any other CBP-authorized EDI
system, at the time of entry. This action facilitates automated ``May
Proceed'' determinations by us for those veterinary devices that
present a low risk to public health which, in turn, allows the Agency
to focus our limited 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 this final rule are those domestic and foreign
importers of medical devices that import or offer to import veterinary
devices into the United States and ACE filers.
    Reporting: As of July 23, 2016, ACE became the sole EDI system
authorized by CBP for the electronic filing of entries of FDA-regulated
articles into the United States. FDA has revised subpart D of part 1 of
chapter I, which was recently added by the ACE final rule, to establish
requirements for the electronic filing of entries of FDA-regulated
products in ACE or any other EDI system authorized by CBP. That final
rule took effect on December 29, 2016.
    Currently, importers of certain FDA-regulated products must submit
the general data elements in Sec.  1.72 at the time of entry in ACE. We
use the information collected to initially screen and review FDA-
regulated products being imported or offered for import into the United
States for admissibility in order to prevent violative FDA-regulated
products from entering the United States. This final rule makes the
data elements that are required to be submitted for FDA-regulated
products pursuant to Sec.  1.72 also mandatory for the electronic
filing of entries containing a veterinary device: FDA Country of
Production; complete FDA Product Code; full intended use code; and
telephone number and email address of the importer of record.
Submission of these data elements in ACE would help us to more
effectively and efficiently make admissibility determinations for
veterinary devices by increasing the opportunity for an

automated ``May Proceed'' of these entries by FDA.
    Although veterinary devices were not included in the ACE final
rule, veterinary devices were included in its RIA, as aggregate data
for both animal drugs and devices was included in the analysis. As a
result of inadvertently including veterinary device import lines in the
RIA of the ACE final rule, the information collection burden estimates
of the ACE final rule likewise incorporated the importation of
veterinary devices.
    As stated above, the analysis of the collection of information and
its related burden on respondents for the ACE final rule incorporated
the one-time and recurring burden related to importation of veterinary
devices by medical devices importers; thus, for this final rule there
is no additional estimated burden beyond the burden hours that were
included in the PRA section of the ACE final rule. We are, however,
revising the information collection approved under OMB control number
0910-0046 to identify the subset of burden specific to the import
entries for veterinary devices by importers of medical devices for the
purpose of allowing stakeholders to comment on this subset.
    The portion of the annual recurring reporting burden of this
collection of information specific to importers of medical devices that
import veterinary devices is estimated as follows:

                                                      Table 3--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
                                               Number of     responses per    Total annual
                 Activity                     respondents      respondent       responses            Average burden per response            Total hours
                                                             (approximate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing the required information                     944             0.51             484  0.03889 (2.333 minutes)....................              19
 (applies to unique lines only).
Quality checks and data submission into                285           117.87          33,592  0.01944 (1.166 minutes)....................             653
 ACE.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ...............  ..............  ...........................................             672
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    We adopt the average burden per response estimates reported in
table 3 from the analysis in the ACE final rule (81 FR 85854 at 85869).
To estimate the number of respondents, number of responses per
respondent, and total annual responses reported in table 3, we have
used the relevant assumptions and estimates discussed in Section VI.
Economic Analysis of Impacts and the actual data for 2016 to 2018.
Other key assumptions in the RIA for the ACE final rule (Ref. 2) and
for this final rule that affect our estimate of the annual recurring
reporting burden are:
     Average burden per response for preparing the required
information that applies to unique product-manufacturer import lines
only (81 FR 85854 at 85869). It is estimated to take between 0.0167
hours (1 minute) and 0.0667 (4 minutes), with the best estimate of
0.03889 hours (2.333 minutes).
     Average burden per response for quality checks and data
submission into ACE applies to all veterinary device lines. It is
estimated to take between 0.0083 hours (0.5 minute) and 0.0333 hours (2
minutes) with the best estimate of 0.01944 hours (1.166 minutes).

                                                     Table 4--Estimated One-Time Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
                                               Number of     responses per    Total annual
                 Activity                     respondents      respondent       responses            Average burden per response            Total hours
                                                             (approximate)
--------------------------------------------------------------------------------------------------------------------------------------------------------
First year adjusting to new requirements               206           119.74          24,667  0.00486 (0.29 minutes).....................             120
 that will result in an average of 25
 percent more time for quality checks and
 submission into ACE.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 4 shows the subset of the estimated one-time (i.e., occurring
only in the first year) reporting burden associated specifically with
the importation of veterinary medical devices by medical device
importers. We adopt the average burden per response estimates reported
in table 4 from the analysis in the ACE final rule (81 FR 85854 at
85869). We expect that, in the first year, respondents would be
required to adjust to new requirements that will result in an average
of 25 percent more time for quality checks and submission into ACE, for
a total of 120 hours. Table 2 from the analysis in the ACE final rule
(81 FR 85854 at 85869) also included an estimate of the time needed for
review and familiarization with the rule. We have not included that
estimate in this analysis because all importers of medical devices that
import veterinary medical devices also import human medical devices,
which are covered in the ACE final rule; thus, they are already
familiar with those requirements.
    We estimate the subset of burden specific to the import entries for
veterinary devices approved under OMB control number 0910-0046 to be
792 hours in the first year (672 recurring hours + 120 one-time hours)
and 672 hours recurring after the first year.
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has
submitted the information collection provisions of this final rule to
OMB for review. These requirements will not be effective until FDA
obtains OMB approval. FDA will publish a notice concerning OMB approval
of these requirements in the Federal Register.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the final
rule does not contain policies that have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that this final
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 final rule in accordance with the principles
set forth in Executive Order 13175. We have determined that the final
rule does not contain policies that have substantial direct effects on
one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.

