
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Rules and Regulations]
[Pages 85854-85873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28582]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 1005, and 1271

[Docket No. FDA-2016-N-1487]
RIN 0910-AH41


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final rule/regulation 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, and foster U.S. 
economic security through lawful international trade and policy. FDA is 
a Partner Government Agency (PGA) for purposes of submission of import 
data in ACE. As of July 23, 2016, ACE became the sole EDI system 
authorized by CBP for entry of FDA-regulated articles into the United 
States. We also updated certain sections of FDA regulations related to 
imports. This rule 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: This rule is effective December 29, 2016.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the final rule: 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: FDA PRA Staff, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St.,

[[Page 85855]]

North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Specific Comments and FDA Response
    D. Technical Amendments in the Final Rule
VI. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits and Costs of the Final Rule
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Reference

I. Executive Summary

A. Purpose of the Final Rule

    The rule requires that certain data elements material to our import 
admissibility review be submitted in ACE or any other CBP-authorized 
EDI system, at the time of entry. This action 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. We also made technical revisions to certain sections of 
FDA regulations to make updates and provide clarifications.

B. Summary of the Major Provisions of the Final Rule

    This rule adds subpart D to part 1 of 21 CFR chapter I (21 CFR part 
1) 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). We 
also added Sec.  1.81 to the final rule to clarify that FDA may reject 
an import filing for failure to provide the complete and accurate 
information required in the rule.
    We made technical revisions to certain sections of 21 CFR chapter I 
to update them. We revised 21 CFR 1.83 and 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 revised Sec.  1.90 
to allow FDA to provide notice of sampling directly to an owner or 
consignee. Additionally, we revised Sec.  1.94 to clarify that written 
notice can be provided electronically by FDA to owners or consignees of 
FDA actions to refuse and/or subject certain products to administrative 
destruction. Under Sec.  1.94, owners or consignees 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 also amended 21 CFR 1271.420 to make 
clear that, unless otherwise exempt, importers of record of human 
cells, tissues or cellular or tissue-based products (HCT/Ps) that are 
regulated solely under section 361 of the Public Health Service Act 
(PHS Act) (42 U.S.C. 264) and part 1271 (21 CFR part 1271) would be 
required to submit the applicable data elements included in this rule 
in ACE.
    The final rule does not include certain aspects of the proposed 
rule that were opposed by many who submitted comments. For example, the 
final rule no longer includes FDA Value, FDA Quantity, Entity Contact 
Information other than for the importer of record, name and address of 
the ACE filer for tobacco products, and the Investigational New Drug 
Application Number for device-drug combination products as data 
elements that must be submitted in ACE at the time of entry. We have 
also removed, at our own initiative, the Drug Listing Number 
requirement for those human drugs that are regulated by FDA's Center 
for Biologics Evaluation and Research (CBER).

C. Legal Authority

    The legal authority for this 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 PHS Act (42 U.S.C. 262, 264, and 271, respectively).

D. Costs and Benefits

    The costs of complying with this regulation are between $27 million 
and $69 million per year (using 3 and 7 percent discount rates). The 
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 are estimated to range 
from $2.6 million to $43.4 million (using 3 and 7 percent discount 
rates).

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
       Abbreviation/acronym                     What it means
------------------------------------------------------------------------
ACE...............................  Automated Commercial Environment or
                                     any other CBP-authorized EDI
                                     system.
ACE filer.........................  The person who is authorized to
                                     submit an electronic import entry
                                     for an FDA-regulated product in
                                     ACE.
ACS...............................  Automated Commercial System--the
                                     predecessor CBP-authorized EDI
                                     system to ACE.
Agency............................  U.S. Food and Drug Administration.
CATAIR............................  Customs and Border Protection and
                                     Trade Automated Interface
                                     Requirements.
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.
HCT/P.............................  Human cells, tissues, or cellular or
                                     tissue-based products.

[[Page 85856]]

 
ITDS..............................  International Trade Data System.
OASIS.............................  FDA's 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

    In the Federal Register of July 1, 2016 (81 FR 43155), FDA proposed 
a rule to require that certain data elements material to our import 
admissibility review be submitted in ACE at the time of entry. We also 
proposed to make technical revisions to certain sections of FDA 
regulations to make updates and provide clarifications. Interested 
parties were given 60 days to submit comments on the proposed rule to 
the public docket.
    We received 13 comment letters on the proposed rule by the close of 
the comment period, each containing one or more comments on one or more 
issues. These comments were submitted to the public docket by trade 
organizations, the trade industry, and the public. The final rule has 
been revised in response to comments received on the proposed rule. Our 
responses are discussed in section V. As discussed earlier in this 
document, we also decided, on our own initiative, to not include one 
required data element in the final rule. Additionally, the final rule 
includes several minor editorial revisions. Substantive changes from 
the proposed rule to the final rule are summarized in table 1.

  Table 1--Substantive Changes From the Proposed Rule to the Final Rule
------------------------------------------------------------------------
 21 CFR  section in  final
           rule               Description of change from proposed rule
------------------------------------------------------------------------
1.71......................  Definitions.
                             Removed definition of ``combination
                             product'' because Investigational New Drug
                             Application Number (Sec.   1.76(h) in the
                             proposed rule) removed.
                             Removed definition of ``import
                             line'' because FDA Value (Sec.   1.72(a)(3)
                             in the proposed rule) removed.
1.72......................  Data elements that must be submitted in ACE
                             for articles regulated by FDA.
                             Removed FDA Value (Sec.
                             1.72(a)(3) in the proposed rule).
                             Removed FDA Quantity (Sec.
                             1.72(a)(4) in the proposed rule).
                             Removed 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 (Sec.
                             1.72(b)(1) in the proposed rule).
                             Added submission of the full
                             intended use code (Sec.   1.72(a)(3)); not
                             in the proposed rule.
1.73......................  Food.
                             Removed requirement to submit FDA
                             Value under Sec.   1.72(a)(3) for food
                             (Sec.   1.73(a) in the proposed rule).
                             Removed requirement to provide Food
                             Canning Establishment Number and the
                             Submission Identifier, and can dimensions
                             or volume for low-acid canned foods and
                             acidified foods imported or offered for
                             import for laboratory analysis only, when
                             such foods will not be taste tested or
                             otherwise ingested
1.76......................  Medical Devices.
                             Removed requirement to submit
                             Investigational New Drug Application Number
                             (Sec.   1.76(h) in the proposed rule).
1.78......................  Biological products, HCT/Ps, and related
                             drugs and medical devices.
                             Removed requirement to submit Drug
                             Listing Number (removed from Sec.   1.78(d)
                             in the proposed rule).
1.79......................  Tobacco products.
                             Excludes products solely intended
                             for further manufacturing and
                             investigational tobacco products from
                             requirement. Requires submission of a
                             commercial name for any such tobacco
                             product that does not have a specific brand
                             name (Sec.   1.79(a) of the proposed rule).
                             Removed name and address of the ACE
                             filer for any entry that includes an
                             article that is a tobacco product (Sec.
                             1.79(b) of the proposed rule).
1.81......................  Rejection of Entry Filing.
                             Clarifies that FDA may reject an
                             entry filing for failure to provide
                             complete and accurate information as
                             required in the final rule; not included in
                             the proposed rule.
------------------------------------------------------------------------

IV. Legal Authority

    We have 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 of the PHS Act 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

[[Page 85857]]

Act in the 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 rule under authority granted to FDA by 
section 801(r) of the FD&C Act, 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) of the FD&C Act 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. This rule is being jointly prescribed 
by FDA and the Department of the Treasury, with the exception of the 
provisions of the 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. Comments on the Proposed Rule and FDA Response

A. Introduction

    Sections V.B and V.C contain summaries of the relevant portions of 
the responsive comments and the Agency's responses to those comments. 
We have numbered each comment to help distinguish between different 
comments. We have grouped similar comments together under the same 
number, and, in some cases, we have separated different issues 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which 
comments were received.
    The Agency also received a number of comments that were not 
responsive to the content of the proposed rule and therefore were not 
considered in its final development.

