[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
[email protected]. 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,
[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 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
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Abbreviation/acronym What it means
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ACE............................... Automated Commercial Environment or
any other CBP-authorized EDI
system.
ACE filer......................... The person who is authorized 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.
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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).
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\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.
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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
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Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
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Benefits:
Annualized Monetized, $millions/ .......... .......... .......... .......... 7 20 ........................................
year. 3 20
Annualized Quantified............. .......... .......... .......... .......... 7 20 ........................................
3 20
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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.
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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
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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:
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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