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NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-27
Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995. the National Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of Health (NIH) has submitted to the
Office of Management and Budget (OMB) a request for review and approval
the information collection listed below. This proposed information
NOTICES: Federal agency urine drug testing; certified laboratories meeting minimum standards, list,
Published: 2006-12-26
The Department of Health and Human Services (HHS) notifies
Federal agencies of the laboratories currently certified to meet the
standards of Subpart C of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory
Guidelines were first published in the Federal Register on April 11,
1988 (53 FR 11970),
PROPOSED RULES: Internal analgesic, antipyretic, and antirheumatic products (OTC); tentative final monograph; required warnings and other labeling,
Published: 2006-12-26
The Food and Drug Administration (FDA) is proposing to amend
its overthecounter (OTC) labeling regulations and the tentative final
monograph (TFM) for OTC internal analgesic, antipyretic, and
antirheumatic (IAAA) drug products to include new warnings and other
labeling requirements advising consumers about potential risks and when
to consult a
NOTICES: Premarket notification exemptions; Class II devices—; Cranial orthosis type devices,
Published: 2006-12-26
The Food and Drug Administration (FDA) is publishing an order
denying a petition requesting exemption for cranial orthosis type
devices from the premarket notification requirements for certain class
II devices. A cranial orthosis device is a device intended to apply
pressure to prominent regions of an infant's cranium in order to
improve cranial
NOTICES: Medical Devices Advisory Committee,
Published: 2006-12-26
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of the meeting of the Neurological Devices Panel of the
Medical Devices Advisory Committee. This meeting was originally
announced in the Federal Register of December 6, 2006 (71 FR page
70780). The amendment is being made to reflect a change in the Agenda
portion
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-22
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-22
Part V: Health and Human Services Department, Centers for Medicare & Medicaid Services,
Published: 2006-12-22
This notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published from July 2006 through September 2006, relating to the
Medicare and Medicaid programs. This notice provides information on
national coverage determinations (NCDs) affecting specific medical and
health care
NOTICES: Medicare—; Ambulatory Payment Classification Groups Advisory Panel,
Published: 2006-12-22
In accordance with section 10(a) of the Federal Advisory
Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the
first biannual meeting of the Advisory Panel on Ambulatory Payment
Classification (APC) Groups (the Panel) for 2007. The purpose of the
Panel is to review the APC groups and their associated weights and to
advise the
NOTICES: Medicare Education Advisory Panel,
Published: 2006-12-22
In accordance with the Federal Advisory Committee Act, 5
U.S.C. Appendix 2, section 10(a) (Pub. L. 92463), this notice announces a meeting of the Advisory Panel on
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Medicare Education (the Panel) on January 24, 2007. The Panel advises
and makes recommendations to the Secretary of Health and Human Services
(the Secretary) and the
NOTICES: New Medical Services and Technologies Informational Workshop,
Published: 2006-12-22
This notice announces a Town Hall Meeting to discuss fiscal
year (FY) 2008 applications for addon payments for new medical
services and technologies under the Inpatient Prospective Payment
System (IPPS). Interested parties are invited to this meeting to
present their comments, recommendations, and data regarding whether the
FY 2008 new medical
NOTICES: Native Americans Administration program policies and procedures; proposed adoption,
Published: 2006-12-22
Pursuant to section 814 of the Native American Programs Act of
1974 (the Act) 42 U.S.C. 2992b1, ANA herein describes its proposed
interpretive rules, statements of general policy and rules of agency
procedure or practice in relation to the Social and Economic
Development Strategies (hereinafter referred to as SEDS), Native
Language Preservation
RULES: Gentamicin,
Published: 2006-12-22
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA
provides for use of a gentamicin sulfate injectable solution in piglets
for treatment of porcine colibacillosis.
RULES: Disqualification of a clinical investigator; technical amendment,
Published: 2006-12-22
The Food and Drug Administration (FDA) is amending a medical
device regulation to include references to the Center for Biologics
Evaluation and Research (CBER) and the Center for Drug Evaluation and
Research (CDER). This regulation pertains to the disqualification of a
clinical investigator. Currently, only a reference to the Center for
Devices
NOTICES: Reproductive Health Drugs Advisory Committee,
Published: 2006-12-22
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Advisory Committee for Reproductive Health Drugs.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory
NOTICES: Additional safeguards for children in clinical investigations; process for handling referrals to FDA,
Published: 2006-12-22
The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Clinical
Investigators, Institutional Review Boards, and Sponsors; Process for
Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for
Children in Clinical Investigations.'' This guidance is intended to
assist clinical
NOTICES: National Cancer Institute,
Published: 2006-12-22
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 following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the
NOTICES: National Institute of Allergy and Infectious Diseases,
Published: 2006-12-22
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 following meetings
The meetings will be closed to the public in accordance with the
provisions seth forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C, as amended. The grant applications and the
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-22
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: Scientific Review Center,
Published: 2006-12-22
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 following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
[[Page 77037]]
as amended. The grant applications
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-22
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: Vion Pharmaceuticals, Inc.,
Published: 2006-12-22
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR Part 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 invention embodied in U.S.
Provisional Patent Application No. 60/718,172, filed September 16,
2005,
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-22
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: 2006-12-22
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
Part IV: Health and Human Services Department, Centers for Medicare & Medicaid Services,
Published: 2006-12-22
This proposed rule would implement the provisions of the
Deficit Reduction Act of 2005 (DRA) pertaining to prescription drugs
under the Medicaid program. The DRA requires the Secretary of Health
and Human Services to publish a final regulation no later than July 1,
2007. In addition, we would add to existing regulations certain
established