Department of Health and Human Services October 7, 2005 – Federal Register Recent Federal Regulation Documents
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Solicitation of Public Review and Comment on Research Protocol: Gonadotropin-releasing Hormone Agonist Test in Disorders of Puberty
The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA), are soliciting public review and comment on a proposed research protocol entitled ``Gonadotropin-releasing Hormone (GnRH) Agonist Test in Disorders of Puberty.'' The proposed research would be conducted at the University of Chicago Hospitals General Clinical Research Facility and supported by the National Center for Research Resources of the National Institutes of Health (NIH). Public review and comment are solicited regarding the proposed research protocol under the requirements of HHS and FDA regulations.
Prospective Grant of Exclusive License: North-2'-Deoxy-Methanocarbathmydines as Antiviral Agents Against Poxvirus
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications: HHS Ref. No. E-047-2005; U.S. Provisional Patent Application Number 60/684,811, filed on May 25, 2005 to N&N Scientific, having a place of business in Maryland but incorporated in Illinois. The patent rights in these inventions have been assigned to the United States of America.
Assistant Secretary for Planning & Evaluation; Medicaid Program; Meeting of the Medicaid Commission-October 26-27, 2005
This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Regulations Under the Federal Import Milk Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Medicare and Medicaid Programs; Condition of Participation: Immunization Standard for Long Term Care Facilities
The goal of this final rule is to increase immunization rates in Medicare and Medicaid participating long term care (LTC) facilities by requiring LTC facilities to offer each resident immunization against influenza annually, as well as lifetime immunization against pneumococcal disease. LTC facilities will be required to ensure that before offering the immunization, each resident or the resident's legal representative receives education regarding the benefits and potential side effects of immunization. The facilities will be required to offer immunization against influenza annually and immunization against pneumococcal disease once, unless medically contraindicated or the resident or the resident's legal representative refuses immunization. Increasing the use of Medicare-funded preventive services is a goal of both CMS and the Centers for Disease Control and Prevention (CDC). This final rule is intended to increase the number of elderly receiving influenza and pneumococcal immunization and decrease the morbidity and mortality rate from influenza and pneumococcal diseases.
Medicare Program; Termination of Non-Random Prepayment Review
This proposed rule would implement the statutory requirements regarding the termination of non-random prepayment review under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This proposed rule provides the criteria for terminating a provider or supplier from non-random prepayment review.
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