Department of Health and Human Services June 11, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Medicare and Medicaid Programs; Procedure for Hospitals Seeking To Enter Into an Agreement With a Different Organ Procurement Organization Following an 1138(a)(2) Waiver
This notice announces the procedures that will be used when a hospital, that has previously been granted a waiver under sections 1138(a)(2) of the Social Security Act (the Act), seeks to enter into an agreement with a different Organ Procurement Organization (OPO). The procedures are modeled after the public process required by 1138(a)(2) of the Act. The process affords the public an opportunity to comment on the proposed change and to submit information and material with respect to whether the change is likely to increase organ donation and will assure equitable treatment for patients in both affected OPO service areas.
Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Technical Amendment
The Food and Drug Administration (FDA) published a final rule in the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II device, reclassified dental mercury from class I to class II, and designated special controls for dental amalgam, mercury, and amalgam alloy. The effective date of the rule was November 2, 2009. The final rule was published with an inadvertent error in the codified section. This document corrects that error. This action is being taken to ensure the accuracy of the agency's regulations.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be conducted as a telephone conference call. The meeting will be open to the public through a conference call phone number.
Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop jointly sponsored by the National Institute of Allergy and Infectious Diseases and the Infectious Diseases Society of America (IDSA) regarding scientific and potential research issues in antibacterial drug resistance, rapid diagnostic device development for bacterial diseases, and antibacterial drug development. The workshop
Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for Comments
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product labeling (SPL). FDA has previously identified pharmacologic class as a top priority for indexing of product labeling information. FDA is now announcing that medical product indications is another category of product labeling information that the agency has identified as a high priority for indexing. CDER and CBER are announcing the establishment of a public docket to provide an opportunity for interested parties to share information, research, and ideas on the FDA indexing process.
Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products.'' This guidance describes a new process for making available recommendations on how to design product- specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs are able to access BE study guidance on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations.
Request for Information (RFI) on the National Institutes of Health Plan To Develop the Genetic Testing Registry
The National Institutes of Health, an agency within the Department of Health and Human Services (HHS), is seeking input and feedback on its plan to develop the Genetic Testing Registry (GTR); a centralized public resource that will provide information about the availability, scientific basis, and usefulness of genetic tests. Submission of test information to the GTR will be voluntary, and the NIH expects to receive wide interest and participation from researchers, test developers, and manufacturers.
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