Department of Health and Human Services April 1, 2015 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), HHS is establishing a new department- wide system of records, ``Records about Restricted Dataset Requesters,'' System Number 09-90-1401, to cover records about individuals within and outside HHS who request restricted datasets and software products from HHS (e.g., for health-related scientific research and study purposes), when HHS maintains the requester records in a system from which they are retrieved directly by an individual requester's name or other personal identifier. The System of Records Notice (SORN) previously published at 78 FR 32654 for ``Online Application Ordering for Products from the Healthcare Cost and Utilization Project (HCUP),'' System Number 09-35-0003, is being deleted and replaced by this new department-wide SORN.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Procedures for Meetings of the Medical Devices Advisory Committee.''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 Dispute Resolution Panel (DRP). This guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information between 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. This draft guidance is not final nor is it in effect at this time.

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:// beta.samhsa.gov/workplace.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the April meeting, the Advisory Council will build on the goals of White House Conference on Aging (WHCOA) through a half- day session with dementia-focused panels on each WHCOA topic area: Healthy aging, long-term services and supports, retirement security, and elder justice. Following this session, the Advisory Council will also hold a brief discussion on the 2015 Update to the National Plan to Address Alzheimer's, as well as a discussion of international events on dementia.

NIH Office of Dietary Supplements (ODS) and the National Institute of Standards and Technology (NIST), in collaboration with the College of American Pathologists (CAP) and Vitamin D External Quality Assessment Scheme (DEQAS), announce that as part of the Vitamin D Standardization Program (VDSP), they are recruiting laboratories to participate in a study of the commutability of pooled serum samples used in assays to measure total 25-hydroxyvitamin D [25(OH)D].