Department of Health and Human Services July 17, 2013 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Submission for OMB review; 30-Day Comment Request: Evaluation of the Brain Disorders in the Developing World Program of the John E. Fogarty International Center
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 2, 2013, page 19723 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The John E. Fogarty International Center (FIC), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Medicare Program; Comprehensive ESRD Care Initiative; Extension of the Submission Deadlines for the Letters of Intent and Applications
This notice reopens the Letter of Intent submission period for the Comprehensive ESRD Care initiative letters of intent. Letters of Intent are now due on or before July 19, 2013. All potential applicants must submit a Letter of Intent to be eligible to submit an application. The submission deadline for the application has been extended to August 1, 2013.
School-Based Health Center Program
HRSA will be transferring a School-Based Health Center Capital (SBHCC) Program grant, as authorized by the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148), Title IV, Section 4101(a)), originally awarded to ICAN/ICAN TOO Organization, Inc., Havana, Florida, in order to ensure that significant and pressing capital needs to improve service delivery and support the expansion of services at school-based health centers will continue.
Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel; Consumer Assistance Tools and Programs of an Exchange and Certified Application Counselors
This final rule addresses various requirements applicable to Navigators and non-Navigator assistance personnel in Federally- facilitated Exchanges, including State Partnership Exchanges, and to non-Navigator assistance personnel in State Exchanges that are funded through federal Exchange Establishment grants. It finalizes the requirement that Exchanges must have a certified application counselor program. It creates conflict-of-interest, training and certification, and meaningful access standards; clarifies that any licensing, certification, or other standards prescribed by a state or Exchange must not prevent application of the provisions of title I of the Affordable Care Act; adds entities with relationships to issuers of stop loss insurance to the list of entities that are ineligible to become Navigators; and clarifies that the same ineligibility criteria that apply to Navigators apply to certain non-Navigator assistance personnel. The final rule also directs that each Exchange designate organizations which will then certify their staff members and volunteers to be application counselors that assist consumers and facilitate enrollment in qualified health plans and insurance affordability programs, and provides standards for that designation.
Anneri Izurieta; Conviction Reversal; Final Order Withdrawing Debarment Order
The U.S. Food and Drug Administration (FDA) is issuing an order, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), withdrawing its January 13, 2012, order debarring Anneri Izurieta from importing food or offering food for importation into the United States. FDA is issuing this order because the U.S. Court of Appeals for the Eleventh Circuit issued an order vacating the conviction and sentence of Anneri Izurieta.
Yuri Izurieta; Conviction Reversal; Final Order Withdrawing Debarment Order
The U.S. Food and Drug Administration (FDA) is issuing an order, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), withdrawing its January 25, 2012, order debarring Yuri Izurieta from importing food or offering food for importation into the United States. FDA is issuing this order because the U.S. Court of Appeals for the Eleventh Circuit issued an order vacating the conviction and sentence of Yuri Izurieta.
Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to correct the description of ammonium formate used as an acidifying agent in swine feed. This action is being taken to improve the accuracy of the regulations.
Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic (the FD&C) Act, as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves MERS-CoV. On the basis of such determination, the Secretary also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of MERS-CoV subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
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