Department of Health and Human Services July 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Cancer Clinical Trial Eligibility Criteria: Brain Metastases.'' This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with brain metastases. This guidance finalizes the draft guidance of the same title that published on March 13, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.'' This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations on the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV) infections, and hepatitis C virus (HCV) infections. Exclusion of patients with HIV, HBV, or HCV infections from cancer clinical trials remains common in most studies of investigational drugs. Expanding cancer clinical trial eligibility to be more inclusive of patients with HIV, HBV, or HCV infections is justified in many cases and may accelerate the development of effective therapies in cancer patients with these chronic infections. This guidance finalizes the draft guidance of the same title that published on March 13, 2019.

The Food and Drug Administration (FDA, the Agency, or we) is holding a virtual meeting entitled ``FDA Hiring and Retention Interim Assessment'' and an opportunity for public comment. The topic to be discussed is FDA's hiring and retention interim assessment which was an independent assessment performed by Booz Allen Hamilton, published on June 5, 2020. This public meeting will take place virtually due to extenuating circumstances and will be held by webcast only.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories. This action is in response to a petition filed by Oakshire Naturals, LP.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension to continue collecting data for the study, Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS). Data collection has been delayed due to the COVID-19 pandemic and will not be complete by the current expiration date of October 31, 2020. There are no changes proposed to the current instruments.

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.

The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit input and comments from stakeholders interested in informing strategic priorities for the Office of Women's Health (OWH). This will help the Agency ensure that important health concerns are carefully considered in establishing OWH's scientific, educational, and outreach priorities.

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.

In accordance with the Federal Advisory Committee Act, section 1111(g) of the Public Health Service Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable- disorders/.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to extend approval for data collection using the current Refugee Data Submission System for Formula Funds Allocations (ORR-5) until January 31, 2021, and revise the current form for use after Fiscal Year (FY) 2020. The revised form will collect additional client-level data.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit a Supplemental Information Request (SIR), described below, to the Office of Management and Budget (OMB). Prior to submitting the SIR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the SIR.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.