Department of Health and Human Services October 21, 2022 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2022-22949
Type: Notice
Date: 2022-10-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 Data Collection Submitted for Public Comment and Recommendations
Document Number: 2022-22932
Type: Notice
Date: 2022-10-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled 2022 Ebola Airport Entry Questionnaires. The purpose of this information collection is to determine the public health risk posed by travelers from areas affected by the 2022 outbreak of Ebola originating in Uganda.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2022-22930
Type: Notice
Date: 2022-10-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Developmental/Methodologic Projects to Improve the National Health and Nutrition Examination Survey and Related Programs. The goals of these projects are to conduct voluntary customer surveys to assess strengths in agency products and services and to evaluate how well it addresses the emerging needs of its data users.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2022-22929
Type: Notice
Date: 2022-10-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Community Health Workers for COVID Response and Resilient Communities (CCR) National Evaluation. This data collection will assess the activities implemented by the 68 recipients of the CDC-RFA-DP21- 2109 CCR NOFO (CCR award recipients).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2022-22928
Type: Notice
Date: 2022-10-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Collection; 60-Day Comment Request, National Institute on Drug Abuse (NIDA) Summer Research Internship Program
Document Number: 2022-22960
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
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.
Submission for OMB Review; 30-Day Comment Request National Cancer Institute (NCI) A Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Document Number: 2022-22959
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products
Document Number: 2022-22876
Type: Rule
Date: 2022-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that have not entered into a standard memorandum of understanding (MOU) with FDA addressing certain distributions of compounded human drug products. FDA is extending the period, which was scheduled to end on October 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Evidence-Based Telehealth Network Program Measures
Document Number: 2022-22869
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Optimizing Virtual Care Grant Program Performance Measures
Document Number: 2022-22868
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
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: Proposed Collection: Public Comment Request; Information Collection Request Title: Health Resources and Services Administration Uniform Data System
Document Number: 2022-22867
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2022-22836
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences: Notice of Closed Meeting
Document Number: 2022-22835
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Opportunity To Co-Sponsor Office of Research Integrity Events
Document Number: 2022-22887
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Office of the Secretary
The Office of Research Integrity (ORI) announces the opportunity for non-federal public and private sector entities to co- sponsor ORI conferences, workshops, symposia, meetings, roundtables, or other such events (collectively, ``Events''). ORI co-sponsors a limited number of events with non-federal entities each year. Potential co- sponsors must have demonstrated interest and experience in the responsible conduct of research or handling allegations of research misconduct. Potential co-sponsors must be willing to participate substantively in the co-sponsored event.
Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry; Availability
Document Number: 2022-22884
Type: Notice
Date: 2022-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Refusal of Inspection by a Foreign Food Establishment or Foreign Government.'' The guidance will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Multiple Endpoints in Clinical Trials; Guidance for Industry; Availability
Document Number: 2022-22882
Type: Notice
Date: 2022-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Multiple Endpoints in Clinical Trials.'' This guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. This guidance finalizes the draft guidance of the same title issued on January 13, 2017.
Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2022-22878
Type: Notice
Date: 2022-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare.'' FDA has developed this draft guidance to propose select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or healthcare disparities. This draft guidance is not final nor is it for implementation at this time.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Healthy Start Evaluation and Quality Improvement; OMB No. 0915-0338-Revision
Document Number: 2022-22863
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Initial and Reconciliation Application Forms To Report Graduate Medical Education Data and Full-Time Equivalent (FTE) Residents Trained by Hospitals Participating in the Children's Hospitals Graduate Medical Education Payment Program; and FTE Resident Assessment Forms To Report FTE Residents Trained by Organizations Participating in the Children's Hospitals and Teaching Health Center Graduate Medical Education Programs, OMB No. 0915-0247-Revision
Document Number: 2022-22862
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Fiscal Year (FY) 2023 Notice of Supplemental Funding Opportunity
Document Number: 2022-22860
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements to the 54 grant recipients funded under the FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity (988 State and Territory Grants) Notice of Funding Opportunity (NOFO) SM-22-015, which have a project end date of April 2024. This supplemental funding is within scope and is expected to increase and/or expand original workforce capacity, ease of access to services, contact demand, including coverage area, through phone, chat, and text, and contact answer rates for 988 crisis care. The 988 State and Territory Cooperative Agreement grant recipients are eligible to apply for awards from $458,333 to $2,000,000 for a total funding of $50,000,000 from the Bipartisan Safer Communities Act (BSCA). The supplements will support 988 response and workforce expansion by improving 988 collaborations, infrastructure, hiring and retention, communications and marketing, and evaluation activities. These awards will help improve 988 and 911 coordination, especially in cases of emergency intervention due to suicidal behavior, improve state/ territory infrastructure to answer 988 Lifeline chat and text request initiated within their state or territory, align communications and marketing of the 988 Lifeline in conjunction with SAMHSA and HHS's 988 communications and marketing strategy, help streamline access to mobile crisis and crisis response teams for all 988 crisis centers, assist the development and expansion of human resource systems to increase the pace of 988 recruitment and hiring, conduct root cause analyses on identified critical incidents contacting through the 988 system, support continuity of care throughout the larger crisis response system and improve follow up and referral outcomes to decrease suicide and ensure individuals are connected to post-contact care. This is not a formal request for application. Assistance will only be provided to the 54 recipients funded in FY 2022 under the 988 State and Territory Cooperative Agreement NOFO SM-22-015 based on the receipt of a satisfactory application and associated budget that is approved by a review group. Funding Opportunity Title: FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity NOFO SM 22-015. Assistance Listing Number: 93.243. Authority: Section 520E-3 of the Public Health Services (PHS) Act [290bb-36c], as amended. Justification: SAMHSA is limiting eligibility for this supplemental funding to the 988 State and Territory grant recipients, which were funded in FY 2022 under the Cooperative Agreements for States and Territories to Build Local 988 Capacity, SM-22-015. These recipients provide leadership and oversee the current 988 and state- and territory-wide local crisis service systems. In addition, the recipients have the required active relationships with and can quickly provide fiscal resources directly to local and statewide Lifeline crisis centers for 988 response; thereby reducing burden on the nationwide network of Lifeline crisis centers, ensuring all those needing 988 services have awareness and access to localized care. Due to the requirements of the FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity, recipients are the only entities that can utilize these funds to successfully complete the required activities to improve 988 Lifeline crisis center workforce response and meet defined state and territory key performance indicators. Contact: James Wright, LPC, Chief of Crisis Center Operations, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857, telephone 240-276-1615; email: james.wright@samhsa.hhs.gov.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2022-22844
Type: Notice
Date: 2022-10-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On Wednesday, October 5, 2022, the Centers for Medicare & Medicaid Services (CMS) published a notice document entitled, ``Agency Information Collection Activities: Proposed Collection; Comment Request''. That notice invited public comments on two separate information collection requests, under Document Identifiers: CMS-10260 and CMS-10142. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled, '' Medicare Advantage and Prescription Drug Program: Final Marketing Provisions.'' Form number: CMS-10260 (OMB control number: 0938-1051).
Supplemental Evidence and Data Request on Strategies for Integrating Behavioral Health and Primary Care
Document Number: 2022-22843
Type: Notice
Date: 2022-10-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 Strategies for Integrating Behavioral Health and Primary Care, 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.
Submission for OMB Review; Trafficking Victim Assistance Program Data (OMB #0970-0467)
Document Number: 2022-22842
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, Administration for Children and Families
The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to renewal with revisions of an approved information collection: Trafficking Victim Assistance Program (TVAP) Data (OMB #0970-0467).
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-22910
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-22909
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2022-22908
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2022-22907
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2022-22906
Type: Notice
Date: 2022-10-21
Agency: Department of Health and Human Services, National Institutes of Health
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