[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Proposed Rules]
[Pages 43155-43178]
[FR Doc No: 2016-15684]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 1005, and 1271

[Docket No. FDA-2016-N-1487]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to establish requirements for the electronic filing of
entries of FDA-regulated products in the Automated Commercial
Environment (ACE) or any other electronic data interchange (EDI) system
authorized by the U.S. Customs and Border Protection Agency (CBP), in
order for the filing to be processed by CBP and to help FDA in
determining admissibility of that product. 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, foster U.S. economic security
through lawful international trade and policy, and to replace the
Automated Commercial System (ACS). FDA is a Partner Government Agency
(PGA) in the initiative to establish ITDS, the ``single window'' for
the submission of import and export data to the United States
Government. The proposed rule would also update certain sections of FDA
regulations related to imports. This rule, as proposed, does not affect
the ability of filers to continue to submit their import entries and
entry summaries by paper for FDA-regulated products that are being
imported or offered for import. Once finalized, this action will
facilitate effective and efficient admissibility review by the Agency
and protect public health by allowing FDA to focus its limited
resources on those FDA-regulated products being imported or offered for
import that may be associated with a greater public health risk.

DATES: Submit either electronic or written comments on the proposed
rule by August 30, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-1487 for ``Submission of FDA Import Data into the Automated
Commercial Environment.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.gpo.gov/fdsys/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 http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 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:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title, ``Submission of FDA Import Data into the Automated Commercial
Environment.''

FOR FURTHER INFORMATION CONTACT: Ann M. Metayer, Office of Regulatory
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 4338, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    With regard to the information collection: Jonnalynn Capezzuto,
Office of Operations, Food and Drug Administration, 8455 Colesville
Rd., Rm. 14526, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>
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
    A. Scope/Applicability
    B. Definitions
    C. Data Elements that Must Be Submitted in ACE for FDA-Regulated
Products
    D. Technical Amendments
VI. Proposed Effective Date
VII. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits and Costs of the Proposed Rule
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

    The proposed rule would require that certain data elements material
to our admissibility determination on FDA-regulated products being
imported or offered for import, be submitted in ACE or any other CBP-
authorized EDI system, at the time of entry. This action, once
finalized, will facilitate automated ``May Proceed'' determinations by
us for low-risk FDA-regulated products which, in turn, will allow the
Agency to focus our limited resources on products that may be
associated with a greater public health risk.
    FDA also proposes to make technical revisions to certain sections
of FDA regulations to make updates and provide clarifications.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule would add Subpart D to Part 1 of 21 CFR Chapter
I to require that certain data elements be submitted in ACE or any
other CBP-authorized EDI system, at the time of entry in order to
facilitate admissibility review by the Agency of FDA-regulated products
being imported or offered for import into the United States. Submission
of these data elements in ACE will help us to more effectively and
efficiently make admissibility determinations for FDA-regulated
products by increasing the opportunity for automated review by FDA's
Operational and Administrative System for Import Support (OASIS).
    The proposed rule would also make technical revisions to certain
sections of 21 CFR Chapter I to update them. We propose to revise 21
CFR 1.83 and 21 CFR 1005.2 to update the definition of owner or
consignee in order to make that definition consistent with Title 19 of
the U.S. Code. We also propose to revise 21 CFR 1.90 to allow FDA to
provide notice of sampling directly to an owner or consignee.
Additionally, we propose to revise 21 CFR 1.94 to clarify that written
notice can be provided electronically by FDA to owners or consignees of
FDA actions to detain, refuse, and/or subject certain products to
administrative destruction. Under Sec.  1.94, owners or consignees will
receive notice that FDA intends to take a certain action against an
FDA-regulated product that is being imported or offered for import and
the owner or consignee will have an opportunity to introduce testimony
to the Agency in opposition to such action. We are also proposing to
amend 21 CFR 1271.420 to make clear that, unless otherwise exempt,
importers of record of human cells, tissues and cellular and tissue-
based products (HCT/Ps) that are regulated solely under section 361 of
the Public Health Service Act (42 U.S.C. 264) and 21 CFR part 1271
would be required to submit the applicable data elements included in
the proposed rule in ACE.

C. Legal Authority

    The legal authority for the proposed rule includes sections 536,
701, and 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360mm, 371, and 381, respectively), and sections 351, 361, and
368 of the Public Health Service Act (PHS Act) (42 U.S.C. 262, 264, and
271, respectively).

D. Costs and Benefits

    The Agency has determined that this proposed rule may be a
significant regulatory action as defined by Executive Order 12866.
Although at this time we cannot fully quantify the benefits of this
proposed rule, adopting the proposed rule is expected to provide a
positive net benefit (estimated benefits minus estimated costs) to
society.

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.
Agency............................  U.S. Food and Drug Administration.
CBP...............................  U.S. Customs and Border Protection
                                     Agency.
CBER..............................  FDA Center for Biologics Evaluation
                                     and Research.
CDER..............................  FDA Center for Drug Evaluation and
                                     Research.
CDRH..............................  FDA Center for Devices and
                                     Radiological Health.
CTP...............................  FDA Center for Tobacco Products.
CVM...............................  FDA Center for Veterinary Medicine.
EDI...............................  Electronic Data Interchange.
FDA...............................  U.S. Food and Drug Administration.
FDASIA............................  Food and Drug Administration Safety
                                     and Innovation Act.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
ITDS..............................  International Trade Data System.
OASIS.............................  FDA Operational and Administrative
                                     System for Import Support.
PGA...............................  Partner Government Agency in ACE.
PHS Act...........................  Public Health Service Act.
We, Our, Us.......................  U.S. Food and Drug Administration.
------------------------------------------------------------------------

III. Background

    The number of FDA-regulated products imported into the United
States has grown steadily, from approximately 6 million import lines in
2002 to over 35 million import lines in 2015. In 2014, FDA-regulated
products imported or offered for import were manufactured in more than
322,500 foreign facilities and arrived in the United States from more
than 100 countries. This increase in the

