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

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Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11802
Type: Notice
Date: 2020-06-02
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 Pulmonary Function Test Course Approval Application. The program consists of an application submitted by potential sponsors (universities, hospitals, and private consulting firms) who seek NIOSH approval to conduct courses, and if approved, notification to NIOSH of any course or faculty changes during the approval period, which is limited to five years.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11801
Type: Notice
Date: 2020-06-02
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 the Medical Monitoring Project Facility Survey, a one-time survey of the characteristics of HIV care facilities in order to collect information on the nation's existing HIV care infrastructure and the capacity of facilities to implement the strategies of the U.S. Ending the HIV Epidemic Federal Initiative.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11800
Type: Notice
Date: 2020-06-02
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 YRBS Test-Retest Reliability Study. This study is designed to test the reliability of the data collected through the Youth Risk Behavior Survey (YRBS) questionnaires. The YRBS is a biennially school-based survey of high school students in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11799
Type: Notice
Date: 2020-06-02
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 ``Assessments of adults' professional experiences for improving programs to decrease sexual risk and related behaviors and adverse health outcomes among youth,'' a generic information collection package that supports qualitative and quantitative data collection from adults who help implement programs and services designed to prevent HIV, other sexually transmitted diseases (STDs), and pregnancy or influence related risk and protective factors; data will be collected for needs assessment and program refinement.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11798
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11797
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11796
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11795
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11794
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11793
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the Advisory Committee on Infant Mortality
Document Number: 2020-11774
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice announces a correction to the time of the Secretary's Advisory Committee on Infant Mortality (ACIM) scheduled public meeting. The ACIM meeting, originally scheduled for June 17, 2020, 11:00 a.m.-6:00 p.m. Eastern Time (ET) and June 18, 2020, 11:00 a.m.-3:00 p.m. ET, has been extended by 30 minutes on June 18, 2020. The meeting will now end at 3:30 p.m. on June 18, 2020. This meeting was originally announced in the Federal Register, Vol. 85, No. 95, on Friday, May 15, 2020 (FR Doc. 2020-10447 Filed 5-14-20; 8:45 a.m.). The location and agenda for the re-scheduled ACIM meeting remains the same as posted. Information about ACIM and the agenda for this meeting will be available on the ACIM website at https://www.hrsa.gov/advisory- committees/infant-mortality/index.html.
Amendments to the HHS-Operated Risk Adjustment Data Validation Under the Patient Protection and Affordable Care Act's HHS-Operated Risk Adjustment Program
Document Number: 2020-11703
Type: Proposed Rule
Date: 2020-06-02
Agency: Department of Health and Human Services
This rule proposes to adopt certain changes to the risk adjustment data validation error estimation methodology starting with the 2019 benefit year and beyond for states where the Department of Health and Human Services (HHS) operates the risk adjustment program. The Patient Protection and Affordable Care Act (PPACA) established a permanent risk adjustment program under which payments are made to health insurance issuers that attract higher-than-average risk populations funded by payments from health insurance issuers that attract lower-than-average risk populations. To ensure the integrity of the HHS-operated risk adjustment program, CMS, on behalf of HHS, performs risk adjustment data validation, also known as HHS-RADV, to validate the accuracy of data submitted by issuers for the purposes of risk adjustment transfer calculations. Based on lessons learned from the first payment year of HHS-RADV, this rule proposes changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also proposes to change the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied starting with 2021 benefit year HHS-RADV. These proposals seek to further the integrity of the HHS-RADV program, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2020-11695
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program
Document Number: 2020-11342
Type: Rule
Date: 2020-06-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise regulations for the Medicare Advantage (MA or Part C) program, Medicare Prescription Drug Benefit (Part D) program, and Medicare Cost Plan program to implement certain sections of the Bipartisan Budget Act of 2018 and the 21st Century Cures Act. In addition, it will enhance the Part C and D programs, codify several existing CMS policies, and implement other technical changes.
Food Additives Permitted in Feed and Drinking Water of Animals; Silicon Dioxide
Document Number: 2020-10033
Type: Rule
Date: 2020-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of silicon dioxide as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed components (ingredients, intermediate premixes, premixes, supplements, or concentrates). This action is in response to a food additive petition filed by Evonik Corp.
Notice of Closed Meeting
Document Number: 2020-11736
Type: Notice
Date: 2020-06-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Commission on Childhood Vaccines Meeting Cancellation
Document Number: 2020-11705
Type: Notice
Date: 2020-06-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
This is to notify the public that the June 4, 2020, and June 5, 2020, meeting of the Advisory Commission on Childhood Vaccines (ACCV) is canceled.
Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program; Correction
Document Number: 2020-11701
Type: Notice
Date: 2020-06-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the notice published in the Federal Register on April 1, 2020 entitled ``Medicare and Medicaid Programs; Application from the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program.''
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; University Centers of Excellence in Developmental Disabilities Education, Research and Service Annual Report [OMB# 0985-0030]
Document Number: 2020-11685
Type: Notice
Date: 2020-06-01
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) 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 under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Proposed Revision and solicits comments on the information collection requirements related to the University Centers of Excellence in Developmental Disabilities (UCEDD) Education, Research and Service final 5-year report.
Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments
Document Number: 2020-11684
Type: Notice
Date: 2020-06-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). We are soliciting comments on the types of patents currently listed in the Orange Book and the impact that any change to current patent listing practices may have on drug product development. This notice is not intended to communicate our regulatory expectations on these issues but is instead intended to seek early input from the public to inform further regulatory action if determined to be appropriate.
Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange Book”); Establishment of a Public Docket; Request for Comments
Document Number: 2020-11683
Type: Notice
Date: 2020-06-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a public docket to solicit comments on FDA's publication entitled ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). The Orange Book identifies drug products approved by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and includes related information. As part of FDA's Drug Competition Action Plan and our continued effort to improve transparency and provide useful information to regulated industry and the public, we are seeking comments on how stakeholders and the public use the Orange Book and whether it can be improved.
Orange Book-Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2020-11682
Type: Notice
Date: 2020-06-01
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 entitled ``Orange BookQuestions and Answers.'' This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This guidance provides answers to commonly asked questions FDA has received from interested parties regarding the Orange Book.
Notice of Approval of Product U nder Voucher: Rare Pediatric Disease Priority Review Voucher
Document Number: 2020-11681
Type: Notice
Date: 2020-06-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that NURTEC ODT (rimegepant), approved February 27, 2020, meets the redemption criteria.
Proprietary Names for New Animal Drugs; Guidance for Industry; Availability
Document Number: 2020-11679
Type: Notice
Date: 2020-06-01
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 final guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' This guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This guidance proposes a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how new animal drug sponsors can request that CVM evaluate a proposed proprietary name.
Rare Disease Clinical Trial Networks; Request for Information and Comments
Document Number: 2020-11655
Type: Notice
Date: 2020-06-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public regarding practical steps and successful approaches to establish a rare disease clinical trials network.
Submission for OMB Review: Title V State Sexual Risk Avoidance Education (SRAE) Program (New Collection)
Document Number: 2020-11628
Type: Notice
Date: 2020-06-01
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) is accepting mandatory formula grant applications and State Plans from states and territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Funding Opportunity Announcement sets forth the application requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2020-11624
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-11623
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-11622
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2020-11621
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Federal Case Registry (FCR) (OMB #0970-0421)
Document Number: 2020-11578
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Federal Case Registry (FCR). There are no changes to the collection instruments used for the FCR (current Office of Management and Budget (OMB) approval expires January 31, 2021).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Delta States Rural Development Network Grant Program, OMB No. 0915-0386-Extension
Document Number: 2020-11571
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
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. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11555
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
Office of The Director, National Institutes of Health; Notice of Meeting
Document Number: 2020-11554
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2020-11552
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11543
Type: Notice
Date: 2020-05-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2020-11514
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-11503
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-11502
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-11501
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-11500
Type: Notice
Date: 2020-05-29
Agency: Department of Health and Human Services, National Institutes of Health
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT) Meeting
Document Number: 2020-11496
Type: Notice
Date: 2020-05-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC and the Health Resources and Services Administration (HRSA), announces the following meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). This meeting is open to the public, limited only by audio and web conference lines available, by accessing the (information below). Time will be available for oral public comment. Persons who desire to make an oral statement, may request it at the time of the public comments period on July 21, 2020 at 3:45 p.m., EDT. Written comments received in advance of the meeting will be included in the official record of the meeting.
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised); Guidance for Industry; Availability
Document Number: 2020-11463
Type: Notice
Date: 2020-05-29
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 revised guidance for industry entitled ``Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).'' This is a revision to the first edition of this final guidance, which issued in March 2020, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the May 8, 2020, court order that postponed, by 120 days, the effective date of the final rule, entitled ``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.'' Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event within 5 months and 120 days after the date of publication of the final rule (i.e., by December 16, 2020).
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
Document Number: 2020-11462
Type: Rule
Date: 2020-05-29
Agency: Food and Drug Administration, Department of Health and Human Services
In accordance with an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020, from June 18, 2021, to October 16, 2021.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-11424
Type: Notice
Date: 2020-05-29
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-11389
Type: Notice
Date: 2020-05-29
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-11387
Type: Notice
Date: 2020-05-29
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.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals
Document Number: 2020-10122
Type: Proposed Rule
Date: 2020-05-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2021 and to implement certain recent legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) for teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2021. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2021. In this FY 2021 IPPS/LTCH PPS proposed rule, we are proposing changes to the new technology add-on payment pathway for certain antimicrobial products and other changes to new technology add-on payment policies, and to collect market-based rate information on the Medicare cost report for cost reporting periods ending on or after January 1, 2021, and requesting comment on a potential market based MS-DRG relative weight methodology beginning in FY 2024 that we may adopt in this rulemaking. We are proposing to establish new requirements or revise existing requirements for quality reporting by acute care hospitals and PPS- exempt cancer hospitals. We also are proposing to establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are providing estimated and newly established performance standards for the Hospital Value-Based Purchasing (VBP) Program, and proposing updated policies for the Hospital Readmissions Reduction Program and the Hospital- Acquired Condition (HAC) Reduction Program.
Agency Information Collection Activities: Coronavirus 2019 (COVID-19) Data Report, OMB No. 0906-xxxx-Emergency
Document Number: 2020-11586
Type: Notice
Date: 2020-05-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
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. OMB will accept comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 10-day comment period for this notice has closed.
Mitigation Strategies to Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Extension of the Comment Period
Document Number: 2020-11455
Type: Notice
Date: 2020-05-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of February 14, 2020, entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration; Draft Guidance for Industry.'' This supplemental draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.'' FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.