81 FR 96459 - Electronic Filing of Certain Import Data Into the Document Image System Through the Automated Commercial Environment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 251 (December 30, 2016)

Through publication of this notice, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces a new policy and guidance for the electronic submission of data related to the importation of CDC- regulated items in the International Trade Data System (ITDS). Certain data, forms, and documents required to be submitted to HHS/CDC will be submitted through the U.S. Customs and Border Protection (CBP)'s Automated Commercial Environment (ACE) system, using the Document Image System (DIS). This electronic process will replace certain paper-based processes in keeping with Federal policy and improve operations to further assist HHS/CDC's mission to protect public health.

[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96459-96460]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Electronic Filing of Certain Import Data Into the Document Image 
System Through the Automated Commercial Environment

AGENCY: Centers for Disease Control and Prevention, Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: Through publication of this notice, the Centers for Disease 
Control and Prevention (CDC) located within the Department of Health 
and Human Services (HHS) announces a new policy and guidance for the 
electronic submission of data related to the importation of CDC-
regulated items in the International Trade Data System (ITDS). Certain 
data, forms, and documents required to be submitted to HHS/CDC will be 
submitted through the U.S. Customs and Border Protection (CBP)'s 
Automated Commercial Environment (ACE) system, using the Document Image 
System (DIS). This electronic process will replace certain paper-based 
processes in keeping with Federal policy and improve operations to 
further assist HHS/CDC's mission to protect public health.

DATES: This action is effective December 30, 2016.

FOR FURTHER INFORMATION CONTACT: For information regarding this Notice: 
Ashley A. Marrone, J.D., Division of Global Migration and Quarantine, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
E03, Atlanta, GA 30329. For information regarding CDC operations 
related to this Notice: Kendra Stauffer, D.V.M., Division of Global 
Migration and Quarantine, Quarantine and Border Health Services Branch, 
Importations and Animal Contact Team, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE., MS-E28, Atlanta, GA 30345. Either 
may also be reached by telephone 404-498-1600 or email 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On February 19, 2014, the President signed Executive Order 13659, 
Streamlining the Export/Import Process for America's Businesses (79 FR 
10655), that requires the completion and government-wide utilization by 
December 31, 2016 of the International Trade Data System (ITDS) and 
establishes a two-tiered governance process to oversee its 
implementation. Once fully implemented, ITDS, through the Automated 
Commercial Environment (ACE), will allow importers to submit the data 
required by U.S. Customs and Border Protection and its Partner 
Government Agencies (PGAs) relating to the import or export of cargo 
through a ``single window'' concept. CBP has developed ACE as the 
single window for the trade community to transmit electronically all 
required cargo-related information.
    This notice announces HHS/CDC's updated policy concerning the 
electronic transmission of HHS/CDC permits, forms, and documents using 
CBP's Document Image System (DIS). This DIS capability will satisfy the 
HHS/CDC data and electronic document requirements for any entry filed 
electronically in ACE and enable the trade community to have a CBP-
managed single window for the electronic submission of data and 
documents required by HHS/CDC during the cargo importation and review 
process. The list of PGA forms and documents, including documents 
required by HHS/CDC, which may be transmitted using DIS may be found at 
http://www.cbp.gov/trade/ace/features under the DIS tab by clicking on 
the ``ACE PGA Forms List'' hyperlink in the ``References'' column. The 
HHS/CDC permits, forms, and documents listed in the ACE PGA Forms List 
are those eligible to be transmitted using DIS.

II. Current HHS/CDC Paper-Based Procedures

    Under current applicable HHS/CDC policy and operations, the 
importation of HHS/CDC-regulated commodities into the customs territory 
of the United States typically requires the submission

[[Page 96460]]

of one or more of the following documents:
    (1) Animal and Plant Health Inspection Service (APHIS)/CDC Form 2--
Request to Transfer Select Agents and Toxins (42 CFR 73);
    (2) CDC Form 0.0728--Permit to Import or Transfer Etiologic Agents 
or Vectors of Human Disease (42 CFR 71.54);
    (3) Rabies Vaccination Certificate (42 CFR 71.51);
    (4) CDC Approval of Confinement Agreement Issuance Letter (42 CFR 
71.51);
    (5) CDC Permission Letter--Permit to Import African Rodents, 
Civets, or Turtles (42 CFR 71.56, 42 CFR 71.32(b), 42 CFR 71.52);
    (6) CDC Nonhuman Primate Notification Message--Confirmation from 
CDC to the importer that CDC has given permission to import the 
nonhuman primate shipment (42 CFR 71.53); and
    (7) Certification statement of a material that is not known to 
contain or suspected of containing an infectious biological agent, or 
has been rendered noninfectious (42 CFR 71.54).
    Under the new policy, for those HHS/CDC items filed within ACE, 
individuals will continue to use the designated HHS/CDC application and 
filing processes; however, the processes will be electronic rather than 
paper-based.

III. Implementation of E.O. 13659

    Under this new Federal policy, which HHS/CDC has adopted, importers 
and brokers who file electronic entries for HHS/CDC-regulated items are 
now required to:
     Obtain the copy of the permit/permission letter, form, or 
document for submission to DIS:
    (1) The APHIS/CDC Form 2, Request to Transfer Select Agents and 
Toxins, is used by entities to request prior authorization of a 
transfer including importation into the United States of select 
agent(s) or toxin(s) from the Federal Select Agent Program as required 
by regulations (7 CFR 331, 9 CFR 121, and 42 CFR 73). The form is 
available at: http://www.selectagents.gov/form2.html.
    (2) CDC Form 0.0728--Permit to Import or Transfer Etiologic Agents 
or Vectors of Human Disease: http://www.cdc.gov/od/eaipp/index.htm. For 
infectious biological agents, infectious substances, and vectors of 
human disease, importers must have a permit from HHS/CDC's Import 
Permit Program.
    (3) A rabies vaccination certificate for a dog must be issued by a 
licensed veterinarian.
    (4) and (5) For certain animals and animal products capable of 
causing human disease, you must have a permit or letter of permission. 
See https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/index.html. Email inquiries about these importations to 
[email protected]. Note that CDC is transitioning to the CDC 
Import Permit for a Dog not immunized against Rabies during the first 
quarter of 2017. Permits will be issued using an online application 
process.
    (6) Only registered importers may bring nonhuman primates into the 
United States. HHS/CDC emails this approval to the broker after 
receiving notification of an incoming shipment by a registered 
importer. For information on how to become a registered importer, see 
http://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/monkeys.html. The HHS/CDC Nonhuman Primate Notification Message 
is automatically generated when a registered importer notifies HHS/CDC 
of an incoming shipment.
    (7) For material that is not known to contain or suspected of 
containing an infectious biological agent, or has been rendered 
noninfectious, importers must provide an importer certification 
statement with the imported material. The certification statement must 
include a detailed description of the material and a statement on 
official letterhead signed by the sender or recipient clearly stating 
that (1) the material is not known or suspected to contain an 
infectious biological agent and (2) how the person making the 
certification knows that the specimen does not contain an infectious 
biological agent; or why that person believes there is no reason to 
suspect that the specimen contains an infectious biological agent; or a 
detailed description of how the material was rendered noninfectious. 
For more information, see the Import Regulations for Infectious 
Biological Agents, Infectious Substances and Vectors at http://www.cdc.gov/phpr/ipp/regulations.htm.
     Follow all applicable rules for obtaining and certifying 
DIS software as set forth by CBP. For more information, see https://www.cbp.gov/trade/automated/systems.
     Transmit import filings to CBP via ACE.
     Transmit only information to CBP that has been requested 
by CBP or CDC.
     Check CDC's Importation Web site http://www.cdc.gov/importation/index.html regularly for updated guidance for electronic 
filing.
    The following processes will remain as paper-based submissions:
    A. Human remains for interment or cremation after entering the 
United States will not have an electronic entry within ACE. The 
required paper-based documents must continue to accompany the human 
remains, including those required by 42 CFR 71.55. For more 
information, see http://www.cdc.gov/quarantine/human-remains.html.
    B. Form 75.37--``Notice to Owners and Importers of Dogs 
(Requirement for Dog Confinement)'' Dogs imported into the United 
States are expected to be healthy and vaccinated against rabies. There 
is no requirement to have this information electronically available 
within ACE. CBP issues a notice to owners and importers post-arrival 
only when dogs arrive in the U.S. port of entry without the required 
vaccination, meet certain criteria, and have been preapproved by HHS/
CDC. For more information, visit the CDC Web page for how to bring an 
animal into the United States at http://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/dogs.html.
    For more information on this policy and updates or changes to the 
forms eligible for electronic submission, please see http://www.cdc.gov/importation/index.html.

IV. Paperwork Reduction Act

    This change does not institute a new collection of information. The 
collection of information, including the use of the DIS, has been 
previously approved by the Office of Management and Budget (OMB) in 
accordance with the requirements of the Paperwork Reduction Act (44 
U.S.C. 3507) and assigned the following OMB control numbers: (1) 
Foreign Quarantine: OMB Control No. 0920-0134, expiration date 5/31/
2019; (2) Import Permit Applications: OMB Control No. 0920-0199, 
expiration date 1/31/2017; (3) Requirements for the Importation of 
Nonhuman Primates into the United States: OMB Control No. 0920-0263, 
expiration date 9/30/2017; and (4) Possession, Use, and Transfer of 
Select Agents and Toxins: OMB Control No. 0920-0576, expiration date 
12/31/18.

    Dated: December 27, 2016.
Lauren Hoffmann,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-31750 Filed 12-29-16; 8:45 am]
 BILLING CODE 4163-18-P