importation of FDA-regulated products has posed challenges to FDA
including enforcement of sections 536 and 801 of the FD&C Act and
sections 351, 361, and 368 of the PHS Act.
    Section 484 of the Tariff Act of 1930 as amended (19 U.S.C. 1484)
established the requirement for importers of record to make entry for
merchandise imported into the customs territory of the United States.
When goods are imported into the United States they must be entered at
one of the CBP ports. The term entry refers to the information or
documentation that an importer of record must file with CBP. An import
line is each portion of an import entry that is listed as a separate
item on an entry document.
    An importer of record is the owner or purchaser of the article
being offered for import or a customs broker licensed by CBP under 19
U.S.C. 1641 who has been designated by the owner, purchaser, or
consignee to file the import entry. There is one importer of record per
entry. Approximately 98 percent of all entries containing FDA-regulated
products subject to the proposed rule are filed by customs brokers.
    In December 1993, the Customs Modernization Act (Title VI of the
North American Free Trade Agreement Implementation Act (Pub. L. 103-
182)) was enacted. A prominent feature of the Customs Modernization Act
is the legal requirement that importers of record exercise reasonable
care when filing entries (19 U.S.C. 1484). Reasonable care requires
that CBP be provided with the accurate and complete information or
documentation deemed necessary by CBP to determine whether all legal
requirements for admissibility of that article have been met.
    The Customs Modernization Act also included the development of ACE,
the planned successor to ACS which has been the electronic system used
by CBP to track, control, and process all commercial goods imported
into the United States for decades. ACE is intended to streamline
business processes, facilitate growth in trade, ensure cargo security,
and foster participation in global commerce while ensuring compliance
with U.S. laws and regulations.
    The ITDS, as described in section 405 of the Security and
Accountability for Every Port Act of 2006 (SAFE Port Act) (Pub. L. 109-
347), was established to modernize and simplify the way in which PGAs,
including FDA, interact with importers by creating a ``single window''
through which industry will transmit the data elements required for
importation or exportation of cargo. The purpose of ITDS is to
eliminate redundant filing requirements, to efficiently regulate the
flow of commerce, and to effectively enforce laws and regulations
relating to international trade, by establishing a single portal
system, operated by CBP, for the collection and distribution of
standard electronic import and export data required by all PGAs (19
U.S.C. 1411(d)(1)(B)). CBP has designed ACE to provide that ``single
window'' for the filing of entries. Over the last several years, CBP
has tested ACE and provided significant public outreach to ensure that
the trade community is fully aware of the transition from ACS to ACE
(81 FR 10264, February 29, 2016). FDA has actively participated as a
PGA in the development of ITDS and ACE.
    On February 19, 2014, President Obama issued an Executive Order,
Streamlining the Export/Import Process for America's Businesses
(Executive Order 13659), requiring that, by December 31, 2016, PGAs
have the capabilities, agreements, and other requirements in place to
utilize the ITDS and supporting systems, such as ACE as the primary
means of receipt of the data and other relevant information necessary
for the release and clearance of imported goods. Executive Order 13659
envisions a simpler, more efficient automated system for trade use for
the benefit of both the trade industry and PGAs. ACE is expected to
become the sole EDI system authorized by CBP for processing electronic
entry and entry summary filings; ACS incrementally is being
decommissioned by CBP for those functions.
    While primary responsibility for administering U.S. laws relating
to imports is exercised by CBP, FDA is responsible for determining
whether or not an FDA-regulated article being imported or offered for
import is in compliance with the laws enforced by FDA. The discharge of
this joint responsibility has involved close coordination and
cooperation between FDA and CBP for such imports.
    FDA receives notice from CBP of the arrival at each U.S. port of
entry (sea, land, rail, and air) where FDA-regulated products are
imported, of each shipment containing an FDA-regulated product. The PGA
Message Set in ACE for FDA-regulated products contains the data that
assists FDA in determining the admissibility of those products under
FDA authorities. This data is transmitted to CBP by an ACE filer
through the Automated Broker Interface (ABI), which permits a
participant to file import data electronically in ACE. ABI is the
primary mechanism for data submission in ACS, and will continue to be
used in ACE. After the data is submitted through ABI in ACE, it is
validated by CBP and made available to FDA. Transmission of data via
ABI enables more effective enforcement and faster release decisions, as
well as more certainty for the importer in determining logistics of
cargo delivery (81 FR 10264). ABI is available to brokers, importers,
and independent service bureaus, and currently over 96 percent of all
entries filed with CBP in ACS are filed through ABI (Ref. 1).
    If a required data element is not submitted in ACE, CBP cannot
process the entry. The ACE filer will then receive an electronic
message indicating that a particular data element was missing and that
the entry will not be processed without submission of that data
element. The ACE filer may refile the entry and it will be processed by
CBP if all of the required elements are submitted.
    Because, under ACE, CBP will relay the data in the PGA Message Set
to FDA using an electronic interface with OASIS, the ACE filer will
only need to submit this entry information once provided that the
information submitted in ACE is accurate. ACE entries will be
electronically screened in OASIS against criteria developed by FDA, as
they were in ACS. FDA's Predictive Risk-based Evaluation for Dynamic
Import Compliance Targeting (PREDICT) is a risk-based electronic
screening tool for OASIS that performs this initial electronic
screening to assist FDA entry reviewers by evaluating the potential
risks associated with each article, and identifying those articles that
may present a higher public health risk for further examination by FDA.
    OASIS expedites the clearance of FDA-regulated products that
present a low public health risk but only if the importer of record
provides accurate and complete import information. If the FDA
electronic screening evaluation of the potential public health risk is
determined to be low, OASIS will transmit a message back through the
FDA/CBP interface that indicates an article being imported or offered
for import ``May Proceed'' into U.S. commerce, barring any alternate
determination by CBP. A ``May Proceed'' message 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 FDA electronic review
determines that further evaluation by FDA is necessary, FDA personnel
will manually 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.
    CBP collects in ACS four data elements to assist FDA in making
admissibility decisions for FDA-regulated products: (1) The complete
FDA Product Code; (2) FDA country of production; (3) FDA manufacturer
and shipper; and (4) the ultimate consignee. Under the proposed rule,
two of these data elements would be mandatory submissions at the time
of entry in ACE or any other CBP-authorized EDI system: The complete
FDA product code and FDA Country of Production.
    In ACS, filers are also able to make optional submissions of
certain information such as Affirmations of Compliance regarding
requirements related to the FDA-regulated product. By submitting data
using an Affirmation of Compliance Code, the filer affirms that the
firm or FDA-regulated article identified in an entry line meets the
requirements specific to each Affirmation of Compliance Code. FDA
publishes a list of current Affirmation of Compliance Codes on the FDA
Web site at http://www.fda.gov/forindustry/importprogram/entryprocess/entrysubmissionprocess/ucm461234.htm.
    Submissions of Affirmations of Compliance assist FDA in expediting
the initial screening and further review of an entry, and can
significantly increase the likelihood that an entry line will receive
an automated ``May Proceed.'' The number of Affirmation of Compliance
submissions in ACS has varied depending on the commodity. For example,
in 2015 approximately 98 percent of entry lines that are or include a
medical device have at least one Affirmation of Compliance Code
submitted in ACS, but only 24 percent of entry lines that are or
include an animal drug have at least one of the Affirmations of
Compliance Codes.
    We propose to make mandatory, at the time of entry in ACE,
submission of certain data elements (that have been submitted in ACS)
in order to more effectively and efficiently screen for those FDA-
regulated products which are likely to pose a low public health risk.
Historically, when these data fields are inaccurate or incomplete,
these entries must be manually reviewed for an admissibility
determination by FDA. Entries are delayed, sometimes significantly,
while FDA reviewers either search for that information in our data
systems or request followup documentation from the importer of record.
An automated review to determine whether an article ``May Proceed'' is
much faster and less resource intensive for FDA and the importer than a
manual review. For example, the average time for the OASIS system to
process an import entry submitted in ACS in 2015 and issue an automated
``May Proceed'' determination was approximately 24 minutes whereas the
average time for an FDA-reviewer to manually review and issue a ``May
Proceed'' determination was about 28 hours. FDA expects that mandatory
submission of these data elements will increase the number of import
entries of FDA-regulated products that receive an automated ``May
Proceed'' determination. The average time for FDA to issue an automated
``May Proceed'' determination is expected to be faster for entries to
be submitted in ACE than it was for entries submitted in ACS. As a
result of a more streamlined import process, the proposed rule is
expected to lead to a more effective use of FDA and importer resources,
and more efficient enforcement of section 801(a) of the FD&C Act.
    The PGA Message Set in ACE also includes optional submission of
information relevant to FDA's admissibility determination on FDA-
regulated products. We strongly encourage ACE filers to submit the
optional data elements in the PGA Message Set 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: http://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM459926.pdf). Accurate and complete information submitted by an ACE
filer increases the likelihood that an entry line will receive an
automated ``May Proceed'' determination from FDA.
    For example, the PGA Message Set in ACE contains optional active
pharmaceutical ingredient (API) data elements for finished human and
animal drugs. The API data elements include the name of the API, the
amount and unit of measure of the API in the finished drug, and the
name of the manufacturer of the API in the finished drug. FDA believes
that submission of this additional information may expedite import
entry review by facilitating electronic ``May Proceed'' determinations
for low risk drugs. FDA invites comments on the advantages,
disadvantages, and feasibility of providing these API data elements for
human and animal drugs, if they were to become mandatory data elements
for entry filing in ACE.
    FDA also invites comments on the advantages, disadvantages, and
feasibility of requiring the submission of data elements related to the
approval or clearance status of FDA-regulated medical products. We
propose to require the submission at the time of entry of application
numbers for those articles that are the subject of such applications.
In particular, we invite comment on whether the submission of these
data elements will help us achieve our goals of facilitating
admissibility review and focusing our resources on those products that
may be associated with a serious public health risk to consumers.
    Additionally, FDA invites comments on the advantages,
disadvantages, and feasibility of the Agency requiring the submission
of the following data elements in ACE at the time of entry: (1) An
intended use code for the FDA-regulated article being imported or
offered for import and (2) a disclaimer indicating that that the
article is not currently regulated by FDA or that FDA does not
currently have any requirements for submission of data for importation
of that article per Agency guidance. Submission of intended use codes
assists us in differentiating between products in the same product
category which may have the same product code. For example, an ACE
filer would submit in ACE at the time of entry an intended use code
``For Human Medical Use as a Medical Device'' as the intended use for a
medical device, accessory, or component that is regulated as a finished
medical device for use in humans. Use of another intended use code
would inform the Agency that the finished medical device for use in
humans is only to be used for research and development as a medical
device, for bench testing or nonclinical research use or as a device
sample for customer evaluation.
    By submitting a disclaimer in ACE at the time of entry, the ACE
filer indicates that the article being imported or offered for import
is not currently regulated by FDA or that FDA does not currently have
any requirements for submission of data for importation of that article
per Agency guidance.
    In particular, we invite comment on whether the submission of these
data elements would help us achieve our goals of facilitating
admissibility review and focusing our resources on those products that
may be associated with a serious public health risk to consumers, if
they were to become mandatory FDA data elements for entry filing in
ACE.
    FDA announced its participation in the National Customs Automation
Program (NCAP) test in the Federal Register in August 27, 2015 (80 FR
52051). An increasing number of filers

are currently filing entries of FDA-regulated products in ACE. Although
our NCAP test ended May 2, 2016, CBP is allowing the filing of entries
for FDA-regulated products in ACS to continue in order to provide more
time for the trade community to transition to ACE (81 FR 18634, March
31, 2016). In the Federal Register on May 16, 2016 (81 FR 30320), and
May 23, 2016 (81 FR 32339), CBP announced that effective June 15, 2016,
and July 23, 2016, respectively, ACE will be the sole EDI system for
electronic entry and entry summary filings for merchandise specified in
the notices and subject to the import requirements of FDA, and ACS will
no longer be a CBP-authorized EDI system for purposes of processing
such filings. CBP will continue to monitor FDA filing rates in ACE and
should there be a need to avoid a substantial adverse impact on trade,
CBP will reassess the transition completion date for FDA filings (81 FR
30320 at 30321).

IV. Legal Authority

    FDA has the legal authority under the FD&C Act and the PHS Act to
regulate foods, cosmetics, drugs, biological products, medical devices,
and tobacco products being imported or offered for import into the
United States (sections 701 and 801 of the FD&C Act; section 351 of the
PHS Act). We also have the legal authority to regulate the importation
of radiation-emitting electronic products (section 536 of the FD&C
Act).
    Additionally, section 361 of the PHS Act authorizes FDA to make and
enforce such regulations as it judges necessary to prevent the
introduction, transmission, or spread of communicable diseases from
foreign countries into the United States or from State to State. FDA
has issued regulations in part 1271 to regulate HCT/Ps. HCT/Ps that do
not meet the criteria listed in Sec.  1271.10(a) for them to be
regulated solely under section 361 and the regulations in part 1271 are
regulated as drugs, devices, and/or biological products under the FD&C
Act and/or section 351 of the PHS Act and must follow applicable
regulations, including the applicable regulations in part 1271. FDA has
determined that improving the efficiency of admissibility
determinations for HCT/Ps, thus improving the allocation of Agency
resources, is necessary to prevent the introduction, transmission, or
spread of communicable diseases from foreign countries. We are
therefore relying on the authority of section 361 of the PHS Act in the
proposed amendments to Sec.  1271.420. Authority for enforcement of
section 361 of the PHS Act is provided by section 368 of the PHS Act.
    We are also issuing this proposed rule under authority granted to
FDA by section 801(r) of the FD&C Act (21 U.S.C. 381(r)), added by
section 713 of the Food and Drug Administration Safety and Innovation
Act (Pub. L. 112-144) (FDASIA). Title VII of FDASIA provides FDA with
important new authorities to help the Agency better protect the
integrity of the drug supply chain. Section 801(r) authorizes FDA to
require, as a condition of granting admission to a drug imported or
offered for import into the United States, that the importer of record
electronically submit information demonstrating that the drug complies
with the applicable requirements of the FD&C Act. This information may
include:
     Information demonstrating the regulatory status of the
drug, such as the new drug application, the abbreviated new drug
application, investigational new drug, or drug master file number;
     facility information, such as proof of registration and
the unique facility identifier; and
     any other information deemed necessary and appropriate by
FDA to assess compliance of the article being offered for import.
    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. These regulations would be jointly
prescribed by FDA and the Department of the Treasury, with the
exception of the provisions of the proposed rule related to the
importation of HCT/Ps which are regulated solely under section 361 of
the PHS Act and part 1271 and the importation of radiation-emitting
electronic products which are regulated under section 536 of the FD&C
Act; neither of these provisions will be issued for the efficient
enforcement of section 801 of the FD&C Act.

V. Description of the Proposed Rule

    We propose to add subpart D to part 1 of 21 CFR Chapter I to
require certain data elements for FDA-regulated products to be
submitted in ACE or any other CBP-authorized EDI system, at the time
the electronic entry is filed. If an ACE filer fails to submit any of
the data elements specified in proposed subpart D applicable to the
entry, the entry will be rejected. All but four of the data elements
specified in proposed subpart D are currently collected in ACS. The two
new required submissions in proposed Sec.  1.72 which apply to food
contact substances, drugs, biological products, HCT/Ps, medical
devices, radiation-emitting electronic products, cosmetics, and tobacco
products, are a name, telephone number, and email address for one of
the persons related to the importation of the product, which may
include the manufacturer, shipper, importer of record, or Deliver to
Party, and a telephone number and email address for the importer of
record which we need to facilitate electronic notice under Sec.  1.94
for certain FDA actions. The two other new required data elements, in
proposed 21 CFR 1.79, are name and address of the ACE filer and brand
name for tobacco products.
    FDA is also proposing to make technical and clarifying amendments
to parts 1 and 1005 to update certain sections of those regulations.
The updates include striking references to statutes or procedures no
longer in effect and clarifying that electronic notice can be given of
FDA actions related to a product that is being imported or offered for
import. The proposed technical amendments to part 1 consist of
amendments to Sec. Sec.  1.83, 1.90, and 1.94. The proposed technical
amendment to part 1005 consists of an amendment to Sec.  1005.2.
    We are also proposing to revise Sec.  1271.420 to make clear that
the applicable requirements of the proposed rule would apply to HCT/Ps
that are regulated solely under section 361 of the PHS Act and part
1271, except those HCT/Ps that would otherwise be exempt from these
requirements.

A. Scope/Applicability

    The proposed rule would apply to the submission of import entries
in ACE or any other CBP-authorized EDI system for certain foods, drugs,
medical devices, radiation-emitting electronic products, biological
products, HCT/Ps, cosmetics, and tobacco products regulated by FDA.

B. Definitions

    The proposed rule contains a number of definitions for terms used
in the rule. These definitions are based on existing definitions in
statutes or other FDA regulations, or are definitions commonly used by
industry.

