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

Results 51 - 100 of 270
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2022
Document Number: 2021-16043
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2022 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2022.
Generic Drug User Fee Rates for Fiscal Year 2022
Document Number: 2021-16039
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2022 rates for GDUFA II fees.
Determination That EFUDEX (Fluorouracil) Topical Solution, 5 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-16037
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that EFUDEX (fluorouracil) topical solution, 5 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug application (ANDA) that refers to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting
Document Number: 2021-16034
Type: Notice
Date: 2021-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2021-15992
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-15990
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2021-15989
Type: Notice
Date: 2021-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Class I Surgeon's and Patient Examination Gloves
Document Number: 2021-15891
Type: Notice
Date: 2021-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Department of Health and Human Services (HHS or ``the Department'') issued a Notice in the Federal Register of January 15, 2021, (``the January 15 notice'') which identified seven types of reserved class I devices that the Department had determined no longer require premarket notification. The Department and the Food and Drug Administration (FDA or ``the Agency'') issued a Notice in the Federal Register of April 16, 2021 (``the April 16 notice'') explaining the basis for our current view that the seven types of reserved class I devices identified in the January 15 notice require a premarket notification, and explaining why the reasoning supporting the prior determination was unsound. HHS and FDA sought comment on the matters discussed in the April 16 notice, and have considered the comments that were submitted to the docket. HHS and FDA are issuing this final order and determination that the seven types of class I surgeon's gloves and patient examination gloves listed in the January 15 notice are reserved class I devices for which a premarket notification is required.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: COVID-19 Provider Relief Fund Reporting Activities, OMB No. 0906-XXXX New
Document Number: 2021-15885
Type: Notice
Date: 2021-07-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-15866
Type: Notice
Date: 2021-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Office of The Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-15865
Type: Notice
Date: 2021-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Tick-Borne Disease Working Group
Document Number: 2021-15830
Type: Notice
Date: 2021-07-26
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, TBDWG members will focus on plans to develop the next report due December 2022 on federal tick-borne activities and research, taking into consideration the 2018 and 2020 reports. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research.
National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee Meeting
Document Number: 2021-15801
Type: Notice
Date: 2021-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The CDC, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by audio. Online Registration is not required.
Mine Safety and Health Research Advisory Committee (MSHRAC); Cancellation of Meeting
Document Number: 2021-15800
Type: Notice
Date: 2021-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-15799
Type: Notice
Date: 2021-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web. For more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/index.html.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-15796
Type: Notice
Date: 2021-07-26
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 National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Monitoring Activities. Proposed study is designed to collect information about implementation, including delivery of screening and follow-up clinical services, and outcomes of the NBCCEDP.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-15795
Type: Notice
Date: 2021-07-26
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 Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns. CDC is requesting a Revision to this Generic Clearance to include an additional cancer-related communications campaign, expand the modes of data collection to include online focus groups and in- depth interviews (in-person, phone, and online), and to focus on respondents from the general public.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-15794
Type: Notice
Date: 2021-07-26
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 Application for Training, which supports the management and evaluation of online training and professional development opportunities for public health and health care professionals.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-15793
Type: Notice
Date: 2021-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-15792
Type: Notice
Date: 2021-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-15791
Type: Notice
Date: 2021-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-15790
Type: Notice
Date: 2021-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-15783
Type: Notice
Date: 2021-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. Matters considered at the meeting will include discussion of the toxicity risks of adeno-associated virus (AAV) vector-based gene therapy products. The discussion topics include oncogenicity risks due to vector genome integration and safety issues identified during preclinical and/or clinical evaluation. The meeting will be open to the public on both days. FDA is establishing a docket for public comment on this document.
Jonathan Doyle: Final Debarment Order
Document Number: 2021-15775
Type: Notice
Date: 2021-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jonathan Doyle for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Doyle was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Doyle was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of April 8, 2021 (30 days after receipt of the notice), Mr. Doyle has not responded. Mr. Doyle's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-15756
Type: Notice
Date: 2021-07-23
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 Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2021-15744
Type: Notice
Date: 2021-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Award of a Single-Source Unsolicited Grant To Fund the Community Education Group
Document Number: 2021-15738
Type: Notice
Date: 2021-07-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the award of approximately $5,000,000 annually in COVID-19 funding for a three-year period in response to an unsolicited application that has been submitted by the Community Education Group to support vaccine coverage, in particular for COVID-19.
Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment Meeting
Document Number: 2021-15727
Type: Notice
Date: 2021-07-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for Calendar Year 2021. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut; Request for Comments
Document Number: 2021-15685
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is inviting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of seven drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
Document Number: 2021-15680
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2021-15663
Type: Notice
Date: 2021-07-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and can be accessed via telephone or webcast only, and not in person. Agenda with call-in information will be posted on SAMHSA's website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
Reduction of Issuer Burden Through Technology Grant
Document Number: 2021-15656
Type: Notice
Date: 2021-07-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the issuance of the March 10, 2021 (and amended on April 29, 2021) single-source funding opportunity titled ``Reduction of Issuer Burden Through Technology Grant'' (hereafter referred to as the ``RIBTT Grant'') available solely to the National Association of Insurance Commissioners (NAIC) to build a connection between the State Electronic Rate and Form Filing (SERFF) system, owned and operated by the NAIC, and the Health Insurance Oversight System (HIOS), which is operated by the Centers for Medicare and Medicaid Services (CMS). This connection will enable health insurance issuers to enter rate justification data into the SERFF system and then have this rate justification data automatically transfer to HIOS. Currently, health insurance issuers have to enter duplicate data into both the SERFF system and HIOS in order to maintain compliance with federal and state law in 49 states and the District of Columbia.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Content of Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling and Recommendations for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities
Document Number: 2021-15653
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Guidance Documents Related to Coronavirus Disease 2019; Availability
Document Number: 2021-15649
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertising
Document Number: 2021-15648
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-15647
Type: Notice
Date: 2021-07-23
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport; Extension of Comment Period
Document Number: 2021-15646
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 15, 2021. In the notice, FDA requested comments by August 16, 2021. The Agency is taking this action in response to a correction to the notice's docket number that appeared in the Federal Register of June 30, 2021, to allow interested persons time to submit comments in response to the corrected notice.
Field Alert Report Submission: Questions and Answers; Guidance for Industry; Availability
Document Number: 2021-15645
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' This guidance provides FDA's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA's recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions about FARs. This guidance finalizes the draft guidance of the same title issued on July 19, 2018.
Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
Document Number: 2021-15643
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the Office of Patient Affairs, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner, and is hosted by CTTI. Through the PEC, the patient community and regulators are able to discuss an array of topics regarding increasing meaningful patient engagement in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in non-product specific aspects of the medical product development and FDA review process.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2022
Document Number: 2021-15642
Type: Notice
Date: 2021-07-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2022 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2022.
Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements.
Document Number: 2021-14973
Type: Proposed Rule
Date: 2021-07-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major proposed rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare provider enrollment policies; requirements for prepayment and post-payment medical review activities; requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA- PD) plan; updates to the Medicare Ground Ambulance Data Collection System; changes to the Medicare Diabetes Prevention Program (MDPP) expanded model; and amendments to the physician self-referral law regulations.
Proposed Information Collection Activity; Office of Child Care Data Collection for ACF-218: FFY 2021 Quality Progress Report (QPR)
Document Number: 2021-15711
Type: Notice
Date: 2021-07-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Care (OCC) is requesting a 1-year extension of the form ACF-218: Quality Progress Report (QPR) (OMB #0970-0517, expiration 9/30/2021). There are minor changes requested to the form related to COVID-19 pandemic supplemental funding increases.
Public Health Determination Regarding an Exception for Unaccompanied Noncitizen Children From the Order Suspending the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists
Document Number: 2021-15699
Type: Notice
Date: 2021-07-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces an Order excepting unaccompanied noncitizen children (UC) from the Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists, issued on October 13, 2020 (October Order). CDC finds that, at this time, there is appropriate infrastructure in place to protect the children, caregivers, and local communities from elevated risk of COVID-19 transmission as a result of the introduction of UC, and U.S. healthcare resources are not significantly impacted by providing UC necessary care. CDC believes the COVID-19-related public health concerns associated with UC introduction can be adequately addressed without the UC being subject to the October Order, thereby permitting the government to better address the humanitarian challenges for these children. Therefore, CDC is fully excepting UC from the October Order, and the Notice regarding the temporary exception of UC published February 17, 2021 is hereby superseded.
Medicare Program; Calendar Year 2021 Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
Document Number: 2021-15652
Type: Rule
Date: 2021-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-15621
Type: Notice
Date: 2021-07-22
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The AHRQ Safety Program for Methicillin-Resistant Staphylococcus aureus (MRSA) Prevention.'' This proposed information collection was previously published in the Federal Register on May 3rd, 2021 and allowed 60 days for public comment. AHRQ did not receive any substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Proposed Information Collection Activity; Child Support Portal Registration (OMB No.: 0970-0370)
Document Number: 2021-15614
Type: Notice
Date: 2021-07-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) approve the ``Child Support Portal Registration,'' with revisions, for an additional three years. OCSE's Child Support Portal (``Portal'') contains applications to assist state child support agencies with administering their programs. Authorized Portal users must register with OCSE to access Portal applications and provide OCSE with certain preferences. The current OMB approval expires on February 28, 2022.
World Trade Center Health Program; Request for Information
Document Number: 2021-15611
Type: Notice
Date: 2021-07-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), is soliciting public comment on the scope of an upcoming funding announcement for FY2022 regarding the World Trade Center (WTC) Health Program's research priorities involving WTC survivors. The WTC Health Program's research program helps answer critical questions about potential 9/11-related physical and mental health conditions as well as diagnosing and treating health conditions on the List of WTC-Related Health Conditions.
Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: Rural Health Care Services Outreach Program Performance Improvement and Measurement Systems (PIMS) Measures, OMB No. 0906-0009, Revision
Document Number: 2021-15607
Type: Notice
Date: 2021-07-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.