Blood Products Advisory Committee; Notice of Meeting, 6890 [05-2452]
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Federal Register / Vol. 70, No. 26 / Wednesday, February 9, 2005 / Notices
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 Small Business
Representative Program, which are in
part to respond to industry inquiries,
develop educational materials, 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 (Public Law 104–121), as outreach
activities by Government agencies 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 regulation,
compliance policy guides, and
information previously made available
to the public. Topics to be discussed at
the workshop include: (1) Mandatory
label elements, (2) nutrition labeling
requirements, (3) health and nutrition
claims, (4) FDA’s allergen declaration
policy, 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 increased voluntary compliance.
Dated: February 2, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–2450 Filed 2–8–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Blood 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: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
VerDate jul<14>2003
16:49 Feb 08, 2005
Jkt 205001
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 17, 2005, from 8 a.m. to
5:30 p.m., and on March 18, 2005, from
8:30 a.m. to 2:30 p.m.
Location: Holiday Inn Gaithersburg, 2
Montgomery Village Ave., Gaithersburg,
MD.
Contact Person: William Freas or
Pearline K. Muckelvene, 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
3014519516. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On March 17, 2005, the
committee will hear updates on the
following topics: Summary of the
Department of Health and Human
Services Advisory Committee on Blood
Safety and Availability meeting,
summary of the Transmissible
Spongiform Encephalopathies Advisory
Committee meeting, update on West
Nile Virus guidance, and summaries of
the Critical Path Initiative workshop. In
the morning, the committee will also
discuss and provide recommendations
on the safety of albumin. In the
afternoon, the committee will hear
additional updates on the following
topics: International agreements, and a
presentation on sharing information
with the public. Additionally, the
committee will hear presentations, and
discuss and provide recommendations
on rapid freezing of plasma for
transfusion. On the morning of March
18, 2005, the committee will hear
presentations, and discuss and provide
recommendations on the study design
for the abbreviated uniform donor
history questionnaire. The committee
also will hear presentations related to
the review of the site visit report for the
Laboratory of Molecular Virology,
Division of Emerging and Transfusion
Transmitted Diseases, Office of Blood
Research and Review.
Procedure: On March 17, 2005, from
8 a.m. to 5:30 p.m., and on March 18,
2005, from 8:30 a.m. to 12:30 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 by February 25, 2005. Oral
presentations from the public will be
scheduled between approximately 11
a.m. and 12 noon, and 3:30 p.m. and
4:45 p.m. on March 17, 2005, and
between approximately 9:30 a.m. and 10
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
a.m. on March 18, 2005. Time allotted
for each presentation may be limited.
Those desiring to make formal oral
presentations should notify the contact
person before March 9, 2005, 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.
Closed Committee Deliberations: On
March 18, 2005, between 1:30 p.m. and
2:30 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 site visit report for the Laboratory of
Molecular Virology, Division of
Emerging and Transfusion Transmitted
Diseases, Office of Blood Research and
Review, Center for Biologics Evaluation
and Research.
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 William
Freas or Pearline K. Muckelvene at least
7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–2452 Filed 2–8–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Chiropractor Loan Repayment
Demonstration Project
Health Resources and Services
Administration (HRSA), HHS.
ACTION: General notice.
AGENCY:
SUMMARY: The authority for the
Demonstration Project has been
extended with respect to chiropractors
(see legislative authority below). The
Health Resources and Services
Administration (HRSA) announces that
applications from qualified
chiropractors who agree to serve
E:\FR\FM\09FEN1.SGM
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[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Notices]
[Page 6890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2452]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood 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: Blood 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 March 17, 2005, from 8
a.m. to 5:30 p.m., and on March 18, 2005, from 8:30 a.m. to 2:30 p.m.
Location: Holiday Inn Gaithersburg, 2 Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: William Freas or Pearline K. Muckelvene, 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 3014519516. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On March 17, 2005, the committee will hear updates on the
following topics: Summary of the Department of Health and Human
Services Advisory Committee on Blood Safety and Availability meeting,
summary of the Transmissible Spongiform Encephalopathies Advisory
Committee meeting, update on West Nile Virus guidance, and summaries of
the Critical Path Initiative workshop. In the morning, the committee
will also discuss and provide recommendations on the safety of albumin.
In the afternoon, the committee will hear additional updates on the
following topics: International agreements, and a presentation on
sharing information with the public. Additionally, the committee will
hear presentations, and discuss and provide recommendations on rapid
freezing of plasma for transfusion. On the morning of March 18, 2005,
the committee will hear presentations, and discuss and provide
recommendations on the study design for the abbreviated uniform donor
history questionnaire. The committee also will hear presentations
related to the review of the site visit report for the Laboratory of
Molecular Virology, Division of Emerging and Transfusion Transmitted
Diseases, Office of Blood Research and Review.
Procedure: On March 17, 2005, from 8 a.m. to 5:30 p.m., and on
March 18, 2005, from 8:30 a.m. to 12:30 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 by February 25, 2005.
Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 noon, and 3:30 p.m. and 4:45 p.m. on March
17, 2005, and between approximately 9:30 a.m. and 10 a.m. on March 18,
2005. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before March 9, 2005, 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.
Closed Committee Deliberations: On March 18, 2005, between 1:30
p.m. and 2:30 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
site visit report for the Laboratory of Molecular Virology, Division of
Emerging and Transfusion Transmitted Diseases, Office of Blood Research
and Review, Center for Biologics Evaluation and Research.
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 William Freas or
Pearline K. Muckelvene at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-2452 Filed 2-8-05; 8:45 am]
BILLING CODE 4160-01-S
