Department of Health and Human Services September 2009 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 292
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Contract Health Services Report
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 60-day advance opportunity for public comment on the proposed information collection project, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
Request for Information on Glutaraldehyde
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on glutaraldehyde, and develop appropriate communication documents, such as a Criteria Document, which will convey the potential health risks, recommended measures for safe handling, and establish an updated Recommended Exposure Limit (REL) for glutaraldehyde. The current NIOSH REL for glutaraldehyde is 0.2 ppm as a ceiling limit.
Request for Information on 1-Bromopropane
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on the brominated organic solvent, 1- Bromopropane (1-BP, CAS 106-94-5, also known as n-propyl bromide), and develop appropriate communication documents, such as a Current Intelligence Bulletin, Criteria Document and/or other informational products, and establish a Recommended Exposure Limit (REL) for 1-BP. NIOSH is requesting information on the following: (1) published and unpublished reports and findings from in vitro and in vivo toxicity studies with 1-BP, (2) information on possible health effects observed in workers exposed to 1-BP, (3) information on workplaces and products in which 1-BP can be found, (4) description of work tasks and scenarios with a potential for exposure to 1-BP, (5) workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to 1-BP occur.
Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The supplemental NADA provides for a revised human food safety warning for use of diclofenac sodium topical cream in horses.
Request for Information on Alternative Duty: Temporary Reassignment for Health Care Workers Who Work With Hazardous Drugs
NIOSH intends to publish a Current Intelligence Bulletin (CIB) on alternative duty and other forms of administrative controls for health care workers who work with hazardous drugs and are trying to conceive, are pregnant, and/or are breast feeding. Alternative duty involves transferring the worker to a similar position, but one in which they would not be required to handle hazardous drugs.
Medicare Program; Limitation on Recoupment of Provider and Supplier Overpayments
This final rule implements a provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) which prohibits recouping Medicare overpayments from a provider or supplier that seeks a reconsideration from a Qualified Independent Contractor (QIC). This provision changes how interest is to be paid to a provider or supplier whose overpayment is reversed at subsequent administrative or judicial levels of appeal. This final rule defines the overpayments to which the limitation applies, how the limitation works in concert with the appeals process, and the change in our obligation to pay interest to a provider or supplier whose appeal is successful at levels above the QIC.
Children's Health Insurance Program (CHIP); Allotment Methodology and States' Fiscal Year 2009 CHIP Allotments
This proposed rule describes the implementation of certain funding provisions under title XXI of the Social Security Act (the Act), the Children's Health Insurance Program (CHIP), as amended by the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), by the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA), and by other related CHIP legislation. Specifically, this
National Fisheries Institute; Filing of Food Additive Petition; Amendment
The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by the National Fisheries Institute, to provide for the safe use of ionizing radiation for control of foodborne pathogens in crustaceans and processed crustaceans.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey
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.
Agency Emergency Processing Under the Office of Management and Budget Review; Tobacco Product Establishment Registration and Submission of Certain Health Information; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by the Family Smoking Prevention and Tobacco Control Act. The document was published with an incorrect date for submitting written or electronic comments on the proposed collection. This document corrects that error.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.
Office of the National Coordinator for Health Information Technology; HIT Standards Committee; Notice and Publication of Committee Recommendations to the National Coordinator for Health Information Technology
This notice publishes recommendations made by the HIT Standards Committee (Committee) at its public meeting on August 20, 2009, and invites public input on the recommendations at the Committee's next meeting on September 15, 2009. The Committee is a Federal advisory committee to the Office of the National Coordinator for Health Information Technology (ONC).
Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.'' This draft guidance provides FDA's proposed recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation. This draft guidance is not final nor is it in effect at this time.
Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes.'' The purpose of the public workshop is to solicit information from primary and secondary health care providers, academia, industry, and professional societies on various aspects of device clinical trials involving pediatric diseases and patients. Information from this public workshop will help stimulate interest in pediatric device clinical trial research methods, and develop topics for further discussion regarding the safety of pediatric device clinical trials. The information gathered in this and future workshops will help to develop future guidance for developing safe clinical trials for devices intended for pediatric patients. We encourage participation and comments from workshop attendees on the topics and questions discussed. Please see instructions for registration and for providing comments in the sections of this document entitled ``Registration'' and ``Comments.''
Memorandum of Understanding With Duke University
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and Duke University. The purpose of this MOU is to establish a framework for collaboration between the Parties and for pursuing specific collaborative projects. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium.
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