Department of Health and Human Services September 17, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Medicare Program; Approval of Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
This final notice announces our decision to approve the request from Doctors Hospital at Renaissance for an exception to the prohibition against expansion of facility capacity.
Bridging the Word Gap Competition Challenge
The Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau (MCHB), announces the funding opportunity for the Bridging the Word Gap Incentive Prize Challenge. MCHB is sponsoring the Word Gap Challenge (Challenge) to spur innovative solutions to promote the early language environment and address the ``word gap,'' the large difference in exposure to language for children from low-income families as compared to children from higher-income families. This Challenge will reward the development and testing of scalable innovations that drive behavior change among parents and caregivers. The goal of the Challenge is to develop a low-cost, scalable technologically-based intervention that drives parents and caregivers to talk and engage in more back-and-forth interactions with their young children (ages 0-4). This Challenge, structured in three phases, with a narrowing of applicants through each phase to result in one final winner, will reach a diverse population of innovators and solvers, including coders, public health experts, individuals affiliated with academic institutions, research and development communities in the private sector, and others. All submissions will be evaluated; separate prizes will be awarded for each of the three phases below. Phase 1: Design Phase 2: Development and Small Scale Testing Phase 3: Scaling The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (COMPETES Act, Pub. L. 111-358). Estimated dates for each phase are as follows: Phase 1: Effective on September 30, 2015 Phase 1 Submission ends: December 31, 2015, 11:59 p.m. ET Phase 1 Judging Period: January 1-January 31, 2016 Phase 1 Winners Announced: February 10, 2016 Phase 2 Begins: February 11, 2016 Phase 2 Submission Period Ends: July 11, 2016 Phase 2 Judging Period: July 12-August 12, 2016 Phase 2 Winners Announced: August 20, 2016 Phase 3 Begins: August 21, 2016 Phase 3 Submission Period Ends: February 21, 2017 Phase 3 Winner Announced: March 1, 2017
Alliance for Innovation on Maternal and Child Health Cooperative Agreement
HRSA announces the award of a program expansion supplement in the amount of $100,000 for the Alliance for Innovation on Maternal and Child Health (AIM) cooperative agreement. The purpose of the AIM cooperative agreement, as stated in the funding opportunity announcement (FOA), is to expand access to care for the maternal and child health (MCH) populations through the following program focus areas: (1) Ensuring continuity of coverage and care for pregnant women and children; (2) improving systems of care for children with special health care needs; and (3) promoting the use of Bright Futures Guidelines for all children. The program expansion supplement will provide funds to the Association of State and Territorial State Health Officials (ASTHO), the cooperative agreement awardee, during the budget period of September 30, 2015, through September 29, 2016, to provide targeted technical assistance to two States at risk for rapid transmission of HIV and Hepatitis C virus (HCV) through injection drug use, to build capacity and expand access to care, document and share best practices with other State Health Officials also seeking to prevent HIV and HCV infection through injection drug use.
Centers of Excellence in Maternal and Child Health in Education, Science, and Practice Program
HRSA announces the award of a program expansion supplement in the amount of $40,000 for the Centers of Excellence in Maternal and Child Health (MCH) in Education, Science, and Practice grant. The purpose of the Centers of Excellence in MCH program is for the training of graduate and post-graduate public health professionals in an interdisciplinary MCH setting. The purpose of this notice is to award supplemental funds to conduct a rigorous evaluation of the Pediatric Obesity Collaborative Improvement and Innovation Network (CoIIN) to spread evidence-based practices, and to translate knowledge into practice by the University of Washington, the awardee who serves as the Centers of Excellence in MCH, during the budget period of June 1, 2015, through May 31, 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
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 the information collection provisions of the Notification Procedure for Substances Generally Recognized as Safe (GRAS).
User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications; Correction
The Food and Drug Administration (FDA or we) is correcting a document that appeared in the Federal Register of July 24, 2015, entitled ``User Fee Program for Accreditation of Third-Party Auditors/ Certification Bodies To Conduct Food Safety Audits and To Issue Certifications.'' That document proposed amending the document, ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,'' and proposed establishing a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA). The document was published with an incorrect RIN. This document corrects that error.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products
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 FDA's meetings with tobacco manufacturers, importers, researchers, and/or investigators relating to their plans to conduct research to inform the regulation of tobacco products, or support the development or marketing of tobacco products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification
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 Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a small business and pay certain medical device user fees at reduced rates.
Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the RA). The purpose of the RA is to provide a science-based risk analysis of those activity/animal food combinations that would be considered low risk when conducted in an animal food facility co-located on a farm. We conducted this RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.
Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the RA). The purpose of the RA is to provide a science-based risk analysis of those activity/food combinations that would be considered low risk when conducted in a food facility co-located on a farm. We conducted this RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
The Food and Drug Administration (FDA or we) is adding regulations for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. These regulations will, for the first time, establish requirements for the current good manufacturing practice (CGMP) for food for animals. In addition, we are adding requirements for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to humans and animals and to implement new statutory provisions in the FDA Food Safety Modernization Act (FSMA). The rule is intended to build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long-standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk- based preventive controls for human food. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for ``farms'' and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk-based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1986 and to implement new statutory provisions in the FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system.
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