81_FR_43282 81 FR 43155 - Submission of Food and Drug Administration Import Data in the Automated Commercial Environment

81 FR 43155 - Submission of Food and Drug Administration Import Data in the Automated Commercial Environment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 127 (July 1, 2016)

Page Range43155-43178
FR Document2016-15684

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

Federal Register, Volume 81 Issue 127 (Friday, July 1, 2016)
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Proposed Rules]
[Pages 43155-43178]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15684]



[[Page 43155]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 1005, and 1271

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-1487 for ``Submission of FDA Import Data into the Automated 
Commercial Environment.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 to the Office of Management and Budget 
(OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
[email protected]. All comments should be identified with the 
title, ``Submission of FDA Import Data into the Automated Commercial 
Environment.''

FOR FURTHER INFORMATION CONTACT: Ann M. Metayer, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4338, Silver Spring, MD 20993-0002, 301-796-3324, 
[email protected].
    With regard to the information collection: Jonnalynn Capezzuto, 
Office of Operations, Food and Drug Administration, 8455 Colesville 
Rd., Rm. 14526, Silver Spring, MD 20993-0002, 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule

[[Page 43156]]

    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
IV. Legal Authority
V. Description of the Proposed Rule
    A. Scope/Applicability
    B. Definitions
    C. Data Elements that Must Be Submitted in ACE for FDA-Regulated 
Products
    D. Technical Amendments
VI. Proposed Effective Date
VII. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits and Costs of the Proposed Rule
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. References

I. Executive Summary

A. Purpose of the Proposed Rule

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

B. Summary of the Major Provisions of the Proposed Rule

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

C. Legal Authority

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

D. Costs and Benefits

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

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

------------------------------------------------------------------------
       Abbreviation/Acronym                     What it means
------------------------------------------------------------------------
ACE...............................  Automated Commercial Environment or
                                     any other CBP-authorized EDI
                                     system.
ACE filer.........................  The person who is authorized to
                                     submit an electronic import entry
                                     for an FDA-regulated product in
                                     ACE.
ACS...............................  Automated Commercial System.
Agency............................  U.S. Food and Drug Administration.
CBP...............................  U.S. Customs and Border Protection
                                     Agency.
CBER..............................  FDA Center for Biologics Evaluation
                                     and Research.
CDER..............................  FDA Center for Drug Evaluation and
                                     Research.
CDRH..............................  FDA Center for Devices and
                                     Radiological Health.
CTP...............................  FDA Center for Tobacco Products.
CVM...............................  FDA Center for Veterinary Medicine.
EDI...............................  Electronic Data Interchange.
FDA...............................  U.S. Food and Drug Administration.
FDASIA............................  Food and Drug Administration Safety
                                     and Innovation Act.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
ITDS..............................  International Trade Data System.
OASIS.............................  FDA Operational and Administrative
                                     System for Import Support.
PGA...............................  Partner Government Agency in ACE.
PHS Act...........................  Public Health Service Act.
We, Our, Us.......................  U.S. Food and Drug Administration.
------------------------------------------------------------------------

III. Background

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

[[Page 43157]]

importation of FDA-regulated products has posed challenges to FDA 
including enforcement of sections 536 and 801 of the FD&C Act and 
sections 351, 361, and 368 of the PHS Act.
    Section 484 of the Tariff Act of 1930 as amended (19 U.S.C. 1484) 
established the requirement for importers of record to make entry for 
merchandise imported into the customs territory of the United States. 
When goods are imported into the United States they must be entered at 
one of the CBP ports. The term entry refers to the information or 
documentation that an importer of record must file with CBP. An import 
line is each portion of an import entry that is listed as a separate 
item on an entry document.
    An importer of record is the owner or purchaser of the article 
being offered for import or a customs broker licensed by CBP under 19 
U.S.C. 1641 who has been designated by the owner, purchaser, or 
consignee to file the import entry. There is one importer of record per 
entry. Approximately 98 percent of all entries containing FDA-regulated 
products subject to the proposed rule are filed by customs brokers.
    In December 1993, the Customs Modernization Act (Title VI of the 
North American Free Trade Agreement Implementation Act (Pub. L. 103-
182)) was enacted. A prominent feature of the Customs Modernization Act 
is the legal requirement that importers of record exercise reasonable 
care when filing entries (19 U.S.C. 1484). Reasonable care requires 
that CBP be provided with the accurate and complete information or 
documentation deemed necessary by CBP to determine whether all legal 
requirements for admissibility of that article have been met.
    The Customs Modernization Act also included the development of ACE, 
the planned successor to ACS which has been the electronic system used 
by CBP to track, control, and process all commercial goods imported 
into the United States for decades. ACE is intended to streamline 
business processes, facilitate growth in trade, ensure cargo security, 
and foster participation in global commerce while ensuring compliance 
with U.S. laws and regulations.
    The ITDS, as described in section 405 of the Security and 
Accountability for Every Port Act of 2006 (SAFE Port Act) (Pub. L. 109-
347), was established to modernize and simplify the way in which PGAs, 
including FDA, interact with importers by creating a ``single window'' 
through which industry will transmit the data elements required for 
importation or exportation of cargo. The purpose of ITDS is to 
eliminate redundant filing requirements, to efficiently regulate the 
flow of commerce, and to effectively enforce laws and regulations 
relating to international trade, by establishing a single portal 
system, operated by CBP, for the collection and distribution of 
standard electronic import and export data required by all PGAs (19 
U.S.C. 1411(d)(1)(B)). CBP has designed ACE to provide that ``single 
window'' for the filing of entries. Over the last several years, CBP 
has tested ACE and provided significant public outreach to ensure that 
the trade community is fully aware of the transition from ACS to ACE 
(81 FR 10264, February 29, 2016). FDA has actively participated as a 
PGA in the development of ITDS and ACE.
    On February 19, 2014, President Obama issued an Executive Order, 
Streamlining the Export/Import Process for America's Businesses 
(Executive Order 13659), requiring that, by December 31, 2016, PGAs 
have the capabilities, agreements, and other requirements in place to 
utilize the ITDS and supporting systems, such as ACE as the primary 
means of receipt of the data and other relevant information necessary 
for the release and clearance of imported goods. Executive Order 13659 
envisions a simpler, more efficient automated system for trade use for 
the benefit of both the trade industry and PGAs. ACE is expected to 
become the sole EDI system authorized by CBP for processing electronic 
entry and entry summary filings; ACS incrementally is being 
decommissioned by CBP for those functions.
    While primary responsibility for administering U.S. laws relating 
to imports is exercised by CBP, FDA is responsible for determining 
whether or not an FDA-regulated article being imported or offered for 
import is in compliance with the laws enforced by FDA. The discharge of 
this joint responsibility has involved close coordination and 
cooperation between FDA and CBP for such imports.
    FDA receives notice from CBP of the arrival at each U.S. port of 
entry (sea, land, rail, and air) where FDA-regulated products are 
imported, of each shipment containing an FDA-regulated product. The PGA 
Message Set in ACE for FDA-regulated products contains the data that 
assists FDA in determining the admissibility of those products under 
FDA authorities. This data is transmitted to CBP by an ACE filer 
through the Automated Broker Interface (ABI), which permits a 
participant to file import data electronically in ACE. ABI is the 
primary mechanism for data submission in ACS, and will continue to be 
used in ACE. After the data is submitted through ABI in ACE, it is 
validated by CBP and made available to FDA. Transmission of data via 
ABI enables more effective enforcement and faster release decisions, as 
well as more certainty for the importer in determining logistics of 
cargo delivery (81 FR 10264). ABI is available to brokers, importers, 
and independent service bureaus, and currently over 96 percent of all 
entries filed with CBP in ACS are filed through ABI (Ref. 1).
    If a required data element is not submitted in ACE, CBP cannot 
process the entry. The ACE filer will then receive an electronic 
message indicating that a particular data element was missing and that 
the entry will not be processed without submission of that data 
element. The ACE filer may refile the entry and it will be processed by 
CBP if all of the required elements are submitted.
    Because, under ACE, CBP will relay the data in the PGA Message Set 
to FDA using an electronic interface with OASIS, the ACE filer will 
only need to submit this entry information once provided that the 
information submitted in ACE is accurate. ACE entries will be 
electronically screened in OASIS against criteria developed by FDA, as 
they were in ACS. FDA's Predictive Risk-based Evaluation for Dynamic 
Import Compliance Targeting (PREDICT) is a risk-based electronic 
screening tool for OASIS that performs this initial electronic 
screening to assist FDA entry reviewers by evaluating the potential 
risks associated with each article, and identifying those articles that 
may present a higher public health risk for further examination by FDA.
    OASIS expedites the clearance of FDA-regulated products that 
present a low public health risk but only if the importer of record 
provides accurate and complete import information. If the FDA 
electronic screening evaluation of the potential public health risk is 
determined to be low, OASIS will transmit a message back through the 
FDA/CBP interface that indicates an article being imported or offered 
for import ``May Proceed'' into U.S. commerce, barring any alternate 
determination by CBP. A ``May Proceed'' message does not constitute a 
determination by FDA about the article's compliance status, and it does 
not preclude FDA action at a later time. If the FDA electronic review 
determines that further evaluation by FDA is necessary, FDA personnel 
will manually review the entry information submitted by the ACE filer 
and may request additional information to make an admissibility 
determination and/or may

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examine or sample the FDA-regulated article.
    CBP collects in ACS four data elements to assist FDA in making 
admissibility decisions for FDA-regulated products: (1) The complete 
FDA Product Code; (2) FDA country of production; (3) FDA manufacturer 
and shipper; and (4) the ultimate consignee. Under the proposed rule, 
two of these data elements would be mandatory submissions at the time 
of entry in ACE or any other CBP-authorized EDI system: The complete 
FDA product code and FDA Country of Production.
    In ACS, filers are also able to make optional submissions of 
certain information such as Affirmations of Compliance regarding 
requirements related to the FDA-regulated product. By submitting data 
using an Affirmation of Compliance Code, the filer affirms that the 
firm or FDA-regulated article identified in an entry line meets the 
requirements specific to each Affirmation of Compliance Code. FDA 
publishes a list of current Affirmation of Compliance Codes on the FDA 
Web site at http://www.fda.gov/forindustry/importprogram/entryprocess/entrysubmissionprocess/ucm461234.htm.
    Submissions of Affirmations of Compliance assist FDA in expediting 
the initial screening and further review of an entry, and can 
significantly increase the likelihood that an entry line will receive 
an automated ``May Proceed.'' The number of Affirmation of Compliance 
submissions in ACS has varied depending on the commodity. For example, 
in 2015 approximately 98 percent of entry lines that are or include a 
medical device have at least one Affirmation of Compliance Code 
submitted in ACS, but only 24 percent of entry lines that are or 
include an animal drug have at least one of the Affirmations of 
Compliance Codes.
    We propose to make mandatory, at the time of entry in ACE, 
submission of certain data elements (that have been submitted in ACS) 
in order to more effectively and efficiently screen for those FDA-
regulated products which are likely to pose a low public health risk. 
Historically, when these data fields are inaccurate or incomplete, 
these entries must be manually reviewed for an admissibility 
determination by FDA. Entries are delayed, sometimes significantly, 
while FDA reviewers either search for that information in our data 
systems or request followup documentation from the importer of record. 
An automated review to determine whether an article ``May Proceed'' is 
much faster and less resource intensive for FDA and the importer than a 
manual review. For example, the average time for the OASIS system to 
process an import entry submitted in ACS in 2015 and issue an automated 
``May Proceed'' determination was approximately 24 minutes whereas the 
average time for an FDA-reviewer to manually review and issue a ``May 
Proceed'' determination was about 28 hours. FDA expects that mandatory 
submission of these data elements will increase the number of import 
entries of FDA-regulated products that receive an automated ``May 
Proceed'' determination. The average time for FDA to issue an automated 
``May Proceed'' determination is expected to be faster for entries to 
be submitted in ACE than it was for entries submitted in ACS. As a 
result of a more streamlined import process, the proposed rule is 
expected to lead to a more effective use of FDA and importer resources, 
and more efficient enforcement of section 801(a) of the FD&C Act.
    The PGA Message Set in ACE also includes optional submission of 
information relevant to FDA's admissibility determination on FDA-
regulated products. We strongly encourage ACE filers to submit the 
optional data elements in the PGA Message Set at the time of entry if 
the importer of an FDA-regulated product is interested in an expedited 
admissibility review on its products by the Agency (see the FDA 
Supplemental Guidance which includes the optional data elements 
published at: http://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM459926.pdf). Accurate and complete information submitted by an ACE 
filer increases the likelihood that an entry line will receive an 
automated ``May Proceed'' determination from FDA.
    For example, the PGA Message Set in ACE contains optional active 
pharmaceutical ingredient (API) data elements for finished human and 
animal drugs. The API data elements include the name of the API, the 
amount and unit of measure of the API in the finished drug, and the 
name of the manufacturer of the API in the finished drug. FDA believes 
that submission of this additional information may expedite import 
entry review by facilitating electronic ``May Proceed'' determinations 
for low risk drugs. FDA invites comments on the advantages, 
disadvantages, and feasibility of providing these API data elements for 
human and animal drugs, if they were to become mandatory data elements 
for entry filing in ACE.
    FDA also invites comments on the advantages, disadvantages, and 
feasibility of requiring the submission of data elements related to the 
approval or clearance status of FDA-regulated medical products. We 
propose to require the submission at the time of entry of application 
numbers for those articles that are the subject of such applications. 
In particular, we invite comment on whether the submission of these 
data elements will help us achieve our goals of facilitating 
admissibility review and focusing our resources on those products that 
may be associated with a serious public health risk to consumers.
    Additionally, FDA invites comments on the advantages, 
disadvantages, and feasibility of the Agency requiring the submission 
of the following data elements in ACE at the time of entry: (1) An 
intended use code for the FDA-regulated article being imported or 
offered for import and (2) a disclaimer indicating that that the 
article is not currently regulated by FDA or that FDA does not 
currently have any requirements for submission of data for importation 
of that article per Agency guidance. Submission of intended use codes 
assists us in differentiating between products in the same product 
category which may have the same product code. For example, an ACE 
filer would submit in ACE at the time of entry an intended use code 
``For Human Medical Use as a Medical Device'' as the intended use for a 
medical device, accessory, or component that is regulated as a finished 
medical device for use in humans. Use of another intended use code 
would inform the Agency that the finished medical device for use in 
humans is only to be used for research and development as a medical 
device, for bench testing or nonclinical research use or as a device 
sample for customer evaluation.
    By submitting a disclaimer in ACE at the time of entry, the ACE 
filer indicates that the article being imported or offered for import 
is not currently regulated by FDA or that FDA does not currently have 
any requirements for submission of data for importation of that article 
per Agency guidance.
    In particular, we invite comment on whether the submission of these 
data elements would help us achieve our goals of facilitating 
admissibility review and focusing our resources on those products that 
may be associated with a serious public health risk to consumers, if 
they were to become mandatory FDA data elements for entry filing in 
ACE.
    FDA announced its participation in the National Customs Automation 
Program (NCAP) test in the Federal Register in August 27, 2015 (80 FR 
52051). An increasing number of filers

[[Page 43159]]

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

IV. Legal Authority

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

V. Description of the Proposed Rule

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

A. Scope/Applicability

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

B. Definitions

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

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

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

[[Page 43160]]

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

[[Page 43161]]

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

[[Page 43162]]

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

[[Page 43163]]

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

[[Page 43164]]

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

[[Page 43165]]

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

[[Page 43166]]

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

[[Page 43167]]

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

[[Page 43168]]

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

[[Page 43169]]

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

D. Technical Amendments

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

[[Page 43170]]

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

VI. Proposed Effective Date

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

VII. Economic Analysis of Impacts

A. Introduction

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits (both quantitative and qualitative) of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). We have developed a 
comprehensive Economic Analysis of Impacts that assesses the impacts of 
the proposed rule. We believe that this proposed rule may be a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The Agency tentatively concludes that this rule 
would not have a significant economic impact on a substantial number of 
small entities covered by this proposed rule, but the impacts are 
uncertain so we are explicitly seeking comment on the impacts.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $146 million, using the most current (2015) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

B. Summary of Benefits and Costs of the Proposed Rule

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

[[Page 43171]]

