Department of Health and Human Services November 3, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Privacy Act of 1974; System of Records Notice
In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), the Department of Health and Human Services (HHS) is updating an existing, department-wide system of records, System No. 09-90-0024, titled ``Unified Financial Management System'' (UFMS), which covers accounts payable records and accounts receivable records retrieved by personal identifier; and is transferring one routine use (pertaining to administrative wage garnishment) to a related system of records, System No. 09-40-0012, titled ``Debt Management and Collection System.'' System No. 09-90-0024, ``Unified Financial Management System,'' was established prior to 1979 (see 44 FR 58149). The System of Records Notice (SORN) was last revised and republished in full in 2005 (see 70 FR 38145). This Notice proposes to change the name to ``HHS Financial Management System Records;'' update records locations and System Manager contact information; narrow the scope of the SORN by excluding certain descriptions and routine uses pertaining to collection of overdue and delinquent federal debts, which are currently covered in, or are now proposed to be covered in, the SORN for System No. 09-40- 0012 ``Debt Management and Collection System;'' add several new routine uses, combine and revise certain existing routine uses, and delete unnecessary routine uses; and update the safeguards, record retention procedures, and record source descriptions. The changes are more fully explained in the Supplementary Information section of this Notice.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration StaffClass II Special Controls Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Health Canada and United States Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Public Webinar; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a regional public webinar entitled ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).'' The goal of this webinar is to provide information and receive comments on the ICH, as well as the upcoming ICH meetings in Jacksonville, FL, in December 2015. The topics to be discussed are the topics for discussion at the forthcoming ICH Management Steering Meeting. The purpose of the webinar is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Jacksonville, FL, scheduled for December 5 to 10, 2015, at which the discussion of the topics underway and ICH reforms will continue.
Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Prescription Drug Product Labeling; Medication Guide Requirements
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 (the PRA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey on Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institutes of Health, National Institute on Drug Abuse (NIDA) Announcement of Requirements and Registration for “Addiction Research: There's an App for That” Challenge
The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), announces the Challenge, ``Addiction Research: There's an App for that''. With this Challenge, NIDA aims to develop novel mobile applications (apps) for future addiction research explicitly created on Apple Inc.'s ResearchKit framework. ResearchKit is open-source software which makes it easy for researchers and developers to create apps for specific biomedical research questions by circumventing development of custom code. Contestants will create the solicited app for use by addiction researchers to engage mobile device users in future society-changing research.
Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs and therapeutic biologic products for the treatment of HIV-1 infection.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.
Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies
This proposed rule would revise the discharge planning requirements that Hospitals, including Long-Term Care Hospitals and Inpatient Rehabilitation Facilities, Critical Access Hospitals, and Home Health Agencies must meet in order to participate in the Medicare and Medicaid programs. The proposed rule would also implement the discharge planning requirements of the Improving Medicare Post-Acute Care Transformation Act of 2014.
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