C. Data Elements that Must Be Submitted in ACE for FDA-Regulated
Products

1. General Data Elements for FDA-Regulated Commodities
    The proposed rule would require that the following data elements be

submitted at the time of entry in ACE or any other CBP-authorized EDI
system, for food as applicable, drugs, biological products, HCT/Ps,
medical devices, radiation-emitting electronic products, cosmetics, and
tobacco products. The specific information to be submitted may vary
depending on the article being imported or offered for import.
    The required FDA data elements in the proposed rule are in addition
to the data elements CBP requires for submission in ACE. The FDA
required data elements specified in proposed Sec.  1.72 generally fall
into two categories: Those data elements that identify the article
being imported or offered for import and those data elements that
identify the person(s) who are seeking to import the article into the
United States. This additional information will assist us in our
efforts to more effectively and efficiently determine the admissibility
of the article being imported or offered for import. All but two of the
general data elements in proposed Sec.  1.72--name, telephone number,
and email address for one of the persons related to the importation of
the product which may include the manufacturer, shipper, importer of
record, or Deliver to Party, and telephone number and email address of
the importer of record--are currently collected in ACS.
    a. Product identification information. By more precisely
identifying the article being imported or offered for import, FDA can
determine what statutory and regulatory requirements apply to that
article. The product identification information that FDA proposes to be
required in submissions at the time of entry in ACE includes:
    i. FDA country of production. The FDA Country of Production
identifies the country where an FDA-regulated article was last
manufactured, processed or grown (including harvested or collected and
readied for shipment to the United States).
    The FDA Country of Production may be different than the Country of
Origin required by CBP for an article that is being imported or offered
for import. The country of origin as defined by CBP is the country of
manufacture, production or growth of the article. There is only one
country of origin for each article. When an article has undergone a
``substantial transformation'' in a different country, CBP requires
that the country of origin be changed to the country where the
substantial transformation has taken place. Substantial transformation
occurs in the country where the article acquired the name, character or
intended use that matches the article identified in the entry. The
substantial transformation test is applied by the importer of record to
the facts and circumstances of each case. The FDA Country of
Production, however, is the country where the article last underwent
any manufacturing or processing but only if such manufacturing or
processing was of more than a minor, negligible or insignificant
nature.
    ii. The complete FDA Product Code. The FDA Product Code is an
alphanumeric code that is used by us for classification and analysis of
regulated products. The FDA Product Code builder application is
currently available on FDA's Web site at http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM. The Product Code builder application allows
ACE filers to locate or build the appropriate FDA Product Code. The FDA
Product Code is based on the following five components.
     Industry designates the broadest area into which a product
falls;
     class is directly related to an industry and designates
the food group, source, product, use, pharmacological action, category,
or animal species of the product;
     subclass designates the container type, method of
application, use, market class, or type of product and relates directly
to a particular Industry grouping by utilizing a unique set of
definitions specific to those products;
     Process indicator code specifies the process, storage or
dosage form depending on the type of product; and
     product relates to a particular industry/class
combination.
    The complete FDA Product Code is a critical data element for our
admissibility review because it clearly identifies the type of article
that is being entered in ACE, which allows FDA to determine which
statutory and/or regulatory requirements apply to that article. Under
the proposed rule, the complete FDA Product Code entered in ACE would
be required to agree with the invoice description of the article.
    iii. FDA Value. FDA is proposing to require that the total value of
an entry as required by CBP or the total value of the article(s) in
each import line be submitted at the time of entry in ACE. CBP requires
that the value of an entry based on the invoice value of the shipment
in U.S. dollars (rounded off to the nearest whole dollar) be submitted
in ACE at the time of entry. Submission by an ACE filer of the value of
an entry is necessary because all goods imported into the United States
are subject to the provisions of the Harmonized Tariff Schedule of the
United States, Annotated for Statistical Reporting Purposes (HTS), that
is published by the U.S. International Trade Commission as directed by
Congress in section 1207 of the Omnibus Trade and Competitiveness Act
of 1988 (Pub. L. 100-418; 19 U.S.C. 3007) regarding any duties to be
paid for importation of the article(s) contained in that entry. For
FDA-regulated products, we propose to allow the ACE filer to choose
whether to submit the total value of the entry as reported to CBP or to
apportion the value of the entry to the total value of the article(s)
in each import line at the time of entry in ACE. If an ACE filer
chooses to submit the total value for the article(s) in each import
line, that value must match the total invoice value of the article(s)
in that import line.
    We invite comments on the advantages, disadvantages, and
feasibility of allowing the ACE filer to submit the total value of the
entry or the total value apportioned to the article(s) in each import
line. In particular, we invite comment on whether the submission by an
ACE filer of the value apportioned to the article(s) in an import line
in ACE at the time of entry will help us achieve our goals of
facilitating admissibility review and focusing our resources on those
products that may be associated with a serious public health risk to
consumers.
    iv. FDA Quantity. FDA is proposing to require submission of the
quantity of the FDA-regulated article(s) in each import line at the
time of entry in ACE. Quantity would include the quantity of each
layer/level of packaging of the article(s), the unit of measure which
is the description of each type of package, and the volume and/or
weight of each of the smallest of the packaging units. The quantity
would be required to be submitted in decreasing size of packing unit
(starting with the outermost/largest package to the innermost/smallest
package). An example of a quantity description that would be submitted
in ACE at the time of entry includes these layer/levels of packaging:
200 cases of surgical gauze, 100 rolls per case and 75 square yards of
surgical gauze per roll.
    Quantity and packaging help us identify the article as a specific
FDA-regulated product. Although CBP and FDA utilize the HTS codes to
generally identify which imports are subject to an FDA admissibility
review, these codes are often not sufficient to specifically identify a
product for FDA decisionmaking. There are several products that FDA
considers to be different from each other because of how the product is
packaged. Packaging can also affect the potential safety of an FDA-
regulated product particularly where an article is represented at time
of entry as ``sterile.'' In addition, FDA

submission of the quantity in ACE at the time of entry would assist the
Agency in performing any needed followup action on an entry line such
as field examinations, label examinations, sample collections,
detentions, and refusals. Thus, the initial availability of quantity
per import line would increase efficiency and expedite FDA activities
throughout the admissibility process.
    We invite comments on the advantages, disadvantages, and
feasibility of requiring an ACE filer to submit the FDA quantity of the
article(s) in each import line in ACE at the time of entry. In
particular, we invite comment on whether the submission by an ACE filer
of the FDA quantity of the article(s) in an import line will help us
achieve our goals of facilitating admissibility review and focusing our
resources on those products that may be associated with a serious
public health risk to consumers.
    b. Entity identification information.
    i. Entity contact information. The proposed rule would require that
the name, telephone, and email address of any one of the persons
related to the importation of the article(s) in the entry, which may
include the manufacturer, shipper, importer of record, or Deliver to
Party, be submitted in ACE at the time of entry. This information would
facilitate FDA's decisionmaking on admissibility of an entry because
FDA would have the information to quickly and easily contact a person
with knowledge of the entry regarding questions about the entry and/or
a particular import line in the entry.
    We invite comments on the advantages, disadvantages, and
feasibility of requiring an ACE filer to submit the name, telephone,
and email address of any one of the persons related to the importation
of the article(s) in the entry, in ACE at the time of entry. In
particular, we invite comment on whether the submission by an ACE filer
of this information will help us achieve our goals of facilitating
admissibility review and focusing our resources on those products that
may be associated with a serious public health risk to consumers.
    ii. Importer of record contact information. We are proposing to
require that the email and phone number of the importer of record be
submitted in ACE at the time of entry. This information will provide us
with the contact information for the importer of record to enable us to
contact that person with any questions about the import entry as well
as send notices of FDA Actions such as detention, refusal, and/or
administrative destruction electronically to that person.
    We are proposing to revise Sec.  1.94 to clarify that electronic
notice may be sent by the Agency to the owner or consignee, which will
be defined in Sec.  1.83 as the importer of record, for detention,
refusal, and/or administrative destruction of an FDA-regulated article
being imported or offered for import into the United States. A refused
drug valued at $2,500 or less (or such higher amount as the Secretary
of the Treasury may set by regulation) is subject to administrative
destruction (section 801(a) of the FD&C Act). Obtaining a current email
address for the importer of record is critical to FDA's ability to
provide such electronic notice. We are also requiring a telephone
number to contact the importer of record in the event that the email
address submitted in ACE is incorrect or out of date.
2. Food
    For purposes of this rule, food means foods as defined in section
201(f) of the FD&C Act (21 U.S.C. 321(f)) (see proposed Sec.  1.71(i)).
Examples of food covered by this rule include fruits, vegetables, fish,
including seafood, dairy products, eggs, raw agricultural commodities
for use as food or as components of food, animal feed (including pet
food), food and feed ingredients, food and feed additives, dietary
supplements and dietary ingredients, infant formula, beverages
(including alcoholic beverages and bottled water), live food animals,
bakery goods, snack foods, candy, and canned foods.
    One aspect of importation of food via ACS and ACE is regulated
under the Prior Notice of Imported Food regulation, part 1, subpart I.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (Pub. L. 107-188) (the BT Act) amended the FD&C Act by
adding section 801(m) requiring prior notification of imported food. In
accordance with section 801(m)(1) of the FD&C Act, we published a final
rule in the Federal Register on November 7, 2008 (73 FR 66294).
    For every article of food imported or offered for import into the
United States, except those articles identified in Sec. Sec.
1.276(b)(5)(i) and 1.277(b), the information required under Sec.  1.281
must be submitted in ACS or the FDA Prior Notice System Interface
(PNSI) before the arrival of that food article in the United States.
Food articles imported or offered for import without adequate prior
notice are subject to refusal under section 801(m) of the FD&C Act. The
prior notice regulation under Sec.  1.280 requires that prior notice
information be submitted via ACS or via PNSI. We issue a Prior Notice
Confirmation Number (PN Confirmation Number) when prior notice has been
submitted and confirmed for review (Sec.  1.279(d)). We use prior
notice information to make decisions, based on public health risk,
about which food to inspect at the port of arrival.
    If the prior notice information required under Sec.  1.281 for a
food article is submitted via ACS simultaneously with the required
entry information, no additional transmission of information for the
admissibility determination on that food article under section 801(a)
of the FD&C Act is necessary. If prior notice is submitted via PNSI,
additional transmission via ACS for the import entry may be necessary
for CBP purposes and FDA's admissibility determination under section
801(a) of the FD&C Act (see 68 FR 58976, October 10, 2003). The PN
Confirmation Number must be submitted into ACS at the time of the
food's arrival into the United States under Sec.  1.279(g).
    This proposed rule does not address or impact the current import
entry review process for food articles requiring prior notice; this
process will be operationally transitioned from ACS to ACE.
    a. FDA Value. We are proposing to require the submission in ACE at
the time of entry of the FDA Value described in Sec.  1.72(a)(3) of the
proposed rule, for all food being imported or offered for import into
the United States. FDA Value is explained earlier in the General Data
Elements for FDA-Regulated Commodities section. As noted in that
section, we are inviting comments on the advantages, disadvantages, and
feasibility of requiring an ACE filer to submit this information in ACE
at the time of entry
    b. Food contact substances. For the purposes of prior notice, food
contact substances are exempted from the definition of food under Sec.
1.276(b)(5)(i)(A) and are, therefore, not subject to the requirements
under the prior notice regulation. We are proposing to require the
submission in ACE at the time of entry of the general data elements
described in Sec.  1.72 of the proposed rule, for food contact
substances being imported or offered for import into the United States.
This additional information will assist us in our efforts to more
effectively and efficiently determine admissibility of the food contact
substance being imported or offered for import.
    c. Acidified and low-acid canned food data. If the article of food
being imported or offered for import is an acidified food (AF) or a
thermally processed low-acid canned food

