Document ID: FDA-2016-N-1487-0001
Agency: fda
Document Type: Proposed Rule
Title: Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
Posted Date: 2016-07-01T04:00Z

[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Proposed Rules]
[Pages 43155-43178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15684]

[[Page 43155]]

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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: 202-395-7285, or email to 
oira_submission@omb.eop.gov. 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, 301-796-3324, 
Ann.Metayer@fda.hhs.gov.
    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, 
Jonnalynn.Capezzuto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule

[[Page 43156]]

    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

------------------------------------------------------------------------
       Abbreviation/Acronym                     What it means
------------------------------------------------------------------------
ACE...............................  Automated Commercial Environment or
                                     any other CBP-authorized EDI
                                     system.
ACE filer.........................  The person who is authorized to
                                     submit an electronic import entry
                                     for an FDA-regulated product in
                                     ACE.
ACS...............................  Automated Commercial System.
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

[[Page 43157]]

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

[[Page 43158]]

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

[[Page 43159]]

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

[[Page 43160]]

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

[[Page 43161]]

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

[[Page 43162]]

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

[[Page 43163]]

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

[[Page 43164]]

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

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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)

[[Page 43166]]

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

[[Page 43167]]

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

[[Page 43168]]

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

[[Page 43169]]

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

[[Page 43170]]

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

[[Page 43171]]

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.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the OMB under the Paperwork Reduction Act of 
1995 (PRA) (44 U.S.C. 3501-3520). A

[[Page 43172]]

description of these provisions is given in the Description portion of 
this section with an estimate of the annual reporting burden. Included 
in the estimate is the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Importer's Entry Notice (OMB Control Number 0910-0046).
    Description of Respondents: The respondents to this collection of 
information are domestic and foreign ``importers of record'' of FDA-
regulated articles being offered for import into the United States. An 
``importer of record'' may be the owner or purchaser of the article 
being imported, 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 only one importer of record per entry.
    Using the estimates in the Preliminary Regulatory Impact Analysis 
(PRIA) for the proposed rule (Ref. 4), we have estimated there are 
about 59,292 owners or purchasers who seek to import FDA-regulated 
articles into the United States on an annual basis, and we have 
estimated that 97.7 percent of these owners or purchasers will use 
customs brokers to file their import entries in ACE, and the other 2.3 
percent will file their import entries themselves. We estimate that 
there are a total of 4,010 filers, which includes the 1,364 owners or 
purchasers of the article who will file their own import entry in ACE 
(= 59,292 owners or purchasers of the article offered for import x 
(100-97.7) percent).
    Description: FDA is proposing to revise the information collection 
request (ICR) currently approved under OMB Control Number 0910-0046 to 
account for the provisions of the proposed rule that provide for 
collection of information from importers via ACE. This ICR (titled 
``Importer's Entry Notice'') was most recently approved by OMB on June 
30, 2014, and received an expiration date of June 30, 2017. The 
