Department of Health and Human Services November 23, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Request for Information (RFI): Vaccines National Strategic Plan Available for Public Comment
The Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft Vaccines National Strategic Plan 2021-2025 (Vaccine Plan) available for public comment. The draft Vaccine Plan may be reviewed at www.hhs.gov/oidp.
Submission for OMB Review: State Personal Responsibility Education Program (PREP) (OMB #0970-0380)
The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) requires mandatory formula grant applications, state plans, and performance progress reports from states and territories for the development and implementation of their State Personal Responsibility Education Program (PREP). The State PREP Funding Opportunity Announcement sets forth the application and state plan requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report. ACYF/FYSB are requesting a reinstatement with no changes to the previously approved information collections under OMB #0970-0380.
Submission for OMB Review; Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits (OMB #0970-0171)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting a 3-year extension of the Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits (OMB #0970-0171). There are no changes requested to the form, but burden estimates have been adjusted.
Submission for OMB Review; TANF Expenditure Report, ACF-196R (OMB #0970-0446)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Expenditure Report, Form ACF-196R (OMB #0970-0446, expiration 2/28/2021). ACF is reporting a change to remove certain guidance that was associated with an earlier ACF-196 report in order to devote the instructions to the singular ACF-196R report. In addition, ACF has clarified instructions where states have previously expressed confusion and has reorganized the format and chronology of section headers to better reflect the flow of the TANF reporting process.
Agency Information Collection Activities; Proposed Collection; Comment Request; Consultation Procedures: Foods Derived From New Plant Varieties
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to FDA consultation procedures for foods derived from new plant varieties, including information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.
Clinical Drug Interaction Studies With Combined Oral Contraceptives; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clinical Drug Interaction Studies With Combined Oral Contraceptives.'' This guidance assists sponsors of investigational new drug applications and new drug applications in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs) during drug development as well as determining how to communicate the results and recommendations from the DDI studies. Specifically, this guidance focuses on the conduct of clinical studies to evaluate the DDI potential of an investigational drug on a COC, including the need for and design of the clinical studies and the interpretation of the study results.
Medicare Program; National Expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports
This notice announces the national expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports to all states, but we are delaying the implementation of the expansion to all additional states due to the COVID-19 Public Health Emergency. The model will continue to operate in the states currently participating in the model under section 1115A of the Social Security Act (the Act), which includes Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia. CMS will continue to monitor the Public Health Emergency and will provide public notice before implementing the model in additional states.
Elemental Impurities in Animal Drug Products-Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' This guidance provides recommendations to sponsors regarding the control of elemental impurities in animal drug products, including all dosage forms and routes of administration.
Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and FDA staff.'' The guidance for industry and FDA staff describes how and when FDA intends to collect, compile, and publicize lists of retail consignees that may have received recalled foods. While FDA intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the guidance. FDA's goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2021
This notice announces a $599.00 calendar year (CY) 2021 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2021 and on or before December 31, 2021.
Medicare Program; Town Hall Meeting on Merit-Based Incentive Payment System (MIPS) Value Pathway (MVP) Implementation
This notice announces a virtual Town Hall meeting for CMS to share updates on the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) policy considerations and for stakeholders to provide feedback on those MVP considerations for future implementation. Clinicians, professional organizations, third party vendors, stakeholders, and other interested parties are invited to this meeting to present their individual views on MVP design and implementation. The opinions and alternatives provided during this meeting will assist us as we evaluate our policies on essential components of the MVP framework, including, but not limited to, expanding reporting options to allow clinicians to form subgroups and report MVPs, MVP scoring policies, as well as other areas of MVP refinement. The meeting is open to the public, but registration is required, and attendance is limited. We encourage early registration to secure a spot.
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