packaged in a hermetically sealed container (LACF), we propose that the
Food Canning Establishment (FCE) Number, the Submission Identifier
(SID), and the can dimensions or volume (e.g., pouches and bottles) be
required submissions in ACE at the time of entry.
    Although some hermetically sealed containers (e.g., pouches and
glass bottles) used to package thermally processed low-acid food would
not be viewed as ``cans'', the term ``low-acid canned food'' has been
used for decades as a shorthand description for ``thermally processed
low-acid foods packaged in hermetically sealed containers''. We
continue to use that term (and its abbreviation, LACF) for the purposes
of this document.
    Botulism, a rare but serious paralytic illness that can be fatal,
is one of the serious public health risks associated with inadequate or
improper manufacture, processing or packaging of AF and LACF. Every
commercial processor, when engaging in the manufacture, processing, or
packing of an AF or LACF, is required to register and file with FDA
information including the name of the establishment, principal place of
business, the location of each establishment in which the processing of
acidified foods or low-acid canned foods is carried on, the processing
method, and a list of foods so processed in each establishment. (21 CFR
108.25(c)(1) and (j); 21 CFR 108.35(c)(1) and (k)). After an
establishment is registered, FDA assigns a unique FCE number
identifying the physical processing plant located at the address on the
registration form (currently Form FDA 2541). The FCE registration
requirement in 21 CFR part 108 for LACF and AF commercial processors is
different from the Food Facility Registration (FFR) that is required
under section 415 of the FD&C Act (21 U.S.C. 350d) for domestic and
foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States. The registration
requirement in section 415 of the FD&C Act was created by the BT Act
and amended by the FDA Food Safety Modernization Act (Pub. L. 111-353).
AF and LACF commercial processors must register with FDA as required in
part 108 using Form FDA 2541, and must also register with FDA under the
FFR system using Form FDA 3537 as required by section 415 of the FD&C
Act. We use the term ``FFR'' interchangeably with the term ``BT Act
registration.''
    After registering, the commercial processor must also, no later
than 60 days after registering with FDA and before packing a new
product, provide FDA with information on the scheduled processes for
each AF and LACF in each container size (Sec.  108.25(c)(2) and (j);
Sec.  108.35(c)(2) and (k)). When processors submit a process filing
form, they include the FCE number for the location of the processing
plant where the product will be manufactured, processed, or packed. The
FCE number on the process filing form links the process filing to the
establishment (Ref. 2).
    The filed scheduled process is required to provide certain
information relevant to the processing of each AF and LACF, including
information related to heat during processing, among other requirements
(Sec. Sec.  108.25(c)(2) and 108.35(c)(2)). A manufacturer of an AF and
LACF product, such as canned corn in brine, is required to file
separate scheduled processes for each type and sized container.
    When processors use the electronic AF/LACF system to create a
process filing, the system automatically generates a SID. When the
processor creates a process filing using a paper form, the processor
generates the SID and includes it on the paper form. A SID identifies
each process filing, and consists of the year, month, and day of the
month that a process filing form is created, and a unique sequence
number to identify each form when multiple forms are created on the
same day. An FCE can have multiple SIDs. The SID enables both the
commercial processor and FDA to quickly and accurately identify a
specific process filing.
    To effectively identify an AF or LACF article that is being
imported or offered for import, we need information regarding that
product's FCE, SID, and can dimensions or volume. This information
allows us to match the specific AF or LACF article being imported or
offered for import to the applicable scheduled process and processing
facility. We may use this information to verify that the scheduled
processes filed for each LACF or AF corresponds to the FCE and SID
submitted at the time of entry. Such identifying information assists
FDA in efficiently enforcing section 801 of the FD&C Act in that it
assists FDA in determining the admissibility of a given article.
3. Human Drugs
    Globalization of the pharmaceutical market in the United States has
resulted in dramatic increases in drug imports, complex and fragmented
global supply chains, and increasing threats from counterfeit and
substandard drugs.
    This rule proposes to make certain information pertaining to
imports of drugs regulated by FDA's CDER that importers can submit in
ACS, required submissions in ACE or any other CBP-authorized EDI
system.
    a. Registration and Listing. All persons who own or operate
domestic establishments that engage in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs must
annually register with FDA, with limited exceptions (section 510(b) of
the FD&C Act (21 U.S.C. 360(b)); 21 CFR part 207). Every person who
owns or operates any establishment within any foreign country engaged
in the manufacture, preparation, propagation, compounding, or
processing of a drug that is being imported or offered for import into
the United States, is required to annually register with FDA (section
510(i) of the FD&C Act). Each annual establishment registration must
include a unique facility identifier (UFI) for each establishment under
section 510(b) and (i) of the FD&C Act. Every person who registers
must, at the time of registration, also file with FDA a list of all
drugs they manufacture, prepare, propagate, compound, or process for
commercial distribution in the United States (section 510(j) of the
FD&C Act). Registration of foreign establishments must include the name
of each importer of the firm's drugs that is known to the establishment
and the name of each person who imports or offers for import such drugs
to the United States for purposes of importation (section 510(j) of the
FD&C Act).
    This rule would require the submission in ACE at the time of entry
of the Drug Registration Number. For purposes of this proposed rule,
the Drug Registration Number that would be submitted in ACE is the UFI
of the foreign establishment where the drug was manufactured, prepared,
propagated, compounded or processed before being imported or offered
for import into the United States.
    Currently the Affirmation of Compliance Code for submission of the
Drug Registration Number is ``REG''.
    The rule would also require the submission of the Drug Listing
Number in ACE. Each listed drug associated with a registration must
include a unique identifier. Currently we use the ``National Drug
Code'' (NDC) numbering system as that unique identifier. An NDC is a
unique three-segment identifier that identifies the labeler, product
(including, for example, specific strength and dosage form), and trade
package. For purposes of this proposed rule, the Drug Listing Number is
the NDC of the drug being imported

or offered for import. The current Affirmation of Compliance Code for
submission of the drug listing number is ``DLS''.
    Failure to register or list in accordance with section 510 of the
FD&C Act causes a drug to be misbranded under section 502(o) of the
FD&C Act (21 U.S.C. 352(o)). Drugs that appear to be misbranded are
subject to detention and refusal under section 801(a) of the FD&C Act.
    b. Drug application number. A new drug must be approved by FDA
before it can be marketed in the United States (section 505(a) of the
FD&C Act (21 U.S.C. 355(a))). A new drug application (NDA) must be
submitted to the Agency for the sale or marketing of a new drug
(section 505(b) of the FD&C Act). An abbreviated new drug application
(ANDA) must be submitted to the Agency for the sale or marketing of a
generic drug (section 505(j) of the FD&C Act). FDA issues a unique
number for each NDA or ANDA, and that number would be required to be
submitted in ACE at the time of entry for each drug that is subject to
an approved NDA or ANDA, under the proposed rule.
    CDER also regulates certain biological products. Although the
majority of therapeutic biological products are licensed under section
351 of the PHS Act, some protein products historically have been
approved under section 505 of the FD&C Act. The Biologics Price
Competition and Innovation Act of 2009 (BPCI Act) changed the statutory
authority under which certain protein products will be regulated by
amending the definition of a ``biological product'' in section 351(i)
of the PHS Act to include a ``protein (except any chemically
synthesized polypeptide).'' Section 7002(e) of the BPCI Act requires
that a marketing application for a biological product must be submitted
under section 351 of the PHS Act, subject to certain exceptions during
a 10-year transition period ending on March 23, 2020. On March 23,
2020, an approved application for a biological product under section
505 of the FD&C Act will be deemed to be a license for the biological
product under section 351 of the PHS Act (section 7002(e)(4) of the
BPCI Act) (Ref. 3). The number of the biologics license application
(BLA) or the NDA is required to be submitted at the time of entry in
ACE.
    Currently the Affirmation of Compliance Code for submission of the
NDA, ANDA, or BLA number in ACE is ``DA''.
    c. Investigational new drug application number. The proposed rule
mandates that the number of the investigational new drug application
(IND) be submitted in ACE at the time of entry for a drug that is
subject to an IND and is being imported or offered for import into the
United States. An investigational new drug is a new drug that is used
in a clinical investigation (section 505(i) of the FD&C Act and 21 CFR
312.3(b)). An investigational new drug for which an IND is in effect is
exempt from the premarket approval requirements that are otherwise
applicable and may be shipped lawfully for the purpose of conducting
clinical investigations of that drug (part 312). Additionally, an
investigational new drug for which an IND is not yet in effect may be
shipped lawfully to an investigator named in the IND if the sponsor has
received earlier FDA authorization to ship the drug (Sec.
312.40(c)(2)).
    Currently the Affirmation of Compliance Code for submission of the
investigational new drug application number is ``IND''.
4. Animal Drugs
    In broad outline, the data elements required to be submitted in ACE
or any other CBP-authorized EDI system, for importation of animal drugs
under the proposed rule tracks those required for human drugs. The
proposed rule makes certain information, pertaining to animal drug
imports that importers can optionally submit in ACS, required
submissions in ACE at the time of entry. As in the case of human drugs,
a more streamlined import process could lead to a more effective use of
FDA and importer resources, and more efficient enforcement of section
801(a) of the FD&C Act for animal drugs.
    a. Registration and listing. All persons who own or operate
domestic establishments that engage in the manufacture, preparation,
propagation, compounding, or processing of an animal drug or drugs,
must annually register with FDA, with limited exceptions (section
510(b) of the FD&C Act; part 207). Every person who owns or operates
any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of an
animal drug that is imported or offered for import into the United
States is required to annually register with the FDA (section 510(i) of
the FD&C Act). Each annual establishment registration must include a
UFI for each establishment under section 510(b) and (i) of the FD&C
Act). Every person who registers must, at the time of registration,
also file with FDA a list of all drugs they manufacture, prepare,
propagate, compound, or process for commercial distribution in the
United States (section 510(j) of the FD&C Act). Registration of foreign
establishments must include the names of each importer of the firm's
drugs that is known to the establishment and the name of each person
who imports or offers for import such drugs to the United States for
purposes of importation (section 510(i) of the FD&C Act).
    This rule would require the submission in ACE of the Animal Drug
Registration Number at the time of entry. For purposes of this proposed
rule, the Animal Drug Registration Number that would be submitted in
ACE is the UFI 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.
    Currently the Affirmation of Compliance Code for submission of the
Animal Drug Registration Number is ``REG''.
    The rule would also require the submission of the Animal Drug
Listing Number at the time of entry in ACE. Each listed animal drug
associated with a registration must include a unique identifier.
Currently we use the NDC numbering system as that unique identifier. An
NDC is a unique three-segment identifier that identifies the labeler,
product (drug formulation), and trade package. For purposes of this
proposed rule, the Drug Listing Number is the NDC of the animal drug
being imported or offered for import. The current Affirmation of
Compliance Code for submission of the Animal Drug Listing Number is
``NDC''.
    Failure to register and list in accordance with section 510 of the
FD&C Act causes an animal drug to be misbranded under section 502(o) of
the FD&C Act. Animal drugs that appear to be misbranded are subject to
detention and refusal under section 801(a) of the FD&C Act.
    b. New animal drug application and the minor species index file. A
new animal drug must be approved, conditionally approved, or index
listed by FDA before it can be legally marketed in the United States
(sections 512(a)(1)(A), 571, and 572 of the FD&C Act (21 U.S.C.
360b(a)(1)(A), 360ccc, and 360ccc-1)). A new animal drug is defined, in
part, as a drug intended for use in animals other than man, including
any drug intended for use in animal feed, which is not generally
recognized by experts as safe and effective for use under the
conditions prescribed, recommended, or suggested in its labeling
(section 201(v) of the

