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

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.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for sponsor-investigators entitled ``IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.'' FDA is publishing this draft guidance to provide sponsor-investigators (hereafter referred to as sponsors) who are interested in developing individualized antisense oligonucleotide (ASO) drug products for a rapidly progressive, severely debilitating, or life-threatening (SDLT) genetic disease (caused by a unique genetic variant or variants), with clinical recommendations for submission of investigational new drug applications (INDs). These recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment of clinical response to treatment.

This notice of proposed rulemaking (NPRM) proposes changes to ANA regulations to allow grant recipients to apply for an emergency waiver of part or all of their proposed non-Federal share (NFS) due to emergency circumstances.

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.

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 Enhancing Data-drive Disease Detection in Newborns (ED3N). CDC is developing this new national newborn screening (NBS) data platform to serve as a secure, central, and national data sharing resource for the U.S. state and territorial NBS community.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the form OCSE-75 Tribal Child Support Enforcement Annual Data Report (OMB #0970-0320, expiration 01/31/2023). We are requesting changes to this form.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the agricultural water provisions of the produce safety regulation that covered farms have found complex and challenging to implement. This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with provisions for systems-based agricultural water assessments that are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protections. Additionally, we are proposing to require expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands, in light of findings from several recent produce outbreak investigations. These proposed revisions to the produce safety regulation, if finalized, would more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.

The Office of Child Care (OCC), Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF- 801: CCDF Quarterly Case-Level Report (OMB #0970-0167, expiration 2/28/ 2022). OCC proposes minor changes to the response categories under the following three data elements: Child's gender, ethnicity, and race.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective February 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.

The U.S. Department of Health and Human Services (HHS) solicits written comments on three new objectives proposed to be added to Healthy People 2030 since its launch in August 2020; written comments from the public proposing additional new core, developmental, or research objectives to be included in Healthy People 2030; and evidence-based information regarding the relationship between voter participation and health status as a measure of civic engagement. Public comment informed the development of Healthy People 2030. HHS will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2030 reflects current public health priorities and public input. The updated set of Healthy People 2030 objectives will be incorporated on www.health.gov/HealthyPeople2030. This updated set will reflect further review and deliberation by federal Healthy People topic area workgroups, the Federal Interagency Workgroup on Healthy People 2030, and other federal subject matter experts.

The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Establishing this program will help FDA improve the safety of the U.S. food supply and protect U.S. consumers by helping ensure that certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards to produce reliable and valid test results.

The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization 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 esophageal tissue characterization 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.

On April 4, 2018, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a notice of proposed rulemaking (NPRM) to amend the National Vaccine Injury Compensation Program (VICP or Program) Vaccine Injury Table (Table), consistent with the statutory requirement to include vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in pregnant women. Specifically, the Secretary sought public comment regarding how the addition of this new category should be formatted on the Table. Through this final rule, the Secretary amends the Table to add ``and/or pregnant women'' after ``children'' to the existing language in Item XVII as proposed in the NPRM. This change will apply only to petitions for compensation under the VICP filed after the effective date of this final rule.

The Food and Drug Administration (FDA or we) is classifying the intraoperative orthopedic strain sensor 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 intraoperative orthopedic strain sensor'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.

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).

The Food and Drug Administration (FDA or we) is classifying the trunk and limb electrical stimulator to treat headache 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 trunk and limb electrical stimulator to treat headache'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.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

This notice announces an administrative hearing to be held on January 12, 2022, at the Department of Health and Human Services, Division of Medicaid Field Operations, South, Centers for Medicare & Medicaid Services, Division of Medicaid and Children's Health Operations, 61 Forsyth St., Suite 4T20, Atlanta, Georgia 30303-8909 to reconsider CMS' decision to disapprove South Carolina's Medicaid SPA 19-0004-A.

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).

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''.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for multiple patient use, from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is reclassifying these four types of blood lancets on its own initiative based on new information.

The Food and Drug Administration (FDA or Agency) has extended the comment period for the over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled ``Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use'' (Proposed Order), which was issued on September 24, 2021. A notice of availability for the Proposed Order appeared in the Federal Register of September 27, 2021. FDA issued the Proposed Order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The Proposed Order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would also set forth certain characteristics that would establish that a sunscreen drug product is not GRASE. FDA has extended the comment period for the Proposed Order in response to a request for an extension to allow interested persons additional time to submit comments.

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 Food and Drug Administration (FDA or Agency) 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 for administrative detention and banned medical devices.

The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.

