Department of Health and Human Services June 4, 2013 – Federal Register Recent Federal Regulation Documents

Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2013-13160
Type: Notice
Date: 2013-06-04
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). 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 If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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.
Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Small Business Health Options Program
Document Number: 2013-13149
Type: Rule
Date: 2013-06-04
Agency: Department of Health and Human Services
This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) related to the Small Business Health Options Program (SHOP). Specifically, this final rule amends existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and implements a transitional policy regarding employees' choice of qualified health plans (QHPs) in the SHOP.
Announcement of Requirements and Registration for “Blue Button Co-Design Challenge”
Document Number: 2013-13128
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services
Blue Button Plus represents the technical standards and policy levers that help patients make use of their clinical and financial data in technology such as personal health records and health apps. All patients whose providers use Meaningful Use Stage 2 certified technology have the ability to view, download, and securely transmit their clinical data from their provider's Electronic Health Record into another product or holding place of their choice. This is an enormous opportunity for patient-facing, data receiver applications that previously struggled to collect complete and accurate clinical data without manual patient entry. As part of the Department of Health and Human Services digital services strategy, the Office of the National Coordinator for Health Information Technology (ONC) is launching the Blue Button Co-Design Challenge, intended to increase the number of priority patient-facing applications able to receive clinical data via Blue Button Plus. The Challenge will also uniquely engage the patient community to teach us what patients most want to do with their clinical data by crowdsourcing application ideas and incorporating patients in product design. The Blue Button Co-Design Challenge builds upon previous ONC activities to support consumer health and patient access to their data. These include Challenges such as Blue Button for All Americans, the Blue Button Mash Up Challenge, and the Health Design Challenge. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer's Research, Care, and Services
Document Number: 2013-13127
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services
HHS is soliciting nominations for a new, non-Federal member of the Advisory Council on Alzheimer's Research, Care, and Services. Specifically, the position is for someone with a diagnosis of Alzheimer's disease or a related dementia. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume. Nominations submitted within the past 6 months for other positions on the Advisory Council on Alzheimer's Research, Care, and Services will be considered for this position.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-13125
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-13124
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2013-13123
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-13122
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-13121
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-13120
Type: Notice
Date: 2013-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Tobacco Product Analysis; Scientific Workshop; Request for Comments
Document Number: 2013-13084
Type: Notice
Date: 2013-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments
Document Number: 2013-13083
Type: Notice
Date: 2013-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is seeking public comments from interested persons on the proposed availability of de- identified and masked data derived from medical product applications. Improving the efficiency and effectiveness of medical product development is a national priority. The ability to make available de-identified and masked clinical and preclinical data derived from marketing applications could make an important contribution to that goal by providing scientific data that may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products. The contribution of patients who participate in clinical trials should be maximized for the benefit of society. The Agency invites comments on the issues to be considered with regard to such availability and on any limitations that should be placed on the availability of these data.
Arthritis Advisory Committee; Notice of Meeting
Document Number: 2013-13082
Type: Notice
Date: 2013-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX
Document Number: 2013-13053
Type: Notice
Date: 2013-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets, held by Eli Lilly and Co. (Lilly), Lilly Corporate Center, Indianapolis, IN 46285. Lilly has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing.
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