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

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

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

VIII. Analysis of Environmental Impact

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

IX. Paperwork Reduction Act of 1995

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

[[Page 43172]]

description of these provisions is given in the Description portion of 
this section with an estimate of the annual reporting burden. Included 
in the estimate is the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Importer's Entry Notice (OMB Control Number 0910-0046).
    Description of Respondents: The respondents to this collection of 
information are domestic and foreign ``importers of record'' of FDA-
regulated articles being offered for import into the United States. An 
``importer of record'' may be the owner or purchaser of the article 
being imported, or a customs broker licensed by CBP under 19 U.S.C. 
1641 who has been designated by the owner, purchaser, or consignee to 
file the import entry. There is only one importer of record per entry.
    Using the estimates in the Preliminary Regulatory Impact Analysis 
(PRIA) for the proposed rule (Ref. 4), we have estimated there are 
about 59,292 owners or purchasers who seek to import FDA-regulated 
articles into the United States on an annual basis, and we have 
estimated that 97.7 percent of these owners or purchasers will use 
customs brokers to file their import entries in ACE, and the other 2.3 
percent will file their import entries themselves. We estimate that 
there are a total of 4,010 filers, which includes the 1,364 owners or 
purchasers of the article who will file their own import entry in ACE 
(= 59,292 owners or purchasers of the article offered for import x 
(100-97.7) percent).
    Description: FDA is proposing to revise the information collection 
request (ICR) currently approved under OMB Control Number 0910-0046 to 
account for the provisions of the proposed rule that provide for 
collection of information from importers via ACE. This ICR (titled 
``Importer's Entry Notice'') was most recently approved by OMB on June 
30, 2014, and received an expiration date of June 30, 2017. The 
currently approved collection of information allows the collection of 
several FDA data elements in ACS specific to FDA-regulated products in 
order for FDA to make import admissibility decisions. The ICR currently 
covers the following data elements for all FDA-regulated products: (1) 
FDA Product Code; (2) FDA country of production; (3) FDA manufacturer 
and shipper; and (4) ultimate consignee, as well as various 
affirmations of compliance specific to certain types of FDA-regulated 
products which an importer may submit to FDA to help facilitate FDA's 
review process. In making admissibility decisions FDA also uses 
additional entry information that CBP regulations require importers to 
submit (such as the entry number, importer of record, country of 
origin, etc.), but that information is collected under CBP statutes and 
regulations and ICRs managed by CBP (e.g., 19 U.S.C. 1484 and 1448(b), 
19 CFR 142.3, 142.16, 142.22, and 142.24, and the associated ICR 
approved by OMB under OMB Control Number 1651-0024). The annual 
recordkeeping requirements for this collection are covered by the 
``Customs Modernization Act Recordkeeping Requirements'' information 
collection approved by OMB under OMB Control Number 1651-0076.
    The proposed rule and information collection would streamline FDA's 
admissibility review of FDA-regulated products, promote more effective 
utilization of industry and FDA resources, including electronic 
screening technology, and support FDA's ability to continue to meet its 
statutory responsibilities under the FD&C Act and the PHS Act. The 
information collection aspects of the proposed rule would specify the 
FDA-specific data elements that would be required as part of an import 
entry submitted in ACE for the FDA-regulated products covered by the 
proposed rule being imported or offered for import into the United 
States. Most data elements that would be collected in ACE under the 
proposed rule, with certain exceptions as explained below, are 
currently collected in ACS and approved for collection by OMB under OMB 
Control Number 0910-0046. Furthermore, under the proposed rule two of 
the data elements currently collected in ACS--FDA manufacturer and 
shipper and the ultimate consignee--would no longer be collected in ACE 
or any other CBP-authorized EDI system.
    The authority to issue this proposed regulation and to conduct the 
associated information collection is found in sections 801, 701 and 536 
of the FD&C Act, sections 351, 361, and 368 of the PHS Act, and section 
713 of FDASIA (which added section 801(r) to the FD&C Act).
    The information collection provisions of the proposed rule are in 
proposed Sec. Sec.  1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 
1.80. Proposed Sec.  1.72 would require certain product identifying 
data elements and entity identifying data elements to be submitted in 
ACE at the time of entry for food as applicable, drugs, biological 
products, HCT/Ps, medical devices, radiation-emitting electronic 
products, cosmetics, and tobacco products. Proposed Sec. Sec.  1.73 
through 1.80 would require certain data elements to be submitted in ACE 
depending on the type of FDA-regulated article being imported or 
offered for import into the United States. Proposed Sec. Sec.  1.73, 
1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 1.80 apply, respectively, to 
certain food products; human drugs; animal drugs; medical devices; 
radiation-emitting electronic products; biological products, HCT/Ps, 
and related drugs and medical devices regulated by CBER; tobacco 
products; and cosmetics.
    All but four of the data elements that proposed subpart D would 
require filers to submit in ACE are currently collected in ACS and 
already approved for collection under OMB Control Number 0910-0046. Two 
of these four new data elements would be required by proposed Sec.  
1.72, which applies to certain foods as applicable, and drugs, 
biological products, HCT/Ps, medical devices, radiation-emitting 
electronic products, cosmetics, and tobacco products, and are the name, 
telephone number and email address for one of the persons related to 
the importation of the product, which may include the manufacturer, 
shipper, importer of record, or Deliver to Party, and a telephone 
number and email address for the importer of record, which we need to 
facilitate electronic notice under Sec.  1.94 for certain FDA actions. 
The other two new data elements would be required by proposed Sec.  
1.79, which applies only to tobacco products, and are the name and 
address of the ACE filer and brand name of the tobacco product.
    FDA concludes that the proposed data element of a telephone number 
and email address for the importer of record (which would be required 
by proposed Sec.  1.72(b)(ii)) is not subject to the requirements of 
the PRA because the data element falls under an exception to

[[Page 43173]]

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

[[Page 43174]]

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

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

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

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

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

X. Federalism

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

[[Page 43175]]

summary impact statement is not required.

XI. References

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

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

List of Subjects

21 CFR Part 1

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

21 CFR Part 1005

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

21 CFR Part 1271

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

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

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

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

Subpart D--Electronic Import Entries


Sec.  1.70  Scope.

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


Sec.  1.71  Definitions.

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


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

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

[[Page 43176]]

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


Sec.  1.73  Food.

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


Sec.  1.74  Human drugs.

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


Sec.  1.75  Animal drugs.

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


Sec.  1.76  Medical devices.

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

[[Page 43177]]

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


Sec.  1.77  Radiation-emitting electronic products.

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


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

    In addition to the data required to be submitted in Sec.  1.72, an 
ACE filer must submit the following information at the time of entry 
for biological products, HCT/Ps, and related drugs and medical devices 
regulated by the FDA Center for Biologics Evaluation and Research.
    (a) Product name which identifies the article being imported or 
offered for import by the name commonly associated with that article 
including the established name, trade name, brand name, proper name, or 
product description if the article does not have an established name, 
trade name, brand name or proper name.
    (b) HCT/P registration and affirmation. (1) For an HCT/P regulated 
solely under section 361 of the Public Health Service Act and the 
regulations in part 1271 of this chapter that is manufactured by an 
establishment that is required to be registered under part 1271 of this 
chapter, the HCT/P Registration Number; and
    (2) For an HCT/P regulated solely under section 361 of the Public 
Health Service Act and the regulations in part 1271 of this chapter, an 
affirmation of compliance with the applicable requirements of part 1271 
of this chapter.
    (c) Licensed biological products. For a biological product that is 
the subject of an approved biologics license application under section 
351 of the Public Health Service Act, the Submission Tracking Number of 
the biologics license application and/or the Biologics License Number.
    (d) Drug registration and listing. For a drug intended for human 
use, the Drug Registration Number and the Drug Listing Number. For the 
purposes of this section, the Drug Registration Number that must be 
submitted in ACE is the unique facility identifier of the foreign 
establishment where the human drug was manufactured, prepared, 
propagated, compounded or processed before being imported or offered 
for import into the United States. The unique facility identifier is 
the identifier submitted by a registrant in accordance with the system 
specified under section 510(b) of the Federal Food, Drug, and Cosmetic 
Act. For the purposes of this section, the Drug Listing Number is the 
National Drug Code number of the human drug article being imported or 
offered for import.
    (e) Drug application number. For a drug intended for human use that 
is the subject of an approved application under section 505(b) or 
505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the 
new drug application or the abbreviated new drug application.
    (f) Investigational new drug application number. For a drug 
intended for human use that is the subject of an investigational new 
drug application under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act, the number of the investigational new drug application.
    (g) Medical device registration and listing. For a medical device 
subject to the registration and listing procedures contained in part 
807 of this chapter, the Registration Number for Foreign Manufacturers, 
Foreign Exporters, and/or Domestic Manufacturers, and the Device 
Listing Number, required under section 510 of the Federal Food, Drug, 
and Cosmetic Act and part 807 of this chapter.
    (h) Investigational devices. For an investigational medical device 
that has an investigational device exemption granted under section 
520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational 
Device Exemption Number. For an investigational medical device being 
imported or offered for import for use in a nonsignificant risk or 
exempt study, an Affirmation of Compliance that identifies the device 
as being used in such a study.
    (i) Medical device premarket number. For a medical device that has 
one, the premarket number. This is the premarket approval number for 
those medical devices that have received pre-market approval under 
section 515 of the Federal Food, Drug, and Cosmetic Act; the Product 
Development Protocol Number for those medical devices for which FDA has 
declared the Product Development Protocol complete under section 515(f) 
of the Federal Food, Drug, and Cosmetic Act; the De Novo number for 
those medical devices granted marketing authorization under section 
513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket 
Notification Number for those medical devices that received premarket 
clearance under section 510(k) of the Federal Food, Drug, and Cosmetic 
Act; or the Humanitarian Device Exemption Number for those medical 
devices for which an exemption has been granted under section 520(m) of 
the Federal Food, Drug, and Cosmetic Act.

[[Page 43178]]

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


Sec.  1.79  Tobacco products.

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


Sec.  1.80  Cosmetics.

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


Sec.  1.83  Definitions.

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


Sec.  1.90  Notice of sampling.

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


Sec.  1.94  Hearing on refusal of admission or destruction.

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

PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS

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

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

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


Sec.  1005.2  Definitions.

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

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

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

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

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


Sec.  1271.420  HCT/Ps offered for import.

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

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

    In concurrence with FDA:

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



                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                              43155

                                                      DEPARTMENT OF HEALTH AND                                  • Federal eRulemaking Portal: http://                the claimed confidential information, in
                                                      HUMAN SERVICES                                          www.regulations.gov. Follow the                        its consideration of comments. The
                                                                                                              instructions for submitting comments.                  second copy, which will have the
                                                      Food and Drug Administration                            Comments submitted electronically,                     claimed confidential information
                                                                                                              including attachments, to http://                      redacted/blacked out, will be available
                                                      21 CFR Parts 1, 1005, and 1271                          www.regulations.gov will be posted to                  for public viewing and posted on http://
                                                                                                              the docket unchanged. Because your                     www.regulations.gov. Submit both
                                                      [Docket No. FDA–2016–N–1487]                            comment will be made public, you are                   copies to the Division of Dockets
                                                      Submission of Food and Drug                             solely responsible for ensuring that your              Management. If you do not wish your
                                                                                                              comment does not include any                           name and contact information to be
                                                      Administration Import Data in the
                                                                                                              confidential information that you or a                 made publicly available, you can
                                                      Automated Commercial Environment
                                                                                                              third party may not wish to be posted,                 provide this information on the cover
                                                      AGENCY:    Food and Drug Administration,                such as medical information, your or                   sheet and not in the body of your
                                                      HHS.                                                    anyone else’s Social Security number, or               comments and you must identify this
                                                      ACTION:   Proposed rule.                                confidential business information, such                information as ‘‘confidential.’’ Any
                                                                                                              as a manufacturing process. Please note                information marked as ‘‘confidential’’
                                                      SUMMARY:    The Food and Drug                           that if you include your name, contact                 will not be disclosed except in
                                                      Administration (FDA, the Agency, or                     information, or other information that                 accordance with 21 CFR 10.20 and other
                                                      we) is proposing to establish                           identifies you in the body of your                     applicable disclosure law. For more
                                                      requirements for the electronic filing of               comments, that information will be                     information about FDA’s posting of
                                                      entries of FDA-regulated products in the                posted on http://www.regulations.gov.                  comments to public dockets, see 80 FR
                                                      Automated Commercial Environment                          • If you want to submit a comment                    56469, September 18, 2015, or access
                                                      (ACE) or any other electronic data                      with confidential information that you                 the information at: http://www.gpo.gov/
                                                      interchange (EDI) system authorized by                  do not wish to be made available to the                fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                      the U.S. Customs and Border Protection                  public submit the comment as a written/                23389.pdf.
                                                      Agency (CBP), in order for the filing to                paper submission and in the manner                        Docket: For access to the docket to
                                                      be processed by CBP and to help FDA                     detailed (see ‘‘Written/Paper                          read background documents or the
                                                      in determining admissibility of that                    Submissions’’ and ‘‘Instructions.’’)                   electronic and written/paper comments
                                                      product. ACE is a commercial trade                      Written/Paper Submissions                              received, go to http://
                                                      processing system operated by CBP that                                                                         www.regulations.gov and insert the
                                                      is designed to implement the                               Submit written/paper submissions as                 docket number, found in brackets in the
                                                      International Trade Data System (ITDS),                 follows:                                               heading of this document, into the
                                                                                                                 • Mail/Hand delivery/Courier (for
                                                      automate import and export processing,                                                                         ‘‘Search’’ box and follow the prompts
                                                                                                              written/paper submissions): Division of
                                                      enhance border security, foster U.S.                                                                           and/or go to the Division of Dockets
                                                                                                              Dockets Management (HFA–305), Food
                                                      economic security through lawful                                                                               Management, 5630 Fishers Lane, Rm.
                                                                                                              and Drug Administration, 5630 Fishers
                                                      international trade and policy, and to                                                                         1061, Rockville, MD 20852.
                                                                                                              Lane, Rm. 1061, Rockville, MD 20852.                      Submit comments on information
                                                      replace the Automated Commercial
                                                                                                                 • For written/paper comments
                                                      System (ACS). FDA is a Partner                                                                                 collection issues under the Paperwork
                                                                                                              submitted to the Division of Dockets
                                                      Government Agency (PGA) in the                                                                                 Reduction Act of 1995 to the Office of
                                                                                                              Management, FDA will post your
                                                      initiative to establish ITDS, the ‘‘single                                                                     Management and Budget (OMB) in the
                                                                                                              comment, as well as any attachments,
                                                      window’’ for the submission of import                                                                          following ways:
                                                                                                              except for information submitted,                         • Fax to the Office of Information and
                                                      and export data to the United States
                                                                                                              marked and identified, as confidential,                Regulatory Affairs, OMB, Attn: FDA
                                                      Government. The proposed rule would
                                                                                                              if submitted as detailed in                            Desk Officer, FAX: 202–395–7285, or
                                                      also update certain sections of FDA
                                                                                                              ‘‘Instructions.’’                                      email to oira_submission@omb.eop.gov.
                                                      regulations related to imports. This rule,                 Instructions: All submissions received
                                                      as proposed, does not affect the ability                                                                       All comments should be identified with
                                                                                                              must include the Docket No. FDA–
                                                      of filers to continue to submit their                                                                          the title, ‘‘Submission of FDA Import
                                                                                                              2016–N–1487 for ‘‘Submission of FDA
                                                      import entries and entry summaries by                                                                          Data into the Automated Commercial
                                                                                                              Import Data into the Automated
                                                      paper for FDA-regulated products that                                                                          Environment.’’
                                                                                                              Commercial Environment.’’ Received
                                                      are being imported or offered for import.               comments will be placed in the docket                  FOR FURTHER INFORMATION CONTACT: Ann
                                                      Once finalized, this action will facilitate             and, except for those submitted as                     M. Metayer, Office of Regulatory Affairs,
                                                      effective and efficient admissibility                   ‘‘Confidential Submissions,’’ publicly                 Food and Drug Administration, 10903
                                                      review by the Agency and protect public                 viewable at http://www.regulations.gov                 New Hampshire Ave., Bldg. 32, Rm.
                                                      health by allowing FDA to focus its                     or at the Division of Dockets                          4338, Silver Spring, MD 20993–0002,
                                                      limited resources on those FDA-                         Management between 9 a.m. and 4 p.m.,                  301–796–3324, Ann.Metayer@
                                                      regulated products being imported or                    Monday through Friday.                                 fda.hhs.gov.
                                                      offered for import that may be                             • Confidential Submissions—To                          With regard to the information
                                                      associated with a greater public health                 submit a comment with confidential                     collection: Jonnalynn Capezzuto, Office
                                                      risk.                                                   information that you do not wish to be                 of Operations, Food and Drug
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      DATES: Submit either electronic or                      made publicly available submit your                    Administration, 8455 Colesville Rd.,
                                                      written comments on the proposed rule                   comments only as a written/paper                       Rm. 14526, Silver Spring, MD 20993–
                                                      by August 30, 2016.                                     submission. You should submit two                      0002, Jonnalynn.Capezzuto@
                                                      ADDRESSES: You may submit comments                      copies total. One copy will include the                fda.hhs.gov.
                                                      as follows:                                             information you claim to be confidential               SUPPLEMENTARY INFORMATION:
                                                                                                              with a heading or cover note that states
                                                      Electronic Submissions                                  ‘‘THIS DOCUMENT CONTAINS                               Table of Contents
                                                        Submit electronic comments in the                     CONFIDENTIAL INFORMATION.’’ The                        I. Executive Summary
                                                      following way:                                          Agency will review this copy, including                   A. Purpose of the Proposed Rule



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                                                      43156                             Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

                                                         B. Summary of the Major Provisions of the                 regulations to make updates and                        a certain action against an FDA-
                                                            Proposed Rule                                          provide clarifications.                                regulated product that is being imported
                                                         C. Legal Authority                                                                                               or offered for import and the owner or
                                                         D. Costs and Benefits                                     B. Summary of the Major Provisions of
                                                                                                                                                                          consignee will have an opportunity to
                                                      II. Table of Abbreviations/Commonly Used                     the Proposed Rule
                                                            Acronyms in This Document
                                                                                                                                                                          introduce testimony to the Agency in
                                                                                                                      This proposed rule would add                        opposition to such action. We are also
                                                      III. Background
                                                      IV. Legal Authority
                                                                                                                   Subpart D to Part 1 of 21 CFR Chapter                  proposing to amend 21 CFR 1271.420 to
                                                      V. Description of the Proposed Rule                          I to require that certain data elements be             make clear that, unless otherwise
                                                         A. Scope/Applicability                                    submitted in ACE or any other CBP-                     exempt, importers of record of human
                                                         B. Definitions                                            authorized EDI system, at the time of                  cells, tissues and cellular and tissue-
                                                         C. Data Elements that Must Be Submitted                   entry in order to facilitate admissibility             based products (HCT/Ps) that are
                                                            in ACE for FDA-Regulated Products                      review by the Agency of FDA-regulated                  regulated solely under section 361 of the
                                                         D. Technical Amendments                                   products being imported or offered for                 Public Health Service Act (42 U.S.C.
                                                      VI. Proposed Effective Date                                  import into the United States.
                                                      VII. Economic Analysis of Impacts
                                                                                                                                                                          264) and 21 CFR part 1271 would be
                                                                                                                   Submission of these data elements in                   required to submit the applicable data
                                                         A. Introduction                                           ACE will help us to more effectively and
                                                         B. Summary of Benefits and Costs of the                                                                          elements included in the proposed rule
                                                            Proposed Rule
                                                                                                                   efficiently make admissibility                         in ACE.
                                                      VIII. Analysis of Environmental Impact                       determinations for FDA-regulated
                                                      IX. Paperwork Reduction Act of 1995                          products by increasing the opportunity                 C. Legal Authority
                                                      X. Federalism                                                for automated review by FDA’s                            The legal authority for the proposed
                                                      XI. References                                               Operational and Administrative System                  rule includes sections 536, 701, and 801
                                                                                                                   for Import Support (OASIS).                            of the Federal Food, Drug, and Cosmetic
                                                      I. Executive Summary                                            The proposed rule would also make                   Act (FD&C Act) (21 U.S.C. 360mm, 371,
                                                      A. Purpose of the Proposed Rule                              technical revisions to certain sections of             and 381, respectively), and sections 351,
                                                                                                                   21 CFR Chapter I to update them. We
                                                        The proposed rule would require that                                                                              361, and 368 of the Public Health
                                                                                                                   propose to revise 21 CFR 1.83 and 21
                                                      certain data elements material to our                                                                               Service Act (PHS Act) (42 U.S.C. 262,
                                                                                                                   CFR 1005.2 to update the definition of
                                                      admissibility determination on FDA-                                                                                 264, and 271, respectively).
                                                                                                                   owner or consignee in order to make
                                                      regulated products being imported or                         that definition consistent with Title 19               D. Costs and Benefits
                                                      offered for import, be submitted in ACE                      of the U.S. Code. We also propose to
                                                      or any other CBP-authorized EDI                                                                                       The Agency has determined that this
                                                                                                                   revise 21 CFR 1.90 to allow FDA to
                                                      system, at the time of entry. This action,                                                                          proposed rule may be a significant
                                                                                                                   provide notice of sampling directly to
                                                      once finalized, will facilitate automated                                                                           regulatory action as defined by
                                                                                                                   an owner or consignee. Additionally, we
                                                      ‘‘May Proceed’’ determinations by us for                                                                            Executive Order 12866. Although at this
                                                                                                                   propose to revise 21 CFR 1.94 to clarify
                                                      low-risk FDA-regulated products which,                                                                              time we cannot fully quantify the
                                                                                                                   that written notice can be provided
                                                      in turn, will allow the Agency to focus                                                                             benefits of this proposed rule, adopting
                                                                                                                   electronically by FDA to owners or
                                                      our limited resources on products that                                                                              the proposed rule is expected to provide
                                                                                                                   consignees of FDA actions to detain,
                                                      may be associated with a greater public                                                                             a positive net benefit (estimated benefits
                                                                                                                   refuse, and/or subject certain products
                                                      health risk.                                                                                                        minus estimated costs) to society.
                                                                                                                   to administrative destruction. Under
                                                        FDA also proposes to make technical                        § 1.94, owners or consignees will                      II. Table of Abbreviations/Commonly
                                                      revisions to certain sections of FDA                         receive notice that FDA intends to take                Used Acronyms in This Document

                                                        Abbreviation/Acro-                                                                         What it means
                                                              nym

                                                      ACE .........................    Automated Commercial Environment or any other CBP-authorized EDI system.
                                                      ACE filer ..................     The person who is authorized to submit an electronic import entry for an FDA-regulated product in ACE.
                                                      ACS .........................    Automated Commercial System.
                                                      Agency ....................      U.S. Food and Drug Administration.
                                                      CBP .........................    U.S. Customs and Border Protection Agency.
                                                      CBER ......................      FDA Center for Biologics Evaluation and Research.
                                                      CDER ......................      FDA Center for Drug Evaluation and Research.
                                                      CDRH ......................      FDA Center for Devices and Radiological Health.
                                                      CTP .........................    FDA Center for Tobacco Products.
                                                      CVM ........................     FDA Center for Veterinary Medicine.
                                                      EDI ..........................   Electronic Data Interchange.
                                                      FDA .........................    U.S. Food and Drug Administration.
                                                      FDASIA ...................       Food and Drug Administration Safety and Innovation Act.
                                                      FD&C Act ................        Federal Food, Drug, and Cosmetic Act.
                                                      ITDS ........................    International Trade Data System.
                                                      OASIS .....................      FDA Operational and Administrative System for Import Support.
                                                      PGA ........................     Partner Government Agency in ACE.
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                                                      PHS Act ..................       Public Health Service Act.
                                                      We, Our, Us ............         U.S. Food and Drug Administration.



