Department of Health and Human Services September 1, 2017 – Federal Register Recent Federal Regulation Documents
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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). 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 If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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 Program; Recognition of Revised NAIC Model Standards for Regulation of Medicare Supplemental Insurance
This notice announces the changes made by the Medicare Access and CHIP Reauthorization of 2015 (MACRA) to section 1882 of the Social Security Act (the Act), which governs Medicare supplemental insurance. This notice also recognizes that the Model Regulation adopted by the National Association of Insurance Commissioners (NAIC) on August 29, 2016, is considered to be the applicable NAIC Model Regulation for purposes of section 1882 of the Act, subject to our clarifications that are set forth in this notice.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the end of support for Version 1.2 of Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) and an update to the FDA Data Standards Catalog. FDA will continue its support of the newer SDTM Version 1.3 and Version 1.4, which have been listed in the FDA Data Standards Catalog since December 2012 and August 2015, respectively. FDA support for SDTM Version 1.2 will end for studies that start 12 months after March 15, 2018.
Procedures for Meetings of the Medical Devices Advisory Committee; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Procedures for Meetings of the Medical Devices Advisory Committee.'' The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Medical Devices Dispute Resolution Panel (DRP). This guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information among CDRH, the members of the panel, industry, and the public, and the conduct of panel meetings. This guidance supplements existing FDA Agency-wide guidance on the conduct of Advisory Committee meetings.
Determination That NIZORAL (Ketoconazole) Tablets, 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that NIZORAL (ketoconazole) tablets, 200 milligrams (mg), 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 NIZORAL, and it will allow FDA to continue to approve ANDAs that reference NIZORAL as long as they meet relevant legal and regulatory requirements.
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