Department of Health and Human Services September 7, 2007 – Federal Register Recent Federal Regulation Documents

``Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms''; Availability
Document Number: E7-17709
Type: Notice
Date: 2007-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms'' dated September 2007. The guidance document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The guidance document provides recommendations to industry in response to changes made to the requirements for spore-forming microorganisms to allow greater flexibility in manufacturing. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms'' dated February 2005.
Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine
Document Number: E7-17696
Type: Rule
Date: 2007-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
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 Orion Corp. The supplemental NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative and analgesic in cats.
National Institute for Occupational Safety and Health (NIOSH); Advisory Board on Radiation and Worker Health (ABRWH)
Document Number: E7-17681
Type: Notice
Date: 2007-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Implantation or Injectable Dosage Form New Animal Drugs; Etodolac
Document Number: E7-17645
Type: Rule
Date: 2007-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of etodolac injectable solution in dogs for the control of pain and inflammation associated with osteoarthritis.
Office of Child Support Enforcement (OCSE); Privacy Act of 1974; Amended System of Records
Document Number: E7-17642
Type: Notice
Date: 2007-09-07
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
In accordance with the requirement of the Privacy Act of 1974 (5 U.S.C. 552a), the Office of Child Support Enforcement (OCSE) is publishing notice of its amendment of its system of records entitled ``The Location and Collection System,'' No. 09-90-0074.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-17625
Type: Notice
Date: 2007-09-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Memorandum of Understanding Between the Food and Drug Administration and the University System of Maryland
Document Number: 07-4404
Type: Notice
Date: 2007-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the University System of Maryland to establish terms of collaboration to support shared interests that can proceed through a variety of programs including collaborative research, public outreach, cooperative international initiatives, interdisciplinary training, and exchange of scientists and staff through sabbaticals, postdoctoral fellowships, and student internships.
National Institute on Aging; Notice of Closed Meetings
Document Number: 07-4367
Type: Notice
Date: 2007-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 07-4366
Type: Notice
Date: 2007-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority Health and Health Disparities; Notice of Meeting
Document Number: 07-4365
Type: Notice
Date: 2007-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 07-4364
Type: Notice
Date: 2007-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 07-4363
Type: Notice
Date: 2007-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Elimination of Reimbursement Under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School
Document Number: 07-4356
Type: Proposed Rule
Date: 2007-09-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Under the Medicaid program, Federal payment is available for the costs of administrative activities ``as found necessary by the Secretary for the proper and efficient administration of the State plan.'' The proposed rule would eliminate reimbursement under the Medicaid program for the costs of certain activities based on a Secretarial finding that these activities are not necessary for the proper and efficient administration of the State plan, nor do they meet the definition of an optional transportation benefit. Based on these determinations, under the proposed rule, Federal Medicaid payments would no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and transportation from home to school and back for school-aged children with an Individualized Education Program (IEP) or an Individualized Family Services Plan (IFSP) established pursuant to the Individuals with Disabilities Education Act (IDEA).
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