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


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                            43157

                                                      importation of FDA-regulated products                   redundant filing requirements, to                      submitted through ABI in ACE, it is
                                                      has posed challenges to FDA including                   efficiently regulate the flow of                       validated by CBP and made available to
                                                      enforcement of sections 536 and 801 of                  commerce, and to effectively enforce                   FDA. Transmission of data via ABI
                                                      the FD&C Act and sections 351, 361,                     laws and regulations relating to                       enables more effective enforcement and
                                                      and 368 of the PHS Act.                                 international trade, by establishing a                 faster release decisions, as well as more
                                                         Section 484 of the Tariff Act of 1930                single portal system, operated by CBP,                 certainty for the importer in
                                                      as amended (19 U.S.C. 1484) established                 for the collection and distribution of                 determining logistics of cargo delivery
                                                      the requirement for importers of record                 standard electronic import and export                  (81 FR 10264). ABI is available to
                                                      to make entry for merchandise imported                  data required by all PGAs (19 U.S.C.                   brokers, importers, and independent
                                                      into the customs territory of the United                1411(d)(1)(B)). CBP has designed ACE to                service bureaus, and currently over 96
                                                      States. When goods are imported into                    provide that ‘‘single window’’ for the                 percent of all entries filed with CBP in
                                                      the United States they must be entered                  filing of entries. Over the last several               ACS are filed through ABI (Ref. 1).
                                                      at one of the CBP ports. The term entry                 years, CBP has tested ACE and provided                    If a required data element is not
                                                      refers to the information or                            significant public outreach to ensure                  submitted in ACE, CBP cannot process
                                                      documentation that an importer of                       that the trade community is fully aware                the entry. The ACE filer will then
                                                      record must file with CBP. An import                    of the transition from ACS to ACE (81                  receive an electronic message indicating
                                                      line is each portion of an import entry                 FR 10264, February 29, 2016). FDA has                  that a particular data element was
                                                      that is listed as a separate item on an                 actively participated as a PGA in the                  missing and that the entry will not be
                                                      entry document.                                         development of ITDS and ACE.                           processed without submission of that
                                                         An importer of record is the owner or                   On February 19, 2014, President                     data element. The ACE filer may refile
                                                      purchaser of the article being offered for              Obama issued an Executive Order,                       the entry and it will be processed by
                                                      import or a customs broker licensed by                  Streamlining the Export/Import Process                 CBP if all of the required elements are
                                                      CBP under 19 U.S.C. 1641 who has been                   for America’s Businesses (Executive                    submitted.
                                                      designated by the owner, purchaser, or                  Order 13659), requiring that, by                          Because, under ACE, CBP will relay
                                                      consignee to file the import entry. There               December 31, 2016, PGAs have the                       the data in the PGA Message Set to FDA
                                                      is one importer of record per entry.                    capabilities, agreements, and other
                                                                                                                                                                     using an electronic interface with
                                                      Approximately 98 percent of all entries                 requirements in place to utilize the
                                                                                                                                                                     OASIS, the ACE filer will only need to
                                                      containing FDA-regulated products                       ITDS and supporting systems, such as
                                                      subject to the proposed rule are filed by                                                                      submit this entry information once
                                                                                                              ACE as the primary means of receipt of
                                                      customs brokers.                                                                                               provided that the information submitted
                                                                                                              the data and other relevant information
                                                         In December 1993, the Customs                                                                               in ACE is accurate. ACE entries will be
                                                                                                              necessary for the release and clearance
                                                      Modernization Act (Title VI of the North                                                                       electronically screened in OASIS
                                                                                                              of imported goods. Executive Order
                                                      American Free Trade Agreement                                                                                  against criteria developed by FDA, as
                                                                                                              13659 envisions a simpler, more
                                                      Implementation Act (Pub. L. 103–182))                                                                          they were in ACS. FDA’s Predictive
                                                                                                              efficient automated system for trade use
                                                      was enacted. A prominent feature of the                                                                        Risk-based Evaluation for Dynamic
                                                                                                              for the benefit of both the trade industry
                                                      Customs Modernization Act is the legal                  and PGAs. ACE is expected to become                    Import Compliance Targeting
                                                      requirement that importers of record                    the sole EDI system authorized by CBP                  (PREDICT) is a risk-based electronic
                                                      exercise reasonable care when filing                    for processing electronic entry and entry              screening tool for OASIS that performs
                                                      entries (19 U.S.C. 1484). Reasonable                    summary filings; ACS incrementally is                  this initial electronic screening to assist
                                                      care requires that CBP be provided with                 being decommissioned by CBP for those                  FDA entry reviewers by evaluating the
                                                      the accurate and complete information                   functions.                                             potential risks associated with each
                                                      or documentation deemed necessary by                       While primary responsibility for                    article, and identifying those articles
                                                      CBP to determine whether all legal                      administering U.S. laws relating to                    that may present a higher public health
                                                      requirements for admissibility of that                  imports is exercised by CBP, FDA is                    risk for further examination by FDA.
                                                      article have been met.                                  responsible for determining whether or                    OASIS expedites the clearance of
                                                         The Customs Modernization Act also                   not an FDA-regulated article being                     FDA-regulated products that present a
                                                      included the development of ACE, the                    imported or offered for import is in                   low public health risk but only if the
                                                      planned successor to ACS which has                      compliance with the laws enforced by                   importer of record provides accurate
                                                      been the electronic system used by CBP                  FDA. The discharge of this joint                       and complete import information. If the
                                                      to track, control, and process all                      responsibility has involved close                      FDA electronic screening evaluation of
                                                      commercial goods imported into the                      coordination and cooperation between                   the potential public health risk is
                                                      United States for decades. ACE is                       FDA and CBP for such imports.                          determined to be low, OASIS will
                                                      intended to streamline business                            FDA receives notice from CBP of the                 transmit a message back through the
                                                      processes, facilitate growth in trade,                  arrival at each U.S. port of entry (sea,               FDA/CBP interface that indicates an
                                                      ensure cargo security, and foster                       land, rail, and air) where FDA-regulated               article being imported or offered for
                                                      participation in global commerce while                  products are imported, of each shipment                import ‘‘May Proceed’’ into U.S.
                                                      ensuring compliance with U.S. laws and                  containing an FDA-regulated product.                   commerce, barring any alternate
                                                      regulations.                                            The PGA Message Set in ACE for FDA-                    determination by CBP. A ‘‘May
                                                         The ITDS, as described in section 405                regulated products contains the data                   Proceed’’ message does not constitute a
                                                      of the Security and Accountability for                  that assists FDA in determining the                    determination by FDA about the
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                                                      Every Port Act of 2006 (SAFE Port Act)                  admissibility of those products under                  article’s compliance status, and it does
                                                      (Pub. L. 109–347), was established to                   FDA authorities. This data is                          not preclude FDA action at a later time.
                                                      modernize and simplify the way in                       transmitted to CBP by an ACE filer                     If the FDA electronic review determines
                                                      which PGAs, including FDA, interact                     through the Automated Broker Interface                 that further evaluation by FDA is
                                                      with importers by creating a ‘‘single                   (ABI), which permits a participant to                  necessary, FDA personnel will manually
                                                      window’’ through which industry will                    file import data electronically in ACE.                review the entry information submitted
                                                      transmit the data elements required for                 ABI is the primary mechanism for data                  by the ACE filer and may request
                                                      importation or exportation of cargo. The                submission in ACS, and will continue to                additional information to make an
                                                      purpose of ITDS is to eliminate                         be used in ACE. After the data is                      admissibility determination and/or may


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                                                      43158                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

                                                      examine or sample the FDA-regulated                     importer than a manual review. For                     feasibility of requiring the submission of
                                                      article.                                                example, the average time for the OASIS                data elements related to the approval or
                                                         CBP collects in ACS four data                        system to process an import entry                      clearance status of FDA-regulated
                                                      elements to assist FDA in making                        submitted in ACS in 2015 and issue an                  medical products. We propose to
                                                      admissibility decisions for FDA-                        automated ‘‘May Proceed’’                              require the submission at the time of
                                                      regulated products: (1) The complete                    determination was approximately 24                     entry of application numbers for those
                                                      FDA Product Code; (2) FDA country of                    minutes whereas the average time for an                articles that are the subject of such
                                                      production; (3) FDA manufacturer and                    FDA-reviewer to manually review and                    applications. In particular, we invite
                                                      shipper; and (4) the ultimate consignee.                issue a ‘‘May Proceed’’ determination                  comment on whether the submission of
                                                      Under the proposed rule, two of these                   was about 28 hours. FDA expects that                   these data elements will help us achieve
                                                      data elements would be mandatory                        mandatory submission of these data                     our goals of facilitating admissibility
                                                      submissions at the time of entry in ACE                 elements will increase the number of                   review and focusing our resources on
                                                      or any other CBP-authorized EDI                         import entries of FDA-regulated                        those products that may be associated
                                                      system: The complete FDA product                        products that receive an automated                     with a serious public health risk to
                                                      code and FDA Country of Production.                     ‘‘May Proceed’’ determination. The                     consumers.
                                                         In ACS, filers are also able to make                 average time for FDA to issue an                          Additionally, FDA invites comments
                                                      optional submissions of certain                         automated ‘‘May Proceed’’                              on the advantages, disadvantages, and
                                                      information such as Affirmations of                     determination is expected to be faster                 feasibility of the Agency requiring the
                                                      Compliance regarding requirements                       for entries to be submitted in ACE than                submission of the following data
                                                      related to the FDA-regulated product.                   it was for entries submitted in ACS. As                elements in ACE at the time of entry: (1)
                                                      By submitting data using an Affirmation                 a result of a more streamlined import                  An intended use code for the FDA-
                                                      of Compliance Code, the filer affirms                   process, the proposed rule is expected                 regulated article being imported or
                                                      that the firm or FDA-regulated article                  to lead to a more effective use of FDA                 offered for import and (2) a disclaimer
                                                      identified in an entry line meets the                   and importer resources, and more                       indicating that that the article is not
                                                      requirements specific to each                           efficient enforcement of section 801(a)                currently regulated by FDA or that FDA
                                                      Affirmation of Compliance Code. FDA                     of the FD&C Act.                                       does not currently have any
                                                      publishes a list of current Affirmation of                 The PGA Message Set in ACE also                     requirements for submission of data for
                                                      Compliance Codes on the FDA Web site                    includes optional submission of                        importation of that article per Agency
                                                      at http://www.fda.gov/forindustry/                      information relevant to FDA’s                          guidance. Submission of intended use
                                                      importprogram/entryprocess/                             admissibility determination on FDA-                    codes assists us in differentiating
                                                      entrysubmissionprocess/                                 regulated products. We strongly                        between products in the same product
                                                      ucm461234.htm.                                          encourage ACE filers to submit the                     category which may have the same
                                                         Submissions of Affirmations of                       optional data elements in the PGA                      product code. For example, an ACE filer
                                                      Compliance assist FDA in expediting                     Message Set at the time of entry if the                would submit in ACE at the time of
                                                      the initial screening and further review                importer of an FDA-regulated product is                entry an intended use code ‘‘For Human
                                                      of an entry, and can significantly                      interested in an expedited admissibility               Medical Use as a Medical Device’’ as the
                                                      increase the likelihood that an entry line              review on its products by the Agency                   intended use for a medical device,
                                                      will receive an automated ‘‘May                         (see the FDA Supplemental Guidance                     accessory, or component that is
                                                      Proceed.’’ The number of Affirmation of                 which includes the optional data                       regulated as a finished medical device
                                                      Compliance submissions in ACS has                       elements published at: http://                         for use in humans. Use of another
                                                      varied depending on the commodity.                      www.fda.gov/downloads/ForIndustry/                     intended use code would inform the
                                                      For example, in 2015 approximately 98                   ImportProgram/UCM459926.pdf).                          Agency that the finished medical device
                                                      percent of entry lines that are or include              Accurate and complete information                      for use in humans is only to be used for
                                                      a medical device have at least one                      submitted by an ACE filer increases the                research and development as a medical
                                                      Affirmation of Compliance Code                          likelihood that an entry line will receive             device, for bench testing or nonclinical
                                                      submitted in ACS, but only 24 percent                   an automated ‘‘May Proceed’’                           research use or as a device sample for
                                                      of entry lines that are or include an                   determination from FDA.                                customer evaluation.
                                                      animal drug have at least one of the                       For example, the PGA Message Set in                    By submitting a disclaimer in ACE at
                                                      Affirmations of Compliance Codes.                       ACE contains optional active                           the time of entry, the ACE filer indicates
                                                         We propose to make mandatory, at the                 pharmaceutical ingredient (API) data                   that the article being imported or offered
                                                      time of entry in ACE, submission of                     elements for finished human and animal                 for import is not currently regulated by
                                                      certain data elements (that have been                   drugs. The API data elements include                   FDA or that FDA does not currently
                                                      submitted in ACS) in order to more                      the name of the API, the amount and                    have any requirements for submission of
                                                      effectively and efficiently screen for                  unit of measure of the API in the                      data for importation of that article per
                                                      those FDA-regulated products which are                  finished drug, and the name of the                     Agency guidance.
                                                      likely to pose a low public health risk.                manufacturer of the API in the finished                   In particular, we invite comment on
                                                      Historically, when these data fields are                drug. FDA believes that submission of                  whether the submission of these data
                                                      inaccurate or incomplete, these entries                 this additional information may                        elements would help us achieve our
                                                      must be manually reviewed for an                        expedite import entry review by                        goals of facilitating admissibility review
                                                      admissibility determination by FDA.                     facilitating electronic ‘‘May Proceed’’                and focusing our resources on those
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                                                      Entries are delayed, sometimes                          determinations for low risk drugs. FDA                 products that may be associated with a
                                                      significantly, while FDA reviewers                      invites comments on the advantages,                    serious public health risk to consumers,
                                                      either search for that information in our               disadvantages, and feasibility of                      if they were to become mandatory FDA
                                                      data systems or request followup                        providing these API data elements for                  data elements for entry filing in ACE.
                                                      documentation from the importer of                      human and animal drugs, if they were                      FDA announced its participation in
                                                      record. An automated review to                          to become mandatory data elements for                  the National Customs Automation
                                                      determine whether an article ‘‘May                      entry filing in ACE.                                   Program (NCAP) test in the Federal
                                                      Proceed’’ is much faster and less                          FDA also invites comments on the                    Register in August 27, 2015 (80 FR
                                                      resource intensive for FDA and the                      advantages, disadvantages, and                         52051). An increasing number of filers


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                            43159

