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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Amendment to 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the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry.'' The draft guidance document, when finalized, is intended to amend the document entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of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'' dated December 2010 (2010 Chagas Guidance) by expanding the scope of the guidance to include the collection of blood and blood components for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device; removing the recommendation to ask donors about a history of Chagas disease; and providing a recommendation for a reentry algorithm for donors deferred on the basis of screening test results for antibodies to Trypanosoma cruzi (T. cruzi) or on the basis of answering ``yes'' to the Chagas screening question. Further, the guidance is intended to notify blood establishments that collect blood and blood components that FDA has licensed a supplemental test for antibodies to T. cruzi and further testing of donations found repeatedly reactive to a screening test for T. cruzi is therefore required. The draft guidance does not apply to the collection of Source Plasma.

This request for information seeks information and data on additional reforms and policy options that we can consider to accelerate the provision of home and community-based services (HCBS) to Medicaid beneficiaries taking into account issues affecting beneficiary choice and control, program integrity, ratesetting, quality infrastructure, and the homecare workforce.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Ninth Annual Sentinel Initiative Public Workshop.'' Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1- day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA's Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel Initiative projects.

The Food and Drug Administration (FDA or Agency) has determined that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for verapamil hydrochloride extended-release oral tablet, 180 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.'' This draft guidance contains 15 sections of a multisection guidance intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that Novus International, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (2- vinylpyridine-co-styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SDSP template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDSP template for regulatory submissions.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995), HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

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.

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.

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.