Department of Health and Human Services December 19, 2014 – Federal Register Recent Federal Regulation Documents

Announcement of a Workshop and a Request for Public Comment on Questions Regarding Dietary Reference Intakes and Chronic Disease Endpoints
Document Number: 2014-29766
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services
The Dietary Reference Intakes (DRI) Committees of the U.S. and Canadian governments will hold a workshop entitled ``Options for Consideration of Chronic Disease Endpoints for Dietary Reference Intakes.'' The objective of the workshop is to critically evaluate key scientific issues involved in using chronic disease endpoints for setting DRIs and, in this context, to provide information for future decisions as to whether and/or how chronic disease endpoints can be incorporated into the setting of DRI values. In preparation for this meeting, the DRI Committees are asking for public comment on the set of questions that the meeting panelists will discuss.
Medicare and Medicaid Programs: Application from the Joint Commission for Continued CMS-Approval of its Hospice Accreditation Program
Document Number: 2014-29757
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services
This proposed notice with comment period acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare conditions for participation as required under 42 CFR 488.6(b). The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Document Number: 2014-29752
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-29741
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-29740
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-29739
Type: Notice
Date: 2014-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Minimizing Risk for Children's Toy Laser Products; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-29725
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This guidance is intended to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health's (CDRH) current thinking on the safety of children's toy laser products and to provide specific safety recommendations for the manufacture and labeling of children's toy laser products.
Public Meeting on Patient-Focused Drug Development for Breast Cancer; Request for Comments
Document Number: 2014-29721
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on patient- focused drug development for breast cancer. Patient-focused drug development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of breast cancer on daily life and patient views on treatment approaches.
Serious Drug-Induced Liver Injury: The Importance of Getting It Right: How To Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnoses; Public Conference; Request for Comments
Document Number: 2014-29720
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public conference entitled ``Serious Drug-Induced Liver Injury (DILI): The Importance of Getting It Right: How to Measure and Interpret DILI Information and Make Correct Diagnoses.'' This conference will be cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. The purpose of the public conference is to discuss, debate, and share views among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-29715
Type: Notice
Date: 2014-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
Document Number: 2014-28697
Type: Rule
Date: 2014-12-19
Agency: Agency for International Development, Agencies and Commissions, Department of the Interior, Department of Justice, Department of Labor, National Aeronautics and Space Administration, National Archives and Records Administration, National Science Foundation, Small Business Administration, Social Security Administration, Department of State, Department of Transportation, Department of Treasury, Department of Veterans Affairs, National Institute of Food and Agriculture, National Endowment for the Arts, Office of the Chief Financial Officer, National Endowment for the Humanities, Institute of Museum and Library Services, Department of Housing and Urban Development, Department of Homeland Security, Department of Agriculture, Commodity Credit Corporation, Farm Service Agency, Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Department of Commerce, Corporation for National and Community Service, Department of Defense, Department of Education, Department of Energy, Environmental Protection Agency, Executive Office of the President, Management and Budget Office, National Drug Control Policy Office, Federal Emergency Management Agency, Department of Health and Human Services
This joint interim final rule implements for all Federal award-making agencies the final guidance Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) published by the Office of Management and Budget (OMB) on December 26, 2013. This rule is necessary in order to incorporate into regulation and thus bring into effect the Uniform Guidance as required by OMB. Implementation of this guidance will reduce administrative burden and risk of waste, fraud, and abuse for the approximately $600 billion per year awarded in Federal financial assistance. The result will be more Federal dollars reprogrammed to support the mission, new entities able to compete and win awards, and ultimately a stronger framework to provide key services to American citizens and support the basic research that underpins the United States economy.