Department of Health and Human Services August 2021 – Federal Register Recent Federal Regulation Documents

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 Field Pilot to Inform the Development of a NIOSH Training Product, the Safety Skills at Work Curriculum. The purpose of this field pilot is to inform the development of a draft foundational OSH training intervention, the Safety Skills at Work curriculum, as well as the study methods and data collection instruments for the evaluation of the intervention.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice ADC Therapeutics Ltd (ADCT), located in Lausanne, Switzerland.

In compliance with of the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) is being forwarded by HRSA to the Office of Management and Budget (OMB) for review and approval. 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.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Australian Laboratory Services, PTY LTD., on behalf of Piotrovska, PTY LTD., proposing that the color additive regulations be amended to expand the permitted uses of synthetic iron oxide as a color additive to include use in edible decorative paint.

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 CDC's contraception recommendations. Two guidance documents, U.S. Medical Eligibility Criteria for Contraceptive Use (US MEC) and U.S. Selected Practice Recommendations for Contraceptive Use (US SPR), provide evidence-based recommendations to assist health care providers when counseling patients on contraceptive choice and use. Updates to these guidance documents typically occur every 5 years. As part of the planning process for the next update, CDC is requesting public comment on content to consider for revision or addition to the recommendations and how to improve the implementation of the guidance documents. This action is necessary to consider multiple and diverse perspectives and ensure that the documents meet the needs of U.S. health care providers and the persons they serve.

Findings of research misconduct have been made against Viravuth Yin, Ph.D. (Respondent), former Associate Professor, Mount Desert Island Biological Laboratory (MDIBL). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants P20 GM104318 and P20 GM103423. The administrative actions, including supervision for a period of two (2) years, were implemented beginning on August 2, 2021, and are detailed below.

Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (the Committee) will be held on September 8 and 9, 2021. The purpose of the meeting is for the Committee to begin reviewing responses to the Committee's State Self-Assessment Survey and develop a framework for the Committee's final report. The members of the Committee request comments from the public to inform their ongoing work and final report. Please submit your comments to NAC@nhttac.org with the subject ``NAC Comments'' as soon as possible and before September 6, 2021.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the award of approximately $47,000,000 in COVID-19 funding with an expected total funding of $100,000,000 over a five-year period to the Task Force for Global Health to expand the influenza and COVID-19 vaccine coverage in low- and middle-income countries.

The Centers for Disease Control and Prevention within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on October 20-21, 2021.

The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled ``International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut'' that appeared in the Federal Register of July 23, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances.

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 proposed extensions of collections for public comment.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of stored serum, plasma, and urine samples obtained from participants in the National Health and Nutrition Examination Survey (NHANES) and the proposal parameters and fee schedule for use. The National Health and Nutrition Examination Survey (NHANES) is one of a series of health-related surveys conducted by CDC's National Center for Health Statistics (NCHS).

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct semi-structured, qualitative interviews with Head Start staff (grantee administrators, managers/coordinators, center directors, teachers, staff), parents, affiliated community providers, and partner Local Education Agency (LEA) staff (administrators, elementary school principals, staff, and kindergarten teachers) at six sites. A comparative case study design will explore varying strategies and approaches to supporting children's transitions from Head Start to kindergarten.

The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension with minor changes to the approved information collection: The Cost Study of Trauma-Specific Evidence-Based Programs used in the Regional Partnership Grants (RPG) Program. This data collection request was previously approved and scheduled for spring 2021 but was delayed due to the COVID-19 pandemic. Data collection is now feasible but will extend beyond the current expiration date of November 30, 2021, so an extension is needed. Additionally, since approval, minor changes were made to the instruments to include a question in the time log to ask about virtual service delivery since the COVID-19 pandemic resulted in grantees offering virtual services.

The Office of Head Start, Administration for Children and Families (ACF), is proposing to collect data for a new evaluation of a trauma-informed care program that will include a small randomized controlled trial across 10 sites within Head Start Region V. The goals of the project are to identify the implementation supports and methods needed to enable teachers to effectively implement Trauma-Informed Care in early care and education programs, and to evaluate its outcomes. Information collected will be used to inform ongoing training and technical assistance (TTA) work provided by the Head Start Centers, particularly decisions regarding allocation of TTA resources. More generally, results may inform OHS guidance around social-emotional programming.

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. A notice of this ACIP meeting has also been posted on CDC's ACIP website at: https://www.cdc.gov/vaccines/acip/ index.html. In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about ACIP.

The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee. The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.