Department of Health and Human Services November 7, 2016 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26831
Type: Notice
Date: 2016-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26830
Type: Notice
Date: 2016-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26829
Type: Notice
Date: 2016-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2017
Document Number: 2016-26828
Type: Notice
Date: 2016-11-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a $560.00 calendar year (CY) 2017 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2017 and on or before December 31, 2017.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-26806
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, Administration for Children and Families
Revision of Organization and Conforming Changes to Regulation
Document Number: 2016-26799
Type: Rule
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organization change in the Agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration
Document Number: 2016-26794
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 resulting from focus groups about drug products as used by FDA.
Agency Information Collection Activities; Proposed Collection; Comment Request; Character-Space-Limited Online Prescription Drug Communications
Document Number: 2016-26793
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Character-Space- Limited Online Prescription Drug Communications.'' The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about that drug are made within character-space- limited communications used in prescription drug promotion.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion
Document Number: 2016-26792
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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 establishing notification of a consignee and consignee notification of a recipient's physician of record regarding a possible increased risk of Trypanosoma cruzi (T. cruzi) infection.
Establishment of the Patient and Care-Partner Connection; Establishment of a Public Docket; Request for Comments
Document Number: 2016-26784
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive input on the Center for Devices and Radiological Health's (CDRH) new program, entitled the Patient and Care-partner Connection (P&CC). P&CC will partner with patient organizations to provide a means for CDRH staff to formally engage with patients and care-partners. The purpose of this partnership is to gain perspective and feedback from patients, care-partners, and patient organizations on particular topics of interest, such as, the scope and nature of P&CC and how to partner with patient organizations. The Agency is interested in facilitating staff engagement with patients and care-partners regarding specific disease states and/or medical devices used for treatment, diagnosis, or assessment.
Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-26783
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.'' The Center for Devices and Radiological Health (CDRH) developed this guidance to assist sponsors who intend to submit an IDE to FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes. FDA considered comments received on the draft guidance and revised the guidance as appropriate.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2016-26774
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-26773
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-26772
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-26771
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-26769
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26768
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-26767
Type: Notice
Date: 2016-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
Document Number: 2016-26758
Type: Notice
Date: 2016-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 collection of information contained in FDA's Tobacco Product Violations Reporting Form.