[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Rules and Regulations]
[Pages 62977-62984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22532]



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

[[Page 62977]]



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, 240-402-4490, [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, 301-796-5733, 
[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

[[Page 62978]]

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

[[Page 62979]]

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

[[Page 62980]]

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:
                                          --------------------------------------------------------------------------------------------------------------

[[Page 62981]]

 
    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

[[Page 62982]]

 
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

[[Page 62983]]

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.

[[Page 62984]]

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


