[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Proposed Rules]
[Pages 46566-46575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15571]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we), 
with the Department of the Treasury's concurrence, is proposing to 
amend 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 that veterinary device. 
The proposed rule would 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 proposed rule would 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: Submit either electronic or written comments on the proposed 
rule

[[Page 46567]]

by October 19, 2020. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 (PRA) by September 2, 2020.

ADDRESSES: You may submit comments as follows: Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 19, 2020; the https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 19, 2020; or comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-4268 for ``Submission of Food and Drug Administration Import 
Data in the Automated Commercial Environment for Veterinary Devices.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 
a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Submit comments on information collection issues under the PRA to 
the Office of Management and Budget (OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or email to 
oira_submission@omb.eop.gov. All comments should be identified with the 
title, ``Importer's Entry Notice--OMB Control Number 0910-0046--
Revision.''

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: 
Randall Gnatt, Center for Veterinary Medicine (HFV-200), Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7231, 
Randall.Gnatt@fda.hhs.gov. 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, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
IV. Legal Authority
V. Description of the Proposed Rule
VI. Proposed 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 Proposed 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 proposed rule would require the submission of certain data 
elements material to FDA's process of making decisions on 
admissibility. This action would facilitate automated ``May Proceed'' 
determinations by FDA for those veterinary devices that present a low 
risk to public health which, in turn, would allow 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 Proposed Rule

    FDA proposes to revise subpart D of part 1 of 21 CFR chapter I (21 
CFR part 1), which was 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

[[Page 46568]]

system authorized by CBP. That final rule took effect on December 29, 
2016.
    This proposed rule would make 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 would help 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 
Operational and Administrative System for Import Support (OASIS). These 
data elements are currently required to be submitted for the electronic 
filing of entries containing food contact substances, drugs, biological 
products, HCT/Ps, medical devices for human use, radiation-emitting 
electronic products, cosmetics, and tobacco products.

C. Legal Authority

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

D. Costs and Benefits

    Cost savings would 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, would 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 FDA has estimated the annualized costs of complying with this 
proposed regulation to be between $0.028 million and $0.073 million per 
year (using 3 and 7 percent discount rates). These costs were already 
previously inadvertently included and the benefits were discussed in 
the regulatory impact analysis (RIA) for the ``Submission of Food and 
Drug Administration Import Data in the Automated Commercial 
Environment'' final rule (Ref. 2). We tentatively conclude that this 
proposed rule would have no additional costs beyond the costs that were 
included in that RIA (Ref. 2).

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.
OASIS.............................  FDA's Operational and Administrative
                                     System for Import Support.
RIA...............................  Regulatory Impact Analysis.
PRA...............................  Paperwork Reduction Act of 1995.
We, Our, Us.......................  U.S. Food and Drug Administration.
------------------------------------------------------------------------

III. Background

    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 (81 FR 85854), 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 proposed rule would add 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, and which does not achieve its primary 
intended purposes through chemical action within or on the body of man 
or other animals and which 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, 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

[[Page 46569]]

veterinary devices. We expect that receipt of this information will 
increase the opportunity for automated ``May Proceed'' determinations 
by us for those veterinary devices that present a low public health 
risk which, in turn, would allow 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 OASIS via an electronic interface. The entry is 
then initially screened by FDA using FDA's Predictive Risk-based 
Evaluation for Dynamic Import Compliance Targeting, a risk-based 
electronic screening tool for OASIS, 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 at a 
later time. If the initial electronic review indicates that manual 
further review is appropriate, FDA personnel will review the entry 
information submitted by the ACE filer and may request additional 
information to make an admissibility determination and/or may 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 Guidance which includes the optional data elements 
published at: https://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM459926.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.

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 proposed 
rule is being jointly prescribed by FDA and the Department of the 
Treasury.

