Department of Health and Human Services April 6, 2010 – Federal Register Recent Federal Regulation Documents
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Cancer Therapy Evaluation Program Intellectual Property Option to Collaborator
The National Cancer Institute, Division of Cancer Treatment and Diagnosis, is seeking comments on a proposed revision to its policy on intellectual property agreements with certain funding recipients, entitled the Cancer Therapy Evaluation Program (CTEP) INTELLECTUAL PROPERTY OPTION. The proposed policy, if finalized, would establish that potential applicants for CTEP funding should include an assurance of agreement with the recommended Intellectual Property Option and Institution Notification if they wish to be considered for funding support to carry out any CTEP-sponsored clinical trial for which CTEP holds the investigational new drug (IND) application.
Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 20, 2010, page 3237 and allowed 60 days for public comment. Two comments were received and appropriate responses were given. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised or implemented on or after October 1, 1995 unless it displays a current valid OMB control number.
Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of March 8, 2010 (75 FR 10490). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.
Determination of Regulatory Review Period for Purposes of Patent Extension; TOVIAZ
The Food and Drug Administration (FDA) has determined the regulatory review period for TOVIAZ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; FANAPT
The Food and Drug Administration (FDA) has determined the regulatory review period for FANAPT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and Human Services and the Association of Minority Health Profession Schools, Inc.
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the FDA, U.S. Department of Health and Human Services and the Association of Minority Health Profession Schools, Inc. The purpose of the MOU is to establish the terms for collaboration to enhance the diversity pool of candidates and to promote shared interests in increasing science and public health internship opportunities for socio-economically disadvantaged students.
Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and Human Services and the National Alliance for Hispanic Health
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, U.S. Department of Health and Human Services and the National Alliance for Hispanic Health. The purpose of the MOU is to establish the terms for collaboration to enhance the diversity pool of candidates and to promote shared interests in increasing science and public health internship opportunities for socio-economically disadvantaged students.
Temporary Assistance for Needy Families (TANF) Carry-Over Funds
This final rule implements the statutory change to section 404(e) of the Social Security Act as enacted by the American Recovery and Reinvestment Act of 2009. This change allows States, Tribes and Territories to use Temporary Assistance for Needy Families (TANF) program funds carried over from a prior year for any allowable TANF benefit, service or activity. Previously these funds could be used only to provide assistance. This final rule applies to States, local governments, and Tribes that administer the TANF program.
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