81 FR 40889 - Invitation To Participate in Account Management Pilot for the Import Trade Auxiliary Communication System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 121 (June 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 121 (June 23, 2016)
| Page Range | 40889-40889 | |
| FR Document | 2016-14874 |
[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)] [Notices] [Page 40889] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14874] [[Page 40889]] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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 [email protected] 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
![Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Notices 40889
DEPARTMENT OF HEALTH AND II. Description and Conditions of the Please include the following
HUMAN SERVICES Pilot Program information in your pilot participation
request email:
Food and Drug Administration The purpose of this pilot is to test and • Your name, position, and contact
evaluate a new ITACS account information including email;
[Docket No. FDA–2016–N–1548] management function. • your firm’s name and address; and
This pilot will not impact the • your firm’s role in the importation
Invitation To Participate in Account availability of current functionality of of FDA-regulated entries (Filer, Importer
Management Pilot for the Import Trade ITACS. Rather, it will provide FDA and of Record, Consignee, or any
Auxiliary Communication System a small group of volunteers with the combination thereof).
opportunity to test expanded FDA will contact volunteers selected
AGENCY: Food and Drug Administration, functionality of ITACS, specifically the for participation in the pilot program via
HHS. use of user login accounts. User login email within 2 weeks of the closure of
ACTION: Notice. accounts enable FDA to distribute the solicitation period.
Notices of FDA Action to users Dated: June 17, 2016.
SUMMARY: The Food and Drug
electronically via email (rather than Leslie Kux,
Administration (FDA) is announcing
regular mail) and enable users to Associate Commissioner for Policy.
that it intends to conduct a pilot
download Notices of FDA Action from [FR Doc. 2016–14874 Filed 6–22–16; 8:45 am]
program to test and evaluate a new
within ITACS. User login accounts also
Import Trade Auxiliary Communication BILLING CODE 4164–01–P
allow users to view in ITACS the details
System (ITACS) Account Management
of specific information requests, which
function. Participation will be needed
are currently delivered via hard copy DEPARTMENT OF HEALTH AND
from a small group of Filers, Importers
Notices of FDA Action. Implementation HUMAN SERVICES
of Record, and Consignees, who will use
of user login accounts would also allow
the new ITACS Account Management
for potential future ITACS Food and Drug Administration
function and provide feedback to FDA.
enhancements, requested by the import
FDA is inviting individual firms that [Docket No. FDA–2016–N–0001]
trade community, that require user
wish to participate in this pilot program
authentication. Pediatric Oncology Subcommittee of
to submit participation requests via
email. Pilot participants should be prepared the Oncologic Drugs Advisory
to commit to: (1) Attending a kickoff Committee; Amendment of Notice
DATES: To be considered for training session, using the new
participation in this ITACS pilot, please AGENCY: Food and Drug Administration,
functionality, (2) providing real-time
send an email with the subject line HHS.
feedback, and (3) participating in any
‘‘ITACS Pilot Participation Request’’ by followup meetings FDA deems ACTION: Notice.
July 7, 2016. necessary over the course of the pilot SUMMARY: The Food and Drug
ADDRESSES: Submit pilot participation period. Pilot participants should also be Administration (FDA) is announcing an
request emails to FDA’s ITACS Support willing to receive their Notices of FDA amendment to the notice of meeting of
at itacssupport@fda.hhs.gov. Action electronically in lieu of FDA the Pediatric Oncology Subcommittee of
FOR FURTHER INFORMATION CONTACT: distribution of paper Notices of FDA the Oncologic Drugs Advisory
Sandra Abbott, Division of Compliance action. Committee. This meeting was
Systems, Office of Enforcement and III. Duration announced in the Federal Register of
Import Operations, Office of Regulatory June 16, 2016. The amendment is being
Affairs, Food and Drug Administration, FDA currently anticipates the pilot to made to reflect a change in the
12420 Parklawn Dr., Rockville, MD begin in July 2016 and to last through Procedure portion of the document.
20852–1740, 301–796–3240, October 2016. However, these dates are There are no other changes.
itacssupport@fda.hhs.gov. subject to change. A more definitive FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION: schedule will be determined after FDA Lauren D. Tesh, Center for Drug
has selected volunteers. FDA will Evaluation and Research, Food and
I. Background contact selected volunteers via email Drug Administration, 10903 New
ITACS currently provides the import within 2 weeks of the closure of the Hampshire Ave., Bldg. 31, Rm. 2417,
trade community with four functions: solicitation period. Silver Spring, MD 20993–0002, 301–
(1) The ability to check the status of IV. How To Apply for Participation in 796–9001, FAX: 301–847–8533, email:
FDA-regulated entries and lines, (2) the the Pilot ODAC@fda.hhs.gov; or FDA Advisory
ability to submit entry documentation Committee Information Line, 1–800–
electronically, (3) the ability to To be considered for participation in 741–8138 (301–443–0572 in the
electronically submit the location of this ITACS pilot, please send an email Washington, DC area). Please call the
goods availability for those lines with the subject line ‘‘ITACS Pilot Information Line for up-to-date
targeted for FDA physical examination, Participation Request’’ to itacssupport@ information on this meeting.
and (4) the ability to check the fda.hhs.gov by July 7, 2016. Please limit SUPPLEMENTARY INFORMATION: In the
estimated laboratory analysis participation requests to one individual Federal Register of June 16, 2016, 81 FR
asabaliauskas on DSK3SPTVN1PROD with NOTICES
completion dates. No user login per firm at the corporate level. That 39274, FDA announced that a meeting
accounts are necessary to access these person should be a high-ranking of the Pediatric Oncology Subcommittee
functions; all that is necessary is a valid individual within the firm who could of the Oncologic Drugs Advisory
customs entry number that has been have the capability to create and manage Committee would be held on June 28
successfully transmitted to FDA. FDA ITACS accounts for other users at and 29, 2016. On page 39274, in the
has developed, and wishes to test, an different locations within the same firm. third column, the Procedure portion of
ITACS user account management FDA expects to select nine or fewer the document is changed to read as
function. participants for this pilot program. follows:
VerDate Sep<11>2014 17:24 Jun 22, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\23JNN1.SGM 23JNN1](https://thefederalregister.org/doc/81_FR_41010/page/1.svg)
Document Created: 2018-02-08 07:41:33
Document Modified: 2018-02-08 07:41:33
| 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 | 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. | |
| 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, [email protected] | |
| FR Citation | 81 FR 40889 |
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