Department of Health and Human Services November 30, 2021 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; Mother and Infant Home Visiting Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten data collection (MIHOPE-K) [OMB #0970-0402]
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
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
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
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
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
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.
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
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)
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)
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)
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)
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
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.
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