Department of Health and Human Services January 2006 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 248
Use of Federal Real Property To Assist the Homeless
Title V of the McKinney-Vento Homeless Assistance Act, 42 U.S.C. 11411 (Title V) authorizes the Secretary of Health and Human Services (the Secretary) to make suitable Federal properties categorized as excess or surplus available to representatives of persons experiencing homelessness as a permissible use in the protection of public health. The Department of Health and Human Services (HHS) is requesting comment on its proposal to revise its current policy under Title V to include permanent supportive housing as an allowable use of surplus real property to assist persons experiencing homelessness. The purpose of this proposed change is to increase the housing and service opportunities available to communities as they respond to homelessness, and is consistent with efforts within the Federal, state, and local governments, and communities themselves, to end chronic homelessness.
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.
Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; New Proposed and Final Documents; Availability
The Food and Drug Administration (FDA) is announcing the availability of several proposed and final documents that have been prepared by Study Groups 1, 2, 3, and 4 of the Global Harmonization Task Force (GHTF). These documents are intended to provide information only and represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for FDA Regulated Products
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 Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
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.
Proposed Collection; Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of 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. Proposed Collection: Title: A Survey of Estimated GFR Reporting Practices of Clinical Laboratories: Type of Information Collection Request: New. Need and Use of Information Collection: This study will assess the level of U.S. clinical laboratory reporting of estimated GFR as a measure of kidney function. This will be accomplished through baseline and follow-up surveys of a representative sample of clinical laboratories in the U.S. Information will be used to establish baseline data necessary to measure an anticipated increased in use of estimated GFR, following the implementation of the NKDEP's communications and Lab Working Group (LWG) activities promoting use of estimated GFR for patients at risk for kidney disease. The LWG, whose members are experts in their field, strongly believes that routine reporting of estimated GFR will result in a significant increase in early detection of chronic kidney disease, therefore enabling treatment that can slow or prevent patients' progression to kidney failure. Frequency of Response: Baseline survey only. Affected Public: Clinical laboratory community. Type of Respondents: Laboratory directors. The annual reporting burden is as follow: Estimated Number of Respondents: Anticipate 4,126 completed surveys; Estimated Number of Responses per Respondent: Respondents will complete one paper-and-pencil or online survey; Average Burden Hours Per Response: .083 hours [5 minutes]; and Estimated Total Annual Burden Hours Requested: 342.46 hours. The annualized total cost to respondents is estimated at $11,759.10. (Note: Completing this survey is similar to other data reporting carried out by lab directors. Since lab directors will be able to responded to the survey within their usual workday, this collection of information will not cost labs.employers additional time and money.) There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Notice of Hearing: Reconsideration of Disapproval of Ohio State Plan Amendments 05-07 and 05-020
This notice announces an administrative hearing to be held on February 28, 2006, in Suite 500, 233 N. Michigan Avenue, Minnesota Conference Room, Chicago, IL 60202, to reconsider CMS' decision to disapprove Ohio State plan amendments 05-07 and 05-020. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by February 8, 2006.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Good Laboratory Practice Regulations for Nonclinical Studies
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Good Laboratory Practice Regulations for Nonclinical Studies'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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 Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols
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 requirements relating to the regulations which state that protocols for samples of biological products must be submitted to the agency.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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.
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