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

Results 251 - 300 of 29,744
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-08313
Type: Notice
Date: 2019-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2019-08312
Type: Notice
Date: 2019-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
Document Number: 2019-08143
Type: Proposed Rule
Date: 2019-04-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year 2020. This rule proposes to rebase the continuous home care, general inpatient care, and the inpatient respite care per diem payment rates in a budget-neutral manner to more accurately align Medicare payments with the costs of providing care. In addition, this rule proposes to modify the election statement by requiring an addendum that includes information aimed at increasing coverage transparency for patient under a hospice election. Finally, this rule proposes changes to the Hospice Quality Reporting Program.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2020
Document Number: 2019-08108
Type: Proposed Rule
Date: 2019-04-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020. We also propose minor revisions to the regulation text to reflect the revised assessment schedule under Patient Driven Payment Model (PDPM). Additionally, we propose to revise the definition of group therapy under the SNF PPS, and to implement a subregulatory process for updating the code lists (International Classification of Diseases, Tenth Version (ICD-10) codes) used under PDPM. We are also soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust SNF payments. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020
Document Number: 2019-08017
Type: Rule
Date: 2019-04-25
Agency: Department of Health and Human Services
This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally- facilitated Exchanges (FFEs) and State-based Exchanges on the Federal Platform (SBE-FPs). It finalizes changes that will allow greater flexibility related to the duties and training requirements for the Navigator program and changes that will provide greater flexibility for direct enrollment entities, while strengthening program integrity oversight over those entities. It finalizes a change intended to reduce the costs of prescription drugs. This final rule also includes changes to Exchange standards related to eligibility and enrollment; exemptions; and other related topics.
Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability
Document Number: 2019-08284
Type: Rule
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.
Natural Resources Defense Council et al.: Response to the Objections and Denial of the Requests for a Public Hearing
Document Number: 2019-08262
Type: Proposed Rule
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is overruling the objections and is denying the requests for a public hearing, submitted by the Environmental Defense Fund, Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2019-08261
Type: Notice
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
Document Number: 2019-08260
Type: Proposed Rule
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for ``manual surgical instrument for general use'' and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the proposed special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also proposing to amend the existing classification for ``manual surgical instrument for general use'' to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-08259
Type: Notice
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Surgical Staplers and Staples for Internal UseLabeling Recommendations.'' FDA is issuing this draft guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This draft guidance is not final nor is it currently in effect.
Notice of a Supplemental Award to the Emergency Medical Services for Children Innovation and Improvement Center at the Baylor College of Medicine
Document Number: 2019-08257
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement for $500,000 to the Emergency Medical Services for Children (EMSC) Innovation and Improvement Center. The supplement will permit the Baylor College of Medicine, the cooperative agreement recipient, to establish and lead a new Quality Improvement Collaborative to support the EMSC State Partnership Program during the budget period of 07/1/2018-06/30/2019. EMSC plans to increase the proportion of EMS agencies that have a designated individual responsible for the coordination of pediatric emergency care by 2020 to 30 percent.
Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information; Reopening of the Comment Period
Document Number: 2019-08251
Type: Notice
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period provided in the notice entitled ``Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information'' that appeared in the Federal Register of December 7, 2018. That notice announced the establishment of a docket to obtain data, information, and comments that will assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter human use. The Agency is taking this action to allow interested persons additional time to submit comments, data, or information.
Proposed Information Collection Activity; Native Employment Works (NEW) Program Plan Guidance and Report Requirements, (OMB No.: 0970-0174)
Document Number: 2019-08249
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a three-year extension of the form OFA-0086, NEW Plan Guidance and NEW Program Report (OMB #0970-0174, expiration 7/31/2019). There are changes requested to these forms, including the deletion of guidance for NEW programs included in Public Law 102-477 programs.
Proposed Information Collection Activity; The Early Head Start Family and Child Experiences Survey (Baby FACES 2020; OMB #0970-0354)
Document Number: 2019-08248
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2020 (Baby FACES 2020).
Proposed Continued Information Collection Activity; Evaluation of the Child Welfare Capacity Building Collaborative (OMB Number: 0970-0484)
Document Number: 2019-08247
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a three-year extension of the previously approved forms that include satisfaction surveys; a leadership interview protocol; a web- based collaboration survey; assessment tools; and service-specific feedback forms (OMB #0970-0484, expiration 8/31/2019). There are no changes to the forms.
Characterizing the Food and Drug Administration's Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle; Public Meeting; Request for Comments
Document Number: 2019-08219
Type: Notice
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Characterizing FDA's Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle'' and an opportunity for public comment. The meeting will be convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, patient, researcher, and other stakeholder input on applying FDA's Benefit-Risk Framework throughout the human drug lifecycle and best approaches to communicating FDA's benefit-risk assessment. Input from this meeting will support development of a draft guidance on benefit-risk assessment for new drugs and biologics and result in a publicly available summary report from Duke-Margolis. This meeting is intended to meet an FDA commitment included in the sixth authorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).
Initiation of Voluntary Recalls Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-08198
Type: Proposed Rule
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.'' The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products. The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-08196
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-08195
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-08194
Type: Notice
Date: 2019-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
National Institute on Aging; Notice of Closed Meetings
Document Number: 2019-08193
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2019-08192
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-08191
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-08189
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2019-08188
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-08186
Type: Notice
Date: 2019-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-08184
Type: Notice
Date: 2019-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-08175
Type: Notice
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealer's Certificate
Document Number: 2019-08174
Type: Notice
Date: 2019-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program
Document Number: 2019-07885
Type: Proposed Rule
Date: 2019-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. As required by the Social Security Act (the Act), this proposed rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups (CMGs) and a description of the methodologies and data used in computing the prospective payment rates for FY 2020. We are proposing to rebase and revise the IRF market basket to reflect a 2016 base year rather than the current 2012 base year. Additionally, we are proposing to replace the previously finalized unweighted motor score with a weighted motor score to assign patients to CMGs and remove one item from the score beginning with FY 2020 and to revise the CMGs and update the CMG relative weights and average length of stay values beginning with FY 2020, based on analysis of 2 years of data (FY 2017 and FY 2018). We are proposing to update the IRF wage index to use the concurrent FY inpatient prospective payment system (IPPS) wage index beginning with FY 2020. We are soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust IRF payments. We are proposing to amend the regulations to clarify that the determination as to whether a physician qualifies as a rehabilitation physician (that is, a licensed physician with specialized training and experience in inpatient rehabilitation) is made by the IRF. For the IRF Quality Reporting Program (QRP), we are proposing to adopt two new measures, modify an existing measure, and adopt new standardized patient assessment data elements. We also propose to expand data collection to all patients, regardless of payer, as well as proposing updates related to the system used for the submission of data and related regulation text.
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers; Supplement and Extension of Comment Period
Document Number: 2019-08181
Type: Proposed Rule
Date: 2019-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the proposed rule entitled ``Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers'' that appeared in the March 4, 2019 Federal Register. The comment period for the proposed rule, which would end on May 3, 2019, is extended 30 days to June 3, 2019. We additionally note that based on public comments received on this proposed rule, we will adjust the effective dates of our policies to allow for adequate implementation timelines, as appropriate.
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
Document Number: 2019-08178
Type: Proposed Rule
Date: 2019-04-23
Agency: Department of Health and Human Services, Office of the Secretary
On March 4, 2019, the Department of Health and Human Services (HHS) published a proposed rule that would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The comment period for the rule was scheduled to close on May 3, 2019. This document extends the comment period for the proposed rule by 30 days to June 3, 2019.
Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
Document Number: 2019-08167
Type: Notice
Date: 2019-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) hereby announces the renewal of the Best Pharmaceuticals for Children Act (BPCA) Program. The Best Pharmaceuticals for Children Act (BPCA) seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations, publish a list of drugs/needs in pediatric therapeutics, and fund studies in the prioritized areas. This notice will provide a brief summary of recent changes in the legislation, a brief update on the current progress of the BPCA Program and provide the current Priority List of Needs in Pediatric Therapeutics.
