Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Amendment of Notice, 40889-40890 [2016-14827]
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Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Description and Conditions of the
Pilot Program
Food and Drug Administration
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.
[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.
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.
SUMMARY:
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:
DATES:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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.
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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.
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40889
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee. This meeting was
announced in the Federal Register of
June 16, 2016. The amendment is being
made to reflect a change in the
Procedure portion of the document.
There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ODAC@fda.hhs.gov; or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 16, 2016, 81 FR
39274, FDA announced that a meeting
of the Pediatric Oncology Subcommittee
of the Oncologic Drugs Advisory
Committee would be held on June 28
and 29, 2016. On page 39274, in the
third column, the Procedure portion of
the document is changed to read as
follows:
SUMMARY:
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40890
Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Notices
FDA regrets that it was unable to
publish this notice 15 days prior to the
June 28 and 29, 2016, Pediatric
Oncology Subcommittee of the
Oncologic Drugs Advisory Committee
meeting. Because the Agency believes
there is some urgency to bring these
issues to public discussion and
qualified members of the Pediatric
Oncology Subcommittee of the
Oncologic Drugs Advisory Committee
meeting were available at this time, the
Commissioner of Food and Drugs
concluded that it was in the public
interest to hold this meeting even if
there was not sufficient time for the
customary 15-day public notice.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: June 16, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–14827 Filed 6–22–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1280]
International Conference on
Harmonisation; Electronic
Transmission of Postmarket Individual
Case Safety Reports for Drugs and
Biologics, Excluding Vaccines;
Availability of Food and Drug
Administration Regional
Implementation Specifications for ICH
E2B(R3) Reporting to the Food and
Drug Administration Adverse Event
Reporting System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of its FDA Adverse Event
Reporting System (FAERS) Regional
Implementation Specifications for the
International Conference on
Harmonisation (ICH) E2B(R3)
Specification. FDA is making this
technical specifications document
available to assist interested parties in
electronically submitting individual
case safety reports (ICSRs) (and ICSR
attachments) to the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER). This document,
entitled ‘‘FDA Regional Implementation
Specifications for ICH E2B(R3)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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17:24 Jun 22, 2016
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Implementation: Postmarket Submission
of Individual Case Safety Reports
(ICSRs) for Drugs and Biologics,
Excluding Vaccines’’ supplements the
‘‘E2B(R3) Electronic Transmission of
Individual Case Safety Reports (ICSRs)
Implementation Guide—Data Elements
and Message Specification’’ final
guidance for industry and describes
FDA’s technical approach for receiving
ICSRs, for incorporating regionally
controlled terminology, and for adding
region-specific data elements when
reporting to FAERS.
DATES: Submit either electronic or
written comments on the Regional
Implementation Specifications
document at any time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
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Instructions: All submissions received
must include the Docket No. FDA–
2016–D–1280 for ‘‘FDA Regional
Implementation Specifications for ICH
E2B(R3) Implementation: Postmarket
Submission of Individual Case Safety
Reports for Drugs and Biologics,
Excluding Vaccines.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
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]]>Agencies
[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)]
[Notices]
[Pages 40889-40890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14827]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee. This meeting
was announced in the Federal Register of June 16, 2016. The amendment
is being made to reflect a change in the Procedure portion of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, email: ODAC@fda.hhs.gov; or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). Please call the Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 16, 2016, 81
FR 39274, FDA announced that a meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee would be held on
June 28 and 29, 2016. On page 39274, in the third column, the Procedure
portion of the document is changed to read as follows:
[[Page 40890]]
FDA regrets that it was unable to publish this notice 15 days prior
to the June 28 and 29, 2016, Pediatric Oncology Subcommittee of the
Oncologic Drugs Advisory Committee meeting. Because the Agency believes
there is some urgency to bring these issues to public discussion and
qualified members of the Pediatric Oncology Subcommittee of the
Oncologic Drugs Advisory Committee meeting were available at this time,
the Commissioner of Food and Drugs concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: June 16, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-14827 Filed 6-22-16; 8:45 am]
BILLING CODE 4164-01-P
