Department of Health and Human Services September 15, 2015 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Announcement of Requirements and Registration for the NIEHS Climate Change and Environmental Exposures Challenge
To assist the country in preparing for the potential health risks from climate change, the National Institutes of Health (NIH) through the National Institute on Environmental Health Sciences (NIEHS) is sponsoring the NIEHS Climate Change and Environmental Exposures Challenge (the ``Challenge'') under the America COMPETES Reauthorization Act of 2010. This Challenge calls on talented software developers, data scientists, and other innovators from around the country to create data visualizations, tools, and applications that use the best available science on environmental exposures and the relationship of these exposures to increased temperature, precipitation, flooding, and sea level rise. The Challenge has two goals: To raise awareness of how environmental health risks may be exacerbated by climate change in communities, and to enable protective decision-making from local to national levels.
State Planning Grants
HRSA announces the award of a one-time extension in the amount of $54,244 each to four State Planning Grants for Improving Services for Children and Youth with Autism Spectrum Disorder (ASD) and Other Developmental Disabilities (DD) grants. The purpose of the program is to support states in the planning and development of activities that are designed to improve state systems of care for children and youth with ASD and related DDs and increase access to comprehensive coordinated health care. Grantees develop comprehensive, measurable state plans in collaboration with a diverse group of stakeholders that outline an approach to improve access to comprehensive, coordinated health care and related services for children and youth with ASD and other DDs. The purpose of this notice is to award a one-time, 12-month extension to ensure the completion of activities and an orderly phase out of HRSA support.
Administrative Destruction of Certain Drugs Refused Admission to the United States
The Food and Drug Administration (FDA or Agency) is implementing its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by issuing a rule that provides to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to destruction. This regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Implementation of this authority will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.
Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities; Reopening of Comment Period
This document reopens the comment period for the July 16, 2015 proposed rule entitled ``Reform of Requirements for Long-Term Care Facilities''. The comment period for the proposed rule, which ends on September 14, 2015, is reopened for 30 days.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a newly proposed information collection request entitled Improving Fetal Alcohol Spectrum Disorders Prevention Practice through Practice and Implementation Centers and National Partnerships.
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