B. Description of General Comments and FDA Response

    A number of comments made general remarks supporting or opposing 
the proposed rule without focusing on a particular proposed provision. 
In the following paragraphs, we discuss and respond to such general 
comments.
    (Comment 1) We received a comment expressing concern that several 
of the data elements in the proposed rule appear to require information 
that is already being provided in ACE pursuant to CBP requirements. We 
also received comments that many of the required data elements 
represent information that is already available to the Agency.
    (Response 1) FDA acknowledges that some of the required data 
elements in this rule may appear similar to CBP data requirements in 
ACE. The rule, however, only contains those data elements that provide 
additional information that is material to FDA's initial admissibility 
review of an FDA-regulated article that is being imported or offered 
for import. Where information is already being collected by CBP and is 
acceptable for FDA admissibility review purposes, we did not include 
those data elements in the rule. For example, CBP collected FDA 
manufacturer and shipper, and ultimate consignee information in the 
Automated Commercial System (ACS), the predecessor CBP-authorized EDI 
system to ACE, to assist FDA in admissibility review of FDA-regulated 
products. We determined that the information CBP collects in ACE for 
manufacturer and shipper and Deliver to Party is sufficient for our 
purposes so we did not include those data elements in this rule.
    We acknowledge that FDA may have access to some of the information 
which is required by the rule to be submitted by ACE filers at the time 
of entry. However, ACE filers and importers are in a better position to 
know the identity and characteristics of the particular article being 
imported or offered for import. For example, the importer should be 
aware of what Drug Listing Number is applicable to a particular drug 
article, what the applicable Food Canning Establishment Registration 
(FCE) number, Submission Identifier (SID), or can dimensions or volume 
are applicable to a particular low-acid canned food, or what the brand 
name is of a particular tobacco product.
    In addition, submission of the required data elements in the final 
rule will 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.'' 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 an FDA-reviewer either 
searches for that information in our data systems or requests 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 both FDA and the importer.
    (Comment 2) Several commenters requested that FDA make some or all 
of the required data elements in the proposed rule optional or, in the 
alternative, allow ACE filers to submit ``UNK'' representing 
``unknown'' in ACE for those data elements. These commenters stated 
that the data elements are not always known or available to the ACE 
filer at the time entry is electronically filed in ACE. They expressed 
concern that CBP would not process the entry filing in ACE if all the 
required data elements are not submitted at time of entry. But, if the 
data is optional or if ``UNK'' is allowed to be submitted for a 
required data element, they asserted, CBP would process the entry and 
transmit the entry data to FDA's OASIS system. These commenters 
recognized that an FDA ``May Proceed'' would not issue until the 
missing data was provided by the ACE filer but that CBP may issue a 
delivery authorization to allow the goods to move from the port to the 
importer's premises in the interim. This would, they believe, avoid a 
backlog of cargo at the port and the cost of storage and demurrage as 
an ACE filer waited to receive the information from the importer.
    (Response 2) As discussed in Response 6 in this document, we are 
requiring submission of intended use codes in ACE in the final rule but 
are allowing ACE filers to submit ``UNK'' as the intended use code in 
ACE at the time of entry. We decline, however, to accept ``UNK'' for 
any other required

[[Page 85858]]

data element in the final rule. As stated in the proposed rule, the 
number of import lines that include FDA-regulated articles continues to 
grow steadily every year and this is posing challenges to the Agency in 
enforcing sections 536 and 801 of the FD&C Act and sections 351, 361, 
and 368 of the PHS Act. The number of import lines in 2015 that 
included an FDA-regulated article exceeded 35 million. In ACS, where 
submission of data elements was optional, the number of submissions 
varied depending on commodity. As stated previously in this document, 
where certain data was missing or inaccurate, entries had to be 
manually reviewed for an admissibility determination by FDA and entries 
were sometimes significantly delayed. In the final rule, we are 
requiring only certain data elements that we have determined to be 
material to our import admissibility review be submitted in ACE at the 
time of entry. The purpose of the rule is to 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. 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. As expected, we have seen a decrease in the FDA 
processing time for both automated and manual ``May Proceed'' 
determinations since ACE became the sole CBP-authorized EDI system in 
July 2016. The average time for the OASIS system to process an import 
entry submitted in ACS from August 27 to October 22, 2015, and issue an 
automated ``May Proceed'' determination was approximately 7.1 minutes 
which has been reduced to approximately 2 minutes in ACE from August 27 
to October 22, 2016. The average time for an FDA-reviewer to manually 
review and issue a ``May Proceed'' determination in ACS from August 27 
to October 22, 2015, was about 28 hours and that has been reduced to 
under 2 hours in ACE from August 27 to October 22, 2016. As a result of 
a more streamlined import process, the rule is expected to lead to a 
more effective use of FDA and importer resources, and more efficient 
enforcement of the FD&C Act and the PHS Act for imported products.
    In addition, we expect that, after the initial adjustment phase, 
submission of the data elements required by the rule will become 
incorporated into the business practices of importers and customs 
brokers. Persons wishing to import FDA-regulated products into the 
United States are required to file the entry documentation or data 
required by CBP and FDA at the time of entry in ACE in order to secure 
the release of an FDA-regulated article from CBP custody (19 CFR 
142.3). Entry and entry summary documentation that is filed 
electronically in ACE must be certified by the importer of record or 
his/her duly authorized customs broker as being true and correct to the 
best of his/her knowledge. A certified electronic transmission is 
binding in the same manner and to the same extent as a signed document 
(19 CFR 141.61(a)(2)).
    Approximately 98 percent of importers use customs brokers to file 
their entries containing FDA-regulated products subject to the final 
rule. Customs brokers are required to exercise due diligence in 
preparing or assisting in the preparation of records for import entries 
(19 CFR 111.29). We expect that importers and customs brokers will 
adapt their business practices to provide the required data elements in 
ACE at the time of entry in order to secure the release of an FDA-
regulated article from CBP custody and submission of these data 
elements will become routine.
    (Comment 3) Some commenters requested that we use the term 
``transmission of data elements in ACE'' instead of ``submission of 
data elements in ACE'' by ACE filers suggesting that FDA distinguish 
between the importer (as the provider of information) and the customs 
broker/filer (as the transmitter of the information provided by the 
importer). One comment suggested that we adopt the distinction between 
``submitter'' and ``transmitter'' that appears in the Prior Notice of 
Imported Food regulation (21 CFR part 1, subpart I).
    (Response 3) We decline to make that change. ``Submission'' is the 
term used in CBP regulations to characterize the electronic submission 
to ACE of the entry summary documentation or data for preliminary 
review or of entry documentation or data for other purposes (19 CFR 
141.0a(c)). Further, as stated previously, approximately 98 percent of 
importers use customs brokers to file their entries containing FDA-
regulated products subject to the rule; the other 2 percent file these 
entries themselves. The obligations of customs brokers extend beyond 
the mere electronic transmission of data received for transmission to 
CBP (see definition of ``customs business'' in 19 CFR 111.1).
    It should also be noted that this rule does not address or impact 
the current import entry review process for food articles requiring 
prior notice which has been operationally transitioned from ACS to ACE. 
The prior notice information required under Sec.  1.281 is currently 
submitted in ACE or the FDA Prior Notice System Interface (PNSI) before 
the arrival of a food article in the United States. The different roles 
of transmitter and submitter for prior notice are tied to the existence 
of two systems for filing prior notice and the particular roles of 
filers in that process. We do not see a benefit in applying those 
concepts to the process of filing entry for FDA-regulated products that 
are not subject to prior notice.
    (Comment 4) Some commenters expressed doubts that submission of 
additional data in ACE for FDA-regulated products will result in 
increased efficiencies in FDA admissibility review particularly an 
increase in automated ``May Proceed'' determinations by the Agency.
    (Response 4) Although we do not at this time have statistics on the 
numbers of automated ``May Proceed'' determinations that will result 
from implementation of the rule, we have already seen a substantial 
decrease in average FDA processing times for both automated and manual 
``May Proceed'' determinations since ACE became the sole CBP-authorized 
EDI system in July 2016. As we and the trade industry continue to 
adjust to the new system and various technological issues with ACE that 
have arisen during the transition to ACE are addressed, we expect these 
processing times to continue to improve.

C. Specific Comments and FDA Response

    For some of the proposed data elements and other requirements, FDA 
either did not receive comments or the comments were generally 
supportive. Unless otherwise noted, FDA has kept these requirements in 
the final rule for the reasons given in the proposal.
1. Approval or Clearance Status of FDA-Regulated Medical Products
    In the Notice of Proposed Rulemaking, we invited 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 proposed 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 invited comment on 
whether the submission of these data elements would help us achieve our 
goals of facilitating admissibility review and focusing our

[[Page 85859]]

