Department of Health and Human Services August 2010 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 334
National Cancer Institute's Best Practices for Biospecimen Resources
As part of the commitment to maintaining current and scientifically accurate best practices, the National Cancer Institute (NCI) is seeking public comment on a revised version of the NCI Best Practices for Biospecimen Resources. This revised version of the NCI Best Practices is intended to both respond to comments received from the biospecimen resource community and provide more current and detailed recommendations related to biospecimen and data quality. Major revisions include the addition of new sections on Biospecimen Resource Management and Operations and Conflict of Interest, expansion of recommendations related to Custodianship and Informed Consent based on NCI workshops, addition of current references throughout the document and harmonization with current federal guidance documents and recommendations from international biospecimen organizations.
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Evaluation of the Health Effects of Low-Level Lead Exposure: Call for Information and Nomination of Scientific Experts
CERHR is evaluating the scientific evidence regarding the potential health effects associated with low-level lead exposure (defined as having blood lead levels < 10 [mu]g/dL). CERHR invites the submission of information about ongoing studies or upcoming publications on the health effects of low-level lead exposure that might be considered for inclusion in the evaluation. CERHR also invites the nomination of scientific experts to potentially serve as technical advisors in conducting the evaluation or as members of an ad hoc expert panel to be convened to peer review the draft NTP Monograph on Low- level Lead (see SUPPLEMENTARY INFORMATION below). This expert panel peer review meeting is tentatively scheduled for Spring 2011. When set, the date and location of the meeting will be announced in the Federal Register and posted on the CERHR Web site (https://cerhr.niehs.nih.gov). CERHR expert panel peer review meetings are open to the public with time scheduled for oral public comment.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Quality and Compliance in Merging and Emerging Cultures; Public Conference
The Food and Drug Administration (FDA) is announcing a public conference entitled ``The New Paradigm: Quality and Compliance in Merging and Emerging Cultures.'' The conference, cosponsored with the Parenteral Drug Association (PDA), will focus on challenges facing the medical products industry in navigating regulatory compliance, achieving worldwide quality improvement, and enhancing quality system controls in an environment of merging and emerging cultures.
Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The purpose of this workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions.
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
The Food and Drug Administration (FDA) New Jersey District Office, in cosponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRBs, and research sponsors.
Request for Measures of Health Plan Efforts To Address Health Plan Members' Health Literacy Needs
The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or items that measure how well
ASK (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices) Study Children Workshop; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing a public workshop entitled ASK (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices) Study Children Workshop. The purpose of the public workshop is to solicit comments from academic investigators and clinicians associated with the use, research and/or development of pediatric neuroprostheses regarding approaches for enhancing the protection and promotion of public health in children and adolescents with neuroprostheses. The public workshop will provide an overview of pediatric initiatives across the Agency, neurological and neurosurgical perspectives on medical devices, a review of pediatric assessments and outcome measures, and scientific research issues associated with the use of neuroprotheses in pediatric populations, including cochlear implants, deep brain stimulators, hydrocephalus shunts, spinal cord stimulators, and vagus nerve stimulators. Information from this public workshop will help establish a science-based framework of recommendations to aid in the development of more efficient strategies in evaluating pediatric neuroprostheses regulated by the Agency.
Medicare Program; Announcement of Five New Members to the Advisory Panel on Ambulatory Payment Classification Groups
This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Department of Health and Human Services (the Secretary) and the Administrator of Centers for Medicare & Medicaid Services concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).
Medicare and Medicaid Programs; Approval of the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Deeming Authority for Ambulatory Surgical Centers
This final notice announces our decision to approve without condition the American Association for Accreditation of Ambulatory Surgery Facilities' (AAAASF) request for continued recognition as a national accreditation program for ambulatory surgical centers (ASC) seeking to participate in the Medicare or Medicaid programs.
Proposed Collection; Comment Request; STAR METRICS-Science and Technology in America's Reinvestment: Measuring the Effects of Research on Innovation, Competitiveness and Science
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Science Policy Analysis (OSPA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Expanded Human Immunodeficiency Virus (HIV) Testing for Disproportionately Affected Populations
This notice provides public notice of CDC's intent to increase available funding for the Centers for Disease Control and Prevention Funding Opportunity Announcement PS10-10138, ``Expanded Human Immunodeficiency Virus (HIV) Testing for Disproportionately Affected Populations'' to make awards to state and county and local public health departments. It is the intent of CDC to increase the amount of funds available to applicants who applied for awards under the previously announced funding opportunity CDC-RFA-PS10-10138, which closed on June 24, 2010.
Oversight of Laboratory Developed Tests; Public Meeting; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until September 15, 2010, the comment period for the notice that published in the Federal Register of Thursday, June 17, 2010 (75 FR 34463). In the notice, FDA requested input and comments from interested stakeholders on the agency's oversight of laboratory developed tests (LDTs). FDA is reopening the comment period to update comments and to receive any new information.
Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on the Food and Drug Administration/Center for Veterinary Medicine's Regulated Products Used in Animals
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on communication studies involving FDA/Center for Veterinary Medicine (CVM) regulated products intended for use in animals. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission in protecting the public health.
Seth M. Yoser: Debarment Order
The Food and Drug Administration (FDA) (the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Seth M. Yoser, MD from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Yoser was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Dr. Yoser was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. In a May 20, 2010, letter to FDA, Dr. Yoser, through counsel, notified FDA that he acquiesces to debarment and therefore he has waived his right to a hearing concerning this action.
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