Approaches To Reducing Sodium Consumption; Public Meeting, 63305-63308 [2011-26371]
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<![CDATA[
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
section for electronic
access to the guidance document.
Submit electronic comments on the
guidance 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.
FOR FURTHER INFORMATION CONTACT: John
L. Smith, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, rm. 2619, Silver Spring,
MD 20993, 301–796–1757.
SUPPLEMENTARY INFORMATION:
INFORMATION
jlentini on DSK4TPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Incorporation of Physical-Chemical
Identifiers Into Solid Oral Dosage Form
Drug Products for Anticounterfeiting.’’
For the purpose of this guidance, a PCID
is a substance or combination of
substances possessing a unique physical
or chemical property that unequivocally
identifies a drug product or dosage form
as authentic and distinguishes it from
counterfeits. To thwart drug product
counterfeiting, pharmaceutical
manufacturers have been investigating
technologies that may make drug
products more difficult to duplicate,
including the incorporation of PCIDs
into SODFs. One approach that
manufacturers appear to be considering
involves adding a trace amount of one
or more inactive ingredients to an
existing section of the dosage form (in
the guidance, section is the term used
for a discrete, contained solid or a layer
in a solid oral dosage form). Any section
can be described by its composition, the
functional characteristics that
distinguish it from other sections in that
dosage form, and its position relative to
other sections that may be present (e.g.,
coatings, capsule shells, encapsulated
particles, a layer in a bilayer tablet, and
compressed powders). A unique
physical-chemical characteristic of that
ingredient makes it possible to detect
and authenticate legitimate dosage
forms, and to identify counterfeits.
Examples of substances that may be
incorporated into SODFs as PCIDs
include inks, pigments, flavors, and
molecular taggants. Such PCIDs may
allow product authentication by their
presence alone or may be used to code
the product identity into or onto the
SODF.
This guidance provides
recommendations to pharmaceutical
manufacturers on the following topics:
(1) Design considerations for PCIDs into
SODFs, (2) supporting documentation to
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Jkt 226001
be submitted in NDAs or ANDAs to
address the proposed incorporation of
PCIDs in SODFs, (3) supporting
documentation to be submitted in
postapproval submissions to report or
request approval to incorporate PCIDs
into SODFs, and (4) procedures for
reporting or requesting approval to
incorporate PCIDs into SODFs as a
postapproval change. Although not
addressed in this guidance, FDA is
considering whether to address the
incorporation of a PCID into a drug’s
packaging or labeling in a future
guidance.
In the Federal Register of July 14,
2009 (74 FR 34021), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Draft Guidance for
Industry on Incorporation of PhysicalChemical Identifiers Into Solid Oral
Dosage Form Drug Products for
Anticounterfeiting.’’ The notice gave
interested persons an opportunity to
comment by October 13, 2009. We have
carefully considered the comments we
received and, where appropriate, have
made corrections, added information, or
clarified the information in the guidance
in response to the comments.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the use of PCIDs in
SODF drug products to prevent
counterfeiting. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The
documentation in premarketing
regulatory submissions recommended
for applicants incorporating PCIDs into
SODFs would be covered under 21 CFR
314.50 and 314.94, and the
documentation in postapproval
regulatory submissions would be
covered under 21 CFR 314.70. This
information collection has been
approved under OMB control number
0910–0001. The recommendations for
labeling would be covered under 21
CFR 201.57. This information collection
has been approved under OMB control
number 0910–0572.
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63305
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either http:
//www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–26296 Filed 10–11–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0400]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2011–0014]
Approaches To Reducing Sodium
Consumption; Public Meeting
Food and Drug Administration,
HHS; Food Safety and Inspection
Service, USDA.
ACTION: Notice of public meeting;
request for comments.
AGENCY:
The Food and Drug
Administration (FDA), the Centers for
Disease Control and Prevention (CDC),
the Food Safety and Inspection Service
(FSIS), the Agricultural Research
Service (ARS) and the Center for
Nutrition Policy and Promotion (CNPP)
are announcing a public meeting
entitled ‘‘Approaches to Reducing
Sodium Consumption.’’ FDA and FSIS
recently published a Federal Register
notice that announced the establishment
of dockets to obtain comments, data,
and evidence relevant to the dietary
intake of sodium as well as current and
emerging approaches designed to
promote sodium reduction. The purpose
of the public meeting is to provide
interested persons an opportunity to
SUMMARY:
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63306
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
discuss the topics raised in the earlier
notice.
