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

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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.''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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.