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

The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC 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 SAMHSA's website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings. The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).

The Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting an update to the existing data collection for the Advance Planning Document (APD) process (OMB #0970-0417). OCSE proposes revisions to the annual burden estimates to reflect an increase in the number of states seeking approval to implement modernization solutions in efforts to replace antiquated legacy child support enforcement systems and to address an excess demand for emergency funding requests due to the impacts of the COVID-19 pandemic.

In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the Advisory Committee on Organ Transplantation (ACOT) has been renewed. The effective date of the renewed charter is August 31, 2020.

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates for appointment to five positions on the Committee for terms of up to 4 years.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that VILTEPSO (viltolarsen) manufactured by Nippon Shinyaku Co., Ltd. (NS Pharma Inc., U.S. Agent), meets the criteria for a priority review voucher.

Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2019 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that received FY 2020 direct LIHEAP grants. No subgrantees or other entities may apply for these funds.

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 Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new data collection, the Serious Medical Procedure Request (SMR) Form.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, entitled ``Control of Nitrosamine Impurities in Human Drugs.'' This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy to identify and minimize nitrosamines in any pharmaceutical product at risk for their presence.

This is a primary data collection request for the Infant and Toddler Teacher and Caregiver Competencies (ITTCC) study to examine, using qualitative case studies, different approaches to implementing competency frameworks and assessing competencies of teachers and caregivers of infants and toddlers who work in group early care and education (ECE) settings (centers and family child care homes). Each case study will focus on a specific competency framework used by states, institutions of higher education, professional organizations, or ECE programs. This study aims to present an internally valid description of the implementation of competency frameworks and assessment of competencies for up to seven purposively selected cases, not to promote statistical generalization to different sites or service populations.

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.

The Food and Drug Administration (FDA or Agency) has determined that MICRO-K LS (potassium chloride) extended-release liquid suspension, 20 milliequivalents (mEq)/packet, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MICRO-K LS (potassium chloride) extended-release liquid suspension, 20 mEq/packet, if all other legal and regulatory requirements are met.

The original Federal Register Notice announcing the September 2020 Advisory Commission on Childhood Vaccines (ACCV) meeting indicated that this meeting would be held on September 3-4, 2020. This meeting is not being conducted over 2 days, and instead will only take place only on September 4, 2020. The ACCV will hold a public meeting on September 4, 2020, at 10:00 a.m. ET. The meeting will be held via Adobe Connect and telephone conference. This will not be an in-person meeting. The public can join the meeting by: 1. (Audio Portion) Calling the conference phone number 888-790-1734 and providing the following information:

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 the Agency) has determined the regulatory review period for LUMOXITI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human biological product.

This document contains technical amendments to the Health and Human Services (HHS) regulation regarding the Standards of Care for Chimpanzees Held in the Federally Supported Sanctuary System. The regulatory content is being amended to correct references that are made throughout the regulation regarding delegated authorities and activities of the National Center for Research Resources (NCRR) of the National Institutes of Health (NIH). With the abolishment of NCRR in 2011, the Director, NIH, delegated these authorities to the Office of Research Infrastructure Programs (ORIP) within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), NIH. The ORIP/DPCPSI now has the lead responsibility for coordinating all efforts on behalf of HHS concerning the sanctuary system for surplus chimpanzees from both federal and non-federal sources. The references to NCRR throughout the regulation are corrected to reflect ORIP/DPCPSI, the definition of National Primate Research Center is corrected to reflect the correct number of currently existing centers, and the office address provided for ORIP/DPCPSI in the regulation is corrected.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.'' The FDA encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices, including digital health technologies. Patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as scientific evidence to support the regulatory and healthcare decision-making process. This draft guidance describes principles that should be considered when using PRO instruments in the evaluation of medical devices and provides recommendations about the importance of ensuring the measures are ``fit-for-purpose.'' This draft guidance is not final nor is it in effect at this time.

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 Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive studythe Cost Study of Trauma-Specific Evidence-Based Programs used in the Regional Partnership Grants (RPG) Program.

In the August 6, 2015 issue of the Federal Register, we published a final rule that provided hospice quality reporting program updates, including finalizing the proposal to codify the Hospice Quality Reporting Program Submission Extension and Exemption Requirements. The effective date of the final rule was October 1, 2015. This correcting amendment corrects an omission identified in the August 6, 2015 final rule.

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 ``Cruise Operator COVID-19 Response Plans,'' which will provide CDC with the ability require cruise ship operators to submit plans outlining their response procedures for preventing the spread of COVID-19 onboard, and for preventing the use of scarce U.S. domestic resources in response to COVID-19 cases originating on cruise ships.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Availability, Use, and Public Health Impact of Emergency Supply Kits among Disaster- Affected Populations.'' The goal of this study is to determine the efficacy and public health impact of emergency supply kits among disaster-affected populations to understand how emergency supply kits are used during and after a natural disaster, if public health outcomes are associated with access to emergency supply kits, and what the most useful items to include in an emergency supply kit are across different types of disasters.

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, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.

The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS, to implement the Proposed Action, referred to as the Proposed Action in the Final EIS. The Surgery, Radiology and Laboratory Medicine (SRLM) action is for construction of an additional 527,100 gross square feet (gsf) to the exiting Building 10. In addition to 527,100 gsf of space in the new building, the Proposed Action will include renovation of 102,600 gsf of existing space within the West Laboratory Wing of the Clinical Research Center. The footprint of the SRLM will occupy 55,500 gsf. A proposed patient parking garage is also included in the proposed action. The proposed garage will be a multi-level, self-park garage, accommodating approximately 780 cars.

