Health Resources and Services Administration April 10, 2008 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System. This system of records is required to comply with the implementation directives of Public Law 109-129. HRSA published in the Federal Register of September 8, 2003, a document concerning notice of a new system of records, 09-15-0055, Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, 68 FR 52950. This document more fully explains the routine uses of records maintained in the system and amends the records' purpose and routine uses of records maintained in the system. Accordingly, the notice is published below in its entirety, as amended.
Agency Information Collection Activities: Proposed Collection: Comment Request
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.
Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.
Statement of Organization, Functions and Delegations of Authority
The Health Resources and Services Administration published a Statement of Organization, Functions and Delegations of Authority document in the Federal Register of March 10, 2008 (73 FR 12742), regarding the Bureau of Health Professions. In section heading RP, Office of the Administrator, the title was incorrect. Correction
''Low Income Levels'' Used for Various Health Professions and Nursing Programs Included in Titles III, VII, and VIII of the Public Health Service Act
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) Disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ``low income '' families.
Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
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