resources on those products that may be associated with a serious 
public health risk to consumers.
    We received several comments supportive of our position and none of 
the comments suggested revising the provisions in the proposed rule 
related to the submission of application numbers. We are finalizing 
those provisions without change.
2. Active Pharmaceutical Ingredient Data Elements
    We also invited comments on the advantages, disadvantages, and 
feasibility of requiring what are now optional active pharmaceutical 
ingredient (API) data elements for finished human and animal drugs 
contained in the PGA Message Set (e.g., name of the API, the amount and 
unit of measure of the API, and the name of the manufacturer of the API 
in the finished drug) to be submitted in ACE at the time of entry.
    (Comment 5) Several comments asserted that requiring submission of 
these API data elements in ACE at the time of filing entry would create 
a significant burden on industry. These commenters urged FDA to leave 
the API data elements as optional submissions in ACE, so that an ACE 
filer could choose to transmit the information if available at time of 
entry. The comments noted that by keeping the API data elements 
optional, CBP would be able to process the entry for a drug product, 
even if the API information were not transmitted in ACE at the time of 
entry. If, however, FDA determines further evaluation is necessary, FDA 
could then request API information during our review of the entry for 
admissibility.
    (Response 5) In response to these comments, we have decided to keep 
the API data elements as optional submissions in ACE at the time of 
entry. Although these data elements will remain optional, FDA strongly 
encourages ACE filers to submit the API data elements at the time of 
entry to facilitate FDA's admissibility review. These API data elements 
provide us with information that may be material to our admissibility 
review for drug products. For example, submission of these API data 
elements would help FDA assess whether a finished dosage form drug that 
is being imported or offered for import appears to be adulterated and 
may be subject to refusal of admission under section 801(a) of the FD&C 
Act. If an API has not been manufactured in compliance with Current 
Good Manufacturing Practices (CGMP), it is deemed adulterated within 
the meaning of section 501(a)(2)(B) of the FD&C Act because the methods 
used in, or the facilities or controls used for, the drug's 
manufacture, processing, packing or holding did not conform to, or were 
not operated or administered in conformity with, CGMP requirements. A 
finished dosage form drug is deemed adulterated if it contains an API 
that is adulterated. Drugs that appear to be adulterated are subject to 
detention and refusal under section 801(a) of the FD&C Act. FDA has 
placed a number of foreign API suppliers on Import Alert 66-40, which 
may subject their APIs to detention without physical examination, 
because the firms have not met CGMPs. As a consequence, FDA has refused 
admission of drug products that have been manufactured using APIs on 
Import Alert 66-40, under section 801(a)(3) of the FD&C Act.
    In addition, if a foreign-manufactured API was used in a drug 
product that is the subject of an approved application under section 
505 or 512 of the FD&C Act (21 U.S.C. 355 or 360b), the API 
manufacturer must be an acceptable source listed in the approved NDA or 
ANDA for human drugs (see, e.g., 21 CFR 314.50(d)(1)(i)) or in the 
approved NADA or ANADA for animal drugs (see, e.g., 21 CFR 
514.1(b)(5)(i)). Submitting the API data elements in ACE for a drug 
product that is the subject of an approved application would facilitate 
FDA's assessment of whether the finished dosage form drug complies with 
section 505 or 512.
    If ACE filers submit the optional API data elements in ACE, it 
likely will increase the likelihood that the import entry will receive 
an automated ``May Proceed'' determination from the Agency. If the API 
data elements are not submitted in ACE, the entry may receive a manual 
review and the FDA reviewer may request that the importer provide API 
information for the finished dosage product.
3. Intended Use Code and Disclaimer
    FDA invited 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.
    a. Intended use code. We received several comments supporting 
inclusion of intended use codes in the final rule. Historically, FDA 
derived intended use information for the purposes of FDA's 
admissibility review from the free text information submitted in the 
CBP-required product description field in ACS. Intended use codes were 
developed for ACE in the PGA message set to provide a consistent, 
systematic approach to collection of certain intended use information 
about articles that are being imported or offered for import into the 
United States. These codes standardize the data input for computer 
processing in ACE. If FDA needs a particular intended use code (IUC) 
for the ACE system to identify what FDA data elements are needed for a 
particular FDA-regulated product, the proposed IUC is submitted to CBP 
for inclusion in Appendix R to the Customs and Border Protection and 
Trade Automated Interface Requirements (CATAIR).
    We added Sec.  1.72(a)(3) to the final rule to require that a full 
IUC be submitted in ACE at the time of entry for each FDA-regulated 
article that is being imported or offered for import into the United 
States. Appendix R defines a full IUC as consisting of a base code that 
designates the general use intended for the article and a subcode, if 
applicable, that designates the specific use intended for the article.
    (Comment 6) One commenter supported mandatory intended use codes 
and several commenters requested that IUCs be optional data submissions 
at the time of entry in ACE or, in the alternative, that FDA continue 
to allow ACE filers to submit ``UNK'' as the IUC in ACE at the time of 
entry. These commenters assert that the intended use of an article is 
often not known at the time of entry and that if FDA needs this 
information, it can be provided at a later date.
    (Response 6) Because IUCs are such an integral part of the ACE 
system regarding the identification of those required data elements in 
the rule applicable to a particular article that must be submitted in 
ACE at the time of entry, we decline to make IUCs optional. After 
considering the comments, we have decided, however, to continue to 
allow submission of the intended use code ``UNK'' for FDA-regulated 
articles. ``UNK'' is currently listed as an IUC in Appendix R of the 
CATAIR. Operationally, submission of ``UNK'' will not trigger the ACE 
system to identify all of the FDA data elements that are required to be 
submitted for a particular FDA-regulated article whereas submission of 
the specific IUC applicable to that article will trigger the ACE system 
to identify the required data

[[Page 85860]]

fields and reject the filing if the required data is not submitted.
    If ``UNK'' is submitted as the IUC for the article, the ACE filer 
is still responsible for submitting the other required data elements in 
this rule that are applicable to that article, in ACE at the time of 
entry. If those other data elements are not submitted in ACE at the 
time of entry, the entry may be transmitted by ACE to OASIS for FDA's 
admissibility review but FDA may decide to not perform an admissibility 
review until those data elements have been submitted. We have added 
Sec.  1.81 to the final rule to make clear that FDA may reject any 
entry filing that does not contain the complete and accurate 
information required by the rule without performing an admissibility 
review. If FDA rejects an entry filing under Sec.  1.81, the ACE filer 
will need to withdraw the entry in ACE and resubmit the entry with the 
complete and accurate information required under the rule in order to 
have FDA perform an admissibility review of that entry. ACE filers also 
need to be aware that submitting ``UNK'' as the intended use code will, 
in most cases, subject the entry to a manual review for admissibility 
provided the entry filing is not rejected by FDA.
    b. Disclaimer. By submitting a disclaimer in ACE at the time of 
entry, an 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.
    (Comment 7) Several commenters expressed the opinion that the 
current disclaimer procedures in ACE should not be changed.
    (Response 7) After consideration of the comments received, we have 
decided not to include FDA-required disclaimer data elements in the 
final rule. ACE filers can continue to submit disclaimers in ACE at the 
time of entry following current procedures.
4. General Data Elements for FDA-Regulated Commodities
    a. FDA country of production. The FDA Country of Production 
identifies the country where an FDA-regulated article last underwent 
any manufacturing or processing but only if such manufacturing or 
processing was of more than a minor, negligible, or insignificant 
nature. This differs from the CBP country of origin which uses a 
substantial transformation test. 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.
    CBP collected FDA Country of Production in ACS to assist FDA in 
making admissibility decisions for FDA-regulated products.
    (Comment 8) Some commenters requested additional guidance on what 
FDA considers to be manufacturing or processing of more than a minor, 
negligible, or insignificant nature. One commenter suggested that FDA 
consider issuing a ``positive'' list of manufacturing activities or 
processes that definitively impart ``FDA Country of Production'' status 
or alternatively issue a list of manufacturing or processing activities 
that are considered by the Agency to be minor, negligible or 
insignificant.
    (Response 8) Whether the manufacturing or processing of a 
particular FDA-regulated article is of more than a minor, negligible or 
insignificant nature is dependent on the facts of each particular case 
which include the specific manufacturing or processing activities 
involved as well as the type of commodity that is being affected by 
those activities. We have provided below some examples to illustrate 
activities FDA would consider to be more than minor, negligible, or 
insignificant which would impact the FDA Country of Production.
    For example:
     If an FDA-regulated article undergoes further 
manufacturing/processing at a facility, such as encapsulating a drug, 
the country where the facility that performed the additional 
manufacturing/processing is located is considered to be the FDA Country 
of Production.
     Conversely if an article was not further manufactured/
processed by a facility, such as repacking retail packages into a 
different master carton for shipping, the country where the facility 
that performed this repacking is located would not be considered to be 
the FDA Country of Production.
    We will also consider the issuance of additional guidance in the 
future as resources allow.
    (Comment 9) One comment requested clarification regarding the 
application of FDA Country of Production to Foreign Trade Zone (FTZ) 
operations. The Commenter suggested revising the FDA Country of 
Production data element by adding this sentence: ``For articles 
imported from foreign-trade zones, if the article has undergone 
manufacturing in the foreign-trade zone, the FDA Country of Production 
is the United States for FDA import purposes.''
    (Response 9) FDA recognizes that the FDA Country of Production will 
be the United States if more than minimal, negligible, or insignificant 
manufacture or processing occurs in an FTZ but we decline to make the 
suggested revision because it is unnecessary.
    b. The complete FDA product code. CBP also collected the Complete 
FDA Product Code in ACS to assist FDA in making admissibility decisions 
for FDA-regulated products.
    (Comment 10) Some commenters supported the requirement for 
submission of the Complete FDA Product Code but requested clarification 
regarding the requirement that the code `` . . . must agree with the 
invoice description of the product. '' They expressed concern that 
``agreement'' could be interpreted in various ways by both FDA-
reviewers and industry resulting in unintended and unnecessary 
detentions or delays for completion of admissibility determinations. 
For example, ``agreement'' with the invoice description could be 
understood as requiring a partial or complete verbatim match between 
the invoice description and the product code.
    (Response 10) FDA does not intend for the invoice description and 
the Complete FDA Product Code to be identical. In order to clarify this 
requirement, we have revised the language in the rule to require that 
the Complete FDA Product Code be ``consistent'' with the invoice 
description.
    c. FDA value. We proposed 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 and invited 
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 
invited 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 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.
    (Comment 11) We received several comments that expressed confusion 
over the products that would be subject to the proposed FDA Value 
requirement, as well as the ``value'' that was required to be submitted 
in ACE for an entry that

