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

Submission for OMB Review; Mother and Infant Home Visiting Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten data collection (MIHOPE-K) [OMB #0970-0402]
Document Number: 2021-26102
Type: Notice
Date: 2021-11-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), in partnership with the Health Resources and Services Administration (HRSA), both of the U.S. Department of Health and Human Services (HHS), is proposing to extend data collection activity as part of the kindergarten phase of the Mother and Infant Home Visiting Program Evaluation Long-Term Follow-Up project (MIHOPE-K). The purpose of MIHOPE-K is to conduct a follow-up study that assesses the long-term impact of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program when the participating children are in kindergarten. This Federal Register notice is seeking to extend data collection for the kindergarten follow-up. The original Federal Register notices for the MIHOPE-K data collection were titled under MIHOPE-Long-Term Follow- Up (MIHOPE-LT).
Agency Information Collection Activities; Proposed Collections; Comment Request; Prescription Drug User Fee Program
Document Number: 2021-26079
Type: Notice
Date: 2021-11-30
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 collections 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 information collection associated with FDA's Prescription Drug User Fee program.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program; Correction
Document Number: 2021-26069
Type: Rule
Date: 2021-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects typographical errors in the final rule that appeared in the August 13, 2021, Federal Register as well as additional typographical errors in a related correcting amendment that appeared in the October 20, 2021, Federal Register. The final rule was titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program''.
National Institute for Occupational Safety and Health Tribal Consultation Session
Document Number: 2021-26016
Type: Notice
Date: 2021-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC) announces a CDC Tribal Consultation Session. CDC will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for a virtual tribal consultation session on the NIOSH draft strategic plan entitled American Indian and Alaska Native Worker Safety and Health Strategic Plan. The proceedings will be open to the public.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZEPZELCA
Document Number: 2021-26009
Type: Notice
Date: 2021-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEPZELCA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability
Document Number: 2021-26006
Type: Notice
Date: 2021-11-30
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 ``Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.'' FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision-making. This guidance provides sponsors and other stakeholders with considerations when either proposing to design a registry or using an existing registry to support regulatory decision-making about a drug's effectiveness or safety.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-26005
Type: Notice
Date: 2021-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-26003
Type: Notice
Date: 2021-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
Document Number: 2021-26002
Type: Notice
Date: 2021-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective January 1, 2022, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Announcement of Intent To Issue Two Replacement Awards To Provide Residential Services (Shelter)
Document Number: 2021-25973
Type: Notice
Date: 2021-11-30
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR announces the issuance of two replacement awards to SWK, Inc. in the amount of up to $178,007,159. On September 17, 2021, Comprehensive Health Services, LLC (CHS) relinquished two federally funded discretionary grants. Per HHS policy, ORR identified current recipient SWK, Inc. to transfer the current permanent capacity to provide shelter for apprehensions of Unaccompanied Children (UC) at the Southwest Border. The continuation of permanent capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter and appropriate services for UC referred to its care by the Department of Homeland Security. The purpose of these awards is to ensure the continuation of residential services for the capacity of 1,312 shelter beds for UC.
Announcement of Intent To Issue Replacement Award To Provide Residential Services (Shelter)
Document Number: 2021-25971
Type: Notice
Date: 2021-11-30
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR announces the issuance of a replacement award in the amount of up to $18,871,413 to Urban Strategies, San Benito, Texas. On September 17, 2021, Comprehensive Health Services, LLC (CHS) relinquished a federally funded discretionary grant. Per HHS policy, ORR identified the current recipient Urban Strategies to transfer the current permanent capacity to provide shelter for apprehensions of Unaccompanied Children (UC) at the Southwest Border. The continuation of permanent capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter and appropriate services for UC referred to its care by the Department of Homeland Security. The purpose of this award is to ensure the continuation of residential services for the capacity of 100 shelter beds for UC.
Announcement of Intent To Issue Replacement Award To Provide Residential Services (Shelter)
Document Number: 2021-25970
Type: Notice
Date: 2021-11-30
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR announces the intent to award a Replacement Award to LSS Upbring in the amount of up to $20,929,074 in Brownsville, Texas. On September 17, 2021, Comprehensive Health Services, LLC (CHS) relinquished a federally funded discretionary grant. Per HHS policy, ORR has identified current recipient LSS Upbring to transfer the current permanent capacity to provide shelter for apprehensions of Unaccompanied Children (UC) at the Southwest Border. The continuation of permanent capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter and appropriate services for UC referred to its care by the Department of Homeland Security. The purpose of this award is to ensure the continuation of residential services for the capacity of 76 shelter beds for UC.
Announcement of Intent To Issue Two Replacement Awards To Provide Residential Services (Shelter)
Document Number: 2021-25968
Type: Notice
Date: 2021-11-30
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR announces the intent to award two Replacement Awards in the amount of up to $77,496,593 to BCFS Health and Human Services in Los Fresnos, Texas. On September 17, 2021, Comprehensive Health Services, LLC (CHS) relinquished two federally funded discretionary grants. Per HHS policy, ORR identified the current recipient BCFS Health and Human Services to transfer the current permanent capacity to provide shelter for apprehensions of Unaccompanied Children (UC) at the Southwest Border. The continuation of permanent capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter and appropriate services for UC referred to its care by the Department of Homeland Security. The purpose of this award is to ensure the continuation of residential services for the capacity of 560 shelter beds for UC.
Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in Head Start Programs
Document Number: 2021-25869
Type: Rule
Date: 2021-11-30
Agency: Department of Health and Human Services, Administration for Children and Families
This interim final rule with comment (IFC) adds new provisions to the Head Start Program Performance Standards to mitigate the spread of the coronavirus disease 2019 (COVID-19) in Head Start programs. This IFC requires effective upon publication, universal masking for all individuals two years of age and older, with some noted exceptions, and all Head Start staff, contractors whose activities involve contact with or providing direct services to children and families, and volunteers working in classrooms or directly with children to be vaccinated for COVID-19 by January 31, 2022.
Submission for OMB Review; Understanding the Value of Centralized Services Study (New Collection)
Document Number: 2021-25946
Type: Notice
Date: 2021-11-29
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 a new data collection activity as part of the Understanding the Value of Centralized Services study. The objective of this descriptive study is to understand the advantages, disadvantages, and costs of centralizing services for individuals and families with low incomes.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-25874
Type: Notice
Date: 2021-11-29
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusivity Under Non-Exclusive Patent License: AAV Isolate and Fusion Protein Comprising Nerve Growth Factor Signal Peptide and Parathyroid Hormone
Document Number: 2021-25873
Type: Notice
Date: 2021-11-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Diabetes and Digestive and Kidney Disease and National Institute of Dental and Craniofacial Research, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive rights under active Non-exclusive Patent License to practice the inventions embodied in the United States, European and Japan Applications listed in the Supplementary Information section of this notice to Atsena Therapeutics, Inc., located in Durham, North Carolina, USA.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-25872
Type: Notice
Date: 2021-11-29
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee for Dose Reconstruction Reviews (SDRR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-25863
Type: Notice
Date: 2021-11-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Dose Reconstruction Reviews (SDRR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-25816
Type: Notice
Date: 2021-11-26
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.
Grants Regulation; Removal of Non-Discrimination Provisions and Repromulgation of Administrative Provisions Under the Uniform Grant Regulation
Document Number: 2021-25792
Type: Rule
Date: 2021-11-26
Agency: Department of Health and Human Services
The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (D.D.C. Feb. 2, 2021), has postponed the effectiveness of portions of the final rule making amendments to the Uniform Administrative Requirements, promulgated on January 12, 2021. Those provisions are now effective January 17, 2022.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310-Extension
Document Number: 2021-25786
Type: Notice
Date: 2021-11-26
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.
Notice of Award of a Single-Source Cooperative Agreement To Fund the World Health Organization (WHO)
Document Number: 2021-25765
Type: Notice
Date: 2021-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $375,000 with an expected total funding of $1,875,000 over a five-year period to the World Health Organization (WHO) to support activities that promote the development of data systems to monitor injuries and violence; and to implement and evaluate evidence-based strategies to prevent and control injuries and violence.
Notice of Award of a Single-Source Cooperative Agreement To Fund the United Nations Children's Fund (UNICEF)
Document Number: 2021-25764
Type: Notice
Date: 2021-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the award of $750,000 with an expected total funding of approximately $3,750,000 in funding to the United Nations Children's Fund (UNICEF) to plan and conduct assessments of micronutrient deficiencies burden and to design and implement systems to monitor and evaluate micronutrient and nutrition interventions in select countries, including Nepal, Ghana, Tanzania, Uganda, Niger, and Guatemala.
Privacy Act of 1974; System of Records
Document Number: 2021-25760
Type: Notice
Date: 2021-11-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act of 1974, as amended, the HHS is establishing a new system of records to be maintained by HHS's HRSA, 09-15-0093, ``Provider Support Records.'' The new system of records will include payment-related records containing information about any sole proprietor health care providers (including health care-practitioners and suppliers) who applied for payments or reimbursements, received a payment, attested to a payment, reported on the use of a payment, or otherwise participated in one of HRSA's provider support programs, and about patients identified in certain claims records submitted to HRSA for payment by entity providers and sole proprietor providers. The records are used to support the health care population and administer the programs.
Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry (Office of the Director)
Document Number: 2021-25670
Type: Notice
Date: 2021-11-24
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2021-25661
Type: Notice
Date: 2021-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Delegation of Authority
Document Number: 2021-25632
Type: Notice
Date: 2021-11-24
Agency: Department of Health and Human Services, Office of the Secretary
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
Document Number: 2021-25615
Type: Notice
Date: 2021-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) 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 information collection associated with investigational new drug application requirements.
Determination of Regulatory Review Period for Purposes of Patent Extension; TRODELVY
Document Number: 2021-25612
Type: Notice
Date: 2021-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRODELVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Submission for OMB Review; 30-Day Comment Request Investigational Agent Accountability Record Forms and International Investigator Statement in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute)
Document Number: 2021-25605
Type: Notice
Date: 2021-11-24
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests
Document Number: 2021-25372
Type: Proposed Rule
Date: 2021-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, a postamendments class III device with the product code MZF, into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify this device type from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices because manufacturers will no longer be required to submit a premarket approval application (PMA) for this device type but can instead submit a less burdensome premarket notification (510(k)) and receive clearance before marketing their device.