                                                      are currently filing entries of FDA-                    for enforcement of section 361 of the                  two new required submissions in
                                                      regulated products in ACE. Although                     PHS Act is provided by section 368 of                  proposed § 1.72 which apply to food
                                                      our NCAP test ended May 2, 2016, CBP                    the PHS Act.                                           contact substances, drugs, biological
                                                      is allowing the filing of entries for FDA-                 We are also issuing this proposed rule              products, HCT/Ps, medical devices,
                                                      regulated products in ACS to continue                   under authority granted to FDA by                      radiation-emitting electronic products,
                                                      in order to provide more time for the                   section 801(r) of the FD&C Act (21                     cosmetics, and tobacco products, are a
                                                      trade community to transition to ACE                    U.S.C. 381(r)), added by section 713 of                name, telephone number, and email
                                                      (81 FR 18634, March 31, 2016). In the                   the Food and Drug Administration                       address for one of the persons related to
                                                      Federal Register on May 16, 2016 (81                    Safety and Innovation Act (Pub. L. 112–                the importation of the product, which
                                                      FR 30320), and May 23, 2016 (81 FR                      144) (FDASIA). Title VII of FDASIA                     may include the manufacturer, shipper,
                                                      32339), CBP announced that effective                    provides FDA with important new                        importer of record, or Deliver to Party,
                                                      June 15, 2016, and July 23, 2016,                       authorities to help the Agency better                  and a telephone number and email
                                                      respectively, ACE will be the sole EDI                  protect the integrity of the drug supply               address for the importer of record which
                                                      system for electronic entry and entry                   chain. Section 801(r) authorizes FDA to                we need to facilitate electronic notice
                                                      summary filings for merchandise                         require, as a condition of granting                    under § 1.94 for certain FDA actions.
                                                      specified in the notices and subject to                 admission to a drug imported or offered                The two other new required data
                                                      the import requirements of FDA, and                     for import into the United States, that                elements, in proposed 21 CFR 1.79, are
                                                      ACS will no longer be a CBP-authorized                  the importer of record electronically                  name and address of the ACE filer and
                                                      EDI system for purposes of processing                   submit information demonstrating that                  brand name for tobacco products.
                                                      such filings. CBP will continue to                      the drug complies with the applicable                     FDA is also proposing to make
                                                      monitor FDA filing rates in ACE and                     requirements of the FD&C Act. This                     technical and clarifying amendments to
                                                      should there be a need to avoid a                       information may include:                               parts 1 and 1005 to update certain
                                                      substantial adverse impact on trade,                       • Information demonstrating the                     sections of those regulations. The
                                                      CBP will reassess the transition                        regulatory status of the drug, such as the             updates include striking references to
                                                      completion date for FDA filings (81 FR                  new drug application, the abbreviated                  statutes or procedures no longer in
                                                      30320 at 30321).                                        new drug application, investigational                  effect and clarifying that electronic
                                                                                                              new drug, or drug master file number;                  notice can be given of FDA actions
                                                      IV. Legal Authority                                        • facility information, such as proof               related to a product that is being
                                                         FDA has the legal authority under the                of registration and the unique facility                imported or offered for import. The
                                                      FD&C Act and the PHS Act to regulate                    identifier; and                                        proposed technical amendments to part
                                                      foods, cosmetics, drugs, biological                        • any other information deemed
                                                                                                                                                                     1 consist of amendments to §§ 1.83,
                                                      products, medical devices, and tobacco                  necessary and appropriate by FDA to
                                                                                                                                                                     1.90, and 1.94. The proposed technical
                                                      products being imported or offered for                  assess compliance of the article being
                                                                                                                                                                     amendment to part 1005 consists of an
                                                      import into the United States (sections                 offered for import.
                                                                                                                 Section 701(a) of the FD&C Act                      amendment to § 1005.2.
                                                      701 and 801 of the FD&C Act; section
                                                                                                              authorizes the Agency to issue                            We are also proposing to revise
                                                      351 of the PHS Act). We also have the
                                                                                                              regulations for the efficient enforcement              § 1271.420 to make clear that the
                                                      legal authority to regulate the
                                                                                                              of the FD&C Act, while section 701(b) of               applicable requirements of the proposed
                                                      importation of radiation-emitting
                                                                                                              the FD&C Act authorizes FDA and the                    rule would apply to HCT/Ps that are
                                                      electronic products (section 536 of the
                                                                                                              Department of the Treasury to jointly                  regulated solely under section 361 of the
                                                      FD&C Act).
                                                         Additionally, section 361 of the PHS                 prescribe regulations for the efficient                PHS Act and part 1271, except those
                                                      Act authorizes FDA to make and enforce                  enforcement of section 801 of the FD&C                 HCT/Ps that would otherwise be exempt
                                                      such regulations as it judges necessary                 Act. These regulations would be jointly                from these requirements.
                                                      to prevent the introduction,                            prescribed by FDA and the Department                   A. Scope/Applicability
                                                      transmission, or spread of                              of the Treasury, with the exception of
                                                      communicable diseases from foreign                                                                               The proposed rule would apply to the
                                                                                                              the provisions of the proposed rule
                                                      countries into the United States or from                                                                       submission of import entries in ACE or
                                                                                                              related to the importation of HCT/Ps
                                                      State to State. FDA has issued                                                                                 any other CBP-authorized EDI system
                                                                                                              which are regulated solely under section
                                                      regulations in part 1271 to regulate                                                                           for certain foods, drugs, medical
                                                                                                              361 of the PHS Act and part 1271 and
                                                      HCT/Ps. HCT/Ps that do not meet the                                                                            devices, radiation-emitting electronic
                                                                                                              the importation of radiation-emitting
                                                      criteria listed in § 1271.10(a) for them to                                                                    products, biological products, HCT/Ps,
                                                                                                              electronic products which are regulated
                                                      be regulated solely under section 361                                                                          cosmetics, and tobacco products
                                                                                                              under section 536 of the FD&C Act;
                                                      and the regulations in part 1271 are                                                                           regulated by FDA.
                                                                                                              neither of these provisions will be
                                                      regulated as drugs, devices, and/or                     issued for the efficient enforcement of                B. Definitions
                                                      biological products under the FD&C Act                  section 801 of the FD&C Act.
                                                      and/or section 351 of the PHS Act and                                                                            The proposed rule contains a number
                                                      must follow applicable regulations,                     V. Description of the Proposed Rule                    of definitions for terms used in the rule.
                                                      including the applicable regulations in                   We propose to add subpart D to part                  These definitions are based on existing
                                                      part 1271. FDA has determined that                      1 of 21 CFR Chapter I to require certain               definitions in statutes or other FDA
                                                      improving the efficiency of                             data elements for FDA-regulated                        regulations, or are definitions
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                                                      admissibility determinations for HCT/                   products to be submitted in ACE or any                 commonly used by industry.
                                                      Ps, thus improving the allocation of                    other CBP-authorized EDI system, at the                C. Data Elements that Must Be
                                                      Agency resources, is necessary to                       time the electronic entry is filed. If an              Submitted in ACE for FDA-Regulated
                                                      prevent the introduction, transmission,                 ACE filer fails to submit any of the data              Products
                                                      or spread of communicable diseases                      elements specified in proposed subpart
                                                      from foreign countries. We are therefore                D applicable to the entry, the entry will              1. General Data Elements for FDA-
                                                      relying on the authority of section 361                 be rejected. All but four of the data                  Regulated Commodities
                                                      of the PHS Act in the proposed                          elements specified in proposed subpart                   The proposed rule would require that
                                                      amendments to § 1271.420. Authority                     D are currently collected in ACS. The                  the following data elements be


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                                                      43160                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

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


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                            43161

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


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                                                      43162                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

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


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                         43163

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


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                                                      43164                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

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


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                           43165

                                                      Comment 5 in 77 FR 45927 at 45930,                      Act). Medical devices that appear to be                   • Product Development Protocol
                                                      August 2, 2012).                                        misbranded are subject to detention and                (PDP) Number for those medical devices
                                                         When a registrant successfully                       refusal (section 801(a) of the FD&C Act).              for which FDA has declared the PDP
                                                      completes the required registration                        b. Investigational devices. An                      complete under section 515(f) of the
                                                      process, a unique Registration Number                   investigational device is a medical                    FD&C Act;
                                                      is assigned by FDA. The current                         device that is the object of a clinical                   • Humanitarian Device Exemption
                                                      Affirmation of Compliance Codes for                     investigation or research involving one                (HDE) Number for those medical
                                                      submission of the registration number of                or more subjects to determine the safety               devices for which an exemption has
                                                      a Domestic Manufacturer is ‘‘DDM’’; of                  or effectiveness of a medical device (21               been granted under section 520(m) of
                                                      a Foreign Manufacturer is ‘‘DEV’’; and                  CFR 812.3(g) and (h)). An                              the FD&C Act;
                                                      of a Foreign Exporter is ‘‘DFE.’’                       investigational device exemption (IDE)                    • Premarket Notification (PMN)
                                                         The information required to be                       permits a medical device that otherwise                Number is the 510(k) number for those
                                                      submitted for each listed medical                       would be required to be approved or                    medical devices that have received
                                                      device, as enumerated in part 807,                      cleared by us to be lawfully introduced                premarket clearance under section
                                                      includes the proprietary or brand                       into interstate commerce for the purpose               510(k) of the FD&C Act (21 U.S.C.
                                                      name(s) under which each medical                        of conducting investigations.                          360(k)); or
                                                      device is marketed and the activities or                   The IDE regulations (21 CFR part 812)                  • De Novo (DEN) Number is the
                                                      processes that are conducted on or done                 describe three types of device studies:                number for those medical devices that
                                                      to the medical device at each                           significant risk (SR), nonsignificant risk             have received marketing authorization
                                                      establishment (e.g., manufacturing,                     (NSR), and exempt studies. For a study                 under section 513(f) of the FD&C Act.
                                                      repacking, relabeling, developing                       determined to be SR, the sponsor must                     This change from ACS should reduce
                                                      specifications, remanufacturing, single-                submit an IDE application to FDA for                   the opportunity for filer error in ACE as
                                                      use device reprocessing, contract                       the investigational device and obtain the              the applicable Premarket Number,
                                                      manufacturing, or contract sterilizing).                Agency’s approval before beginning the                 whether it is a PMA, PDP, HDE, PMN,
                                                      When the listing process is complete,                   study (§ 812.20). A medical device used                or DEN Number, would be entered in
                                                      FDA issues a Device Listing Number for                  in an NSR study is considered by FDA                   the one data field rather than in ACS
                                                      each medical device associated with the                 to have an approved IDE, as long as the                where a PMN Number could be
                                                      registration. While the Registration                    sponsor satisfies the requirements set                 erroneously entered in the field for a
                                                      Number is publicly available, the Device                forth in § 812.2(b). Devices used in                   PMA Number.
                                                      Listing Number is not available to the                  exempt studies are not required to have                   The premarket approval pathway is
                                                      public. The current Affirmation of                      an approved IDE.                                       used by the Agency to review and
                                                      Compliance Code for the Device Listing                     The current Affirmation of                          evaluate the safety and effectiveness of
                                                      Number that must be submitted in ACE                    Compliance Code for investigational                    most class III devices. The PMA must
                                                      is ‘‘LST.’’ The requirements for                        devices is ‘‘IDE.’’ The proposed rule                  include, among other things,
                                                      registration and device listing are found               would require that an ACE filer submit                 descriptions of the methods used in,
                                                      in part 807.                                            in ACE at the time of entry, in the data               and the facilities and controls used for,
                                                         Mandatory submission of the                          field for the ‘‘IDE’’ code in ACE, for an              the manufacture, processing, packing,
                                                      Registration and Device Listing                         investigational device that is being                   storage, and, where appropriate,
                                                      Numbers in ACE at the time of entry                     imported or offered for import: (1) The                installation of the medical device
                                                      serves as a safeguard against                           IDE number for a medical device                        (§ 814.20(b)). Premarket approval is
                                                      substandard and counterfeit medical                     granted an exemption under section                     based on a determination by FDA that
                                                      devices entering the U.S. market.                       520(g) of the FD&C Act (21 U.S.C.                      the PMA contains sufficient valid
                                                      Medical devices manufactured for other                  360j(g)) or (2) ‘‘NSR’’ for a medical                  scientific evidence that there is
                                                      countries may not be as safe and                        device to be used in a nonsignificant                  reasonable assurance of the medical
                                                      effective as medical devices made for                   risk or in an exempt study.                            device’s safety and effectiveness for its
                                                      the U.S. market. Additionally, medical                     An investigational device that lacks a              intended use(s). The PMA Number is
                                                      devices from foreign manufacturers that                 required IDE is deemed adulterated and                 the number issued by FDA upon the
                                                      were not initially intended for sale in                 misbranded (sections 501(f)(1) and                     approval of a PMA.
                                                      the United States may not be adequately                 502(o) of the FD&C Act). Medical                          Any person may submit to FDA a PDP
                                                      stored or maintained, which can affect                  devices that appear to be adulterated                  with respect to a class III device that is
                                                      package integrity, sterilization, and                   and/or misbranded are subject to                       required to have an approved PMA
                                                      other issues relating to the medical                    detention and refusal (section 801(a) of               (section 515(f) of the FD&C Act). Under
                                                      device’s performance capabilities.                      the FD&C Act).                                         § 814.19, a class III device for which a
                                                      Package labeling for these products may                    c. Premarket number. In ACS, there                  PDP protocol has been declared
                                                      not comply with the requirements for                    are separate submissions for Premarket                 completed by FDA is considered to have
                                                      distribution in the United States as the                Approval and Premarket Notification                    an approved PMA. The PDP Number is
                                                      labeling may not be in English, may not                 Numbers. Under the proposed rule,                      the number issued by FDA upon
                                                      contain adequate directions for use,                    there would be only one submission in                  completion of the PDP.
                                                      and/or may not comply with other                        ACE at the time of entry: Premarket                       A humanitarian use device (HUD) is
                                                      labeling requirements for the U.S.                      Number ‘‘PM#.’’ The Premarket Number                   a medical device that is intended to
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      market. All of these issues can impact                  that would be a required submission in                 benefit patients in the treatment or
                                                      patient safety.                                         ACE at the time of entry is the following              diagnosis of a disease or condition that
                                                         A medical device that is                             number/unique identifier that is issued                affects or is manifested in fewer than
                                                      manufactured, prepared, propagated,                     by FDA:                                                4,000 individuals in the United States
                                                      compounded, or processed by an                             • Premarket Approval Application                    per year (§ 814.3(n)). A HDE is an
                                                      establishment that fails to register and/               (PMA) Number for those medical                         exemption for a HUD from the
                                                      or that is not listed as required in                    devices that have received pre-market                  effectiveness requirements of sections
                                                      section 510 of the FD&C Act is deemed                   approval under section 515 of the FD&C                 514 and 515 of the FD&C Act, which is
                                                      misbranded (section 502(o) of the FD&C                  Act (21 U.S.C. 360e);                                  granted by FDA under section 520(m)(2)


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                                                      43166                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

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


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                            43167

                                                      radiation-emitting electronic products                     Submission of the following                         Ps. We also established donor-
                                                      can be found at 21 CFR parts 1000–                      information in ACE or any other CBP-                   eligibility, current good tissue practice,
                                                      1050.                                                   authorized EDI system, at the time of                  and other procedures to prevent the
                                                         Importers of radiation-emitting                      entry would allow FDA to identify,                     introduction, transmission, and spread
                                                      electronic products subject to an FDA                   appropriately categorize, and apply the                of communicable diseases by HCT/Ps.
                                                      performance standard are required to                    applicable statutory and regulatory                       Certain conditions provided under
                                                      submit a written declaration on                         requirements to these CBER-regulated                   § 1271.420 apply to the importation of
                                                      ‘‘Declaration of Products Subject to                    products. This information would                       HCT/Ps regulated solely under section
                                                      Radiation Control Standards,’’ Form                     enable us to more effectively and                      361 of the PHS Act and part 1271. When
                                                      FDA 2877 (19 CFR 12.91). Mandatory                      efficiently conduct admissibility review               an HCT/P meeting the criteria under
                                                      radiation safety performance standards                  for these articles. FDA has determined                 § 1271.10(a) is offered for import, unless
                                                      established by FDA are enumerated in                    that improving the efficiency of                       otherwise exempt, the importer of
                                                      parts 1020 through 1050. The first                      admissibility determinations for HCT/                  record must notify, either before or at
                                                      section of each standard defines and                    Ps, thus improving the allocation of                   the time of importation, the director of
                                                      describes the products subject to that                  Agency resources, is necessary to                      the FDA District Office having
                                                      standard. Table 1 of part 1002.1                        prevent the introduction, transmission,                jurisdiction over the port of entry
                                                      contains a list of products followed by                 or spread of communicable diseases                     through which the HCT/P is imported or
                                                      a reference to any applicable standards.                from foreign countries.                                offered for import, or such officer of the
                                                      A completed Form FDA 2877 is                               a. Product name. This data element                  district as the director may designate to
                                                      currently required to be submitted with                 identifies the CBER-regulated article by               act in his or her behalf, and must
                                                      the entry (19 CFR 12.91). In ACE or any                 the name commonly associated with                      provide sufficient information for FDA
                                                      other CBP-authorized EDI system, the                    that article such as established name,                 to make an admissibility decision.
                                                      declarations required in Form FDA 2877                  trade name, brand name, proper name,                   Additionally, unless otherwise exempt,
                                                      must be submitted electronically at the                 or product description if the article does             the HCT/P must be held intact by the
                                                      time of entry for those radiation-                      not have an established name, trade                    importer or consignee, under conditions
                                                      emitting electronic products subject to                 name, brand name, or proper name.                      necessary to prevent transmission of
                                                      the standards under parts 1020 through                  This information is currently collected                communicable diseases, until we
                                                      1050.                                                   in ACS but would become a required                     determine admissibility.
                                                                                                              submission in ACE at the time of entry                    Most foreign manufacturers of HCT/Ps
                                                         Radiation-emitting electronic                        under the proposed rule.                               are required to register and submit a list
                                                      products that are being imported or                        For certain products, the established               of every HCT/P manufactured, except
                                                      offered for import that do not have the                 name, trade name, brand name, proper                   those exempt from registration under
                                                      Form FDA 2877 declarations                              name, or product description is                        § 1271.15. Establishments that
                                                      electronically submitted in ACE at the                  necessary to verify compliance with an                 manufacture HCT/Ps that are regulated
                                                      time of entry or that otherwise appear to               FDA approval, licensing, or registration               solely under the authority of section 361
                                                      be noncompliant with the applicable                     and listing requirement. A proper name                 of the PHS Act are required to register
                                                      performance standard(s) may be                          is the name designated in a biologics                  and list their HCT/Ps with CBER and to
                                                      detained and refused (section 536 of the                license issued by FDA under section                    comply with the requirements of part
                                                      FD&C Act).                                              351 of the PHS Act. If no established                  1271, whether or not the HCT/P enters
                                                      7. Biological Products, HCT/Ps, and                     name, trade name, brand name, or                       into interstate commerce
                                                      Related Drugs and Medical Devices                       proper name is available, a product                    (§ 1271.1(b)(1)).
                                                                                                              description would be required to be                       When an establishment successfully
                                                         FDA’s CBER regulates biological                      submitted in ACE at the time of entry.                 completes the required registration
                                                      products under sections 351 and 361 of                  For HCT/Ps regulated solely under                      process, CBER assigns a unique
                                                      the PHS Act and various provisions of                   section 361 of the PHS Act and the                     registration number to that firm (see
                                                      the FD&C Act. These products include                    regulations in part 1271 (e.g. tendon,                 § 1271.27). For HCT/Ps manufactured by
                                                      blood and blood products (including                     bone, cornea for transplantation) that do              establishments required to register
                                                      certain kinds of devices), vaccines,                    not have established names, trade                      under part 1271 and regulated solely
                                                      allergenics, tissues, and cellular and                  names, brand names, or proper names,                   under section 361 of the PHS Act and
                                                      gene therapies. CBER also regulates a                   a description of the type of HCT/P that                the regulations in part 1271, FDA is
                                                      number of drugs approved under                          complies with § 1271.370 would be                      proposing to require the submission of
                                                      section 505 of the FD&C Act, including                  required.                                              that registration number in ACE at the
                                                      plasma volume expanders, and drugs                         b. HCT/Ps registration number and                   time of entry. The list of registered firms
                                                      used in the collection and processing of                affirmation of compliance. Human cells,                and product listings are publicly
                                                      blood components and human cellular                     tissues, or cellular or tissue-based                   available at https://
                                                      products. Medical devices involved in                   products are articles containing or                    www.accessdata.fda.gov/scripts/cber/
                                                      the manufacture and administration of                   consisting of human cells or tissues                   CFAppsPub/tiss/index.cfm. The current
                                                      licensed blood, blood components, and                   intended for implantation,                             Affirmation of Compliance Code for the
                                                      cellular products and all HIV test kits                 transplantation, infusion or transfer into             HCT/P Registration Number is ‘‘HRN’’.
                                                      used both to screen donor blood, blood                  a human recipient (§ 1271.3(d)). FDA is                   For HCT/Ps regulated solely under
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      components, and cellular products and                   authorized to make and enforce such                    section 361 of the PHS Act and the
                                                      to diagnose, treat, and monitor persons                 regulations as are necessary to prevent                regulations in part 1271, FDA has
                                                      with HIV and AIDs, are also regulated                   the introduction, transmission, or                     established requirements in part 1271
                                                      by CBER. Also regulated by CBER are                     spread of communicable diseases from                   such as applicable donor screening and
                                                      HCT/Ps, including those HCT/Ps that                     foreign countries into the United States               testing, processing, and labeling, in
                                                      meet the criteria listed in § 1271.10(a)                (section 361 of the PHS Act). Under that               order to prevent the introduction,
                                                      and that are therefore subject to                       authority, we created a unified                        transmission, and spread of
                                                      regulation solely under section 361 of                  registration and listing system for                    communicable diseases by HCT/Ps. The
                                                      the PHS Act and part 1271.                              establishments that manufacture HCT/                   proposed rule would require for HCT/Ps


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                                                      43168                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

                                                      regulated solely under section 361 of the               those articles that are CBER-regulated                    ii. Premarket number. For those
                                                      PHS Act and the regulations in part                     drugs. Currently the Affirmation of                    CBER-regulated medical devices that
                                                      1271 being imported or offered for                      Compliance Code for submission of the                  require premarket approval or
                                                      import that are not otherwise exempt,                   Drug Registration Number is ‘‘REG’’.                   notification, the Premarket Number
                                                      that an Affirmation of Compliance with                     The rule would also require the                     (PM#) would be required to be
                                                      all applicable requirements of part 1271                submission of the Drug Listing Number                  submitted in ACE at the time of entry.
                                                      be submitted in ACE at the time of                      in ACE at the time of entry, as explained              The Premarket Number would be the
                                                      entry. The current Affirmation of                       earlier in the Human Drugs section, and                PMA Number for those medical devices
                                                      Compliance Code for HCT/Ps to affirm                    this number would also be submitted for                that have received premarket approval
                                                      compliance with Part 1271 is ‘‘HCT’’.                   those articles that are CBER-regulated                 under section 515 of the FD&C Act; the
                                                         c. CBER-regulated licensed biological                drugs. The current Affirmation of                      PDP Number for those medical devices
                                                      products. A biological product is                       Compliance Code for submission of the                  for which FDA has declared the PDP
                                                      defined as a virus, therapeutic serum,                  Drug Listing Number is ‘‘DLS’’.                        complete under section 515(f) of the
                                                      toxin, antitoxin, vaccine, blood, blood                    We invite comments on the                           FD&C Act; the HDE Number for those
                                                      component or derivative, allergenic                     advantages, disadvantages, and                         medical devices for which an exemption
                                                      product, protein (except any chemically                 feasibility of requiring an ACE filer to               has been granted for a humanitarian
                                                      synthesized polypeptide), or analogous                  submit the Drug Listing Number for                     device under section 520(m) of the
                                                      product, or arsphenamine or derivative                  those articles that are CBER-regulated                 FD&C Act; the PMN Number for those
                                                      of arsphenamine (or any other trivalent                 drugs. In particular, we invite comment                medical devices that have received
                                                      organic arsenic compound), applicable                   on whether the submission by an ACE                    premarket clearance under section
                                                      to the prevention, treatment, or cure of                filer of this information will help us                 510(k) of the FD&C Act; or the DEN
                                                      a disease or condition of human beings                  achieve our goals of facilitating                      Number for those medical devices that
                                                      (section 351(i) of the PHS Act). The                    admissibility review and focusing our                  have received marketing authorization
                                                      introduction or delivery for introduction               resources on those products that may be                under section 513(f) of the FD&C Act.
                                                      into interstate commerce of any                         associated with a serious public health                As explained earlier, under the
                                                      biological product, including certain                   risk to consumers.                                     proposed rule, there is only one
                                                      devices, without a biologics license in                    ii. Drug application number. In                     Affirmation of Compliance Code that
                                                      effect for that specific product is                     addition, the proposed rule would                      covers PMA, PDP, HDE, PMN and DEN
                                                      prohibited (section 351(a)(1) of the PHS                require that the number of the NDA or                  Numbers: Premarket Number ‘‘PM#’’.
                                                      Act). The BLA is a request for                          the number of the ANDA be submitted                       iii. Components. For those articles
                                                      authorization to introduce, or deliver for              in ACE at the time of entry for those                  that are a component of a CBER-
                                                      introduction, a biological product into                 articles that are CBER-regulated drugs                 regulated medical device and that
                                                      interstate commerce. The licensing                      subject to an approved NDA or ANDA.                    require further processing or inclusion
                                                      requirements and applicable standards                   Currently the Affirmation of                           into a CBER-regulated medical device,
                                                      for biological products are found in 21                 Compliance Code for submission of the                  an affirmation that the article is such a
                                                      CFR parts 600–680. CBER assigns a                       NDA or ANDA number in ACE is ‘‘DA’’.                   component (CPT) would be required to
                                                      unique number to the original BLA or                       iii. Investigational new drug                       be submitted in ACE at the time of
                                                      supplement and that serves as the                       application number. The proposed rule                  entry. The current Affirmation of
                                                      Submission Tracking Number (STN).                       would require the number of the IND                    Compliance Code for a component is
                                                         Upon approval of the first BLA                       also be submitted in ACE at the time of                ‘‘CPT.’’
                                                      submitted by a manufacturer, CBER                       entry for those CBER-regulated articles,                  iv. Investigational medical devices.
                                                      issues a Biologics License Number                       including unapproved drugs and                         The current Affirmation of Compliance
                                                      (BLN) to that manufacturer. A                           unlicensed biological products that are                Code for investigational medical devices
                                                      manufacturer may have several                           subject to an IND under section 505(i)                 is ‘‘IDE.’’ If the CBER-regulated device is
                                                      biological products with approved                       of the FD&C Act. Currently the                         an investigational device being
                                                      applications under one biologics license                Affirmation of Compliance Code for                     imported or offered for import for use in
                                                      and each of the approved products will                  submission of the IND Number is                        an SR study which has been granted an
                                                      have its own STN.                                       ‘‘IND’’.                                               exemption under section 520(g) of the
                                                         For biological products being                           e. CBER-regulated medical devices.                  FD&C Act, the number of the IDE would
                                                      imported or offered for import that are                    i. Registration and listing number. For             be required to be submitted in the data
                                                      subject to an approved BLA, the                         those CBER-regulated medical devices                   field for the ‘‘IDE’’ Code in ACE at the
                                                      applicable BLN and/or STN would be a                    that must be registered with FDA under                 time of entry. If the investigational
                                                      required submission in ACE at the time                  part 807, the proposed rule would                      device is being imported or offered for
                                                      of entry. Currently the Affirmation of                  require that the applicable Registration               import for use in an NSR or exempt
                                                      Compliance Code for submission of the                   and Listing numbers of the Domestic                    study, as explained earlier in the
                                                      BLN or STN in ACE is ‘‘BLN’’ or ‘‘STN’’.                Manufacturer, Foreign Manufacturer,                    Medical Devices section, ‘‘NSR’’ would
                                                      Failure to obtain an approved BLA as                    and/or Foreign Exporter for each                       be submitted in the data field for the
                                                      required under section 351 of the PHS                   medical device identified in the entry,                ‘‘IDE’’ Code in ACE at the time of entry.
                                                      Act subjects a biological product that is               be submitted in ACE at the time of
                                                                                                              entry. The current Affirmation of                      8. Tobacco Products
                                                      being imported or offered for import to
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      detention and refusal under section                     Compliance Codes for submission of the                    On June 22, 2009, the President
                                                      801(a)(3) of the FD&C Act.                              registration number of a Domestic                      signed the Family Smoking Prevention
                                                         d. CBER-regulated human drugs.                       Manufacturer is ‘‘DDM’’; of a Foreign                  and Tobacco Control Act (Tobacco
                                                         i. Drug registration and listing. The                Manufacturer is ‘‘DEV’’; and of a                      Control Act) (Pub. L. 111–31) into law.
                                                      proposed rule would require that the                    Foreign Exporter is ‘‘DFE.’’ For the                   The Tobacco Control Act granted FDA
                                                      Drug Registration Number be submitted                   Device Listing Number that would be                    important new authority to regulate the
                                                      in ACE at the time of entry, as explained               required to be submitted in ACE at the                 manufacture, marketing, and
                                                      earlier in the Human Drugs section, and                 time of entry, the current Affirmation of              distribution of tobacco products to
                                                      this number would also be submitted for                 Compliance Code is ‘‘LST.’’                            protect the public health generally and


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                           43169

                                                      to reduce tobacco use by minors. A                      and targeting, to help determine which                 adulterated or misbranded, under
                                                      ‘‘tobacco product’’ means any product                   products to review manually. In                        sections 601 and 602 of the FD&C Act
                                                      made or derived from tobacco that is                    addition, brand name may help FDA to                   (21 U.S.C. 361 and 362).
                                                      intended for human consumption,                         determine if a tobacco product is                        The proposed rule would require the
                                                      including any component, part, or                       adulterated under section 902 of the                   submission at the time of entry in ACE
                                                      accessory of a tobacco product (except                  FD&C Act (21 U.S.C. 387b) or may be                    or any other CBP-authorized EDI system
                                                      for raw materials other than tobacco                    misbranded under section 903(a)(1) of                  of only the general data elements under
                                                      used in manufacturing a component,                      the FD&C Act (21 U.S.C. 387c(a)(1)) or                 proposed § 1.72 for cosmetic articles
                                                      part, or accessory of a tobacco product)                in violation of other provisions of the                being imported or offered for import
                                                      but does not include an article that is a               FD&C Act. Tobacco products that                        into the United States.
                                                      drug, a device, or a combination product                appear to be misbranded or adulterated
                                                                                                                                                                     D. Technical Amendments
                                                      (section 201(rr) of the FD&C Act).                      are subject to detention and refusal
                                                      Tobacco products are not limited to                     (section 801 of the FD&C Act).                         1. Revisions to §§ 1.83 and 1005.2
                                                      products containing tobacco, but also                      b. Name and address of the ACE filer.
                                                                                                                                                                        We are proposing to revise §§ 1.83
                                                      include components, parts, or                           We are proposing to require that the
                                                                                                                                                                     and 1005.2 to update the legal
                                                      accessories of tobacco products,                        name and address of the ACE filer for
                                                                                                                                                                     references in those sections and to
                                                      whether they are sold for further                       import entries that include a tobacco
                                                                                                                                                                     clarify the definition of ‘‘owner or
                                                      manufacturing or for consumer use; e.g.                 product be submitted in ACE at the time
                                                                                                                                                                     consignee.’’ When section 801 of the
                                                      cigarette rolling papers and filters are                of entry. The name and address of ACE
                                                                                                                                                                     FD&C Act was enacted, the term used to
                                                      tobacco products, whether they are sold                 filers of imports that include a tobacco
                                                                                                                                                                     describe the person responsible for
                                                      to consumers for use with roll-your-own                 product would help to facilitate
                                                                                                                                                                     making entry of an imported product
                                                      tobacco or are sold for further                         distribution by the Agency to ACE filers
                                                                                                                                                                     was ‘‘owner or consignee.’’ This term
                                                      manufacturing into a product sold to a                  of materials related to the regulation and
                                                                                                              importation of tobacco products and                    was the same term found in the relevant
                                                      consumer, such as a cigarette.
                                                         Importers are reminded that tobacco                  otherwise communicate with the ACE                     Customs statutes for the person required
                                                      products imported or offered for import                 filer.                                                 to make entry of imported merchandise.
                                                      into the United States must comply with                    We invite comments on the                           At the time section 801 of the FD&C Act
                                                      all the applicable requirements under                   advantages, disadvantages, and                         was enacted, 19 U.S.C. 1483, 1484, and
                                                      the FD&C Act as amended by the                          feasibility of requiring an ACE filer to               1485, provided that the ‘‘consignee’’
                                                      Tobacco Control Act. For a tobacco                      submit this information in ACE at the                  was deemed to be the ‘‘owner’’ of
                                                      product to be legally marketed in the                   time of entry. In particular, we invite                imported merchandise and was required
                                                      United States, it must be grandfathered                 comment on whether the submission by                   to make entry with Customs (now CBP).
                                                      or a manufacturer generally must: (1)                   an ACE filer of the name and address of                When FDA first issued §§ 1.83 and
                                                      Have submitted a pre-market tobacco                     the ACE filer for import entries that                  1005.2 we defined ‘‘owner or
                                                      application (PMTA) and received a                       include a tobacco product will help us                 consignee’’ as the term is used in
                                                      subsequent marketing authorization                      achieve our goals of facilitating                      section 801(a), (b), and, (c) of the FD&C
                                                      order under section 910(c)(1)(A)(i) of the              admissibility review and focusing our                  Act to be interchangeable with the terms
                                                      FD&C Act (21 U.S.C. 387j(c)(1)(A)), or                  resources on those products that may be                in the relevant provisions of the Tariff
                                                      (2) have submitted a substantial                        associated with a serious public health                Act of 1930. Therefore, we defined
                                                      equivalence (SE) report under section                   risk to consumers and whether this                     ‘‘owner or consignee’’ ‘‘for purposes of
                                                      905(j) of the FD&C Act (21 U.S.C.                       could be sufficiently accomplished                     section 801(a), (b), and (c) of the FD&C
                                                      387e(j)) and received a subsequent                      through proposed § 1.72(b) or other                    Act as . . . the person who has the
                                                      marketing authorization order, or (3)                   means.                                                 rights of a consignee under the
                                                      have been granted a request for an                                                                             provisions of section 1483, 1484, and
                                                                                                              9. Cosmetics                                           1495 of the Tariff Act of 1930, as
                                                      exemption from demonstrating
                                                      substantial equivalence (EXE) under                        The FD&C Act defines ‘‘cosmetic’’ as                amended (19 U.S.C. 1483, 1484, 1495).’’
                                                      section 905(j)(3) or filed a report under               articles intended to be rubbed, poured,                   In 1983, the relevant provisions of the
                                                      section 905(j)(1)(A)(ii) of the FD&C Act                sprinkled, sprayed on, introduced into,                Tariff Act of 1930 were amended to
                                                      and waited 90 days from submission of                   or otherwise applied to the human body                 change the designation of the person
                                                      that report. CTP issues a Submission                    for cleansing, beautifying, promoting                  with the right to make entry. Section
                                                      Tracking Number for a PMTA, SE., or                     attractiveness or altering the appearance              1483 was repealed and the text of
                                                      EXE.                                                    and articles intended for use as a                     sections 1484 and 1485 was revised to
                                                         We recommend that ACE filers submit                  component of such articles (section                    provide that the person authorized to
                                                      the optional data elements identifying                  201(i) of the FD&C Act). The definition                make entry is the ‘‘importer of record’’
                                                      the legal marketing status of the tobacco               of ‘‘cosmetic,’’ however, does not                     who can be the owner, the purchaser, or
                                                      product, as described previously, in                    include soap (see definition in 21 CFR                 a customs broker who is appropriately
                                                      ACE or any other CBP-authorized EDI                     701.20).                                               designated as such by the owner,
                                                      system, at the time of entry to help us                    FDA regulates cosmetic products.                    purchaser, or consignee. FDA is now
                                                      efficiently evaluate the admissibility of               Although we do not have the legal                      updating its regulations to bring the
                                                      a tobacco product being imported or                     authority to approve cosmetic products                 definition back in line with the customs
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                                                      offered for import.                                     before they enter the market, we do                    terminology and to make clear that
                                                         a. Brand name. The proposed rule                     approve color additives used in                        ‘‘owner or consignee’’ continues to
                                                      would require that the brand name for                   cosmetic products (except for coal tar                 mean the person authorized to make
                                                      a tobacco product be submitted in ACE                   hair dyes). However, under section                     entry, now designated under customs
                                                      at the time of entry. This data element                 301(a) of the FD&C Act (21 U.S.C.                      law as the ‘‘importer of record.’’ As a
                                                      identifies a tobacco product by the name                331(a)), cosmetic articles that are                    result, we are updating §§ 1.83 and
                                                      commonly associated with it: Brand                      imported or offered for import cannot be               1005.2 to remove the reference to
                                                      name. Along with product code, the                      lawfully marketed in interstate                        section 1483, which was repealed, and
                                                      brand name will help us with screening                  commerce if they are deemed to be                      to reflect the amended language in


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                                                      43170                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

                                                      sections 1484 and 1485. This proposed                   are required to provide sufficient                     B. Summary of Benefits and Costs of the
                                                      rule will clarify that, for purposes of                 information for FDA to make an                         Proposed Rule
                                                      section 801(a), (b), and (c) of the FD&C                admissibility decision on these products                  FDA is proposing a rule that would
                                                      Act, the term ‘‘owner or consignee’’                    (§ 1271.420(a)).                                       require certain data elements material to
                                                      means the person eligible to make entry                                                                        imports admissibility determination
                                                      under sections 19 U.S.C. 1484 and 1485,                 VI. Proposed Effective Date
                                                                                                                                                                     into the United States be submitted to
                                                      namely, the ‘‘importer of record.’’                       FDA proposes that the effective date                 the FDA via ACE as part of an import
                                                      2. Revisions to § 1.90                                  of the final rule will be 30 days after its            entry. The proposed regulation would
                                                                                                              publication in the Federal Register.                   help streamline FDA’s existing
                                                         We are proposing revisions to § 1.90
                                                                                                                                                                     admissibility procedures for FDA-
                                                      to better reflect current practice of FDA               VII. Economic Analysis of Impacts                      regulated commodities imported or
                                                      and CBP regarding the issuance of
                                                      notice of sampling to persons importing                 A. Introduction                                        offered for import into the United
                                                      merchandise that FDA desires to                                                                                States. For import entries submitted
                                                                                                                 FDA has examined the impacts of the                 electronically, FDA would require that
                                                      sample. The current language of § 1.90
                                                      provides that FDA is to request that the                proposed rule under Executive Order                    certain key data be submitted as a part
                                                      collector of customs provide the notice                 12866, Executive Order 13563, the                      of the import entry filing in the new
                                                      of sampling. The proposed rule revises                  Regulatory Flexibility Act (5 U.S.C.                   ACE system. This rule proposes to make
                                                      § 1.90 to allow FDA to provide this                     601–612), and the Unfunded Mandates                    the submission of these data elements
                                                      notice directly, which will normally                    Reform Act of 1995 (Pub. L. 104–4).                    mandatory in ACE for each import entry
                                                      happen through a secure electronic                      Executive Orders 12866 and 13563                       line for the FDA-regulated commodities
                                                      system. The proposed rule also updates                  direct Agencies to assess all costs and                specified in the proposed rule for which
                                                      ‘‘collector of customs’’ to ‘‘Customs and               benefits (both quantitative and                        entry requests are submitted
                                                      Border Protection’’ which is the Federal                qualitative) of available regulatory                   electronically. The proposed regulation
                                                      agency within the Department of                         alternatives and, when regulation is                   also provides further clarifications to
                                                      Homeland Security that is primarily                     necessary, to select regulatory                        the import process by revising sections
                                                      responsible for maintaining the integrity               approaches that maximize net benefits                  of 21 CFR Chapter I relating to the
                                                      of the borders and ports of entry in the                (including potential economic,                         definition of owner or consignee; the
                                                      United States.                                          environmental, public health and safety,               notice of sampling; and notices of FDA
                                                                                                              and other advantages; distributive                     actions related to FDA-regulated
                                                      3. Revisions to § 1.94                                  impacts; and equity). We have                          products being imported or offered for
                                                         We are proposing to revise § 1.94 to                 developed a comprehensive Economic                     import into the United States, such as
                                                      clarify that electronic notification can be             Analysis of Impacts that assesses the                  notices of hearing on refusal of
                                                      provided to importers of merchandise                    impacts of the proposed rule. We                       admission or destruction, to allow for
                                                      when FDA has determined that an                         believe that this proposed rule may be                 electronic notification by FDA. The rule
                                                      article being imported or offered for                   a significant regulatory action as defined             also clarifies that importers of record of
                                                      import may be subject to refusal of                     by Executive Order 12866.                              human cells, tissues and cellular and
                                                      admission and/or administrative                                                                                tissue-based products (HCT/Ps) that are
                                                                                                                 The Regulatory Flexibility Act
                                                      destruction. Section 1.94 states that                                                                          regulated solely under section 361 of the
                                                                                                              requires Agencies to analyze regulatory
                                                      FDA shall provide written notice in                                                                            Public Health Service Act and part
                                                                                                              options that would minimize any
                                                      these circumstances that we currently                                                                          1271, unless exempted, would be
                                                                                                              significant impact of a rule on small
                                                      implement by providing written notice                                                                          required to submit the applicable data
                                                                                                              entities. The Agency tentatively
                                                      by mail. FDA is proposing to revise this                                                                       elements included in the proposed rule
                                                                                                              concludes that this rule would not have
                                                      section to clarify that FDA can provide                                                                        in ACE at the time of entry.
                                                                                                              a significant economic impact on a                        The estimated costs of this proposed
                                                      either written or electronic notification.              substantial number of small entities
                                                      In the case of electronic notification, the                                                                    rule—and the cost savings—stem from
                                                                                                              covered by this proposed rule, but the                 the mandatory information that would
                                                      notice will usually be provided through
                                                                                                              impacts are uncertain so we are                        be submitted and collected under the
                                                      a secure electronic system.
                                                                                                              explicitly seeking comment on the                      ACE system. In the baseline scenario for
                                                      4. Revisions to § 1271.420                              impacts.                                               our estimates of these costs, we treated
                                                         FDA has determined that improving                       The Unfunded Mandates Reform Act                    ACS as the shell for the submission of
                                                      the efficiency of admissibility                         of 1995 (section 202(a)) requires us to                the information but assumed that
                                                      determinations for HCT/Ps, thus                         prepare a written statement, which                     without the proposed FDA regulation,
                                                      improving the allocation of Agency                      includes an assessment of anticipated                  the information would be collected in
                                                      resources, is necessary to prevent the                  costs and benefits, before proposing                   ACE only if voluntarily provided by
                                                      introduction, transmission, or spread of                ‘‘any rule that includes any Federal                   ACE filers like under the current ACS
                                                      communicable diseases from foreign                      mandate that may result in the                         system (scenario 1, table 1). An
                                                      countries. We are, therefore, proposing                 expenditure by State, local, and tribal                alternative baseline is CBP
                                                      to revise § 1271.420 to make clear that,                governments, in the aggregate, or by the               implementation of ACE with the data
                                                      unless otherwise exempt, importers of                   private sector, of $100,000,000 or more                elements for the entry of FDA-regulated
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                                                      record importing or offering for import                 (adjusted annually for inflation) in any               products (scenario 2, table 1). Under
                                                      HCT/Ps meeting the criteria in                          one year.’’ The current threshold after                this scenario, the benefits, costs, and
                                                      § 1271.10(a) would be required to                       adjustment for inflation is $146 million,              cost savings estimated for the proposed
                                                      submit at the time of entry the                         using the most current (2015) Implicit                 rule would be the same but would be
                                                      applicable information under the                        Price Deflator for the Gross Domestic                  attributed to ACE’s full implementation.
                                                      proposed rule in ACE or any other CBP-                  Product. FDA does not expect this                      The incremental costs and cost savings
                                                      authorized EDI system. Currently,                       proposed rule to result in any 1-year                  of this proposed rule, should it become
                                                      unless they fall within an exception,                   expenditure that would meet or exceed                  final, would be zero under this baseline
                                                      importers of record for these products                  this amount.                                           (scenario 2, table 1). This scenario now


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                                                                                     Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                                                      43171

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

                                                                                      TABLE 1—TOTAL ANNUALIZED COSTS AND BENEFITS OF THE PROPOSED RULE 1
                                                                                                                                                                                           Total benefits
                                                          Discount rate                  Total annualized costs                                                                                              Other benefits
                                                                                                                                                  Cost savings                                              (not quantified)

                                                                                      SCENARIO 1.—The benefits, the costs and cost savings are attributed to FDA regulation

                                                      3 percent ................   Range $53 million to $193                         Range $3 to $89 million .........                More efficient use of FDA’s internal resources; poten-
                                                                                    million.                                                                                           tially fewer import recalls; reduced misbranding; reduc-
                                                                                                                                                                                       tion of counterfeit imports on the U.S. market; in-
                                                                                                                                                                                       creased efficiency of the overall import process due to
                                                                                                                                                                                       fewer errors because of a better defined the owner or
                                                                                                                                                                                       consignee term and the clarifications related to notice
                                                                                                                                                                                       of sampling, allowing for electronic notice of hearing
                                                                                                                                                                                       on refusal of admission and notice of potential de-
                                                                                                                                                                                       struction of drugs.
                                                      7 percent ................   Range $51 million to $186                         Range $3 million to $88 mil-                     More efficient use of FDA’s internal resources; poten-
                                                                                    million.                                           lion.                                           tially fewer import recalls; reduced misbranding; reduc-
                                                                                                                                                                                       tion of counterfeit imports on the U.S. market; in-
                                                                                                                                                                                       creased efficiency of the overall import process due to
                                                                                                                                                                                       fewer errors because of a better defined the owner or
                                                                                                                                                                                       consignee term and the clarifications related to notice
                                                                                                                                                                                       of sampling, allowing for electronic notice of hearing
                                                                                                                                                                                       on refusal of admission and notice of potential de-
                                                                                                                                                                                       struction of drugs.

                                                       SCENARIO 2.—The benefits, costs, and cost savings estimated under SCENARIO 1 would still be incurred, but would be attributed to
                                                                                                         the implementation of ACE

                                                      3 percent ................   $0 ...........................................    $0 ...........................................   $0
                                                      7 percent ................   $0 ...........................................    $0 ...........................................   $0
                                                         1 We   generated lower and upper bounds using Monte Carlo simulations.


                                                        The Economic Analysis of Impacts of                               FDA’s Web site at http://www.fda.gov/                                 environment. Therefore, neither an
                                                                                                                          AboutFDA/ReportsManualsForms/                                         environmental assessment nor an
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      the proposed rule performed in
                                                      accordance with Executive Order 12866,                              Reports/EconomicAnalyses/default.htm                                  environmental impact statement is
                                                      Executive Order 13563, the Regulatory                               (Ref. 4). We invite comments on this                                  required.
                                                      Flexibility Act, and the Unfunded                                   analysis.
                                                                                                                                                                                                IX. Paperwork Reduction Act of 1995
                                                      Mandates Reform Act of 1995 is                                      VIII. Analysis of Environmental Impact
                                                      available to the public in the docket for                                                                                                   This proposed rule contains
                                                                                                                            We have determined under 21 CFR                                     information collection provisions that
                                                      this proposed rule at http://
                                                                                                                          25.30(h) that this action is of a type that                           are subject to review by the OMB under
                                                      www.regulations.gov (Docket No. FDA–
                                                                                                                          does not individually or cumulatively                                 the Paperwork Reduction Act of 1995
                                                      2016–N–1487) and is also available on                               have a significant impact on the human                                (PRA) (44 U.S.C. 3501–3520). A


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                                                      43172                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

                                                      description of these provisions is given                OMB on June 30, 2014, and received an                     The authority to issue this proposed
                                                      in the Description portion of this section              expiration date of June 30, 2017. The                  regulation and to conduct the associated
                                                      with an estimate of the annual reporting                currently approved collection of                       information collection is found in
                                                      burden. Included in the estimate is the                 information allows the collection of                   sections 801, 701 and 536 of the FD&C
                                                      time for reviewing instructions,                        several FDA data elements in ACS                       Act, sections 351, 361, and 368 of the
                                                      searching existing data sources,                        specific to FDA-regulated products in                  PHS Act, and section 713 of FDASIA
                                                      gathering and maintaining the data                      order for FDA to make import                           (which added section 801(r) to the
                                                      needed, and completing and reviewing                    admissibility decisions. The ICR                       FD&C Act).
                                                      each collection of information.                         currently covers the following data                       The information collection provisions
                                                         FDA invites comments on these                        elements for all FDA-regulated                         of the proposed rule are in proposed
                                                      topics: (1) Whether the proposed                        products: (1) FDA Product Code; (2)                    §§ 1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78,
                                                      collection of information is necessary                  FDA country of production; (3) FDA                     1.79, and 1.80. Proposed § 1.72 would
                                                      for the proper performance of FDA’s                     manufacturer and shipper; and (4)                      require certain product identifying data
                                                      functions, including whether the                        ultimate consignee, as well as various                 elements and entity identifying data
                                                      information will have practical utility;                affirmations of compliance specific to                 elements to be submitted in ACE at the
                                                      (2) the accuracy of FDA’s estimate of the               certain types of FDA-regulated products                time of entry for food as applicable,
                                                      burden of the proposed collection of                    which an importer may submit to FDA                    drugs, biological products, HCT/Ps,
                                                      information, including the validity of                  to help facilitate FDA’s review process.               medical devices, radiation-emitting
                                                      the methodology and assumptions used;                   In making admissibility decisions FDA                  electronic products, cosmetics, and
                                                      (3) ways to enhance the quality, utility,               also uses additional entry information                 tobacco products. Proposed §§ 1.73
                                                      and clarity of the information to be                    that CBP regulations require importers                 through 1.80 would require certain data
                                                      collected; and (4) ways to minimize the                 to submit (such as the entry number,                   elements to be submitted in ACE
                                                      burden of the collection of information                 importer of record, country of origin,                 depending on the type of FDA-regulated
                                                      on respondents, including through the                   etc.), but that information is collected               article being imported or offered for
                                                      use of automated collection techniques,                 under CBP statutes and regulations and                 import into the United States. Proposed
                                                      when appropriate, and other forms of                    ICRs managed by CBP (e.g., 19 U.S.C.                   §§ 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79,
                                                      information technology.                                 1484 and 1448(b), 19 CFR 142.3, 142.16,                and 1.80 apply, respectively, to certain
                                                         Title: Importer’s Entry Notice (OMB                  142.22, and 142.24, and the associated                 food products; human drugs; animal
                                                      Control Number 0910–0046).                              ICR approved by OMB under OMB
                                                         Description of Respondents: The                                                                             drugs; medical devices; radiation-
                                                                                                              Control Number 1651–0024). The                         emitting electronic products; biological
                                                      respondents to this collection of
                                                                                                              annual recordkeeping requirements for                  products, HCT/Ps, and related drugs
                                                      information are domestic and foreign
                                                                                                              this collection are covered by the                     and medical devices regulated by CBER;
                                                      ‘‘importers of record’’ of FDA-regulated
                                                                                                              ‘‘Customs Modernization Act                            tobacco products; and cosmetics.
                                                      articles being offered for import into the
                                                                                                              Recordkeeping Requirements’’                              All but four of the data elements that
                                                      United States. An ‘‘importer of record’’
                                                      may be the owner or purchaser of the                    information collection approved by                     proposed subpart D would require filers
                                                      article being imported, or a customs                    OMB under OMB Control Number                           to submit in ACE are currently collected
                                                      broker licensed by CBP under 19 U.S.C.                  1651–0076.                                             in ACS and already approved for
                                                      1641 who has been designated by the                        The proposed rule and information                   collection under OMB Control Number
                                                      owner, purchaser, or consignee to file                  collection would streamline FDA’s                      0910–0046. Two of these four new data
                                                      the import entry. There is only one                     admissibility review of FDA-regulated                  elements would be required by
                                                      importer of record per entry.                           products, promote more effective                       proposed § 1.72, which applies to
                                                         Using the estimates in the Preliminary               utilization of industry and FDA                        certain foods as applicable, and drugs,
                                                      Regulatory Impact Analysis (PRIA) for                   resources, including electronic                        biological products, HCT/Ps, medical
                                                      the proposed rule (Ref. 4), we have                     screening technology, and support                      devices, radiation-emitting electronic
                                                      estimated there are about 59,292 owners                 FDA’s ability to continue to meet its                  products, cosmetics, and tobacco
                                                      or purchasers who seek to import FDA-                   statutory responsibilities under the                   products, and are the name, telephone
                                                      regulated articles into the United States               FD&C Act and the PHS Act. The                          number and email address for one of the
                                                      on an annual basis, and we have                         information collection aspects of the                  persons related to the importation of the
                                                      estimated that 97.7 percent of these                    proposed rule would specify the FDA-                   product, which may include the
                                                      owners or purchasers will use customs                   specific data elements that would be                   manufacturer, shipper, importer of
                                                      brokers to file their import entries in                 required as part of an import entry                    record, or Deliver to Party, and a
                                                      ACE, and the other 2.3 percent will file                submitted in ACE for the FDA-regulated                 telephone number and email address for
                                                      their import entries themselves. We                     products covered by the proposed rule                  the importer of record, which we need
                                                      estimate that there are a total of 4,010                being imported or offered for import                   to facilitate electronic notice under
                                                      filers, which includes the 1,364 owners                 into the United States. Most data                      § 1.94 for certain FDA actions. The other
                                                      or purchasers of the article who will file              elements that would be collected in                    two new data elements would be
                                                      their own import entry in ACE (= 59,292                 ACE under the proposed rule, with                      required by proposed § 1.79, which
                                                      owners or purchasers of the article                     certain exceptions as explained below,                 applies only to tobacco products, and
                                                      offered for import × (100–97.7) percent).               are currently collected in ACS and                     are the name and address of the ACE
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                         Description: FDA is proposing to                     approved for collection by OMB under                   filer and brand name of the tobacco
                                                      revise the information collection request               OMB Control Number 0910–0046.                          product.
                                                      (ICR) currently approved under OMB                      Furthermore, under the proposed rule                      FDA concludes that the proposed data
                                                      Control Number 0910–0046 to account                     two of the data elements currently                     element of a telephone number and
                                                      for the provisions of the proposed rule                 collected in ACS—FDA manufacturer                      email address for the importer of record
                                                      that provide for collection of                          and shipper and the ultimate                           (which would be required by proposed
                                                      information from importers via ACE.                     consignee—would no longer be                           § 1.72(b)(ii)) is not subject to the
                                                      This ICR (titled ‘‘Importer’s Entry                     collected in ACE or any other CBP-                     requirements of the PRA because the
                                                      Notice’’) was most recently approved by                 authorized EDI system.                                 data element falls under an exception to


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                          43173

