Department of Health and Human Services March 1, 2017 – Federal Register Recent Federal Regulation Documents

Patient Safety Organizations: Expired Listing From the Surgical Momentum PSO
Document Number: 2017-03999
Type: Notice
Date: 2017-03-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing from the Surgical Momentum PSO has expired and AHRQ has delisted the PSO accordingly.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2017-03998
Type: Notice
Date: 2017-03-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories
Document Number: 2017-03997
Type: Rule
Date: 2017-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures (``specialized surgical instrumentation for use with urogynecologic surgical mesh''). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2017-03948
Type: Notice
Date: 2017-03-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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 http:// www.samhsa.gov/workplace.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2017-03944
Type: Notice
Date: 2017-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
Document Number: 2017-03931
Type: Rule
Date: 2017-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors' requests because the products are no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
Document Number: 2017-03930
Type: Rule
Date: 2017-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor's name.
Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Reopening of Comment Period
Document Number: 2017-03929
Type: Proposed Rule
Date: 2017-03-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled ``Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry'' that appeared in the Federal Register of December 14, 2016. The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color additive regulations. We are taking this action in response to requests to allow interested persons additional time to submit comments.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03903
Type: Notice
Date: 2017-03-01
Agency: Department of Health and Human Services, National Institutes of Health