V. Description of the Proposed Rule

    We are proposing to amend Sec.  1.72 to make that section 
applicable to veterinary devices, as defined in proposed Sec.  1.71. In 
addition, Sec.  1.75 would be amended 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 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 (81 FR 85854 at 85859-85860).
    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 entry in ACE for animal drugs being imported or 
offered for import beyond that listed in Sec.  1.72. The proposed rule 
would amend 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) proposes 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 proposed 
rule, if finalized, would be 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.'' The 
section would thus use the more appropriate terminology 
``investigational new animal drug file number'' and ``investigational 
new animal drug file,'' which would be consistent with the terminology 
used in other FDA regulations.

VI. Proposed Effective Date

    We propose that any final rule based on this proposal become 
effective 30 days after the date on which it is published in the 
Federal Register.

VII. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, 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). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this proposed 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

[[Page 46570]]

proposed rule would simply extend 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 would bear the costs, but would 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 would be impacted by this proposed rule, we propose to 
certify that the proposed rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $156 million, using the most current (2019) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    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 proposed rule would 
require the submission of certain data elements material to FDA's 
process of making decisions on admissibility. This proposed rule 
therefore would simply extend to veterinary devices the submission of 
the data elements that are currently required for other products by 
Sec.  1.72.
    The costs of this proposed rule were inadvertently included and the 
benefits were 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 $0.073 million per year (using 
3 and 7 percent discount rates) (table 1). 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. We tentatively conclude that this proposed 
rule has no additional costs beyond the costs that were included in the 
RIA of the ACE final rule (Ref. 2).
---------------------------------------------------------------------------

    \1\ We assume that the importer would bear 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.
---------------------------------------------------------------------------

    Annualized over a 20-year horizon, the costs of complying with this 
proposed regulation are between $0.029 million and $0.073 million per 
year with the best estimate of $0.051 million per year at a 3 percent 
discount rate; these costs are between $0.028 million and $0.071 
million per year with the best estimate of $0.049 million per year at a 
7 percent discount rate (table 1).

                                  Table 1--Summary of Costs, Benefits, and Distributional Effects of the Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized, $millions/    ..........  ..........  ..........  ..........           7          20  ........................................
     year.                                                                                       3          20
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7          20  ........................................
                                                                                                 3          20
                                       ------------------------------------------------------------------------
    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/        $0.049      $0.028      $0.071        2015           7          20  ........................................
     year.                                  $0.051      $0.029      $0.073        2015           3          20
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7          20  ........................................
                                                                                                 3          20
                                       ------------------------------------------------------------------------
    Qualitative
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:

[[Page 46571]]

 
    Federal Annualized Monetized,       ..........  ..........  ..........  ..........           7          20  ........................................
     $millions/year.                                                                             3          20
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........           7          20  ........................................
     $millions/year.                                                                             3          20
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No significant effect
    Small Business: Small businesses would be affected by this proposed rule, if finalized, 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 would bear the costs of this
     rule, but also 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 would 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We are unable at this time to quantify exact resource savings to 
the Agency and cost savings to the industry because of the lack of data 
about certain industry practices and uncertainty about future changes 
in the usual and customary business practices, import volumes, and 
incoming data quality.
    In line with Executive Order 13771, in table 2 we estimate present 
and annualized values of costs and cost savings over an infinite time 
horizon. The present value of costs are approximately $0.77 million, 
discounted at 7 percent over an infinite time horizon, with a lower 
bound of approximately $0.45 million and an upper bound of 
approximately $1.12 million. The annualized costs of the proposed rule 
are approximately $0.054 million, discounted at 7 percent over an 
infinite time horizon, with a lower bound of approximately $0.031 
million and an upper bound of approximately $0.078 million. Discounted 
at 3 percent over an infinite time horizon, the net present value of 
the costs of this proposed rule are approximately $2.03 million, with a 
lower bound of approximately $1.18 million and an upper bound of 
approximately $2.93 million. The annualized costs of the proposed rule 
are approximately $0.061 million, discounted at 3 percent over an 
infinite time horizon, with a lower bound of approximately $0.035 
million and an upper bound of approximately $0.088 million. The 
proposed rule, if finalized as proposed, is expected to be an Executive 
Order 13771 regulatory action.