[[Page 85861]]

includes an FDA-regulated article. The commenters suggested that the 
Agency accept the total value of an entry required by CBP without the 
need to break-out the value of each import line. Pro-rating the value 
to each import line, they assert, can be a cumbersome, time intensive 
process with no practical value to FDA for typical entries containing 
FDA-regulated products which may have many separate lines.
    (Response 11) FDA will accept the total value of an entry required 
by CBP and, therefore, we have decided not to finalize Sec.  1.72(a)(3) 
in the proposed rule. ACE filers, however, will continue to have the 
option to submit the total value of the article(s) in each import line.
    d. FDA quantity. FDA proposed to require submission of the quantity 
of the FDA-regulated article(s) in each import line at the time of 
entry in ACE. FDA 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). 
We invited 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 
invited comment on whether the submission by an ACE filer of the FDA 
quantity of the article(s) in an import line 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.
    (Comment 12) We received several comments that this level of detail 
for quantity as an ``across-the-board'' data requirement would entail 
significant data input on the part of ACE filers and would not enhance 
admissibility review by FDA.
    (Response 12) In response to the comments we received we have 
decided not to finalize Sec.  1.72(a)(4) of the proposed rule which 
would have required FDA Quantity to be submitted in ACE at the time of 
entry. ACE filers, however, will still have the option of submitting 
this information.
    e. Entity contact information. In the proposed rule, we proposed to 
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. We invited 
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 invited 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.
    (Comment 13) We received several comments opposing this provision 
in the proposed rule. One commenter expressed concern that the proposed 
entity contact information was unnecessarily duplicative of the contact 
information the Agency was proposing to require for the importer of 
record. In addition, the commenter suggested that the email and phone 
of the importer of record should only be required at the header level, 
not for each import line.
    (Response 13) After review of the comments we have decided to 
require email address and phone for the importer of record only. The 
contact information for other parties to the shipment, which may 
expedite the entry review process, can be provided to the Agency at the 
option of the ACE filer.
    However, FDA does not determine what information is submitted at 
the header level, CBP makes those determinations. In addition, the 
burden to input the same data repeatedly on the same entry may be 
ameliorated through software programming.
5. Food
    Low-acid canned food. We proposed 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.
    (Comment 14) One comment asked us to clarify whether the FCE 
number, SID, and can dimensions or volume information will be required 
for LACF products that are imported for research and testing at 
laboratories, but that are not sold or marketed in the United States 
and are not intended for consumption in the United States.
    (Response 14) We do not believe we will generally need the FCE 
number, SID, and can dimensions or volume to effectively identify LACF 
products that are being imported or offered for import for laboratory 
analysis only, when such foods will not be consumed by humans or 
animals. Consequently, we have revised Sec.  1.73(b). Under the final 
rule, Sec.  1.73(b) provides that for an article of food that is a low-
acid canned food, the ACE filer must transmit at the time of filing 
entry the FCE number, SID, and can dimensions or volume, except that 
the ACE filer does not need to submit this information if the LACF 
product is for laboratory analysis only and will not be taste tested or 
otherwise ingested. Because we also do not believe we will generally 
need this information to effectively identify acidified food products 
in similar circumstances, we have made similar revisions to Sec.  
1.73(c). Specifically, we have revised Sec.  1.73(c) to provide that 
for an article of food that is an acidified food, the ACE filer must 
submit at the time of filing entry the FCE number, SID, and can 
dimensions or volume, except that the ACE filer does not need to submit 
this information if the acidified food product is for laboratory 
analysis only and will not be taste tested or otherwise ingested. We 
consider LACF and acidified food products to be for laboratory analysis 
only and not taste tested or otherwise ingested only if the entire 
article will be used completely in the laboratory analysis, destroyed 
by the laboratory analysis, or destroyed following a reasonable 
retention period after the laboratory analysis. No portions of the 
article can be taste tested or otherwise consumed by humans or animals. 
Consequently, if an LACF or acidified food product being imported or 
offered for import will be used for product promotional tasting or 
other types of research in which the food will be ingested, ACE filers 
are required to submit the FCE number, SID, and can dimensions or 
volume information in ACE at the time of entry. In order to allow ACE 
filers to identify in ACE any LACF or acidified foods that are for 
laboratory analysis which do not require submission of the FCE number, 
SID, and can dimension or volume, we intend to create an FDA product 
code that can be used to identify such foods. When ACE filers use this 
product code, they will not be required to submit the FCE number, SID, 
and can dimension or volume information in ACE at the time of entry. 
ACE filers should be aware that entries submitted in ACE that include 
this new product code will be subject to manual review for an 
admissibility determination by FDA.
6. Human Drugs
    Drug registration number. We proposed to require the submission of 
the Drug Registration Number in ACE at the time of entry. For purposes 
of this rule, the Drug Registration Number that would be submitted in 
ACE is the

[[Page 85862]]

unique facility identifier (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.
    (Comment 15) One commenter requested clarification regarding what 
number was required to be submitted for the Drug Registration Number.
    (Response 15) We published a final rule on August 31, 2016, 
regarding the requirements for Drug Registration and Listing (81 FR 
60170). FDA also provides guidance and instruction on establishment 
registration on our Web site (see, e.g., http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm)
7. Animal Drugs
    One comment supported inclusion of all of the proposed data 
elements to be submitted in ACE for importation of animal drugs, noting 
that all clearly impact admissibility. We are finalizing these 
provisions without change.
8. Medical Devices
    a. Registration and Listing. We proposed to 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.
    (Comment 16) One commenter stated that if there are different 
medical device registrants involved in the same entry, for example a 
foreign manufacturer and a foreign exporter, only one medical device 
registration and listing number should be required and this would be 
sufficient for FDA to make an admissibility decision.
    (Response 16) As explained in the preamble of the proposed rule, we 
have determined that the registration numbers of certain parties 
involved in the importation of a medical device (as well as the device 
listing number) may be material to our admissibility review. Submission 
of one party's registration number does not convey the registration 
information for another party involved in the importation of a medical 
device. Device foreign exporters can and do vary for medical devices 
manufactured at a particular firm and thus the information for all 
parties involved is needed at the time of entry. In addition, the time 
needed for an FDA reviewer to attempt to ascertain that information 
from our records or to request that information from the ACE filer or 
importer during a manual review can result in a lengthy delay in our 
admissibility determination. As such, we are not amending this 
requirement.
    b. Device listing number. We proposed to require that the Device 
Listing Number (LST) required under section 510 of the FD&C Act (21 
U.S.C. 360) and part 807 (21 CFR part 807) for each medical device 
identified in the entry, be submitted in ACE at the time of entry. 
Providing the LST will allow FDA to review important information during 
our initial admissibility review as the information for each listed 
medical device, as enumerated in Sec.  807.25(g), 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 an LST 
for each medical device associated with a particular registration.
    (Comment 17) Some commenters, while recognizing that the LST is a 
critical component of our admissibility review, felt that the LST 
should be made publicly available by FDA to ensure that ACE filers have 
this information to submit in ACE at the time of entry. The commenters 
asserted that, if LSTs are not publicly available (and thus potentially 
not readily available to ACE filers), this will cause unnecessary 
disruptions and additional caged shipments. They suggest that an 
alternative to making the LST publicly available is to continue to 
allow ``UNK'' to be submitted for the LST.
    (Response 17) We do not agree that FDA should make LSTs publicly 
available, and decline to make the requested revisions to the 
requirement to submit the LST (i.e., permit the use of ``UNK'' instead 
of the LST).
    As explained in the preamble to the proposed rule, in the device 
registration and listing process, FDA issues a registration number to 
the registrant that is publicly available and an LST for each device 
associated with the registration. Under section 510(f) of the FD&C Act, 
device listing information ``shall be exempt from such inspection 
unless the Secretary finds that such an exemption would be inconsistent 
with protection of the public health.'' Under Sec.  807.37(b)(2), FDA-
assigned LSTs are expressly excluded from public inspection or posting 
on the FDA Web site. In the Federal Register, FDA provided the 
following brief explanation for that exclusion: ``Listing numbers serve 
important governmental functions that may be harmed if they were made 
public'' (77 FR 45927 at 45930 (Aug. 2, 2012)).
    The confidentiality of LSTs serves important public health 
interests and helps to prevent the importation of substandard, 
mislabeled, and counterfeit medical devices. Some imports, e.g., 
counterfeit devices, may not be as safe and effective as devices 
approved or cleared for the U.S. market, may have been inadequately 
stored or maintained according to standards applicable outside the 
United States, or may be labeled or bear inadequate instructions for 
use in foreign markets. All of these issues can impact patient safety. 
FDA, therefore, will not be making LSTs publicly available as requested 
by commenters. Moreover, FDA will not be allowing ``UNK'' to be entered 
for LST as doing so would also increase the likelihood that counterfeit 
devices could enter the U.S. market and harm consumers. Although 
``UNK'' cannot be used in lieu of an LST, ``UNK'' is an option for the 
intended use code.
    ACE filers and importers in an established transactional or 
commercial relationship with the registrant will have access to the 
proprietary LST to submit in ACE at the time of entry.
    c. Investigational devices. We proposed to require that an ACE 
filer submit in ACE at the time of entry, in the data field for the 
investigational device exemption (IDE) number 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 (Sec.  1.76(b)).
    One comment supportive of this provision in the proposed rule was 
received and we are finalizing this provision without change.
    d. Impact resistant lens. We proposed to require for impact 
resistant lenses in eyeglasses and sunglasses an Affirmation of 
Compliance with the applicable requirements of Sec.  801.410 (21 CFR 
801.410) at the time of entry in ACE. 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 current Affirmation of Compliance Code is ``IRC.''
    (Comment 18) Two commenters requested that FDA clarify whether 
impact-resistant lenses imported for personal use require submission of 
the IRC Affirmation of Compliance Code at

[[Page 85863]]

the time of entry in ACE and whether an ACE filer must possess or 
submit the results of the ``drop fall'' test under Sec.  801.410 in 
order to submit that Affirmation of Compliance when applicable.
    (Response 18) For further relevant information on the importation 
of impact-resistant lenses for personal use, please see FDA's 
Supplemental Guide to the CATAIR (available at https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16), Chapter 9 of 
FDA's Regulatory Procedures Manual (available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf), and FDA's Impact-Resistant Lenses: Questions and 
Answers Guidance (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070755.pdf).
    As in the past, an ACE filer submitting ``IRC'' in ACE at the time 
of entry may rely on a drop-fall test certificate from the manufacturer 
or from a third party confirming to the ACE filer that the import 
satisfies the applicable requirements of Sec.  801.410.
    e. Investigational new drug application number. Proposed Sec.  
1.76(h), as explained in section V.C.5.h of the preamble of the 
Proposed Rule, would require the ACE filer, in the case of a 
combination product consisting of at least one medical device and one 
drug intended for human use and subject to an investigational new drug 
application (IND), to submit in ACE at the time of entry the IND number 
if FDA has designated the Center for Devices and Radiological Health 
(CDRH) as the center with primary jurisdiction for the premarket review 
and regulation of the combination product.
    (Comment 19) We received a comment asserting that a combination 
product consisting of at least one medical device and one 
investigational new drug where FDAs CDRH has been designated as the 
center with primary jurisdiction would rightfully be conducted under an 
IDE rather than an IND. The commenter expressed the opinion that the 
final rule should distinguish between a combination product approved 
under an IDE and a combination product approved under an IND.
    The commenter also observed that the proposed rule only addressed 
the importation of stand-alone medical devices not associated with a 
combination product and not the importation of devices that are 
included in combination products. Although medical device components of 
combination products may be integrated directly with a drug or biologic 
(21 CFR 3.2(e)(1)) or co-packaged with a drug or biologic (21 CFR 
3.2(e)(2)), the commenter stated, the proposed rule did not appear to 
discuss the importation of medical device components of drug- or 
biologic-primary mode of action combination products regulated by CDER 
or CBER and approved for marketing under a new drug application or a 
biologics license application.
    (Response 19) In light of this comment and based on further FDA 
review, FDA is not finalizing proposed Sec.  1.76(h). FDA believes that 
the other requirements in Sec. Sec.  1.74, 1.76, and 1.78 of the final 
rule, regarding products subject to the various types of applications, 
including investigational use applications, will suffice for 
combination products. If warranted, FDA will provide additional 
information on submitting this information for imported combination 
products in future guidance or other published materials.
    f. Convenience kit. We proposed to 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.''
    (Comment 20) One commenter was not sure that this data element will 
aid FDA in making admissibility decisions.
    (Response 20) The purpose of the convenience kit data element is to 
facilitate our admissibility review of medical device products approved 
or cleared for marketing as a kit by FDA, and to identify convenience 
kits that include recalled or unapproved medical devices. As explained 
in the preamble to the proposed rule, convenience kits imported or 
offered for import have been found at times to contain recalled or 
unapproved medical devices.
9. Radiation-Emitting Electronic Products
    We received no comments regarding this proposed provision, and we 
are finalizing it without change.
10. Biological Products, HCT/Ps, and Related Drugs and Medical Devices
    HCT/P 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)). 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, we proposed to 
require the submission of that registration number in ACE at the time 
of entry. The current Affirmation of Compliance Code for the HCT/P 
Registration Number is ``HRN''.
    We also proposed to require for HCT/Ps regulated solely under 
section 361 of the PHS Act and the regulations in part 1271 being 
imported or offered for import that are not otherwise exempt, that an 
Affirmation of Compliance with all applicable requirements of part 1271 
be submitted in ACE at the time of entry. The current Affirmation of 
Compliance Code for HCT/Ps to affirm compliance with part 1271 is 
``HCT''.
    (Comment 21) One comment agreed with most of the proposed 
requirements specific to biological products, HCT/Ps, and related drugs 
and medical devices, because the data clearly impacts admissibility. 
However, the comment questioned the need for the submission of HCT/P 
registration number and Affirmation of Compliance, and expressed a 
belief that this information is not applicable to admissibility.
    (Response 21) We acknowledge and appreciate the supportive 
comments. We disagree that the HCT/P registration number and 
Affirmation of Compliance are not applicable to our admissibility 
review. As noted in the proposed rule, establishments that manufacture 
HCT/Ps are required to register and list their HCT/Ps in accordance 
with part 1271, subpart B, unless they are subject to an exception 
under 21 CFR 1271.15. When an establishment successfully completes the 
required registration process, CBER assigns a unique registration 
number to that firm. FDA established these registration requirements, 
as well as other requirements in part 1271 (e.g., donor eligibility and 
current good tissue practice requirements) to prevent the introduction, 
transmission, or spread of communicable diseases by HCT/Ps. Requiring 
submission of the HCT/P registration number and Affirmation of 
Compliance helps to ensure compliance with the part 1271 requirements 
and is necessary to prevent the introduction, transmission, or spread 
of communicable diseases by HCT/Ps. Accordingly, we have finalized 
these requirements as proposed.
11. Tobacco Products
    a. Brand name. We proposed to require that the brand name for a 
tobacco product be submitted in ACE at the time of entry.

[[Page 85864]]

    (Comment 22) Several comments expressed concern that not all 
tobacco products have brand names.
    (Response 22) FDA recognizes that not all tobacco products have 
specific brand names. One key example is tobacco products for further 
manufacturing; another example is rolling papers that may not have a 
specific brand name, and only bear the manufacturer name. Thus, the 
final rule allows the ACE filer to submit the commercial name for the 
brand name in ACE if the product is unbranded. Further, in the final 
rule, this data element does not apply to products solely intended for 
further manufacturing or to investigational tobacco products.
    We note that, for purposes of this rule, brand name includes brand 
and sub-brand, for example: ``Acme Silver Box 100s,'' or ``Acme Little 
Cigars.''
    b. Name and address of the ACE filer. We proposed 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. We invited 
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 invited 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 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 and whether this could be sufficiently accomplished through 
proposed Sec.  1.72(b) or other means.
    We received a number of comments in opposition to this provision 
and after consideration of those comments we have decided not to 
finalize this provision.
12. Cosmetics
    We received no comment regarding proposed Sec.  1.80, other than 
the comments regarding Sec.  1.72 which are addressed previously in 
this document. Under proposed Sec.  1.80, we proposed to require that 
an ACE filer must submit the data specified in Sec.  1.72 at the time 
of filing entry in ACE. We are finalizing this provision without 
change.
13. Technical Amendments in the Proposed Rule
    a. Revisions to Sec. Sec.  1.83 and 1005.2. We proposed to revise 
Sec. Sec.  1.83 and 1005.2 to update the legal references in those 
sections in order to bring the definition of ``owner and consignee'' in 
section 801 of the FD&C Act 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.''
    (Comment 23) Several comments stated that redefining ``owner or 
consignee'' in Sec.  1.83 as ``the person eligible to make entry'' 
under the relevant provisions of the Tariff Act of 1930 was confusing 
because several persons are in fact eligible to become the ``importer 
of record'' and therefore to make entry. The commenters suggested that 
FDA define ``owner or consignee'' as the ``person who makes entry.''
    (Response 23) We agree and have revised the final rule to provide 
that the ``owner or consignee'' is defined as the ``person who makes 
entry'' under section 484 of the Tariff Act of 1930 (19 U.S.C. 1484). 
We removed the reference to section 485 of the Tariff Act of 1930 and 
19 U.S.C. 1485 as that section relates to the filing of a declaration 
by the importer of record. We made the same change to Sec.  1005.2.
    (Comment 24) One commenter suggested that we should adopt a 
definition of ``owner or consignee'' that is more consistent with the 
definition of ``importer'' adopted by FDA in other areas, for example, 
in our proposed rule on Foreign Supplier Verification Programs (FSVP).
    (Response 24) We decline to revise the rule as suggested in this 
comment. FDA adopted a definition of ``importer'' (Sec.  1.500) in our 
final FSVP rule published on November 27, 2015, that best serves the 
specific purposes of the FSVP requirements for importers of food for 
humans and animals, consistent with the statutory provisions the FSVP 
regulation must implement (80 FR 74226 at 74239). The purpose of the 
technical amendments to 21 CFR 1.83 and 1005.2 is to update the 
definition of ``owner or consignee'' to take into account revisions to 
the provisions of the Tariff Act of 1930 that were referenced in those 
regulations. Since the relevant person for these purposes is the 
``importer of record,'' FDA is defining ``owner or consignee'' as the 
``importer of record'' as that term is used in the Tariff Act of 1930.
    b. Electronic notification in Sec. Sec.  1.90 and 1.94. We proposed 
to revise Sec.  1.90 to allow FDA to provide notice of sampling 
directly rather than through the ``collector of customs'' which will 
normally happen through a secure electronic system. We also proposed to 
revise Sec.  1.94 to clarify that FDA can provide either written or 
electronic notification to an owner or consignee when FDA has 
determined that an article being imported or offered for import may be 
subject to refusal of admission and/or administrative destruction.
    (Comment 25) One commenter requested clarification regarding 
whether electronic notification will completely replace written or 
facsimile communication for these purposes.
    (Response 25) While our intent is to move to an automated, 
electronic process to expedite the notification process for both the 
Agency and the trade, FDA will still consider providing a written or 
facsimile notification if, under the circumstances, that is the most 
efficient and effective means to provide any such notification.
    (Comment 26) Several commenters supported FDA providing electronic 
notification of FDA actions but also requested that, in addition to 
providing notification to the owner or consignee, FDA provide 
electronic notification to other parties to the import.
    (Response 26) We decline to require that the Agency provide 
electronic notification under Sec.  1.94 to a person other than the 
owner or consignee which, pursuant to the revision to Sec.  1.83 in the 
final rule, is the importer of record. The purpose of Sec.  1.94 is to 
provide the importer of record of an FDA-regulated article being 
imported or offered for import into the United States with notice and 
opportunity to present testimony to the Agency prior to refusal of 
admission of an FDA-regulated article or prior to administrative 
destruction of certain refused drugs. There is only one importer of 
record and only that person has the right to notification and a hearing 
under Sec.  1.94.
14. Effective Date
    FDA proposed that the effective date of the final rule would be 30 
days after its publication in the Federal Register.
    (Comment 27) FDA received comments expressing concern about an 
effective date of 30 days after publication of the final rule, stating 
that this does not provide enough time for the necessary programming 
integration between ACE, FDA's OASIS system, the ACE filers' and the 
importers' systems. One comment suggested that the trade industry will 
resort to manual data entry while the data feeds are being developed. 
The comments suggested effective dates that ranged from 60 days to 180 
days after publication of the final rule. One comment suggested that 
FDA adopt a gradual and incremental approach to requiring submission of 
the data elements in the final rule.

[[Page 85865]]

    (Response 27) We decline to change the effective date of the final 
rule. As of July 23, 2016, ACE became the sole CBP-authorized EDI 
system for electronic entry and entry summary filings for importation 
of FDA-regulated products. The trade community has already transitioned 
to ACE and software is available in the marketplace that conforms with 
the requirements in FDA's Supplemental Guide to the CATAIR. FDA 
acknowledges that software vendors and the trade community may need to 
make a small number of alterations to their current programming to be 
consistent with the requirements in the final rule but 30 days should 
be sufficient for that purpose. FDA will shortly issue an updated FDA 
Supplemental Guide to assist software vendors and the trade industry 
with their programming needs.
15. Summary of Benefits and Costs
    (Comment 28) Several commenters emphasized that each additional 
data element that will be mandated by this FDA rulemaking represents 
real cost added to the entry process.
    (Response 28) We understand that each additional data element that 
firms will be required to submit in ACE at the time of entry represents 
added cost to the entry process. FDA has removed some of data elements 
from the final rule, which should lessen the burden.
    While FDA is requiring ACE filers to submit more data upfront, we 
believe that this may not necessarily end up being burdensome to the 
industry over time. The Agency believes that, after the initial 
adjustment stage, submission of the required data will result in faster 
processing time and cost savings to the industry and FDA.
    (Comment 29) Some commenters opined that FDA underestimated 
transition costs.
    (Response 29) In the Preliminary Regulatory Impact Analysis (PRIA) 
we recognized the uncertainty surrounding our cost estimates for 
scenario 1, including transition cost estimates in the first year. We 
requested comments to provide additional data and information to 
improve these cost estimates. We did not receive any additional 
information that would help improve our transition cost estimates.
    (Comment 30) Several commenters complained that the PGA message set 
in ACE often experiences system outages, failures to perform necessary 
functions, and that the time that FDA takes to process entries has 
already doubled for some ACE filers. They assert that this causes 
``down time'' and significant added costs to the trade industry.
    (Response 30) System outages and failures to perform necessary 
functions should be in part attributed to ACE implementation by CBP. In 
order to address these comments and also Comment 27 about alleging 
underestimated transition costs, we have revised our ranges for first 
year estimates and doubled the time necessary for filing entries in ACE 
for FDA-regulated products during the initial adjustment period.
    (Comment 31) Some commenters said that FDA dismissed additional 
costs of reprogramming caused by further changes to the CATAIR.
    (Response 31) In the PRIA (page 22), we stated that because the 
costs of updating the existing software or purchasing a new one would 
fall under the cost of CBP action of implementing ACE, we do not 
include these transition costs in our economic impact analysis. FDA 
expects that software updates occur regularly as a part of ongoing 
business practice and the price of new off-the-shelf software would 
incorporate all ACE requirements, including FDA PGA message set 
requirements. The commenters did not provide any new information that 
can be used to estimate the share of reprogramming costs that should be 
attributed only to FDA rulemaking and not the entire CBP action of 
implementing ACE.
    (Comment 32) One commenter stated that only importers with large 
budgets can generate, maintain, and provide data electronically.
    (Response 32) FDA acknowledges this viewpoint, but because most 
importers including small businesses typically hire customs brokers to 
electronically file entries for them in ACE, FDA expects that 
reprogramming costs would fall on customs brokers as a part of costs of 
doing business related to imports. As stated previously, approximately 
98 percent of importers use customs brokers to file their entries of 
FDA-regulated products impacted by the final rule.
    (Comment 33) Some commenters stated that the cost to file FDA 
entries in ACE increased by 8 minutes (by over 50 percent) and that 40 
percent more staffing is required because, compared to ACS, FDA data 
requirements are different in ACE.
    (Response 33) We incorporated this new information from the 
industry into our ranges of cost and time estimates for the final rule. 
That being said, the 50 percent time increase to process an FDA entry 
in ACE and the estimated 40 percent labor cost increase asserted by 
commenters could be caused by: (1) The overall switch from ACS to ACE 
(which should be attributed to the cost of ACE implementation by CBP) 
and (2) the additional time required for filing FDA data elements that 
are required in the final rule (which should be attributed to the cost 
of the FDA rulemaking; that is unless a filer already voluntarily 
provided these data elements to FDA in ACS on a regular basis). Only 
the costs caused by (2) should be attributed to FDA rulemaking (see 
scenario 1 in the PRIA).
    Furthermore, it is not clear from the comment whether the 50 
percent time increase and the 40 percent staffing cost increase are the 
same across the entire industry. In the PRIA, FDA estimated that for 
each FDA-regulated unique product-manufacturer import line, it would 
take up to 8 additional minutes to prepare and look up information 
mandated by the proposed rule and up to 4 additional minutes (5 minutes 
in the first year) to file that information in ACE, for a total of up 
to 12 minutes per unique import line (up to 13 minutes in the first 
year). Therefore, an 8 minute increase (= 24 minutes minus 16 minutes) 
per import line described by these comments is a possible outcome, 
especially in the initial adjustment stage, that is consistent with our 
analysis in the PRIA.
D. Technical Amendments in the Final Rule
    We made three technical changes to the proposed rule due to our 
issuance of a final rule on August 31, 2016, regarding the requirements 
for drug registration and listing (81 FR 60170) that was published 
after our Notice of Proposed Rulemaking for this rule (published on 
July 1, 2016 (81 FR 43155)).
    Under Sec. Sec.  1.74(a), 1.75(a) and 1.78(d) of our proposed rule, 
an ACE filer would be required to submit the Drug Registration Number 
and Drug Listing Number in ACE at the time of entry for an article 
which is a drug if it is from a foreign establishment where the drug 
was manufactured, prepared, propagated, compounded, or processed before 
being imported or offered for import into the United States that is 
required to be registered and the drug to be listed under section 510 
of the FD&C Act. The final drug registration and listing rule amended 
21 CFR parts 207 and 607 which provide the regulatory requirements for 
drug registration and listing including who must register their 
establishments and list their drugs annually with the FDA.
    In this final rule, we have not changed the requirement that ACE 
filers submit a Drug Registration Number and a Drug Listing Number in 
ACE at the time of entry except that, as discussed earlier in

[[Page 85866]]

this document, we have removed the requirement for submission of a drug 
listing number from Sec.  1.78(d) for CBER-regulated drugs. For 
purposes of clarity regarding the underlying requirement of who must 
register and list their drugs with FDA, we have added a reference to 
part 207 in Sec.  1.74(a) for human drugs, Sec.  1.75(a) for animal 
drugs, and Sec.  1.78(d) for those drugs regulated by CBER. Because the 
drugs regulated by CBER include blood and blood products we have also 
added a reference in Sec.  1.78(d) to part 607, which contains the 
registration and listing requirements for blood and blood products.

