Department of Health and Human Services 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products.'' This guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This guidance finalizes the draft guidance for industry of the same title issued in June 2018.

The Food and Drug Administration (FDA or Agency) is requesting nominations for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. A nominee may either be self-nominated or nominated by an organization. In addition, FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the TPSAC notify FDA in writing. Nominations will be accepted for either the representative to serve on TPSAC or for the selection group effective with this notice.

In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME or Council) will hold public meetings for the 2020 calendar year (CY). Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https://www.hrsa.gov/advisory- committees/graduate-medical-edu/.

This proposed rule is being issued by the Office of Inspector General (OIG) in conjunction with the Department of Health and Human Services' Regulatory Sprint to Coordinated Care. It proposes to add, on a prospective basis only after a final rule is issued, safe harbor protections under the Federal anti-kickback statute for certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions. It also would add protections under the anti-kickback statute and civil monetary penalty (CMP) law that prohibits inducements offered to patients for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care delivery that squarely meet all safe harbor conditions. The proposed rule would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records (EHR) arrangements, warranties, local transportation, and personal services and management contracts. Further, the proposed rule would add a new safe harbor pursuant to a statutory change set forth in the Bipartisan Budget Act of 2018 (Budget Act of 2018) related to beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis, also pursuant to the Budget Act of 2018.

The Rural Communities Opioid Response ProgramTechnical Assistance (RCORP-TA), program supports rural consortiums and opioid recipients that provide treatment for and prevention of substance use disorder with a focus on opioid use disorder. The TA efforts will enhance the organizational and infrastructural capacity of multi-sector consortiums at the community, county, state, and/or regional levels. The overall goal is the reduction of morbidity and mortality associated with opioid overdoses in high-risk rural communities. The RCORP-TA award recipient provides resources and expertise in support of the execution of the following focus areas: (1) Preventionreducing the occurrence of opioid use disorder (OUD) among new and at-risk users as well as fatal opioid-related overdoses through community and provider education and harm reduction measures including the strategic placement of overdose reversing devices, such as naloxone; (2) treatment implementing or expanding access to evidence-based practices for opioid addiction/OUD treatment such as medication-assisted treatment, including developing strategies to eliminate or reduce treatment costs to uninsured and underinsured patients; and (3) recoveryexpanding peer recovery and treatment options to help people start and stay in recovery. The RCORP-TA initiative is part of a multi-year, opioid focused effort by HRSA that will include: Improving access to and recruitment of new substance use disorder providers; building sustainable treatment resources; increasing the use of telehealth; establishing cross-sector community partnerships; implementing new models of care, including integrated behavioral health; and providing technical assistance.

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) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2020. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.

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 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 Potential Tobacco Product Violations Reporting Form.

The National Toxicology Program (NTP) announces the availability of two draft NTP Technical Reports on toxicology and carcinogenesis studies scheduled for peer review for the following substances: 2-hydroxy-4-methoxybenzophenone and perfluorooctanoic acid. The peer-review meeting will be held by webcast only and available to the public for remote viewing. Registration is required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Coronary, Peripheral, and Neurovascular GuidewiresPerformance Tests and Recommended Labeling.'' This guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature.

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.

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.

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.

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 Application Form and Related Forms for the Operation of the National Death Index. The National Death Index (NDI) is designed to allow NCHS to collect mortality data, to support epidemiological research and to furnish mortality information.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that JYNNEOS, (Smallpox and Monkeypox Vaccine, Live, Non-replicating), manufactured by Bavarian Nordic A/S, meets the criteria for a priority review voucher.

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.

In FY 2019, HRSA provided $788,000 in additional funding to The University of Iowa for the Telehealth Focused Rural Health Research Center and extended the project period for 12 months.

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, parents/ guardians, and community providers at six Head Start programs for case studies that explore case management and coordination of family support services.

The United States National Authority for Containment of Poliovirus (NAC), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), announces the availability of the National Inventory for Poliovirus Containment survey. This survey is designed to collect relevant laboratory inventory data to ensure facilities throughout the United States are in compliance with requirements established in the World Health Organization (WHO) Global Action Plan (GAPIII), as adapted for the WHO Region of the Americas. Per GAPIII, each country is required to complete a national inventory of poliovirus-containing materials, including poliovirus potentially infectious materials (PIM).

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.

This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community Based Linkages (ACICBL) will hold public meetings for the 2020 calendar year (CY). Information about ACICBL, agendas, and materials for these meetings can be found on the ACICBL website at https://www.hrsa.gov/advisory-committees/interdisciplinary-co mmunity- linkages/.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Tuesday, August 20, 2019. The document announced a ``Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1.'' The document was published with the incorrect contact name, phone number, and email address in the FOR FURTHER INFORMATION CONTACT section. This document corrects those errors.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter 14Recall Plan.''

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 Institutes of Health Office of the Director (OD) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ICSH. The ICSH consists of 5 experts in fields that represent private entities involved in informing the public about the health effects of smoking. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of the health effects of smoking. Additionally, desirable qualifications include: (1) Knowledge of emerging tobacco control policies and experience in analyzing, evaluating, and interpreting Federal, State and/or local health or regulatory policy; and/or (2) familiarity and expertise in developing or contributing to the development of policies and/or programs for reducing health disparities in tobacco use in the United States; and/or (3) knowledge of the intersection of behavioral health conditions (mental and/or substance use disorders) and tobacco use/tobacco control. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ICSH objectives https://www.cdc.gov/tobacco/about/icsh/index.htm.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 4, 2019. That notice, withdrawing approval of five abbreviated new drug applications for pemoline products, contained an incorrect website address for an archived web page of a Postmarket Drug Safety Information for Healthcare Professionals communication that FDA issued on October 24, 2005, stating its conclusion that the overall liver toxicity risk of CYLERT (new drug applications 016832 and 017703) and generic pemoline products outweighed the benefits of these products. This document corrects that error.

