Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 47605-47606 [2010-19462]
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Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Notices
Information’’ to support their continued
use in CVM for the approval of new
animal drugs (e.g., removed references
to human drug and biological products).
The guidance announced in this notice
finalizes the draft guidance dated June
1, 2006.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on the 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 the
applicable statutes 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
section 512 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b) have
been approved under OMB Control No.
0910–0032.
IV. Comments
sroberts on DSKD5P82C1PROD with NOTICES
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.
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 guidance at either https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
16:35 Aug 05, 2010
[FR Doc. 2010–19360 Filed 8–5–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Significance of Guidance
VerDate Mar<15>2010
Dated: July 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Jkt 220001
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Vaccines and Related Biological
Products 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: Vaccines and
Related Biological Products 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 September 21, 2010, from 2
p.m. to approximately 6 p.m.
Location: National Institutes of Health
(NIH), Building 29B/Conference Room
C. The public is welcome to attend the
meeting at the specified location where
a speakerphone will be provided. Public
participation in the meeting is limited to
the use of the speakerphone in the
conference room. Important information
about transportation and directions to
the NIH campus, parking, and security
procedures is available on the Internet
at https://www.nih.gov/about/visitor/
index.htm. (FDA has verified the Web
site address, but FDA is not responsible
for any subsequent changes to the Web
site after this document publishes in the
Federal Register.) Visitors must show
two forms of identification, one of
which must be a government-issued
photo identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. Detailed
information about security procedures is
located at https://www.nih.gov/about/
visitorsecurity.htm. Due to the limited
available parking, visitors are
encouraged to use public transportation.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
PO 00000
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47605
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. 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 September 21, 2010, the
committee will meet in open session to
hear updates of the research programs in
the Laboratory of Respiratory & Special
Pathogens, Division of Bacterial,
Parasitic, & Allergenic Products;
Laboratory of Hepatitis Viruses, and
Laboratory of Vector Borne Virus
Diseases, Division of Viral Products,
Office of Vaccines Research and Review,
Center for Biologics Evaluation and
Research, FDA.
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 September 21, 2010,
from 2 p.m. to approximately 5:10 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
September 15, 2010. Oral presentations
from the public will be scheduled
between approximately 4:10 p.m. and
5:10 p.m. Those desiring to make 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 September 9, 2010. 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,
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47606
Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Notices
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
September 10, 2010.
Closed Committee Deliberations: On
September 21, 2010, from
approximately 5:10 p.m. to
approximately 6 p.m., the meeting will
be closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the report of the
intramural research programs and make
recommendations regarding personnel
staffing decisions.
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 Christine
Walsh or Denise Royster 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/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Dated: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–19462 Filed 8–5–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Postponement of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice.
The meeting of the General
and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee
scheduled for August 26, 2010, is
postponed. The meeting was announced
in the Federal Register of June 24, 2010
(75 FR 36102). The meeting is
SUMMARY:
VerDate Mar<15>2010
16:35 Aug 05, 2010
Jkt 220001
postponed so that FDA can review and
consider additional information that
was submitted. A future meeting date
will be announced in the Federal
Register at a later date.
FOR FURTHER INFORMATION CONTACT:
Margaret McCabe-Janicki, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., rm. 1535, Silver
Spring, MD 20993–0002, 301–796–7029
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512519. Please call the
Information Line for up-to-date
information on this meeting.
Center’s Contact: Danielle Schor,
Office of Foods, Food and Drug
Administration, WO-Bldg. 1, rm.
3230, Silver Spring, MD 20993,
301–796–5404, email:
Danielle.Schor@fda.hhs.gov.
[FR Doc. 2010–19383 Filed 8–5–10; 8:45 am]
Grants Management Contact: Camille
Peake, Division of Acquisition
Support and Grants (HFA–500),
Food and Drug Administration,
5630 Fishers Lane, rm. 2139,
Rockville, MD 20857, 301–827–
7175, FAX: 301–827–7101, email:
Camille.Peake@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.fda.gov/AboutFDA/CentersOffices/
OC/OfficeofFoods/ucm212095.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
I. Funding Opportunity Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Funding Opportunity Description
Number RFA–FD–10–015
Catalog of Federal Domestic Assistance
Number: 93.103
Food and Drug Administration
A. Background
[Docket No. FDA–2010–N–0386]
This Federal Register notice is being
issued by the Office of Foods within the
Office of the Commissioner soliciting a
sole source grant application from PFSE
for funding in support of strategic
planning for consumer education. PFSE,
begun in May 1997, is the only
organization that unites industry
associations, consumer and public
health groups, academia and
government (the U.S. Department of
Agriculture (USDA), the Centers for
Disease and Control and Prevention,
and the Food and Drug Administration)
to educate the public about safe food
handling and preparation. In 2009,
PFSE had 18 association and non-profit
contributing members. PFSE, a nonprofit organization, is the creator and
steward of the ‘‘Fight BAC! Campaign’’,
a food safety education program
developed using scientifically based
recommendations and resulting from an
extensive consumer research process. In
2007, PFSE joined with USDA to create
the ‘‘Be Food Safe’’ platform—designed
to bring a new look to the four core safe
food handling practices and to bring
food safety reminders to places where
people shop for food. ‘‘Fight BAC!
Campaign’’ materials are fully accessible
online and utilized by consumers,
teachers, dietitians, public health
officials, and extension agents across the
nation. FDA is one of several
government agencies that has signed a
Memorandum of Understanding with
PFSE.
Dated: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
Strategic Plan for Consumer Education
via Cooperative Agreement (U18)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing its
intention to receive and consider a
single source application under a
cooperative agreement grant (U18) in
fiscal year (FY) 2010 to the Partnership
for Food Safety Education (PFSE)
located in Washington, DC. This
cooperative agreement grant is being
provided to facilitate a ‘‘Strategic Plan
for Consumer Education’’ to determine
future directions for PFSE in carrying
out a nationwide food safety education
program on safe handling practices to
prevent foodborne illness. The goal of
the cooperative agreement is to help
strengthen PFSE, so that FDA’s goal may
be achieved in improving consumer
food safety practices and in turn reduce
the incidence of foodborne illness.
DATES: Important dates are as follows:
1. The application due date is August
13, 2010.
2. The anticipated start date is
September 2010.
3. The opening date is August 6, 2010.
4. The expiration date is August 16,
2010.
SUMMARY:
FOR FURTHER INFORMATION CONTACT AND
ADDITIONAL REQUIREMENTS CONTACT:
PO 00000
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]]>Agencies
[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47605-47606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19462]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Vaccines and Related Biological Products 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: Vaccines and Related Biological Products
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 September 21, 2010, from
2 p.m. to approximately 6 p.m.
Location: National Institutes of Health (NIH), Building 29B/
Conference Room C. The public is welcome to attend the meeting at the
specified location where a speakerphone will be provided. Public
participation in the meeting is limited to the use of the speakerphone
in the conference room. Important information about transportation and
directions to the NIH campus, parking, and security procedures is
available on the Internet at https://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.) Visitors must show two
forms of identification, one of which must be a government-issued photo
identification such as a Federal employee badge, driver's license,
passport, green card, etc. Detailed information about security
procedures is located at https://www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking, visitors are encouraged to use
public transportation.
Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512391. 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 September 21, 2010, the committee will meet in open
session to hear updates of the research programs in the Laboratory of
Respiratory & Special Pathogens, Division of Bacterial, Parasitic, &
Allergenic Products; Laboratory of Hepatitis Viruses, and Laboratory of
Vector Borne Virus Diseases, Division of Viral Products, Office of
Vaccines Research and Review, Center for Biologics Evaluation and
Research, FDA.
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 September 21, 2010, from 2 p.m. to approximately 5:10
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 September 15, 2010. Oral presentations from the
public will be scheduled between approximately 4:10 p.m. and 5:10 p.m.
Those desiring to make 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 September 9, 2010.
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,
[[Page 47606]]
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 September 10, 2010.
Closed Committee Deliberations: On September 21, 2010, from
approximately 5:10 p.m. to approximately 6 p.m., the meeting will be
closed to permit discussion where disclosure would constitute a clearly
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the report of the intramural research programs
and make recommendations regarding personnel staffing decisions.
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 Christine Walsh or
Denise Royster 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.
Dated: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-19462 Filed 8-5-10; 8:45 am]
BILLING CODE 4160-01-S
