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

Results 51 - 100 of 2,836
Submission for OMB Review; 30-Day Comment Request; Federal COVID Response-Audience Feedback To Inform Ongoing Messaging and Strategies for “Combat COVID”
Document Number: 2021-25413
Type: Notice
Date: 2021-11-22
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.
Proposed Collection; 60-Day Comment Request; NIH COVID-19 Vaccination Status Form Extension
Document Number: 2021-25412
Type: Notice
Date: 2021-11-22
Agency: Department of Health and Human Services, National Institutes of Health
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.
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.
Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets
Document Number: 2021-25376
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 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.
Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests
Document Number: 2021-25374
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 certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named ``hepatitis C virus (HCV) antibody 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.
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period
Document Number: 2021-25371
Type: Notice
Date: 2021-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2021-25370
Type: Notice
Date: 2021-11-22
Agency: Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-25343
Type: Notice
Date: 2021-11-22
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-25335
Type: Notice
Date: 2021-11-22
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
Document Number: 2021-25323
Type: Notice
Date: 2021-11-22
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 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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2021-25161
Type: Notice
Date: 2021-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications
Document Number: 2021-25111
Type: Notice
Date: 2021-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2021
Document Number: 2021-25103
Type: Notice
Date: 2021-11-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2021, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Possession, Use, and Transfer of Select Agents and Toxins-Addition of 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 HHS List of Select Agents and Toxins
Document Number: 2021-25204
Type: Rule
Date: 2021-11-17
Agency: Department of Health and Human Services
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.
Medicare Program; Virtual Public Meetings in December 2021 for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set
Document Number: 2021-25132
Type: Notice
Date: 2021-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates and times of virtual Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in December 2021 to discuss our preliminary coding recommendations for new revisions to the HCPCS Level II code set, as well as how to register for those meetings.
Submission for OMB Review; Head Start Evaluation of a Trauma-Informed Care Program (New Collection)
Document Number: 2021-25065
Type: Notice
Date: 2021-11-17
Agency: Department of Health and Human Services, Administration for Children and Families
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.
Medicare Program; CY 2022 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2021-25052
Type: Notice
Date: 2021-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces Medicare's Hospital Insurance Program (Medicare Part A) premium for uninsured enrollees in calendar year 2022. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain individuals with disabilities who have exhausted other entitlement. The monthly Medicare Part A premium for the 12 months beginning January 1, 2022 for these individuals will be $499. The premium for certain other individuals as described in this notice will be $274.
Medicare Program; CY 2022 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2021-25051
Type: Notice
Date: 2021-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2022
Document Number: 2021-25050
Type: Notice
Date: 2021-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2022. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2022, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2022 are $334.20 for aged enrollees and $368.90 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2022 is $170.10, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus the $3.00 repayment amount required under current law. (The 2021 standard premium rate was $148.50, which included the $3.00 repayment amount.) The Part B deductible for 2022 is $233.00 for all Part B beneficiaries. (The 2021 Part B deductible was $203.00.) If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80, or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60, or $10.20, respectively.
Fiscal Year (FY) 2022 Funding Opportunity
Document Number: 2021-25035
Type: Notice
Date: 2021-11-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2021-25031
Type: Notice
Date: 2021-11-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-24997
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-24995
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-24994
Type: Notice
Date: 2021-11-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a 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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-24993
Type: Notice
Date: 2021-11-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a 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 the One Health Harmful Algal Bloom System (OHHABS). OHHABS is a surveillance platform which captures data on harmful algal bloom (HAB) events and HAB-associated illnesses.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-24992
Type: Notice
Date: 2021-11-16
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-24991
Type: Notice
Date: 2021-11-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-24990
Type: Notice
Date: 2021-11-16
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-24989
Type: Notice
Date: 2021-11-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; QINLOCK
Document Number: 2021-24978
Type: Notice
Date: 2021-11-16
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 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.
Sanyasi Raju Kalidindi; Grant of Special Termination
Document Number: 2021-24973
Type: Notice
Date: 2021-11-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has issued an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting special termination of the debarment of Sanyasi Raju Kalidindi. FDA based the order on a finding that Dr. Kalidindi provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction and that terminating Dr. Kalidindi's debarment served the interest of justice and protected the integrity of the drug approval process.
Submission for OMB Review; Head Start Family and Child Experiences Survey (FACES) (OMB #0970-0151)
Document Number: 2021-24951
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services, Administration for Children and Families
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-24938
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Evidence Based Program Fidelity Surveys [OMB #0985-New]
Document Number: 2021-24923
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services
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].
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0906-0039-Extension
Document Number: 2021-24922
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA is submitting an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this Notice has closed.
Submission for OMB Review; 30-Day Comment Request; Division of Extramural Research and Training (DERT) Extramural Grantee Data Collection (National Institute of Environmental Health Sciences)
Document Number: 2021-24920
Type: Notice
Date: 2021-11-16
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.
Submission for OMB Review; Intergovernmental Reference Guide (IRG) (OMB No.: 0970-0209)
Document Number: 2021-24919
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is requesting the Office of Management and Budget (OMB) to approve the Intergovernmental Reference Guide (IRG), with content and organizational revisions, for an additional three years. The IRG contains state and tribal child support information that assists state and tribal child support enforcement (CSE) agencies administering their respective programs. The current OMB approval expires on January 31, 2022.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2021-24895
Type: Notice
Date: 2021-11-16
Agency: Department of Health and Human Services
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
Meeting for Software Developers on the Common Formats for Patient Safety Data Collection
Document Number: 2021-24888
Type: Notice
Date: 2021-11-16
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model
Document Number: 2021-24011
Type: Rule
Date: 2021-11-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
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.
Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
Document Number: 2021-24916
Type: Rule
Date: 2021-11-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule repeals the ``Medicare Coverage of Innovative Technology (MCIT) and Definition of ``Reasonable and Necessary'' final rule, which was published on January 14, 2021, and was to be effective on December 15, 2021.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-24873
Type: Notice
Date: 2021-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-24872
Type: Notice
Date: 2021-11-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-24871
Type: Notice
Date: 2021-11-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-24870
Type: Notice
Date: 2021-11-15
Agency: Department of Health and Human Services, National Institutes of Health