                                                      the term ‘‘information’’ under 5 CFR                    the proposed rule, is approximately                       We have found based on our
                                                      1320.3(h)(1).                                           1,039,957 hours (= 35,133,681 lines ×                  experience that filers no longer need to
                                                         Under the currently approved ICR, the                0.0296 hours).                                         take a long time to familiarize
                                                      average time that it takes a filer to obtain               Using the estimates in the PRIA for                 themselves with changes in laws and
                                                      and submit the four data elements and                   the proposed rule, we have estimated                   rules relating to imports to determine
                                                      relevant affirmations of compliance                     that 33,988,154 import lines will be                   how those changes would apply to an
                                                      information currently collected in ACS                  impacted by the proposed rule in the                   article being imported or offered for
                                                      for all lines in an import entry is                     first year. We have also estimated that                import, because much of these updates
                                                      estimated at 8.4 minutes (0.14 hours).                  975,460 import lines in the first year                 are now software-driven. For example,
                                                      We did not receive any comments on                      represent unique product-manufacturer                  importers often rely on the electronic
                                                      the estimated burden enumerated in the                  combinations (2.87 percent of the                      messages CBP sends to them notifying
                                                      ICR or its estimate of an average of 8.4                33,988,154 import lines). We have                      them of changes to data requirements.
                                                      minutes per entry. This estimate of 8.4                 estimated that the number of impacted                  Furthermore, the proposed rule is fairly
                                                      minutes includes the time for reviewing                 import lines will grow at an average rate              short, not complex, and does not require
                                                      instructions, searching existing data                   of about 3.3 percent per year.                         an inordinate number of data elements
                                                      sources, gathering and maintaining the                     Other key assumptions in Option 1 of                to be submitted in ACE for an FDA-
                                                      data needed, and completing, reviewing,                 the PRIA for the proposed rule that                    regulated product.
                                                      and filing each entry. The estimate of                  affect our estimate of the additional                     Additionally, most of the general data
                                                      8.4 minutes is an average time across all               annual reporting burden are:                           elements that would be required by
                                                      import entries for FDA-regulated                           • Respondents would have to become                  proposed § 1.72 of the proposed rule are
                                                      products and it accounts for the various                aware of the rule requirements, which                  currently collected in ACS, so filers
                                                      realities of the entry filing process, such             include activities related to reading the              should be very familiar with them.
                                                      as the fact that the vast majority of lines             rule, understanding the reporting                      Almost all the data elements that would
                                                      (approximately 97 percent) are not                      requirements, consulting with                          be required by the proposed rule in
                                                      unique lines, even unique lines in a                    specialists if necessary, determining                  proposed §§ 1.73 through 1.80 have also
                                                      single entry may contain redundant                      how to best meet these requirements                    been available for submission in ACS as
                                                      information, filers use sophisticated                   and communicating these requirements                   Affirmations of Compliance and have
                                                      software that facilitates the entry filing              to workers; and this is a one-time event               been described in various FDA
                                                      process, and the time required per line                 that would require an average of 30                    memoranda to the U.S. import trade
                                                      may vary depending on the commodity                     minutes.                                               community, so most filers should be
                                                      and the specific characteristics of the                    • Respondents would require an                      generally familiar with them as well.
                                                      product, manufacturer, etc.                             administrative worker to locate, gather,                  Entry filing processes have evolved
                                                         Because two of the data elements that                and prepare the additional information                 technologically over time. The vast
                                                      are currently collected in ACS—FDA                      required by this rule for each unique                  majority of filers currently rely on
                                                      manufacturer and shipper and the                        product-manufacturer import line; and                  sophisticated software, which interacts
                                                      ultimate consignee—will not be                          this would require about 4 minutes                     with ACS and can be programmed to
                                                      collected in ACE or any other CBP-                      (0.0667 hours) per line on average.                    interact with ACE, to perform many of
                                                      authorized EDI system under the                         Because FDA has concluded that the                     the tasks and functions that were
                                                      proposed rule, we are reducing this                     proposed data element of a telephone                   previously performed manually, such as
                                                      estimate of 8.4 minutes to an estimate of               number and email address for the                       flagging mandatory data fields,
                                                      7.4 minutes.                                            importer of record (which would be                     providing quality checks, and record
                                                         In 2014, when OMB most recently                      required by proposed § 1.72(b)(ii)) is not             keeping. This increased reliance on
                                                      approved this ICR, there was an average                 subject to the requirements of the PRA,                sophisticated software has substantially
                                                      of 4.166 lines per entry for FDA-                       we have reduced this estimated time to                 reduced the entry filing burden.
                                                      regulated products. We are converting                   3.8 minutes for PRA purposes                           Importers also rely on the ACE system
                                                      the average of 7.4 minutes per entry into               (approximately 0.0633 hours).                          to flag mandatory data submissions and
                                                      the average time per line. Therefore, the                  • Respondents would require an                      show an error message when an entry is
                                                      estimated time per import line that it                  administrative worker to complete entry                rejected because a required data field is
                                                      takes a filer to submit the data elements               request for each import line and quality               empty or is not completed in the
                                                      that are currently approved under OMB                   check using software that is connected                 required manner.
                                                      Control Number 0910–0046 and would                      to ACE, and that this would require                       Our estimate of the increase in the
                                                      be submitted in ACE pursuant to the                     about 2 minutes (0.033 hours) per line                 reporting burden from the proposed rule
                                                      proposed rule, is approximately 1.776                   on average. Because FDA has concluded                  primarily accounts for the proposed rule
                                                      minutes or 0.0296 hours (= 7.4 minutes                  that the proposed data element of a                    requiring submission of some data
                                                      / 4.166 lines).                                         telephone number and email address for                 elements in ACE that are currently
                                                         The current estimated burden for this                the importer of record (which would be                 routinely collected submissions in ACS.
                                                      information collection approved under                   required by proposed § 1.72(b)(ii)) is not             We expect that some filers who were not
                                                      OMB Control Number 0910–0046,                           subject to the requirements of the PRA,                submitting these data elements in ACS
                                                      updated to account for the total number                 we have reduced this estimated time to                 would have to change their submissions
                                                      of FDA-regulated product lines                          1.8 minutes (0.03 hours) for PRA                       to comply with the proposed rule, if
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      submitted in ACS in 2015                                purposes.                                              finalized. The annual reporting burden
                                                      (approximately 34 million lines) and                       • It would take respondents about                   is higher in the first year than in years
                                                      annualized to account for estimated 3.3                 12.5 percent more time in the first year               after because we expect most filers to
                                                      percent increases in year two and three                 for an administrative worker to                        adapt to submitting the required data
                                                      (for an annualized average of 35,133,681                complete an entry request for each                     they had not been submitting in ACS
                                                      lines in years one, two, and three), but                import line and quality check using                    and to electronically store such data for
                                                      not accounting for the estimated                        software that is connected to ACE                      future repeat lines.
                                                      additional burden of the proposed rule                  because they would have to adjust to the                  Of note, FDA data shows that
                                                      for those lines that would be affected by               new system and data elements.                          submission rates for the data elements


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                                                      43174                              Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

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

                                                                                           TABLE 2—ESTIMATED ADDITIONAL ANNUAL RECURRING REPORTING BURDEN 1
                                                                                                                                                              No. of re-                                           Average burden per re-
                                                                                                                                   No. of re-               sponses per                  Total annual
                                                                                    Activity                                                                                                                               sponse                            Total hours
                                                                                                                                   spondents                 respondent                   responses                      (in hours)
                                                                                                                                                           (approximate)

                                                      Preparing the required information (applies to                                         59,292                       17.01                 1,008,337          0.0633 ...........................              63,828
                                                        unique lines only).                                                                                                                                        (3.8 minutes) ................
                                                      Quality checks and data submission into ACE ....                                         4,010                      8,762              35,113,681            0.03 ...............................         1,053,410
                                                                                                                                                                                                                   (1.8 minutes) ................

                                                            Total Hours ....................................................    ........................   ........................     ........................   .......................................      1,117,238
                                                         1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


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

                                                                                                              TABLE 3.—ESTIMATED ONE TIME REPORTING BURDEN 1
                                                                                                                                                              No. of re-                                           Average burden per re-
                                                                                                                                   No. of re-               sponses per                  Total annual
                                                                                    Activity                                                                                                                               sponse                            Total hours
                                                                                                                                   spondents                 respondent                   responses                      (in hours)
                                                                                                                                                           (approximate)

                                                      Review and familiarization with the rule ...............                                 4,010                             1                    4,010        .5 ...................................           2,005
                                                                                                                                                                                                                   (30 minutes) .................
                                                      First year adjusting to new requirements that                                            4,010                     8,476               33,988,154            .00375 ...........................            127,456
                                                         would result in an average of 12.5 percent                                                                                                                (0.225 minutes) ............
                                                         more time for quality checks and submission
                                                         into ACE.

                                                      Total Hours ...........................................................   ........................   ........................     ........................   .......................................       129,461
                                                         1 There    are no capital costs or operating and maintenance costs associated with this collection of information.


                                                        Accordingly, we estimate that the                                   the current annual reporting burden,                                           concerning OMB approval of these
                                                      additional annual reporting burden                                    would be 2,286,656 hours in the first                                          requirements in the Federal Register.
                                                      under the proposed rule, if finalized,                                year (= 1,039,957 current burden +
                                                      would be 1,246,699 hours in the first                                                                                                                X. Federalism
                                                                                                                            1,117,238 recurring burden + 129,461
                                                      year and 1,117,238 hours recurring after                              one-time burden) and 2,157,195 hours                                             We have analyzed this proposed rule
                                                      the first year.                                                       annually after the first year (= 1,039,957                                     in accordance with the principles set
                                                        As noted previously, the current                                    current burden + 1,117,238 recurring                                           forth in Executive Order 13132. We
                                                      estimated burden for this information                                 burden).                                                                       have determined that this proposed rule
                                                      collection, updated to account for the                                  In compliance with the PRA (44                                               does not contain policies that would
                                                      number of total FDA-regulated lines                                   U.S.C. 3407(d)), the Agency has                                                have substantial direct effects on the
                                                      submitted to FDA in 2015 and an                                       submitted the information collection                                           States, on the relationship between the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      estimated 3.3 percent per year increase                               provisions of this proposed rule to OMB                                        National Government and the States, or
                                                      in lines in years two and three, but not                              for review. To ensure that comments on                                         on the distribution of power and
                                                      accounting for the estimated additional                               information collection are received,                                           responsibilities among the various
                                                      burden of the proposed rule, is                                       OMB recommends that written                                                    levels of government. Accordingly, we
                                                      1,039,957 hours. Therefore, we estimate                               comments be faxed or emailed (see                                              conclude that the rule does not contain
                                                      that the total burden under this ICR,                                 ADDRESSES). These requirements will                                            policies that have federalism
                                                      revised to include the estimated                                                                                                                     implications as defined in the Executive
                                                                                                                            not be effective until FDA obtains OMB
                                                      additional annual reporting burden                                                                                                                   order and, consequently, a federalism
                                                                                                                            approval. FDA will publish a notice
                                                      under the proposed rule in addition to


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                             43175

                                                      summary impact statement is not                         PART 1—GENERAL ENFORCEMENT                             103–182, 107 Stat. 2057, 2170,
                                                      required.                                               REGULATIONS                                            December 8, 1993) (Customs
                                                                                                                                                                     Modernization Act), or any other CBP-
                                                      XI. References                                          ■ 1. The authority citation for part 1                 authorized EDI system.
                                                        The following references are on                       continues to read as follows:                             Biological product means a biological
                                                      display in the Division of Dockets                        Authority: 15 U.S.C. 1333, 1453, 1454,               product as defined in section 351(i)(1)
                                                      Management (see ADDRESSES) and are                      1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.            of the Public Health Service Act.
                                                      available for viewing by interested                     321, 331, 332, 333, 334, 335a, 342i, 343,                 Combination product means a
                                                                                                              350c, 350d, 350e, 352, 355, 360b, 360ccc,              product comprised of two or more
                                                      persons between 9 a.m. and 4 p.m.,
                                                                                                              360ccc-1, 360ccc-2, 362, 371, 373, 374, 381,           regulated components as defined in
                                                      Monday through Friday; they are also                    382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241,
                                                      available electronically at http://                                                                            § 3.2(e) of this chapter.
                                                                                                              243, 262, 264.                                            Cosmetic means a cosmetic as defined
                                                      www.regulations.gov. FDA has verified
                                                      the Web site addresses, as of the date                  ■ 2. Add subpart D, consisting of §§ 1.70              in section 201(i) of the Federal Food,
                                                      this document publishes in the Federal                  through 1.80, to read as follows:                      Drug, and Cosmetic Act.
                                                      Register, but Web sites are subject to                  Subpart D—Electronic Import Entries                       Customs and Border Protection or
                                                      change over time.                                                                                              CBP means the Federal Agency within
                                                                                                              Sec.
                                                                                                                                                                     the Department of Homeland Security
                                                        1. Automated Commercial System and ABI                1.70 Scope.
                                                                                                              1.71 Definitions.                                      that is primarily responsible for
                                                      CATAIR, CBP http://www.cbp.gov/trade/acs/                                                                      maintaining the integrity of the borders
                                                      catair (April 13, 2016).                                1.72 Data elements that must be submitted
                                                                                                                   in ACE for articles regulated by FDA.             and ports of entry in the United States.
                                                        2. FDA Guidance for Industry: Submitting
                                                                                                              1.73 Food.                                                Drug means those articles meeting the
                                                      Form FDA 2541 (Food Canning
                                                      Establishment Registration) and Forms FDA               1.74 Human drugs.                                      definition of a drug in section 201(g)(1)
                                                                                                              1.75 Animal drugs.                                     of the Federal Food, Drug, and Cosmetic
                                                      2541d, FDA 2541e, FDA 2541f, and FDA
                                                                                                              1.76 Medical devices.                                  Act.
                                                      2541g (Food Process Filing Forms) to FDA in
                                                                                                              1.77 Radiation-emitting electronic products.              FDA or Agency means the U.S. Food
                                                      Electronic or Paper Format. November 2015.
                                                                                                              1.78 Biological products, HCT/Ps, and                  and Drug Administration.
                                                      http://www.fda.gov/Food/Guidance                             related drugs and medical devices.
                                                      Regulation/GuidanceDocumentsRegulatory                                                                            Food means food as defined in section
                                                                                                              1.79 Tobacco products.
                                                      Information/ucm309376.htm.                              1.80 Cosmetics.                                        201(f) of the Federal Food, Drug, and
                                                        3. FDA Draft Guidance for Industry:                                                                          Cosmetic Act.
                                                      Implementation of the ‘‘Deemed to be a                  Subpart D—Electronic Import Entries                       Food contact substance means any
                                                      License’’ Provision of the Biologics Price                                                                     substance, as defined in section
                                                      Competition and Innovation Act of 2009.                 § 1.70   Scope.                                        409(h)(6) of the Federal Food, Drug, and
                                                      March 2016. http://www.fda.gov/downloads/                  This subpart specifies the data                     Cosmetic Act, that is intended for use as
                                                      drugs/guidancecomplianceregulatory                      elements that are required by the Food                 a component of materials used in
                                                      information/guidances/ucm490264.pdf.                    and Drug Administration (FDA) to be                    manufacturing, packing, packaging,
                                                        4. FDA, Full Disclosure of Preliminary
                                                                                                              included in an electronic import entry                 transporting, or holding food if such use
                                                      Regulatory Impact Analysis, Initial
                                                      Regulatory Flexibility Analysis, and
                                                                                                              submitted in the Automated                             is not intended to have any technical
                                                      Unfunded Mandates Reform Act Analysis on                Commercial Environment (ACE) system                    effect in such food.
                                                      Regulations on Electronic Submission of                 or any other U.S. Customs and Border                      HCT/Ps means human cells, tissues or
                                                      Import Data: Automated Commercial                       Protection (CBP)-authorized electronic                 cellular or tissue-based products, as
                                                      Environment Proposed Rule. Available at:                data interchange (EDI) system operated                 defined in § 1271.3(d) of this chapter.
                                                      http://www.fda.gov/AboutFDA/Reports                     by the CBP, which contains an article                     Import line means each portion of an
                                                      ManualsForms/Reports/EconomicAnalyses/                  that is being imported or offered for                  import entry that is listed as a separate
                                                      default.htm.                                            import into the United States and that                 item on an entry document.
                                                                                                              is regulated by FDA.                                      Low-acid canned food means a
                                                      List of Subjects
                                                                                                                                                                     thermally processed low-acid food (as
                                                                                                              § 1.71   Definitions.                                  defined in § 113.3(n) of this chapter) in
                                                      21 CFR Part 1
                                                                                                                For purposes of subpart D:                           a hermetically sealed container (as
                                                        Cosmetics, Drugs, Exports, Food                         ACE filer means the person who is                    defined in § 113.3(j) of this chapter), and
                                                      Labeling, Imports, Labeling, Reporting                  authorized to submit an electronic                     subject to the requirements in parts 108
                                                      and recordkeeping requirements.                         import entry for an FDA-regulated                      and 113 of this chapter.
                                                                                                              product in the Automated Commercial                       Medical device means a device as
                                                      21 CFR Part 1005                                        Environment or any other CBP-                          defined in section 201(h) of the Federal
                                                        Administrative practice and                           authorized EDI system.                                 Food, Drug, and Cosmetic Act, that is
                                                      procedure, Electronic products, Imports,                  Acidified food means acidified food,                 intended for use in humans.
                                                      Radiation protection, Surety bonds.                     as defined in § 114.3(b) of this chapter,                 Radiation-emitting electronic product
                                                                                                              and subject to the requirements in parts               means an electronic product as defined
                                                      21 CFR Part 1271                                        108 and 114 of this chapter.                           in section 531 of the Federal Food,
                                                                                                                Automated Commercial Environment                     Drug, and Cosmetic Act.
                                                         Biologics, Drugs, Human cells and                    or ACE means the automated and
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      tissue-based products, Medical devices,                                                                           Tobacco product means a tobacco
                                                                                                              electronic system for processing                       product as defined in section 201(rr) of
                                                      Reporting and recordkeeping                             commercial importations that is
                                                      requirements.                                                                                                  the Federal Food, Drug, and Cosmetic
                                                                                                              operated by the United States Customs                  Act.
                                                         Therefore, under the Federal Food,                   and Border Protection in accordance
                                                      Drug, and Cosmetic Act and the Public                   with the National Customs Automation                   § 1.72 Data elements that must be
                                                      Health Service Act, and under authority                 Program established in Subtitle B of                   submitted in ACE for articles regulated by
                                                      delegated to the Commissioner of Food                   Title VI—Customs Modernization, in                     FDA.
                                                      and Drugs, it is proposed that parts 1,                 the North American Free Trade                            General. When filing an entry in ACE,
                                                      1005, and 1271 be amended as follows:                   Agreement Implementation Act (Pub. L.                  the ACE filer shall submit the following


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                                                      43176                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