Maytee Lledo: Final Debarment Order
Document Number: 2021-25589
Type: Notice
Date: 2021-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Maytee Lledo 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. Lledo was convicted of a felony under Federal law for conduct that relates to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Ms. Lledo was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why she should not be debarred within the timeframe prescribed by regulation. Ms. Lledo has not responded to the notice. Ms. Lledo's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.
Medical Devices; General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System
Document Number: 2021-25585
Type: Rule
Date: 2021-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the general laparoscopic power morcellation containment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the general laparoscopic power morcellation containment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Ground Ambulance and Patient Billing Advisory Committee
Document Number: 2021-25560
Type: Notice
Date: 2021-11-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021, requires the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury (the Secretaries) to establish and convene an advisory committee for the purpose of reviewing options to improve the disclosure of charges and fees for ground ambulance services, better inform consumers of insurance options for such services, and protect consumers from balance billing. This notice announces the establishment of the Advisory Committee on Ground Ambulance and Patient Billing (the GAPB Advisory Committee) and solicits nominations for members to be appointed by the Secretaries.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-25556
Type: Notice
Date: 2021-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2021-25553
Type: Notice
Date: 2021-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2021-25519
Type: Notice
Date: 2021-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2021-25518
Type: Notice
Date: 2021-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of Nominations for Membership To Serve on the National Advisory Council on Nurse Education and Practice
Document Number: 2021-25516
Type: Notice
Date: 2021-11-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the National Advisory Council on Nurse Education and Practice (NACNEP) or Advisory Council. NACNEP provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other matters of significance concerning the activities under Title VIII of the Public Health Service (PHS) Act, as amended. NACNEP also prepares and submits an annual report to the Secretary and Congress describing its activities, including NACNEP's findings and recommendations concerning activities under Title VIII, as required by the PHS Act. HRSA is seeking nominations of qualified candidates to fill positions on NACNEP as they become available. Authority: NACNEP is authorized by section 851 of the PHS Act (42 U.S.C. 297t), as amended. The Federal Advisory Committee Act of 1972 (5 U.S.C. App.), as amended, which sets forth standards for the formation and use of advisory committees, shall apply to the Advisory Council under this section only to the extent that the provisions of such Act do not conflict with the requirements of this section.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2021-25508
Type: Notice
Date: 2021-11-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
National Eye Institute; Notice of Closed Meeting
Document Number: 2021-25465
Type: Notice
Date: 2021-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Prescription Drug and Health Care Spending
Document Number: 2021-25183
Type: Rule
Date: 2021-11-23
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury, Office of Personnel Management
This document sets forth interim final rules implementing provisions of the Internal Revenue Code (the Code), the Employee Retirement Income Security Act (ERISA), and the Public Health Service Act (PHS Act), as enacted by the Consolidated Appropriations Act, 2021 (CAA). These provisions are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage. These interim final rules add provisions to existing rules under the Code, ERISA, and the PHS Act. These interim final rules implement provisions of the Code, ERISA, and PHS Act that increase transparency by requiring group health plans and health insurance issuers in the group and individual markets to submit certain information about prescription drugs and health care spending to the Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (collectively, the Departments). The Departments are issuing these interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage. The Office of Personnel Management (OPM) is also issuing interim final rules that require Federal Employees Health Benefits (FEHB) carriers to report information about prescription drugs and health care spending in the same manner as a group health plan or health insurance issuer offering group or individual health insurance coverage.
Proposed Information Collection Activity; Tribal Maternal, Infant, and Early Childhood Home Visiting Program Form 1: Demographic and Service Utilization Data (OMB #0970-0389)
Document Number: 2021-25408
Type: Notice
Date: 2021-11-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Care (OCC) is requesting a 3-year extension of the Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program's Form 1: Demographic and Service Utilization Data (OMB #0970-0389; expiration 6/30/2022). There are minor updates to the existing Form 1.
Proposed Information Collection Activity; Measuring Human Trafficking Prevalence in Construction: A Field Test of Multiple Estimation Methods (New Collection)
Document Number: 2021-25392
Type: Notice
Date: 2021-11-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is proposing a new data collection activity for Measuring Human Trafficking Prevalence in Construction: A Field Test of Multiple Estimation Methods. This study will examine the labor trafficking and other labor exploitation experiences among individuals who work in construction. The goal of this study is to advance knowledge of promising methods for estimating human trafficking prevalence by field- testing two methods of prevalence estimation within the construction industry in Houston, Texas.
National Institutes of Health; Notice of Meeting
Document Number: 2021-25388
Type: Notice
Date: 2021-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-25386
Type: Notice
Date: 2021-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Effective Date of Requirement for Premarket Approval for Blood Lancets
Document Number: 2021-25381
Type: Rule
Date: 2021-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.
Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
Document Number: 2021-25379
Type: Rule
Date: 2021-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named ``nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests.'' FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.