currently approved collection of information allows the collection of 
several FDA data elements in ACS specific to FDA-regulated products in 
order for FDA to make import admissibility decisions. The ICR currently 
covers the following data elements for all FDA-regulated products: (1) 
FDA Product Code; (2) FDA country of production; (3) FDA manufacturer 
and shipper; and (4) ultimate consignee, as well as various 
affirmations of compliance specific to certain types of FDA-regulated 
products which an importer may submit to FDA to help facilitate FDA's 
review process. In making admissibility decisions FDA also uses 
additional entry information that CBP regulations require importers to 
submit (such as the entry number, importer of record, country of 
origin, etc.), but that information is collected under CBP statutes and 
regulations and ICRs managed by CBP (e.g., 19 U.S.C. 1484 and 1448(b), 
19 CFR 142.3, 142.16, 142.22, and 142.24, and the associated ICR 
approved by OMB under OMB Control Number 1651-0024). The annual 
recordkeeping requirements for this collection are covered by the 
``Customs Modernization Act Recordkeeping Requirements'' information 
collection approved by OMB under OMB Control Number 1651-0076.
    The proposed rule and information collection would streamline FDA's 
admissibility review of FDA-regulated products, promote more effective 
utilization of industry and FDA resources, including electronic 
screening technology, and support FDA's ability to continue to meet its 
statutory responsibilities under the FD&C Act and the PHS Act. The 
information collection aspects of the proposed rule would specify the 
FDA-specific data elements that would be required as part of an import 
entry submitted in ACE for the FDA-regulated products covered by the 
proposed rule being imported or offered for import into the United 
States. Most data elements that would be collected in ACE under the 
proposed rule, with certain exceptions as explained below, are 
currently collected in ACS and approved for collection by OMB under OMB 
Control Number 0910-0046. Furthermore, under the proposed rule two of 
the data elements currently collected in ACS--FDA manufacturer and 
shipper and the ultimate consignee--would no longer be collected in ACE 
or any other CBP-authorized EDI system.
    The authority to issue this proposed regulation and to conduct the 
associated information collection is found in sections 801, 701 and 536 
of the FD&C Act, sections 351, 361, and 368 of the PHS Act, and section 
713 of FDASIA (which added section 801(r) to the FD&C Act).
    The information collection provisions of the proposed rule are in 
proposed Sec. Sec.  1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 
1.80. Proposed Sec.  1.72 would require certain product identifying 
data elements and entity identifying data elements to be submitted in 
ACE at the time of entry for food as applicable, drugs, biological 
products, HCT/Ps, medical devices, radiation-emitting electronic 
products, cosmetics, and tobacco products. Proposed Sec. Sec.  1.73 
through 1.80 would require certain data elements to be submitted in ACE 
depending on the type of FDA-regulated article being imported or 
offered for import into the United States. Proposed Sec. Sec.  1.73, 
1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 1.80 apply, respectively, to 
certain food products; human drugs; animal drugs; medical devices; 
radiation-emitting electronic products; biological products, HCT/Ps, 
and related drugs and medical devices regulated by CBER; tobacco 
products; and cosmetics.
    All but four of the data elements that proposed subpart D would 
require filers to submit in ACE are currently collected in ACS and 
already approved for collection under OMB Control Number 0910-0046. Two 
of these four new data elements would be required by proposed Sec.  
1.72, which applies to certain foods as applicable, and drugs, 
biological products, HCT/Ps, medical devices, radiation-emitting 
electronic products, cosmetics, and tobacco products, and are the 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 other two new data elements would be required by proposed Sec.  
1.79, which applies only to tobacco products, and are the name and 
address of the ACE filer and brand name of the tobacco product.
    FDA concludes that the proposed data element of a telephone number 
and email address for the importer of record (which would be required 
by proposed Sec.  1.72(b)(ii)) is not subject to the requirements of 
the PRA because the data element falls under an exception to