                                                     Table 2--Summary of Executive Order 13771 Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                         Lower bound (7%)     Primary (7%)     Upper bound (7%)   Lower bound (3%)     Primary (3%)     Upper bound (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs................           $449,016           $772,586         $1,117,741         $1,178,755         $2,027,690         $2,933,639
                                       -----------------------------------------------------------------------------------------------------------------
Present Value of Cost Savings.........                       Not Quantified
                                                             Not Quantified
                                       -----------------------------------------------------------------------------------------------------------------
Present Value of Net Cost Savings.....                       Not Quantified
                                                             Not Quantified
                                       -----------------------------------------------------------------------------------------------------------------
Annualized Costs......................            $31,438            $54,081            $78,248            $35,363            $60,831            $88,009
                                       -----------------------------------------------------------------------------------------------------------------
Annualized Cost Savings...............                       Not Quantified
                                                             Not Quantified
                                       -----------------------------------------------------------------------------------------------------------------
Annualized Net Cost Savings...........                       Not Quantified
                                                             Not Quantified
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Next, we qualitatively discuss the cost savings, the benefits, and 
the costs of this proposed rule that were previously discussed in the 
RIA of the ACE final rule (Ref. 2) and would also apply to veterinary 
devices covered by this proposed rule. The cost savings to both the 
industry and FDA that we are unable to quantify would potentially 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

[[Page 46572]]

admissibility decision by FDA. Such time savings would arise as a 
result of increased efficiency in FDA's imports admissibility process.
    Without this proposed 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 proposed rule into ACE, FDA intends to 
further streamline review of import entry declarations for veterinary 
devices and to facilitate a more efficient use of FDA's internal 
resources.
    Potential benefits to consumers from this proposed rule that we are 
similarly unable to quantify would 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 would 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 could be discovered upon a manual review that would 
be triggered as a result of information submitted in ACE.
    In the RIA of the ACE final rule, we estimated 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 proposed 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.
    The estimated costs, cost savings, and benefits of the proposed 
rule are summarized in table 3. The lower and upper estimates are at 
the 5 and 95 percent confidence interval, respectively. The present 
discounted value of total costs over 20 years is $0.753 million at a 3 
percent discount rate and $0.517 million at a 7 percent discount rate 
(table 3).

              Table 3--Summary of Estimated Costs, Cost Savings, and Benefits of the Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                   Discount rate                      Primary
                                                        (%)       Lower estimate     estimate     Upper estimate
----------------------------------------------------------------------------------------------------------------
Year 1 Costs....................................  ..............         $27,007         $46,457         $67,213
Year 2 Costs....................................  ..............          22,381          38,503          55,702
Year 3 Costs....................................  ..............          23,120          39,774          57,540
Year 4 Costs....................................  ..............          23,883          41,086          59,439
Year 5 Costs....................................  ..............          24,671          42,441          61,400
Year 6 Costs....................................  ..............          25,485          43,840          63,427
Year 7 Costs....................................  ..............          26,326          45,290          65,520
Year 8 Costs....................................  ..............          27,195          46,783          67,682
Year 9 Costs....................................  ..............          28,092          48,324          69,915
Year 10 Costs...................................  ..............          29,020          49,924          72,223
Year 11 Costs...................................  ..............          29,977          51,571          74,606
Year 12 Costs...................................  ..............          30,966          53,274          77,068
Year 13 Costs...................................  ..............          31,988          55,026          79,611
Year 14 Costs...................................  ..............          33,044          56,849          82,238
Year 15 Costs...................................  ..............          34,134          58,724          84,952
Year 16 Costs...................................  ..............          35,261          60,660          87,756
Year 17 Costs...................................  ..............          36,424          62,654          90,652
Year 18 Costs...................................  ..............          37,626          64,726          93,643
Year 19 Costs...................................  ..............          38,868          66,871          96,733
Year 20 Costs...................................  ..............          40,151          69,065          99,926
Total Costs.....................................  ..............         605,621       1,041,842       1,507,246
Present Discounted Value of Costs...............               3         437,739         753,036       1,089,427
Present Discounted Value of Costs...............               7         300,891         517,619         748,846
Annualized Costs................................               3          29,423          50,616          73,227
Annualized Costs................................               7          28,402          48,860          70,686
                                                                 -----------------------------------------------
Total Benefits..................................  ..............                  Not Quantified
                                                                 -----------------------------------------------
Present Discounted Value of Benefits............  ..............                  Not Quantified
----------------------------------------------------------------------------------------------------------------
Annualized Benefits.............................  ..............                  Not Quantified
                                                                 -----------------------------------------------
Total Cost Savings..............................  ..............                  Not Quantified
                                                                 -----------------------------------------------

