Department of Health and Human Services March 16, 2011 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License
Pursuant to 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), this will serve to notify the public that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to intellectual property broker ICAP Ocean Tomo to promote the utilization by the public of the inventions described in the following U.S. patents: 7,122,624 entitled ``PH2 Receptor Ligands'' (HHS Ref. No. E-123-1999/0), and 7,087,736 entitled ``Tyrosine DNA phosphodiesterases (TDP) and related polypeptides, nucleic acids, vectors, TDP producing host cells, antibodies and methods of use'' (HHS Ref. No. E-281-1999/0). The patent rights in this invention have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be for the use of the Licensed Patent Rights in developing biopharmaceutical products.
``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.
Draft Action Plan-A Public Health Action Plan To Combat Antimicrobial Resistance
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is publishing this notice requesting public comment on the draft A Public Health Action Plan to Combat Antimicrobial Resistance. HHS/CDC is publishing this notice on behalf of the HHS Interagency Task Force on Antimicrobial Resistance. The draft Action Plan and supporting documents can be found at https://www.regulations.gov.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Focus Groups About Drug Products, as Used by the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Focus Groups About Drug Products, as Used by the Food and Drug Administration'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Special Protocol Assessment'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Exchange of Letters Between Dr. Murray M. Lumpkin, Deputy Commissioner, International Programs, Food and Drug Administration and Mr. Martin Heraghty, Assistant Secretary General, Department of Agriculture, Fisheries and Food of Ireland Concerning Certification Requirements for Caseins, Caseinates, and Mixtures Thereof Exported From Ireland to the United States
The Food and Drug Administration (FDA) is providing notice of exchange of letters between Dr. Murray M. Lumpkin, Deputy Commissioner, International and Special Programs, FDA and Mr. Martin Heraghty, Assistant Secretary General, Department of Agriculture, Fisheries and Food (DAFF), concerning certification requirements for caseins, caseinates, and mixtures thereof exported from Ireland to the United States. The mutual goals of FDA and DAFF in establishing certification requirements for caseins, caseinates, and mixtures thereof exported from Ireland to the United States are to assure that contaminated products will not be imported into the United States and to minimize the need for extensive FDA audit sampling of these products from Ireland. DAFF and FDA have a history of cooperation on this issue and it is, therefore, desirable that the two Agencies continue to cooperate to maintain and improve consumer protection.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information concerning the guidance for industry on cooperative manufacturing arrangements for licensed biologics.
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