Department of Health and Human Services November 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 251
Submission for OMB Review; Understanding Children's Transitions From Head Start to Kindergarten (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct semi-structured, qualitative interviews with Head Start staff (grantee administrators, managers/coordinators, center directors, teachers, staff), parents, affiliated community providers, and partner local education agency staff (administrators, elementary school principals, staff, and kindergarten teachers) at six sites. A comparative case study design will explore varying strategies and approaches to supporting children's transitions from Head Start to kindergarten.
Proposed Information Collection Activity; Comment Request; Healthy Marriage and Responsible Fatherhood Performance Measures and Additional Data Collection (New Collection)
The Administration for Children and Families (ACF), Office of Family Assistance (OFA), has had administrative responsibility for federal funding of programs that strengthen families through healthy marriage and relationship education and responsible fatherhood programming since 2006 through the Healthy Marriage (HM) and Responsible Fatherhood (RF) Grant Programs. ACF required the 2015 cohort of HMRF granteeswhich received 5-year grants in September 2015to collect and report performance measures about program operations, services, and clients served (OMB #0970-0460). A performance measures data collection system called nFORM (Information, Family Outcomes, Reporting, and Management) was implemented with the 2015 cohort to improve the efficiency of data collection and reporting and the quality of data. This system allows for streamlined and standardized submission of grantee performance data through regular progress reports and supports grantee-led and federal research projects. ACF will continue performance measure and other data collection activities for the HMRF grant program with a new cohort of grantees who received 5-year awards in September 2020. ACF is requesting comment on a new data collection to support these activities with the 2020 HMRF grantee cohort. ACF has made changes to the previous cohort's data collection instruments and performance reports for use in the new cohort. This new grantee cohort is expected to begin collecting performance measure data and reporting to ACF in April 2021.
John Kapoor: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring John Kapoor from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that John Kapoor was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. John Kapoor was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. Mr. Kapoor, through counsel, submitted a letter to FDA, which commented on some of the factual circumstances surrounding the case. In the letter, he also stated that he did not intend to request a hearing nor, however, would he acquiesce to debarment. As of August 26, 2020 (30 days after receipt of the notice), Mr. Kapoor has not requested a hearing. His failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the CLIAC. The CLIAC consists of 20 experts including the Chair who represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative.
Barry J. Cadden: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Barry J. Cadden from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Cadden was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Cadden was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of July 9, 2020 (30 days after receipt of the notice), Mr. Cadden had not responded. Mr. Cadden's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Health Care Coordination Program OMB No. 0906-0024-Reinstate With Changes
In compliance with the requirement for opportunity for public comment on the 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.
Tuan Anh Tran: 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 Tuan Anh Tran for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Tran engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with his personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Mr. Tran was given notice of the proposed debarment and an opportunity to request a hearing to show why he should not be debarred. As of September 14, 2020 (30 days after receipt of the notice), Mr. Tran had not responded. Mr. Trans's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Proposed Information Collection Activity; Human Services Programs in Rural Contexts Study
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services is proposing to collect data on the challenges and unique opportunities of administering human services programs in rural contexts. Case studies of 12 communities, in combination with analysis of administrative data and qualitative comparative analysis of the qualitative data, will provide ACF with a rich description of human services programs in rural contexts and provide ACF opportunities for strengthening human services programs' capacity to promote the economic and social wellbeing of individuals, families, and communities in rural contexts.
Recharter for the National Advisory Council on Nurse Education and Practice
In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the National Advisory Council on Nurse Education and Practice (NACNEP) has been rechartered. The effective date of the recharter is November 30, 2020.
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.
Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
Discounts for prescription pharmaceutical products are central to this final rule, in which the Department of Health and Human Services (Department or HHS) amends the safe harbor regulation concerning discounts. Amending this regulation changes the definition of certain conduct that is protected from liability under the Federal anti-kickback statute of the Social Security Act (the Act). New regulatory text in the amendment revises the discount safe harbor. By excluding from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D or pharmacy benefit managers (PBMs) under contract with them, the Department modifies the existing discount safe harbor in particular contexts. Existing safe harbors otherwise remain unchanged. Safe harbors are also created for two additional types of arrangements. The first protects certain point-of-sale reductions in price on prescription pharmaceutical products, and the second protects certain PBM service fees.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. Consistent with FDA's regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a recent submission of a request for Emergency Use Authorization (EUA) for an investigational vaccine to prevent Coronavirus Disease 2019 (COVID-19) and the need for prompt discussion of such submission, given the COVID-19 pandemic.
Michael L. Babich: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Michael L. Babich from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Babich was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Babich was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of September 2, 2020 (30 days after receipt of the notice), Mr. Babich had not responded. Mr. Babich's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.
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.
In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #242 entitled ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling.
Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing a public meeting and requesting comments that appeared in the Federal Register of October 13, 2020. In that notice, FDA announced a public meeting, held on November 16, 2020, and requested public input on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. Specifically, the Agency requested comments on the potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs. FDA is taking this action in response to several requests for extension to allow interested persons additional time to submit comments.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.
Agency Information Collection Activities: Submission for OMB Review; 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 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Ag Chem Resources, LLC; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Ag Chem Resources, LLC, proposing that the food additive regulations be amended to provide for the safe use of tannic acid as a flavoring agent in animal feed.
Most Favored Nation (MFN) Model
This interim final rule with comment period (IFC) implements the Most Favored Nation (MFN) Model, a new Medicare payment model under section 1115A of the Social Security Act (the Act). The MFN Model will test whether more closely aligning payment for Medicare Part B drugs and biologicals (hereafter, referred to as ``drugs'') with international prices and removing incentives to use higher-cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.
Policy on Redundant, Overlapping, or Inconsistent Regulations
The Immediate Office of the Secretary (IOS) is issuing this policy regarding redundant, overlapping, or inconsistent regulations.
Request for Information (RFI) on Redundant, Overlapping, or Inconsistent Regulations
The Immediate Office of the Secretary (IOS) is issuing this Request for Information (RFI) to assist the Department in identifying redundant, overlapping, or inconsistent regulations.
Termination of the Food and Drug Administration's Unapproved Drugs Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effective
The Department of Health and Human Services is issuing this Notice to withdraw FDA's Marketed Unapproved DrugsCompliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs, and to request information from the public regarding drugs that may be grandfathered or generally recognized as safe and effective.
Submission for OMB Review; ORR Serious Medical Procedure Request (SMR) Form (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new data collection, the Serious Medical Procedure Request (SMR) Form.
Findings of Research Misconduct
Findings of research misconduct have been made against Dr. David J. Panka (Respondent), former Harvard Medical School (HMS) Instructor of Medicine, and former HMS Associate Professor of Medicine at Beth Israel Deaconess Medical Center (BIDMC). Dr. Panka engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P50 CA093683 and P50 CA101942. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on November 9, 2020, and are detailed below.
Request for Information on Research Opportunities Related to the National Institutes of Health Scientific Workshop on Violence and Related Health Outcomes in Sexual and Gender Minority Communities
Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities related to the upcoming NIH Scientific Workshop on Violence and Related Health Outcomes in Sexual and Gender Minority (SGM) Communities. The overarching purpose of this workshop is to identify and prioritize key research opportunities to further our understanding of violence against SGM individuals.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction and Combination Products
The Food and Drug Administration (FDA or we) 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 (PRA) of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
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.
Qualification Process for Drug Development Tools; Guidance for Industry; Availability
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a final guidance for industry and FDA staff entitled ``Qualification Process for Drug Development Tools.'' Under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage qualification process for drug development tools (DDTs). This guidance meets the Cures Act's requirement to issue guidance on this qualification process. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs. This guidance finalizes the draft guidance of the same title issued on December 16, 2019.
Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.'' This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this guidance provides information on requesting and conducting product development meetings, presubmission meetings, and midreview cycle meetings with FDA. This guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II). This guidance finalizes the draft guidance of the same title issued on October 3, 2017.
Supplemental Evidence and Data Request on Models of Care That Include Primary Care for Adult Survivors of Childhood Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Models of Care that Include Primary Care for Adult Survivors of Childhood Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
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