[[Page 46573]]

 
Present Discounted Value of Cost Savings........  ..............                  Not Quantified
                                                                 -----------------------------------------------
Annualized Cost Savings.........................  ..............                  Not Quantified
----------------------------------------------------------------------------------------------------------------

Regulatory Flexibility Analysis

    FDA has examined the economic implications of this proposed rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities consistent with statutory objectives. Because no 
additional business would be impacted by this proposed rule (Ref. 3), 
we propose to certify that the proposed rule will not have a 
significant economic impact on a substantial number of small entities. 
Importers that are impacted by this proposed rule are the same 
businesses as some of the importers impacted by the ACE final rule 
(Ref. 1). The impacts on these small businesses are already discussed 
in the Regulatory Flexibility Analysis for the ACE final rule (Ref. 2).

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the 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.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Importer's Entry Notice--OMB Control Number 0910-0046--
Revision.
    Description: This proposed rule would require that certain data 
elements material to our import admissibility review of veterinary 
devices be submitted in ACE or any other CBP-authorized EDI system, at 
the time of entry. This action would facilitate automated ``May 
Proceed'' determinations by us for those veterinary devices that 
present a low risk to public health which, in turn, would allow 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 proposed 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 proposes to revise 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 proposed rule would make 
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's OASIS.
    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 proposed 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:

[[Page 46574]]



                            Table 4--Estimated Annual Recurring Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
                                    Number of     responses per   Total annual   Average burden per
            Activity               respondents     respondent       responses       response (in     Total hours
                                                  (approximate)                        hours)
----------------------------------------------------------------------------------------------------------------
Preparing the required                      654            0.60             392  0.03889 (2.333               15
 information (applies to unique                                                   minutes).
 lines only).
Quality checks and data                     206          123.74          25,490  0.01944 (1.166              496
 submission into ACE.                                                             minutes).
                                --------------------------------------------------------------------------------
    Total Hours................  ..............  ..............  ..............  ..................          511
----------------------------------------------------------------------------------------------------------------
\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 4 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 4, we have 
used the relevant assumptions and estimates discussed in Section VI. 
Economic Analysis of Impacts. Other key assumptions in the RIA for the 
ACE final rule (Ref. 2) and for this proposed 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 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 5--Estimated One Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
                                    Number of     responses per   Total annual   Average burden per
            Activity               respondents     respondent       responses       response (in     Total hours
                                                  (approximate)                        hours)
----------------------------------------------------------------------------------------------------------------
First year adjusting to new                 206          119.74          24,667  0.00486 (0.29               120
 requirements that will result                                                    minutes).
 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 5 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 5 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.
    If this rule is finalized as proposed, we estimate the subset of 
burden specific to the import entries for veterinary devices approved 
under OMB control number 0910-0046 to be 631 hours in the first year 
(511 recurring hours + 120 one-time hours) and 511 hours recurring 
after the first year.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title of the information collection. In compliance 
with the PRA (44 U.S.C. 3407(d)), the Agency has submitted the 
information collection provisions of this proposed 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 proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the proposed rule does not contain policies that have 
federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

XII. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available

[[Page 46575]]

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. Cited: January 31, 2017. 
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. Cited: January 31, 2017. https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm530862.htm.
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, we propose 
that 21 CFR part 1 be 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, 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: July 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.

    In concurrence with FDA:

    Dated: July 2, 2020.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy), Department 
of the Treasury.
[FR Doc. 2020-15571 Filed 7-31-20; 8:45 am]
BILLING CODE 4164-01-P


