University of Arkansas/Food and Drug Administration Food Labeling Workshop; Public Workshop, 4714-4715 [E7-1570]
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4714
Federal Register / Vol. 72, No. 21 / Thursday, February 1, 2007 / Notices
Dated: January 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1576 Filed 1–31–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
University of Arkansas/Food and Drug
Administration Food Labeling
Workshop; 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 10, 2007, from 8
a.m. to 5 p.m., and on April 11, 2007,
from 8 a.m. to 4 p.m.
Location: The public workshop will
be held at the Continuing Education
Center, 2 East Center St., Fayetteville,
AR (located downtown).
Contact: David Arvelo, Small
Business Representative, Food and Drug
Administration, Southwest Regional
Office, 4040 North Central Expressway,
suite 900, Dallas, TX 75204, 214–253–
4952, FAX: 214–253–4970, or e-mail:
david.arvelo@fda.hhs.gov.
For information on accommodation
options, 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.
Registration: You are encouraged to
register by March 23, 2007. 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.
UNIVERSITY OF ARKANSAS/FOOD AND DRUG ADMINISTRATION FOOD LABELING WORKSHOP REGISTRATION FORM
Name:
Affiliation:
Mailing Address:
City/State/Zip Code:
Phone:
Fax:
E-mail:
rwilkins on PROD1PC63 with NOTICES
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.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: This
public workshop is being held in
response to the large volume of food
labeling inquiries from small food
manufacturers and startups originating
VerDate Aug<31>2005
16:47 Jan 31, 2007
Jkt 211001
from the area covered by the FDA Dallas
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,
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 (Public Law 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
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
E:\FR\FM\01FEN1.SGM
01FEN1
Federal Register / Vol. 72, No. 21 / Thursday, February 1, 2007 / Notices
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: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1570 Filed 1–31–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
Food and Drug Administration
[Docket No. 2007D–0025]
Guidance for Industry; Class II Special
Controls Guidance Document: Cord
Blood Processing System and Storage
Container; Availability
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Class II Special Controls Guidance
Document: Cord Blood Processing
System and Storage Container.’’ The
guidance document describes a means
by which a cord blood processing
system and storage container may
comply with the requirement of special
controls for class II devices. Elsewhere
in this issue of the Federal Register,
FDA is publishing a final rule
classifying a cord blood processing
system and storage container into class
II (special controls). This guidance
document is immediately in effect as the
special control for this device, but it
remains subject to comment in
accordance with the agency’s good
guidance practices (GGPs).
DATES: Submit written or electronic
comments on this guidance at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
VerDate Aug<31>2005
16:47 Jan 31, 2007
Jkt 211001
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. 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.
FOR FURTHER INFORMATION CONTACT:
Denise Sanchez, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
classifying a cord blood processing
system and storage container into class
II (special controls) under section
513(f)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360c(f)(2)). This notice announces the
availability of the guidance document
that will serve as the special control for
this device.
Section 513(f)(2) of the act provides
that any person who submits a
premarket notification under section
510(k) of the act (21 U.S.C. 360(k)) for
a device that has not previously been
classified may, within 30 days after
receiving an order classifying the device
into class III under section 513(f)(1) of
the act, request FDA to classify the
device under the criteria set forth in
section 513(a)(1) of the act. FDA shall,
within 60 days of receiving such a
request, classify the device by written
order. This classification shall be the
initial classification of the device.
Within 30 days after the issuance of an
order classifying the device, FDA must
publish a notice in the Federal Register
announcing such a classification.
Because of the timeframes established
by section 513(f)(2) of the act, FDA has
determined, under § 10.115(g)(2) (21
CFR 10.115(g)(2)), that it is not feasible
or appropriate to allow for public
participation before issuing this
guidance as a final guidance document.
Thus, FDA is issuing this guidance
document as a level 1 guidance
document that is immediately in effect.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
4715
FDA will consider any comments that
are received in response to this notice
to determine whether to amend the
guidance document.
II. Significance of the Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidance represents the agency’s current
thinking on a cord blood processing
system and storage container. 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 statute and regulations.
III. 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 in
21 CFR part 807, subpart E (regulations
governing premarket notification
submissions) have been approved under
OMB Control No. 0910–0120.
IV. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
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/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: January 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1568 Filed 1–31–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 72, Number 21 (Thursday, February 1, 2007)]
[Notices]
[Pages 4714-4715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1570]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
University of Arkansas/Food and Drug Administration Food Labeling
Workshop; 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 10, 2007,
from 8 a.m. to 5 p.m., and on April 11, 2007, from 8 a.m. to 4 p.m.
Location: The public workshop will be held at the Continuing
Education Center, 2 East Center St., Fayetteville, AR (located
downtown).
Contact: David Arvelo, Small Business Representative, Food and Drug
Administration, Southwest Regional Office, 4040 North Central
Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-
4970, or e-mail: david.arvelo@fda.hhs.gov.
For information on accommodation options, 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.
Registration: You are encouraged to register by March 23, 2007. 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.
University of Arkansas/Food and Drug Administration Food Labeling Workshop Registration Form
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. 6-30, Rockville,
MD 20857, approximately 15 working days after the public workshop at a
cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: 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
Dallas 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 (Public Law 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 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
[[Page 4715]]
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: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1570 Filed 1-31-07; 8:45 am]
BILLING CODE 4160-01-S
