Food Labeling Workshop; Public Workshop, 31698-31699 [E8-12301]
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ebenthall on PRODPC60 with NOTICES
31698
Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the drug product. Although only a
portion of a regulatory review period
may count toward the actual amount of
extension that the Director of Patents
and Trademarks may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA approved for marketing the
human drug product VEREGEN
(kunecatechins). VEREGEN is indicated
for the topical treatment of external
genital and perianal warts in
immunocompetent patients 18 years
and older. Subsequent to this approval,
the Patent and Trademark Office
received patent term restoration
applications for VEREGEN (U.S. Patent
Nos. 5,795,911 and 5,968,973) from
Mitsui Norin Co., Ltd., and Cancer
Institute (Hospital), Chinese Academy of
Medical Sciences, and the Patent and
Trademark Office requested FDA’s
assistance in determining these patents’
eligibility for patent term restoration. In
a letter dated July 24, 2007, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of VEREGEN
represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
VEREGEN is 3,002 days. Of this time,
2,605 days occurred during the testing
phase of the regulatory review period,
VerDate Aug<31>2005
14:18 Jun 02, 2008
Jkt 214001
while 397 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: August 14,
1998. The applicant claims August 13,
1998, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 14, 1998,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: September 30, 2005.
The applicant claims September 23,
2005, as the date the new drug
application (NDA) for VEREGEN (NDA
21–902) was initially submitted.
However, FDA records indicate that
NDA 21–902 was submitted on
September 30, 2005.
3. The date the application was
approved: October 31, 2006. FDA has
verified the applicant’s claim that NDA
21–902 was approved on October 31,
2006.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,300 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by August 4, 2008.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 1, 2008. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
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Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA through FDMS only.
Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E8–12296 Filed 6–2–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
‘‘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 August 12, 2008, from
8 a.m. to 5 p.m., and on August 13, 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 email:
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
email: seideman@uark.edu.
Registration: You are encouraged to
register by July 29, 2008. The University
of Arkansas requires a $150 registration
fee to cover the cost of facilities,
materials, and breaks. Seats are limited;
E:\FR\FM\03JNN1.SGM
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Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices
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
31699
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.
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121), as an outreach
activity by a government agency 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
articulated through regulations
guidance. 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
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(f)), 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, and 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
ebenthall on PRODPC60 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
14:18 Jun 02, 2008
Jkt 214001
Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–12301 Filed 6–2–08; 8:45 am]
BILLING CODE 4160–01–S
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Food and Drug Administration
[Docket No. FDA–2008–N–0306]
Preparation for International
Cooperation on Cosmetics
Regulations Meetings in Washington,
DC; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘International
Cooperation on Cosmetics Regulations
(ICCR)—Preparation for ICCR Meetings
in Washington, DC’’ to provide
information and receive comments on
the International Cooperation on
Cosmetics Regulations (ICCR) as well as
the upcoming meetings in Washington,
DC. The topics to be discussed are the
topics for discussion at the forthcoming
ICCR steering committee meeting. The
purpose of the meeting is to solicit
public input prior to the next steering
committee and expert working group
meetings in Washington, DC, the week
of July 28, 2008, at which the action
items from the first ICCR meeting are to
be discussed.
DATES: The meeting will be held on June
19, 2008, from 3 p.m. to 4:30 p.m. Send
E:\FR\FM\03JNN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31698-31699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12301]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 ``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 August 12,
2008, from 8 a.m. to 5 p.m., and on August 13, 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 email: 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 email: seideman@uark.edu.
Registration: You are encouraged to register by July 29, 2008. The
University of Arkansas requires a $150 registration fee to cover the
cost of facilities, materials, and breaks. Seats are limited;
[[Page 31699]]
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: 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(f)), 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,
and 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 an outreach activity by a government agency 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 articulated through regulations guidance. 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: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12301 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S
