Town Hall Discussion With the Director of the Center for Devices and Radiological Health and Other Senior Center Management, 6476-6477 [2011-2490]
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6476
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Notices
‘‘Guidance for Industry: Animal Drug
User Fees and Fee Waivers and
Reductions.’’ This document provides
guidance on the types of fees FDA is
authorized to collect under ADUFA, and
how to request waivers and reductions
from FDA’s animal drug user fees. The
guidance also describes the types of fees
and fee waivers and reductions, the
information FDA recommends
respondents submit in support of a
request for a fee waiver or reduction,
how respondents may submit such a
request, and FDA’s process for
reviewing requests.
Respondents to this collection of
information are new animal drug
sponsors. Requests for waivers or
reductions may be submitted by a
person paying any of the animal drug
user fees assessed—application fees,
product fees, establishment fees, or
sponsor fees.
In the Federal Register of December 2,
2010 (75 FR 75175), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FD&C Act section
740(d)(1)(A) Significant barrier to innovation ......................
740(d)(1)(B) Fees exceed cost ............................................
740(d)(1)(C) Free choice feeds ...........................................
740(d)(1)(D) Minor use or minor species ............................
740(d)(1)(E) Small business ................................................
Request for reconsideration of a decision ...........................
Request for review—(user fee appeal officer) .....................
Annual
frequency per
response
22
0
2
52
0
5
2
Total annual
responses
1
1
1
1
1
1
1
22
0
2
52
0
5
2
Total ..............................................................................
1 There
Dated: January 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–2441 Filed 2–3–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0053]
Town Hall Discussion With the Director
of the Center for Devices and
Radiological Health and Other Senior
Center Management
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
srobinson on DSKHWCL6B1PROD with NOTICES
Total hours
2
2
2
2
0
2
2
44
0
4
104
0
10
4
166
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system,
there are an estimated 250 sponsors of
products subject to ADUFA. However,
not all sponsors will have any
submissions in a given year and some
may have multiple submissions. The
total number of waiver requests is based
on the number of submission types
received by FDA in fiscal year 2008.
AGENCY:
Hours per
response
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled ‘‘Town Hall Discussion with the
Director of the Center for Devices and
Radiological Health and Other Senior
Center Management.’’ The purpose of
this public meeting in the Dallas-Fort
Worth, TX area is to engage in a
VerDate Mar<15>2010
16:05 Feb 03, 2011
Jkt 223001
dialogue about issues of importance to
FDA’s Center for Devices and
Radiological Health (CDRH) and to
members of the public, including the
medical device industry, healthcare
professionals, patients, and consumers.
Dates and Time: The public meeting
will be held on March 10, 2011, from 8
a.m. to 12 noon CST.
Location: The public meeting will be
held at the Irving Convention Center at
Las Colinas, 500 West Las Colinas Blvd.,
Irving, TX 75039. The meeting will not
be videotaped or webcast.
Contact: Heather Howell, Food and
Drug Administration; Center for Devices
and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 4320,
Silver Spring, MD 20993, 301–796–
5718, e-mail:
heather.howell@fda.hhs.gov.
Registration and Requests for Oral
Presentations: If you wish to attend the
public meeting, you must register online
at https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm239730.htm. Persons without
Internet access may call Heather Howell
at 301–796–5718 to register for the
meeting.
Provide complete contact information
for each attendee, including name, title,
company or organization, address, email, telephone and fax number.
Registration requests must be received
by 5 p.m. EST on Friday, February 25,
2011.
If you wish to make an oral
presentation during any of the sessions
at the meeting (see section II of this
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
document, Public Meeting), you must
indicate this at the time of registration.
FDA will do its best to accommodate
requests to speak. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin.
Registration is free and will be on a
first-come, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration the day of the public
meeting will be provided on a spaceavailable basis beginning at 7 a.m. CST.
If you need special accommodations
due to a disability, please contact Susan
Monahan at 301–796–5661, or by e-mail
at susan.monahan@fda.hhs.gov at least
7 days in advance of the meeting.
