University of Arkansas/Food and Drug Administration Food Labeling; Public Workshop, 349-350 [E5-8225]
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349
Federal Register / Vol. 71, No. 2 / Wednesday, January 4, 2006 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of responses
per respondent
Average
burden hours
per response
Total burden
hours
Questionnaire for OCS—CED and JOLI Grantees in the U.S. .......................
172
1
1.5
258
Estimated Total Annual Burden
Hours: 258.
In compliance with the requirements
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: December 27, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–18 Filed 1–3–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
wwhite on PROD1PC61 with NOTICES
Food and Drug Administration
University of Arkansas/Food and Drug
Administration Food Labeling; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
VerDate Aug<31>2005
21:48 Jan 03, 2006
Jkt 208001
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs, Southwest Regional
Small Business Representative (SWR
SBR) Program, in collaboration with The
University of Arkansas (UA), is
announcing a public workshop entitled
‘‘UA/FDA Food Labeling Workshop.’’
This public workshop is intended to
provide information about FDA food
labeling regulations and other related
subjects to the regulated industry,
particularly small businesses and
startups.
Date and Time: This public workshop
will be held on April 5, 2006, from 8
a.m. to 5 p.m., and on April 6, 2006,
from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at the Continuing Education
Center, 2 East Center St., Fayetteville,
AR (located downtown).
Contact: Steven C. Seideman, 2650
North Young Ave., Institute of Food
Science & Engineering, University of
Arkansas, Fayetteville, AR 72704, 479–
575–4221, FAX: 479–575–2165, or email: seideman@uark.edu.
For information on accommodation
options, contact Steven C. Seideman
(see Contact).
Registration: You are encouraged to
register by March 21, 2006. The
University of Arkansas has a $150
registration fee to cover the cost of
facilities, materials, speakers, and
breaks. Seats are limited, 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 8 a.m. The cost of
registration at the site is $200 payable
to: ‘‘The University of Arkansas.’’ If you
need special accommodations due to a
disability, please contact Steven C.
Seideman (see Contact) at least 7 days
in advance.
Registration Form Instructions: To
register, please complete the following
form and submit along with a check or
money order for $150 payable to the
‘‘The University of Arkansas.’’ Mail to:
Institute of Food Science & Engineering,
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
University of Arkansas, 2650 North
Young Ave., Fayetteville, AR 72704.
Name: ______________________
Affiliation: ____________________
Mailing Address: ____________________
City: ____________________ State:_____
Zip Code: ________
Phone: (
) ________________
FAX: (
) ________________
E-mail: (
) _________________
Special Accommodations Required:
____________________________________
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested at cost
through the Freedom of Information
Office (HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
12A–16, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: The FDA
SWR SBR previously presented this
workshop in Fayetteville, AR, on April
5 and 6, 2005 (70 FR 6450, February 7,
2005).
This public workshop is being held in
response to the large volume of food
labeling inquiries from small food
manufacturers and startups originating
from the area covered by the FDA
Denver District Office. The SWR SBR
presents these workshops to help
achieve objectives set forth in section
406 of the Food and Drug
Administration Modernization Act of
1997 (21 U.S.C. 393), which include
working closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. This is consistent with the
purposes of the SBR Program, which are
in part to respond to industry inquiries,
develop educational materials, sponsor
workshops and conferences to provide
firms, particularly small businesses,
with firsthand working knowledge of
FDA’s requirements and compliance
policies. This workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121), as outreach
activities by government agencies to
small businesses.
The goal of this public workshop is to
present information that will enable
manufacturers and regulated industry to
E:\FR\FM\04JAN1.SGM
04JAN1
350
Federal Register / Vol. 71, No. 2 / Wednesday, January 4, 2006 / Notices
better comply with labeling
requirements, especially in light of
growing concerns about obesity and
food allergens. Information presented
will be based on agency position as
articulated through regulation,
compliance policy guides, and
information previously made available
to the public. Topics to be discussed at
the workshop include: (1) Mandatory
label elements, (2) nutrition labeling
requirements, (3) health and nutrition
claims, (4) the Food Allergen Labeling
and Consumer Protection Act of 2004,
and (5) special labeling issues such as
exemptions. FDA expects that
participation in this public workshop
will provide regulated industry with
greater understanding of the regulatory
and policy perspectives on food labeling
and increase voluntary compliance.
Dated: December 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–8225 Filed 1–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0468]
Guidance for Industry on Development
of Target Animal Safety and
Effectiveness Data to Support
Approval of Non-Steroidal AntiInflammatory Drugs for Use in
Animals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
(#123) entitled ‘‘Development of Target
Animal Safety and Effectiveness Data to
Support Approval of Non-Steroidal
Anti-Inflammatory Drugs for Use in
Animals.’’ This guidance provides
recommendations regarding the
development of target animal safety and
effectiveness data to support approval of
veterinary non-steroidal antiinflammatory drugs (NSAIDs),
specifically cyclooxygenase (COX)
inhibitors.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
wwhite on PROD1PC61 with NOTICES
SUMMARY:
VerDate Aug<31>2005
17:18 Jan 03, 2006
Jkt 208001
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
Comments should be identified with the
full title of the guidance and the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Linda Wilmot, Center for Veterinary
Medicine (HFV–114), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0135, email: lwilmot@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November
10, 2004 (69 FR 65202), FDA published
a notice of availability for a draft
guidance entitled ‘‘Development of
Target Animal Safety and Effectiveness
Data to Support Approval of NonSteroidal Anti-Inflammatory Drugs for
Use in Animals’’ giving interested
persons until January 24, 2005, to
comment on the draft guidance. This
final guidance reflects changes in
response to comments received on the
draft guidance. In addition, FDA
provided further clarification regarding
recommendations on the generation of
pharmacokinetic (PK) data. In
particular, FDA included several
examples of the type of PK information
that would be recommended for certain
types of products including those
involving repeated administration or
multiple dosage forms.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information 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 collections of information
addressed in this guidance have been
approved under OMB control number
0910–0032.
III. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the agency’s
current thinking on the development of
target animal safety and effectiveness
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
data to support approval of nonsteroidal anti-inflammatory drugs for
use in animals. 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.
IV. Comments
As with all FDA guidances, the public
is encouraged to submit written or
electronic comments with new data or
other new information pertinent to this
guidance. FDA periodically will review
the comments in the docket, and where
appropriate, will amend the guidance.
The agency will notify the public of any
such amendments through a notice in
the Federal Register.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments should be identified with the
docket number found in brackets in the
heading of this document. A copy of the
guidance and received comments are
available for public examination in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cvm or https://
www.fda.gov/ohrms/dockets/
default.htm.
Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–8223 Filed 1–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0493]
Guidance for Industry and Review Staff
on Recommended Approaches to
Integration of Genetic Toxicology
Study Results; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
E:\FR\FM\04JAN1.SGM
04JAN1
]]>Agencies
[Federal Register Volume 71, Number 2 (Wednesday, January 4, 2006)]
[Notices]
[Pages 349-350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8225]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
University of Arkansas/Food and Drug Administration Food
Labeling; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs, Southwest Regional Small Business Representative (SWR SBR)
Program, in collaboration with The University of Arkansas (UA), is
announcing a public workshop entitled ``UA/FDA Food Labeling
Workshop.'' This public workshop is intended to provide information
about FDA food labeling regulations and other related subjects to the
regulated industry, particularly small businesses and startups.
Date and Time: This public workshop will be held on April 5, 2006,
from 8 a.m. to 5 p.m., and on April 6, 2006, from 8 a.m. to 3 p.m.
Location: The public workshop will be held at the Continuing
Education Center, 2 East Center St., Fayetteville, AR (located
downtown).
Contact: Steven C. Seideman, 2650 North Young Ave., Institute of
Food Science & Engineering, University of Arkansas, Fayetteville, AR
72704, 479-575-4221, FAX: 479-575-2165, or e-mail: seideman@uark.edu.
For information on accommodation options, contact Steven C.
Seideman (see Contact).
Registration: You are encouraged to register by March 21, 2006. The
University of Arkansas has a $150 registration fee to cover the cost of
facilities, materials, speakers, and breaks. Seats are limited, 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 8 a.m. The cost of registration at the site is $200
payable to: ``The University of Arkansas.'' If you need special
accommodations due to a disability, please contact Steven C. Seideman
(see Contact) at least 7 days in advance.
Registration Form Instructions: To register, please complete the
following form and submit along with a check or money order for $150
payable to the ``The University of Arkansas.'' Mail to: Institute of
Food Science & Engineering, University of Arkansas, 2650 North Young
Ave., Fayetteville, AR 72704.
Name: --------------------------------------------
Affiliation: ----------------------------------------
Mailing Address: ----------------------------------------
City: ---------------------------------------- State:---------- Zip
Code: ----------------
Phone: ( ) --------------------------------
FAX: ( ) --------------------------------
E-mail: ( ) ----------------------------------
Special Accommodations Required: --------------------------------------
----------------------------------
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop. Course handouts may be
requested at cost through the Freedom of Information Office (HFI-35),
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville,
MD 20857, approximately 15 working days after the public workshop at a
cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The FDA SWR SBR previously presented this
workshop in Fayetteville, AR, on April 5 and 6, 2005 (70 FR 6450,
February 7, 2005).
This public workshop is being held in response to the large volume
of food labeling inquiries from small food manufacturers and startups
originating from the area covered by the FDA Denver District Office.
The SWR SBR presents these workshops to help achieve objectives set
forth in section 406 of the Food and Drug Administration Modernization
Act of 1997 (21 U.S.C. 393), which include working closely with
stakeholders and maximizing the availability and clarity of information
to stakeholders and the public. This is consistent with the purposes of
the SBR Program, which are in part to respond to industry inquiries,
develop educational materials, sponsor workshops and conferences to
provide firms, particularly small businesses, with firsthand working
knowledge of FDA's requirements and compliance policies. This workshop
is also consistent with the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), as outreach activities by
government agencies to small businesses.
The goal of this public workshop is to present information that
will enable manufacturers and regulated industry to
[[Page 350]]
better comply with labeling requirements, especially in light of
growing concerns about obesity and food allergens. Information
presented will be based on agency position as articulated through
regulation, compliance policy guides, and information previously made
available to the public. Topics to be discussed at the workshop
include: (1) Mandatory label elements, (2) nutrition labeling
requirements, (3) health and nutrition claims, (4) the Food Allergen
Labeling and Consumer Protection Act of 2004, and (5) special labeling
issues such as exemptions. FDA expects that participation in this
public workshop will provide regulated industry with greater
understanding of the regulatory and policy perspectives on food
labeling and increase voluntary compliance.
Dated: December 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8225 Filed 1-3-06; 8:45 am]
BILLING CODE 4160-01-S