The National Eye 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 to Opsis Therapeutics, LLC, (``Opsis'') located in Madison Wisconsin and its affiliate, FUJIFILM Cellular Dynamics, Inc.

The ACF, ORR, Division of Refugee Health announces the intent to award three OPDIV-Initiated Supplements in the amount of $67,724 to each of three current grantees providing direct services funded through the Services for Survivors of Torture (SOT) Program.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry.'' The guidance document provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV). The guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. The guidance updates the recommendations related to the use of an appropriate multiantigen supplemental test contained in ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' dated December 2010. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2018.

The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation is requesting public comment on data collection activities as part of the Formative Evaluation of Family Unification Program (FUP) Vouchers for Youth Transitioning Out of Foster Care. The purpose of the request is to conduct information collection activities, including an online survey, interviews, and focus group discussions.

In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Advisory Committee on Infant Mortality (ACIM or the Committee) has been renewed.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (BPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues related to blood and products derived from blood. The committee will discuss scientific considerations for cold stored platelet products intended for transfusion. The meeting will be open to the public.

The Administration for Children and Families (ACF) is requesting a three-year extension of the previously approved forms that include satisfaction surveys; surveys to assess jurisdiction's foundational capacity; a workshop follow-up survey; webinar and online learning registration forms; and service-specific feedback forms and interview protocol (OMB Number: 0970-0494, expiration March 31, 2020). This request includes one new innovation survey, and requests minor changes to the webinar and online learning registration forms. Three instruments from the original approval are not included with this request. This requested extension relates to a second set of instruments, which are part of a larger data collection effort being conducted for the evaluation of the Child Welfare Capacity Building Collaborative. An extension request for the first group of evaluation instruments was submitted on April 24, 2019, (OMB Number: 0970-0484, FR, 84(79)).

Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: https://www.dhhs.gov/ohrp/sachrp- committee/meetings/.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Embedded Research in Care Delivery Systems.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 29, 2019 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document 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 the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry (GFI) #171 entitled ``Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.'' This draft guidance describes how the Agency intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2020. 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 determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug and biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to sponsors of rare pediatric disease product applications that meet all the requirements of this program and are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2020 and outlines the payment procedures for such fees.

The National Institute of Neurological Disorders and Stroke (NINDS) will launch a public information website and host a webinar to enable public discussion regarding NINDS proposal to reorganize the Office of Communications and Public Liaison and Office of Scientific Liaison.

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.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP or Council) has scheduled a public meeting. Information about NACNEP, the agenda, and materials for this meeting can be found on the NACNEP website at https://www.hrsa.gov/advisory- committees/nursing/.

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 final rule reforms Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This final rule also increases the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Additionally, this rule updates fire safety standards for Medicare and Medicaid participating End-Stage Renal Disease (ESRD) facilities by adopting the 2012 edition of the Life Safety Code and the 2012 edition of the Health Care Facilities Code. Finally, this final rule updates the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These requirements are intended to conform to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.'' This guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software.

The ACF, ANA, Division of Program Operations (DPO) intends to award a grant of $106,638 to 500 Sails, Inc. in Saipan, Commonwealth of the Northern Mariana Islands. The purpose of the award is to support restoration of culturally significant sites and a digital storytelling project after the devastating effects of Typhoon Yutu in October, 2018.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Providing Regulatory Submissions for Medical Devices in Electronic FormatSubmissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain presubmissions and submissions for devices be submitted in electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates and issuing a draft guidance on the topic. This guidance is intended to satisfy the draft guidance documents referenced in FDA regulations and the MDUFA IV Commitment Letter. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing a public meeting entitled ``International Council on Harmonisation (ICH) Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials.'' The purpose of the public meeting is to provide information on the draft revised E8(R1) Guideline ``General Considerations for Clinical Trials'' (ICH E8 Guideline) following the closing of the FDA comment period and closing of the regional consultations conducted in other ICH regions. The ICH E8 Guideline is being revised to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.

The Food and Drug Administration is correcting a document entitled ``Modified Risk Tobacco Product Applications for VLN\TM\ King and VLN\TM\ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group, Inc.'' that published in the Federal Register of July 25, 2019. The document announced the availability of modified risk tobacco product applications for public comment. The document published with incorrect submission tracking numbers. This document corrects that error.

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.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 65th full Council meeting in Miami, Florida. Miami-Dade County is one of the counties indicated in Ending the HIV Epidemic: A Plan for America. Agenda items will include an update on HIV and the Latinx Community, Ending the HIV Epidemic in Florida and Puerto Rico, addressing the unique needs in Florida and Puerto Rico, a federal panel to discuss federal efforts and mechanisms to ensure continued community engagement, and a presentation on performance indicators for tracking the Initiative. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is encouraged for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to Caroline Talev, MPA, at Caroline.Talev@hhs.gov. Pre-Registration must be complete by Tuesday, October 15, 2019.

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 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 CDC Fellowship Programs Assessments (OMB Control No. 0920-1163) This data collection is being submitted to assist CDC with quality improvement of CDC fellowship programs.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry (GFI) #263 entitled ``Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.'' This draft guidance document, when finalized, will provide information to sponsors of medically important antimicrobial new animal drug products who are interested in changing the approved marketing status of these products from over-the-counter (OTC) to by veterinary prescription (Rx) consistent with FDA's recommendation that the use of such drugs in animals be limited to uses that include veterinary oversight to mitigate development of antimicrobial resistance. It also will recommend timeframes for stakeholders wishing to comply voluntarily with this guidance.

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 requirements relating to FDA regulations for human tissue intended for transplantation.