Comments: FDA is holding this public
meeting to share information and
discuss issues of importance to the
public, including the medical device
industry, healthcare professionals,
patients, and consumers.
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
E:\FR\FM\04FEN1.SGM
04FEN1
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Notices
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.
SUPPLEMENTARY INFORMATION:
I. Background
In 2010, CDRH held three Town Hall
meetings in Minneapolis, MN; Boston,
MA; and Los Angeles, CA to provide the
public with a new venue to discuss
issues of interest with the Center. Any
member of the public was invited to
provide comments to or ask questions of
CDRH participants. Due to the positive
feedback we received for holding these
meetings we plan to continue this
activity in 2011 in three different
locations.
II. Public Meeting
The objective of this public meeting is
to engage in a dialogue about issues that
are of importance to the public.
The public meeting will open with an
introduction of CDRH Senior Staff in
attendance. Following introductions, Dr.
Jeffrey Shuren, the Director of CDRH,
will describe CDRH’s Strategic Priorities
for 2011. Members of the public will
then be given the opportunity to present
comments to CDRH Senior Staff
followed by a Question and Answer
session during which any member of the
public may ask questions of the CDRH
Senior Staff on any topic of interest.
In advance of the meeting, additional
information, including a meeting agenda
with a speakers’ schedule, will be made
available on the Internet. This
information will be placed on file in the
public docket (docket number found in
brackets in the heading of this
document), which is available at
https://www.regulations.gov. This
information will also be available at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list).
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–2490 Filed 2–3–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Industry Exchange Workshop on Food
and Drug Administration Drug and
Device Requirements; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Southwest
Regional Office, in co-sponsorship with
SUMMARY:
6477
the Association of Food and Drug
Officials (AFDO), the Mid-Continental
Association of Food and Drug Officials
(MCAFDO), and the FDA Medical
Device Industry Coalition, is
announcing a public workshop entitled
‘‘The Future of Medical Products
Regulation: Ensuring Safety and
Integrity in a Global Market’’. This 2-day
public workshop is intended to provide
information about FDA drug and device
regulation to the regulated industry.
Date and Time: The public workshop
will be held on June 20 and 21, 2011,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Marriott Dallas/Plano at
Legacy Town Center, Plano, Texas, 7120
Dallas Pkwy., Plano, Texas 75024, 972–
473–6444, or toll-free 888–236–2427.
Attendees are responsible for their
own accommodations. To make
reservations at the Marriott Dallas/Plano
at Legacy Town Center, at the reduced
conference rate, contact the Marriott
Dallas/Plano at Legacy Town Center
before May 20, 2011, citing meeting
code ‘‘AFDO Conference’’.
Contact: David Arvelo, Food and Drug
Administration, 4040 North Central
Expressway, suite 900, Dallas, Texas
75204, 214–253–4952, FAX: 214–253–
4970, e-mail: David.Arvelo@fda.hhs.gov.
Registration: You are encouraged to
register by May 24, 2011. The AFDO
registration fees cover the cost of
facilities, materials, and breaks. Seats
are limited; therefore, please submit
your registration as soon as possible.
Course space will be filled in order of
receipt of registration. Those accepted
into the course will receive
confirmation. Registration will close
after the course is filled. Registration at
the site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 7:30 a.m. The cost of
registration follows:
COST OF REGISTRATION
srobinson on DSKHWCL6B1PROD with NOTICES
Government (AFDO/Mid-Continental AFDO Member) ........................................................................................................................
Government (Non-Member): ................................................................................................................................................................
Non-Government (AFDO/MCAFDO Member) .....................................................................................................................................
Non-Government (Non-Member) .........................................................................................................................................................
To be added to registration fee for public workshop registration postmarked after May 24, 2011 ....................................................
If you need special accommodations
due to a disability, please contact David
Arvelo (see Contact) at least 21 days in
advance of the workshop.
