82 FR 24357 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Import Trade Auxiliary Communication System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 101 (May 26, 2017)

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Page 24357]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10817]



[[Page 24357]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2496]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Import Trade 
Auxiliary Communication System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by June 
26, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Import Trade Auxiliary Communication System.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Import Trade Auxiliary Communication System

OMB Control Number 0910--NEW

    The Import Trade Auxiliary Communication System (ITACS) currently 
provides the import trade community with four functions: The ability to 
check the status of FDA-regulated entries and lines, the ability to 
submit entry documentation electronically, the ability to 
electronically submit the location of goods for those lines targeted 
for FDA physical examination, and the ability to check estimated 
laboratory analysis completion dates. No user login accounts are 
currently 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 ITACS user account management functionality. 
Implementation of this functionality would allow members of the import 
trade community to create and manage secure user accounts in ITACS, 
which would enable FDA to distribute Notices of FDA Action to users 
electronically via email (rather than regular mail), enable users to 
download Notices of FDA Action from within ITACS, and allow users to 
view in ITACS the details of specific information requests which are 
currently delivered via hard copy Notices of FDA Action. ITACS user 
account management functionality would also allow for potential future 
ITACS enhancements, requested by the import trade community, that 
require user authentication.
    To create a secure user account for ITACS via the user account 
management function, a person would have to enter basic information 
such as the person's name, their employer's name, a contact email 
address, an account password, etc., into ITACS via the user account 
management function interface.
    In the Federal Register of August 26, 2016 (81 FR 58942), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment.
    The comment, in pertinent part, asks if those with ITACS user 
accounts will be able to create searchable reports of historical data. 
This is not a planned function at this time. We appreciate the 
suggestion and will consider it in the future as we continue to 
consider further expansions and improvements of ITACS Account 
Management functionality.
    The comment also suggests that we add additional ITACS functions in 
the future, such as an ITACS function that explains why an entry 
reviewer has recommended detention and an ITACS function that notes 
receipt of USDA grading certification and allows for the certificate to 
be viewed within ITACS. The commenter states that the addition of such 
ITACS functions would benefit the import trade community. Although the 
suggestions for additional ITACS functions do not relate to the 
proposed ITACS user account function information collection, we 
appreciate the suggestions and we will consider them in the future as 
we continue to consider further expansions and improvements of ITACS 
functionality.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Creation of ITACS account.......           5,000               1           5,000             0.5           2,500
                                                                                    (30 minutes)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10817 Filed 5-25-17; 8:45 am]
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