[[Page 43173]]

the term ``information'' under 5 CFR 1320.3(h)(1).
    Under the currently approved ICR, the average time that it takes a 
filer to obtain and submit the four data elements and relevant 
affirmations of compliance information currently collected in ACS for 
all lines in an import entry is estimated at 8.4 minutes (0.14 hours). 
We did not receive any comments on the estimated burden enumerated in 
the ICR or its estimate of an average of 8.4 minutes per entry. This 
estimate of 8.4 minutes includes the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing, reviewing, and filing each entry. The estimate 
of 8.4 minutes is an average time across all import entries for FDA-
regulated products and it accounts for the various realities of the 
entry filing process, such as the fact that the vast majority of lines 
(approximately 97 percent) are not unique lines, even unique lines in a 
single entry may contain redundant information, filers use 
sophisticated software that facilitates the entry filing process, and 
the time required per line may vary depending on the commodity and the 
specific characteristics of the product, manufacturer, etc.
    Because two of the data elements that are currently collected in 
ACS--FDA manufacturer and shipper and the ultimate consignee--will not 
be collected in ACE or any other CBP-authorized EDI system under the 
proposed rule, we are reducing this estimate of 8.4 minutes to an 
estimate of 7.4 minutes.
    In 2014, when OMB most recently approved this ICR, there was an 
average of 4.166 lines per entry for FDA-regulated products. We are 
converting the average of 7.4 minutes per entry into the average time 
per line. Therefore, the estimated time per import line that it takes a 
filer to submit the data elements that are currently approved under OMB 
Control Number 0910-0046 and would be submitted in ACE pursuant to the 
proposed rule, is approximately 1.776 minutes or 0.0296 hours (= 7.4 
minutes / 4.166 lines).
    The current estimated burden for this information collection 
approved under OMB Control Number 0910-0046, updated to account for the 
total number of FDA-regulated product lines submitted in ACS in 2015 
(approximately 34 million lines) and annualized to account for 
estimated 3.3 percent increases in year two and three (for an 
annualized average of 35,133,681 lines in years one, two, and three), 
but not accounting for the estimated additional burden of the proposed 
rule for those lines that would be affected by the proposed rule, is 
approximately 1,039,957 hours (= 35,133,681 lines x 0.0296 hours).
    Using the estimates in the PRIA for the proposed rule, we have 
estimated that 33,988,154 import lines will be impacted by the proposed 
rule in the first year. We have also estimated that 975,460 import 
lines in the first year represent unique product-manufacturer 
combinations (2.87 percent of the 33,988,154 import lines). We have 
estimated that the number of impacted import lines will grow at an 
average rate of about 3.3 percent per year.
    Other key assumptions in Option 1 of the PRIA for the proposed rule 
that affect our estimate of the additional annual reporting burden are:
     Respondents would have to become aware of the rule 
requirements, which include activities related to reading the rule, 
understanding the reporting requirements, consulting with specialists 
if necessary, determining how to best meet these requirements and 
communicating these requirements to workers; and this is a one-time 
event that would require an average of 30 minutes.
     Respondents would require an administrative worker to 
locate, gather, and prepare the additional information required by this 
rule for each unique product-manufacturer import line; and this would 
require about 4 minutes (0.0667 hours) per line on average. Because FDA 
has concluded that the proposed data element of a telephone number and 
email address for the importer of record (which would be required by 
proposed Sec.  1.72(b)(ii)) is not subject to the requirements of the 
PRA, we have reduced this estimated time to 3.8 minutes for PRA 
purposes (approximately 0.0633 hours).
     Respondents would require an administrative worker to 
complete entry request for each import line and quality check using 
software that is connected to ACE, and that this would require about 2 
minutes (0.033 hours) per line on average. Because FDA has concluded 
that the proposed data element of a telephone number and email address 
for the importer of record (which would be required by proposed Sec.  
1.72(b)(ii)) is not subject to the requirements of the PRA, we have 
reduced this estimated time to 1.8 minutes (0.03 hours) for PRA 
purposes.
     It would take respondents about 12.5 percent more time in 
the first year for an administrative worker to complete an entry 
request for each import line and quality check using software that is 
connected to ACE because they would have to adjust to the new system 
and data elements.
    We have found based on our experience that filers no longer need to 
take a long time to familiarize themselves with changes in laws and 
rules relating to imports to determine how those changes would apply to 
an article being imported or offered for import, because much of these 
updates are now software-driven. For example, importers often rely on 
the electronic messages CBP sends to them notifying them of changes to 
data requirements. Furthermore, the proposed rule is fairly short, not 
complex, and does not require an inordinate number of data elements to 
be submitted in ACE for an FDA-regulated product.
    Additionally, most of the general data elements that would be 
required by proposed Sec.  1.72 of the proposed rule are currently 
collected in ACS, so filers should be very familiar with them. Almost 
all the data elements that would be required by the proposed rule in 
proposed Sec. Sec.  1.73 through 1.80 have also been available for 
submission in ACS as Affirmations of Compliance and have been described 
in various FDA memoranda to the U.S. import trade community, so most 
filers should be generally familiar with them as well.
    Entry filing processes have evolved technologically over time. The 
vast majority of filers currently rely on sophisticated software, which 
interacts with ACS and can be programmed to interact with ACE, to 
perform many of the tasks and functions that were previously performed 
manually, such as flagging mandatory data fields, providing quality 
checks, and record keeping. This increased reliance on sophisticated 
software has substantially reduced the entry filing burden. Importers 
also rely on the ACE system to flag mandatory data submissions and show 
an error message when an entry is rejected because a required data 
field is empty or is not completed in the required manner.
    Our estimate of the increase in the reporting burden from the 
proposed rule primarily accounts for the proposed rule requiring 
submission of some data elements in ACE that are currently routinely 
collected submissions in ACS. We expect that some filers who were not 
submitting these data elements in ACS would have to change their 
submissions to comply with the proposed rule, if finalized. The annual 
reporting burden is higher in the first year than in years after 
because we expect most filers to adapt to submitting the required data 
they had not been submitting in ACS and to electronically store such 
data for future repeat lines.
    Of note, FDA data shows that submission rates for the data elements

