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)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 251 (December 30, 2016)
| Page Range | 96459-96460 | |
| FR Document | 2016-31750 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices 96459
screening rate, and (5) Priority evidence- accurately reported at the clinic level. assistance needs. In addition, data
based EBIs and SAs. CRCCP grantees Conversely, CDC plans to implement a collected will inform program
collected and reported CRCCP clinic- revised CRCCP clinic-level data improvement and help identify
level information for all partnering collection template that includes successful activities that need to be
health system primary care clinic sites. additional data variables related to maintained, replicated, or expanded.
For Program Years 2–5, based on implementation of EBIs and SAs, as OMB approval is requested for three
feedback from grantees, CDC proposes well as monitoring and evaluation years. The number of grantees decreased
use of updated data collection activities, at the clinic level. from 31 grantees in program year one to
instruments. Specifically, CDC plans to Redesigned data elements will enable 30 grantees in program year two. In
implement a revised CRCCP annual CDC to better gauge progress in meeting addition, the total estimated annualized
grantee survey that eliminates survey CRCCP program goals and monitor burden hours have decreased from 210
items related to implementation of EBIs implementation activities, evaluate to 204 hours. There are no costs to
and SAs as these data are more outcomes, and identify grantee technical respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response (in hours)
respondent (in hours)
CRCCP Grantees ............................. CRCCP Annual Grantee Survey ...... 30 1 24/60 12
CRCCP Clinic-level Information Col- 30 12 32/60 192
lection Template.
Total ........................................... ........................................................... ........................ ........................ ........................ 204
Leroy A. Richardson, paper-based processes in keeping with U.S. Customs and Border Protection and
Chief, Information Collection Review Office, Federal policy and improve operations its Partner Government Agencies (PGAs)
Office of Scientific Integrity, Office of the to further assist HHS/CDC’s mission to relating to the import or export of cargo
Associate Director for Science, Office of the protect public health. through a ‘‘single window’’ concept.
Director, Centers for Disease Control and CBP has developed ACE as the single
DATES: This action is effective December
Prevention. window for the trade community to
30, 2016.
[FR Doc. 2016–31740 Filed 12–29–16; 8:45 am] transmit electronically all required
FOR FURTHER INFORMATION CONTACT: For
BILLING CODE 4163–18–P
information regarding this Notice: cargo-related information.
Ashley A. Marrone, J.D., Division of This notice announces HHS/CDC’s
DEPARTMENT OF HEALTH AND Global Migration and Quarantine, updated policy concerning the
HUMAN SERVICES Centers for Disease Control and electronic transmission of HHS/CDC
Prevention, 1600 Clifton Road NE., MS– permits, forms, and documents using
Centers for Disease Control and E03, Atlanta, GA 30329. For information CBP’s Document Image System (DIS).
Prevention regarding CDC operations related to this This DIS capability will satisfy the
Notice: Kendra Stauffer, D.V.M., HHS/CDC data and electronic document
Electronic Filing of Certain Import Data Division of Global Migration and requirements for any entry filed
Into the Document Image System Quarantine, Quarantine and Border electronically in ACE and enable the
Through the Automated Commercial Health Services Branch, Importations trade community to have a CBP-
Environment and Animal Contact Team, Centers for managed single window for the
AGENCY: Centers for Disease Control and Disease Control and Prevention, 1600 electronic submission of data and
Prevention, Department of Health and Clifton Road NE., MS–E28, Atlanta, GA documents required by HHS/CDC
Human Services. 30345. Either may also be reached by during the cargo importation and review
telephone 404–498–1600 or email process. The list of PGA forms and
ACTION: Notice.
