Department of Health and Human Services February 28, 2014 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Human Immunodeficiency Virus-1 Resistance Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Attachment to Guidance on Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data.'' The purpose of this guidance is to assist sponsors in submitting human immunodeficiency virus (HIV) clinical virology data that are important for supporting clinical trials of products in development for the treatment of HIV. HIV resistance data submitted in appropriately formatted datasets are critical components in the review of investigational antiviral products for the treatment of HIV. The information in this guidance will facilitate the development of anti- HIV products. This draft guidance revises the guidance for industry entitled ``Attachment to Guidance on Antiviral Product Development Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data'' issued on June 5, 2006.
Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Receipt Date; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, February 7, 2014 (79 FR 7463). The document announced the availability of a guidance entitled ``Providing Regulatory Submissions in Electronic Format Receipt Date.'' The document was published with an incorrect Web site in the ``Electronic Access'' section. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information From United States Firms and Processors That Export to the European Community
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
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) The accuracy of the estimated burden; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) The use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medicaid Program; Preliminary Disproportionate Share Hospital Allotments (DSH) for Fiscal Year (FY) 2014 and the Preliminary Institutions for Mental Diseases Disproportionate Share Hospital Limits for FY 2014
This notice announces the preliminary federal share DSH allotments for FY 2014 and the preliminary federal share FY 2014 limits on aggregate DSH payments that states may make to institutions for mental diseases (IMDs) and other mental health facilities. This notice also includes additional information regarding the calculation of the FY 2014 DSH allotments and FY 2014 IMD DSH limits.
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