Department of Health and Human Services November 30, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
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.
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