Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) 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 associated with FDA's Voluntary Qualified Importer Program.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic 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 Administration for Children and Families (ACF), in partnership with the Health Resources and Services Administration, both of the U.S. Department of Health and Human Services (HHS), is proposing to collect data as part of the elementary school phase of the Mother and Infant Home Visiting Program Evaluation (MIHOPE). MIHOPE is a longitudinal study of the effects of Maternal, Infant, and Early Childhood Home Visiting (MIECHV)-funded home visiting on child and family outcomes. The purpose of the MIHOPE Long-Term Follow-Up, Third grade (MIHOPE-3G) data collection, which will focus on children when they are in approximately third grade, is to assess the long-term effects of MIECHV-funded home visiting on families and children when participating children are in elementary school.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Amputee Coalition of America, Inc. for the National Limb Loss Resource Center (NLLRC).

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Thermo Fisher Scientific Inc., for the OmniPATH COVID-19 Total Antibody ELISA Test; Detect, Inc., for the Detect Covid-19 Test; and Cepheid, for the Xpert Xpress SARS-CoV-2/Flu/ RSV. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.

The Secretary of the United States Department of Health and Human Services delegated his authorities to the Assistant Secretary for Mental Health and Substance Use within the Substance Abuse and Mental Health Services Administration (SAMHSA) on May 4, 2023. This action is necessary to complete rulemaking being undertaken in conjunction with the Drug Enforcement Administration.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Self-Determination and Education Assistance Act Contracts,'' Office of Management and Budget (OMB) Control Number 0917-0037. The IHS is requesting OMB to approve an extension for this collection, which expires on August 31, 2023.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the NCHA PSO, PSO number P0025, of its status as a PSO, and has delisted the PSO accordingly.

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.

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 accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 audio and web conference lines are available). Time will be available for public.

The National Cancer Institute (NCI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Australian National University (``ANU''), a non-profit research institution located in Canberra, Australia for NCI's rights to the patent applications listed in the Supplementary Information section of this notice.

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.

HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL or Committee).

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA, Agency, or we) is announcing the establishment of a docket to solicit public comments on the identification, assessment, and control of N-nitrosamine (nitrosamine) drug substance-related impurities (NDSRIs) that may be considered by the Agency in its regulation of these types of impurities in drug products. This notice identifies scientific and regulatory considerations regarding the identification, assessment, and control of NDSRIs, including areas that may benefit from collaborative efforts, and requests comments on these topics. This notice is not intended to communicate FDA's regulatory expectations on these issues but is instead intended to seek input from the public to inform scientific and/or regulatory approaches as appropriate.

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.

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) will host a public hearing to enable discussion of the Institute's proposal to reorganize the Division of Lung Disease (DLD). The proposed reorganization aims to ensure effective oversight, alignment of expertise, and translation of knowledge within and across research areas in the lung disease field. It establishes a new branch structure that will strategically position leadership over DLD programs, balance workload, and enhance depth/ succession planning for ingrained operational sustainability. There will be no impact on the National Center on Sleep Disorders Research as a result of the restructuring. The online forums will allow members of the public to review the reorganization proposals and submit comments.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. On June 15, 2023, the committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

This proposed rule would advance CMS' efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and Children's Health Insurance Program (CHIP) managed care enrollees. The proposed rule would specifically address standards for timely access to care and States' monitoring and enforcement efforts, reduce burden for some State directed payments and certain quality reporting requirements, add new standards that would apply when States use in lieu of services and settings (ILOSs) to promote effective utilization and specify the scope and nature of ILOS, specify medical loss ratio (MLR) requirements, and establish a quality rating system for Medicaid and CHIP managed care plans.

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), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during January, February, and March 2023. 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 their accuracy and readability.

The Food and Drug Administration (FDA or Agency) has determined that Levitra (vardenafil hydrochloride) oral tablets, 5 milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.

In compliance with the Paperwork Reduction Act of 1995, HRSA 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) announces a forthcoming public advisory committee meeting of the Antimicrobial 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 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.

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 (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.

This document is to alert Medicare Diabetes Prevention Program (MDPP) expanded model suppliers and interested parties that although current MDPP flexibilities permitted pursuant to regulations issued during the Public Health Emergency (PHE) for COVID-19 are scheduled to expire on May 11, 2023, we are specifying an effective date, for purposes of the regulations of December 31, 2023, through which in- person delivery of MDPP services can be suspended. This extended effective date applies for all MDPP suppliers to allow additional time to resume in-person services. MDPP suppliers may use all of or part of this period to extend the flexibilities described in the regulations. This document provides information to MDPP suppliers regarding the extension of the ability to suspend in-person services as the PHE for COVID-19 concludes.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 12, 2023. The document announced the availability of a final guidance entitled ``A Risk-Based Approach to Monitoring of Clinical InvestigationsQuestions and Answers; Guidance for Industry.'' The notice of availability for this final guidance was published with an incorrect OMB control number. This document corrects that error.

The Food and Drug Administration (FDA) 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The final guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. The recommendations in the guidance endeavor to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles. The final guidance replaces the draft guidance entitled ``S12 Nonclinical Biodistribution Considerations for Gene Therapy Products'' issued on September 9, 2021.

The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance entitled ``Labeling of Plant- Based Milk Alternatives and Voluntary Nutrient Statements; Guidance for Industry,'' which was announced in the Federal Register of February 23, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or Agency) is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies for the electronic submission of PQ/CMC data. Building on the Agency's previous Federal Register notices published on July 11, 2017, and March 18, 2022, requesting comments on PQ/CMC data elements and controlled terminology, the Agency is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data. In addition, the progress toward the establishment of standardized pharmaceutical data elements and terminologies will require further interactions between the Agency and interested parties and various stakeholders, including industry. Accordingly, FDA is planning to request comment on additional PQ/CMC data elements and terminologies over time. FDA is establishing an open docket to facilitate efficient receipt of comments and public posting of updated draft documents on PQ/CMC data elements and terminologies.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing a request for information and comments that appeared in the Federal Register of April 13, 2023. In that notice, FDA requested information and comments on the FDA Data and Technology Strategic Plan. The Agency is taking this action to allow interested persons additional time to submit comments.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces a meeting of the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without an oral public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.

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 Public Health Emergency Management Capacity Assessment Tool (PHEM Tool). The Center for Disease Control and Prevention's (CDC) Global Emergency Management Capacity Development (GEMCD) team will use the PHEM Tool to assess the public health emergency management (PHEM) program and Public Health Emergency Operations Center (PHEOC) capacity of Global Health Security Agenda (GHSA) countries.

This notice is to inform the public the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement in scope of the original award to the University of North Carolina funded in FY 2018 under the National Center of Excellence for Eating Disorders (NCEED), Notice of Funding Opportunity (NOFO) SM-18-021. The recipient may receive up to $747,646. The supplemental funding will extend the project period by 12-months until September 29, 2024 and will: continue to develop and disseminate high-quality training and technical assistance to healthcare practitioners on issues related to eating disorders; facilitate the identification of model eating disorder programs; provide the most up-to-date information on eating disorders; and promote public awareness of eating disorders.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC). The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee. This is a virtual meeting. It is open to the public, limited only by the number of web conference lines (500 web conference lines are available). Time will be available for public comment.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by room seating available (120). The public is also welcomed to listen to the meeting via Zoom; 500 teleconference lines are available. Time will be available for public comment. Registration is required.

The Food and Drug Administration (FDA) 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.

The National Advisory Committee on Seniors and Disasters (NACSD or the Committee) is required by section 2811B of the PHS Act as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACSD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and ASPR to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the needs of older adults. The Secretary of HHS has delegated authority to operate the NACSD to ASPR.

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.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on the proposed information collection. This request is to extend approval of all forms currently approved under OMB #: 0970-0554. This includes two forms that were recently approved through emergency approval in October 2022. These forms expand specific policy and procedural protections to category 2 sponsors, children who wish to challenge placement in restrictive settings, and children seeking access to legal counsel. This request also seeks approval for revisions to a form that will ensure that UC are placed in foster homes that meet their individual needs and ensure continuity of services.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to renew the collection of expenditure estimate forms for the tribal child support enforcement program through an optional financial reporting form, Tribal Budget and Narrative Justification Template (Office of Management and Budget (OMB) #: 0970- 0548; expiration date June 30, 2023). No changes are proposed.

The ACF, OCS, Division of Community Discretionary and Demonstration Programs (DCDDP) announces the intent to award seven single-source cooperative agreements in the aggregate amount of up to $8,181,779 to approved but unfunded applications submitted to the Diaper Distribution Demonstration and Research Pilot (DDDRP) Notice of Funding Opportunity HHS-2022-ACF-OCS-EDA-0161. The purpose of these awards is to evaluate the ability of community action agencies, social services agencies, and other non-profit community organizations to provide diapers and diapering supplies on a consistent basis through diaper distribution programs, while also offering support services for families with low incomes. Recipients will operate and expand diaper distribution programs for families with low incomes.

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 the information collection provisions of FDA's animal drug and animal generic drug user fee programs.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the following final documents are available in the docket and on the NIOSH website: Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings and Managing Hazardous Drug Exposures: Information for Healthcare Settings.

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.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement of up to $900,000 for one grant recipient funded in FY 2019 under the National Center of Excellence for Infant and Early Childhood Mental Health Consultation, Notice of Funding Opportunity (NOFO) SM-19-010, with a project end date of April 29, 2024. The supplemental funding is to support Project LAUNCH and Infant and Early Childhood Mental Health grant recipients by: provide training and technical assistance via individual/grantee-level technical assistance, ECHO style learning communities, peer-to-peer learning, expert presentations, and development of resources on advancing best practices; assist grant recipients in working with state-level systems and leaders to integrate innovations into ongoing initiatives, policies, and sustainable funding streams: assist grant recipients with the development of new early childhood efforts (e.g., statewide mental health consultation systems, infant mental health associations, offices of early childhood mental health); support grant recipients with sharing best practices and advances in infant and early childhood mental health with the early childhood field through webinars, presentations at conferences, and/or development of materials about specific grant programs that can be shared with local, tribal, and state stakeholders; and, conduct a virtual grantee meeting or policy academy to engage all grant recipients in peer learning and technical assistance.

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 the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Pregnant Healthcare Personnel Section (``Draft Guideline: Pregnant Healthcare Personnel Section''). The Draft Guideline: Pregnant Healthcare Personnel Section updates the Guideline for infection control in health care personnel, 1998 (``1998 Guideline''), Part F: Pregnant Personnel, and its corresponding recommendations in Part II of the 1998 Guideline. The updated recommendation in the Draft Guideline: Pregnant Healthcare Personnel Section is intended for use by the leaders and staff of Occupational Health Services. This updated recommendation will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who are pregnant or intend to become pregnant.

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.

This Federal Register notice sets forth upcoming procedures for issuing compliance program guidance documents from HHS-OIG.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.