Department of Health and Human Services October 2020 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting a 3-year extension of the currently approved Information Comparison with Insurance Data (OMB #0970-0342; Expires 1/31/2021).

The National Clinical Care Commission (the Commission) will conduct its ninth meeting virtually on November 17, 2020. 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.

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.

The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program for FYs 2023 through 2027. These comments will be published and available on FDA's website.

The National Institutes of Health (NIH) is issuing this final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This Policy establishes the requirements of submission of Data Management and Sharing Plans (hereinafter Plans) and compliance with NIH Institute, Center, or Office (ICO)-approved Plans. It also emphasizes the importance of good data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. This Policy applies to research funded or conducted by NIH that results in the generation of scientific data.

The Office of Refugee Resettlement (ORR) Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow ORR to monitor Unaccompanied Alien Children (UAC) Program care provider facility compliance with Federal laws and regulations, legal agreements, and ORR policies and procedures; and perform other administrative tasks related to the UAC Program. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection. Information collections related to other aspects of the UAC Programs, such as sponsorship and health care, are covered under OMB Numbers 0970-0278, 0970-0385, 0970-0466, 0970-0490, 0970-0498, 0970-0509, and 0970-0543.

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 (Committee) will be held on December 9 and 10, 2020. The purpose of the meeting is for the Committee to discuss state efforts in implementing the recommendations described in its interim report, Best Practices and Recommendations for States, as well as discuss gap areas and barriers to addressing the sex trafficking of children and youth in the United States as it relates to demand, online exploitation, interstate compacts, and other issue areas. The Committee requests any examples and comments from the public to inform their work and also requests input on barriers pertaining to the recommendations in its interim report, including strategies to ensure that policies and procedures related to interstate compacts (e.g., Interstate Compact on the Placement of Children; Interstate Commission for Juveniles), as well as the implementation of interstate compacts, work to combat the sex trafficking of children and youth; strategies for states to address demand (for the purposes of this discussion, demand reduction refers to any effort to reduce the purchase of sex from a minor); and, strategies for states to address vulnerabilities for human trafficking as it relates to online exploitation, recruitment, and grooming of children and youth, specifically as it relates to engaging with tech companies. Please submit your examples and/or comments to NAC@nhttac.org with the subject ``NAC Comments'' as soon as possible and before December 1, 2020.

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.

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.

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.

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 information collection provisions of the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the information collection provisions of the guidance entitled ``Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.''

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies.'' The draft guidance provides information intended to assist applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence (SE) report. The draft guidance is intended to discuss a variety of scientific issues applicants may want to consider as they design and conduct TPPI studies.

The Centers for Disease Control and Prevention (CDC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, is seeking nominations for membership on the World Trade Center (WTC) Health Program STAC. The STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, mental health, and representatives of World Trade Center (WTC) responders as well as representatives of certified-eligible WTC survivors. The STAC reviews scientific and medical evidence and makes recommendations to the Administrator of the WTC Health Program on additional Program eligibility criteria and additional WTC-related health conditions, reviews and evaluates policies and procedures used to determine whether sufficient evidence exists to support adding a health condition to the List of WTC-Related Health Conditions, makes recommendations regarding individuals to conduct independent peer reviews of the scientific and technical evidence underlying a final rule adding a condition to the List of WTC-Related Health Conditions, and provides consultation on research regarding certain health conditions related to the September 11, 2001 terrorist attacks.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying a system of records maintained by the Centers for Disease Control and Prevention (CDC), 09-20-0170, National Select Agent Registry (NSAR)/Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER. SATERIS is a national database registry containing the name of and location information about individuals possessing, using, or transferring select agents and toxins and characterization information about the agents and toxins, as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. HHS/CDC is changing the name of the system of records to ``Electronic Federal Select Agent Program Portal (eFSAP Portal)'' and making other updates, some of which result from an information technology (IT) system upgrade.

The Indian Health Service published a notice in the Federal Register on October 14, 2020 listing members of the Indian Health Service's Senior Executive Service Performance Review Board. The membership listing failed to include Mr. Christopher Mandregan as a member of the Performance Review Board.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration'' (final standard MOU). The final standard MOU describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the MOU in investigating and responding to complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products.