Department of Health and Human Services June 26, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on child welfare agencies' efforts to identify human trafficking and subsequent service delivery. The goal of the study is to better understand child welfare practice in screening for human trafficking, and the degree to which screening is related to subsequent referrals for, access to, and delivery of specialized services for children identified as trafficking victims or at high-risk of trafficking.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Generic Drug User Fee Amendments (GDUFA) of 2017.'' At the end of September 2022, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (i.e., the GDUFA II Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.