Department of Health and Human Services April 27, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Danisco USA, Inc.; Filing of Food Additive Petition; Amendment
The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Danisco USA, Inc., to indicate that the petition proposes to amend the food additive regulations at 21 CFR 172.841 by incorporating by reference the specifications for polydextrose in the 5th edition of the Food Chemicals Codex (FCC), 2003.
Draft “Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs,'' dated April 2006. The draft guidance document further explains the requirements on informed consent as they relate to plasmapheresis and immunization programs. The draft guidance document is designed to assist blood establishments planning to apply for licensure or those revising their existing informed consent forms in determining whether the documents include all the appropriate information. This draft guidance, when finalized, will supersede the draft guidance document entitled ``Draft Reviewer's Guide: Informed Consent for Plasmapheresis/Immunization,'' dated October 1995.
C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory; Recognition of Cord Blood Bank Accreditation Program(s)
Public Law 109-129 requires the Secretary of Health and Human Services to recognize one or more cord blood accreditation entities for the accreditation of cord blood banks participating in the collection and maintenance of umbilical cord blood units for the National Cord Blood Inventory. These cord blood units will be made available for unrelated donor blood stem cell transplants through the C.W. Bill Young Cell Transplantation Program. The HRSA, Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in the determination of which cord blood bank accreditation program(s) to recognize on an interim basis for the initial cycle of funding for the National Cord Blood Inventory. The purpose of this solicitation is to receive public input on the following: (1) Approaches to accreditation required to ensure quality cord blood bank operations (including collection sites); (2) Utilization of accreditation programs to ensure product quality and best practices; (3) Degree to which accreditation standards are evidence based and supported by published literature; (4) Extent to which accreditation standards allow for variations in cord blood bank practices; (5) Criteria for the Secretary to consider in recognizing cord blood bank accrediting programs for the National Cord Blood Inventory, C.W. Bill Young Cell Transplantation Program. The HRSA intends for this interim process to be followed by a formal, more comprehensive recognition process that will include input from both the Advisory Council, once it is established, and the interested public as required in the legislation. The purpose of this Notice is to invite interested parties to register for and participate in either of two conference calls, described below, that HRSA is scheduling to obtain comment on factors relevant to determining which accrediting organization(s) to recognize for the initial cycle of funding under the National Cord Blood Inventory.
Guidance for Industry on Bar Code Label Requirements-Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Bar Code Label RequirementsQuestions and Answers.'' FDA regulations require certain human drug and biological products to have on their labels a linear bar code that identifies the drug's National Drug Code (NDC) number. We have received several inquiries about how the requirements apply to specific products or circumstances. The purpose of the guidance is to respond to the questions.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill four positions on the Committee membership that will become vacant on January 3, 2007.
New Animal Drugs for Use in Animal Feeds; Lasalocid and Chlortetracycline
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma Inc. The NADA provides for use of approved single-ingredient Type A medicated articles containing lasalocid and chlortetracycline to formulate two-way, combination drug Type B and Type C medicated feeds for pasture cattle and cattle fed in confinement for slaughter.
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