CDCAnimalImports@cdc.gov. documents, including documents
SUMMARY: Through publication of this SUPPLEMENTARY INFORMATION: required by HHS/CDC, which may be
notice, the Centers for Disease Control transmitted using DIS may be found at
and Prevention (CDC) located within the I. Background http://www.cbp.gov/trade/ace/features
Department of Health and Human On February 19, 2014, the President under the DIS tab by clicking on the
Services (HHS) announces a new policy signed Executive Order 13659, ‘‘ACE PGA Forms List’’ hyperlink in the
and guidance for the electronic Streamlining the Export/Import Process ‘‘References’’ column. The HHS/CDC
submission of data related to the for America’s Businesses (79 FR 10655), permits, forms, and documents listed in
importation of CDC-regulated items in that requires the completion and the ACE PGA Forms List are those
the International Trade Data System government-wide utilization by eligible to be transmitted using DIS.
(ITDS). Certain data, forms, and December 31, 2016 of the International
srobinson on DSK5SPTVN1PROD with NOTICES
II. Current HHS/CDC Paper-Based
documents required to be submitted to Trade Data System (ITDS) and Procedures
HHS/CDC will be submitted through the establishes a two-tiered governance
U.S. Customs and Border Protection process to oversee its implementation. Under current applicable HHS/CDC
(CBP)’s Automated Commercial Once fully implemented, ITDS, through policy and operations, the importation
Environment (ACE) system, using the the Automated Commercial of HHS/CDC-regulated commodities
Document Image System (DIS). This Environment (ACE), will allow into the customs territory of the United
electronic process will replace certain importers to submit the data required by States typically requires the submission
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![96460 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices
of one or more of the following (3) A rabies vaccination certificate for index.html regularly for updated
documents: a dog must be issued by a licensed guidance for electronic filing.
(1) Animal and Plant Health veterinarian. The following processes will remain
Inspection Service (APHIS)/CDC Form (4) and (5) For certain animals and as paper-based submissions:
2—Request to Transfer Select Agents animal products capable of causing
and Toxins (42 CFR 73); human disease, you must have a permit A. Human remains for interment or
or letter of permission. See https:// cremation after entering the United
(2) CDC Form 0.0728—Permit to
www.cdc.gov/importation/bringing-an- States will not have an electronic entry
Import or Transfer Etiologic Agents or
animal-into-the-united-states/ within ACE. The required paper-based
Vectors of Human Disease (42 CFR
index.html. Email inquiries about these documents must continue to accompany
71.54);
importations to the human remains, including those
(3) Rabies Vaccination Certificate (42
CDCAnimalImports@cdc.gov. Note that required by 42 CFR 71.55. For more
CFR 71.51);
CDC is transitioning to the CDC Import information, see http://www.cdc.gov/
(4) CDC Approval of Confinement quarantine/human-remains.html.
Agreement Issuance Letter (42 CFR Permit for a Dog not immunized against
71.51); Rabies during the first quarter of 2017. B. Form 75.37—‘‘Notice to Owners
Permits will be issued using an online and Importers of Dogs (Requirement for
(5) CDC Permission Letter—Permit to
application process. Dog Confinement)’’ Dogs imported into
Import African Rodents, Civets, or
(6) Only registered importers may the United States are expected to be
Turtles (42 CFR 71.56, 42 CFR 71.32(b),
bring nonhuman primates into the healthy and vaccinated against rabies.
42 CFR 71.52);
United States. HHS/CDC emails this There is no requirement to have this
(6) CDC Nonhuman Primate approval to the broker after receiving
Notification Message—Confirmation information electronically available
notification of an incoming shipment by within ACE. CBP issues a notice to
from CDC to the importer that CDC has a registered importer. For information
given permission to import the owners and importers post-arrival only
on how to become a registered importer, when dogs arrive in the U.S. port of
nonhuman primate shipment (42 CFR see http://www.cdc.gov/importation/
71.53); and entry without the required vaccination,
bringing-an-animal-into-the-united- meet certain criteria, and have been
(7) Certification statement of a states/monkeys.html. The HHS/CDC
material that is not known to contain or preapproved by HHS/CDC. For more
Nonhuman Primate Notification information, visit the CDC Web page for
suspected of containing an infectious Message is automatically generated
biological agent, or has been rendered how to bring an animal into the United
when a registered importer notifies States at http://www.cdc.gov/
noninfectious (42 CFR 71.54). HHS/CDC of an incoming shipment. importation/bringing-an-animal-into-
Under the new policy, for those HHS/ (7) For material that is not known to the-united-states/dogs.html.