DATES: Submit either electronic or
written comments, data, and evidence to
either FDA’s Division of Dockets
Management or FSIS’s Docket Clerk by
November 29, 2011. See also ‘‘How To
Participate in the Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
ADDRESSES: See Table 1 of this
document for meeting location and
other information regarding registration
for this meeting.
FOR FURTHER INFORMATION CONTACT:
FDA: 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.
FSIS: Rosalyn Murphy-Jenkins, Director,
Labeling and Program Delivery
Division, Office of Policy and Program
Development, Food Safety and
Inspection Service, U.S. Department
of Agriculture, USDA, FSIS, OPPD,
LPDD Stop Code 3784, Patriots Plaza
III, 8–161A, 1400 Independence Ave.,
SW., Washington, DC 20250–3700.
SUPPLEMENTARY INFORMATION:
significant public health goals, the
campaign stresses the need to identify
opportunities for sodium reduction.
II. Purpose and Format of the Meeting
If you wish to attend and/or present
at the meeting scheduled for November
10, 2011, please register at https://
events.SignUp4.net/
FDA_Sodium_Reduction by November
3, 2011. FDA, CDC, FSIS, ARS, and
CNPP are holding the public meeting on
sodium reduction in foods to inform
possible future actions by the Agencies.
In general, the meeting format will
include introductory presentations by
FDA, USDA, and CDC, but listening to
interested persons is the primary
purpose of this meeting. In order to
meet this goal, FDA, CDC, FSIS, ARS
and CNPP will provide multiple
opportunities for individuals to express
their opinions through oral
presentations at the meeting,
participation in break-out sessions on
the issues discussed at the meeting, and
submission of electronic or written
comments, data, and evidence to FDA’s
Division of Dockets Management and/or
FSIS’s Docket Clerk by November 29,
2011. The break-out session topics will
be available prior to the meeting on
I. Background
FDA’s Sodium Reduction Web page at
In the Federal Register of September
https://www.fda.gov/Food/
15, 2011 (76 FR 57050), FDA and FSIS
FoodIngredientsPackaging/
announced the establishment of dockets ucm253316.htm. The plenary sessions
to obtain comments, data, and evidence and some of the breakout sessions will
that will inform future Agency activities be Web cast; see section III of this
regarding the reduction of dietary intake document, ‘‘How to Participate in the
of sodium. FDA, CDC, FSIS, ARS, and
Meeting.’’ In order to provide Web cast
CNPP are announcing a public meeting
participants with information before
entitled ‘‘Approaches to Reducing
and after the meeting, we request
Sodium Consumption’’ to discuss the
attendees provide their name, their
topics raised in section II of that notice.
affiliation, and e-mail address when preInterested persons may also wish to
registering for the Web cast at https://
review the FDA’s Sodium Reduction
events.SignUp4.net/
Web page located at https://www.fda.gov/ FDA_Sodium_Reduction.
Food/FoodIngredientsPackaging/
III. How To Participate in the Meeting
ucm253316.htm.
Interested persons will have an
Reducing sodium consumption is also
opportunity to provide oral comments,
part of the Department of Health and
time permitting. Due to limited space
Human Services’ (the Department’s)
and time, FDA, CDC, FSIS, ARS, and
recently-launched Million Hearts
initiative (https://millionhearts.hhs.gov/). CNPP encourage all persons who wish
to attend the meeting onsite or via Web
The Department, working with several
key initial partners, is aiming to prevent cast to register in advance at https://
events.SignUp4.net/
one million heart attacks and strokes
FDA_Sodium_Reduction. There is no
over the next 5 years. Among other
fee to register for the public meeting,
and registration will be on a first-come,
first-served basis. Early registration is
recommended because seating is
limited. Onsite registration will be
accepted, as space permits, after all
preregistered attendees are seated. Table
1 of this document provides information
on participating in the meeting and on
submitting comments to the docket.
Those requesting an opportunity to
make an oral presentation during the
time allotted for public comment at the
meeting, are asked to submit their
request by November 3, 2011, and to
provide the specific topic or issue to be
addressed and the approximate desired
length of their presentation. Depending
on the number of requests for such oral
presentations, there may be a need to
limit the number and length (e.g., 3
minutes each) of the oral presentations.
