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2626. Proposed Data Collections Submitted for Public Comment and Recommendations

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

2627. Clinical Laboratory Improvement Advisory Committee: Notice of Charter Renewal

NOTICES: Clinical Laboratory Improvement Advisory Committee; Charter Renewal,

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,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

2628. Statement of Organization, Functions, and Delegations of Authority

NOTICES: Statement of Organization, Functions, and Delegations of Authority,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

2629. Outcome of Meeting of the International Cooperation on Cosmetic Regulation, September 26-28, 2007; Availability

NOTICES: International Cooperation on Cosmetic Regulation Outcome of Meeting, Sept. 26-27, 2007; Availability,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2630. State Systems Advance Planning Document (APD) Process

PROPOSED RULES: State Systems Advance Planning Document Process,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

2631. Office of the Secretary; Statement of Organization, Functions, and Delegations of Authority

NOTICES: 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 a title change and adjusted responsibilities within the Office of Inspector General's (OIG) Office of Evaluation and Inspections (OEI) to

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Inspector General Office, Health and Human Services Department

2632. Intramammary Dosage Forms; Cephapirin Benzathine

RULES: Intramammary Dosage Forms; Cephapirin Benzathine,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2633. Revision of the Requirements for Live Vaccine Processing; Confirmation of Effective Date

RULES: Revision of Requirements for Live Vaccine Processing; Confirmation of Effective Date,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2634. Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2635. Determination That RELAFEN (Nabumetone) Tablets and Three Other Drug Products Were Not Withdrawn From Sale for

NOTICES: RELAFEN (Nabumetone) Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2636. Proposed Data Collections Submitted for Public Comment and Recommendations

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

2637. Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of Reformulated Drug Products and

NOTICES: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by Alternate Route; Availability,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2638. Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Reopening of Comment

NOTICES: Guidance for Industry on Drug-Induced Liver Injury; Premarketing Clinical Evaluation,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2639. Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability

NOTICES: Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2640. National Center for Research Resources; Notice of Closed Meetings

NOTICES: National Center for Research Resources,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2641. National Institute of Child Health and Human Development; Notice of Closed Meeting

NOTICES: National Institute of Child Health and Human Development,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2642. National Institute of Child Health and Human Development; Notice of Closed Meeting

NOTICES: National Institute of Child Health and Human Development,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2643. National Institute of Child Health and Human Development; Notice of Meetings

NOTICES: National Institute of Child Health and Human Development,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2644. Notice of the Revised Priority List of Hazardous Substances That Will Be the Subject of Toxicological Profiles

NOTICES: Reader Aids; ; Revised Priority List of Hazardous Substances; Toxicological Profiles,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Agency for Toxic Substances and Disease Registry

2645. National Institute of Child Health and Human Development; Notice of Closed Meeting

NOTICES: National Institute of Child Health and Human Development,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2646. National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

NOTICES: National Institute of Diabetes and Digestive and Kidney Diseases,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2647. Notice of Draft Document Available for Public Comment

NOTICES: Draft Document Available for Public Comment,

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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

2648. National Institute of General Medical Sciences; Notice of Closed Meetings

NOTICES: National Institute of General Medical Sciences,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2649. Notice of Public Meeting

NOTICES: National Institute for Occupational Safety and Health,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

2650. National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

NOTICES: National Institute on Alcohol Abuse and Alcoholism,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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