CDC items filed within ACE, contain or suspected of containing an
individuals will continue to use the infectious biological agent, or has been For more information on this policy
designated HHS/CDC application and rendered noninfectious, importers must and updates or changes to the forms
filing processes; however, the processes provide an importer certification eligible for electronic submission,
will be electronic rather than paper- statement with the imported material. please see http://www.cdc.gov/
based. The certification statement must include importation/index.html.
III. Implementation of E.O. 13659 a detailed description of the material IV. Paperwork Reduction Act
and a statement on official letterhead
Under this new Federal policy, which signed by the sender or recipient clearly This change does not institute a new
HHS/CDC has adopted, importers and stating that (1) the material is not known collection of information. The collection
brokers who file electronic entries for or suspected to contain an infectious of information, including the use of the
HHS/CDC-regulated items are now biological agent and (2) how the person DIS, has been previously approved by
required to: making the certification knows that the the Office of Management and Budget
• Obtain the copy of the permit/ specimen does not contain an infectious (OMB) in accordance with the
permission letter, form, or document for biological agent; or why that person requirements of the Paperwork
submission to DIS: believes there is no reason to suspect Reduction Act (44 U.S.C. 3507) and
(1) The APHIS/CDC Form 2, Request that the specimen contains an infectious assigned the following OMB control
to Transfer Select Agents and Toxins, is biological agent; or a detailed numbers: (1) Foreign Quarantine: OMB
used by entities to request prior description of how the material was Control No. 0920–0134, expiration date
authorization of a transfer including rendered noninfectious. For more 5/31/2019; (2) Import Permit
importation into the United States of information, see the Import Regulations Applications: OMB Control No. 0920–
select agent(s) or toxin(s) from the for Infectious Biological Agents, 0199, expiration date 1/31/2017; (3)
Federal Select Agent Program as Infectious Substances and Vectors at Requirements for the Importation of
required by regulations (7 CFR 331, 9 http://www.cdc.gov/phpr/ipp/ Nonhuman Primates into the United
CFR 121, and 42 CFR 73). The form is regulations.htm. States: OMB Control No. 0920–0263,
available at: http:// • Follow all applicable rules for expiration date 9/30/2017; and (4)
www.selectagents.gov/form2.html. obtaining and certifying DIS software as Possession, Use, and Transfer of Select
(2) CDC Form 0.0728—Permit to set forth by CBP. For more information, Agents and Toxins: OMB Control No.
Import or Transfer Etiologic Agents or see https://www.cbp.gov/trade/ 0920–0576, expiration date 12/31/18.
srobinson on DSK5SPTVN1PROD with NOTICES
Vectors of Human Disease: http:// automated/systems.
Dated: December 27, 2016.
www.cdc.gov/od/eaipp/index.htm. For • Transmit import filings to CBP via
infectious biological agents, infectious ACE. Lauren Hoffmann,
substances, and vectors of human • Transmit only information to CBP Acting Executive Secretary, Centers for
disease, importers must have a permit that has been requested by CBP or CDC. Disease Control and Prevention.
from HHS/CDC’s Import Permit • Check CDC’s Importation Web site [FR Doc. 2016–31750 Filed 12–29–16; 8:45 am]
Program. http://www.cdc.gov/importation/ BILLING CODE 4163–18–P
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Document Created: 2016-12-30 05:16:12
Document Modified: 2016-12-30 05:16:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This action is effective December 30, 2016. | |
| 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] | |
| FR Citation | 81 FR 96459 |
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