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NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-03-10
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: Clinical Laboratory Improvement Advisory Committee; Charter Renewal,
Published: 2008-03-10
This gives notice under the Federal Advisory Committee Act (Pub. L.
92463) of October 6, 1972, that the Clinical Laboratory Improvement
Advisory Committee, Centers for Disease Control and Prevention,
Department of Health and Human Services, has been renewed for a 2year period through February 19, 2010.
For information, contact Thomas Hearn,
NOTICES: Statement of Organization, Functions, and Delegations of Authority,
Published: 2008-03-07
Part F of the Statement of Organization, Functions, and Delegations
of Authority for the Department of Health and Human Services, Centers
for Medicare & Medicaid Services (CMS), (Federal Register, Vol. 72, No.
248, pp. 7384773850, dated Friday, December 28, 2007) is amended to
reflect updates to the functions for the Center for Beneficiary
NOTICES: International Cooperation on Cosmetic Regulation Outcome of Meeting, Sept. 26-27, 2007; Availability,
Published: 2008-03-07
The Food and Drug Administration (FDA) is announcing the
availability of the International Cooperation on Cosmetic Regulation
(ICCR) Outcome of Meeting, September 2628, 2007. This notice is in
keeping with an FDA/ICCR commitment to transparency as well as
providing opportunity for public comment.
PROPOSED RULES: State Systems Advance Planning Document Process,
Published: 2008-03-07
The Advance Planning Document (APD) process governs the
procedure by which States obtain approval for Federal financial
participation in the cost of acquiring automated data processing
equipment and services. This NPRM reduces the submission requirements
for lowerrisk information technology (IT) projects and procurements
and increases oversight
NOTICES: Statement of Organization, Functions, and Delegations of Authority,
Published: 2008-03-07
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 a
title change and adjusted responsibilities within the Office of
Inspector General's (OIG) Office of Evaluation and Inspections (OEI) to
RULES: Intramammary Dosage Forms; Cephapirin Benzathine,
Published: 2008-03-07
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Fort Dodge Animal Health, Division of
Wyeth. The supplemental NADA provides for a revision to the labeling of
cephapirin benzathine intramammary infusion administered to dairy cows
RULES: Revision of Requirements for Live Vaccine Processing; Confirmation of Effective Date,
Published: 2008-03-07
The Food and Drug Administration (FDA) is confirming the
effective date of March 18, 2008, for the direct final rule that
appeared in the Federal Register of October 18, 2007 (72 FR 59000). The
direct final rule amends the biologics regulations by providing options
to the existing requirements for the processing of live vaccines. This
document
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-03-07
The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each
NOTICES: RELAFEN (Nabumetone) Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,
Published: 2008-03-07
The Food and Drug Administration (FDA) has determined that the
four drug products listed in this document were not withdrawn from sale
for reasons of safety or effectiveness. This determination means that
FDA will not begin procedures to withdraw approval of abbreviated new
drug applications (ANDAs) that refer to the drug products, and it will
NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,
Published: 2008-03-07
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on [[Page 12450]]
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
NOTICES: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by Alternate Route; Availability,
Published: 2008-03-07
The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and review staff entitled
``Nonclinical Safety Evaluation of Reformulated Drug Products and
Products Intended for Administration by an Alternate Route.'' The draft
guidance provides recommendations concerning development of safety
profiles to
NOTICES: Guidance for Industry on Drug-Induced Liver Injury; Premarketing Clinical Evaluation,
Published: 2008-03-06
The Food and Drug Administration (FDA) is reopening until June
30, 2008, the comment period for the draft guidance for industry
entitled ``DrugInduced Liver Injury: Premarketing Clinical
Evaluation,'' published in the Federal Register of October 25, 2007 (72
FR 60681). FDA is also announcing a public conference entitled
``Detecting and
NOTICES: Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability,
Published: 2008-03-06
The Food and Drug Administration (FDA) is announcing the
availability of summaries of medical and clinical pharmacology reviews
of pediatric studies submitted in supplements for BETOPTIC (betaxolol),
LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL
(risperidone), and TIMOLOL (timolol). These summaries are being made
available consistent
NOTICES: National Center for Research Resources,
Published: 2008-03-06
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 Child Health and Human Development,
Published: 2008-03-06
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 meeting.
The meeting 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 discussions
NOTICES: National Institute of Child Health and Human Development,
Published: 2008-03-06
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 meeting.
The meeting 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 discussions
NOTICES: National Institute of Child Health and Human Development,
Published: 2008-03-06
Pursuant to section 10(a) of the Federal Advisory Committee Act, as [[Page 12184]]
amended (5 U.S.C. Appendix 2), notice is hereby given of meetings of the National Children's Study Advisory Committee.
The meetings will be open to the public, with attendance limited to
space available. Individuals who plan to attend and need special
NOTICES: Reader Aids; ; Revised Priority List of Hazardous Substances; Toxicological Profiles,
Published: 2008-03-06
The Comprehensive Environmental Response, Compensation, and
Liability Act of 1980 (CERCLA or Superfund), as amended by the
Superfund Amendments and Reauthorization Act of 1986 (SARA), requires
that ATSDR and the Environmental Protection Agency(EPA) prepare a
Priority List of Hazardous Substances commonly found at facilities on
the CERCLA National
NOTICES: National Institute of Child Health and Human Development,
Published: 2008-03-06
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 meeting.
The meeting 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 discussions
NOTICES: National Institute of Diabetes and Digestive and Kidney Diseases,
Published: 2008-03-06
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 meeting 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: Draft Document Available for Public Comment,
Published: 2008-03-06
The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC)
announces the availability of the following draft document available
for public comment entitled ``NIOSH Alert: Preventing Chronic Beryllium
Disease and Beryllium Sensitization.'' The document and instructions
for submitting
NOTICES: National Institute of General Medical Sciences,
Published: 2008-03-06
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 for Occupational Safety and Health,
Published: 2008-03-06
The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC)
announces the availability of the following meeting and request for information:
Opportunity To Provide Input regarding a protocol for the
following: (1) An industry wide research study to evaluate occupational
exposure to
NOTICES: National Institute on Alcohol Abuse and Alcoholism,
Published: 2008-03-06
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 meeting.
The meeting 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 discussions