[[Page 43174]]

currently collected in ACS for many products are quite high. For 
example, for medical device lines, which make up approximately half of 
all import lines (based on 2014 and 2015 data) that would be affected 
by the proposed rule, approximately 98 percent are submitted with at 
least one affirmation of compliance, with an average of approximately 
three affirmations of compliance per line. Further, it appears that 
most medical device lines submitted in 2014 and 2015 through ACS 
already include most of the information that would be required in ACE 
by the proposed rule. Additionally, cosmetic products, which make up 
approximately 8 percent of all import lines (based on 2014 and 2015 
data) that would be affected by the proposed rule, would require no 
submission of information in ACE under the proposed rule other than the 
general data elements specified in proposed Sec.  1.72.
    As we noted previously, we have estimated that the number of import 
lines affected by the proposed rule will grow at an average rate of 
about 3.3 percent per year. For the purposes of calculating the 
additional annual recurring reporting burden of the proposed rule, we 
have annualized those 3.3 percent per year increases for 3 years. 
Accordingly, we expect the additional annual recurring reporting burden 
for the information collection that would result from this proposed 
rule, once finalized, to be as follows:

                       Table 2--Estimated Additional Annual Recurring Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
                                    No. of       responses per   Total annual    Average burden
           Activity               respondents     respondent       responses    per response (in    Total hours
                                                 (approximate)                       hours)
----------------------------------------------------------------------------------------------------------------
Preparing the required                  59,292           17.01       1,008,337  0.0633..........          63,828
 information (applies to                                                        (3.8 minutes)...
 unique lines only).
Quality checks and data                  4,010           8,762      35,113,681  0.03............       1,053,410
 submission into ACE.                                                           (1.8 minutes)...
                               ---------------------------------------------------------------------------------
    Total Hours...............  ..............  ..............  ..............  ................       1,117,238
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We expect the additional one-time (i.e., occurring only in the 
first year) reporting burden for the information collection that would 
result from this proposed rule, if finalized, to be as follows:

                                Table 3.--Estimated One Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    No. of
                                    No. of       responses per   Total annual    Average burden
           Activity               respondents     respondent       responses    per response (in    Total hours
                                                 (approximate)                       hours)
----------------------------------------------------------------------------------------------------------------
Review and familiarization               4,010               1           4,010  .5..............           2,005
 with the rule.                                                                 (30 minutes)....
First year adjusting to new              4,010           8,476      33,988,154  .00375..........         127,456
 requirements that would                                                        (0.225 minutes).
 result in an average of 12.5
 percent more time for quality
 checks and submission into
 ACE.
                               ---------------------------------------------------------------------------------
Total Hours...................  ..............  ..............  ..............  ................         129,461
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Accordingly, we estimate that the additional annual reporting 
burden under the proposed rule, if finalized, would be 1,246,699 hours 
in the first year and 1,117,238 hours recurring after the first year.
    As noted previously, the current estimated burden for this 
information collection, updated to account for the number of total FDA-
regulated lines submitted to FDA in 2015 and an estimated 3.3 percent 
per year increase in lines in years two and three, but not accounting 
for the estimated additional burden of the proposed rule, is 1,039,957 
hours. Therefore, we estimate that the total burden under this ICR, 
revised to include the estimated additional annual reporting burden 
under the proposed rule in addition to the current annual reporting 
burden, would be 2,286,656 hours in the first year (= 1,039,957 current 
burden + 1,117,238 recurring burden + 129,461 one-time burden) and 
2,157,195 hours annually after the first year (= 1,039,957 current 
burden + 1,117,238 recurring burden).
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. To ensure that comments on information collection 
are received, OMB recommends that written comments be faxed or emailed 
(see ADDRESSES). These requirements will not be effective until FDA 
obtains OMB approval. FDA will publish a notice concerning OMB approval 
of these requirements in the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that would have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. 
Accordingly, we conclude that the rule does not contain policies that 
have federalism implications as defined in the Executive order and, 
consequently, a federalism

[[Page 43175]]

summary impact statement is not required.

