Department of Health and Human Services September 2015 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 216
Consumer Comments-Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets
The Food and Drug Administration (FDA or Agency) is changing the Agency's long standing practice of not publically posting on http:/ /www.regulations.gov comments submitted by individuals in their individual capacity. These are generally comments from people who self- identify as an ``individual consumer'' under the field titled ``Category (Required)'' on the ``Your Information'' page on https:// www.regulations.gov. Changing FDA's practice to routinely post these comments, as we do other comments, will increase the transparency and public utility of FDA's public dockets. It will better enable our public dockets to function as intended: To share information and encourage an open exchange of ideas.
In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making; Notice of Webinars and Public Workshop; Registration Information
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.
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.
A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods-Part II (Menu Labeling Requirements in Accordance with the Patient Protection Affordable Care Act of 2010); Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home FoodsPart II (Menu Labeling Requirements in Accordance with 21 CFR 101.11); Draft Guidance for Industry.'' The draft guidance, when finalized, will help certain restaurants and similar retail food establishments comply with the menu labeling requirements, including the requirements to provide calorie and other nutrition information for standard menu items, including food on display and self-service food.
Syed Huda: Debarment Order
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.
Proposed Collection; 60-Day Comment Request; Hazardous Waste Worker Training
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Announcement of Requirements and Registration for the NIEHS Climate Change and Environmental Exposures Challenge
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.
State Planning Grants
HRSA announces the award of a one-time extension in the amount of $54,244 each to four State Planning Grants for Improving Services for Children and Youth with Autism Spectrum Disorder (ASD) and Other Developmental Disabilities (DD) grants. The purpose of the program is to support states in the planning and development of activities that are designed to improve state systems of care for children and youth with ASD and related DDs and increase access to comprehensive coordinated health care. Grantees develop comprehensive, measurable state plans in collaboration with a diverse group of stakeholders that outline an approach to improve access to comprehensive, coordinated health care and related services for children and youth with ASD and other DDs. The purpose of this notice is to award a one-time, 12-month extension to ensure the completion of activities and an orderly phase out of HRSA support.
Administrative Destruction of Certain Drugs Refused Admission to the United States
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.
Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities; Reopening of Comment Period
This document reopens the comment period for the July 16, 2015 proposed rule entitled ``Reform of Requirements for Long-Term Care Facilities''. The comment period for the proposed rule, which ends on September 14, 2015, is reopened for 30 days.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a newly proposed information collection request entitled Improving Fetal Alcohol Spectrum Disorders Prevention Practice through Practice and Implementation Centers and National Partnerships.
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
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.
Submission for OMB Review; 30-Day Comment Request: Population Sciences Biospecimen Catalog (PSBC)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, 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 (June 30, 2015 P.37280) 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 National Cancer Institute (NCI), 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.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0166, scheduled to expire on October 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
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