Department of Health and Human Services May 2007 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 378
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL43, Request for Comments; Availability
The Food and Drug Administration (FDA) is announcing the availability for comments of a draft guidance document for industry (185) entitled ``Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products,''VICH GL43. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document has been developed as a harmonized standard to aid in development of mutually acceptable target animal safety (TAS) studies for the relevant governmental regulatory bodies.
Oral Dosage Form New Animal Drugs; Phenylbutazone Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Superior Equine Pharmaceuticals, Inc. The ANADA provides for the veterinary prescription use of phenylbutazone powder administered to horses in feed for the relief of inflammatory conditions associated with the musculoskeletal system.
Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of butorphanol tartrate injectable solution in cats for the relief of pain.
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Modern Veterinary Therapeutics, LLC.
C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory Related Cord Blood Donor Demonstration Project
Public Law 109-129 requires the Secretary of Health and Human Services to establish a 3-year demonstration project for qualified cord blood banks to collect and store at no charge to families, umbilical cord blood units for families where a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. Umbilical cord blood units collected through the demonstration project do not count toward the current National Cord Blood Inventory (NCBI) goal of 150,000 cord blood units to be made available through the C.W. Bill Young Cell Transplantation Program. Qualified umbilical cord blood banks participating in the demonstration project must provide assurances that the cord blood units will be available for directed transplantation until such time as the cord blood unit is needed. Within 90 days of the termination of the demonstration project, the Secretary will submit to Congress a report on the outcomes of the project including recommendations with respect to the continuation of such a project. HRSA's Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in implementation of the related cord blood demonstration project. The purpose of this solicitation is to receive public input on the following: (1) The key questions that should be studied through this project; (2) the mechanism for funding this project; and, (3) umbilical cord blood bank liability. HRSA has identified the following key study questions to be considered in the design of this demonstration project: (1) What is the value and feasibility of implementing a long-term program modeled after this demonstration project; (2) how often and for what clinical indications are cord blood units banked through this project used for transplantation; (3) what is the breakdown of cord blood units collected, stored, and transplanted by race, ethnicity, and disease; (4) do those cord blood units, especially those released for transplant, represent rare Human Leukocyte Antigen (HLA) types such that the recipient would otherwise have been unable to find a matched unrelated donor; (5) how do transplant outcomes using these cord blood units compare to unrelated allogeneic umbilical cord blood transplants and unrelated allogeneic transplants using blood stem cells from adult donors; and, (6) what are the general physical characteristics of these units (e.g., total nucleated count, CD34+ content) and how does their quality compare to that of the general public inventory. HRSA proposes to invite the first cohort of umbilical cord blood banks receiving NCBI contracts to submit competitive proposals for participation in this demonstration project with an emphasis on: (1) Establishment of nationwide collections; and, (2) encouraging banks to subcontract with other experienced, high-quality cord blood banks to assist in their education, collection, processing, and storing efforts. HRSA has approximately $200,000 available for this demonstration project this fiscal year and anticipates selecting 2 or 3 banks to participate in this demonstration project to be funded through modification of their existing NCBI contracts with HRSA. HRSA recognizes the need for this service is likely greater than what can be satisfied in a limited demonstration project. Because of the great diversity in HLA types among African-Americans, HRSA recognizes that patients from this population are significantly less likely to find a suitably matched unrelated blood stem cell donor than patients from other racial or ethnic groups. Therefore, HRSA invites comments on the desirability of limiting participation to African- American families in which a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. HRSA understands that there may be special considerations associated with liability for those umbilical cord blood banks participating in this project. HRSA invites comment on how umbilical cord blood banks participating in this project may best address these concerns. Interested parties are invited to submit written comments on the key study questions, the funding approach, and umbilical cord blood bank liability for this demonstration project to the address below.
''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 (PHS) 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.
National Advisory Council on the National Health Service Corps; Request for Nominations for Members
The Health Resources and Services Administration (HRSA) is requesting nominations to the National Advisory Council (NAC) on the National Health Service Corps (NHSC). NAC was established by 42 U.S.C. 254j; Section 337 of the Public Health Service Act, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of NHSC and related programs.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice announces the 14th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Nuclear Materials and Equipment Corporation at Apollo, PA (NUMEC Apollo) To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nuclear Materials and Equipment Corporation at Apollo, Pennsylvania (NUMEC Apollo), to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Nuclear Materials and Equipment Corporation (NUMEC). Location: Apollo, Pennsylvania (Apollo). Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1957 through December 31, 1983.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 1, 2006 and allowed 60 days for public comment. The purpose of this notice is to publish prior comments received and agency responses as well as allow an additional 30 days for public comment. Public comments were received and are included at the end of this notice, along with responses to the comments.
National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); the Murine Local Lymph Node Assay: Request for Comments, Nominations of Scientific Experts, and Submission of Data
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) received a nomination from the U.S. Consumer Product Safety Commission (CPSC) to evaluate the validation status of: (1) The murine local lymph node assay (LLNA) as a stand- alone assay for determining potency (including severity) for the purpose of hazard classification; (2) the ``cut-down'' or ``limit dose'' LLNA approach; (3) non-radiolabeled LLNA methods; (4) the use of the LLNA for testing mixtures, aqueous solutions, and metals; and (5) the current applicability domain (i.e., the types of chemicals and substances for which the LLNA has been validated). ICCVAM reviewed the nomination, assigned it a high priority, and proposed that NICEATM and ICCVAM carry out the following activities in its evaluation: (1) Initiate a review of the current literature and available data, including the preparation of a comprehensive background review document, and (2) convene a peer review panel to review the various proposed LLNA uses and procedures for which sufficient data and information are available to adequately assess their validation status. ICCVAM also recommends development of performance standards for the LLNA. At this time, NICEATM requests: (1) Public comments on the appropriateness and relative priority of these activities, (2) nominations of expert scientists to consider as members of a possible peer review panel, and (3) submission of data for the LLNA and/or modified versions of the LLNA.
Proposed Collection; Comment Request; Physicians' Experience of Ethical Dilemmas and Resource Allocation
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 National Institute of Dental and Craniofacial Research (NIDCR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin and Clorsulon
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of an ivermectin and clorsulon solution by subcutaneous injection in cattle for control of various internal and external parasites.
Oral Dosage Form New Animal Drugs; Pimobendan
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of pimobendan chewable tablets in dogs for the management of the signs of congestive heart failure.
Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for use of a one percent ivermectin solution by subcutaneous injection in cattle, swine, reindeer, and American bison for the treatment and control of various internal and external parasites.
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