XI. References

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

    1. Automated Commercial System and ABI CATAIR, CBP http://www.cbp.gov/trade/acs/catair (April 13, 2016).
    2. FDA Guidance for Industry: Submitting Form FDA 2541 (Food 
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, 
FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in 
Electronic or Paper Format. November 2015. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm309376.htm.
    3. FDA Draft Guidance for Industry: Implementation of the 
``Deemed to be a License'' Provision of the Biologics Price 
Competition and Innovation Act of 2009. March 2016. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm490264.pdf.
    4. FDA, Full Disclosure of Preliminary Regulatory Impact 
Analysis, Initial Regulatory Flexibility Analysis, and Unfunded 
Mandates Reform Act Analysis on Regulations on Electronic Submission 
of Import Data: Automated Commercial Environment Proposed Rule. 
Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food Labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 1005

    Administrative practice and procedure, Electronic products, 
Imports, Radiation protection, Surety bonds.

21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical 
devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that parts 1, 1005, and 
1271 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343, 
350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 
371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 
243, 262, 264.

0
2. Add subpart D, consisting of Sec. Sec.  1.70 through 1.80, to read 
as follows:
Subpart D--Electronic Import Entries
Sec.
1.70 Scope.
1.71 Definitions.
1.72 Data elements that must be submitted in ACE for articles 
regulated by FDA.
1.73 Food.
1.74 Human drugs.
1.75 Animal drugs.
1.76 Medical devices.
1.77 Radiation-emitting electronic products.
1.78 Biological products, HCT/Ps, and related drugs and medical 
devices.
1.79 Tobacco products.
1.80 Cosmetics.

Subpart D--Electronic Import Entries

Sec.  1.70  Scope.

    This subpart specifies the data elements that are required by the 
Food and Drug Administration (FDA) to be included in an electronic 
import entry submitted in the Automated Commercial Environment (ACE) 
system or any other U.S. Customs and Border Protection (CBP)-authorized 
electronic data interchange (EDI) system operated by the CBP, which 
contains an article that is being imported or offered for import into 
the United States and that is regulated by FDA.

Sec.  1.71  Definitions.

    For purposes of subpart D:
    ACE filer means the person who is authorized to submit an 
electronic import entry for an FDA-regulated product in the Automated 
Commercial Environment or any other CBP-authorized EDI system.
    Acidified food means acidified food, as defined in Sec.  114.3(b) 
of this chapter, and subject to the requirements in parts 108 and 114 
of this chapter.
    Automated Commercial Environment or ACE means the automated and 
electronic system for processing commercial importations that is 
operated by the United States Customs and Border Protection in 
accordance with the National Customs Automation Program established in 
Subtitle B of Title VI--Customs Modernization, in the North American 
Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 
2057, 2170, December 8, 1993) (Customs Modernization Act), or any other 
CBP-authorized EDI system.
    Biological product means a biological product as defined in section 
351(i)(1) of the Public Health Service Act.
    Combination product means a product comprised of two or more 
regulated components as defined in Sec.  3.2(e) of this chapter.
    Cosmetic means a cosmetic as defined in section 201(i) of the 
Federal Food, Drug, and Cosmetic Act.
    Customs and Border Protection or CBP means 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.
    Drug means those articles meeting the definition of a drug in 
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.
    FDA or Agency means the U.S. Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act.
    Food contact substance means any substance, as defined in section 
409(h)(6) of the Federal Food, Drug, and Cosmetic Act, that is intended 
for use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.
    HCT/Ps means human cells, tissues or cellular or tissue-based 
products, as defined in Sec.  1271.3(d) of this chapter.
    Import line means each portion of an import entry that is listed as 
a separate item on an entry document.
    Low-acid canned food means a thermally processed low-acid food (as 
defined in Sec.  113.3(n) of this chapter) in a hermetically sealed 
container (as defined in Sec.  113.3(j) of this chapter), and subject 
to the requirements in parts 108 and 113 of this chapter.
    Medical device means a device as defined in section 201(h) of the 
Federal Food, Drug, and Cosmetic Act, that is intended for use in 
humans.
    Radiation-emitting electronic product means an electronic product 
as defined in section 531 of the Federal Food, Drug, and Cosmetic Act.
    Tobacco product means a tobacco product as defined in section 
201(rr) of the Federal Food, Drug, and Cosmetic Act.

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

    General. When filing an entry in ACE, the ACE filer shall submit 
the following

[[Page 43176]]

information for food as applicable, and drugs, biological products, 
HCT/Ps, medical devices, radiation-emitting electronic products, 
cosmetics, and tobacco products.
    (a) Product identifying information for the article that is being 
imported or offered for import. This consists of:
    (1) FDA Country of Production, which is, the country where the 
article was last manufactured, processed, or grown (including 
harvested, or collected and readied for shipment to the United States). 
The FDA Country of Production for an article that has undergone any 
manufacturing or processing is the country where that activity occurred 
provided that the manufacturing or processing had more than a minor, 
negligible, or insignificant effect on the article.
    (2) The Complete FDA Product Code, which must agree with the 
invoice description of the product.
    (3) FDA Value which is the total value of the article(s) in an 
import entry or import line, rounded off to the nearest dollar, which 
must match the invoice value of those article(s).
    (4) FDA Quantity which is the quantity of the article(s) in an 
import line delineated by packaging level, including the type of 
package from the largest packaging unit to the smallest packaging unit; 
the quantity of each packaging unit; and the volume and/or weight of 
each of the smallest of the packaging units.
    (b) Entity Identification Information, (1) Name, telephone, and 
email address of any one of the persons related to the importation of 
the product which may include the manufacturer, shipper, importer of 
record, or Deliver to Party.
    (2) Telephone and email address of the importer of record.

Sec.  1.73  Food.

    (a) Food. The information specified in Sec.  1.72(a)(3) must be 
submitted in ACE at the time of filing entry for food.
    (b) Food contact substances. The information specified in Sec.  
1.72 must be submitted in ACE at the time of filing entry for food that 
is a food contact substance.
    (c) Low-acid canned food. For an article of food that is a low-acid 
canned food, the ACE filer must submit at the time of filing entry the 
Food Canning Establishment Number and the Submission Identifier, and 
can dimensions or volume.
    (d) Acidified food. For an article of food that is an acidified 
food, the ACE filer must submit at the time of filing entry the Food 
Canning Establishment Number and the Submission Identifier, and can 
dimensions or volume.

Sec.  1.74  Human drugs.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry for drugs, including biological products, intended for human use 
that are regulated by the FDA Center for Drug Evaluation and Research.
    (a) Registration and listing. For a drug intended for human use, 
the Drug Registration Number and the Drug Listing Number. For the 
purposes of this section, the Drug Registration Number that must be 
submitted in ACE is the unique facility identifier of the foreign 
establishment where the human drug was manufactured, prepared, 
propagated, compounded or processed before being imported or offered 
for import into the United States. The unique facility identifier is 
the identifier submitted by a registrant in accordance with the system 
specified under section 510(b) of the Federal Food, Drug, and Cosmetic 
Act. For the purposes of this section, the Drug Listing Number is the 
National Drug Code number of the human drug article being imported or 
offered for import.
    (b) Drug application number. For a drug intended for human use that 
is the subject of an approved application under section 505(b) or 
505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the 
new drug application or abbreviated new drug application. For a 
biological product regulated by the FDA Center for Drug Evaluation and 
Research that is required to have an approved new drug application or 
an approved biologics license application, the number of the applicable 
application.
    (c) Investigational new drug application number. For a drug 
intended for human use that is the subject of an investigational new 
drug application under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act, the number of the investigational new drug application.

Sec.  1.75  Animal drugs.

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

Sec.  1.76  Medical devices.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry for medical devices regulated by the FDA Center for Devices and 
Radiological Health.
    (a) Registration and listing. For a medical device, the 
Registration Number for Foreign Manufacturers, Foreign Exporters, and/
or Domestic Manufacturers, and the Device Listing Number, required 
under section 510 of the Federal Food, Drug, and Cosmetic Act and part 
807 of this chapter.
    (b) Investigational devices. For an investigational medical device 
that has an investigational device exemption granted under section 
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational 
Device Exemption Number. For an investigational medical device being 
imported or offered for import for use in a nonsignificant risk or 
exempt study, ``NSR'' to be entered in the Affirmation of Compliance 
for the

[[Page 43177]]