If time permits, individuals or
organizations that did not register in
advance may be granted the opportunity
for such an oral presentation. FDA,
CDC, FSIS, ARS, and CNPP would like
to maximize the number of individuals
who make a presentation at the meeting
and will do our best to accommodate all
persons who wish to make a
presentation or express their opinions at
the meeting. We are especially
interested in hearing about sodium
reduction related research results or
research efforts underway. FDA, CDC,
FSIS, ARS, and CNPP anticipate that
there will be several opportunities for
interested persons to speak in break-out
sessions. A Web cast will be available
for interested persons who are not
onsite. Interested persons will also have
an opportunity to submit electronic or
written comments to the docket
following the meeting, but no later than
November 29, 2011.
FDA, CDC, FSIS, ARS, and CNPP
encourage persons and groups who have
similar interests to consolidate their
information for presentation through a
single representative. After reviewing
the presentation requests, FDA will
notify each participant before the
meeting of the amount of time available,
the approximate time their presentation
is scheduled to begin, and the
presentation format.
jlentini on DSK4TPTVN1PROD with NOTICES
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS
Date
Date of Public Meeting.
VerDate Mar<15>2010
Electronic address
Address (non electronic)
November 10, 2011,
from 9 a.m. to
5:30 p.m. EST.
Individuals who wish to participate in person are asked to
pre-register at https://
events.SignUp4.net/
FDA_Sodium_Reduction.
FDA White Oak Campus, The
Great Room, Bldg. 31, Rm.
1503, 10903 New Hampshire Ave., Silver Spring,
MD 20993.
17:43 Oct 11, 2011
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Other information
Registration begins at 7:30
a.m.
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
63307
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS—Continued
Date
Electronic address
Web cast ...................
November 10, 2011,
from 9 a.m. to
5:30 p.m. EST).
Advance Registration
Register by November 3, 2011.
Individuals who wish to view
the Web cast of this meeting
are requested to pre-register
at https://
events.SignUp4.net/
FDA_Sodium_Reduction. It
is recommended that Web
cast attendees test their
Internet connection to confirm access to the Web cast
prior to the meeting. To test
this connection, visit https://
fda.yorkcast.com/webcast/
Catalog/catalogs/default.aspx and click on
‘‘CDRH Television Tutorial
and Firewall Test.’’.
https://events.SignUp4.net/
FDA_Sodium_Reduction.
Request special accommodations due
to disability.
Make a request for
oral presentation.
Register by November 3, 2011.
Register by November 3, 2011.
jlentini on DSK4TPTVN1PROD with NOTICES
Provide a brief deBy November 3,
scription of the oral
2011.
presentation and
any written material
for the presentation.
VerDate Mar<15>2010
17:43 Oct 11, 2011
Jkt 226001
Address (non electronic)
.............................................
https://events.SignUp4.net/
FDA_Sodium_Reduction.
FDA encourages the use of
electronic registration, if
possible.
The Web cast will provide
closed captioning.
FDA encourages the use of
electronic registration, if
possible.
Registration to attend the
meeting will also be accepted onsite on the day of the
meeting, as space permits.
Registration information may
be posted without change to
https://www.regulations.gov,
including any personal information provided.
Patricia M. Kuntze, 301–796–
8641,e-mail: Patricia.Kuntze@fda.hhs.gov.
.............................................
https://events.SignUp4.net/
FDA_Sodium_Reduction.
PO 00000
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Other information
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Requests made on the day of
the meeting to make an oral
presentation may be granted
as time permits. Information
on requests to make an oral
presentation may be posted
without change to https://
www.regulations.gov, including any personal information
provided.
Written material associated
with an oral presentation
should be submitted in
Microsoft PowerPoint, Microsoft Word, or Adobe Portable Document Format
(PDF) and may be posted
without change to https://
www.regulations.gov, including any personal information
provided.
63308
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS—Continued
Date
Submit electronic or
written comments.
Electronic address
Submit comments
by November 29,
2011.
Address (non electronic)
Federal eRulemaking Portal:
https://www.regulations.gov.
Follow the instructions for
submitting comments.
Other information
FDA: FAX: 301–827–6870.
Mail/Hand delivery/Courier
(for paper, disk, or CD–
ROM submissions): Division
of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers
Lane, rm. 1061, Rockville,
MD 20852.
FSIS: Docket Clerk, U.S. Department of Agriculture,
Food Safety and Inspection
Service, George Washington
Carver Center, 5601 Sunnyside Ave., Mailstop 547,
Beltsville, MD 20705–5464.