Registration instructions: To register,
please complete and submit an AFDO
Conference Registration Form, along
with a check or money order payable to
VerDate Mar<15>2010
16:05 Feb 03, 2011
Jkt 223001
‘‘AFDO’’. Please mail your completed
registration form and payment to:
AFDO, 2550 Kingston Rd., suite 311,
York, PA 17402. To register online,
please visit https://www.afdo.org. (FDA
has verified the Web site address, but is
not responsible for subsequent changes
PO 00000
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Fmt 4703
Sfmt 4703
$425.00
525.00
425.00
525.00
100.00
to the Web site after this document
publishes in the Federal Register.)
The registrar will also accept payment
through Visa and MasterCard credit
cards. For more information on the
public workshop, or for questions about
registration, please contact AFDO at
E:\FR\FM\04FEN1.SGM
04FEN1
]]>Agencies
[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6476-6477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2490]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0053]
Town Hall Discussion With the Director of the Center for Devices
and Radiological Health and Other Senior Center Management
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Town Hall Discussion with the Director of the Center
for Devices and Radiological Health and Other Senior Center
Management.'' The purpose of this public meeting in the Dallas-Fort
Worth, TX area is to engage in a dialogue about issues of importance to
FDA's Center for Devices and Radiological Health (CDRH) and to members
of the public, including the medical device industry, healthcare
professionals, patients, and consumers.
Dates and Time: The public meeting will be held on March 10, 2011,
from 8 a.m. to 12 noon CST.
Location: The public meeting will be held at the Irving Convention
Center at Las Colinas, 500 West Las Colinas Blvd., Irving, TX 75039.
The meeting will not be videotaped or webcast.
Contact: Heather Howell, Food and Drug Administration; Center for
Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66,
rm. 4320, Silver Spring, MD 20993, 301-796-5718, e-mail:
heather.howell@fda.hhs.gov.
Registration and Requests for Oral Presentations: If you wish to
attend the public meeting, you must register online at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm239730.htm. Persons without Internet access may call Heather Howell
at 301-796-5718 to register for the meeting.
Provide complete contact information for each attendee, including
name, title, company or organization, address, e-mail, telephone and
fax number. Registration requests must be received by 5 p.m. EST on
Friday, February 25, 2011.
If you wish to make an oral presentation during any of the sessions
at the meeting (see section II of this document, Public Meeting), you
must indicate this at the time of registration. FDA will do its best to
accommodate requests to speak. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and to request time for a joint presentation. FDA will
determine the amount of time allotted to each presenter and the
approximate time that each oral presentation is scheduled to begin.
Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration the day of the public meeting
will be provided on a space-available basis beginning at 7 a.m. CST.
If you need special accommodations due to a disability, please
contact Susan Monahan at 301-796-5661, or by e-mail at
susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.
Comments: FDA is holding this public meeting to share information
and discuss issues of importance to the public, including the medical
device industry, healthcare professionals, patients, and consumers.
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments. Submit electronic
comments to https://www.regulations.gov. Submit written comments to the
Division of Dockets
[[Page 6477]]
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.
SUPPLEMENTARY INFORMATION:
I. Background
In 2010, CDRH held three Town Hall meetings in Minneapolis, MN;
Boston, MA; and Los Angeles, CA to provide the public with a new venue
to discuss issues of interest with the Center. Any member of the public
was invited to provide comments to or ask questions of CDRH
participants. Due to the positive feedback we received for holding
these meetings we plan to continue this activity in 2011 in three
different locations.
II. Public Meeting
The objective of this public meeting is to engage in a dialogue
about issues that are of importance to the public.
The public meeting will open with an introduction of CDRH Senior
Staff in attendance. Following introductions, Dr. Jeffrey Shuren, the
Director of CDRH, will describe CDRH's Strategic Priorities for 2011.
Members of the public will then be given the opportunity to present
comments to CDRH Senior Staff followed by a Question and Answer session
during which any member of the public may ask questions of the CDRH
Senior Staff on any topic of interest.
In advance of the meeting, additional information, including a
meeting agenda with a speakers' schedule, will be made available on the
Internet. This information will be placed on file in the public docket
(docket number found in brackets in the heading of this document),
which is available at https://www.regulations.gov. This information
will also be available at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from
the list).
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2490 Filed 2-3-11; 8:45 am]
BILLING CODE 4160-01-P
