Department of Health and Human Services July 3, 2012 – Federal Register Recent Federal Regulation Documents
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Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.
Current List of 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 certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data-Premarket Notification (510(k)) Submissions; and Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data-Premarket Approval and Premarket Notification (510(k)) Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of two related guidance documents. The first guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Notification (510(k)) Submissions'' (CADe 510(k) guidance), provides recommendations regarding premarket notification (510(k)) submissions of certain computer-assisted detection (CADe)\1\ devices applied to radiology images and radiology device data. The second guidance, entitled ``Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Approval (PMA) and Premarket Notification (510(k)) Submissions'' (CADe clinical performance assessment guidance), provides recommendations on the design and conduct of clinical performance studies for CADe devices applied to radiology images and radiology device data.
Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
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