Department of Health and Human Services March 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 284
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
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.
Submission for OMB Review; Administration for Native Americans Project Outcome Assessment Survey (OMB #0970-0379)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the form Administration for Native Americans (ANA) Project Outcome Assessment Survey (OMB #0970-0379, expiration 6/30/2022). There are minor changes and updates requested to the form.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Application for Health Center Program Recipients for Deemed Public Health Service Employment With Liability Protections Under the Federal Tort Claims Act, 0906-0035, Revision
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.
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Medical Devices; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations, and to remove a submission requirement that is no longer necessary.
Supplemental Evidence and Data Request on Postpartum Home Blood Pressure Monitoring, Postpartum Treatment of Hypertensive Disorders of Pregnancy, and Peripartum Magnesium Sulfate Regimens for Preeclampsia With Severe Features
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Postpartum Home Blood Pressure Monitoring, Postpartum Treatment of Hypertensive Disorders of Pregnancy, and Peripartum Magnesium Sulfate Regimens for Preeclampsia With Severe Features, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Meeting of the National Advisory Council for Healthcare Research and Quality
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates 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.
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Telehealth Resource Center Performance Measurement Tool, OMB No. 0915-0361-Extension
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim “Healthy” on Packaged Foods
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 (PRA).
Submission for OMB Review; Measuring Human Trafficking Prevalence in Construction: A Field Test of Multiple Estimation Methods (New Collection)
The Administration for Children and Families (ACF) is proposing a new data collection activity for Measuring Human Trafficking Prevalence in Construction: A Field Test of Multiple Estimation Methods. This study will examine the labor trafficking and other labor exploitation experiences among individuals who work in construction. The goal of this study is to advance knowledge of promising methods for estimating human trafficking prevalence by field- testing two methods of prevalence estimation within the construction industry in Houston, Texas.
Proposed Information Collection Activity; 45 CFR 303.7-Provision of Services in Intergovernmental IV-D; Federally Approved Forms (OMB #0970-0085)
The Office of Child Support Enforcement is requesting a 3-year extension of the Provision of Services in Intergovernmental IV-D; Federally Approved Forms (OMB #0970-0085, expiration December 31, 2022). There are no changes requested to these forms.
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, Laboratory Response Network (LRN). The LRN is created to maintain an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies.
Prescription Drug User Fee Rates for Fiscal Year 2022; Correction
The Food and Drug Administration (FDA) is correcting a notice entitled ``Prescription Drug User Fee Rates for Fiscal Year 2022'' that appeared in the Federal Register of August 16, 2021. The document announced the Fiscal Year 2022 fee rates for the Prescription Drug User Fee Act. The document published with errors. The errors did not have an impact on the previously published user fee rates but are corrected in this document for clarity.
Extending Refugee Cash Assistance and Refugee Medical Assistance From 8 Months to 12 Months
In accordance with ORR regulations, the Director of ORR is announcing the expansion of the Refugee Cash Assistance (RCA) and Refugee Medical Assistance (RMA) eligibility period from 8 months to 12 months of assistance for participants whose date of eligibility for ORR benefits is on or after October 1, 2021. Through the Refugee Act of 1980, Congress authorized cash and medical assistance up to 36 months, yet by fiscal year (FY) 1992, mainly due to insufficient appropriations, ORR had reduced the RCA and RMA eligibility periods to 8 months. For 30 years, ORR has not increased the RCA or RMA eligibility period. Extending the RCA and RMA eligibility period will lead to more effective resettlement, by providing refugee and other ORR-eligible populations with additional time to become self- sufficient.
Solicitation of Nominations for Organizational Representatives to the Advisory Committee on Heritable Disorders in Newborns and Children
HRSA is seeking nominations from organizations to send representatives to be a liaison to the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). Selections will be based on a review of the organization's subject area of expertise, mission, relevancy, and benefit provided relative to the Committee's purpose. The organizational representatives are non-voting liaisons. The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS.
Proposed Revision to Information Collection Activity; Next Generation of Enhanced Employment Strategies Project
The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families is proposing revisions to data collection activities conducted for the Next Generation of Enhanced Employment Strategies (NextGen) Project (OMB #0970-0545). The project is rigorously evaluating innovative interventions to promote employment and economic security among low-income individuals with complex challenges. The project includes an experimental impact study, descriptive study, and cost study. The project is seeking approval for two participant follow-up surveys and related materials with proposed changes to the instruments and to the tokens of appreciation for the follow-up surveys. The requested changes do not require any changes to the previously submitted and approved burden estimates.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). ACHDNC provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates for appointment to two positions on the Committee beginning in 2023, each serving a term of up-to 4 years.
Proposed Collection; 60-Day Comment Request; Hazardous Waste Worker Training-National Institute of Environmental Health Sciences (NIEHS)
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 of Environmental Health Sciences (NIEHS) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
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.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October Through December 2021
This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from October through December 2021. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
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.
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