Department of Health and Human Services August 9, 2010 – Federal Register Recent Federal Regulation Documents
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Generic Drug User Fee; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the development of a generic drug user fee program. The number of human generic drug applications awaiting FDA action and the median review times for generic drug applications have increased in recent years. A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to allow for the timely review of such applications. Although the President's Fiscal Year (FY) 2011 budget includes generic drug user fees, new legislation would be required for FDA to establish and collect user fees under such a program. As FDA begins negotiations with the regulated industry about generic drug user fees, FDA will hold a public meeting to gather the public's input on such a program.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, the Department of Health and Human Services is establishing a new system of records entitled, ``Facility and Resource Access Control Records,'' System No. 09-90-0777. This notice implements in part Homeland Security Presidential Directive 12 (HSPD-12), ``Policy for a Common Identification Standard for Federal Employees and Contractors'' of August 27, 2004. HSPD-12 requires all employees, contractors, and others who will be granted regular access to federal facilities for more than six months to undergo a background investigation to determine suitability and to be issued a Personal Identity Verification (PIV) Card (i.e. an identification badge). The purpose of the program is to enhance access controls to federal facilities to improve security. The badge stores the individual's name, employing organization, the badge issuer, the badge serial number, the expiration date, a picture of the badge holder, two fingerprints, and four encryption keys that may be used by the PIV card holder, when properly activated, in association with federal information technology resources. The Facility and Resource Access Control Records comprise information about the issuance of Personal Identity Verification (PIV) cards, PIV card holders (e.g. employees, contractors), other individuals who require regular access to HHS facilities or resources, and the use of PIV cards to access facilities or resources. The Facility and Resource Access Control Records also include information about occasional visitors and short- term guests who do not carry PIV cards but to whom HHS will issue temporary credentials.
Notice of Availability: Test Tools and Test Procedures Approved for the Office of the National Coordinator for Health Information Technology (ONC) Temporary Certification Program
This notice announces the availability of test tools and test procedures approved by the National Coordinator for Health Information Technology (the National Coordinator) for the testing of Complete EHRs and/or EHR Modules by ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) under the ONC temporary certification program. The approved test tools and test procedures are identified on the ONC Web site at: https://healthit.hhs.gov/certification.
Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices
Comprehensive List of Guidance Documents at the Food and Drug Administration
The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past 5 years.
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