Department of Health and Human Services July 2006 – Federal Register Recent Federal Regulation Documents
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Request for Information (RFI): Change in Grant Appendix Materials
The National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) are evaluating guidelines for grant application appendixes in an effort to streamline the application and review processes. This RFI requests input from interested applicants, reviewers and other members of the research community regarding the way appendix materials should be used in the grant submission, review and management process. Comments will be considered in the development of new policies on appendix materials for various grant programs.
Draft Manufactured Food Regulatory Program Standards; Availability; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 20, 2006. The document announced the availability of a draft document entitled ``Manufactured Food Regulatory Program Standards.'' The document was published with an incorrect Internet address. This document corrects that error.
Cooperative Agreement for Poison Prevention Education
HRSA will be forming a partnership with the Home Safety Council (HSC) to collaborate on reaching America's low literacy population. Through this project, easy to read and comprehend poison prevention material will be developed and distributed to the public, poison centers, safety and injury prevention professionals, health educators, and first responders.
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of United States Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
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 associated with the guidance document entitled ``Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.''
Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products
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 a 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 a proposed survey of physicians' perceptions of the impact of early risk communication about medical products. The purpose of the proposed survey is to improve FDA's understanding of how and when physicians get, and would like to get, information about the risk of medical products, and what factors might influence the likelihood of reporting their patients' adverse experiences. Together with other information, the data from this survey will be used to assess FDA's communication efforts concerning early risk communication about medical products, and inform any potential communication-related changes.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
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 in the guidance for industry on special protocol assessment.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update-Notice
This notice updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2007. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (the BBRA), the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (the BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the MMA), relating to Medicare payments and consolidated billing for SNFs.
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.
State Children's Health Insurance Program; Final Allotments to States, the District of Columbia, and U.S. Territories and Commonwealths for Fiscal Year 2007
Title XXI of the Social Security Act (the Act) authorizes payment of Federal matching funds to States, the District of Columbia, and U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the State Children's Health Insurance Program (SCHIP). This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2007. States may implement SCHIP through a separate State program under title XXI of the Act, an expansion of a State Medicaid program under title XIX of the Act, or a combination of both.
Medicare Program; Request for Nominations and Meeting of the Practicing Physicians Advisory Council, August 28, 2006
This notice announces a request for nominations and the quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public. In addition, this notice invites all organizations representing physicians to submit nominations for consideration to fill five seats that will be vacated by current Council members in 2007.
Medical Devices; Immunology and Microbiology Devices; Classification of Fecal Calprotectin Immunological Test Systems
The Food and Drug Administration (FDA) is classifying fecal calprotectin immunological test systems into class II (special controls). The special control that will apply to these devices is the guidance document entitled, ``Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.'' The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.'' This guidance document describes a means by which fecal calprotectin immunological test systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify fecal calprotectin immunological test systems into class II (special controls). This guidance document is immediately in effect as the special control for fecal calprotectin immunological test systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Request for Comment From the Field on the Substance Abuse and Mental Health Services Administration's (SAMHSA) Addiction Technology Transfer Center (ATTC) Program
This notice is to request comments from interested stakeholders in the substance use disorders treatment field regarding SAMHSA's ATTC Program. SAMHSA will be issuing a Request for Applications (RFA) for a new round of competitive cooperative agreement awards under the ATTC program in Federal fiscal year (FFY) 2007. To assist SAMHSA in developing the RFA, SAMHSA is seeking input from stakeholders and interested parties on a number of issues relating to these cooperative agreements. Program Title: Addiction Technology Transfer Centers (ATTC) Program. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
Office of the National Coordinator of Health Information Technology; American Health Information Community Confidentiality and Security Workgroup Meeting
This notice announces the first meeting of the American Health Information Community Confidentiality and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Announcement of Anticipated Availability of Funds for Family Planning Services Grants
The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Monday, July 3, 2006 announcing the anticipated availability of funds for family planning services grants. This notice contained an error. The application due date for an eligible State/Population/Area was listed incorrectly. This Notice corrects the application due date for the State of Wisconsin.
Meeting of the Advisory Committee on Blood Safety and Availability
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The ACBSA will meet to review progress and solicit additional input regarding numerous recommendations made during the past year, specifically biovigilance of blood components and its derivatives, cells, tissues, and organs. Vigilance is recognized as a necessary step in monitoring outcomes in a quality assurance process toward the goal of providing safe and available biological products (i.e., blood components and derivatives, cells, tissues and organs) and improvement of care of the donor and recipient. Elements necessary for vigilant surveillance are detection, analysis, reporting, utilizations, research, education, and management of outcomes, including emerging or re-emerging infectious and non-infectious events of transfusion and/or transplantation, will be discussed.
National Institutes of Health Training Grants
The National Institutes of Health (NIH) is amending the current regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training.
Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredient
The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Diethylhexyl butamido triazone, up to 3 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. FDA reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRASE) for its proposed OTC use.
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