Department of Health and Human Services March 2019 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 280
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home and Community Based Services (HCBS) Survey Database.''
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Hospital Survey on Patient Safety Culture Comparative Database.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Use of Symbols in Labeling-Glossary to Support the Use of Symbols in Labeling
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as ``stand- alone symbols'') if certain requirements are met.
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 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.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; No Wrong Door (NWD) System Management Tool
The Administration for Community Living 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 as required by the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to ACL's Aging and Disability Resource Center/No Wrong Door System (ADRC/ NWD) New Data Collection (ICR New).
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; One Protection and Advocacy Annual Program Performance Report
The Administration for Community Living 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 as required by the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed new data collection (ICR New).
Food Additives Permitted in Feed and Drinking Water of Animals; Spent Bleaching Clay
The Food and Drug Administration (FDA, the Agency, or we) is amending a notice of petition announcing that the Canadian Oilseed Processors Association has filed a petition proposing that the food additive regulations be amended to provide for the safe use of spent bleaching clay as a flow agent in canola meal for all livestock and poultry species. Additionally, the petition proposes that the regulations be amended to provide for the safe use of silicon dioxide and diatomaceous earth for use as components of spent bleaching clay. This petition included a request for categorical exclusion, but after review we determined the petitioner should prepare an environmental assessment (EA). The petitioner has prepared and submitted an EA, which at this time is being placed in the docket for public review and comment.
Submission for OMB Review; 30-Day Comment Request; National Children's Study (NCS) Vanguard Data and Sample Archive and Access System (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
In compliance with 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.
Proposed Information Collection Activity; National Medical Support Notice-Part A (OMB #0970-0222)
The Administration for Children and Families (ACF) is requesting a three year extension of the form National Medical Support Notice (NMSN) Part A (OMB #0970-0222 expiration 8/31/2019). The following changes were made to the form: A checkbox was added to distinguish between the National Medical Support Order/Notice (NMSN) and the a Termination Order/Notice. The following instruction was added under the Employer Responsibilities: 3. If the Termination Order/Notice checkbox is checked, you are required to terminate the health care coverage for the child(ren) identified in the order.
Notice of Single Source Award Based on Non-Statutory Earmark to the Delta Region Community Health Systems Development Program
The purpose of the Delta Region Community Health Systems Development program is to support collaboration with and input from the Delta Regional Authority to develop a pilot program to help underserved rural communities in the Delta region identify and better address their health care needs and to help small rural hospitals improve their financial and operational performance. The Federal Office of Rural Health Policy (FORHP), Fiscal Year (FY) 2019 appropriations increased the funding line that supports the Delta Region Community Health Systems Development program by $4,000,000. This increases the overall FY 2019 award for the Delta program from $4,000,000 to $8,000,000. The current award recipient has a need for additional funds to support activities performed under the scope of this program. The current award recipient will use a multipronged approach to deliver phased-in technical assistance (TA), in an effort to provide intensive assistance to all eight Delta Region communities.
Notice of Supplemental Award to the Association of State Territorial Public Health Nutrition Directors for the Children's Healthy Weight Collaborative Improvement and Innovation Cooperative Agreement
HRSA announces the award of a supplement in the amount of $300,000 for the Children's Healthy Weight Collaborative Improvement and Innovation (CoIIN) cooperative agreement. The supplement will permit the Association of State Territorial Public Health Nutrition Directors, the cooperative agreement recipient, during the period of September 1, 2019-August 31, 2020, to collect and analyze additional data from state teams and conduct a robust evaluation of their collective impact approach to prevent childhood obesity.
Medicare and Medicaid Programs: Approval of an Application From the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program for Continued CMS Approval of Its Hospital Accreditation Program
This final notice announces our decision to approve the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (AAHHS/HFAP) (formerly known as the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP)) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Proposed Collection; 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 (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 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.
Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Mining Automation and Safety Research Prioritization
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has recently established a research program to address the rapidly expanding area of automation and associated technologies in mining. NIOSH is requesting information to inform the prioritization of research to be undertaken by The Institute's Mining Program. NIOSH is seeking input on priority gaps in knowledge regarding the safety and health implications of humans working with automated equipment and associated technologies in mining, with an emphasis on worker safety and health research in which NIOSH has the comparative advantage, and is unlikely to be undertaken by other federal agencies, academia, or the private sector.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E
The Food and Drug Administration (FDA, the Agency, or we) is extending, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' rule. We are extending the compliance dates to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to protect public health.
