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NOTICES: Post-approval studies imposed by premarket approval application order; handling procedures,
Published: 2006-12-21
The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Procedures for Handling Post
Approval Studies Imposed by PMA Order.'' The guidance provides a
standard format and content for submitting postapproval studies. The
guidance is issued to help ensure that sponsors provide adequate
information about the
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-21
NOTICES: American Health Information Community,
Published: 2006-12-21
This notice announces the first meeting of the American Health
Information Community Personalized Healthcare Workgroup in accordance
with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C.,
App.)
NOTICES: American Health Information Community,
Published: 2006-12-21
This notice announces the 13th meeting of the American Health
Information Community Biosurveillance Workgroup in accordance with the
Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.).
NOTICES: American Health Information Community,
Published: 2006-12-21
This notice announces the sixth meeting of the American Health
Information Community Confidentiality, Privacy and Security Workgroup
in accordance with the Federal Advisory Committee Act (Pub. L. No. 92
463, 5 U.S.C., App.).
NOTICES: American Health Information Community,
Published: 2006-12-21
This notice announces the 12th meeting of the American Health
Information Community Chronic Care Workgroup in accordance with the
Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C., App.).
NOTICES: American Health Information Community,
Published: 2006-12-21
This notice announces the 12th meeting of the American Health
Information Community Electronic Health Records Workgroup in accordance
with the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C.,
App.).
NOTICES: American Health Information Community,
Published: 2006-12-21
This notice announces the 13th meeting of the American Health
Information Community Consumer Empowerment Workgroup in accordance with
the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C.,
App.).
NOTICES: American Health Information Community,
Published: 2006-12-21
This notice announces the fifth meeting of the American Health
Information Community Quality Workgroup in accordance with the Federal
Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C., App.).
RULES: Civilian Board of Contract Appeals; address change,
Published: 2006-12-21
The Indian Health Service is revising its regulations governing
contracts under the Indian SelfDetermination and Education Assistance
Act to reflect a change of address due to a move for the Civilian Board
of Contract Appeals (CBCA).
NOTICES: Evaluation and Inspections Office et al.,
Published: 2006-12-21
Statement of Organization, Functions, and Delegations of
Authority
This notice amends Part A (Office of the Secretary), chapter AF of
the Statement of Organization, Functions, and Delegations of Authority
for the Department of Health and Human Services (HHS) to reflect title
changes and responsibilities within the Office of Inspector
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-21
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 6395960 or send an email
RULES: Food labeling—; Uniform compliance date,
Published: 2006-12-21
The Food and Drug Administration (FDA) is establishing January
1, 2010, as the uniform compliance date for food labeling regulations
that are issued between January 1, 2007, and December 31, 2008. FDA
periodically announces uniform compliance dates for new food labeling
requirements to minimize the economic impact of label changes. On March
14,
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-20
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-20
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-20
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-20
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
NOTICES: Marketed unapproved drugs application process; workshop,
Published: 2006-12-20
The Food and Drug Administration (FDA) is announcing a change
of location and time for the upcoming public workshop on marketed
unapproved drugs. Registration for the public workshop is closed. A new
address and time are given for those persons who have previously
registered with FDA.
NOTICES: Inventions, Government-owned; availability for licensing,
Published: 2006-12-20
The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federallyfunded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies
NOTICES: Inventions, Government-owned; availability for licensing,
Published: 2006-12-20
The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federallyfunded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies
NOTICES: National Center for Complementary and Alternative Medicine,
Published: 2006-12-20
Pursuant to Section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the National
Advisory Council for Complementary and Alternative Medicine (NACCAM) meeting.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to
Part III: Health and Human Services Department,
Published: 2006-12-20
The Department of Health and Human Services is amending its
acquisition regulations (HHSAR) to make administrative and editorial
changes to reflect organizational title changes resulting from Office
of the Secretary (OS) and Operating Division (OPDIV) reorganizations
and to update or remove outdated text and references. The intent of the
final
NOTICES: National Institute of Allergy and Infectious Diseases,
Published: 2006-12-20
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of meetings of
the National Advisory Allergy and Infectious Diseases Council.
The meetings will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and
NOTICES: National Institute of Allergy and Infectious Diseases,
Published: 2006-12-20
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the meetings of the AIDS Research Advisory Committee, NIAID.
The meetings will be open to the public, with attendance limited to
space available. Individuals who plan to attend and need special
assistance, such as
NOTICES: Cambridge Antibody Technology, Ltd.,
Published: 2006-12-20
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive patent license to practice the inventions embodied in U.S.
Patent No. 7,081,518, issued July 25, 2006, entitled ``AntiMesothelin
Antibodies