Department of Health and Human Services January 27, 2020 – Federal Register Recent Federal Regulation Documents
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Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 66th full Council meeting in Washington, DC. Agenda items will include: Discussion of Ending the HIV Epidemic: A Plan for America (EHE) Jurisdictional Plans, Focusing on the Four Pilot Sites: DeKalb County, Georgia; Baltimore, Maryland; East Baton Rouge, Louisiana; and the Cherokee Nation of Oklahoma; the Ready, Set, PrEP National Program; Stigma as a BarrierShared Experiences and Challenges from International and Domestic Perspectives; and Women and HIV. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is encouraged for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to PACHA@hhs.gov. Pre-Registration must be complete by Monday, February 3, 2020.
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled ``Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of December 20, 2019. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a nonfederal public member on the Muscular Dystrophy Coordinating Committee.
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products 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 ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This guidance is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for treating specific hematologic malignancies. An analysis of marketing applications showed inconsistent quality of MRD data. Based on this analysis and discussion at various public workshops on MRD, FDA identified a need to provide guidance on the use of MRD as a biomarker in regulatory submissions. This guidance finalizes the draft guidance of the same title issued on October 16, 2018.
Submission for OMB Review; Domestic Victims of Human Trafficking Program Data (New Collection)
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing to collect data for the Domestic Victims of Human Trafficking Program (DVHT). The DVHT Program is inclusive of three distinct programs: The Domestic Victims of Human Trafficking and Services Outreach Program, Demonstration Grants to Strengthen the Response to Victims of Human Trafficking in Native Communities Program, and the Strengthen the Health Care Response for Victims of Human Trafficking Program grants. The data collection instruments are intended to collect information for all three DVHT programs.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Evaluation of Patient-Centered Outcomes Research Trust Fund Training Program.'' This proposed information collection was previously published in the Federal Register on December 13th, 2019 and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
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