Request for Nominations for Voting Members on Public Advisory Committee, Food Advisory Committee, 39972-39973 [E8-15839]
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39972
Federal Register / Vol. 73, No. 134 / Friday, July 11, 2008 / Notices
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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 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.
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 only through FDMS at
https://www.regulations.gov.
Dated: July 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15766 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Approaches to Reduce Risk of
Transfusion-Transmitted Babesiosis in
the United States; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Approaches to Reduce the
Risk of Transfusion-Transmitted
Babesiosis in the United States.’’ The
purpose of the public workshop is to
discuss the risk and possible approaches
to minimize the incidence of
transfusion-transmitted babesiosis in the
United States. We are convening this
workshop at the present time because
FDA has observed a recent increase in
the number of reports of transfusiontransmitted babesiosis, thus warranting
additional discussion to address this
blood safety issue. The public workshop
will feature presentations and
roundtable discussions led by experts
from academic institutions, government,
and industry.
Date and Time: The public workshop
will be held on September 12, 2008,
from 7:30 a.m. to 5:30 p.m.
VerDate Aug<31>2005
17:19 Jul 10, 2008
Jkt 214001
Location: The public workshop will
be held at the Lister Hill Center
Auditorium, Bldg. 38A, National
Institutes of Health, 8800 Rockville
Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax or e-mail your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person by August 25, 2008.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is limited
to 175 attendees. Registration on the day
of the public workshop will be provided
on a space available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: Babesiosis
is a malaria-like illness caused by
infection of erythrocytes with protozoan
parasites belonging to the genus
Babesia. Transfusion-transmitted
babesiosis is caused by transfusion of
blood or blood components collected
from donors infected with Babesia
parasites. During the last 40 years, more
than 60 cases of transfusion-transmitted
babesiosis have been recognized in the
United States. In fiscal years 2006 and
2007, FDA received a total of five
reports of fatal transfusion-transmitted
babesiosis (primary or contributory
cause of death) in the United States.
The public workshop will facilitate a
scientific discussion on approaches to
reduce the risk of transfusiontransmitted babesiosis in the United
States. Topics to be discussed include:
(1) Biology, pathogenesis, transmission
and epidemiology of babesiosis; (2) risk
of Babesia infections through
transfusion of blood and blood
components; (3) laboratory testing to
detect Babesia infections; and, (4)
possible approaches, including donor
testing and donor deferral, to reduce the
risk of transfusion-transmitted
babesiosis while maintaining blood
availability and safety.
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
PO 00000
Frm 00035
Fmt 4703
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accepted by FDA only through FDMS at
https://www.regulations.gov.
Transcripts: Transcripts of the public
workshop may be requested in writing
from 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. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15799 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting
Members on Public Advisory
Committee, Food Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Food Advisory Committee
(FAC), Center for Food Safety and
Applied Nutrition (CFSAN).
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Nominations received on or
before August 11, 2008 will be given
first consideration for membership on
the Food Advisory Committee.
Nominations received after August 11,
2008 will be considered for nomination
to the committee should nominees still
be needed.
ADDRESSES: All Nominations for
membership should be sent
electronically to CV@FDA.HHS.GOV or
by mail to: Advisory Committee
Oversight and Management Staff, 5600
Fisher Lane (HF–4), rm. 15A–12,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is
Carolyn Jeletic, Center for Food Safety
and Applied Nutrition, 301–436–1913,
FAX: 301–436–2633, e-mail:
E:\FR\FM\11JYN1.SGM
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Federal Register / Vol. 73, No. 134 / Friday, July 11, 2008 / Notices
Carolyn.Jeletic@fda.hhs.gov.
Information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s Web site
by using the following link: https://
www.fda.gov/oc/advisory/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nomination for voting
members on the Food Advisory
Committee.
I. Function of the Food Advisory
Committee
II. Criteria for Voting Members
FDA is requesting nominations of
voting members with appropriate
expertise in the following specialties:
Microbiology, food technology, and
nutrition.
pwalker on PROD1PC71 with NOTICES
III. Nomination Procedures
Pursuant to 21 CFR 14.84(d), any
interested person may nominate one or
more qualified persons for membership
on the advisory committee. Selfnominations are also accepted.
Nominations shall include the name of
the committee, a complete curriculum
vitae of each nominee, and their current
business address and telephone number
and e-mail address if available. Each
nomination shall state that the nominee
is aware of the nomination, is willing to
serve as a member, and appears to have
no conflict of interest that would
preclude membership. FDA will ask the
potential candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflict of interest.
17:19 Jul 10, 2008
Jkt 214001
Dated: July 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–15839 Filed 7–10–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The committee provides advice,
primarily to the Commissioner of Food
and Drugs and other appropriate
officials, on emerging food safety, food
science, nutrition, and other foodrelated health issues that the FDA
considers of primary importance for its
food and cosmetics programs. The
committee may be charged with
reviewing and evaluating available data
and making recommendations on
matters such as those relating to: (1)
Broad scientific and technical food or
cosmetic related issues, (2) the safety of
new foods and food ingredients, (3)
labeling of foods and cosmetics, (4)
nutrient needs and nutritional
adequacy, and (5) safe exposure limits
for food contaminants. The committee
may also be asked to provide advice and
make recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
VerDate Aug<31>2005
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.2) and 21 CFR part 14
relating to advisory committees.
Indian Health Service
Tribal Self-Governance Program;
Planning Cooperative Agreement
Announcement Type: New.
Funding Announcement Number:
HHS–2008–IHS–TSGP–0002.
Catalog of Federal Domestic
Assistance Number(s): 93.2 10.
Key Dates:
Application Deadline Date: August
15, 2008.
Review Date: August 25–26, 2008.
Earliest Anticipated Start Date:
September 1, 2008.
I. Funding Opportunity Description
The purpose of the program is to
award cooperative agreements that
provide planning resources to Tribes
interested in participating in the Tribal
Self-Governance Program (TSGP) as
authorized by Title V, Tribal SelfGovernance Amendments of 2000 of the
Indian Self-Determination and
Education Assistance Act of Public Law
(Pub. L.) 93–638, as amended. There is
limited competition under this
announcement because the authorizing
legislation restricts eligibility to Tribes
that meet specific criteria (Refer to
Section III.1.A., Eligible Applicants in
this announcement). The TSGP is
designed to promote self-determination
by allowing Tribes to assume more
control of Indian Health Service (IHS)
programs and services through
compacts negotiated with the IHS. The
Planning Cooperative Agreement allows
a Tribe to gather information to
determine the current types of
Programs, Services, Functions, and
Activities (PSFAs), and related funding
available at the Service Unit, Area, and
Headquarters levels and provide the
opportunity to improve and enhance the
healthcare delivery system to better
meet the needs of the Tribal community.
This program is described at 93.210 in
the Catalog of Federal Domestic
Assistance (CFDA).
II. Award Information
Type of Awards: Cooperative
Agreement.
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39973
Estimated Funds Available: The total
amount identified for Fiscal Year (FY)
2008 is $600,000 for approximately
twelve (12) Tribes. Awards under this
announcement are subject to the
availability of funds.
Anticipated Number of Awards: The
estimated number of awards to be
funded is approximately 12.
Project Period: 12 months.
Award Amount: $50,000 per year.
Programmatic Involvement: TSGP
funds will be awarded as cooperative
agreements and will have substantial
IHS programmatic involvement to
establish a basic understanding of
PSFAs and associated funding at the
Service Unit, Area, and Headquarters
levels.
The IHS roles and responsibilities
will include:
• Providing a description of PSFAs
and associated funding at all levels,
including funding formulas and
methodologies related to determining
Tribal shares.
• Identifying IHS staff who will
consult with applicants on methods
currently used to manage and deliver
health care.
• Providing applicants with statutes,
regulations and policies that provide
authority for administering IHS
programs.
The grantee roles and responsibilities
are critical to the success of the program
and will include:
• Researching and analyzing the
complex IHS budget, to gain a thorough
understanding of funding distribution at
all levels to determine which PSFAs the
Tribe may elect to assume.
• Establishing a process by which
Tribes can effectively approach the IHS
to identify programs and associated
funding which could be incorporated
into their current programs.
• Determining the Tribe’s share of
each PSFA and evaluating the current
level of health care services being
provided to make an informed decision
on new program assumption(s).
III. Eligibility Information
1. Eligible Applicants
To be eligible for a Planning
Cooperative Agreement under this
announcement, an applicant must meet
all of the following criteria:
A. Be a federally-recognized Tribe as
defined in Title V, Pub. L. 106–260,
Tribal Self-Governance Amendments of
2000, of the Indian Self-Determination
and Education Assistance Act (the Act),
Pub. L. 93–638, as amended. However,
Alaska Native Villages or Alaska Native
Village Corporations are not eligible if
they are located within the area served
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 73, Number 134 (Friday, July 11, 2008)]
[Notices]
[Pages 39972-39973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15839]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting Members on Public Advisory
Committee, Food Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Food Advisory Committee
(FAC), Center for Food Safety and Applied Nutrition (CFSAN).
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.
DATES: Nominations received on or before August 11, 2008 will be given
first consideration for membership on the Food Advisory Committee.
Nominations received after August 11, 2008 will be considered for
nomination to the committee should nominees still be needed.
ADDRESSES: All Nominations for membership should be sent electronically
to CV@FDA.HHS.GOV or by mail to: Advisory Committee Oversight and
Management Staff, 5600 Fisher Lane (HF-4), rm. 15A-12, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, the primary contact is Carolyn Jeletic, Center for Food
Safety and Applied Nutrition, 301-436-1913, FAX: 301-436-2633, e-mail:
[[Page 39973]]
Carolyn.Jeletic@fda.hhs.gov. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's Web site
by using the following link: https://www.fda.gov/oc/advisory/
default.htm.
SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting
members on the Food Advisory Committee.
I. Function of the Food Advisory Committee
The committee provides advice, primarily to the Commissioner of
Food and Drugs and other appropriate officials, on emerging food
safety, food science, nutrition, and other food-related health issues
that the FDA considers of primary importance for its food and cosmetics
programs. The committee may be charged with reviewing and evaluating
available data and making recommendations on matters such as those
relating to: (1) Broad scientific and technical food or cosmetic
related issues, (2) the safety of new foods and food ingredients, (3)
labeling of foods and cosmetics, (4) nutrient needs and nutritional
adequacy, and (5) safe exposure limits for food contaminants. The
committee may also be asked to provide advice and make recommendations
on ways of communicating to the public the potential risks associated
with these issues and on approaches that might be considered for
addressing the issues.
II. Criteria for Voting Members
FDA is requesting nominations of voting members with appropriate
expertise in the following specialties: Microbiology, food technology,
and nutrition.
III. Nomination Procedures
Pursuant to 21 CFR 14.84(d), any interested person may nominate one
or more qualified persons for membership on the advisory committee.
Self-nominations are also accepted. Nominations shall include the name
of the committee, a complete curriculum vitae of each nominee, and
their current business address and telephone number and e-mail address
if available. Each nomination shall state that the nominee is aware of
the nomination, is willing to serve as a member, and appears to have no
conflict of interest that would preclude membership. FDA will ask the
potential candidates to provide detailed information concerning such
matters as financial holdings, employment, and research grants and/or
contracts to permit evaluation of possible sources of conflict of
interest.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.2) and 21 CFR part 14 relating to advisory committees.
Dated: July 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-15839 Filed 7-10-08; 8:45 am]
BILLING CODE 4160-01-S
