Department of Health and Human Services December 19, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
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 information collection requirements for medical device recall authority.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments
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 information collection provisions of the agency's Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments.
Medicaid Program; Fiscal Year Disproportionate Share Hospital Allotments and Disproportionate Share Hospital Institutions for Mental Disease Limits
This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal fiscal year (FFY) 2007 and the preliminary Federal share DSH allotments for FFY 2009. This notice also announces the final FFY 2007 and the preliminary FFY 2009 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FFY DSH allotments.
Medicare Program; Meeting of the Medicare Evidence Development & Coverage Advisory Committee-February 25, 2009
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, February 25, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the requirements for evidence to determine if diagnostic use of genomic testing in beneficiaries with signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will also discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”)
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 Emergency Shortages Data Collection System.
Determination That RUBRAMIN PC (Cyanocobalamin) Injection and Ten Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the eleven drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Opportunity for Cosponsorship of the Integrated Medical, Public Health, Preparedness, and Response Training Summit
The Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) and Office of the Surgeon General (OSG) announce the opportunity for both private sector and non-profit entities to cosponsor an annual training summit. The focus of this training is medical and public health preparedness and response during disasters and emergencies. Potential cosponsors must have a mutual interest in the subject matter, the capability to provide logistical and educational support, and be willing to participate substantively in the cosponsored activity.
Notice of the Development of a Web-Based System Used To Request Meetings Regarding Medical Countermeasures to Naturally Occurring or Manmade Threats
The Department of Health and Human Services (HHS) is announcing the availability of a new Web-based system, MedicalCountermeasures.gov. MedicalCountermeasures.gov will enable external stakeholders to request meetings with personnel from the organizations that comprise the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) regarding medical countermeasures to threats to public health, either naturally occurring or manmade. The goal of these meetings is to provide an opportunity for stakeholders to share information regarding medical countermeasures. The system can be accessed from the Web site https://www.medicalcountermeasures.gov/ RequestMeeting.aspx. During the BioShield Stakeholders Workshop, HHS Secretary Michael O. Leavitt announced that HHS would develop a Web based system ``through which those in industry and the research and development community can reach the people they need in the federal government, whether they're looking at a basic level of research or are focused on end-stage development.'' In fulfillment of this promise, HHS has developed MedicalCountermeasures.gov. MedicalCountermeasures.gov enables external stakeholders to request a meeting with federal representatives from participating PHEMCE agencies regarding medical countermeasures they are developing for use in response to a public health emergency. The information will then be routed to personnel within the relevant PHEMCE agencies, which currently include: The National Institutes of Health (NIH), the Office of the Biomedical Advanced Research and Development Authority (BARDA), the Food and Drug Administration (FDA), and the Department of Veterans Affairs (VA). MedicalCountermeasures.gov also provides information on upcoming and past conferences; procurements and grants; regulatory information; and strategic plans from throughout the PHEMCE agencies.
Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law
The Department of Health and Human Services (HHS) is issuing a final rule to ensure that Department funds do not support morally coercive or discriminatory practices or policies in violation of federal law, pursuant to the Church Amendments (42 U.S.C. 300a-7), Public Health Service (PHS) Act Sec. 245 (42 U.S.C. 238n), and the Weldon Amendment (Consolidated Appropriations Act, 2008, Public Law 110-161, Div. G, Sec. 508(d), 121 Stat. 1844, 2209). This final rule defines certain key terms. In order to ensure that recipients of Department funds know about their legal obligations under these federal health care conscience protection laws, the Department is requiring written certification by certain recipients that they will comply with all three statutes, as applicable. Finally, this final rule assigns responsibility for complaint handling and investigation among the Department's Office for Civil Rights and Department program offices.
Guidance for Industry on Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.'' This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. We are issuing this guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes.
Medicare Program; First Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-February 18-20, 2009
This notice announces the first semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2009. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the proposed and final rules that would update the hospital Outpatient Prospective Payment System (OPPS) for CY 2010.
Medicaid Program; Disproportionate Share Hospital Payments
This final rule sets forth the data elements necessary to comply with the requirements of Section 1923(j) of the Social Security Act (Act) related to auditing and reporting of disproportionate share hospital payments under State Medicaid programs. These requirements were added by Section 1001(d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Medicaid Program; State Option To Establish Non-Emergency Medical Transportation Program
This final rule implements section 6083 of the Deficit Reduction Act of 2005, which provides States with additional State plan flexibility to establish a non-emergency medical transportation (NEMT) brokerage program, and to receive the Federal medical assistance percentage matching rate. This authority supplements the current authority that States have to provide NEMT to Medicaid beneficiaries who need access to medical care, but have no other means of transportation.
Deeming Notice for American Society for Histocompatibility and Immunogenetics (ASHI) as an Accrediting Organization Under the Clinical Laboratory Improvement Amendments of 1988
The American Society for Histocompatibility and Immunogenetics (ASHI) was granted deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program on March 25, 2005. The deeming authority was granted for the CLIA specialty of Histocompatibility and the subspecialty ABO/Rh. In this notice, we approve and grant ASHI deeming authority for the additional CLIA subspecialty of General Immunology.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
