Town Hall Discussion With the Director of the Center for Devices and Radiological Health and Other Senior Center Management, 13642-13643 [2011-5735]
Download as PDF
<![CDATA[
13642
Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
presentation may be granted if time
permits.
Persons who registered in advance for
the hearing should check in at the onsite
registration desk between 8:30 a.m. and
9 a.m. Persons who wish to register
onsite on the day of the hearing should
do so at the registration desk between
8:30 a.m. and 9 a.m. FDA encourages all
participants to attend the entire hearing.
V. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
table 1 of this document) either
electronic or written comments
regarding this document. 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.
VI. 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.
mstockstill on DSKH9S0YB1PROD with NOTICES
VII. References
The following references are on
display at the Division of Dockets
Management (see Transcripts), between
9 a.m. and 4 p.m., Monday through
Friday. (FDA has verified the following
Web site addresses, but FDA is not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. President’s Food Safety Working
Group findings, https://
www.foodsafetyworkinggroup.gov/
ContentKeyFindings/
HomeKeyFindings.htm.
2. Codex Guidelines on the Judgment
of Equivalence of Sanitary Measures
Associated with Food Inspection and
Certification systems (CAC/GL 53/2003):
https://www.codexalimentarius.net/
download/standards/10047/
CXG_053e.pdf.
VerDate Mar<15>2010
16:20 Mar 11, 2011
Jkt 223001
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5943 Filed 3–10–11; 4:15 pm]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
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.
Notice of public meeting;
request for comments.
ACTION:
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 Orlando, FL,
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, health care
professionals, patients, and consumers.
Date and Time: The public meeting
will be held on May 5, 2011, from 8 a.m.
to 12 noon EST.
Location: The public meeting will be
held at the Sheraton Orlando Downtown
Hotel, 400 West Livingston St., Orlando,
FL 32801. Attendees requiring sleeping
rooms should call 401–843–6664 and
request the group rate for the ‘‘Food &
Drug Administration Town Hall
Meeting’’ room block. The meeting will
not be videotaped or Web cast.
Contact: Heather Howell, Center for
Devices and Radiological Health, Food
and Drug Administration, 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/
ucm244462.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, and telephone and fax number.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Registration requests must be received
by 5 p.m. EST on Friday, April 22, 2011.
If you wish to make an oral
presentation during any of the sessions
at the meeting (see section II of this
document), 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. EST.
If you need special accommodations
due to a disability, please contact Susan
Monahan, 301–796–5661 or
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, health care 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
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. We received
positive feedback on these meetings and
E:\FR\FM\14MRN1.SGM
14MRN1
Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices
plan to continue this activity in 2011 in
three different locations. In March 2011,
the meeting will be held in Dallas, TX.
After this meeting, CDRH will host one
more this year in the San Francisco, CA,
area.
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
mstockstill on DSKH9S0YB1PROD with NOTICES
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: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–5735 Filed 3–11–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:20 Mar 11, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–N–0134, FDA–
2011–N–0143, FDA–2011–N–0144, FDA–
2011–N–0145, and FDA–2011–N–0146]
FDA Food Safety Modernization Act:
Title III—A New Paradigm for
Importers; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comment.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘FDA Food
Safety Modernization Act: Title III—A
New Paradigm for Importers.’’ The
purpose of the public meeting is to
provide interested persons an
opportunity to discuss implementation
of the import safety provisions of the
recently enacted FDA Food Safety
Modernization Act (FSMA). FDA is
seeking information on importer
verification, the Voluntary Qualified
Importer Program, import certifications
for food, and third-party accreditation.
In a separate notice published elsewhere
in this issue of the Federal Register,
FDA is announcing a public hearing to
provide stakeholders the opportunity to
discuss FDA’s use of international
comparability assessments as a
mechanism to enhance the safety of
imported foods and animal feed and
lessons learned through equivalence
determinations. The public hearing will
include a separate discussion of FDA’s
efforts to gather information from
regulators in other countries regarding
the regulatory policies, practices, and
programs they currently use to ensure
the safety of foods and animal feed
imported into their countries.
DATES: See ‘‘How to Participate in the
Meeting’’ in the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
Patricia M. Kuntze, Office of External
Affairs, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
rm. 5322, Silver Spring, MD 20993,
301–796–8641,
Patricia.Kuntze@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
FSMA (Pub. L. 111–353) amends the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to establish the
foundation for a modernized,
prevention-based food safety system
that emphasizes accountability for
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
13643
domestic and foreign food and animal
feed firms in the supply chain from farm
to U.S. table. In particular, title III of
FSMA significantly enhances FDA’s
authority for oversight of the millions of
food products that enter the United
States each year and, among other
things, requires FDA to develop
regulations, guidance, and to otherwise
implement the following provisions:
Section 301. Foreign Supplier
Verification Program (FSVP) requires
importers to conduct risk-based foreign
supplier verification activities to verify
that imported food is not adulterated
under section 402 of the FD&C Act (21
U.S.C. 342) or misbranded under section
403(w) of the FD&C Act (21 U.S.C.
343(w)) (relating to allergens) and is
produced in compliance with FDA’s
preventive controls requirements and
produce safety standards, where
applicable. Facilities in compliance
with FDA’s seafood, juice, or low-acid
canned food products requirements are
exempted in whole or in part from the
FSVP requirements. The statute directs
FDA to exempt, by notice in the Federal
Register, importers of food imported
into the United States in small
quantities for research uses or for
personal consumption. The statute
further directs FDA to issue
implementing regulations and guidance
on FSVPs.
Section 302. Voluntary qualified
importer program (VQIP) requires FDA
to establish a voluntary, user-fee funded
program to expedite entry into the
United States of imported food from
eligible, qualified importers. To be
eligible to participate in VQIP, an
importer must offer food for importation
from a facility that has a certification by
an accredited third party. FDA will
qualify eligible importers to participate
in VQIP based on risk considerations.
The statute directs FDA to issue
guidance on participation in and
compliance with VQIP.
Section 303. Authority to require
import certifications for food authorizes
FDA, based on risk considerations, to
require an article of food offered for
import into the United States to be
accompanied by certifications or other
assurances that the food complies with
relevant provisions of the FD&C Act.
Certifications may be issued by
designated foreign governments or
accredited third parties.
Section 307. Accreditation of thirdparty auditors directs FDA to establish
a system for the recognition of
accreditation bodies that accredit thirdparty auditors to issue certifications for
purposes of the import certification for
food and VQIP provisions described
previously in this document. Foreign
E:\FR\FM\14MRN1.SGM
14MRN1
]]>Agencies
[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13642-13643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5735]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 Orlando, FL,
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, health care
professionals, patients, and consumers.
Date and Time: The public meeting will be held on May 5, 2011, from
8 a.m. to 12 noon EST.
Location: The public meeting will be held at the Sheraton Orlando
Downtown Hotel, 400 West Livingston St., Orlando, FL 32801. Attendees
requiring sleeping rooms should call 401-843-6664 and request the group
rate for the ``Food & Drug Administration Town Hall Meeting'' room
block. The meeting will not be videotaped or Web cast.
Contact: Heather Howell, Center for Devices and Radiological
Health, Food and Drug Administration, 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/ucm244462.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, and telephone and
fax number. Registration requests must be received by 5 p.m. EST on
Friday, April 22, 2011.
If you wish to make an oral presentation during any of the sessions
at the meeting (see section II of this document), 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. EST.
If you need special accommodations due to a disability, please
contact Susan Monahan, 301-796-5661 or 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, health care 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 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. We received positive feedback on these meetings and
[[Page 13643]]
plan to continue this activity in 2011 in three different locations. In
March 2011, the meeting will be held in Dallas, TX. After this meeting,
CDRH will host one more this year in the San Francisco, CA, area.
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: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5735 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P