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 Program of Cancer Registries Cancer Surveillance System. This information collection provides useful data on cancer incidence and trends.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH), Office of Research Services (ORS), Division of Occupational Health and Safety (DOHS) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is amending its select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS- CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. HHS/CDC intends to regulate this agent and to require the regulated entity to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.

The Office of Head Start, Administration for Children and Families (ACF), is proposing to collect data for a new evaluation of a trauma-informed care program that will include a small randomized controlled trial across 10 sites within Head Start Region V. The goals of the project are to identify the implementation supports and methods needed to enable teachers to effectively implement Trauma-Informed Care in early care and education programs, and to evaluate its outcomes. Information collected will be used to inform ongoing training and technical assistance (TTA) work provided by the Head Start Centers, particularly decisions regarding allocation of TTA resources. More generally, results may inform OHS guidance around social-emotional programming.

This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2022 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2022, the inpatient hospital deductible will be $1,556. The daily coinsurance amounts for CY 2022 will be: $389 for the 61st through 90th day of hospitalization in a benefit period; $778 for lifetime reserve days; and $194.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $152,000,000 (total costs) for up to two years to Vibrant Emotional Health for the 988 National Suicide Prevention Lifeline Expansion for Behavioral Health Crisis Response (Lifeline Expansion). Under this cooperative agreement, Vibrant Emotional Health will improve and expand the national Lifeline backup centers, text/chat centers, and Spanish language crisis centers to: (1) Respond, intervene, and provide follow- up to individuals experiencing a behavioral health crisis by recruiting and training additional behavioral health staff; (2) support and expand services for populations at high risk of suicide; and (3) develop the infrastructure needed to meet the increased service demand requirements anticipated with the FCC's national launch of 988 in July 2022. It is expected that this program will: (1) Increase response rates for national Lifeline backup centers, text/chat centers, and Spanish language crisis centers; (2) increase the workforce capacity of the national Lifeline backup centers, text/chat centers, and Spanish language crisis centers; and (3) improve the oversight and standardization of outcomes of the Lifeline. With this award, Vibrant Emotional Health will directly support the much needed expansion of the behavioral health workforce for all designated national Lifeline backup centers, text/chat centers, and Spanish language crisis centers to ensure the Network can meet or exceed established metrics; provide direct support to increase the workforce at national Lifeline back-up centers, text/chat centers, and Spanish language crisis centers to expand the implementation of follow-up protocols; expand and enhance core Lifeline network functions; expand and facilitate timely and ongoing communication with the existing network of backup and text/chat centers to minimize wait time and maximize call connectivity; expand the ability of backup and text/chat centers to respond to sudden and large spikes in call volume immediately following a public service announcement, disaster, or other type of traumatic event; expand collaboration with backup and text/chat centers to ensure they have sufficient policies and procedures for the training and supervision of center staff in caller engagement, risk assessment, intervention, and linkage to appropriate services; develop and implement a quality improvement plan focusing on policies, first contact, assessment, referral, and access to local care to ensure there is a comprehensive and coordinated response to individuals at imminent risk for suicide; develop and implement a plan to support backup call centers, text/chat centers, and the Spanish language sub-network in accessing mobile crisis services and coordinating with 911 throughout the United States; provide technical assistance to states and crisis centers in communicating and aligning 988 implementation plans, including the ability to meet Key Performance Indicator expectations; establish interoperability with the VA infrastructure and operations to ensure veterans, service members, and families can access at the VA through authorized 988 phone and text services; and expand the Lifeline network by incorporating additional centers or developing formal agreements with service providers for populations at higher risk of suicide for the expansion of services, training, referrals, facilitated transfers and other approaches to link individuals in crisis with the most person centered and culturally appropriate responses. This is not a formal request for application. Assistance will be provided only to Vibrant Emotional Health based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: Lifeline Expansion. Assistance Listing Number: 93.243. Authority: Section 520E-3 of the Public Health Service Act, as amended; and Section 9005 of the 21st Century Cures Act. Justification: Eligibility for this award is limited to the Mental Health Association of New York City, Inc. (DBA Vibrant Emotional Health). Vibrant Emotional Health is the current Lifeline system administrator and this award funds a rapid expansion of the ongoing Lifeline services to meet the anticipated demands of the FCC's 988 launch before July 2022. Since 2005, Vibrant Emotional Health has provided oversight and management of the Suicide Prevention Lifeline and its local call centers, backup centers, and chat/text functions with a network of over 180 centers in all fifty states. This longstanding history has positioned Vibrant Emotional Health as the best suited organization as the only identified organization with the required experience and national reach to work with the backup centers and chat/text organizations with expansion of their workforce and development of the infrastructure that is needed for the launch of 988 in July 2022. Vibrant Emotional Health's history, experience, and ongoing communications with these centers are critical given the time sensitivity of the need for sufficient capacity to be in place by July 2022. Several external evaluations have reinforced the evidence of effectiveness of Lifeline services through oversight of the Lifeline by Vibrant Emotional Health. The Federal Communication Commission has ordered that by July 16, 2022 every cell phone, land line and voice over internet provider in the United States must make 988 operational and this date of implementation is also a requirement in the National Suicide Hotline Designation Act. Given the anticipated significantly increased contact volumes with the universal availability of 988, a rapid upgrading of Lifeline capacity is required by July 2022. It would not be possible for any other organization to establish the relationships with crisis centers that Vibrant Emotional Health has built over the last 15 years by July 2022, running the risk of significant numbers of unanswered calls, chats, and texts. In addition, if these funds were awarded to another organization, oversight of the expanded backup and chat/text centers would be fragmented and the network would run the risk of inefficiencies and adverse outcomes to individuals in crisis during the period when the demand for Lifeline is expected to surge with the launch of 988. Coordination, quality monitoring, and rapid response would be compromised. Vibrant Emotional Health also has extensive engagement with the Department of Veterans Affairs Veterans Crisis Line (VCL) that helps ensure call connectivity between Vibrant Emotional Health and VCL, backup services, and engagement across the Lifeline local crisis centers on Veteran identification, care, and linkage to the VA. Vibrant Emotional Health has long been recognized throughout the nation for its state-of-art technology-enabled services, community wellness programs, and advocacy and education work and is uniquely qualified to carry-out the requirements of this funding opportunity.

