Tobacco Products Scientific Advisory Committee; Notice of Meeting, 32219-32220 [2011-13779]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
participates in the VICH Steering
Committee meetings.
jlentini on DSK4TPTVN1PROD with NOTICES
II. Guidance on Microbiological
Acceptable Daily Intake
In February 2011, the VICH Steering
Committee agreed that a draft revised
guidance entitled ‘‘Studies to Evaluate
the Safety of Residues of Veterinary
Drugs in Human Food: General
Approach to Establish a Microbiological
ADI (Revision)’’ (VICH GL36(R)) should
be made available for public comment.
This draft revised VICH guidance is a
revision of a final guidance on the same
topic for which a notice of availability
was published in the Federal Register of
February 11, 2005 (70 FR 7278). This
draft revised guidance was revised to
include Appendix D–Supplement to
Section 2 Regarding the Determination
of the Fraction of Oral Dose Available to
Microorganisms. This VICH guidance
provides guidance for assessing the
human food safety of residues from
veterinary antimicrobial drugs with
regard to effects on the human intestinal
flora. The objectives of this guidance are
to: (1) Outline the recommended steps
in determining the need for establishing
a microbiological acceptable daily
intake (ADI); (2) recommend test
systems and methods for determining
no-observable adverse effect
concentrations (NOAECs) and noobservable adverse effect levels
(NOAELs) for the endpoints of health
concern; and (3) recommend a
procedure to derive a microbiological
ADI. It is recognized that different tests
may be useful. The experience gained
with the recommended tests may result
in future modifications to this guidance
and its recommendations.
The draft revised guidance is a
product of the Quality Expert Working
Group of the VICH. Comments about
this draft will be considered by FDA
and the VICH Quality Expert Working
Group.
10.115). For example, the document has
been designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘must,’’ ‘‘shall,’’
‘‘require’’ or ‘‘requirement’’ unless FDA is
using these words to describe a statutory
or regulatory requirement.
This draft revised VICH guidance
when finalized, will represent the
Agency’s current thinking on this topic.
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 applicable statutes and
regulations.
V. 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.
VI. Electronic Access
Persons with access to the Internet
may obtain the draft revised guidance at
either https://www.fda.gov/Animal
Veterinary/GuidanceCompliance
Enforcement/GuidanceforIndustry/
default.htm or https://
www.regulations.gov.
Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13821 Filed 6–2–11; 8:45 am]
BILLING CODE 4160–01–P
III. Paperwork Reduction Act of 1995
This draft revised 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 this revised guidance
have been approved under OMB control
number 0910–0032.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Significance of Guidance
This draft revised guidance,
developed under the VICH process, has
been revised to conform to FDA’s good
guidance practices regulation (21 CFR
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
VerDate Mar<15>2010
15:49 Jun 02, 2011
Jkt 223001
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Tobacco Products Scientific Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00085
Fmt 4703
Sfmt 4703
32219
Name of Committee: Tobacco
Products Scientific Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 21, 2011, from 9 a.m. to 5
p.m., and on July 22, 2011, from 8 a.m.
to 5 p.m.
Location: Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373.
Contact Person: Caryn Cohen, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373
(choose option 4), e-mail: TPSAC@fda.
hhs.gov, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), and follow the prompts to the
desired center or product area. Please
call the Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: On the morning of July 21,
2011, the committee will discuss
changes proposed by committee
members to the Tobacco Products
Scientific Advisory Committee (TPSAC)
Menthol Report submitted to the
Agency on March 18, 2011. The
committee will consider additional oral
and written comments from the public
on the Menthol Report and the proposed
changes to the report, as submitted
according to the instructions in the
Procedure portion of this document.
The committee will consider and
deliberate on proposed changes to the
report and adopt amendments that
constitute the advice of the committee.
Redacted versions of the document,
reflecting the changes to the report
proposed by the committee members,
will be made available on the FDA Web
site at https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
TobaccoProductsScientificAdvisory
Committee/ucm237359.htm, no later
than June 22, 2011. On the afternoon of
July 21, 2011, and on July 22, 2011, the
TPSAC will initiate discussions on the
issue of the nature and impact of the use
of dissolvable tobacco products on the
E:\FR\FM\03JNN1.SGM
03JNN1
jlentini on DSK4TPTVN1PROD with NOTICES
32220
Federal Register / Vol. 76, No. 107 / Friday, June 3, 2011 / Notices
public health. These discussions will
begin the process for the TPSAC’s
required report to the Secretary of
Health and Human Services regarding
the issue of the nature and impact of the
use of dissolvable tobacco products on
the public health, including such use
among children. The final report should
take into consideration the following:
(1) The risks and benefits to the
population as a whole, including users
and nonusers of tobacco products; (2)
the increased or decreased likelihood
that existing users of tobacco products
will stop using such products; and (3)
the increased or decreased likelihood
that those who do not use tobacco
products will start using such products.
FDA intends to make redacted
background material available to the
public no later than 2 business days
before the meeting. If FDA is unable to
post the background material on its Web
site prior to the meeting, the background
material will be made publicly available
at the location of the advisory
committee meeting, and the background
material will be posted on FDA’s Web
site after the meeting. Background
material is available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
link.
Procedure: On July 21, 2011, from 9
a.m. to 5 p.m., and on July 22, from 8
a.m. to 12 noon, the meeting is open to
the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 5, 2011. Oral
presentations from the public will be
scheduled between approximately 10
a.m. and 11 a.m. on both July 21, 2011,
and July 22, 2011. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 27,
2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 28, 2011.
Closed Committee Deliberations: On
July 22, 2011, from 1 p.m. to 5 p.m., the
VerDate Mar<15>2010
15:49 Jun 02, 2011
Jkt 223001
meeting will be closed to permit
discussion and review of trade secret
and/or confidential commercial
information (5 U.S.C. 552b(c)(4)). This
portion of the meeting must be closed
because the Committee will be
discussing trade secret and/or
confidential data regarding dissolvable
tobacco products provided by the
tobacco companies.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caryn Cohen
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 25, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–13779 Filed 6–2–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Gastrointestinal Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastrointestinal
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
Date and Time: The meeting will be
held on July 21, 2011, from 8 a.m. to
4 p.m.
Location: Hilton Washington
DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910.
The hotel’s phone number is 301–589–
5200.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
301–847–8533, e-mail:
GIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On July 21, 2011, the
committee will discuss the results from
a clinical trial of supplement biologics
license application 103772/5301,
REMICADE (infliximab), by Centocor
Ortho Biotech Inc., in the treatment of
pediatric patients with moderately to
severely active ulcerative colitis.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 6, 2011. Oral
presentations from the public will be
scheduled between approximately
1 p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
E:\FR\FM\03JNN1.SGM
03JNN1
]]>Agencies
[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32219-32220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13779]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Tobacco Products Scientific Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Name of Committee: Tobacco Products Scientific Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 21, 2011, from 9
a.m. to 5 p.m., and on July 22, 2011, from 8 a.m. to 5 p.m.
Location: Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-
1373.
Contact Person: Caryn Cohen, Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-
287-1373 (choose option 4), e-mail: TPSAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On the morning of July 21, 2011, the committee will discuss
changes proposed by committee members to the Tobacco Products
Scientific Advisory Committee (TPSAC) Menthol Report submitted to the
Agency on March 18, 2011. The committee will consider additional oral
and written comments from the public on the Menthol Report and the
proposed changes to the report, as submitted according to the
instructions in the Procedure portion of this document. The committee
will consider and deliberate on proposed changes to the report and
adopt amendments that constitute the advice of the committee. Redacted
versions of the document, reflecting the changes to the report proposed
by the committee members, will be made available on the FDA Web site at
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm237359.htm, no later than
June 22, 2011. On the afternoon of July 21, 2011, and on July 22, 2011,
the TPSAC will initiate discussions on the issue of the nature and
impact of the use of dissolvable tobacco products on the
[[Page 32220]]
public health. These discussions will begin the process for the TPSAC's
required report to the Secretary of Health and Human Services regarding
the issue of the nature and impact of the use of dissolvable tobacco
products on the public health, including such use among children. The
final report should take into consideration the following: (1) The
risks and benefits to the population as a whole, including users and
nonusers of tobacco products; (2) the increased or decreased likelihood
that existing users of tobacco products will stop using such products;
and (3) the increased or decreased likelihood that those who do not use
tobacco products will start using such products.
FDA intends to make redacted background material available to the
public no later than 2 business days before the meeting. If FDA is
unable to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at the
location of the advisory committee meeting, and the background material
will be posted on FDA's Web site after the meeting. Background material
is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: On July 21, 2011, from 9 a.m. to 5 p.m., and on July 22,
from 8 a.m. to 12 noon, the meeting is open to the public. Interested
persons may present data, information, or views, orally or in writing,
on issues pending before the committee. Written submissions may be made
to the contact person on or before July 5, 2011. Oral presentations
from the public will be scheduled between approximately 10 a.m. and 11
a.m. on both July 21, 2011, and July 22, 2011. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before June 27, 2011. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by June 28, 2011.
Closed Committee Deliberations: On July 22, 2011, from 1 p.m. to 5
p.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential commercial information (5 U.S.C.
552b(c)(4)). This portion of the meeting must be closed because the
Committee will be discussing trade secret and/or confidential data
regarding dissolvable tobacco products provided by the tobacco
companies.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Caryn Cohen at least
7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 25, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-13779 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P