                                                      information for food as applicable, and                 § 1.74   Human drugs.                                  Unique Facility Identifier is the
                                                      drugs, biological products, HCT/Ps,                       In addition to the data required to be               identifier submitted by a registrant in
                                                      medical devices, radiation-emitting                     submitted in § 1.72, an ACE filer must                 accordance with the system specified
                                                      electronic products, cosmetics, and                     submit the following information at the                under section 510(b) of the Federal
                                                      tobacco products.                                       time of filing entry for drugs, including              Food, Drug, and Cosmetic Act. For the
                                                         (a) Product identifying information for              biological products, intended for human                purposes of this section, the Drug
                                                      the article that is being imported or                   use that are regulated by the FDA Center               Listing Number is the National Drug
                                                      offered for import. This consists of:                   for Drug Evaluation and Research.                      Code number of the animal drug article
                                                         (1) FDA Country of Production, which                   (a) Registration and listing. For a drug             being imported or offered for import.
                                                      is, the country where the article was last              intended for human use, the Drug                          (b) New animal drug application
                                                      manufactured, processed, or grown                       Registration Number and the Drug                       number. For a drug intended for animal
                                                      (including harvested, or collected and                  Listing Number. For the purposes of this               use that is the subject of an approved
                                                      readied for shipment to the United                      section, the Drug Registration Number                  application under section 512 of the
                                                      States). The FDA Country of Production                  that must be submitted in ACE is the                   Federal Food, Drug, and Cosmetic Act,
                                                      for an article that has undergone any                   unique facility identifier of the foreign              the number of the new animal drug
                                                      manufacturing or processing is the                      establishment where the human drug                     application or abbreviated new animal
                                                      country where that activity occurred                    was manufactured, prepared,                            drug application. For a drug intended
                                                      provided that the manufacturing or                      propagated, compounded or processed                    for animal use that is the subject of a
                                                      processing had more than a minor,                       before being imported or offered for                   conditionally approved application
                                                      negligible, or insignificant effect on the              import into the United States. The                     under section 571 of the Federal Food,
                                                      article.                                                unique facility identifier is the identifier           Drug, and Cosmetic Act, the application
                                                         (2) The Complete FDA Product Code,                   submitted by a registrant in accordance                number for the conditionally approved
                                                      which must agree with the invoice                       with the system specified under section                new animal drug.
                                                      description of the product.                             510(b) of the Federal Food, Drug, and                     (c) Veterinary minor species index file
                                                         (3) FDA Value which is the total value               Cosmetic Act. For the purposes of this                 number. For a drug intended for use in
                                                      of the article(s) in an import entry or                 section, the Drug Listing Number is the                animals that is the subject of an Index
                                                      import line, rounded off to the nearest                 National Drug Code number of the                       listing under section 572 of the Federal
                                                      dollar, which must match the invoice                    human drug article being imported or                   Food, Drug, and Cosmetic Act, the
                                                      value of those article(s).                              offered for import.                                    Minor Species Index File number of the
                                                         (4) FDA Quantity which is the                          (b) Drug application number. For a                   new animal drug on the Index of Legally
                                                      quantity of the article(s) in an import                 drug intended for human use that is the                Marketed Unapproved New Animal
                                                      line delineated by packaging level,                     subject of an approved application                     Drugs for Minor Species.
                                                      including the type of package from the                  under section 505(b) or 505(j) of the                     (d) Investigational new animal drug
                                                      largest packaging unit to the smallest                  Federal Food, Drug, and Cosmetic Act,                  number. For a drug intended for animal
                                                      packaging unit; the quantity of each                    the number of the new drug application                 use that is the subject of an
                                                      packaging unit; and the volume and/or                   or abbreviated new drug application.                   investigational new animal drug or
                                                      weight of each of the smallest of the                   For a biological product regulated by the              generic investigational new animal drug
                                                      packaging units.                                        FDA Center for Drug Evaluation and                     application under part 511 of this
                                                         (b) Entity Identification Information,               Research that is required to have an                   chapter, the number of the
                                                      (1) Name, telephone, and email address                  approved new drug application or an                    investigational new animal drug or
                                                      of any one of the persons related to the                approved biologics license application,                generic investigational new animal drug
                                                      importation of the product which may                    the number of the applicable                           file.
                                                      include the manufacturer, shipper,                      application.
                                                                                                                (c) Investigational new drug                         § 1.76    Medical devices.
                                                      importer of record, or Deliver to Party.
                                                         (2) Telephone and email address of                   application number. For a drug                           In addition to the data required to be
                                                      the importer of record.                                 intended for human use that is the                     submitted in § 1.72, an ACE filer must
                                                                                                              subject of an investigational new drug                 submit the following information at the
                                                      § 1.73   Food.                                          application under section 505(i) of the                time of filing entry for medical devices
                                                         (a) Food. The information specified in               Federal Food, Drug, and Cosmetic Act,                  regulated by the FDA Center for Devices
                                                      § 1.72(a)(3) must be submitted in ACE at                the number of the investigational new                  and Radiological Health.
                                                      the time of filing entry for food.                      drug application.                                        (a) Registration and listing. For a
                                                         (b) Food contact substances. The                                                                            medical device, the Registration
                                                      information specified in § 1.72 must be                 § 1.75   Animal drugs.                                 Number for Foreign Manufacturers,
                                                      submitted in ACE at the time of filing                    In addition to the data required to be               Foreign Exporters, and/or Domestic
                                                      entry for food that is a food contact                   submitted in § 1.72, an ACE filer must                 Manufacturers, and the Device Listing
                                                      substance.                                              submit the following information at the                Number, required under section 510 of
                                                         (c) Low-acid canned food. For an                     time of filing entry for animal drugs:                 the Federal Food, Drug, and Cosmetic
                                                      article of food that is a low-acid canned                 (a) Registration and listing. For a drug             Act and part 807 of this chapter.
                                                      food, the ACE filer must submit at the                  intended for animal use, the Drug                        (b) Investigational devices. For an
                                                      time of filing entry the Food Canning                   Registration Number and the Drug                       investigational medical device that has
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                                                      Establishment Number and the                            Listing Number for the purposes of this                an investigational device exemption
                                                      Submission Identifier, and can                          section, the Drug Registration Number                  granted under section 520(g) of the
                                                      dimensions or volume.                                   that must be submitted in ACE is the                   Federal Food, Drug, and Cosmetic Act,
                                                         (d) Acidified food. For an article of                Unique Facility Identifier of the foreign              the Investigational Device Exemption
                                                      food that is an acidified food, the ACE                 establishment where the animal drug                    Number. For an investigational medical
                                                      filer must submit at the time of filing                 was manufactured, prepared,                            device being imported or offered for
                                                      entry the Food Canning Establishment                    propagated, compounded or processed                    import for use in a nonsignificant risk
                                                      Number and the Submission Identifier,                   before being imported or offered for                   or exempt study, ‘‘NSR’’ to be entered
                                                      and can dimensions or volume.                           import into the United States. The                     in the Affirmation of Compliance for the


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                                                                                 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules                                          43177

                                                      ‘‘investigational device exemption’’ that               § 1.77 Radiation-emitting electronic                   section, the Drug Listing Number is the
                                                      identifies the device as being used in a                products.                                              National Drug Code number of the
                                                      nonsignificant risk or exempt study.                       In addition to the data required to be              human drug article being imported or
                                                         (c) Premarket number. For a medical                  submitted in § 1.72, an ACE filer must                 offered for import.
                                                      device that has one, the Premarket                      submit all of the declarations required                   (e) Drug application number. For a
                                                      Number. This is the Premarket Approval                  in Form FDA 2877 electronically in ACE                 drug intended for human use that is the
                                                      Number for those medical devices that                   at the time of filing entry for products               subject of an approved application
                                                      have received pre-market approval                       subject to the standards under parts                   under section 505(b) or 505(j) of the
                                                      under section 515 of the Federal Food,                  1020–1050 of this chapter.                             Federal Food, Drug, and Cosmetic Act,
                                                      Drug, and Cosmetic Act; the Product                                                                            the number of the new drug application
                                                                                                              § 1.78 Biological products, HCT/Ps, and
                                                      Development Protocol Number for those                   related drugs and medical devices.                     or the abbreviated new drug application.
                                                      medical devices for which FDA has                                                                                 (f) Investigational new drug
                                                                                                                 In addition to the data required to be
                                                      declared the product development                                                                               application number. For a drug
                                                                                                              submitted in § 1.72, an ACE filer must
                                                      protocol complete under section 515(f)                                                                         intended for human use that is the
                                                                                                              submit the following information at the
                                                      of the Federal Food, Drug, and Cosmetic                                                                        subject of an investigational new drug
                                                                                                              time of entry for biological products,
                                                      Act; the De Novo number for those                                                                              application under section 505(i) of the
                                                                                                              HCT/Ps, and related drugs and medical
                                                      medical devices granted marketing                                                                              Federal Food, Drug, and Cosmetic Act,
                                                                                                              devices regulated by the FDA Center for
                                                      authorization under section 513(f)(2) of                                                                       the number of the investigational new
                                                                                                              Biologics Evaluation and Research.
                                                      the Federal Food, Drug, and Cosmetic                       (a) Product name which identifies the               drug application.
                                                      Act; the Premarket Notification Number                  article being imported or offered for                     (g) Medical device registration and
                                                      for those medical devices that received                 import by the name commonly                            listing. For a medical device subject to
                                                      premarket clearance under section                       associated with that article including                 the registration and listing procedures
                                                      510(k) of the Federal Food, Drug, and                   the established name, trade name, brand                contained in part 807 of this chapter,
                                                      Cosmetic Act; or the Humanitarian                       name, proper name, or product                          the Registration Number for Foreign
                                                      Device Exemption Number for those                       description if the article does not have               Manufacturers, Foreign Exporters, and/
                                                      medical devices for which an exemption                  an established name, trade name, brand                 or Domestic Manufacturers, and the
                                                      has been granted under section 520(m)                   name or proper name.                                   Device Listing Number, required under
                                                      of the Federal Food, Drug, and Cosmetic                    (b) HCT/P registration and                          section 510 of the Federal Food, Drug,
                                                      Act.                                                    affirmation. (1) For an HCT/P regulated                and Cosmetic Act and part 807 of this
                                                         (d) Component. If applicable for a                   solely under section 361 of the Public                 chapter.
                                                      medical device, an affirmation                          Health Service Act and the regulations                    (h) Investigational devices. For an
                                                      identifying that the article being                      in part 1271 of this chapter that is                   investigational medical device that has
                                                      imported or offered for import is a                     manufactured by an establishment that                  an investigational device exemption
                                                      component that requires further                         is required to be registered under part                granted under section 520(g) of the
                                                      processing or inclusion into a finished                 1271 of this chapter, the HCT/P                        Federal Food, Drug, and Cosmetic Act,
                                                      medical device.                                         Registration Number; and                               the Investigational Device Exemption
                                                         (e) Lead wire/patient cable. For                        (2) For an HCT/P regulated solely                   Number. For an investigational medical
                                                      electrode lead wires and patient cables                 under section 361 of the Public Health                 device being imported or offered for
                                                      intended for use with a medical device,                 Service Act and the regulations in part                import for use in a nonsignificant risk
                                                      an Affirmation of Compliance with the                   1271 of this chapter, an affirmation of                or exempt study, an Affirmation of
                                                      applicable performance standard under                   compliance with the applicable                         Compliance that identifies the device as
                                                      § 898.12 of this chapter.                               requirements of part 1271 of this                      being used in such a study.
                                                         (f) Impact resistant lens. For impact                chapter.                                                  (i) Medical device premarket number.
                                                      resistant lenses in eyeglasses and                         (c) Licensed biological products. For a             For a medical device that has one, the
                                                      sunglasses, an Affirmation of                           biological product that is the subject of              premarket number. This is the
                                                      Compliance with the applicable                          an approved biologics license                          premarket approval number for those
                                                      requirements of § 801.410 of this                       application under section 351 of the                   medical devices that have received pre-
                                                      chapter.                                                Public Health Service Act, the                         market approval under section 515 of
                                                         (g) Convenience kit. If applicable for               Submission Tracking Number of the                      the Federal Food, Drug, and Cosmetic
                                                      a medical device, an Affirmation of                     biologics license application and/or the               Act; the Product Development Protocol
                                                      Compliance that the article imported or                 Biologics License Number.                              Number for those medical devices for
                                                      offered for import is a convenience kit                    (d) Drug registration and listing. For a            which FDA has declared the Product
                                                      or part of a convenience kit.                           drug intended for human use, the Drug                  Development Protocol complete under
                                                         (h) Investigational new drug                         Registration Number and the Drug                       section 515(f) of the Federal Food, Drug,
                                                      application number. For a combination                   Listing Number. For the purposes of this               and Cosmetic Act; the De Novo number
                                                      product consisting of at least one                      section, the Drug Registration Number                  for those medical devices granted
                                                      medical device and one drug intended                    that must be submitted in ACE is the                   marketing authorization under section
                                                      for human use that is the subject of an                 unique facility identifier of the foreign              513(f)(2) of the Federal Food, Drug, and
                                                      investigational new drug application                    establishment where the human drug                     Cosmetic Act; the Premarket
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                                                      under section 505(i) of the Federal                     was manufactured, prepared,                            Notification Number for those medical
                                                      Food, Drug, and Cosmetic Act, where                     propagated, compounded or processed                    devices that received premarket
                                                      the FDA Center for Devices and                          before being imported or offered for                   clearance under section 510(k) of the
                                                      Radiological Health has been designated                 import into the United States. The                     Federal Food, Drug, and Cosmetic Act;
                                                      by FDA as the center with primary                       unique facility identifier is the identifier           or the Humanitarian Device Exemption
                                                      jurisdiction for the premarket review                   submitted by a registrant in accordance                Number for those medical devices for
                                                      and regulation of the combination                       with the system specified under section                which an exemption has been granted
                                                      product, the number of the                              510(b) of the Federal Food, Drug, and                  under section 520(m) of the Federal
                                                      investigational new drug application.                   Cosmetic Act. For the purposes of this                 Food, Drug, and Cosmetic Act.


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                                                      43178                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Proposed Rules

                                                         (j) Medical device component. If                     give the owner or consignee a single                     Dated: June 28, 2016.
                                                      applicable for a medical device, an                     written or electronic notice that                      Timothy E. Skud,
                                                      affirmation identifying that the article                provides the notice on refusal of                      Deputy Assistant Secretary (Tax, Trade, and
                                                      being imported or offered for import is                 admission and the notice on destruction                Tariff Policy), Department of the Treasury.
                                                      a component that requires further                       of an article described in paragraph (a)               [FR Doc. 2016–15684 Filed 6–30–16; 8:45 am]
                                                      processing or inclusion into a finished                 of this section. * * *                                 BILLING CODE 4164–01–P
                                                      medical device.
                                                                                                              PART 1005—IMPORTATION OF
                                                      § 1.79   Tobacco products.                              ELECTRONIC PRODUCTS
                                                         In addition to the data required to be                                                                      DEPARTMENT OF HOMELAND
                                                      submitted in § 1.72, an ACE filer must                  ■ 6. The authority citation for part 1005              SECURITY
                                                      submit the following information at the                 continues to read as follows:
                                                      time of filing entry in ACE.                                                                                   Coast Guard
                                                                                                                  Authority: 21 U.S.C. 360ii, 360mm.
                                                         (a) Brand name of the article that is
                                                      a tobacco product being imported or                     ■   7. Revise § 1005.2 to read as follows:             33 CFR Part 165
                                                      offered for import.
                                                         (b) Name and address of the ACE filer                § 1005.2    Definitions.
                                                                                                                                                                     [Docket No. USCG–2016–0451]
                                                      for any entry that includes an article                     As used in this part:
                                                      that is a tobacco product.
                                                                                                                 The term owner or consignee means                   RIN 1625–AA00
                                                      § 1.80   Cosmetics.                                     the person eligible to make entry under
                                                        An ACE filer must submit the data                     the provisions of sections 484 and 485                 Safety Zone; South Branch of the
                                                      specified in § 1.72 at the time of filing               of the Tariff Act of 1930, as amended                  Chicago River and Chicago Sanitary
                                                      entry in ACE.                                           (19 U.S.C. 1484 and 1485), namely, the                 and Ship Canal, Chicago, IL
                                                      ■ 3. In § 1.83, revise paragraph (a) to                 ‘‘importer of record.’’                                AGENCY:   Coast Guard, DHS.
                                                      read as follows:
                                                                                                              PART 1271—HUMAN CELLS, TISSUES,                        ACTION:   Notice of proposed rulemaking.
                                                      § 1.83   Definitions.                                   AND CELLULAR AND TISSUE-BASED                          SUMMARY:   The Coast Guard proposes to
                                                      *     *    *      *     *                               PRODUCTS                                               establish a temporary safety zone on the
                                                        (a) The term owner or consignee                                                                              South Branch of the Chicago River and
                                                      means the person eligible to make entry                 ■ 8. The authority citation for part 1271              the Chicago Sanitary and Ship Canal,
                                                      under the provisions of sections 484 and                continues to read as follows:                          Chicago, IL. This action is necessary to
                                                      485 of the Tariff Act of 1930, as                         Authority: 42 U.S.C. 216, 243, 263a, 264,            protect spectators, participants, and
                                                      amended (19 U.S.C. 1484 and 1485),                      271.                                                   vessels from the hazards associated with
                                                      namely, the ‘‘importer of record.’’                                                                            the Tough Cup event. This proposed
                                                      *     *    *      *     *                               ■ 9. In § 1271.420, revise paragraph (a)               rulemaking would prohibit persons and
                                                      ■ 4. Revise § 1.90 to read as follows:                  to read as follows:                                    vessels from being in the safety zone
                                                      § 1.90   Notice of sampling.                            § 1271.420    HCT/Ps offered for import.               unless authorized by the Captain of the
                                                                                                                                                                     Port Lake Michigan.
                                                        When a sample of an article offered                      (a) Except as provided in paragraphs
                                                      for import has been requested by the                                                                           DATES: Comments and related material
                                                                                                              (c) and (d) of this section, when an                   must be received by the Coast Guard on
                                                      district director, FDA shall provide to                 HCT/P is offered for import, the
                                                      the owner or consignee prompt notice of                                                                        or before August 1, 2016.
                                                                                                              importer of record must notify, either
                                                      delivery of, or intention to deliver, such                                                                     ADDRESSES: You may submit comments
                                                                                                              before or at the time of importation, the
                                                      sample. Upon receipt of the notice, the                                                                        identified by docket number USCG–
                                                                                                              director of the district of the Food and
                                                      owner or consignee shall hold such                                                                             2016–0451 using the Federal
                                                                                                              Drug Administration (FDA) having
                                                      article and not distribute it until further                                                                    eRulemaking Portal at http://
                                                                                                              jurisdiction over the port of entry
                                                      notice from the district director or U.S.                                                                      www.regulations.gov. See the ‘‘Public
                                                                                                              through which the HCT/P is imported or
                                                      Customs and Border Protection of the                                                                           Participation and Request for
                                                                                                              offered for import, or such officer of the
                                                      results of examination of the sample.                                                                          Comments’’ portion of the
                                                                                                              district as the director may designate to
                                                      ■ 5. In § 1.94, revise the first sentence of                                                                   SUPPLEMENTARY INFORMATION section for
                                                                                                              act in his or her behalf in administering
                                                      paragraphs (a) and (c) to read as follows:                                                                     further instructions on submitting
                                                                                                              and enforcing this part, and must
                                                                                                                                                                     comments.
                                                      § 1.94 Hearing on refusal of admission or               provide sufficient information,
                                                      destruction.                                            including information submitted in the                 FOR FURTHER INFORMATION CONTACT:   If
                                                        (a) If it appears that the article may be             Automated Commercial Environment                       you have questions about this proposed
                                                      subject to refusal of admission, or that                (ACE) system or any other Electronic                   rulemaking, call or email LT Lindsay
                                                      the article is a drug that may be subject               Data Interchange system authorized by                  Cook, Marine Safety Unit Chicago, U.S.
                                                      to destruction under section 801(a) of                  the United States Customs and Border                   Coast Guard; telephone (630) 986–2155,
                                                      the Federal Food, Drug, and Cosmetic                    Protection Agency as required in part 1,               email Lindsay.N.Cook@uscg.mil.
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                                                      Act, the district director shall give the               subpart D of this chapter, for FDA to                  SUPPLEMENTARY INFORMATION:
                                                      owner or consignee a written or                         make an admissibility decision.
                                                                                                                                                                     I. Table of Abbreviations
                                                      electronic notice to that effect, stating               *      *     *    *      *
                                                      the reasons therefor. * * *                                                                                    CFR Code of Federal Regulations
                                                                                                                Dated: June 28, 2016.                                DHS Department of Homeland Security
                                                      *     *      *     *      *                                                                                    FR Federal Register
                                                                                                              Leslie Kux,
                                                        (c) If the article is a drug that may be                                                                     NPRM Notice of proposed rulemaking
                                                      subject to destruction under section                    Associate Commissioner for Policy, Food and
                                                                                                                                                                     Pub. L. Public Law
                                                      801(a) of the Federal Food, Drug, and                   Drug Administration.
                                                                                                                                                                     § Section
                                                      Cosmetic Act, the district director may                     In concurrence with FDA:                           U.S.C. United States Code



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Document Created: 2016-07-14 11:37:11
Document Modified: 2016-07-14 11:37:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesSubmit either electronic or written comments on the proposed rule by August 30, 2016.
ContactAnn 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, [email protected]
FR Citation81 FR 43155 
CFR Citation21 CFR 1005
21 CFR 1271
21 CFR 1
CFR AssociatedCosmetics; Drugs; Exports; Food Labeling; Imports; Labeling; Reporting and Recordkeeping Requirements; Administrative Practice and Procedure; Electronic Products; Radiation Protection; Surety Bonds; Biologics; Human Cells and Tissue-Based Products and Medical Devices

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