Department of Health and Human Services April 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 262
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Federal-State Food Regulatory Program Standards
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Endorser Status and Actual Use in Direct-to-Consumer Television Ads
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.
Cheese Slice Products Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA or we) is announcing that a temporary permit has been issued to Bongards Creameries (the applicant) to market test several pasteurized standardized cheeses that deviate from the standards of identity for cheese products. The temporary permit will allow the applicant to evaluate commercial viability of the products and to collect data on consumer acceptance of the products.
National Advisory Committee on Seniors and Disasters
The National Advisory Committee on Seniors and Disasters (NACSD or the Committee) is required by section 2811B of the PHS Act as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACSD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and ASPR to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the needs of older adults. The Secretary of HHS has delegated authority to operate the NACSD to ASPR.
Submission for Office of Management and Budget Review; State Plan Child Support Collection and Establishment of Paternity Title IV-D of the Social Security Act
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the forms OCSE-21- U4: Transmittal and Notice of Approval of State Plan Material for: Title IV-D of the Social Security Act, and OCSE-100: State Plan (Office of Management and Budget (OMB) #0970-0017, expiration July 31, 2023). No changes are proposed.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
The Food and Drug Administration (FDA 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Submission for Office of Management and Budget (OMB) Review; Placement and Transfer of Unaccompanied Children Into Office of Refugee Resettlement Care Provider Facilities
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on the proposed information collection. This request is to extend approval of all forms currently approved under OMB #: 0970-0554. This includes two forms that were recently approved through emergency approval in October 2022. These forms expand specific policy and procedural protections to category 2 sponsors, children who wish to challenge placement in restrictive settings, and children seeking access to legal counsel. This request also seeks approval for revisions to a form that will ensure that UC are placed in foster homes that meet their individual needs and ensure continuity of services.
Submission for OMB Review; Tribal Budget and Narrative Justification Template (OMB #: 0970-0548)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to renew the collection of expenditure estimate forms for the tribal child support enforcement program through an optional financial reporting form, Tribal Budget and Narrative Justification Template (Office of Management and Budget (OMB) #: 0970- 0548; expiration date June 30, 2023). No changes are proposed.
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2024
This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation programs, as well as 2024 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also has requirements related to updating standardized plan options and reducing plan choice overload; the automatic re-enrollment hierarchy; plan and plan variation marketing name requirements for QHPs; essential community providers (ECPs) and network adequacy; failure to file and reconcile; special enrollment periods (SEPs); the annual household income verification; the deadline for QHP issuers to report enrollment and payment inaccuracies; requirements related to the State Exchange improper payment measurement program; and requirements for agents, brokers, and web-brokers assisting FFE and SBE-FP consumers.
Announcement of the Intent To Award Single-Source Cooperative Agreements to Approved but Unfunded Diaper Distribution Pilot Applications From FY2022
The ACF, OCS, Division of Community Discretionary and Demonstration Programs (DCDDP) announces the intent to award seven single-source cooperative agreements in the aggregate amount of up to $8,181,779 to approved but unfunded applications submitted to the Diaper Distribution Demonstration and Research Pilot (DDDRP) Notice of Funding Opportunity HHS-2022-ACF-OCS-EDA-0161. The purpose of these awards is to evaluate the ability of community action agencies, social services agencies, and other non-profit community organizations to provide diapers and diapering supplies on a consistent basis through diaper distribution programs, while also offering support services for families with low incomes. Recipients will operate and expand diaper distribution programs for families with low incomes.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Airline and Vessel Traveler Information Collection. The information collected will be used to conduct contact tracing and public health follow-up on travelers who have been identified in a risk exposure zone on a conveyance where a traveler was confirmed or suspected of traveling with infectious with a communicable disease of public health importance.
Good Manufacturing Practices for Cosmetic Products Listening Session; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual listening session entitled ``Good Manufacturing Practices for Cosmetic Products Listening Session.'' The purpose of the listening session is to consult cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts, to inform Agency efforts to develop regulations to establish good manufacturing practices for facilities that manufacture or process cosmetic products distributed in the United States.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
The Food and Drug Administration (FDA or Agency) 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 the information collection provisions of FDA's animal drug and animal generic drug user fee programs.
Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Monthly Implementation Assessment
The Food and Drug Administration (FDA or Agency) 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 a 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 a proposed information collection entitled ``The Real Cost Monthly Implementation Assessment.''
Hazardous Drugs: Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings and Managing Hazardous Drug Exposures: Information for Healthcare Settings
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the following final documents are available in the docket and on the NIOSH website: Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings and Managing Hazardous Drug Exposures: Information for Healthcare Settings.
Agency Father Generic Information Collection Request. 30-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.
Agency Information Collection Request. 30-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.
Clarifying Eligibility for a Qualified Health Plan Through an Exchange, Advance Payments of the Premium Tax Credit, Cost-Sharing Reductions, a Basic Health Program, and for Some Medicaid and Children's Health Insurance Programs
This proposed rule would make several clarifications and update the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in States that elect to operate a BHP; and for some State Medicaid and Children's Health Insurance Programs (CHIPs).
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement of up to $900,000 for one grant recipient funded in FY 2019 under the National Center of Excellence for Infant and Early Childhood Mental Health Consultation, Notice of Funding Opportunity (NOFO) SM-19-010, with a project end date of April 29, 2024. The supplemental funding is to support Project LAUNCH and Infant and Early Childhood Mental Health grant recipients by: provide training and technical assistance via individual/grantee-level technical assistance, ECHO style learning communities, peer-to-peer learning, expert presentations, and development of resources on advancing best practices; assist grant recipients in working with state-level systems and leaders to integrate innovations into ongoing initiatives, policies, and sustainable funding streams: assist grant recipients with the development of new early childhood efforts (e.g., statewide mental health consultation systems, infant mental health associations, offices of early childhood mental health); support grant recipients with sharing best practices and advances in infant and early childhood mental health with the early childhood field through webinars, presentations at conferences, and/or development of materials about specific grant programs that can be shared with local, tribal, and state stakeholders; and, conduct a virtual grantee meeting or policy academy to engage all grant recipients in peer learning and technical assistance.
World Trade Center Health Program; Youth Research Cohort; Request for Information
The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), in the Department of Health and Human Services, announces an opportunity for the public to provide information about approaches to establishing a new World Trade Center (WTC) Health Program research cohort of persons who were exposed to the September 11, 2001, terrorist attacks and were aged 21 years or younger at the time of their exposure. This research cohort will be designed to allow the WTC Health Program to conduct future research studies on the health and educational impacts in the population of persons aged 21 years or younger at the time of their exposures to airborne toxins, or any other hazard or adverse condition, resulting from the terrorist attacks on September 11, 2001. Once established, this new WTC Health Program ``youth cohort'' would serve as the basis for future WTC Health Program research into the health and educational impacts of this potentially vulnerable group, hereafter referred to as ``WTC Youth.'' Information is requested on specific adverse health, social, and educational effects that are of interest for future research; desired characteristics of the proposed cohort and associated control groups (e.g., size and demographics), and methods for identifying, recruiting, and obtaining informed consent from members; as well as data collection, storage, and management methods necessary for future research investigations.
Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Pregnant Healthcare Personnel Section
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Pregnant Healthcare Personnel Section (``Draft Guideline: Pregnant Healthcare Personnel Section''). The Draft Guideline: Pregnant Healthcare Personnel Section updates the Guideline for infection control in health care personnel, 1998 (``1998 Guideline''), Part F: Pregnant Personnel, and its corresponding recommendations in Part II of the 1998 Guideline. The updated recommendation in the Draft Guideline: Pregnant Healthcare Personnel Section is intended for use by the leaders and staff of Occupational Health Services. This updated recommendation will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who are pregnant or intend to become pregnant.
Notice of Award of a Single-Source Cooperative Agreement To Fund United Way of Middle Tennessee Greater Nashville dba United Way of Greater Nashville
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $4,000,000, for one-year funding period to United Way of Middle Tennessee dba United Way of Greater Nashville. The award will fund a community-based organization (CBO) to expand the implementation of comprehensive high-impact community-based HIV prevention programs in Tennessee.
Proposed Collection; 60-Day Comment Request; ABCD Study® Data Use Certification (National Institute on Drug Abuse)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Notice of Award of a Single-Source Cooperative Agreement To Fund the International Organization for Migration (IOM)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,000,000, for Year 1 to International Organization for Migration (IOM). The award will support public health activities for refugees, immigrants and migrants that are US-bound through the United States Refugee Admission Program and in the United States. Funding amounts for years 2-5 will be set at continuation.
Modernization of Compliance Program Guidance Documents
This Federal Register notice sets forth upcoming procedures for issuing compliance program guidance documents from HHS-OIG.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Authorization of Emergency Use of a Medical Device During COVID-19; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for a medical device related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorization indicated in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is specified in this document, and can be accessed on FDA's website from the links indicated.
Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Satisfaction Surveys
The Food and Drug Administration (FDA or Agency) 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 customer service satisfaction surveys.
Agency Information Collection Activities; Proposed Collection; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed study entitled ``A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising.''
Proposed Information Collection Activity; Guidance for Tribal Temporary Assistance for Needy Families Program (Office of Management and Budget #0970-0157)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-123: Guidance for the Tribal Temporary Assistance for Needy Families (TANF) Program (Office of Management and Budget (OMB) #0970-0157, expiration date: August 31, 2023). There are minor clarifying changes requested to the guidance.
Submission for OMB Review; Generic Clearance for Reviewer Recruitment Forms
The Administration for Children and Families (ACF) proposes to extend approval of the existing overarching generic clearance for Reviewer Recruitment Forms (Office of Management and Budget (OMB) #0970-0477). No changes are proposed to the terms of the overarching generic.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Study of Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages
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.
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