Department of Health and Human Services July 2021 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 270
Proposed Information Collection Activity; ACF-901-American Rescue Plan (ARP) Stabilization Grants Provider-Level Data (New Collection)
The Office of Child Care, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new collection, ACF-901American Rescue Plan (ARP) Stabilization Grants Provider-Level Data. The data collection will provide numbers and characteristics of child care providers receiving ARP Act stabilization grant awards.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Advisory Committee on Heritable Disorders in Newborns and Children's Public Health System Assessment Surveys, OMB No. 0906-0014, Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Proposed Information Collection Activity; The Study of Disability Services Coordinators and Inclusion in Head Start (New Collection)
This is a new request for data collection for the Study of Disability Services Coordinators and Inclusion in Head Start. The study aims to provide a nationally representative picture of the Early Head Start (EHS) and Head Start (HS) Disability Services Coordinator (DSC) workforce, as well as services provided to children with disabilities and their families within these programs and how EHS/HS collaborates with services in the community, including health providers, Local Education Agencies, and Part C. This is the first study of the HS/EHS DSC workforce and will contain three waves of data collection using surveys and qualitative interviews.
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting to be held on Thursday, August 12, 2021, and Friday, August 13, 2021. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable- disorders/.
Submission for OMB Review; Early Head Start-Child Care Partnerships Sustainability Study (OMB #0970-0471)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect information for the Early Head Start-Child Care Partnerships Sustainability Study.
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.
Proposed Information Collection Activity; National Human Trafficking Hotline (NHTH) Performance Indicators
The Administration for Children and Families (ACF) is requesting approval for a new information collection: National Human Trafficking Hotline (NHTH) Performance Indicators.
National Practitioner Data Bank: Change in User Fees
HRSA, a sub-agency of the Department of Health and Human Services, is announcing a change in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank (NPDB). The new fee will be $2.50 for both continuous and one-time queries and $3.00 for self-queries. In addition, as self-query results are now digitally certified, the NPDB will no longer automatically provide a mailed paper copy of self-query results. If self-queriers would like paper copies mailed to them, there will be an additional $3.00 charge per copy. The change in NPDB user fees is intended to encourage electronic processing while both ensuring sufficient funding to the full cost of NPDB operations and retaining appropriate cash reserves. The cash reserves are used to mitigate risks, cover operational costs should revenue decrease, and cover the cost of reasonable enhancement and maintenance of the NPDB management system. HRSA operational standards require review of NPDB user fees every 2 years. The biennial review of NPDB user fees offers HRSA the opportunity to evaluate its reserves as well as revenue relative to costs. Further, the review provides essential information on whether the fee rates and authorized activities are aligned with actual program costs and activities, and can help promote greater understanding of the fee by NPDB users.
Proposed Information Collection Activity; Early Head Start Family and Child Experiences Survey 2022 (Baby FACES 2022) (OMB #0970-0354)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to continue to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2022 (Baby FACES 2022). This information collection is to provide nationally representative data on Early Head Start (EHS) programs, centers, classrooms, staff, and families to guide program planning, technical assistance, and research. This data collection will complete the previously approved second round of data collection originally planned to take place in 2020 (OMB 0970- 0354). The work began in early 2020 but had to be postponed after only 3 weeks due to the COVID-19 pandemic. No changes are proposed to the currently approved information collection materials.
Proposed Information Collection Activity; National Survey of Early Care and Education COVID-19 Follow-Up (OMB #0970-0391)
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), plans to request from the Office of Management and Budget (OMB) an extension to complete data collection for a two-wave COVID-19 Follow-up data collection currently underway as part of the National Survey of Early Care and Education (NSECE). The objective of the NSECE COVID-19 Follow-up is to document the nation's current supply of early care and education services (that is, home-based providers, center-based providers, and the center-based provider workforce). There are no changes proposed.
Twelfth Meeting of the National Clinical Care Commission
The National Clinical Care Commission (the Commission) will conduct its twelfth and final meeting virtually on September 8, 2021. The Commission is charged to evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
Advisory Committee on Immunization Practices (ACIP)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. The meeting will be webcast live via the World Wide Web. Time will be available for public comment. A notice of this ACIP meeting has also been posted on CDC's ACIP website at: https://www.cdc.gov/vaccines/acip/. In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about ACIP.
