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)
Food and Drug Administration
Federal Register Volume 82, Issue 101 (May 26, 2017)
| Page Range | 24357-24357 | |
| FR Document | 2017-10817 |
[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]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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\ ---------------------------------------------------------------------------------------------------------------- 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) ---------------------------------------------------------------------------------------------------------------- \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] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 101 / Friday, May 26, 2017 / Notices 24357
DEPARTMENT OF HEALTH AND North Bethesda, MD 20852, 301–796– import trade community, that require
HUMAN SERVICES 3794. user authentication.
SUPPLEMENTARY INFORMATION: In To create a secure user account for
Food and Drug Administration compliance with 44 U.S.C. 3507, FDA ITACS via the user account management
[Docket No. FDA–2016–N–2496] has submitted the following proposed function, a person would have to enter
collection of information to OMB for basic information such as the person’s
Agency Information Collection review and clearance. name, their employer’s name, a contact
Activities; Submission for Office of email address, an account password,
Management and Budget Review; Import Trade Auxiliary etc., into ITACS via the user account
Comment Request; Import Trade Communication System management function interface.
Auxiliary Communication System OMB Control Number 0910—NEW In the Federal Register of August 26,
The Import Trade Auxiliary 2016 (81 FR 58942), FDA published a
AGENCY: Food and Drug Administration,
Communication System (ITACS) 60-day notice requesting public
HHS.
currently provides the import trade comment on the proposed collection of
ACTION: Notice. information. FDA received one
community with four functions: The
SUMMARY: The Food and Drug ability to check the status of FDA- comment.
Administration (FDA or we) is regulated entries and lines, the ability to The comment, in pertinent part, asks
announcing that a proposed collection submit entry documentation if those with ITACS user accounts will
of information has been submitted to the electronically, the ability to be able to create searchable reports of
Office of Management and Budget electronically submit the location of historical data. This is not a planned
(OMB) for review and clearance under goods for those lines targeted for FDA function at this time. We appreciate the
the Paperwork Reduction Act of 1995 physical examination, and the ability to suggestion and will consider it in the
(PRA). check estimated laboratory analysis future as we continue to consider
completion dates. No user login further expansions and improvements of
DATES: Fax written comments on the
accounts are currently necessary to ITACS Account Management
collection of information by June 26,
access these functions; all that is functionality.
2017.
necessary is a valid customs entry The comment also suggests that we
ADDRESSES: To ensure that comments on number that has been successfully add additional ITACS functions in the
the information collection are received, transmitted to FDA. future, such as an ITACS function that
OMB recommends that written FDA has developed ITACS user explains why an entry reviewer has
comments be faxed to the Office of account management functionality. recommended detention and an ITACS
Information and Regulatory Affairs, Implementation of this functionality function that notes receipt of USDA
OMB, Attn: FDA Desk Officer, FAX: would allow members of the import grading certification and allows for the
202–395–7285, or emailed to oira_ trade community to create and manage certificate to be viewed within ITACS.
submission@omb.eop.gov. All secure user accounts in ITACS, which The commenter states that the addition
comments should be identified with the would enable FDA to distribute Notices of such ITACS functions would benefit
OMB control number 0910-New and of FDA Action to users electronically the import trade community. Although
title ‘‘Import Trade Auxiliary via email (rather than regular mail), the suggestions for additional ITACS
Communication System.’’ Also include enable users to download Notices of functions do not relate to the proposed
the FDA docket number found in FDA Action from within ITACS, and ITACS user account function
brackets in the heading of this allow users to view in ITACS the details information collection, we appreciate
document. of specific information requests which the suggestions and we will consider
FOR FURTHER INFORMATION CONTACT: are currently delivered via hard copy them in the future as we continue to
JonnaLynn Capezzuto, Office of Notices of FDA Action. ITACS user consider further expansions and
Operations, Food and Drug account management functionality improvements of ITACS functionality.
Administration, Three White Flint would also allow for potential future FDA estimates the burden of this
North, 10A63, 11601 Landsdown St., ITACS enhancements, requested by the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Creation of ITACS account .................................................. 5,000 1 5,000 0.5 2,500
(30 minutes)
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]
BILLING CODE 4164–01–P
VerDate Sep<11>2014 19:14 May 25, 2017 Jkt 241001 PO 00000 Frm 00083 Fmt 4703 Sfmt 9990 E:\FR\FM\26MYN1.SGM 26MYN1](https://thefederalregister.org/doc/82_FR_24458/page/1.svg)
Document Created: 2017-05-26 02:24:29
Document Modified: 2017-05-26 02:24:29
| 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 | Fax written comments on the collection of information by June 26, 2017. | |
| 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. | |
| FR Citation | 82 FR 24357 |
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