VI. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. We believe that this final rule 
is not a significant regulatory action as defined by Executive Order 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. By requiring import entry filers to submit data elements 
mandated by this final rule into ACE and updating certain sections of 
21 CFR Chapter I, we intend to streamline our import entry 
admissibility review and reduce ambiguity about the import process. 
Small businesses will be affected by this final rule in the same way as 
non-small businesses. Because the burden of switching from ACS to ACE 
is already covered by CBP's ACE regulation, for those small business 
filers that choose to continue filing electronically (and, therefore, 
must use ACE), we believe that providing several additional data 
elements to FDA via ACE in exchange for a more streamlined process and 
potentially receiving an import admissibility decision faster would not 
cause a significant impact. These small businesses would bear the costs 
of this rule, but would also enjoy most of the benefits. We therefore 
certify that the final rule will not have a significant economic impact 
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

B. Summary of Benefits and Costs of the Final Rule

    FDA is issuing a final rule to establish requirements for the 
electronic filing of import entries in ACE. The final rule will require 
that certain data elements material to our admissibility review be 
submitted to the FDA via ACE as part of an electronic import entry. 
This final regulation will 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 will require that certain key data be submitted as a part of the 
import entry filing in ACE. The final 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 administrative 
destruction, to allow for electronic notification by FDA. The rule also 
clarifies that importers of record of human cells, tissues, or cellular 
or tissue-based products (HCT/Ps) that are regulated solely under 
section 361 of the PHS Act and part 1271, unless exempted, will be 
required to submit the applicable data elements included in the final 
rule in ACE at the time of entry.
    The estimated costs of the final rule--and the cost savings--stem 
from the mandatory information that will be submitted and collected 
under the ACE system. In the baseline scenario for our estimates of 
these costs, we assumed that without this final regulation the 
information would be collected by ACE only if and to the extent that it 
is voluntarily provided by filers like under the former ACS system 
(table 2). Annualized over a 20-year horizon, the costs of complying 
with this final regulation are between $27.7 million and $69.1 million 
per year with a 3 percent discount rate; these costs are between $26.8 
million and $66.7 million per year with a 7 percent discount rate 
(table 2). The total annualized cost savings to the entire society 
cannot be fully quantified because of the lack of certain data 
currently available to the Agency. Partially quantifiable cost savings 
are estimated to range from $2.6 million to $43.4 million with a 3 
percent discount rate; these partially quantifiable benefits are 
estimated to range from $2.6 million to $43.4 million with a 7 percent 
discount rate (table 2). These benefits, in terms of cost savings, to 
both FDA and the industry that we are able to quantify will 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.
    Cost savings to both the industry and FDA that we are unable to 
quantify will potentially arise from the reduced time of import entry 
processing and fewer imported products being held, and a shorter 
timeframe between the time of entry submission and a final 
admissibility decision by FDA as a result of increased efficiency in 
FDA's imports admissibility process. Other potential benefits of this 
final rule that we are unable to quantify will 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 will arise because by revising certain 
sections of 21 CFR Chapter I the Agency would provide more clarity to 
the industry about certain aspects of the overall process of import 
admissibility for FDA-regulated products.

[[Page 85867]]



                       Table 2--Total Annualized Costs and Benefits of the Final Rule \1\
----------------------------------------------------------------------------------------------------------------
                                                                              Total benefits
     Discount rate (percent)         Total annualized   --------------------------------------------------------
                                           costs             Cost savings      Other benefits  (not quantified)
----------------------------------------------------------------------------------------------------------------
3................................  $46.7 million (range  $21.0 million        Potential time reduction for
                                    $27.7 million to      (range $2.6 to       processing import entry
                                    $69.1 million).       $43.4 million).      declarations by FDA; potential
                                                                               increase in predictability of the
                                                                               import process; potentially
                                                                               shorter timeframes for imported
                                                                               products being held pending a
                                                                               final admissibility decision;
                                                                               more efficient use of FDA's
                                                                               internal resources; potentially
                                                                               fewer recalls of imported
                                                                               products; reduction of
                                                                               counterfeit and misbranded
                                                                               imports on the U.S. market;
                                                                               increased efficiency of the
                                                                               overall import process due to
                                                                               decreased ambiguity because of a
                                                                               better defined the owner or
                                                                               consignee term, the
                                                                               clarifications related to notice
                                                                               of sampling, and allowing for
                                                                               electronic notice of certain FDA
                                                                               actions related to hearing on
                                                                               refusal of admission of imports
                                                                               and destruction of drugs.
7................................  $45.1 million (range  $21.0 million        Potential time reduction for
                                    $26.8 million to      (range $2.6          processing import entry
                                    $66.7 million).       million to $43.4     declarations by FDA; potential
                                                          million).            increase in predictability of the
                                                                               import process; potentially
                                                                               shorter timeframes for imported
                                                                               products being held pending a
                                                                               final admissibility decision;
                                                                               more efficient use of FDA's
                                                                               internal resources; potentially
                                                                               fewer recalls of imported
                                                                               products; reduction of
                                                                               counterfeit and misbranded
                                                                               imports on the U.S. market;
                                                                               increased efficiency of the
                                                                               overall import process due to
                                                                               decreased ambiguity because of a
                                                                               better defined the owner or
                                                                               consignee term, the
                                                                               clarifications related to notice
                                                                               of sampling, and allowing for
                                                                               electronic notice of certain FDA
                                                                               actions related to hearing on
                                                                               refusal of admission of imports
                                                                               and destruction of drugs.
----------------------------------------------------------------------------------------------------------------
\1\ We generated upper and lower bounds using Monte Carlo simulations.

    The Economic Analysis of Impacts of the final 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 final rule 
(Docket No. FDA-2016-N-1487) at https://www.regulations.gov and is also 
available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 1).

VII. Analysis of Environmental Impact

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

VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the annual reporting burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering the data needed, and completing and reviewing each collection 
of information.

    Title: Importer's Entry Notice.
    Description: We are issuing a regulation that requires ACE filers 
to submit certain information in ACE or any other CBP-authorized EDI 
system related to FDA-regulated products they are importing or offering 
for import into the United States. The information collection 
provisions of the rule, specifically the amendment of 21 CFR part 1 by 
adding Sec. Sec.  1.70 through 1.81, will allow us to require ACE 
filers to submit in ACE at the time of entry important and useful 
information about FDA-regulated products being imported or offered for 
import into the United States, beyond the information that was 
submitted previously. The information collection provisions of this 
rule will facilitate an effective and efficient admissibility review of 
FDA-regulated products being imported or offered for import into the 
United States, and protect public health by allowing us to focus our 
limited resources on those FDA-regulated products being imported or 
offered for import that may be associated with a greater public health 
risk.
    The authority to issue this 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).
    To account for the information collection provisions of the rule, 
we are amending the information collection currently approved under OMB 
control number 0910-0046. The information collection approved under OMB 
control number 0910-0046 has historically accounted for the collection 
of information from entry filers for FDA-regulated products being 
imported or offered for import into the United States. The vast 
majority of this information was submitted by entry filers 
electronically in ACS. On July 23, 2016, ACE replaced ACS as the sole 
EDI system authorized by CBP for submission of electronic entry and 
entry summary information for FDA-regulated products being imported, or 
offered for import, into the United States. Although much of the 
information collection pursuant to this rule was previously collected 
from entry filers for FDA-regulated products being imported or offered 
for import into the United States, and was approved for collection 
under OMB control number 0910-0046, this rule requires ACE filers to 
submit certain information in addition to what entry filers were 
previously submitting.
    The annual recordkeeping requirements for this collection are 
accounted for by the ``Customs Modernization Act Recordkeeping 
Requirements'' information collection approved by OMB under OMB control 
number 1651-0076.
    Of note, in addition to accounting for the information collection 
pursuant to

[[Page 85868]]

the rule, we are also adjusting the existing estimated burden approved 
under OMB control number 0910-0046 upwards to account for an increase 
in FDA-regulated import lines, to account for the submission of 
intended use information, which had previously been submitted by entry 
filers but not accounted for under an approved FDA information 
collection, and to correct for our previous underestimates of the 
number of FDA-regulated entries. Accordingly, we are adjusting upward 
the estimated existing burden under OMB control number 0910-0046 
(without yet accounting for the information collection of the rule) to 
1,186,464 hours.
    The information collection provisions of this rule are in 
Sec. Sec.  1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 1.80. 
Section 1.72 requires certain product identifying data elements and 
certain entity identifying data elements to be submitted in ACE at the 
time of entry for food contact substances, drugs, biological products, 
HCT/Ps, medical devices, radiation-emitting electronic products, 
cosmetics, and tobacco products. Sections 1.73 through 1.80 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. Sections 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 
1.80 apply, respectively, to certain food products (food contact 
substances, low-acid canned food, and acidified food); 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.
    Although we did not receive any comments specifically relating to 
the information collection burden pursuant to the information 
collection provisions of the rule, we did receive comments relating to 
the rule and the Regulatory Impact Analysis (RIA). We have revised our 
information collection burden estimates as appropriate to reflect those 
revisions we made to the rule and the RIA.
    Description of Respondents: The primary respondents to this 
collection of information are domestic and foreign importers of FDA-
regulated articles being imported or offered for import into the United 
States and ACE filers. An importer of record may be the owner or 
purchaser of the article being imported or 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 only one importer of record per entry.
    Using the estimates in the RIA for the rule, we estimate there are 
about 41,703 owners or purchasers of FDA-regulated commodities who seek 
to import FDA-regulated articles (``importers'') into the United States 
on an annual basis. We have estimated that 97.7 percent of these 
importers will use customs brokers to file their import entries in ACE, 
and the other 2.3 percent will file their import entries themselves. We 
thereby estimate that there are a total of 3,667 entry filers, which 
includes the 959 owners or purchasers of the article who will file 
their own import entry in ACE (= 41,703 importers x (100 - 97.7) 
percent).
    Reporting Burden: We have used the relevant assumptions and 
estimates in Option 1 of the RIA for this rule to estimate the annual 
information collection burden pursuant to the rule. Option 1 of the RIA 
is the option which reflects the rule.
    Of the data elements that the rule requires ACE filers to submit in 
ACE at the time of entry, all except for four, were previously 
collected from entry filers (as either required or optional 
submissions, depending on the data element) and have been accounted for 
by the previously approved information collection under OMB control 
number 0910-0046. One of those four data elements, intended use 
information, had been collected from entry filers but not accounted for 
under an OMB approved information collection. Under the rule, intended 
use information is collected in ACE in the form of an IUC, instead of 
in the form of a text input into the CBP-required product description 
field, as it had been collected previously in ACS. The rule provides 
for the collection of three data elements to be collected in ACE that 
are new, i.e., we have not previously collected the information from 
entry filers. One of the three new data elements is required by Sec.  
1.72 which applies to food contact substances, drugs, biological 
products, HCT/Ps, medical devices, radiation-emitting electronic 
products, cosmetics, and tobacco products, and is the telephone and 
email address for the importer of record, which will help to facilitate 
electronic notices provided by FDA under Sec.  1.94 for certain FDA 
actions. One of the other two new data elements is required by Sec.  
1.78, which applies only to biological products, HCT/Ps, and related 
drugs and medical devices, and is the product name, and the other is 
required by Sec.  1.79, which applies only to tobacco products, and is 
the brand name of the tobacco product.
    Although just three data elements collected pursuant to the rule 
are new, we expect that filers who were not submitting certain 
previously optional data elements in ACS that the rule now requires ACE 
filers to submit in ACE will begin submitting those data elements in 
order to comply with the rule. We expect this to be the primary cause 
of the increased reporting burden pursuant to the rule. Notably, 
however, the submission rates of many of these data elements in ACS 
were quite high, although their submission varied by commodity. For 
example, in 2015 approximately 98 percent of medical device lines were 
submitted in ACS with at least one Affirmation of Compliance. Based on 
2014 and 2015 data, we estimate that medical device lines will make up 
approximately seventy percent of all import lines that will be impacted 
by the rule. On the other hand, for example, in 2015 only 24 percent of 
animal drug import lines were submitted in ACS with at least one 
Affirmation of Compliance, although, based on 2014 and 2015 data, we 
estimate that animal drugs will make up less than 0.5 percent of all 
import lines that will be affected by the rule.
    Using the estimates in the RIA for the rule, we have estimated that 
the rule will impact 23,119,465 import lines in the first year. The 
rule will not impact import lines of foods other than acidified foods, 
low-acid canned foods, and food contact substances. We have also 
estimated that 504,768 of affected import lines in the first year 
represent unique product-manufacturer combinations. We have estimated 
that the number of impacted import lines 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 rule, we have 
annualized those 3.3 percent per year increases for 3 years.
    Other key assumptions in the RIA (Option 1) for the rule that 
affect our estimate of the additional annual reporting burden are:
     Respondents (ACE filers) will have to become aware of the 
rule's requirements, which will 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 will require an average of 30 minutes.
     Respondents (owners or purchasers) will require an 
administrative worker to locate, gather, and prepare the additional 
information required by this

