Department of Health and Human Services October 1, 2008 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Correction
This document corrects technical errors that appeared in the August 8, 2008 Federal Register entitled, ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2009.''
National Biodefense Science Board; Notification of a Public Teleconference
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public teleconference. The meeting is open to the public.
Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting; Correction
The Food and Drug Administration (FDA) is announcing a correction to the notice of a public meeting entitled ``Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting.'' This meeting was announced in the Federal Register of September 16, 2008 (73 FR 53428). The correction is being made to reflect changes in the Summary, Date and Time, Location, Contact Person, Background, and Agenda portions of the document.
Privacy Act of 1974; CMS Computer Match No. 2008-02 HHS Computer Match No. 0602
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a computer matching agreement between CMS and the Department of Defense (DoD). We have provided background information about the proposed matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.
Determination That ATROVENT (Ipatropium Bromide) Inhalation Solution and 10 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the 11 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Memorandum of Agreement Between the Food and Drug Administration, the National Cancer Institute, a Part of the National Institutes of Health, and the CRIX International Association
The Food and Drug Administration FDA) is providing notice of a memorandum of agreement (MOA) between FDA, the National Cancer Institute (NCI) and CRIX International Association. The purpose of the MOA is to establish a public-private partnership to pilot the use of a nonprofit organization to manage the production instance of the Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD) system as a vehicle for secure, rapid and efficient electronic exchange of clinical investigator credentialing information among clinical investigators at trial sites, sponsors (including NCI), and FDA; and to continue the development of FIREBIRD to fulfill the requirements of FDA and sponsors (including the NCI).
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
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 information collection requirements for Humanitarian Use Devices.
Agency Information Collection Activities; Proposed Collection; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007
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 requirement established by Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) that device establishments must submit registration and listing information by electronic means, using FDA Form 3673, unless the Secretary of the Department of Health and Human Services (the Secretary) grants them a waiver from the electronic submission requirement.
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