Department of Health and Human Services February 2022 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 264
Data Standards; Requirement Begins for Version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research and (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the date that support begins for version 3.1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG), and the date that this version update is required in certain submissions. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes.
Compliance Policy Guide Sec. 510.800 Beverages-Serving Size Labeling; Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp-Microbiological Criteria for Evaluating Compliance With Current Good Manufacturing Practice Regulations; and Compliance Policy Guide Sec. 562.800 Vending Machine Food-Labeling; Withdrawal of Guidances
The Food and Drug Administration (FDA or we) is announcing the withdrawal of three compliance policy guides (CPG) entitled ``Compliance Policy Guide Sec. 510.800 BeveragesServing Size Labeling,'' ``Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp Microbiological Criteria for Evaluating Compliance with Current Good Manufacturing Practice Regulations,'' and ``Compliance Policy Guide Sec. 562.800 Vending Machine FoodLabeling.'' We are withdrawing these CPGs because they have become outdated or have been superseded by subsequent FDA actions.
Meeting of the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality)
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.
Brian Michael Parks: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Brian Michael Parks for a period of 5 years from importing or offering for import any article of food (including dietary supplements) or drug into the United States. FDA bases this order on a finding that Mr. Parks was convicted of one felony count under Federal law for distribution of an unapproved new drug with the intent to defraud and mislead. The factual basis supporting Mr. Parks' conviction, as described below, is conduct relating to the importation into the United States of any food and of any drug or controlled substance. Mr. Parks was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 17, 2021 (30 days after receipt of the notice), Mr. Parks had not responded. Mr. Parks' failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Food and Drug Administration Hiring and Retention Final Assessment; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is holding a virtual meeting entitled ``FDA Hiring and Retention Final Assessment'' and an opportunity for public comment. The topic to be discussed is the FDA Hiring and Retention Final Assessment, which was an independent assessment performed by Booz Allen Hamilton, published on December 10, 2021. This public meeting will take place virtually due to extenuating circumstances and will be held by webcast only.
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator
The Food and Drug Administration (FDA or we) is classifying the adjunctive predictive cardiovascular indicator 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 adjunctive predictive cardiovascular indicator'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.
Proposed Collection; 60-Day Comment Request; International Research Fellowship Award Program of the National Institute on Drug Abuse (NIDA)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection via application forms, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed collections to be submitted to the Office of Management and Budget (OMB) for review and approval.
Motif FoodWorks, Inc.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Motif FoodWorks, Inc., proposing that the color additive regulations be amended to provide for the safe use of myoglobin as a color additive in meat and poultry analogue products.
Medical Devices; General Hospital and Personal Use Devices; Classification of the Spore Test Strip
The Food and Drug Administration (FDA, the Agency, or we) is classifying the spore test strip 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 spore test strip'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.
National Health Security Strategy
The Office of the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), is soliciting public comment regarding national health security threats, challenges, and promising practices to help inform the development of the 2023-2026 National Health Security Strategy (NHSS). Since 2006, Congress has required the Secretary of HHS to develop and submit a 4-year NHSS and implementation plan that describe ``potential emergency health security threats and identify the process to be prepared to identify and respond to such threats.'' The quadrennial NHSS is a key U.S. Government vehicle for advancing public health and medical emergency capabilities, and serves as a tool to address priority threats, measure progress, identify gaps, and focus action to implement national health security capabilities.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by audio and web conference lines (300 audio and web conference lines are available). Registration is required. To register for this web conference, please go to: www.cdc.gov/hicpac. All registered participants will receive the meeting link and instructions shortly before the meeting.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, NIOSH. The BSC NIOSH consists of 15 experts in fields associated with occupational safety and health, such as occupational medicine, occupational nursing, industrial hygiene, occupational safety, engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, biostatistics, psychology, wellness, research translation, and evaluation.
Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Advisory Council for the Elimination of Tuberculosis (ACET). The ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care delivery. ACET provides advice and recommendations regarding the elimination of tuberculosis (TB) to the Secretary, HHS; the Assistant Secretary for Health, HHS; and the CDC Director. ACET (a) makes recommendations on policies, strategies, objectives, and priorities; (b) addresses development and application of new technologies; (c) provides guidance and review of CDC's TB prevention research portfolio and program priorities; and (d) reviews the extent to which progress has been made toward eliminating TB.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Monitoring and Reporting for the Overdose Data to Action Co-Operative Agreement. Information collected will provide crucial data for program performance monitoring, budget tracking, and where applicable, program success for programs funded under Overdose Data to Action (CDC-RFA-CE19-1904).
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Performance Progress and Monitoring Report (PPMR). The PPMR is designed to allow CDC to collect information related to CDC Awardee's budgets, strategies and activities, and the process and outcome performance measures outlined by the cooperative agreement programs, in order to evaluate partnerships and the work that is done on behalf of CDC.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 CDC/ATSDR Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. The information collection activities provide a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the federal government's commitment to improving service delivery.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Notifiable Diseases Surveillance System (NNDSS). The purpose of this data collection is to provide the official source of statistics in the United States for nationally notifiable conditions.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Population-based Surveillance of Outcomes, Needs, and Well-being of Children and Adolescents with Congenital Heart Defects (CHD). The purpose of this collection is to provide insight into public health questions that remain for CHD and to develop services and allocate resources to improve long-term health and well-being.
Meeting of the Substance Abuse and Mental Health Services Administration National Advisory Council
Notice is hereby given for the meeting on March 24, 2022 of the Substance Abuse and Mental Health Services Administration National Advisory Council (SAMHSA NAC). The meeting is open to the public and can only be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https:// www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of prior meeting minutes; updates on SAMHSA priorities; follow up on topics related to the previous SAMHSA NAC meeting; and council discussions.
Request for Information (RFI): Inviting Comments and Suggestions on a Framework for the NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility
This Request for Information (RFI) is intended to gather broad public input to assist the National Institutes of Health (NIH) in developing the NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility (DEIA). NIH invites input from stakeholders throughout the scientific research, advocacy, and clinical practice communities, as well as the general public, regarding the proposed framework for the NIH-Wide Strategic Plan for DEIA. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.
Request for Public Comment: 60 Day Information Collection: Urban Indian Organization On-Site Review
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Urban Indian Organization On-Site Review,'' Office of Management and Budget (OMB) Control Number 0917- 00XX. IHS is requesting OMB to approve a new collection.
Proposed Information Collection Activity; Tribal TANF Data Report, TANF Annual Report, and Reasonable Cause/Corrective Action Documentation Process
The Administration for Children and Families (ACF) is requesting a 3-year extension of the form OFA-0084: Tribal TANF Data Report, TANF Annual Report, and Reasonable Cause/Corrective Action Documentation Process (OMB #0970-0215, expiration 4/30/2022). There are no changes requested to the form.
Proposed Information Collection Activity; Evaluation of Employment Coaching for TANF and Related Populations
The Administration for Children and Families (ACF) is proposing to continue ongoing approved data collection activities and add additional activities for the sample enrolled in the Evaluation of Employment Coaching for TANF and Related Populations (Office of Management and Budget (OMB)#: 0970-0506). This includes (1) an extension for the previously approved second follow-up survey data collection; (2) new data collection through a third follow-up survey; and (3) new data collection through follow-up semi-structured interviews with management, staff, supervisors, and participants.
Proposed Information Collection Activity; LIHEAP Carryover and Reallotment Report
The Administration for Children and Families (ACF) is requesting renewal of the Low Income Home Energy Assistance Program (LIHEAP) Carryover and Reallotment Report (Office of Management and Budget (OMB) #0970-0106, expiration date April 30, 2022) with changes. Changes include the addition of one and the removal of two sources in pre-populated lines, the re-descriptions of annual funding sources, and minor wording changes.
Proposed Information Collection Activity; OPRE Data Collection for State Child Welfare Data Linkages Descriptive Study (New Collection)
The Administration for Children and Families (ACF) is requesting approval from the Office of Management and Budget (OMB) for a new primary data collection about connected child welfare data. We define connected data as child welfare data that are linked or integrated with data from other systems or agencies. The State Child Welfare Data Linkages Descriptive Study (Data Linkages Descriptive Study) will gather systematic information on the extent to which states connect their child maltreatment data to other data sets; how any linked data sets are created, managed, and used; and challenges states face in linking data.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of Non-Opioid Analgesics for Acute Pain.'' In connection with the SUPPORT for Patients and Communities Act (SUPPORT Act), the purpose of this guidance is to spur the development of alternatives to opioids for the management of acute pain by providing information about product development-related issues, ``opioid-sparing'' claims, and expedited programs as they pertain to this purpose.
Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery National Institute of Allergy and Infectious Diseases (NIAID)
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 Institute of Allergy and Infectious Diseases (NIAID) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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; Corrections
In the November 19, 2021 issue of the Federal Register, we published a final rule entitled ``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; and Provider and Supplier Prepayment and Post-Payment Medical Review Requirements'' (referred to hereafter as the ``CY 2022 PFS final rule''). The effective date was January 1, 2022. This document corrects a limited number of technical and typographical errors identified in the November 19, 2021 final rule.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant
The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a ``subsection (k) applicant'') notified FDA that an action for patent infringement was filed in connection with the applicant's BLA. Under the PHS Act, within 30 days after the subsection (k) applicant is served with a complaint in an action for patent infringement described under the PHS Act, the subsection (k) applicant shall provide the Secretary of HHS with notice and copy of such complaint. FDA is required to publish notice of the complaint in the Federal Register.
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