[[Page 85869]]

rule for each unique product-manufacturer import line; and this will 
require on average about 2.333 minutes (0.03889 hours) per line.
     Respondents (ACE filers) will require an administrative 
worker to submit the applicable data elements required in the final 
rule and Respondents (ACE filers) may also require an owner or manager 
to check if the information is correct, or alternatively, the 
administrative worker to quality check their submission using software 
that is connected to ACE and this will require about 1.166667 minutes 
(approximately 0.01944 hours) per line on average.
     It will take respondents about 25 percent more time in the 
first year for an administrative worker to complete each import line 
and quality check the information, because the respondent will have to 
adjust to the new system and data elements.
    We expect the annual recurring reporting burden for the information 
collection pursuant to this rule to be as follows:

                       Table 3--Estimated Additional Annual Recurring Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Preparing the required                  41,703            12.5         521,609  0.03889 (2.333            20,285
 information (applies to                                                         minutes).
 unique lines only).
Quality checks and data                  3,667           6,515      23,890,800  0.01944 (1.1667          464,543
 submission into ACE.                                                            minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         484,828
----------------------------------------------------------------------------------------------------------------
\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 will 
result from this rule to be as follows:

                                Table 4--Estimated One Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Review and familiarization               3,667               1           3,667  0.5 (30 minutes)           1,834
 with the rule.
First year adjusting to new              3,667           6,305      23,119,465  0.00486 (0.29            112,386
 requirements that will result                                                   minutes).
 in an average of 25 percent
 more time for quality checks
 and submission into ACE.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         114,220
----------------------------------------------------------------------------------------------------------------
\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 rule will be 599,048 hours in the first year (484,828 
recurring hours + 114,220 one-time hours) and 484,828 hours recurring 
after the first year.
    Pursuant to our revision of the information collection under OMB 
control number 0910-0046, which includes adjustment of the existing 
burden and amendment to account for the information collection 
provisions of the rule, the total reporting burden is 1,785,712 hours 
in the first year (= 1,186,464 adjusted existing burden hours + 484,828 
recurring hours pursuant to the rule + 114,220 one-time hours pursuant 
to the rule) and 1,671,292 hours annually after the first year (= 
1,186,464 adjusted existing burden hours + 484,828 recurring hours 
pursuant to the rule).
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. FDA will publish a subsequent notice 
in the Federal Register announcing OMB's decision to approve, modify, 
or disapprove the information collection provisions in this final rule. 
An Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

IX. Federalism

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

X. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://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. Final Regulatory Impact Analysis, Final Regulatory Flexibility 
Analysis, and Final Unfunded Mandates Reform Act Analysis for 
Submission of Food and Drug Administration Import Data in the Automated 
Commercial Environment, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#

[[Page 85870]]

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, 21 CFR parts 1, 1005, and 1271 are 
amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 
350d, 350e, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 
371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 
393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Public Law 107-188, 116 
Stat. 594, 668-69; Public Law 111-353, 124 Stat. 3885, 3889.


0
2. Add subpart D, consisting of Sec. Sec.  1.70 through 1.81, 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.
1.81 Rejection of entry.

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, 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 U.S. 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.
    Cosmetic means a cosmetic as defined in section 201(i) of the 
Federal Food, Drug, and Cosmetic Act.
    CBP or U.S. Customs and Border Protection means the Federal Agency 
that is primarily responsible for maintaining the integrity of the 
borders and ports of entry of 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.
    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 information for food contact substances, 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 be consistent with 
the invoice description of the product.
    (3) The Full Intended Use Code.
    (b) Importer of record contact information, which is the telephone 
and email address of the importer of record.


Sec.  1.73  Food.

    (a) Food contact substances. An ACE filer must submit the 
information specified in Sec.  1.72 at the time of filing entry in ACE 
for food that is a food contact substance.
    (b) 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, except that the ACE filer does not need to 
submit this information in ACE at the time of entry if the article is 
being imported or offered for import for laboratory analysis only and 
will not be taste tested or otherwise ingested.
    (c) Acidified food. For an article of food that is an acidified 
food, the ACE filer must submit at the time of filing

[[Page 85871]]

entry the Food Canning Establishment Number and the Submission 
Identifier, and can dimensions or volume, except that the ACE filer 
does not need to submit this information in ACE at the time of entry if 
the article is being imported or offered for import for laboratory 
analysis only and will not be taste tested or otherwise ingested.


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 in ACE 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 if 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 is required to register and list the 
drug under part 207 of this chapter. For the purposes of this section, 
the Drug Registration Number that must be submitted at the time of 
entry 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 in ACE for animal drugs:
    (a) Registration and listing. For a drug intended for animal use, 
the Drug Registration Number and the Drug Listing Number if the foreign 
establishment where the drug was manufactured, prepared, propagated, 
compounded, or processed before being imported or offered for import 
into the United States is required to register and list the drug under 
part 207 of this chapter. For the purposes of this section, the Drug 
Registration Number that must be submitted in ACE 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 in ACE 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 ``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 premarket 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

[[Page 85872]]

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.


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 filing 
entry in ACE 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. For a drug intended for human use, the Drug 
Registration Number if 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 is required 
to register the drug under part 207 or part 607 of this chapter as 
applicable. For the purposes of this section, the Drug Registration 
Number that must be submitted at the time of entry 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.
    (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, ``NSR'' to be entered in the Affirmation of Compliance 
for the ``investigational device exemption'' that identifies the device 
as being used in a nonsignificant risk or exempt 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 premarket 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.
    (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 an article that is a tobacco product that is 
being imported or offered for import. If the article does not have a 
specific brand name, the ACE filer must submit a commercial name for 
the brand name. This data element is not applicable to those products 
solely intended either for further manufacturing or as investigational 
tobacco products.
    (b) [Reserved]


Sec.  1.80  Cosmetics.

    An ACE filer must submit the data specified in Sec.  1.72 at the 
time of filing entry in ACE.


Sec.  1.81   Rejection of entry filing.

    FDA may reject an entry filing for failure to provide complete and 
accurate information that is required pursuant to this subpart.

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 who makes entry 
under the provisions of section 484 of the Tariff Act of 1930, as 
amended (19 U.S.C. 1484), namely, the ``importer of record.''
* * * * *

0
4. Revise Sec.  1.90 to read as follows:

[[Page 85873]]

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 of refusal of admission and 
the notice of 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 who makes entry under 
the provisions of section 484 of the Tariff Act of 1930, as amended (19 
U.S.C. 1484), 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 U.S. Customs and Border Protection Agency as required in part 1, 
subpart D of this chapter, for FDA to make an admissibility decision.
* * * * *

    Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and Drug Administration.

    In concurrence with FDA:

    Dated: November 21, 2016.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy), Department 
of the Treasury.
[FR Doc. 2016-28582 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P