FD&C Act). Animal feed is defined in section 201(w) of the FD&C Act.
    FDA issues a unique number for each new animal drug application
(NADA), abbreviated new animal drug application (ANADA), and
conditionally approved new animal drug application (CNADA) submitted to
the Agency for approval to market a new animal drug. For a new animal
drug that is subject to an approved application under section 512(b)(1)
or (2) of the FD&C Act, the number corresponding to the NADA or ANADA,
respectively, is required to be submitted in ACE at the time of entry
under the proposed rule. Under the proposed rule, for new animal drugs
that are subject to a conditionally approved application an ACE filer
would be required to submit in ACE at the time of entry the number
corresponding to the conditionally approved application (section 571 of
the FD&C Act).
    Under the proposed rule, the Minor Species Index File number (MIF)
of the new animal drug on the Index of Legally Marketed Unapproved New
Animal Drugs for Minor Species (Index) would be required to be
submitted in ACE at the time of entry for articles that are being
imported or offered for import that are legally marketed as unapproved
new animal drugs for minor species (section 572 of the FD&C Act).
    The Minor Use and Minor Species Animal Health Act of 2004 (Pub. L.
108-282) (MUMS Act) signed into law on August 2, 2004, amended the FD&C
Act to provide animal drug companies with incentives to develop new
animal drugs for minor species and minor uses in major species, while
still ensuring appropriate safeguards for animal and human health. The
index is limited to minor species for which there is reasonable
certainty the animal or edible products from the animal will not be
consumed by humans or food-producing animals. Minor species are those
animals, other than humans, that are not one of the major species
(horses, dogs, cats, cattle, pigs, turkeys, and chickens). Minor
species include animals such as zoo animals, ornamental fish, parrots,
ferrets, and guinea pigs. Some animals of agricultural importance are
also minor species including sheep, goats, catfish, game birds, and
honey bees among others. Upon request by a sponsor and under the other
requirements in section 573 of the FD&C Act (21 U.S.C. 360ccc-2), FDA
may add a drug intended for use in a minor species or for a minor use
in a major species to the Index. The Index can be found at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125452.htm.
    Currently the Affirmation of Compliance Code for submission of the
NADA, CNADA, or MIF number is the Veterinary New Animal Drug
Application Number ``VNA''. The current Affirmation of Compliance Code
for the ANADA number is the Veterinary Abbreviated New Animal Drug
Application Number ``VAN''.
    c. Investigational new animal drugs. The proposed rule mandates
that the investigational new animal drug (INAD) file number or the
generic investigational new animal drug file (JINAD) number be
submitted in ACE at the time of entry for articles that are subject to
investigational new animal drug or generic investigational new animal
drug applications under 21 CFR part 511. An investigational new animal
drug is an animal drug that is used in a clinical investigation, or for
tests in vitro or in animals only used for laboratory research
purposes. An investigational new animal drug for which an INAD is in
effect in accordance with part 511 is exempt from the premarket
approval requirements that are otherwise applicable and may be shipped
lawfully for the purpose of conducting clinical investigations of that
drug (Sec.  511.1).
    CVM issues a unique number that corresponds to each INAD and JINAD
file that is established. Currently the Affirmation of Compliance Code
for the INAD or JINAD is the Veterinary Investigational New Animal Drug
Number ``VIN''.
5. Medical Devices
    A medical device is an article intended to either: (1) Diagnose a
disease or condition or cure, mitigate, treat or prevent a disease or
(2) affect the structure or any function of the body, and that does not
achieve its primary intended purposes by chemical action or being
metabolized (section 201(h) of the FD&C Act). The proposed rule covers
only those medical devices intended for use in humans. Medical devices
can be as simple as a tongue depressor or as complex as a robotic
surgery device. FDA has issued rules to regulate medical devices that
are intended to be introduced in U.S. commerce and these can be found
at 21 CFR parts 800-900. The classification of a medical device under
section 513 of the FD&C Act (21 U.S.C. 360c) determines, in part, the
extent of FDA's regulation of that medical device. There are currently
1700 generic groups of medical device types that are classified within
16 medical specialties (21 CFR parts 862-892). Class I devices
(approximately 780 medical devices) are considered to be low risk,
class II devices (approximately 800 medical devices) are considered to
be medium risk, and class III devices (approximately 100 medical
devices) are considered to be high risk. Class III devices include
certain medical devices that are life-supporting or life-sustaining,
are for a use that is of substantial importance in preventing
impairment of human health, or present a potential unreasonable risk of
illness or injury (21 CFR 860.3(c)(3)). Because class III devices are
considered to be high risk, most class III devices require premarket
approval from FDA before they can be introduced into interstate
commerce.
    The proposed rule would make the following information for medical
devices regulated by FDA's Center for Devices and Radiological Health
(CDRH) required submissions in ACE or any other CBP-authorized EDI
system, at the time of entry. All of this information can currently be
submitted in ACS.
    a. Registration and listing. The proposed rule would require that
the applicable Registration and Listing Numbers of the Domestic
Manufacturer, Foreign Manufacturer, and/or Foreign Exporter for each
medical device identified in the entry, be submitted in ACE at the time
of entry. Any owner or operator of an establishment, not exempt under
section 510(g) of the FD&C Act, that is engaged in the manufacture,
preparation, propagation, compounding, or processing of a medical
device intended for human use must register on an annual basis and
submit listing information to FDA for those medical devices intended
for commercial distribution (section 510 of the FD&C Act). Foreign
establishments are required to designate a U.S. agent and submit the
name, address, and telephone number of that agent as part of their
registration under 21 CFR 807.40. Such establishments are also required
to register and list the name and contact information, and registration
number, if any has been assigned, of each known importer or any person
who imports or offers to import the establishment's medical devices
into the United States (21 CFR 807.41).
    A Foreign Exporter is required to register and list the medical
devices it imports into the United States (section 510(i) of the FD&C
Act; 21 CFR 807.20). FDA considers a foreign establishment that only
exports medical devices to the United States to be engaged in the
manufacture, preparation, propagation, compounding, or processing of a
medical device which requires registration and listing (see Response to

Comment 5 in 77 FR 45927 at 45930, August 2, 2012).
    When a registrant successfully completes the required registration
process, a unique Registration Number is assigned by FDA. The current
Affirmation of Compliance Codes for submission of the registration
number of a Domestic Manufacturer is ``DDM''; of a Foreign Manufacturer
is ``DEV''; and of a Foreign Exporter is ``DFE.''
    The information required to be submitted for each listed medical
device, as enumerated in part 807, includes the proprietary or brand
name(s) under which each medical device is marketed and the activities
or processes that are conducted on or done to the medical device at
each establishment (e.g., manufacturing, repacking, relabeling,
developing specifications, remanufacturing, single-use device
reprocessing, contract manufacturing, or contract sterilizing). When
the listing process is complete, FDA issues a Device Listing Number for
each medical device associated with the registration. While the
Registration Number is publicly available, the Device Listing Number is
not available to the public. The current Affirmation of Compliance Code
for the Device Listing Number that must be submitted in ACE is ``LST.''
The requirements for registration and device listing are found in part
807.
    Mandatory submission of the Registration and Device Listing Numbers
in ACE at the time of entry serves as a safeguard against substandard
and counterfeit medical devices entering the U.S. market. Medical
devices manufactured for other countries may not be as safe and
effective as medical devices made for the U.S. market. Additionally,
medical devices from foreign manufacturers that were not initially
intended for sale in the United States may not be adequately stored or
maintained, which can affect package integrity, sterilization, and
other issues relating to the medical device's performance capabilities.
Package labeling for these products may not comply with the
requirements for distribution in the United States as the labeling may
not be in English, may not contain adequate directions for use, and/or
may not comply with other labeling requirements for the U.S. market.
All of these issues can impact patient safety.
    A medical device that is manufactured, prepared, propagated,
compounded, or processed by an establishment that fails to register
and/or that is not listed as required in section 510 of the FD&C Act is
deemed misbranded (section 502(o) of the FD&C Act). Medical devices
that appear to be misbranded are subject to detention and refusal
(section 801(a) of the FD&C Act).
    b. Investigational devices. An investigational device is a medical
device that is the object of a clinical investigation or research
involving one or more subjects to determine the safety or effectiveness
of a medical device (21 CFR 812.3(g) and (h)). An investigational
device exemption (IDE) permits a medical device that otherwise would be
required to be approved or cleared by us to be lawfully introduced into
interstate commerce for the purpose of conducting investigations.
    The IDE regulations (21 CFR part 812) describe three types of
device studies: significant risk (SR), nonsignificant risk (NSR), and
exempt studies. For a study determined to be SR, the sponsor must
submit an IDE application to FDA for the investigational device and
obtain the Agency's approval before beginning the study (Sec.  812.20).
A medical device used in an NSR study is considered by FDA to have an
approved IDE, as long as the sponsor satisfies the requirements set
forth in Sec.  812.2(b). Devices used in exempt studies are not
required to have an approved IDE.
    The current Affirmation of Compliance Code for investigational
devices is ``IDE.'' The proposed rule would require that an ACE filer
submit in ACE at the time of entry, in the data field for the ``IDE''
code in ACE, for an investigational device that is being imported or
offered for import: (1) The IDE number for a medical device granted an
exemption under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)) or
(2) ``NSR'' for a medical device to be used in a nonsignificant risk or
in an exempt study.
    An investigational device that lacks a required IDE is deemed
adulterated and misbranded (sections 501(f)(1) and 502(o) of the FD&C
Act). Medical devices that appear to be adulterated and/or misbranded
are subject to detention and refusal (section 801(a) of the FD&C Act).
    c. Premarket number. In ACS, there are separate submissions for
Premarket Approval and Premarket Notification Numbers. Under the
proposed rule, there would be only one submission in ACE at the time of
entry: Premarket Number ``PM#.'' The Premarket Number that would be a
required submission in ACE at the time of entry is the following
number/unique identifier that is issued by FDA:
     Premarket Approval Application (PMA) Number for those
medical devices that have received pre-market approval under section
515 of the FD&C Act (21 U.S.C. 360e);
     Product Development Protocol (PDP) Number for those
medical devices for which FDA has declared the PDP complete under
section 515(f) of the FD&C Act;
     Humanitarian Device Exemption (HDE) Number for those
medical devices for which an exemption has been granted under section
520(m) of the FD&C Act;
     Premarket Notification (PMN) Number is the 510(k) number
for those medical devices that have received premarket clearance under
section 510(k) of the FD&C Act (21 U.S.C. 360(k)); or
     De Novo (DEN) Number is the number for those medical
devices that have received marketing authorization under section 513(f)
of the FD&C Act.
    This change from ACS should reduce the opportunity for filer error
in ACE as the applicable Premarket Number, whether it is a PMA, PDP,
HDE, PMN, or DEN Number, would be entered in the one data field rather
than in ACS where a PMN Number could be erroneously entered in the
field for a PMA Number.
    The premarket approval pathway is used by the Agency to review and
evaluate the safety and effectiveness of most class III devices. The
PMA must include, among other things, descriptions of the methods used
in, and the facilities and controls used for, the manufacture,
processing, packing, storage, and, where appropriate, installation of
the medical device (Sec.  814.20(b)). Premarket approval is based on a
determination by FDA that the PMA contains sufficient valid scientific
evidence that there is reasonable assurance of the medical device's
safety and effectiveness for its intended use(s). The PMA Number is the
number issued by FDA upon the approval of a PMA.
    Any person may submit to FDA a PDP with respect to a class III
device that is required to have an approved PMA (section 515(f) of the
FD&C Act). Under Sec.  814.19, a class III device for which a PDP
protocol has been declared completed by FDA is considered to have an
approved PMA. The PDP Number is the number issued by FDA upon
completion of the PDP.
    A humanitarian use device (HUD) is a medical device that is
intended to benefit patients in the treatment or diagnosis of a disease
or condition that affects or is manifested in fewer than 4,000
individuals in the United States per year (Sec.  814.3(n)). A HDE is an
exemption for a HUD from the effectiveness requirements of sections 514
and 515 of the FD&C Act, which is granted by FDA under section
520(m)(2)

