Department of Health and Human Services October 2, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Advisory Committee on Immunization Practices: Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through April 1, 2022.
Advisory Committee on Breast Cancer in Young Women (ACBCYW); Meeting
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio and web conference lines (100 audio and web conference lines available). The public is welcome to listen to the meeting by accessing the teleconference and web conference information below. Online Registration Required: All ACBCYW Meeting participants must register for the meeting online at least 5 business days in advance at https://www.cdc.gov/cancer/breast/what_cdc_is_doing/ conference.htm. Please complete all the required fields before submitting your registration and submit no later than November 16, 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
The Food and Drug Administration (FDA or Agency) 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 information collection associated with Orphan Drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations.
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment.'' This draft guidance provides recommendations to sponsors regarding the development of drugs and biologics (referred to as drugs in this document) for the adjuvant treatment of renal cell carcinoma. The draft guidance includes recommendations regarding eligibility criteria, choice of comparator, followup imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. This draft guidance is intended to facilitate the development of drugs for the adjuvant treatment of renal cell carcinoma.
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment.'' This draft guidance provides recommendations to sponsors regarding the development of drugs and biologics (referred to as drugs in this document) for the adjuvant treatment of muscle-invasive bladder cancer. The draft guidance includes recommendations regarding eligibility criteria, choice of comparator, follow up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. This draft guidance is intended to facilitate the development of drugs for the adjuvant treatment of bladder cancer.
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment.'' This guidance addresses clinical endpoints acceptable to demonstrate effectiveness of drugs for treatment of opioid use disorder. This guidance addresses comments received for and finalizes the draft guidance of the same name issued August 7, 2018.
Statement of Organization, Functions, and Delegations of Authority
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) is restructuring the Office on Trafficking in Persons (OTIP) within the Office of the Assistant Secretary for Children and Families, ACF, into three divisionsPrevention, Protection, and Research and Policythat report to the OTIP Director.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.
Notice That HRSA Will Not Fund HRSA-20-083: Quality Improvement Solutions for Sustained Epidemic Control Project
HRSA has decided not to provide funding for HRSA-20-083 Quality Improvement Solutions for Sustained Epidemic Control Project, supported by the President's Emergency Plan for AIDS Relief (PEPFAR).
Notice of Class Deviation From Competition Requirements for HRSA-15-021: Quality Improvement Capacity for Impact Project
HRSA is providing supplemental funding for one year to the current recipients of HRSA-15-021, Quality Improvement Capacity for Impact Project.
Recharter for the Council on Graduate Medical Education
In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Council on Graduate Medical Education (COGME) has been rechartered. The effective date of the renewed charter is September 30, 2020.
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