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 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.
Agency Information Collection Activities: Proposed Collection; 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 (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 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.
Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices); Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).'' FDA is issuing this guidance to update the policy regarding the use of animal-derived material in medical device manufacturing. These animal-derived materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured. The guidance describes the information manufacturers should document at the manufacturing facility and include in any premarket submissions.
Proposed Collection; 60-Day Comment Request; Center for Cancer Training (CCT) Application Form for Electronic Individual Development Plan (eIDP) (National Cancer Institute)
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 Institutes of Health, 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.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Performance (Progress) Report for AoA Grantees
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Extension Without Changes (ICR Ext); solicits comments on the information collection requirements related to the Performance (Progress) Report for AoA Grantees under the Older Americans Act Public Law 109-365 Section 411.
Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by the space available. The meeting room accommodates up to 80 people. Public participants should pre-register for the meeting as described below. Members of the public that wish to attend this meeting in person should pre-register by submitting the following information by email, facsimile, or phone (see Contact Person for More Information) no later than 12:00 noon (EDT) on Thursday, April 18, 2019:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Advisory Council for the Elimination of Tuberculosis (ACET)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by the space available. The meeting room will accommodate up to 60 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (100). Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, April 15, 2019. Persons who desire to make an oral statement, may request it at the time of the public comment period on April 16, 2019 at 3:20 p.m. EDT.
Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.'' This guidance outlines nonclinical studies recommended for the development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDs) and addresses comments received to the docket. This guidance is intended to streamline the development of pharmaceuticals used to treat patients with SDLTHDs, other than cancer, while protecting patients' safety and avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles. This guidance applies to pharmaceuticals used both to treat the active disease and to prevent the recurrence of a life-threatening or debilitating event.
Enrichment Strategies for Clinical Trials To Support Demonstration of Effectiveness of Human Drugs and Biological Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.'' The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate effectiveness (and in some cases safety) of human drugs and biological products. This guidance defines several types of enrichment strategies, provides examples of potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. This guidance finalizes the draft guidance entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products'' issued on December 17, 2012.
A Risk-Based Approach To Monitoring of Clinical Investigations: Questions and Answers; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``A Risk- Based Approach to Monitoring of Clinical Investigations: Questions and Answers.'' The draft guidance provides information to sponsors on risk- based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and combinations thereof. This guidance expands on the guidance for industry entitled ``Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring'' (August 2013) (the RBM Guidance) by providing additional guidance to facilitate sponsors' implementation of risk-based monitoring.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program-Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program-Accountable Care Organizations-Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; Correction
This document corrects technical errors in the ``Evaluation and Management Services'' provisions that appeared in the final rule with comment period published in the Federal Register on November 23, 2018, concerning changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
Request for the Technical Review of 10 Draft Skin Notation Assignments and Skin Notation Profiles
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of 10 draft skin notation profile documents now available for public comment entitled:
The National Institutes of Health “Methods and Measurement in Sexual & Gender Minority Health Research: Identifying Research Opportunities”
Sexual and gender minority (SGM) is an umbrella phrase that encompasses lesbian, gay, bisexual, and transgender populations as well as those whose sexual orientation, gender identity and expressions, or reproductive development varies from traditional, societal, cultural, or physiological norms. This includes Disorders or Differences in Sex Development (DSD), sometimes known as intersex. The Sexual & Gender Minority Research Office (SGMRO) at the National Institutes of Health (NIH) has developed the document ``Methods and Measurement in Sexual & Gender Minority Health Research: Identifying Research Opportunities'' pertaining specifically and exclusively to methods and measurement research in SGM health research. Experts in the field identified research opportunities related to methods and measurement in SGM health research during a workshop held in the Spring of 2018. The document reflects the content of the discussion among participants at the Methods and Measurement in SGM Health Research Workshop and does not represent an official position of NIH or any other government agency. We would like to obtain comment on the specifics of this document to consider for the purposes of informing and enhancing its content.
Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: HIV Quality Measures (HIVQM) Module, OMB No. 0906-0022-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects, 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.
Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Modifications to Compliance Policy for Certain Deemed Tobacco Products.'' The draft guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products and describes how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization.
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