Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments, 58411 [2010-23972]
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Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: September 20, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–23979 Filed 9–23–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0481]
Center for Veterinary Medicine
eSubmitter Workshop; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Center for Veterinary
Medicine (CVM) eSubmitter Workshop.’’
The purpose of the public workshop is
to provide the regulated animal health
industry that submits new animal drug
applications to CVM’s Office of New
Animal Drug Evaluation (ONADE)
access to the beta-release of the
electronic submission tool (eSubmitter)
developed by CVM as agreed to in the
Animal Drug User Fee Amendments
(ADUFA II) of 2008 (https://
www.fda.gov/ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/
ucm044941.htm). The ONADE will be
soliciting feedback on both the
eSubmitter tool and its compatibility
with the industry’s current IT systems,
as well as the questions asked within
the tool.
This workshop will fulfill one of the
10 workshops agreed to in ADUFA II.
The workshop will provide insight on
the eSubmitter template development
and its customization for the animal
health industry as well as providing
break-out sessions in which specific
submissions will be built as part of the
demonstration. Lastly, the ONADE will
be seeking up to nine participating
companies to work with CVM in testing
the transmission of eSubmitter
developed files through FDA’s
electronic submission gateway (ESG)
and CVM’s electronic submission
system (ESS). Information about the
workshop and availability of the
eSubmitter tool can be found on FDA’s
eSubmitter Web site at https://
www.fda.gov/ForIndustry/
FDAeSubmitter/default.htm.
VerDate Mar<15>2010
16:12 Sep 23, 2010
Jkt 220001
Dates and Time: The public workshop
will be held on October 21, 2010, from
9 a.m. to 4 p.m. (EST/EDST).
Location: The public workshop will
be held virtually through both Adobe
Connect Pro on-line and with
conference call-in numbers. Both the
call-in numbers and the Adobe Connect
Pro web link will be emailed to all
registrants.
Contact Person: Charles Andres,
Center for Veterinary Medicine (HFV–
100), Food and Drug Administration,
7520 Standish Pl., Rockville, MD 20855,
240–276–8229, email:
charles.andres@fda.hhs.gov.
Registration: Registration for the
workshop can be made at: https://
collaboration.fda.gov/
cvm_esubmitter_workshop_oct21/event/
registration.html on or before October
15, 2010. There is no registration fee for
the public workshop. If you need
special accommodations due to a
disability, please contact Charles
Andres (see Contact Person) at least 7
days in advance.
Comments: FDA is holding this public
workshop to obtain information about
the eSubmitter tool. The deadline for
submitting comments regarding this
public workshop is December 31, 2010.
Regardless of whether a person
attended the public workshop,
interested persons may submit either
electronic or written comments
regarding this document. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville MD 20852. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A recording of the public
workshop will be available on the
Internet at https://www.fda.gov/
ForIndustry/FDAeSubmitter/
default.htm.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
58411
Dated: September 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–23972 Filed 9–23–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3233–N]
Medicare Program; Town Hall Meeting
on the Physician Compare Web Site,
October 27, 2010
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
Section 10331 of the Patient
Protection and Affordable Care Act of
2010, ‘‘Public Reporting of Performance
Information’’ requires CMS to establish
a Physician Compare Web site by
January 1, 2011. This notice announces
a Town Hall meeting to discuss the
Physician Compare Web site. The
purpose of this Town Hall meeting is to
solicit input from stakeholders on the
Physician Compare Web site. The
opinions and alternatives provided
during this meeting will assist us in
future expansion of the Physician
Compare Web site. The meeting is open
to the public, but attendance is limited
to space available.
DATES: Meeting Date: Wednesday,
October 27, 2010 from 1 to 5 p.m.,
eastern daylight time (e.d.t.).
Timeframe for Meeting Registration:
Monday, September 27, 2010 through
Wednesday, October 13, 2010 at 5 p.m.,
e.d.t.
Deadline for Special
Accommodations Requests: Wednesday,
October 13, 2010 at 5 p.m., e.d.t.
ADDRESSES: Meeting Location: The
Town Hall meeting will be held in the
main auditorium of the Centers for
Medicare and Medicaid Services single
site, 7500 Security Boulevard,
Baltimore, MD 21244.
Registration and Special
Accommodations: Persons interested in
attending the meeting or participating
by teleconference must register by
completing the online registration via
the Web site at https://
www.usqualitymeasures.org/qm/.
Individuals who require special
accommodations should send a request
via e-mail or regular mail to the contact
specified in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
SUMMARY:
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Page 58411]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23972]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0481]
Center for Veterinary Medicine eSubmitter Workshop; Public
Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Center for Veterinary Medicine (CVM) eSubmitter
Workshop.'' The purpose of the public workshop is to provide the
regulated animal health industry that submits new animal drug
applications to CVM's Office of New Animal Drug Evaluation (ONADE)
access to the beta-release of the electronic submission tool
(eSubmitter) developed by CVM as agreed to in the Animal Drug User Fee
Amendments (ADUFA II) of 2008 (https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm044941.htm). The ONADE will be soliciting
feedback on both the eSubmitter tool and its compatibility with the
industry's current IT systems, as well as the questions asked within
the tool.
This workshop will fulfill one of the 10 workshops agreed to in
ADUFA II. The workshop will provide insight on the eSubmitter template
development and its customization for the animal health industry as
well as providing break-out sessions in which specific submissions will
be built as part of the demonstration. Lastly, the ONADE will be
seeking up to nine participating companies to work with CVM in testing
the transmission of eSubmitter developed files through FDA's electronic
submission gateway (ESG) and CVM's electronic submission system (ESS).
Information about the workshop and availability of the eSubmitter tool
can be found on FDA's eSubmitter Web site at https://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.
Dates and Time: The public workshop will be held on October 21,
2010, from 9 a.m. to 4 p.m. (EST/EDST).
Location: The public workshop will be held virtually through both
Adobe Connect Pro on-line and with conference call-in numbers. Both the
call-in numbers and the Adobe Connect Pro web link will be emailed to
all registrants.
Contact Person: Charles Andres, Center for Veterinary Medicine
(HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville,
MD 20855, 240-276-8229, email: charles.andres@fda.hhs.gov.
Registration: Registration for the workshop can be made at: https://collaboration.fda.gov/cvm_esubmitter_workshop_oct21/event/registration.html on or before October 15, 2010. There is no
registration fee for the public workshop. If you need special
accommodations due to a disability, please contact Charles Andres (see
Contact Person) at least 7 days in advance.
Comments: FDA is holding this public workshop to obtain information
about the eSubmitter tool. The deadline for submitting comments
regarding this public workshop is December 31, 2010.
Regardless of whether a person attended the public workshop,
interested persons may submit either electronic or written comments
regarding this document. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A recording of the public workshop will be available on
the Internet at https://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.
Dated: September 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23972 Filed 9-23-10; 8:45 am]
BILLING CODE 4160-01-S