Submission for OMB Review; National and Tribal Evaluation of the 2nd Generation of the Health Profession Opportunity Grants (OMB #0970-0462)
Document Number: 2019-08163
Type: Notice
Date: 2019-04-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing data collection activities as part of the Health Profession Opportunity Grants (HPOG) to Serve TANF Recipients and Other Low Income Individuals. ACF has developed a multi-pronged research and evaluation approach for the HPOG Program to better understand and assess the activities conducted and their results. Two rounds of HPOG grants have been awardedthe first in 2010 (HPOG 1.0) and the second in 2015 (HPOG 2.0). There are federal evaluations associated with each round of grants. HPOG grants provide funding to government agencies, community- based organizations, post-secondary educational institutions, and tribal-affiliated organizations to provide education and training services to Temporary Assistance for Needy Families (TANF) recipients and other low-income individuals, including tribal members. Under HPOG 2.0, ACF provided grants to five tribal-affiliated organizations and 27 non-tribal entities. OMB previously approved data collection under OMB Control Number 0970-0462 for the HPOG 2.0 National and Tribal Evaluation. The first submission, approved in August 2015, included baseline data collection instruments and the grant performance management system. A second submission, approved in June 2017, included additional data collection for the National Evaluation impact study, the National Evaluation descriptive study, and the Tribal Evaluation. A third submission for National Evaluation impact study data collection was approved in June 2018. The proposed data collection activities described in this Federal Register Notice will provide data for the impact, descriptive, and cost benefit studies of the 27 non-tribal grantees participating in the National Evaluation of HPOG 2.0.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-08153
Type: Notice
Date: 2019-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Monitoring and Reporting System for the National Tobacco Control Program. This information collection is requested by CDC to monitor progress in the states and territories funded through two CDC cooperative agreements
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-08152
Type: Notice
Date: 2019-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 National HIV Surveillance System (NHSS). This data collection is for continuation of the National HIV Surveillance System which provides the primary population-based data used to describe the epidemiology of HIV in the United States including adult/adolescent and pediatric HIV case reporting, case report evaluations and updates, laboratory updates, deduplication activities, investigation reporting and evaluation, cluster reporting, perinatal HIV exposure reporting, and annual reporting of the standards evaluation report.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-08151
Type: Notice
Date: 2019-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Aggregate Reports for Tuberculosis Program Evaluation. The goal of the study is to allow CDC to collect and monitor indicators for key program activities, such as finding tuberculosis infections in recent contacts of cases and in other high-risk persons likely to be infected and providing therapy for latent tuberculosis infection in an effort to eliminate Tuberculosis in the United States. CDC is requesting approval for 268 burden hours. This is an increase of 42 hour from the previously approved 226 hours.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-08150
Type: Notice
Date: 2019-04-23
Agency: Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Human health effects of drinking water exposures to per- and polyfluoroalkyl substances (PFAS): A multi-site cross-sectional study (The Multi-site Study).'' The purpose of this research is to use sound study methods to see if drinking water exposure to PFAS is related to health outcomes.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-08149
Type: Notice
Date: 2019-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Survey of Engineered Nanomaterial Occupational Safety and Health Practices. The goal of this project is to assess the relevance and impact of NIOSH's contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-08148
Type: Notice
Date: 2019-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 ``Extended Evaluation of the National Tobacco Prevention and Control Public Education Campaign.'' This information collection request will enable the Centers for Disease Control and Prevention (CDC) to continue to measure exposure and awareness of the Tips From Former Smokers[supreg] campaign (Tips[supreg]) and to evaluate its impact on campaign-targeted outcomes among smokers and nonsmokers in the United States.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-08147
Type: Notice
Date: 2019-04-23
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-08146
Type: Notice
Date: 2019-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-08145
Type: Notice
Date: 2019-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; State Access and Visitation Grant Application (OMB #0970-0482)
Document Number: 2019-08109
Type: Notice
Date: 2019-04-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement is requesting a three- year extension of the application form titled, Child Access and Visitation Grant Application Form, expiration 8/31/2019. There are no changes requested to the form.
Medicare Program; FY 2020 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2019 (FY 2020)
Document Number: 2019-07884
Type: Proposed Rule
Date: 2019-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an inpatient prospective payment system hospital or critical access hospital. Additionally, this proposed rule would revise and rebase the IPF market basket to reflect a 2016 base year and remove the IPF Prospective Payment System (PPS) 1-year lag of the wage index data. This proposed rule also solicits comments on the IPF wage index. Finally, this rule proposes updates to the Inpatient Psychiatric Facilities Quality Reporting Program. These changes would be effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2019 through September 30, 2020 (FY 2020).
The National Institutes of Health (NIH) Sexual & Gender Minority Research Office Request for Letters of Intent and Nominations for SGM Investigator Awards Program
Document Number: 2019-08065
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) Sexual & Gender Minority Research Office (SGMRO) is requesting letters of intent for the second annual Investigator Awards Program. The NIH Sexual and Gender Minority (SGM) Investigator Awards Program was developed to recognize early-stage investigators who have made substantial, outstanding research contributions in areas related to SGM health and who are poised to become future leaders or are already leading the field of SGM health research. The NIH SGMRO is currently soliciting nominations for the 2019 NIH SGM Investigator Awards. The NIH SGMRO will make two non-monetary awards this year.
Agency Information Collection Activities; Proposed Collection; Comment Request; Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act
Document Number: 2019-08046
Type: Notice
Date: 2019-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 the information collection ``Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act).''
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2019-08033
Type: Notice
Date: 2019-04-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization
Document Number: 2019-08032
Type: Rule
Date: 2019-04-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the addition of four Healthcare Common Procedure Coding System (HCPCS) codes to the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.
Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
Document Number: 2019-08031
Type: Rule
Date: 2019-04-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the addition of 12 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment.