Department of Health and Human Services June 28, 2021 – Federal Register Recent Federal Regulation Documents
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Temporary Halt in Residential Evictions To Prevent the Further Spread of COVID-19
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the extension of an Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions to prevent the further spread of COVID-19.
Determination of Regulatory Review Period for Purposes of Patent Extension; TAZVERIK
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TAZVERIK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Submission for OMB Review; Community Services Block Grant (CSBG) Model State Plan Applications (OMB No. 0970-0382)
The Office of Community Services (OCS) requests a three-year extension of the forms Community Services Block Grant (CSBG) State Plan, CSBG Eligible Entity Master List, and the American Customer Survey Index (ACSI) (OMB #0970-0382, expiration 6/30/2021). There are minimal changes requested to the State Plan and the Master List. No changes are proposed to the ACSI.
Agency Information Collection Request; 60-Day Public Comment Request
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; GORE CARDIOFORM ASD OCCLUDER
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for GORE CARDIOFORM ASD OCCLUDER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; Smallpox and Monkeypox Vaccine, Live
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Smallpox and Monkeypox Vaccine, Live and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sponsor ResponsibilitiesSafety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/ Bioequivalence Studies.'' The draft guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. In doing so, the guidance provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data to facilitate appropriate IND safety reporting practices. An earlier draft guidance for industry entitled ``Safety Assessment for IND Safety Reporting'' (December 2015) (the 2015 draft guidance) has been incorporated into this draft guidance. However, this content was revised to address feedback from stakeholders and comments received on the 2015 draft guidance. Concurrent with the publication of this draft guidance, we are withdrawing the 2015 draft guidance. Additionally, this draft guidance incorporates content from the final guidance for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/BE Studies'' (December 2012) (the 2012 final guidance). This incorporated content remains largely unchanged in this draft guidance.
Announcement of Opportunity To Become a Healthy People 2030 Champion
The U.S. Department of Health and Human Services' (HHS) Office of Disease Prevention and Health Promotion (ODPHP) invites public and private sector organizations that support Healthy People 2030 (HP2030), the nation's disease prevention and health promotion plan, to become a Healthy People 2030 Champion (HP2030 Champion). Eligibility: Any organization may apply to be a HP2030 Champion. The selected HP2030 Champions will be recognized for their commitment and work toward achieving HP2030's vision of a society in which all people can achieve their full potential for health and well-being across the lifespan. HP2030 Champions. HP2030 Champions can be public and private organizations such as those at the state, local, county, and tribal levels, non-governmental organizations, non-profit organizations, businesses, academic organizations, organizations that impact health outcomes, philanthropic organizations, and tribal organizations that identify themselves as being aligned with or promoting HP2030, HP2030's vision, and HP2030's overarching goals. All organizations may apply. Applicants for HP2030 Champions shall submit a letter of interest and identify how they address or support health promotion, disease prevention, social determinants of health (SDOH), health disparities, health equity, and/or well-being and work in alignment with HP2030 through activities, donations, or other means. Applicants for HP2030 Champions will be evaluated according to the organization's commitment to support the overarching goals of Healthy People 2030 and the Healthy People 2030 objectives. Individuals are not eligible to be HP2030 Champions. HP2030 Champions will receive recognition from ODPHP on Health.gov/ healthypeople2030, a digital HP2030 Champion badge for their website to highlight their support of HP2030, and HP2030 information, tools and resources for dissemination. The following activities may be considered as an organization's demonstrated commitment to HP2030's overarching goals and objectives: Promoting and increasing access to disease prevention and health promotion activities; Providing access to training or certification programs for disease prevention and health promotion; Addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being; Providing training and other necessary resources to adapt or modify disease prevention and health promotion activities to meet the needs of diverse populations, address SDOH, eliminate disparities, achieve health equity, and/or promote well-being; Developing partnerships across a variety of sectors, including business, community, academia, education, faith-based, government, health care, media, public health, and technology; Working across sectors to address SDOH, eliminate disparities, and achieve health equity; Evaluating health promotion and disease prevention programs or partnering with academic institutions or public health organizations to evaluate health promotion and disease prevention activities; Including information in their public facing materials about programs for disease prevention, health promotion, addressing SDOH, eliminating disparities, achieving health equity, and/or promoting well-being in community needs assessments; Adopting or implementing the HP2030 framework (i.e., vision, mission, overarching goals, foundational principles), Leading Health Indicators (LHIs), Overall Health and Well-Being Measures (OHMs) and/or HP2030 objectives in their strategic plan; Promoting HP2030; providing opportunities and venues for disease prevention and health promotion activities; Partnering with national, state, tribal, or local volunteer organizations to provide education, training, or programs regarding health promotion, disease prevention, SDOH, health disparities, health equity, and well-being; Supporting an entity with the responsibility to organize and coordinate efforts within and across sectors to foster health promotion and well-being; Promoting collaboration across all levels, including neighborhoods, communities, tribes, cities, states, counties, and localities, to increase and expand participation in health promotion and disease prevention activities; Disseminating through a variety of platforms messaging about the benefits of and resources available to promote disease prevention, health promotion, well-being and the importance of addressing SDOH, health disparities, and health equity; Supporting the coordination and standardization of data to enable comparisons across national, state, local, county, and/or tribal levels; Providing grants, funding opportunities, and other resources to programs that address disease prevention, health promotion, well-being, SDOH, health equity, and health disparities. Funds: None. Neither HHS nor ODPHP will provide funds to support HP2030 Champions. Applicants and HP2030 Champions will not be expected to contribute funds. Application: Organizations may apply to be an HP2030 Champion. Organizations should submit a letter of interest acknowledging their support of the HP2030 vision of a society in which all people can achieve their full potential for health and well-being across the lifespan and HP2030's overarching goals. Organizations interested in being HP2030 Champions shall identify in their letters of interest those activities from the list noted above that demonstrate commitment to HP2030's overarching goals and objectives and indicate how they address or support health promotion, disease prevention, SDOH, health disparities, health equity, and well-being and work in alignment with HP2030 through activities, donations, or other means.
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