Department of Health and Human Services August 2021 – Federal Register Recent Federal Regulation Documents

Results 201 - 237 of 237
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority
Document Number: 2021-16635
Type: Notice
Date: 2021-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) 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.
Charter Amendment for the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2021-16618
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act (FACA) and section 1111 of the Public Health Service (PHS) Act, HHS is hereby giving notice that the charter for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has been amended to set the time period for appointment of members to a term of up to 4 years. The effective date of the amendment is July 30, 2021.
Notice of Closed Meeting
Document Number: 2021-16610
Type: Notice
Date: 2021-08-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-16609
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-16608
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International Center; Notice of Meeting
Document Number: 2021-16607
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: National Health Service Corps Scholar/Students To Service Travel Worksheet, OMB No. 0915-0278-Extension
Document Number: 2021-16597
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
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: Health Center Program: COVID-19 Data Collection Tools, OMB No. 0906-0062-Revision
Document Number: 2021-16591
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2021-16577
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-16549
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-16538
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-16537
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-16536
Type: Notice
Date: 2021-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)
Document Number: 2021-16336
Type: Rule
Date: 2021-08-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rule also updates and clarifies the IPF teaching policy with respect to IPF hospital closures and displaced residents and finalizes a technical change to one of the 2016-based IPF market basket price proxies. In addition, this final rule finalizes proposals on quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program. We note that this final rule does not finalize two proposals to remove quality measures. The changes finalized in this rule for the IPFQR Program are effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2021 through September 30, 2022 (FY 2022).
Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements
Document Number: 2021-16311
Type: Rule
Date: 2021-08-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. This rule makes changes to the labor shares of the hospice payment rates and finalizes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020. In addition, this rule makes permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the COVID-19 public health emergency (PHE) and updates the hospice conditions of participation. This rule updates the Hospice Quality Reporting Program and finalizes changes beginning with the January 2022 public reporting for the Home Health Quality Reporting Program to address exceptions related to the COVID-19 PHE.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program; Payment for Complex Rehabilitative Wheelchairs and Related Accessories (Including Seating Systems) and Seat and Back Cushions Furnished in Connection With Such Wheelchairs
Document Number: 2021-16310
Type: Rule
Date: 2021-08-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2022. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2022. This final rule also includes updates for the IRF Quality Reporting Program (QRP). In addition, we are finalizing a Medicare provision adopted in an interim final rule with comment period (IFC) issued on May 11, 2018 related to fee schedule adjustments for wheelchair accessories (including seating systems) and seat and back cushions furnished in connection with group 3 or higher complex rehabilitative power wheelchairs as well as changes to the regulations related to the Further Consolidated Appropriations Act, 2020 governing payment for these and other items.
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 2022; and Technical Correction to Long-Term Care Facilities Physical Environment Requirements
Document Number: 2021-16309
Type: Rule
Date: 2021-08-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the final rule includes a forecast error adjustment for FY 2022, updates the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), rebases and revises the SNF market basket, implements a recently-enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates, and includes a discussion of a PDPM parity adjustment. In addition, the final rule includes updates for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program, including a policy to suppress the use of the SNF readmission measure for scoring and payment adjustment purposes in the FY 2022 SNF VBP Program because we have determined that circumstances caused by the public health emergency for COVID-19 have significantly affected the validity and reliability of the measure and resulting performance scores. We are also finalizing a technical correction to the physical environment requirements that Long-Term Care facilities must meet in order to participate in the Medicare and Medicaid programs.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model; Request for Information on Rural Emergency Hospitals
Document Number: 2021-15496
Type: Proposed Rule
Date: 2021-08-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2022 based on our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, update Hospital Price Transparency requirements, and update and refine the design of the Radiation Oncology Model. Finally, this proposed rule includes a Request for Information (RFI) focusing on the health and safety standards, quality measures and reporting requirements, and payment policies for Rural Emergency Hospitals (REHs), a new Medicare provider type. The RFI will be used to inform future rulemaking for REHs.
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Extension of Comment Period
Document Number: 2021-16522
Type: Notice
Date: 2021-08-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled ``Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of June 4, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-16509
Type: Notice
Date: 2021-08-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2021-16508
Type: Notice
Date: 2021-08-03
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; ORR-2 Quarterly Report on Expenditures and Obligations (OMB #0970-0407)
Document Number: 2021-16470
Type: Notice
Date: 2021-08-03
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR) is requesting a three-year extension of the ORR-2 Quarterly Report on Expenditures and Obligations (OMB #0970-0407, expiration 8/31/2021). There are no changes requested to the form.
Prospective Grant of Exclusive Patent License: Improved Live-Attenuated Vaccine for Respiratory Syncytial Virus
Document Number: 2021-16462
Type: Notice
Date: 2021-08-03
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Codagenix, Inc. (Codagenix), having a place of business in Farmingdale, New York, U.S.A.
Medicaid Program; Reassignment of Medicaid Provider Claims
Document Number: 2021-16430
Type: Proposed Rule
Date: 2021-08-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would reinterpret the scope of the general requirement that state payments for Medicaid services under a state plan must be made directly to the individual practitioner providing services, in the case of a class of practitioners for which the Medicaid program is the primary source of revenue. Specifically, this proposal, if finalized, would explicitly authorize states to make payments to third parties to benefit individual practitioners by ensuring health and welfare benefits, training, and other benefits customary for employees, if the practitioner consents to such payments to third parties on the practitioner's behalf.
Medical Device User Fee Rates for Fiscal Year 2022
Document Number: 2021-16408
Type: Notice
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2022, which apply from October 1, 2021, through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16407
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-16406
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16405
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16402
Type: Notice
Date: 2021-08-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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: 2021-16385
Type: Notice
Date: 2021-08-02
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).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
Document Number: 2021-16384
Type: Notice
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-16377
Type: Notice
Date: 2021-08-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-16376
Type: Notice
Date: 2021-08-02
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a continued information collection project titled ``Assessments to Inform Program Refinement for HIV, other STD, and Pregnancy Prevention among Middle and High-School Aged Youth.'' This is a generic information collection package that supports qualitative and quantitative data collection from adolescents (ages 11- 19) and their parents/caregivers for the purpose of needs assessment and program refinement for programs and services designed to prevent HIV, other sexually transmitted diseases (STDs), and pregnancy among middle and high school aged adolescents.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-16356
Type: Notice
Date: 2021-08-02
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.
Belen G. Ngo; Denial of Hearing; Final Debarment Order
Document Number: 2021-16352
Type: Notice
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying Belen G. Ngo's (Ms. Ngo's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ms. Ngo for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Ngo was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Ms. Ngo's debarment, FDA considered the relevant factors listed in the FD&C Act. Ms. Ngo failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Vithal K. Patel; Denial of Hearing; Final Debarment Order
Document Number: 2021-16350
Type: Notice
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Vithal K. Patel (Mr. Patel) and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Mr. Patel for 1 year from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Patel was convicted of conspiracy to commit a felony under Federal law for conduct relating to the regulation of drug products under the FD&C Act and that the type of conduct underlying the conviction undermined the process for the regulation of drugs. In determining the appropriateness and period of Mr. Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. Mr. Patel has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Regulations Regarding “Intended Uses”
Document Number: 2021-15980
Type: Rule
Date: 2021-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product ``intended use'' regulations. This final rule amends FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective.