
[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)]
[Notices]
[Page 40889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14874]



[[Page 40889]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1548]


Invitation To Participate in Account Management Pilot for the 
Import Trade Auxiliary Communication System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
intends to conduct a pilot program to test and evaluate a new Import 
Trade Auxiliary Communication System (ITACS) Account Management 
function. Participation will be needed from a small group of Filers, 
Importers of Record, and Consignees, who will use the new ITACS Account 
Management function and provide feedback to FDA. FDA is inviting 
individual firms that wish to participate in this pilot program to 
submit participation requests via email.

DATES: To be considered for participation in this ITACS pilot, please 
send an email with the subject line ``ITACS Pilot Participation 
Request'' by July 7, 2016.

ADDRESSES: Submit pilot participation request emails to FDA's ITACS 
Support at itacssupport@fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Sandra Abbott, Division of Compliance 
Systems, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20852-1740, 301-796-3240, itacssupport@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    ITACS currently provides the import trade community with four 
functions: (1) The ability to check the status of FDA-regulated entries 
and lines, (2) the ability to submit entry documentation 
electronically, (3) the ability to electronically submit the location 
of goods availability for those lines targeted for FDA physical 
examination, and (4) the ability to check the estimated laboratory 
analysis completion dates. No user login accounts are necessary to 
access these functions; all that is necessary is a valid customs entry 
number that has been successfully transmitted to FDA. FDA has 
developed, and wishes to test, an ITACS user account management 
function.

II. Description and Conditions of the Pilot Program

    The purpose of this pilot is to test and evaluate a new ITACS 
account management function.
    This pilot will not impact the availability of current 
functionality of ITACS. Rather, it will provide FDA and a small group 
of volunteers with the opportunity to test expanded functionality of 
ITACS, specifically the use of user login accounts. User login accounts 
enable FDA to distribute Notices of FDA Action to users electronically 
via email (rather than regular mail) and enable users to download 
Notices of FDA Action from within ITACS. User login accounts also allow 
users to view in ITACS the details of specific information requests, 
which are currently delivered via hard copy Notices of FDA Action. 
Implementation of user login accounts would also allow for potential 
future ITACS enhancements, requested by the import trade community, 
that require user authentication.
    Pilot participants should be prepared to commit to: (1) Attending a 
kickoff training session, using the new functionality, (2) providing 
real-time feedback, and (3) participating in any followup meetings FDA 
deems necessary over the course of the pilot period. Pilot participants 
should also be willing to receive their Notices of FDA Action 
electronically in lieu of FDA distribution of paper Notices of FDA 
action.

III. Duration

    FDA currently anticipates the pilot to begin in July 2016 and to 
last through October 2016. However, these dates are subject to change. 
A more definitive schedule will be determined after FDA has selected 
volunteers. FDA will contact selected volunteers via email within 2 
weeks of the closure of the solicitation period.

IV. How To Apply for Participation in the Pilot

    To be considered for participation in this ITACS pilot, please send 
an email with the subject line ``ITACS Pilot Participation Request'' to 
itacssupport@fda.hhs.gov by July 7, 2016. Please limit participation 
requests to one individual per firm at the corporate level. That person 
should be a high-ranking individual within the firm who could have the 
capability to create and manage ITACS accounts for other users at 
different locations within the same firm. FDA expects to select nine or 
fewer participants for this pilot program.
    Please include the following information in your pilot 
participation request email:
     Your name, position, and contact information including 
email;
     your firm's name and address; and
     your firm's role in the importation of FDA-regulated 
entries (Filer, Importer of Record, Consignee, or any combination 
thereof).
    FDA will contact volunteers selected for participation in the pilot 
program via email within 2 weeks of the closure of the solicitation 
period.

    Dated: June 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14874 Filed 6-22-16; 8:45 am]
 BILLING CODE 4164-01-P