This final rule refines how the Office of Head Start uses deficiencies, Classroom Assessment Scoring System: Pre-K (CLASS[supreg]) scores, and audit findings for designation renewal. It also streamlines and updates the regulatory provisions on designation renewal to make them easier to understand.

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.

This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EVRYSDI (risdiplam), manufactured by Genentech Inc., meets the criteria for a priority review voucher.

The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures.

As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will review the draft 2020 report to the HHS Secretary and Congress and review and approve graphics and images for the report. The 2020 report will address ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, and interventions for individuals with tick- borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.

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 Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to remove the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA's implementation of Executive Orders under which FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

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 Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (``Bright Futures Periodicity Schedule''), as part of the HRSA-supported preventive service guidelines for infants, children, and adolescents, is maintained in part through a national cooperative agreement, the Bright Futures Pediatric Implementation Program.

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 pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.

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 the Agency) has determined the regulatory review period for VYLEESI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant ProgramSummer 2020.'' The purpose of the public meeting is to ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making. To facilitate this, stakeholders including patients, care partners, FDA reviewers, drug developers, as well as other government and academic researchers, health care providers, health technology assessors and health payers are encouraged to attend the meeting.

The Department of Health and Human Services proposes to issue regulations governing the agency's release and maintenance of guidance documents. These regulations would help to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Lead Exposure and Prevention Advisory Committee (LEPAC). This meeting is open to the public by teleconference but advance registration by October 16, 2020 is needed to receive the information to join the meeting. The registration link is https://rossstrategic.zoom.us/webinar/register/WN_QsgX- UlJS02mWW8Kn8SUmg. The public comment period is scheduled on October 30, 2020 from 1:30 p.m. until 1:45 p.m. Individuals wishing to make a comment during the public comment period, please email your name, organization, and phone number by October 16, 2020 to LEPAC@cdc.gov.

Findings of research misconduct have been made against Anil K. Jaiswal, Ph.D. (Respondent), former professor, Department of Pharmacology, University of Maryland at Baltimore, School of Medicine (UMB). Dr. Jaiswal engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA062483 and R01 CA081057; National Institute of Environmental Health Sciences (NIEHS), NIH, grants R01 ES007943, R01 ES012265, and R01 ES021483; and National Institute of General Medical Sciences (NIGMS), NIH, grant R01 GM047466. The administrative actions, including debarment for a period of three (3) years, were implemented beginning on July 21, 2020, and are detailed below.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed Extension without Change and solicits comments on the information collection requirements related to Title III Supplemental Form to Financial Status Report (SF- 425).

The Food and Drug Administration (FDA or Agency) is providing notice of a stay of the effectiveness of provisions for devices in use on specific individuals who have or would need to obtain a physician- directed transition plan as of the date of publication on March 6, 2020, of the final regulation banning electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA is publishing this notification in response to petitions for an administrative stay of action in accordance with regulatory requirements.

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 section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed revision for the information collection requirements related to Evaluation of the Administration for Community Living's American Indian, Alaska Natives and Native Hawaiian Programs (OAA Title VI).

The Food and Drug Administration (FDA, the Agency, or we) is revising its regulations to reflect changes to the Agency's organizational structure, including the reorganization of the Office of Regulatory Affairs (ORA). The revisions update addresses and replace references to the district officials with references to division officials. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and other responsible parties entitled ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff.'' The guidance provides the current thinking of FDA's medical product Centersthe Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Healthregarding civil money penalties that may be assessed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for violations of the requirements to submit clinical trial registration and results information to the ClinicalTrials.gov data bank and certain certifications to FDA.

The Food and Drug Administration (FDA) is proposing to reclassify non-invasive bone growth stimulators, postamendments class III devices (product codes LOF and LPQ), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification with the name ``non-invasive bone growth stimulators'' along with the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these devices will no longer be required to submit a premarket approval application (PMA), but are subject to premarket notification (510(k)) requirements and general and special controls.

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 the information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of July 23, 2020. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.

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. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.

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 Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.'' The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization. The Agency hopes to receive public feedback on how this Integrated Review documentation can continue supporting our stakeholders' needs. Please see information and examples relevant to the Integrated Review at https://wcms-internet.fda.gov/drugs/news- events-human-drugs/integrated-assessment-marketing-applicatio ns- workshop-10302020-10302020.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products to support an indication of treatment of AML, including indications limited to an individual phase of treatment (for example, maintenance, transplantation preparative regimen, etc.). The draft guidance addresses the topics of general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations for AML drug development. In addition, the draft guidance addresses investigational new drug applications, new drug applications, and biologics licensing applications for AML drugs.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Drug Overdose Response Investigation (DORI) Data Collections.'' CDC will use the information collected to respond to urgent requests from state and local health authorities to provide epidemiological information that allows for the selection of interventions to curb local epidemics of drug overdose.

The National Heart, Lung, and Blood Institute, of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive start-up patent license for evaluation to ONK Therapeutics, a start-up company spun-off from the National University of Ireland Galway, and incorporated under the laws of the Republic of Ireland, to practice, for a limited time, the inventions covered by the patent estate listed in the Supplementary Information section of this notice. Upon expiration of the evaluation period the granted licenses may be converted into a fully exclusive patent commercialization license for the term of the last to expire of the patent estate upon the company providing NHLBI with a commercial development plan supporting such a conversion. This notice is intended to apprise the public of a aforementioned license and provide a fifteen (15) day notice period for the objection.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), proposes survey data collection activities as part of the Youth Empowerment IDEAS study.