of the FD&C Act. The HDE Number is issued by FDA upon approval of the
exemption.
    A PMN Number is the 510(k) number for those medical devices that
have received premarket clearance from FDA based on a demonstration
that the medical device to be marketed is substantially equivalent to a
legally marketed predicate device that is not subject to premarket
approval (section 510(k) of the FD&C Act; part 807).
    If manufacturers have received an NSE determination on a 510(k)
submission or determine that there is no legally marketed predicate
device upon which to base a determination of substantial equivalence
for their low to moderate risk medical device, an application for
marketing authorization, known as a de novo request, may be submitted
to FDA under section 513(f) of the FD&C Act. When FDA grants marketing
authorization for a medical device through the de novo pathway, FDA
issues a DEN Number for the medical device.
    A medical device that is being imported or offered for import but
lacks FDA approval or clearance, and is not otherwise exempt from such
approval or clearance, is deemed adulterated and misbranded under
sections 501(f)(1) and 502(o) of the FD&C Act. Medical devices that
appear to be adulterated and/or misbranded are subject to detention and
refusal (section 801(a) of the FD&C Act).
    d. Component. The proposed rule would require an ACE filer to
identify at the time of entry in ACE that the article being imported or
offered for import is a component of a medical device that requires
further processing or inclusion into a finished medical device.
Component means any raw material, substance, piece, part, software,
firmware, labeling, or assembly which is intended to be included as
part of the finished, packaged, and labeled medical device (21 CFR
820.3(c)). Finished medical device means any medical device or
accessory to any medical device that is suitable for use or capable of
functioning, whether or not it is packaged, labeled, or sterilized
(Sec.  820.3(l)). We need this information to distinguish between a
medical device component and a finished medical device that requires
the submission of a ``PM#.'' Components of a medical device may be
subject to different statutory and regulatory requirements than
finished medical devices so distinguishing between a component and a
finished medical device (or accessory) is important in our ability to
conduct an effective admissibility review. The current Affirmation of
Compliance Code for a component is ``CPT.''
    e. Lead wire/patient cable. Electrode lead wires and patient cables
intended for use with a medical device are required to meet the
performance standard in 21 CFR 898.12, unless an exemption or variance
is granted by FDA. Electrode lead wires and patient cables that are
declared, purported or presented as being in conformity with Sec.
898.12 but that are not, and do not have an exemption or variance, are
deemed to be adulterated (section 501(e) of the FD&C Act). A medical
device that is being imported or offered for import that appears to be
adulterated is subject to detention and refusal (section 801(a) of the
FD&C Act). For electrode lead wires and patient cables intended for use
with a medical device, the proposed rule would require an ACE filer to
submit an Affirmation of Compliance with the applicable Performance
Standard for Electrode Lead Wires and Patient Cables (Sec.  898.12) in
ACE at the time of entry. The current Affirmation of Compliance Code
for electrode lead wires and patient cables intended for use with a
medical device is ``LWC.''
    f. Impact resistant lens. The frequency of eye injuries resulting
from the shattering of ordinary crown glass lenses together with the
consensus of the ophthalmic community that the number of eye injuries
would be substantially reduced by the use of impact-resistant lenses in
eyeglasses and sunglasses led to the issue of 21 CFR 801.410. This
regulation states that importers may have the tests required by Sec.
801.410(d) conducted in the country of origin but they must make the
results of the testing available, upon request, to FDA, as soon as
practicable (Sec.  801.410(g)). The proposed rule would require
submission at the time of entry in ACE of an Affirmation of Compliance
with Sec.  801.410. The current Affirmation of Compliance Code is
``IRC.''
    g. Convenience kit. A convenience kit, assembled in kit form for
the convenience of the purchaser or user, must be comprised of legally
marketed medical devices. Convenience kits imported or offered for
import have been found at times to contain recalled or unapproved
medical devices. The proposed rule would require that a medical device
that is a convenience kit or part of a convenience kit and is a re-
import of a medical device manufactured in the United States or is an
import of a medical device manufactured outside the United States be
identified as such in ACE at the time of entry using the current
Affirmation of Compliance Code ``KIT.''
    h. Investigational new drug application number. We propose to
require that the IND number be submitted in ACE at the time of entry
for an article that is subject to an IND and that is a combination
product consisting of at least one medical device and one
investigational new drug where FDA's CDRH has been designated by FDA
pursuant to 21 CFR 3.4 as the center with primary jurisdiction for the
premarket review and regulation of the combination product. A
combination product is defined in 21 CFR 3.2(e). CDRH may have primary
jurisdiction over the following types of combination products with IND
numbers: Investigational drug/device or investigational drug/device/
biologic.
    An investigational new drug is a new drug that is used in a
clinical investigation (section 505(i) of the FD&C Act and Sec.
312.3(b)). An investigational new drug for which an IND is in effect is
exempt from the premarket approval requirements that are otherwise
applicable and may be shipped lawfully for the purpose of conducting
clinical investigations of that drug (part 312). Additionally, an
investigational new drug for which an IND is not yet in effect may be
shipped lawfully to an investigator named in the IND if the sponsor has
received earlier FDA authorization to ship the drug (Sec.
312.40(c)(2)).
    Currently the Affirmation of Compliance Code for submission of the
IND number for a combination product that is subject to an IND
consisting of at least one device and one investigational new drug,
over which CDRH has been designated by FDA as the center with primary
jurisdiction, is ``IND''.
    We invite comments on the advantages, disadvantages, and
feasibility of requiring an ACE filer to submit the IND number for
these combination products in ACE at the time of entry. In particular,
we invite comment on whether the submission by an ACE filer of this
information would help us achieve our goals of facilitating
admissibility review and focusing our resources on those products that
may be associated with a serious public health risk to consumers.
6. Radiation-Emitting Electronic Products
    FDA regulates radiation-emitting electronic products in order to
protect the general public from hazardous and unnecessary exposure to
radiation from electronic products. FDA has the statutory authority to
regulate these products (Chapter 5, subchapter C of the FD&C Act). Our
radiation safety regulations for manufacturers of

radiation-emitting electronic products can be found at 21 CFR parts
1000-1050.
    Importers of radiation-emitting electronic products subject to an
FDA performance standard are required to submit a written declaration
on ``Declaration of Products Subject to Radiation Control Standards,''
Form FDA 2877 (19 CFR 12.91). Mandatory radiation safety performance
standards established by FDA are enumerated in parts 1020 through 1050.
The first section of each standard defines and describes the products
subject to that standard. Table 1 of part 1002.1 contains a list of
products followed by a reference to any applicable standards. A
completed Form FDA 2877 is currently required to be submitted with the
entry (19 CFR 12.91). In ACE or any other CBP-authorized EDI system,
the declarations required in Form FDA 2877 must be submitted
electronically at the time of entry for those radiation-emitting
electronic products subject to the standards under parts 1020 through
1050.
    Radiation-emitting electronic products that are being imported or
offered for import that do not have the Form FDA 2877 declarations
electronically submitted in ACE at the time of entry or that otherwise
appear to be noncompliant with the applicable performance standard(s)
may be detained and refused (section 536 of the FD&C Act).
7. Biological Products, HCT/Ps, and Related Drugs and Medical Devices
    FDA's CBER regulates biological products under sections 351 and 361
of the PHS Act and various provisions of the FD&C Act. These products
include blood and blood products (including certain kinds of devices),
vaccines, allergenics, tissues, and cellular and gene therapies. CBER
also regulates a number of drugs approved under section 505 of the FD&C
Act, including plasma volume expanders, and drugs used in the
collection and processing of blood components and human cellular
products. Medical devices involved in the manufacture and
administration of licensed blood, blood components, and cellular
products and all HIV test kits used both to screen donor blood, blood
components, and cellular products and to diagnose, treat, and monitor
persons with HIV and AIDs, are also regulated by CBER. Also regulated
by CBER are HCT/Ps, including those HCT/Ps that meet the criteria
listed in Sec.  1271.10(a) and that are therefore subject to regulation
solely under section 361 of the PHS Act and part 1271.
    Submission of the following information in ACE or any other CBP-
authorized EDI system, at the time of entry would allow FDA to
identify, appropriately categorize, and apply the applicable statutory
and regulatory requirements to these CBER-regulated products. This
information would enable us to more effectively and efficiently conduct
admissibility review for these articles. FDA has determined that
improving the efficiency of admissibility determinations for HCT/Ps,
thus improving the allocation of Agency resources, is necessary to
prevent the introduction, transmission, or spread of communicable
diseases from foreign countries.
    a. Product name. This data element identifies the CBER-regulated
article by the name commonly associated with that article such as
established name, trade name, brand name, proper name, or product
description if the article does not have an established name, trade
name, brand name, or proper name. This information is currently
collected in ACS but would become a required submission in ACE at the
time of entry under the proposed rule.
    For certain products, the established name, trade name, brand name,
proper name, or product description is necessary to verify compliance
with an FDA approval, licensing, or registration and listing
requirement. A proper name is the name designated in a biologics
license issued by FDA under section 351 of the PHS Act. If no
established name, trade name, brand name, or proper name is available,
a product description would be required to be submitted in ACE at the
time of entry. For HCT/Ps regulated solely under section 361 of the PHS
Act and the regulations in part 1271 (e.g. tendon, bone, cornea for
transplantation) that do not have established names, trade names, brand
names, or proper names, a description of the type of HCT/P that
complies with Sec.  1271.370 would be required.
    b. HCT/Ps registration number and affirmation of compliance. Human
cells, tissues, or cellular or tissue-based products are articles
containing or consisting of human cells or tissues intended for
implantation, transplantation, infusion or transfer into a human
recipient (Sec.  1271.3(d)). FDA is authorized to make and enforce such
regulations as are necessary to prevent the introduction, transmission,
or spread of communicable diseases from foreign countries into the
United States (section 361 of the PHS Act). Under that authority, we
created a unified registration and listing system for establishments
that manufacture HCT/Ps. We also established donor-eligibility, current
good tissue practice, and other procedures to prevent the introduction,
transmission, and spread of communicable diseases by HCT/Ps.
    Certain conditions provided under Sec.  1271.420 apply to the
importation of HCT/Ps regulated solely under section 361 of the PHS Act
and part 1271. When an HCT/P meeting the criteria under Sec.
1271.10(a) is offered for import, unless otherwise exempt, the importer
of record must notify, either before or at the time of importation, the
director of the FDA District Office having jurisdiction over the port
of entry through which the HCT/P is imported or offered for import, or
such officer of the district as the director may designate to act in
his or her behalf, and must provide sufficient information for FDA to
make an admissibility decision. Additionally, unless otherwise exempt,
the HCT/P must be held intact by the importer or consignee, under
conditions necessary to prevent transmission of communicable diseases,
until we determine admissibility.
    Most foreign manufacturers of HCT/Ps are required to register and
submit a list of every HCT/P manufactured, except those exempt from
registration under Sec.  1271.15. Establishments that manufacture HCT/
Ps that are regulated solely under the authority of section 361 of the
PHS Act are required to register and list their HCT/Ps with CBER and to
comply with the requirements of part 1271, whether or not the HCT/P
enters into interstate commerce (Sec.  1271.1(b)(1)).
    When an establishment successfully completes the required
registration process, CBER assigns a unique registration number to that
firm (see Sec.  1271.27). For HCT/Ps manufactured by establishments
required to register under part 1271 and regulated solely under section
361 of the PHS Act and the regulations in part 1271, FDA is proposing
to require the submission of that registration number in ACE at the
time of entry. The list of registered firms and product listings are
publicly available at https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/index.cfm. The current Affirmation of Compliance Code
for the HCT/P Registration Number is ``HRN''.
    For HCT/Ps regulated solely under section 361 of the PHS Act and
the regulations in part 1271, FDA has established requirements in part
1271 such as applicable donor screening and testing, processing, and
labeling, in order to prevent the introduction, transmission, and
spread of communicable diseases by HCT/Ps. The proposed rule would
require for HCT/Ps

regulated solely under section 361 of the PHS Act and the regulations
in part 1271 being imported or offered for import that are not
otherwise exempt, that an Affirmation of Compliance with all applicable
requirements of part 1271 be submitted in ACE at the time of entry. The
current Affirmation of Compliance Code for HCT/Ps to affirm compliance
with Part 1271 is ``HCT''.
    c. CBER-regulated licensed biological products. A biological
product is defined as a virus, therapeutic serum, toxin, antitoxin,
vaccine, blood, blood component or derivative, allergenic product,
protein (except any chemically synthesized polypeptide), or analogous
product, or arsphenamine or derivative of arsphenamine (or any other
trivalent organic arsenic compound), applicable to the prevention,
treatment, or cure of a disease or condition of human beings (section
351(i) of the PHS Act). The introduction or delivery for introduction
into interstate commerce of any biological product, including certain
devices, without a biologics license in effect for that specific
product is prohibited (section 351(a)(1) of the PHS Act). The BLA is a
request for authorization to introduce, or deliver for introduction, a
biological product into interstate commerce. The licensing requirements
and applicable standards for biological products are found in 21 CFR
parts 600-680. CBER assigns a unique number to the original BLA or
supplement and that serves as the Submission Tracking Number (STN).
    Upon approval of the first BLA submitted by a manufacturer, CBER
issues a Biologics License Number (BLN) to that manufacturer. A
manufacturer may have several biological products with approved
applications under one biologics license and each of the approved
products will have its own STN.
    For biological products being imported or offered for import that
are subject to an approved BLA, the applicable BLN and/or STN would be
a required submission in ACE at the time of entry. Currently the
Affirmation of Compliance Code for submission of the BLN or STN in ACE
is ``BLN'' or ``STN''. Failure to obtain an approved BLA as required
under section 351 of the PHS Act subjects a biological product that is
being imported or offered for import to detention and refusal under
section 801(a)(3) of the FD&C Act.
    d. CBER-regulated human drugs.
    i. Drug registration and listing. The proposed rule would require
that the Drug Registration Number be submitted in ACE at the time of
entry, as explained earlier in the Human Drugs section, and this number
would also be submitted for those articles that are CBER-regulated
drugs. Currently the Affirmation of Compliance Code for submission of
the Drug Registration Number is ``REG''.
    The rule would also require the submission of the Drug Listing
Number in ACE at the time of entry, as explained earlier in the Human
Drugs section, and this number would also be submitted for those
articles that are CBER-regulated drugs. The current Affirmation of
Compliance Code for submission of the Drug Listing Number is ``DLS''.
    We invite comments on the advantages, disadvantages, and
feasibility of requiring an ACE filer to submit the Drug Listing Number
for those articles that are CBER-regulated drugs. In particular, we
invite comment on whether the submission by an ACE filer of this
information will help us achieve our goals of facilitating
admissibility review and focusing our resources on those products that
may be associated with a serious public health risk to consumers.
    ii. Drug application number. In addition, the proposed rule would
require that the number of the NDA or the number of the ANDA be
submitted in ACE at the time of entry for those articles that are CBER-
regulated drugs subject to an approved NDA or ANDA. Currently the
Affirmation of Compliance Code for submission of the NDA or ANDA number
in ACE is ``DA''.
    iii. Investigational new drug application number. The proposed rule
would require the number of the IND also be submitted in ACE at the
time of entry for those CBER-regulated articles, including unapproved
drugs and unlicensed biological products that are subject to an IND
under section 505(i) of the FD&C Act. Currently the Affirmation of
Compliance Code for submission of the IND Number is ``IND''.
    e. CBER-regulated medical devices.
    i. Registration and listing number. For those CBER-regulated
medical devices that must be registered with FDA under part 807, the
proposed rule would require that the applicable Registration and
Listing numbers of the Domestic Manufacturer, Foreign Manufacturer,
and/or Foreign Exporter for each medical device identified in the
entry, be submitted in ACE at the time of entry. The current
Affirmation of Compliance Codes for submission of the registration
number of a Domestic Manufacturer is ``DDM''; of a Foreign Manufacturer
is ``DEV''; and of a Foreign Exporter is ``DFE.'' For the Device
Listing Number that would be required to be submitted in ACE at the
time of entry, the current Affirmation of Compliance Code is ``LST.''
    ii. Premarket number. For those CBER-regulated medical devices that
require premarket approval or notification, the Premarket Number (PM#)
would be required to be submitted in ACE at the time of entry. The
Premarket Number would be the PMA Number for those medical devices that
have received premarket approval under section 515 of the FD&C Act; the
PDP Number for those medical devices for which FDA has declared the PDP
complete under section 515(f) of the FD&C Act; the HDE Number for those
medical devices for which an exemption has been granted for a
humanitarian device under section 520(m) of the FD&C Act; the PMN
Number for those medical devices that have received premarket clearance
under section 510(k) of the FD&C Act; or the DEN Number for those
medical devices that have received marketing authorization under
section 513(f) of the FD&C Act. As explained earlier, under the
proposed rule, there is only one Affirmation of Compliance Code that
covers PMA, PDP, HDE, PMN and DEN Numbers: Premarket Number ``PM#''.
    iii. Components. For those articles that are a component of a CBER-
regulated medical device and that require further processing or
inclusion into a CBER-regulated medical device, an affirmation that the
article is such a component (CPT) would be required to be submitted in
ACE at the time of entry. The current Affirmation of Compliance Code
for a component is ``CPT.''
    iv. Investigational medical devices. The current Affirmation of
Compliance Code for investigational medical devices is ``IDE.'' If the
CBER-regulated device is an investigational device being imported or
offered for import for use in an SR study which has been granted an
exemption under section 520(g) of the FD&C Act, the number of the IDE
would be required to be submitted in the data field for the ``IDE''
Code in ACE at the time of entry. If the investigational device is
being imported or offered for import for use in an NSR or exempt study,
as explained earlier in the Medical Devices section, ``NSR'' would be
submitted in the data field for the ``IDE'' Code in ACE at the time of
entry.
8. Tobacco Products
    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act granted FDA important new
authority to regulate the manufacture, marketing, and distribution of
tobacco products to protect the public health generally and

to reduce tobacco use by minors. A ``tobacco product'' means any
product made or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a tobacco
product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product) but
does not include an article that is a drug, a device, or a combination
product (section 201(rr) of the FD&C Act). Tobacco products are not
limited to products containing tobacco, but also include components,
parts, or accessories of tobacco products, whether they are sold for
further manufacturing or for consumer use; e.g. cigarette rolling
papers and filters are tobacco products, whether they are sold to
consumers for use with roll-your-own tobacco or are sold for further
manufacturing into a product sold to a consumer, such as a cigarette.
    Importers are reminded that tobacco products imported or offered
for import into the United States must comply with all the applicable
requirements under the FD&C Act as amended by the Tobacco Control Act.
For a tobacco product to be legally marketed in the United States, it
must be grandfathered or a manufacturer generally must: (1) Have
submitted a pre-market tobacco application (PMTA) and received a
subsequent marketing authorization order under section 910(c)(1)(A)(i)
of the FD&C Act (21 U.S.C. 387j(c)(1)(A)), or (2) have submitted a
substantial equivalence (SE) report under section 905(j) of the FD&C
Act (21 U.S.C. 387e(j)) and received a subsequent marketing
authorization order, or (3) have been granted a request for an
exemption from demonstrating substantial equivalence (EXE) under
section 905(j)(3) or filed a report under section 905(j)(1)(A)(ii) of
the FD&C Act and waited 90 days from submission of that report. CTP
issues a Submission Tracking Number for a PMTA, SE., or EXE.
    We recommend that ACE filers submit the optional data elements
identifying the legal marketing status of the tobacco product, as
described previously, in ACE or any other CBP-authorized EDI system, at
the time of entry to help us efficiently evaluate the admissibility of
a tobacco product being imported or offered for import.
    a. Brand name. The proposed rule would require that the brand name
for a tobacco product be submitted in ACE at the time of entry. This
data element identifies a tobacco product by the name commonly
associated with it: Brand name. Along with product code, the brand name
will help us with screening and targeting, to help determine which
products to review manually. In addition, brand name may help FDA to
determine if a tobacco product is adulterated under section 902 of the
FD&C Act (21 U.S.C. 387b) or may be misbranded under section 903(a)(1)
of the FD&C Act (21 U.S.C. 387c(a)(1)) or in violation of other
provisions of the FD&C Act. Tobacco products that appear to be
misbranded or adulterated are subject to detention and refusal (section
801 of the FD&C Act).
    b. Name and address of the ACE filer. We are proposing to require
that the name and address of the ACE filer for import entries that
include a tobacco product be submitted in ACE at the time of entry. The
name and address of ACE filers of imports that include a tobacco
product would help to facilitate distribution by the Agency to ACE
filers of materials related to the regulation and importation of
tobacco products and otherwise communicate with the ACE filer.
    We invite comments on the advantages, disadvantages, and
feasibility of requiring an ACE filer to submit this information in ACE
at the time of entry. In particular, we invite comment on whether the
submission by an ACE filer of the name and address of the ACE filer for
import entries that include a tobacco product will help us achieve our
goals of facilitating admissibility review and focusing our resources
on those products that may be associated with a serious public health
risk to consumers and whether this could be sufficiently accomplished
through proposed Sec.  1.72(b) or other means.
9. Cosmetics
    The FD&C Act defines ``cosmetic'' as articles intended to be
rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise
applied to the human body for cleansing, beautifying, promoting
attractiveness or altering the appearance and articles intended for use
as a component of such articles (section 201(i) of the FD&C Act). The
definition of ``cosmetic,'' however, does not include soap (see
definition in 21 CFR 701.20).
    FDA regulates cosmetic products. Although we do not have the legal
authority to approve cosmetic products before they enter the market, we
do approve color additives used in cosmetic products (except for coal
tar hair dyes). However, under section 301(a) of the FD&C Act (21
U.S.C. 331(a)), cosmetic articles that are imported or offered for
import cannot be lawfully marketed in interstate commerce if they are
deemed to be adulterated or misbranded, under sections 601 and 602 of
the FD&C Act (21 U.S.C. 361 and 362).
    The proposed rule would require the submission at the time of entry
in ACE or any other CBP-authorized EDI system of only the general data
elements under proposed Sec.  1.72 for cosmetic articles being imported
or offered for import into the United States.

D. Technical Amendments

1. Revisions to Sec. Sec.  1.83 and 1005.2
    We are proposing to revise Sec. Sec.  1.83 and 1005.2 to update the
legal references in those sections and to clarify the definition of
``owner or consignee.'' When section 801 of the FD&C Act was enacted,
the term used to describe the person responsible for making entry of an
imported product was ``owner or consignee.'' This term was the same
term found in the relevant Customs statutes for the person required to
make entry of imported merchandise. At the time section 801 of the FD&C
Act was enacted, 19 U.S.C. 1483, 1484, and 1485, provided that the
``consignee'' was deemed to be the ``owner'' of imported merchandise
and was required to make entry with Customs (now CBP). When FDA first
issued Sec. Sec.  1.83 and 1005.2 we defined ``owner or consignee'' as
the term is used in section 801(a), (b), and, (c) of the FD&C Act to be
interchangeable with the terms in the relevant provisions of the Tariff
Act of 1930. Therefore, we defined ``owner or consignee'' ``for
purposes of section 801(a), (b), and (c) of the FD&C Act as . . . the
person who has the rights of a consignee under the provisions of
section 1483, 1484, and 1495 of the Tariff Act of 1930, as amended (19
U.S.C. 1483, 1484, 1495).''
    In 1983, the relevant provisions of the Tariff Act of 1930 were
amended to change the designation of the person with the right to make
entry. Section 1483 was repealed and the text of sections 1484 and 1485
was revised to provide that the person authorized to make entry is the
``importer of record'' who can be the owner, the purchaser, or a
customs broker who is appropriately designated as such by the owner,
purchaser, or consignee. FDA is now updating its regulations to bring
the definition back in line with the customs terminology and to make
clear that ``owner or consignee'' continues to mean the person
authorized to make entry, now designated under customs law as the
``importer of record.'' As a result, we are updating Sec. Sec.  1.83
and 1005.2 to remove the reference to section 1483, which was repealed,
and to reflect the amended language in

sections 1484 and 1485. This proposed rule will clarify that, for
purposes of section 801(a), (b), and (c) of the FD&C Act, the term
``owner or consignee'' means the person eligible to make entry under
sections 19 U.S.C. 1484 and 1485, namely, the ``importer of record.''
2. Revisions to Sec.  1.90
    We are proposing revisions to Sec.  1.90 to better reflect current
practice of FDA and CBP regarding the issuance of notice of sampling to
persons importing merchandise that FDA desires to sample. The current
language of Sec.  1.90 provides that FDA is to request that the
collector of customs provide the notice of sampling. The proposed rule
revises Sec.  1.90 to allow FDA to provide this notice directly, which
will normally happen through a secure electronic system. The proposed
rule also updates ``collector of customs'' to ``Customs and Border
Protection'' which is the Federal agency within the Department of
Homeland Security that is primarily responsible for maintaining the
integrity of the borders and ports of entry in the United States.
3. Revisions to Sec.  1.94
    We are proposing to revise Sec.  1.94 to clarify that electronic
notification can be provided to importers of merchandise when FDA has
determined that an article being imported or offered for import may be
subject to refusal of admission and/or administrative destruction.
Section 1.94 states that FDA shall provide written notice in these
circumstances that we currently implement by providing written notice
by mail. FDA is proposing to revise this section to clarify that FDA
can provide either written or electronic notification. In the case of
electronic notification, the notice will usually be provided through a
secure electronic system.
4. Revisions to Sec.  1271.420
    FDA has determined that improving the efficiency of admissibility
determinations for HCT/Ps, thus improving the allocation of Agency
resources, is necessary to prevent the introduction, transmission, or
spread of communicable diseases from foreign countries. We are,
therefore, proposing to revise Sec.  1271.420 to make clear that,
unless otherwise exempt, importers of record importing or offering for
import HCT/Ps meeting the criteria in Sec.  1271.10(a) would be
required to submit at the time of entry the applicable information
under the proposed rule in ACE or any other CBP-authorized EDI system.
Currently, unless they fall within an exception, importers of record
for these products are required to provide sufficient information for
FDA to make an admissibility decision on these products (Sec.
1271.420(a)).

VI. Proposed Effective Date

    FDA proposes that the effective date of the final rule will be 30
days after its publication in the Federal Register.

VII. Economic Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits (both quantitative and qualitative) of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We have developed a
comprehensive Economic Analysis of Impacts that assesses the impacts of
the proposed rule. We believe that this proposed rule may be a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The Agency tentatively concludes that this rule
would not have a significant economic impact on a substantial number of
small entities covered by this proposed rule, but the impacts are
uncertain so we are explicitly seeking comment on the impacts.
    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 $146 million, using the most current (2015) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

B. Summary of Benefits and Costs of the Proposed Rule

    FDA is proposing a rule that would require certain data elements
material to imports admissibility determination into the United States
be submitted to the FDA via ACE as part of an import entry. The
proposed regulation would help streamline FDA's existing admissibility
procedures for FDA-regulated commodities imported or offered for import
into the United States. For import entries submitted electronically,
FDA would require that certain key data be submitted as a part of the
import entry filing in the new ACE system. This rule proposes to make
the submission of these data elements mandatory in ACE for each import
entry line for the FDA-regulated commodities specified in the proposed
rule for which entry requests are submitted electronically. The
proposed regulation also provides further clarifications to the import
process by revising sections of 21 CFR Chapter I relating to the
definition of owner or consignee; the notice of sampling; and notices
of FDA actions related to FDA-regulated products being imported or
offered for import into the United States, such as notices of hearing
on refusal of admission or destruction, to allow for electronic
notification by FDA. The rule also clarifies that importers of record
of human cells, tissues and cellular and tissue-based products (HCT/Ps)
that are regulated solely under section 361 of the Public Health
Service Act and part 1271, unless exempted, would be required to submit
the applicable data elements included in the proposed rule in ACE at
the time of entry.
    The estimated costs of this proposed rule--and the cost savings--
stem from the mandatory information that would be submitted and
collected under the ACE system. In the baseline scenario for our
estimates of these costs, we treated ACS as the shell for the
submission of the information but assumed that without the proposed FDA
regulation, the information would be collected in ACE only if
voluntarily provided by ACE filers like under the current ACS system
(scenario 1, table 1). An alternative baseline is CBP implementation of
ACE with the data elements for the entry of FDA-regulated products
(scenario 2, table 1). Under this scenario, the benefits, costs, and
cost savings estimated for the proposed rule would be the same but
would be attributed to ACE's full implementation. The incremental costs
and cost savings of this proposed rule, should it become final, would
be zero under this baseline (scenario 2, table 1). This scenario now

appears likely, with the transition to ACE well-underway and the ACE
system scheduled to become the only CBP-authorized EDI system for the
electronic filing of entries containing an FDA-regulated product this
year.
    Table 1 shows the total costs, cost savings, and other benefits of
this proposed rule; the costs and cost savings are reported on an
annualized basis using a 3 and a 7 percent discount rate over a 20-year
time horizon. Table 1 shows that under scenario 2, the incremental
effects of the proposed rule would be zero ($0); the benefits, costs,
and cost savings would still be incurred but would be attributed to the
implementation of ACE by CBP. Under the alternative scenario 1 the
costs, cost savings, and the benefits would be incurred and attributed
to this rulemaking by FDA. Annualized over a 20-year horizon, the costs
of complying with this regulation (scenario 1) are between $53 million
and $193 million per year with a 3 percent discount rate; these costs
are between $51 million and $186 million per year with a 7 percent
discount rate (table 1).
    The total annualized cost savings to the entire industry cannot be
fully quantified because of the lack of certain data currently
available to the Agency. Partially quantifiable cost savings for
scenario 1are estimated to range from $3 million to $89 million with a
3 percent discount rate; these partially quantifiable benefits are
estimated to range from $3 million to $88 million with a 7 percent
discount rate (table 1). Some of these cost savings to both the trade
community and FDA that we are able to only partially quantify would
arise from the reduced time of import entry request processing and
potentially fewer and shorter product holds as a result of increased
efficiency of FDA's imports admissibility process. Benefits, in terms
of cost savings, to both FDA and the industry that we are able to
quantify would arise from FDA simplifying the notification process on
certain FDA actions taken by the Agency under section 801 of the FD&C
Act by allowing electronic notification of the owner or consignee.
    Other potential benefits that we are unable to quantify at this
time would result from compliant FDA-regulated imports reaching U.S.
consumers faster and a reduction in the number of non-compliant imports
reaching U.S. consumers, thereby making the overall supply of FDA-
regulated products on the U.S. market safer. Other potential benefits
in the form of cost savings that we are similarly unable to quantify
would also arise because by revising certain sections of 21 CFR Chapter
I, the Agency would provide more clarity to the industry about the
overall process of importing FDA-regulated products.

                      Table 1--Total Annualized Costs and Benefits of the Proposed Rule \1\
----------------------------------------------------------------------------------------------------------------
                                                                             Total benefits
          Discount rate             Total annualized   ---------------------------------------------------------
                                          costs             Cost savings        Other benefits (not quantified)
----------------------------------------------------------------------------------------------------------------
             SCENARIO 1.--The benefits, the costs and cost savings are attributed to FDA regulation
----------------------------------------------------------------------------------------------------------------
3 percent.......................  Range $53 million to  Range $3 to $89       More efficient use of FDA's
                                   $193 million.         million.              internal resources; potentially
                                                                               fewer import recalls; reduced
                                                                               misbranding; reduction of
                                                                               counterfeit imports on the U.S.
                                                                               market; increased efficiency of
                                                                               the overall import process due to
                                                                               fewer errors because of a better
                                                                               defined the owner or consignee
                                                                               term and the clarifications
                                                                               related to notice of sampling,
                                                                               allowing for electronic notice of
                                                                               hearing on refusal of admission
                                                                               and notice of potential
                                                                               destruction of drugs.
7 percent.......................  Range $51 million to  Range $3 million to   More efficient use of FDA's
                                   $186 million.         $88 million.          internal resources; potentially
                                                                               fewer import recalls; reduced
                                                                               misbranding; reduction of
                                                                               counterfeit imports on the U.S.
                                                                               market; increased efficiency of
                                                                               the overall import process due to
                                                                               fewer errors because of a better
                                                                               defined the owner or consignee
                                                                               term and the clarifications
                                                                               related to notice of sampling,
                                                                               allowing for electronic notice of
                                                                               hearing on refusal of admission
                                                                               and notice of potential
                                                                               destruction of drugs.
----------------------------------------------------------------------------------------------------------------
SCENARIO 2.--The benefits, costs, and cost savings estimated under SCENARIO 1 would still be incurred, but would
                                   be attributed to the implementation of ACE
----------------------------------------------------------------------------------------------------------------
3 percent.......................  $0..................  $0..................  $0
7 percent.......................  $0..................  $0..................  $0
----------------------------------------------------------------------------------------------------------------
\1\ We generated lower and upper bounds using Monte Carlo simulations.

    The Economic Analysis of Impacts of the proposed rule performed in
accordance with Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of
1995 is available to the public in the docket for this proposed rule at
http://www.regulations.gov (Docket No. FDA-2016-N-1487) and is also
available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 4). We
invite comments on this analysis.

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
impact on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.