Multi-Agency Informational Meetings To Discuss Reporting Requirements for Entities; Public Webinars
The HHS/CDC's Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture/Animal and Plant Health Inspection Service (APHIS)'s Division of Agricultural Select Agents and Toxins (DASAT) are jointly charged with the regulation of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. Due to the continuing pandemic and concerns for the safety of our workshop attendees and employees, DSAT replaced in-person workshops with webinars. The purpose of the webinars is to provide guidance on completing APHIS/CDC Form 2 (Request to Transfer Select Agents and Toxins), APHIS/CDC Form 3 (Report of a Release/Loss/Theft), and APHIS/ CDC Form 4 (Reporting the Identification of a Select Agent or Toxin) (APHIS/CDC Forms 2-4) for interested individuals. Two sessions covering the same agenda will be held to provide two opportunities for interested individuals to participate.
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 an Extension of a previously approved information collection project titled Assessment of Occupational Injury among Fire Fighters Using a Follow-back Survey. The purpose of this project is to collect follow-back telephone interview data from injured and exposed firefighters treated in emergency departments (EDs) and produce a descriptive summary of these injuries and exposures.
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 the National Hospital Care Survey (NHCS). The goal of the project is to assess patient care in hospital- based settings, and to describe patterns of health care delivery and utilization in the United States.
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 Evaluating the use of EHMRs in health settings to improve organizational implementation and worker adoption during and after the COVID-19 pandemic. NIOSH proposes using surveys and interviews to understand how elastomeric half mask respirators (EHMRs) are being perceived and used by healthcare and first responder settings during the COVID-19 pandemic.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
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.
Product-Specific Guidance for Cilastatin Sodium; Imipenem; Relebactam; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cilastatin sodium; imipenem; relebactam for injection.
Best Practices for Advancing Cultural Competency, Language Access and Sensitivity Toward Asian Americans and Pacific Islanders
The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from Asian American and Pacific Islander (AAPI) communities and AAPI-serving organizations to inform the development of guidance describing best practices for advancing cultural competency, language access, and sensitivity toward Asian Americans and Pacific Islanders in the context of the Federal Government's COVID-19 response. This is NOT a solicitation for proposals or proposal abstracts. Please note: This request is for information (RFI) and is for planning purposes only. It is not a notice for a proposal and does not commit the federal government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the federal government and will not be returned. All responses will become part of the public record and will not be held confidential. The federal government reserves the right to use information provided by respondents for purposes deemed necessary and legally appropriate. Respondents are advised that the federal government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses will not be accepted after the due date. After a review of the responses received, a notice of funding opportunity or pre-solicitation synopsis and solicitation may be published.
Notice of Meeting for the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC)
The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory- councils/meetings. The meeting will include information on support for the mission and work of the Committee, federal advances to address challenges in substance use disorder (SUD); non-federal advances to address challenges in SUD. Committee Name: Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC).
Final Environmental Impact Statement; Acquisition of Site for Development of a Replacement Underground Safety Research Program Facility for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) in Mace, West Virginia; Availability and Public Information Meeting
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces the availability of a Final Environmental Impact Statement (FEIS) for the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement for the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The proposed acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia (Site). The Final EIS and this notice are published pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). In parallel with the NEPA process, CDC also completed consultation with the West Virginia State Historic Preservation Office under Section 106 of the National Historic Preservation Act to evaluate the potential effects, if any, of the Proposed Action on historic properties.
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.
Title IV-E Prevention Services Clearinghouse Handbook of Standards and Procedures
The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), established the Title IV-E Prevention Services Clearinghouse (hereafter, the Clearinghouse; https://preventionservices.abtsites.com). This Federal Register Notice (FRN) seeks comments by August 16, 2021 on the Clearinghouse's Handbook of Standards and Procedures, Version 1.0. Responses to this FRN will inform potential updates and clarifications to existing standards and procedures. Readers are referred to the full version of the Handbook of Standards and Procedures, Version 1.0 on the Clearinghouse website (https://preventionservices.abtsites.com/review-process). Specifically, feedback is invited on each of the steps and operational procedures of the Prevention Services Clearinghouse systematic review process.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Developmental Disabilities Council-Annual Program Performance Report (PPR) (OMB Control Number 0985-0033)
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the information collection requirements for the current PPR data collection necessary to determine grantee compliance with Part B of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act).
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