``investigational device exemption'' that identifies the device as 
being used in a nonsignificant risk or exempt study.
    (c) Premarket number. For a medical device that has one, the 
Premarket Number. This is the Premarket Approval Number for those 
medical devices that have received pre-market approval under section 
515 of the Federal Food, Drug, and Cosmetic Act; the Product 
Development Protocol Number for those medical devices for which FDA has 
declared the product development protocol complete under section 515(f) 
of the Federal Food, Drug, and Cosmetic Act; the De Novo number for 
those medical devices granted marketing authorization under section 
513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket 
Notification Number for those medical devices that received premarket 
clearance under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act; or the Humanitarian Device Exemption Number for those medical 
devices for which an exemption has been granted under section 520(m) of 
the Federal Food, Drug, and Cosmetic Act.
    (d) Component. If applicable for a medical device, an affirmation 
identifying that the article being imported or offered for import is a 
component that requires further processing or inclusion into a finished 
medical device.
    (e) Lead wire/patient cable. For electrode lead wires and patient 
cables intended for use with a medical device, an Affirmation of 
Compliance with the applicable performance standard under Sec.  898.12 
of this chapter.
    (f) Impact resistant lens. For impact resistant lenses in 
eyeglasses and sunglasses, an Affirmation of Compliance with the 
applicable requirements of Sec.  801.410 of this chapter.
    (g) Convenience kit. If applicable for a medical device, an 
Affirmation of Compliance that the article imported or offered for 
import is a convenience kit or part of a convenience kit.
    (h) Investigational new drug application number. For a combination 
product consisting of at least one medical device and one drug intended 
for human use that is the subject of an investigational new drug 
application under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act, where the FDA Center for Devices and Radiological Health 
has been designated by FDA as the center with primary jurisdiction for 
the premarket review and regulation of the combination product, the 
number of the investigational new drug application.

Sec.  1.77  Radiation-emitting electronic products.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit all of the declarations required in Form FDA 2877 
electronically in ACE at the time of filing entry for products subject 
to the standards under parts 1020-1050 of this chapter.

Sec.  1.78  Biological products, HCT/Ps, and related drugs and medical 
devices.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of entry 
for biological products, HCT/Ps, and related drugs and medical devices 
regulated by the FDA Center for Biologics Evaluation and Research.
    (a) Product name which identifies the article being imported or 
offered for import by the name commonly associated with that article 
including the 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.
    (b) HCT/P registration and affirmation. (1) For an HCT/P regulated 
solely under section 361 of the Public Health Service Act and the 
regulations in part 1271 of this chapter that is manufactured by an 
establishment that is required to be registered under part 1271 of this 
chapter, the HCT/P Registration Number; and
    (2) For an HCT/P regulated solely under section 361 of the Public 
Health Service Act and the regulations in part 1271 of this chapter, an 
affirmation of compliance with the applicable requirements of part 1271 
of this chapter.
    (c) Licensed biological products. For a biological product that is 
the subject of an approved biologics license application under section 
351 of the Public Health Service Act, the Submission Tracking Number of 
the biologics license application and/or the Biologics License Number.
    (d) Drug registration and listing. For a drug intended for human 
use, the Drug Registration Number and the Drug Listing Number. For the 
purposes of this section, the Drug Registration Number that must be 
submitted in ACE is the unique facility identifier of the foreign 
establishment where the human drug was manufactured, prepared, 
propagated, compounded or processed before being imported or offered 
for import into the United States. The unique facility identifier is 
the identifier submitted by a registrant in accordance with the system 
specified under section 510(b) of the Federal Food, Drug, and Cosmetic 
Act. For the purposes of this section, the Drug Listing Number is the 
National Drug Code number of the human drug article being imported or 
offered for import.
    (e) Drug application number. For a drug intended for human use that 
is the subject of an approved application under section 505(b) or 
505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the 
new drug application or the abbreviated new drug application.
    (f) Investigational new drug application number. For a drug 
intended for human use that is the subject of an investigational new 
drug application under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act, the number of the investigational new drug application.
    (g) Medical device registration and listing. For a medical device 
subject to the registration and listing procedures contained in part 
807 of this chapter, the Registration Number for Foreign Manufacturers, 
Foreign Exporters, and/or Domestic Manufacturers, and the Device 
Listing Number, required under section 510 of the Federal Food, Drug, 
and Cosmetic Act and part 807 of this chapter.
    (h) Investigational devices. For an investigational medical device 
that has an investigational device exemption granted under section 
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational 
Device Exemption Number. For an investigational medical device being 
imported or offered for import for use in a nonsignificant risk or 
exempt study, an Affirmation of Compliance that identifies the device 
as being used in such a study.
    (i) Medical device premarket number. For a medical device that has 
one, the premarket number. This is the premarket approval number for 
those medical devices that have received pre-market approval under 
section 515 of the Federal Food, Drug, and Cosmetic Act; the Product 
Development Protocol Number for those medical devices for which FDA has 
declared the Product Development Protocol complete under section 515(f) 
of the Federal Food, Drug, and Cosmetic Act; the De Novo number for 
those medical devices granted marketing authorization under section 
513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket 
Notification Number for those medical devices that received premarket 
clearance under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act; or the Humanitarian Device Exemption Number for those medical 
devices for which an exemption has been granted under section 520(m) of 
the Federal Food, Drug, and Cosmetic Act.