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 Requirement for Negative Pre- Departure COVID-19 Test Result or Documentation of Recovery from COVID- 19 For All Airline or Other Aircraft Passengers Arriving into the United States from any Foreign Country and Requirement for Proof of COVID-19 Vaccination for Noncitizen, Nonimmigrant Air Passengers Arriving Into The United States From A Foreign Country. This proposed information collection is designed to ensure that CDC complies with Orders published October 25 and October 30, 2021, and to confirm that passengers who are coming into the United States via air travel have tested negative for or recently recovered from COVID-19, and that noncitizen, nonimmigrant passengers are fully vaccinated against COVID- 19.

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 Per-or-Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs). This Revision information collection request (ICR) will allow ATSDR/NCEH to continue to conduct additional Exposure Assessments (EAs) that may be requested at military or non- military installations.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QINLOCK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new wave of the Head Start Family and Child Experiences Survey (FACES) as well as a follow-up to a special data collection fielded in the fall of 2021.

The Administration for Community Living 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 section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the information collection requirements for the Evidence Based Program Fidelity Surveys [OMB #0985-New].

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 U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the committee will discuss and vote on a recommendation pertaining to a proposed update to the 2020 Public Health Service (PHS) Guideline for Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection. The following question will be posed to the committee: Does the available data support exempting solid organ transplant candidates who are

This final rule with comment period revises 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 final rule with comment period, we describe the 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 final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, updates Hospital Price Transparency requirements, and updates and refines the design of the Radiation Oncology Model.

The ACF, ORR, Division of Refugee Services (DRS) announces the intent to award a supplement in the amount of up to $1,500,000 to Upwardly Global in New York, NY. The purpose of this award is to enable the recipient to provide program services to Afghan Special Immigrant Visa holders and humanitarian parolees currently housed on U.S. military installations awaiting resettlement. Upwardly Global will provide on-base services for four months, and then continue to provide remote support to eligible Afghan entrants at resettlement sites throughout the U.S.

The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS (Secretary), through the Assistant Secretary for Health, on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill three positions on the Committee membership that will be vacated during the 2022 calendar year.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) requests a 3-year extension of the State Self-Assessment Review and Report with minor revisions. The information collected in the report assists state child support agencies and OCSE in determining whether the agencies meet federal child support performance requirements. The current Office of Management and Budget (OMB) approval expires on April 30, 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.

HRSA provided supplemental funding to the Association of Clinicians for the Underserved (ACU), a currently funded National Training and Technical Assistance Partner award recipient. ACU leverages data tools and learning collaboratives to enhance current national training and technical assistance activities delivered to health centers to improve their capacity to recruit, develop, and retain their workforce to address national health care workforce shortages.

The Administration for Children and Families is announcing updates to its evaluation policy for research or demonstration projects.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to University of the Sunshine Coast (``USC''), a public university based on the Sunshine Coast, Queensland, Australia, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice.