Department of Health and Human Services May 3, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Extension With No Changes of a Currently Approved Collection; Comment Request; State Program Report
Document Number: 2016-10323
Type: Notice
Date: 2016-05-03
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to an extension with no changes of a currently approved collection of the Title III and VII State Program Report.
Medicare Program; Announcement of Requirements and Registration for the MIPS Mobile Challenge
Document Number: 2016-10301
Type: Notice
Date: 2016-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice launches a challenge related to the new Merit- based Incentive Payment System (MIPS) program, which will assist the Centers for Medicare & Medicaid Services (CMS) in accelerating the transition from the traditional fee-for-service payment model to a system that rewards health care providers for giving better care, not just more care. This challenge will address one of the most important aspects of our programs, which is educating and providing outreach to the potential 1.2 million MIPS eligible clinicians.
Submission for OMB Review; Comment Request
Document Number: 2016-10293
Type: Notice
Date: 2016-05-03
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-10262
Type: Notice
Date: 2016-05-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute: Notice of Closed Meetings
Document Number: 2016-10261
Type: Notice
Date: 2016-05-03
Agency: Department of Health and Human Services, National Institutes of Health
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: 2016-10260
Type: Notice
Date: 2016-05-03
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 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.
Privacy Act of 1974; Report of New System of Records
Document Number: 2016-10253
Type: Notice
Date: 2016-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``CMS Risk Adjustment Data Validation System (RAD-V),'' System No. 09-70-0511. Under Sec. 1343 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), (hereinafter, the ACA), and the implementing regulations at 45 CFR part 153, data collected and maintained in this system will be used to support the audit functions of the risk adjustment program, including validation activities under the risk adjustment data validation program. The goal of the risk adjustment program is to provide payments to non-grandfathered health insurance issuers in the individual and small group markets that attract higher-risk populations, including a validation program to ensure the reliability of data used as a basis for risk adjustment payments and charges. Non-grandfathered plans are health plans that came into existence after March 23, 2010. Insurers offering these plans were required to modify them to follow the ACA rules as of January 1, 2014. The RAD-V system will contain personally identifiable information (PII) about individuals who are current or former enrollees in non- grandfathered health plans, including information obtained through the risk adjustment data validation process to establish the relative deviation from the average. The program and the system of record are more thoroughly described in the SUPPLEMENTARY INFORMATION section and System of Records Notice below. At this time, the only personally identifiable information that will be collected under this System will be through the RAD-V, part of the risk adjustment program.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Technical Amendment
Document Number: 2016-09768
Type: Rule
Date: 2016-05-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of November 27, 2015. That final rule established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. FDA established these standards as part of our implementation of the FDA Food Safety and Modernization Act. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
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