All comments must include the
Agency name and the docket number (see table 2 of
this document for a list of
Agencies and corresponding
docket numbers). All received comments may be
posted without change to
https://www.regulations.gov,
including any personal information provided. FDA and
FSIS encourage the submission of electronic comments
by using the Federal
eRulemaking Portal. For additional information on submitting comments, see the
‘‘Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of this document.
.
jlentini on DSK4TPTVN1PROD with NOTICES
IV. Comments
V. Transcripts
FDA: Regardless of attendance at the
public meeting, interested persons may
submit to FDA’s Division of Dockets
Management (see Addresses in table 1 of
this document) either electronic or
written comments for consideration at
or after the meeting, in addition to, or
in place of, a request for an opportunity
to make an oral presentation. 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.
FSIS: Regardless of attendance at the
public meeting, interested persons may
submit to FSIS’s Docket Clerk (see
Addresses in table 1 of this document)
either electronic or written comments
regarding this document. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the FSIS Docket Room between
8:30 a.m. and 4:30 p.m., Monday
through Friday.
Because two docket numbers are
associated with this document, please
include with your comments the docket
number that corresponds with the
appropriate Agency. Comments
submitted for inclusion in both dockets
should be separately submitted to each
identified docket number to ensure
consideration by both Agencies.
Please be advised that as soon as a
transcript is available, it will be posted
on FDA’s Sodium Reduction Web page
at https://www.fda.gov/Food/
FoodIngredientsPackaging/
ucm253316.htm. It may also 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 (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857.
VerDate Mar<15>2010
17:43 Oct 11, 2011
Jkt 226001
Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy,
Food and Drug Administration.
Dated: October 4, 2011.
Alfred V. Almanza,
Administrator, Food Safety and Inspection
Service.
[FR Doc. 2011–26371 Filed 10–11–11; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Data and Data Needs To Advance Risk
Assessment for Emerging Infectious
Diseases Relevant to Blood and Blood
Products; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Data and Data Needs to
Advance Risk Assessment for Emerging
Infectious Diseases Relevant to Blood
and Blood Products.’’ The purpose of
the public workshop is to discuss data
and data sources currently used by FDA,
possible new sources of data, and
development of new studies and
information through collaboration with
stakeholders. The public workshop will
include presentations and panel
discussions with experts from
stakeholders, academia, regulated
industry, and government.
Date and Time: The public workshop
will be held on November 29, 2011,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the Gaithersburg Hilton, 620
Perry Pkwy., Gaithersburg, MD 20877,
301–977–8900.
Contact Person: Lou Gallagher, Center
for Biologics Evaluation and Research
(HFM–210), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
E:\FR\FM\12OCN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63305-63308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26371]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0400]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2011-0014]
Approaches To Reducing Sodium Consumption; Public Meeting
AGENCY: Food and Drug Administration, HHS; Food Safety and Inspection
Service, USDA.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), the Centers for
Disease Control and Prevention (CDC), the Food Safety and Inspection
Service (FSIS), the Agricultural Research Service (ARS) and the Center
for Nutrition Policy and Promotion (CNPP) are announcing a public
meeting entitled ``Approaches to Reducing Sodium Consumption.'' FDA and
FSIS recently published a Federal Register notice that announced the
establishment of dockets to obtain comments, data, and evidence
relevant to the dietary intake of sodium as well as current and
emerging approaches designed to promote sodium reduction. The purpose
of the public meeting is to provide interested persons an opportunity
to
[[Page 63306]]
discuss the topics raised in the earlier notice.
DATES: Submit either electronic or written comments, data, and evidence
to either FDA's Division of Dockets Management or FSIS's Docket Clerk
by November 29, 2011. See also ``How To Participate in the Meeting'' in
the SUPPLEMENTARY INFORMATION section of this document.
ADDRESSES: See Table 1 of this document for meeting location and other
information regarding registration for this meeting.
FOR FURTHER INFORMATION CONTACT:
FDA: 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.
FSIS: Rosalyn Murphy-Jenkins, Director, Labeling and Program Delivery
Division, Office of Policy and Program Development, Food Safety and
Inspection Service, U.S. Department of Agriculture, USDA, FSIS, OPPD,
LPDD Stop Code 3784, Patriots Plaza III, 8-161A, 1400 Independence
Ave., SW., Washington, DC 20250-3700.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 15, 2011 (76 FR 57050), FDA
and FSIS announced the establishment of dockets to obtain comments,
data, and evidence that will inform future Agency activities regarding
the reduction of dietary intake of sodium. FDA, CDC, FSIS, ARS, and
CNPP are announcing a public meeting entitled ``Approaches to Reducing
Sodium Consumption'' to discuss the topics raised in section II of that
notice. Interested persons may also wish to review the FDA's Sodium
Reduction Web page located at https://www.fda.gov/Food/FoodIngredientsPackaging/ucm253316.htm.
Reducing sodium consumption is also part of the Department of
Health and Human Services' (the Department's) recently-launched Million
Hearts initiative (https://millionhearts.hhs.gov/). The Department,
working with several key initial partners, is aiming to prevent one
million heart attacks and strokes over the next 5 years. Among other
significant public health goals, the campaign stresses the need to
identify opportunities for sodium reduction.
II. Purpose and Format of the Meeting
If you wish to attend and/or present at the meeting scheduled for
November 10, 2011, please register at https://events.SignUp4.net/FDA_Sodium_Reduction by November 3, 2011. FDA, CDC, FSIS, ARS, and CNPP
are holding the public meeting on sodium reduction in foods to inform
possible future actions by the Agencies. In general, the meeting format
will include introductory presentations by FDA, USDA, and CDC, but
listening to interested persons is the primary purpose of this meeting.
In order to meet this goal, FDA, CDC, FSIS, ARS and CNPP will provide
multiple opportunities for individuals to express their opinions
through oral presentations at the meeting, participation in break-out
sessions on the issues discussed at the meeting, and submission of
electronic or written comments, data, and evidence to FDA's Division of
Dockets Management and/or FSIS's Docket Clerk by November 29, 2011. The
break-out session topics will be available prior to the meeting on
FDA's Sodium Reduction Web page at https://www.fda.gov/Food/FoodIngredientsPackaging/ucm253316.htm. The plenary sessions and some
of the breakout sessions will be Web cast; see section III of this
document, ``How to Participate in the Meeting.'' In order to provide
Web cast participants with information before and after the meeting, we
request attendees provide their name, their affiliation, and e-mail
address when pre-registering for the Web cast at https://events.SignUp4.net/FDA_Sodium_Reduction.
III. How To Participate in the Meeting
Interested persons will have an opportunity to provide oral
comments, time permitting. Due to limited space and time, FDA, CDC,
FSIS, ARS, and CNPP encourage all persons who wish to attend the
meeting onsite or via Web cast to register in advance at https://events.SignUp4.net/FDA_Sodium_Reduction. There is no fee to register
for the public meeting, and registration will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. Onsite registration will be accepted, as space permits,
after all preregistered attendees are seated. Table 1 of this document
provides information on participating in the meeting and on submitting
comments to the docket.
Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meeting, are asked to
submit their request by November 3, 2011, and to provide the specific
topic or issue to be addressed and the approximate desired length of
their presentation. Depending on the number of requests for such oral
presentations, there may be a need to limit the number and length
(e.g., 3 minutes each) of the oral presentations. If time permits,
individuals or organizations that did not register in advance may be
granted the opportunity for such an oral presentation. FDA, CDC, FSIS,
ARS, and CNPP would like to maximize the number of individuals who make
a presentation at the meeting and will do our best to accommodate all
persons who wish to make a presentation or express their opinions at
the meeting. We are especially interested in hearing about sodium
reduction related research results or research efforts underway. FDA,
CDC, FSIS, ARS, and CNPP anticipate that there will be several
opportunities for interested persons to speak in break-out sessions. A
Web cast will be available for interested persons who are not onsite.
Interested persons will also have an opportunity to submit electronic
or written comments to the docket following the meeting, but no later
than November 29, 2011.
FDA, CDC, FSIS, ARS, and CNPP encourage persons and groups who have
similar interests to consolidate their information for presentation
through a single representative. After reviewing the presentation
requests, FDA will notify each participant before the meeting of the
amount of time available, the approximate time their presentation is
scheduled to begin, and the presentation format.
Table 1--Information on Participation in the Meeting and on Submitting Comments
----------------------------------------------------------------------------------------------------------------
Address (non
Date Electronic address electronic) Other information
----------------------------------------------------------------------------------------------------------------
Date of Public Meeting.......... November 10, 2011, Individuals who FDA White Oak Registration
from 9 a.m. to wish to Campus, The Great begins at 7:30
5:30 p.m. EST. participate in Room, Bldg. 31, a.m.
person are asked Rm. 1503, 10903
to pre-register New Hampshire
at https:// Ave., Silver
events.SignUp4.ne Spring, MD 20993.
t/FDA--Sodium--
Reduction.
[[Page 63307]]
Web cast........................ November 10, 2011, Individuals who FDA encourages the The Web cast will
from 9 a.m. to wish to view the use of electronic provide closed
5:30 p.m. EST). Web cast of this registration, if captioning.
meeting are possible.
requested to pre-
register at
https://events.SignUp4.net/FDA_Sodium_Reduction Reduction. It is
recommended that
Web cast
attendees test
their Internet
connection to
confirm access to
the Web cast
prior to the
meeting. To test
this connection,
visit https://fda.yorkcast.com/webcast/Catalog/catalogs/default.aspx and
click on ``CDRH
Television
Tutorial and
Firewall Test.''.
Advance Registration............ Register by https:// FDA encourages the Registration to
November 3, 2011. events.SignUp4.ne use of electronic attend the
t/FDA--Sodium-- registration, if meeting will also
Reduction. possible. be accepted
onsite on the day
of the meeting,
as space permits.
Registration
information may
be posted without
change to https://www.regulations.gov ov, including any
personal
information
provided.
Request special accommodations Register by .................. Patricia M.
due to disability. November 3, 2011. Kuntze, 301-796-
8641, e-mail:
Patricia.Kuntze@fda.hhs.gov.
Make a request for oral Register by https:// .................. Requests made on
presentation. November 3, 2011. events.SignUp4.ne the day of the
t/FDA--Sodium-- meeting to make
Reduction. an oral
presentation may
be granted as
time permits.
Information on
requests to make
an oral
presentation may
be posted without
change to https://www.regulations.gov ov, including any
personal
information
provided.
Provide a brief description of By November 3, https:// .................. Written material
the oral presentation and any 2011. events.SignUp4.ne associated with
written material for the t/FDA--Sodium-- an oral
presentation. Reduction. presentation
should be
submitted in
Microsoft
PowerPoint,
Microsoft Word,
or Adobe Portable
Document Format
(PDF) and may be
posted without
change to https://www.regulations.gov ov, including any
personal
information
provided.
[[Page 63308]]
Submit electronic or written Submit comments by Federal FDA: FAX: 301-827- All comments must
comments. November 29, 2011. eRulemaking 6870. Mail/Hand include the
Portal: https:// delivery/Courier Agency name and
www.regulations.g (for paper, disk, the docket number
ov. Follow the or CD-ROM (see table 2 of
instructions for submissions): this document for
submitting Division of a list of
comments. Dockets Agencies and
Management (HFA- corresponding
305), Food and docket numbers).
Drug All received
Administration, comments may be
5630 Fishers posted without
Lane, rm. 1061, change to https://
Rockville, MD www.regulations.g
20852. ov, including any
FSIS: Docket personal
Clerk, U.S. information
Department of provided. FDA and
Agriculture, Food FSIS encourage
Safety and the submission of
Inspection electronic
Service, George comments by using
Washington Carver the Federal
Center, 5601 eRulemaking
Sunnyside Ave., Portal. For
Mailstop 547, additional
Beltsville, MD information on
20705-5464. submitting
comments, see the
``Comments''
heading of the
SUPPLEMENTARY
INFORMATION
section of this
document.
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IV. Comments
FDA: Regardless of attendance at the public meeting, interested
persons may submit to FDA's Division of Dockets Management (see
Addresses in table 1 of this document) either electronic or written
comments for consideration at or after the meeting, in addition to, or
in place of, a request for an opportunity to make an oral presentation.
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.
FSIS: Regardless of attendance at the public meeting, interested
persons may submit to FSIS's Docket Clerk (see Addresses in table 1 of
this document) either electronic or written comments regarding this
document. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the FSIS
Docket Room between 8:30 a.m. and 4:30 p.m., Monday through Friday.
Because two docket numbers are associated with this document,
please include with your comments the docket number that corresponds
with the appropriate Agency. Comments submitted for inclusion in both
dockets should be separately submitted to each identified docket number
to ensure consideration by both Agencies.
V. Transcripts
Please be advised that as soon as a transcript is available, it
will be posted on FDA's Sodium Reduction Web page at https://www.fda.gov/Food/FoodIngredientsPackaging/ucm253316.htm. It may also 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 (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857.
Dated: October 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy, Food and Drug Administration.
Dated: October 4, 2011.
Alfred V. Almanza,
Administrator, Food Safety and Inspection Service.
[FR Doc. 2011-26371 Filed 10-11-11; 8:45 am]
BILLING CODE 4160-01-P