XII. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. FDA, ``Submission of Food and Drug Administration Import Data in
the Automated Commercial Environment.'' Federal Register (Docket No.
FDA-2016-N-1487). Online November 29, 2016. https://www.federalregister.gov/documents/2016/11/29/2016-28582/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment.
2. FDA. Submission of Food and Drug Administration Import Data in
the Automated Commercial Environment (Final Rule) Regulatory Impact
Analysis. Economic Impact Analyses of FDA Regulations. Online
November 29, 2016. https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
3. FDA. Office of Regulatory Affairs Reporting, Analysis, and
Decision Support System (ORADSS). 2015-2017 data.

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, 21 CFR part
1 is amended 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, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384, 384a, 384b, 384d, 387,
387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L.
107-188, 116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885,
3889.

0
2. Amend Sec.  1.71 by adding in alphabetical order the definition for
``Veterinary device'' to read as follows:

Sec.  1.71   Definitions.

* * * * *
    Veterinary device means a device as defined in section 201(h) of
the Federal Food, Drug, and Cosmetic Act, that is intended for use in
animals.

0
3. Revise Sec.  1.72 introductory text to read as follows:

Sec.  1.72   Data elements that must be submitted in ACE for articles
regulated by FDA.

    General. When filing an entry in ACE, the ACE filer shall submit
the following information for food contact substances, drugs,
biological products, HCT/Ps, medical devices, veterinary devices,
radiation-emitting electronic products, cosmetics, and tobacco
products.
* * * * *

0
4. Revise Sec.  1.75 to read as follows:

Sec.  1.75   Animal drugs and veterinary devices.

    (a) Animal drugs. In addition to the data required to be submitted
in Sec.  1.72, an ACE filer must submit the following information at
the time of filing entry in ACE for animal drugs:
    (1) Registration and listing. For a drug intended for animal use,
the Drug Registration Number and the Drug Listing Number if the foreign
establishment where the drug was manufactured, prepared, propagated,
compounded, or processed before being imported or offered for import
into the United States is required to register and list the drug under
part 207 of this chapter. For the purposes of this section, the Drug
Registration Number that must be submitted in ACE at the time of entry
is the Unique Facility Identifier of the foreign establishment where
the animal drug was manufactured, prepared, propagated, compounded, or
processed before being imported or offered for import into the United
States. The Unique Facility Identifier is the identifier submitted by a
registrant in accordance with the system specified under section 510(b)
of the Federal Food, Drug, and Cosmetic Act. For the purposes of this
section, the Drug Listing Number is the National Drug Code number of
the animal drug article being imported or offered for import.
    (2) New animal drug application number. For a drug intended for
animal use that is the subject of an approved application under section
512 of the Federal Food, Drug, and Cosmetic Act, the number of the new
animal drug application or abbreviated new animal drug application. For
a drug intended for animal use that is the subject of a conditionally
approved application under section 571 of the Federal Food, Drug, and
Cosmetic Act, the application number for the conditionally approved new
animal drug.
    (3) Veterinary minor species index file number. For a drug intended
for use in animals that is the subject of an Index listing under
section 572 of the Federal Food, Drug, and Cosmetic Act, the Minor
Species Index File number of the new animal drug on the Index of
Legally Marketed Unapproved New Animal Drugs for Minor Species.
    (4) Investigational new animal drug file number. For a drug
intended for animal use that is the subject of an investigational new
animal drug or generic investigational new animal drug file under part
511 of this chapter, the number of the investigational new animal drug
or generic investigational new animal drug file.
    (b) Veterinary devices. An ACE filer must submit the data specified
in Sec.  1.72 at the time of filing entry in ACE for veterinary
devices.

    Dated: October 6, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.

    In concurrence with FDA.

    Dated: October 6, 2022.
Thomas C. West, Jr.,
Deputy Assistant Secretary of the Treasury for Tax Policy, Department
of the Treasury.
[FR Doc. 2022-22532 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P