Tobacco Products Scientific Advisory Committee; Notice of Meeting, 72422-72423 [2011-30163]
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72422
Federal Register / Vol. 76, No. 226 / Wednesday, November 23, 2011 / Notices
Dated: November 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Emily R. Smith, Center for Veterinary
Medicine (HFV–135), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276–8344,
emily.smith2@fda.hhs.gov.
[FR Doc. 2011–30146 Filed 11–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
[Docket No. FDA–2011–D–0784]
Draft Guidance for Industry on
Evaluating the Effectiveness of
Anticoccidial Drugs in Food-Producing
Animals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of draft guidance for
industry #217 entitled ‘‘Evaluating the
Effectiveness of Anticoccidial Drugs in
Food-Producing Animals.’’
The draft guidance, when finalized, is
intended to provide guidance to
industry for designing and conducting
clinical effectiveness studies, and
describes criteria that the Center for
Veterinary Medicine (CVM) thinks are
the most appropriate for the evaluation
of the effectiveness of anticoccidial
drugs intended for use in poultry and
other food-producing animals. The draft
guidance also suggests times during the
evaluation of effectiveness when
sponsors may wish to consult with
CVM.
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by January 23,
2012.
DATES:
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.,
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for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
sroberts on DSK5SPTVN1PROD with NOTICES
ADDRESSES:
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FDA is announcing the availability of
draft guidance for industry #217 entitled
‘‘Evaluating the Effectiveness of
Anticoccidial Drugs In Food-Producing
Animals.’’ The draft guidance discusses
general considerations for the
evaluation of the efficacy of
anticoccidial drugs in poultry, minor
species and food-producing mammals.
Draft guidance for industry #217
supersedes the CVM draft guidance for
industry #40, entitled ‘‘Draft Guideline
for the Evaluation of The Efficacy of
Anticoccidial Drugs and Anticoccidial
Drug Combinations in Poultry,’’ dated
April 1992.
This draft guidance discusses general
considerations regarding protocol
development, study conduct, animal
welfare, substantial evidence of
effectiveness, feed preparation, drug
assays, and combination approvals.
This draft guidance discusses CVM
considerations for studies used to
substantiate effectiveness of
anticoccidial drugs in poultry, including
battery studies and commercial field
studies. In addition, the draft GFI
discusses CVM considerations for
studies used to substantiate
effectiveness of anticoccidial drugs in
food-producing mammals, in minor
species, and for minor uses.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the Agency’s
current thinking on evaluating the
effectiveness of anticoccidial drugs in
food-producing 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.
III. Paperwork Reduction Act of 1995
This draft 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
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IV. 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.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: November 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30149 Filed 11–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Tobacco Products Scientific Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
II. Significance of Guidance
PO 00000
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in this guidance have
been approved under OMB control nos.
0910–0032 and 0910–0117.
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 January 18, 2012, from 8 a.m.
to 5 p.m., on January 19, 2012, from 8
a.m. to 5 p.m., and on January 20, 2012,
from 8 a.m. to 4 p.m.
Location: Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1 (877) 287–1373.
E:\FR\FM\23NON1.SGM
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sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 226 / Wednesday, November 23, 2011 / Notices
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), email:
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: As part of the Tobacco
Products Scientific Advisory
Committee’s required report to the
Secretary of Health and Human
Services, the committee will continue
discussing issues related to the nature
and impact of the use of dissolvable
tobacco products on the public health,
including such use among children.
Discussion will include such topics as
the composition and characteristics of
dissolvable tobacco products, product
use, potential health effects, and
marketing.
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: On January 18, 2012, from
2 p.m. to 5 p.m., on January 19, 2012,
from 8 a.m. to 5 p.m., and on January
20, 2012 from 8 a.m. to 4 p.m., 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 January 4, 2012.
Oral presentations from the public will
be scheduled between approximately 3
p.m. and 4 p.m. on January 19, 2012.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
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17:03 Nov 22, 2011
Jkt 226001
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 December 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
December 28, 2011.
Closed Committee Deliberations: On
January 18, 2012, from 8 a.m. to 1 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 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: November 16, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–30163 Filed 11–22–11; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
72423
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0780]
Bridging the Idea Development
Evaluation Assessment and LongTerm Initiative and Total Product Life
Cycle Approaches for Evidence
Development for Surgical Medical
Devices and Procedures; Public
Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
correction.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Monday, November 7, 2011
(76 FR 68769). The document
announced a public workshop entitled
‘‘Bridging the Idea Development
Evaluation Assessment and Long-Term
Initiative and Total Product Life Cycle
Approaches for Evidence Development
for Surgical Medical Devices and
Procedures.’’ The document was
published with an incorrect docket
number. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3208,
Silver Spring, MD 20993–0002, (301)
796–9148.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–28722, appearing on page 68769,
in the Federal Register of Monday,
November 7, 2011, the following
correction is made:
On page 68769, in the first column, in
the Docket No. heading, ‘‘[Docket No.
FDA 2011–N–0002]’’ is corrected to read
‘‘[Docket No. FDA–2011–N–0780]’’.
SUMMARY:
Dated: November 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30145 Filed 11–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
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]]>Agencies
[Federal Register Volume 76, Number 226 (Wednesday, November 23, 2011)]
[Notices]
[Pages 72422-72423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30163]
-----------------------------------------------------------------------
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 January 18, 2012, from 8
a.m. to 5 p.m., on January 19, 2012, from 8 a.m. to 5 p.m., and on
January 20, 2012, from 8 a.m. to 4 p.m.
Location: Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1 (877) 287-
1373.
[[Page 72423]]
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), email: 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: As part of the Tobacco Products Scientific Advisory
Committee's required report to the Secretary of Health and Human
Services, the committee will continue discussing issues related to the
nature and impact of the use of dissolvable tobacco products on the
public health, including such use among children. Discussion will
include such topics as the composition and characteristics of
dissolvable tobacco products, product use, potential health effects,
and marketing.
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: On January 18, 2012, from 2 p.m. to 5 p.m., on January
19, 2012, from 8 a.m. to 5 p.m., and on January 20, 2012 from 8 a.m. to
4 p.m., 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 January 4, 2012. Oral presentations from
the public will be scheduled between approximately 3 p.m. and 4 p.m. on
January 19, 2012. 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 December 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 December
28, 2011.
Closed Committee Deliberations: On January 18, 2012, from 8 a.m. to
1 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 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: November 16, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-30163 Filed 11-22-11; 8:45 am]
BILLING CODE 4160-01-P
