Department of Health and Human Services June 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 259
Submission for OMB Review; Head Start Program Performance Standards (OMB #0970-0148)
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the information collection requirements under the Head Start Program Performance Standards (OMB #0970-0148). There are no changes to the information collection.
Determination of Regulatory Review Period for Purposes of Patent Extension; OXBRYTA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OXBRYTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BALVERSA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BALVERSA 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; AXONICS SACRAL NEUROMODULATION SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AXONICS SACRAL NEUROMODULATION SYSTEM 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; FETROJA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FETROJA 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products
The Food and Drug Administration (FDA, Agency, or we) 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 postmarketing reporting and recordkeeping of adverse experiences for drug and biological products.
Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
The Food and Drug Administration (FDA) is correcting a notice announcing receipt of a petition requesting exemption from the premarket notification requirements. The document was published with an incorrect docket number. This document corrects that error.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
The National Advisory Council for Healthcare Research and Quality (the Council) is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2021.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intended for Food Use
The Food and Drug Administration (FDA, Agency, or we) 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.
Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG), proposing that the color additive regulations be amended to provide for the safe use of gardenia blue powder in various foods.
Determination of Regulatory Review Period for Purposes of Patent Extension; POLIVY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POLIVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human biological product.
Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
The Food and Drug Administration (FDA, Agency, or we) 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 FDA's MedWatch adverse experience reporting (AER) program.
Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. This SACATM meeting will be a virtual meeting only and available to the public for remote viewing. Registration is required to access the virtual meeting and to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/ 32822.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the July 19, 2021 meeting the Advisory Council will discuss the implications of and opportunities presented by the approval of aducanumab. The Council will also hear updates from federal workgroups on efforts undertaken in the last quarter. The risk reduction subcommittee will present a summary of their work and recommendations. The research, clinical care, and long- term services and supports subcommittees will present recommendations and the Council will vote on adopting them.
Prospective Grant of an Exclusive Patent License: Adeno-Associated Virus Polynucleotides, Polypeptides and Virions
The National Heart, Lung, and Blood Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive, Sublicensable Patent License to consolidate co-owned rights to the inventions and the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to The Children's Medical Research Institute, having a place of business in Westmead NSW, Australia.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
The Food and Drug Administration (FDA, we, or Agency) 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.
Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings; Draft Guidance for Sponsors; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for sponsors entitled ``Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings.'' The draft guidance provides recommendations to sponsors of clinical trials of investigational cancer drugs regarding the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment options) for their cancer in the non-curative setting. The draft guidance is intended to facilitate increased clinical trial options for patients with non- curable cancers by recognizing that, with appropriate informed consent, it may be reasonable for patients to be eligible for inclusion in trials of investigational cancer drugs, regardless of whether they have received available therapy, in the non-curative setting.
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls for Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
The Food and Drug Administration (FDA or Agency or we) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on class II special controls for human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA, Agency, or we) 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.
Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use; Reopening of Comment Period
The Food and Drug Administration (FDA or Agency) is reopening the comment period for public scoping on the environmental impact statement (EIS) described in the notice entitled ``Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use'' that appeared in the Federal Register of May 13, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program; Correction
This document corrects technical and typographical errors in the proposed rule that appeared in the May 10, 2021 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program.''
Proposed Information Collection Activity; Evaluation of LifeSet (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) is proposing a new information collection activity to assess the impact and implementation of LifeSet, a program that provides services and supports to young adults ages 17 to 21 with previous child welfare involvement. Data collection efforts will include accessing administrative data from the child welfare agency, program, and other private and governmental databases; surveys of young adults (participants and those receiving services as usual); interviews and focus groups with program and child welfare agency administrators and staff; interviews and focus groups with young adult program participants; and interviews with other program stakeholders.
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