[[Page 43178]]

    (j) Medical device component. If applicable for a medical device, 
an affirmation identifying that the article being imported or offered 
for import is a component that requires further processing or inclusion 
into a finished medical device.

Sec.  1.79  Tobacco products.

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of filing 
entry in ACE.
    (a) Brand name of the article that is a tobacco product being 
imported or offered for import.
    (b) Name and address of the ACE filer for any entry that includes 
an article that is a tobacco product.

Sec.  1.80  Cosmetics.

    An ACE filer must submit the data specified in Sec.  1.72 at the 
time of filing entry in ACE.
0
3. In Sec.  1.83, revise paragraph (a) to read as follows:

Sec.  1.83  Definitions.

* * * * *
    (a) The term owner or consignee means the person eligible to make 
entry under the provisions of sections 484 and 485 of the Tariff Act of 
1930, as amended (19 U.S.C. 1484 and 1485), namely, the ``importer of 
record.''
* * * * *
0
4. Revise Sec.  1.90 to read as follows:

Sec.  1.90  Notice of sampling.

    When a sample of an article offered for import has been requested 
by the district director, FDA shall provide to the owner or consignee 
prompt notice of delivery of, or intention to deliver, such sample. 
Upon receipt of the notice, the owner or consignee shall hold such 
article and not distribute it until further notice from the district 
director or U.S. Customs and Border Protection of the results of 
examination of the sample.
0
5. In Sec.  1.94, revise the first sentence of paragraphs (a) and (c) 
to read as follows:

Sec.  1.94  Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of 
admission, or that the article is a drug that may be subject to 
destruction under section 801(a) of the Federal Food, Drug, and 
Cosmetic Act, the district director shall give the owner or consignee a 
written or electronic notice to that effect, stating the reasons 
therefor. * * *
* * * * *
    (c) If the article is a drug that may be subject to destruction 
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the 
district director may give the owner or consignee a single written or 
electronic notice that provides the notice on refusal of admission and 
the notice on destruction of an article described in paragraph (a) of 
this section. * * *

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

0
6. The authority citation for part 1005 continues to read as follows:

    Authority:  21 U.S.C. 360ii, 360mm.

0
7. Revise Sec.  1005.2 to read as follows:

Sec.  1005.2  Definitions.

    As used in this part:
    The term owner or consignee means the person eligible to make entry 
under the provisions of sections 484 and 485 of the Tariff Act of 1930, 
as amended (19 U.S.C. 1484 and 1485), namely, the ``importer of 
record.''

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED 
PRODUCTS

0
8. The authority citation for part 1271 continues to read as follows:

    Authority:  42 U.S.C. 216, 243, 263a, 264, 271.

0
9. In Sec.  1271.420, revise paragraph (a) to read as follows:

Sec.  1271.420  HCT/Ps offered for import.

    (a) Except as provided in paragraphs (c) and (d) of this section, 
when an HCT/P is offered for import, the importer of record must 
notify, either before or at the time of importation, the director of 
the district of the Food and Drug Administration (FDA) 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 in administering and 
enforcing this part, and must provide sufficient information, including 
information submitted in the Automated Commercial Environment (ACE) 
system or any other Electronic Data Interchange system authorized by 
the United States Customs and Border Protection Agency as required in 
part 1, subpart D of this chapter, for FDA to make an admissibility 
decision.
* * * * *

    Dated: June 28, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and Drug Administration.

    In concurrence with FDA:

    Dated: June 28, 2016.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy), Department 
of the Treasury.
[FR Doc. 2016-15684 Filed 6-30-16; 8:45 am]
 BILLING CODE 4164-01-P