Department of Health and Human Services 2019 – Federal Register Recent Federal Regulation Documents
Results 651 - 700 of 3,514
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 proposed information collection titled The National Intimate Partner and Sexual Violence Survey (NISVS). CDC will collect information about individual's experiences of sexual violence, stalking and intimate partner violence and information about the health consequences of these forms of violence. CDC produces national and state level prevalence estimates of these types of violence.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Application Form and Related Forms for the Operation of the National Death Index. The National Death Index (NDI) is designed to allow NCHS to collect mortality data, to support epidemiological research and to furnish mortality information.
Submission for OMB Review; Plan for Foster Care and Adoption Assistance-Title IV-E (OMB #0970-0433)
Public Law 115-123 added two new programs to title IV-E of the Social Security Act: The Prevention Services Program and the Kinship Navigator Program. Title IV-E agencies will be required to report information regarding these programs in title IV-E plans. Therefore, the Administration for Children and Families (ACF) is requesting to revise the existing information collection Plan for Foster Care and Adoption Assistance (OMB #0970-0433) to include two new information collections specific to these two new programs.
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that JYNNEOS, (Smallpox and Monkeypox Vaccine, Live, Non-replicating), manufactured by Bavarian Nordic A/S, meets the criteria for a priority review voucher.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Traumatic Brain Injury (TBI) State Partnership Program, OMB approval number 0985-NEW
The Administration for Community Living (ACL) is announcing an opportunity for the public to review substantive changes to the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (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.
Notice of Single Source Award to the Telehealth Focused Rural Health Research Center
In FY 2019, HRSA provided $788,000 in additional funding to The University of Iowa for the Telehealth Focused Rural Health Research Center and extended the project period for 12 months.
Proposed Changes to the Scholarships for Disadvantaged Students Program
On May 22, 2019, HRSA published a 30-day notice in the Federal Register soliciting feedback on a range of issues pertaining to the Scholarships for Disadvantaged Students (SDS) Program to assist the agency in updating certain SDS policies. HRSA requested feedback on adjusting funding allocations to respond to projected workforce shortages, transitioning data collection from 1 year of data to a 3- year average to demonstrate eligibility, and increasing the maximum scholarship award from $30,000 to $40,000. As a result of HRSA's comprehensive review of existing policies, and taking into consideration the comments received, HRSA is issuing this final notice.
Submission for OMB Review; Head Start (HS) Connects: Individualizing and Connecting Families to Family Support Services (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct semi-structured, qualitative interviews with Head Start staff, parents/ guardians, and community providers at six Head Start programs for case studies that explore case management and coordination of family support services.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Correction
This document corrects technical and typographical errors in the final rule that appeared in the August 16, 2019 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals.''
National Inventory for Poliovirus Containment: Minimizing Risk of Poliovirus Release From Laboratories in the United States; Availability
The United States National Authority for Containment of Poliovirus (NAC), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), announces the availability of the National Inventory for Poliovirus Containment survey. This survey is designed to collect relevant laboratory inventory data to ensure facilities throughout the United States are in compliance with requirements established in the World Health Organization (WHO) Global Action Plan (GAPIII), as adapted for the WHO Region of the Americas. Per GAPIII, each country is required to complete a national inventory of poliovirus-containing materials, including poliovirus potentially infectious materials (PIM).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
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.
Privacy Act of 1974; System of Records
In accordance with requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is updating an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), system No. 09-70-0550, titled ``Medicare Retiree Drug Subsidy Program'' (RDSP), and renaming it ``Retiree Drug Subsidy (RDS), HHS/CMS/CM.'' This system collects and maintains information about individuals who are qualifying covered retirees so that accurate and timely subsidy payments may be made to plan sponsors who continue to offer actuarially equivalent prescription drug coverage to the qualifying covered retirees.
Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Meeting of the Advisory Committee on Interdisciplinary, Community Based Linkages
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community Based Linkages (ACICBL) will hold public meetings for the 2020 calendar year (CY). Information about ACICBL, agendas, and materials for these meetings can be found on the ACICBL website at https://www.hrsa.gov/advisory-committees/interdisciplinary-co mmunity- linkages/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records
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.
Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Tuesday, August 20, 2019. The document announced a ``Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1.'' The document was published with the incorrect contact name, phone number, and email address in the FOR FURTHER INFORMATION CONTACT section. This document corrects those errors.
Submission for OMB Review; Trafficking Victim Assistance Program Data Collection (OMB #0970-0467)
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to reinstate a previously approved information collection with revisions to information collected on clients enrolled in the Trafficking Victim Assistance Grant Program.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2020
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2020. The calendar year 2020 AIC threshold amounts are $170 for ALJ hearings and $1,670 for judicial review.
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter 14Recall Plan.''
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
Proposed Collection; 60-Day Comment Request; Generic Clearance To Collect Research or Educational Tools and Resources (Office of the Director)
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 Office of the Director (OD) 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; 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 Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Nurse Corps Scholarship Program (NCSP), OMB No. 0915-0301-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Children's Hospitals Graduate Medical Education Payment Program, OMB No. 0915-0247, Revision
In compliance with of the Paperwork Reduction Act of 1995, 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.
Solicitation of Nominations for Appointment to the Interagency Committee on Smoking and Health (ICSH)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ICSH. The ICSH consists of 5 experts in fields that represent private entities involved in informing the public about the health effects of smoking. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of the health effects of smoking. Additionally, desirable qualifications include: (1) Knowledge of emerging tobacco control policies and experience in analyzing, evaluating, and interpreting Federal, State and/or local health or regulatory policy; and/or (2) familiarity and expertise in developing or contributing to the development of policies and/or programs for reducing health disparities in tobacco use in the United States; and/or (3) knowledge of the intersection of behavioral health conditions (mental and/or substance use disorders) and tobacco use/tobacco control. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ICSH objectives https://www.cdc.gov/tobacco/about/icsh/index.htm.
Mine Safety and Health Research Advisory Committee (MSHRAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at 412-386-5302 at least 5 business days in advance of the meeting.
Proposed Information Collection Activity; Building Capacity To Evaluate Child Welfare Community Collaborations To Strengthen and Preserve Families (CWCC) Cross-Site Process Evaluation (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to collect data for an evaluation of the initiative, Community Collaborations to Strengthen and Preserve Families (also referred to as Child Welfare Community Collaborations [CWCC]). The cross-site process evaluation will provide insight to ACF about the various factors that promote or impede the implementation of child welfare community collaborations.
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