Department of Health and Human Services September 2015 – Federal Register Recent Federal Regulation Documents

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the U.S. Environmental Protection Agency (EPA) announce the workshop, ``In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making.'' Attendees at the in-person workshop and four webinar presentations leading up to the workshop will discuss the state of the science and best practices for using in vitro to in vivo extrapolation (IVIVE) in a tiered risk decision context.

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

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.

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).

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.

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.

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.

The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Syed Huda from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Huda was convicted of two felonies under Federal law for conduct relating to the regulation of a drug product. Mr. Huda was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Huda failed to respond. Mr. Huda's failure to respond constitutes a waiver of his right to a hearing concerning this action.

To assist the country in preparing for the potential health risks from climate change, the National Institutes of Health (NIH) through the National Institute on Environmental Health Sciences (NIEHS) is sponsoring the NIEHS Climate Change and Environmental Exposures Challenge (the ``Challenge'') under the America COMPETES Reauthorization Act of 2010. This Challenge calls on talented software developers, data scientists, and other innovators from around the country to create data visualizations, tools, and applications that use the best available science on environmental exposures and the relationship of these exposures to increased temperature, precipitation, flooding, and sea level rise. The Challenge has two goals: To raise awareness of how environmental health risks may be exacerbated by climate change in communities, and to enable protective decision-making from local to national levels.

The Food and Drug Administration (FDA or Agency) is implementing its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by issuing a rule that provides to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to destruction. This regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Implementation of this authority will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

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.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) and the Administration for Children and Families (ACF) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.