Department of Health and Human Services September 20, 2013 – Federal Register Recent Federal Regulation Documents
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Tribal Consultation Meeting
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of two 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, 640(l)(4)].
Draft NIH Genomic Data Sharing Policy Request for Public Comments
The National Institutes of Health (NIH) is seeking public comments on the draft Genomic Data Sharing (GDS) Policy that promotes sharing, for research purposes, of large-scale human and nonhuman genomic \1\ data generated from NIH-supported and NIH-conducted research.
Medicare Program; Obtaining Final Medicare Secondary Payer Conditional Payment Amounts via Web Portal
This interim final rule with comment period specifies the process and timeline for expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to conform to section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The interim final rule specifies a timeline for developing a multifactor authentication solution to securely permit authorized users other than the beneficiary to access CMS' MSP conditional payment amounts and claims detail information via the MSP Web portal. It also requires that we add functionality to the existing MSP Web portal that permits users to: notify us that the specified case is approaching settlement; obtain time and date stamped final conditional payment summary forms and amounts before reaching settlement; and ensure that relatedness disputes and any other discrepancies are addressed within 11 business days of receipt of dispute documentation.
Nominations to the Report on Carcinogens; Request for Information
National Toxicology Program (NTP) Office of the Report on Carcinogens (ORoC) requests information on 20 substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') nominated for possible review for future editions of the Report on Carcinogens (RoC).
Prospective Grant of Exclusive Patent License: Oral Treatment of Hemophilia
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an Exclusive Patent License to ProGenetics, LLC, a company having its headquarters in Blacksburg, Virginia, to practice the inventions embodied in U.S. Patent No. 7,220,718, issued 27 February 2007 (HHS Ref. No. E-281-2001/ 0-US-03]), European Patent Application No. 02756904.5 (HHS Ref. No. E281-2001/0-EP-04), filed August 2, 2002, and U.S. Patent No. 7,867,974, issued 11 January 2011 (HHS Ref. No. E-281-2001/0-US-05), entitled respectively, ``Oral Treatment of Hemophilia'' and ``Induction of Tolerance by Oral administration of Factor VIII and Treatment of Hemophilia''. The patent rights in these inventions have been assigned to or exclusively licensed to the Government of the United States of America. The prospective Exclusive Patent License territory may be ``worldwide'', and the field of use may be limited to: ``Treatment of Hemophilia A and B and immunotolerization using oral delivery methods''.
Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.'' This draft guidance provides recommendations to sponsors on the parameters that should be routinely assessed in toxicology studies for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) regulated by the Center for Drug Evaluation and Research to determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses factors to consider in determining the need for additional studies to characterize potential endocrine disruptor properties of a drug.
Announcement of Requirements and Registration for “System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies Ideation Challenge”
The ``System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies'' Ideation Challenge seeks ideas to establish a system for monitoring the location and status of life-sustaining durable medical equipment (DME) during a prolonged power outage or disaster situation. This information would be used by a network of family and friends, formal caregivers, emergency responders and others responding to a disaster to better assist individuals who are dependent on DME. The current Challenge focuses on obtaining information about DME; however, this is part of a larger effort to ensure that these people get the necessary help as quickly as possible. Submissions can be existing applications, or applications developed specifically for this challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
Medicare and Medicaid Programs; Application from the Compliance Team for Initial CMS-Approval of its Rural Health Clinic Accreditation Program
This proposed notice acknowledges the receipt of an application from the Compliance Team for initial recognition as a national accrediting organization for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
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