Department of Health and Human Services March 19, 2019 – Federal Register Recent Federal Regulation Documents
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Patient Safety Organizations: Voluntary Relinquishment From Quality Alliance Patient Safety Organization
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Quality Alliance Patient Safety Organization, PSO number P0163, of its status as a PSO, and has delisted the PSO accordingly.
Mitigation Strategies To Protect Food Against Intentional Adulteration: Draft Guidance for Industry; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry.'' The purpose of the public meeting is to discuss the draft guidance for compliance and implementation of the ``Mitigation Strategies to Protect Food Against Intentional Adulteration'' rule, which was issued under the FDA Food Safety Modernization Act.
Supplemental Evidence and Data Request on Opioid Treatments for Chronic Pain
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Opioid Treatments for Chronic Pain, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
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: ``Child Hospital Consumer Assessment of Healthcare Providers and Systems (Child HCAHPS) Survey Database.'' This proposed information collection was previously published in the Federal Register on November 7th, 2018, and allowed 60 days for public comments. AHRQ received and responded to one substantive comment from a member of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Supplemental Evidence and Data Request on Noninvasive Nonpharmacologic Treatment for Chronic Pain
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Noninvasive Nonpharmacologic Treatment for Chronic Pain, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Supplemental Evidence and Data Request on Nonopioid Pharmacologic Treatments for Chronic Pain
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Nonopioid Pharmacologic Treatments for Chronic Pain, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
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.
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